Journal articles: 'Weekly financial statistics'

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Adnan Fendi, Usama, Asem Tahtamouni, Yaser Jalghoum, and Suleiman Jamal Mohammad. "The study of bubbles in bitcoin behavior." Banks and Bank Systems 14, no. 4 (December 13, 2019): 133–42. http://dx.doi.org/10.21511/bbs.14(4).2019.13.

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Bitcoin is an online communication system that facilitates the use of virtual currency, including electronic payments. This paper aims at analyzing the behavior of Bitcoin returns as a proposal for future currencies while making a comparison between Bitcoin and other conventional currencies. This paper uses quantitative approach to analyze the time series of Bitcoin and that of other conventional currencies during the period 2010–2018. It uses 1) a descriptive statistics for the weekly returns for Bitcoin which includes the mean, standard deviation, maximum value, minimum value, skewness, kurtosis, and Jarque-Bera normal distribution test statistics, and 2) duration dependence test on Bitcoin weekly returns by extracting the weekly returns for the Bitcoin that behave in irregular way of the general Bitcoin return level through autocorrelation regression, and taking the residuals for this regression as a time series for irregular returns.This paper has confirmed no empirical evidence for the existence of a speculative bubble in the Bitcoin values and returns. In addressing the question of whether Bitcoin can act as a reliable substitute for conventional currencies, the returns based analysis shows a huge difference between the behavior of Bitcoin returns from conventional currency returns when comparing both aspects of level and stability. The paper concluded that bitcoin is more an investment than a currency. This paper represents a significant contribution in the path of financial economics and financial risk management, and represents a contribution to the stability of the financial system around the world and mitigating financial crises.

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Handley, Nathan, Kuang-Yi Wen, Sameh Gomaa, Kelly Jean Brassil, Lindsey Jackson, and Adam P. Dicker. "Exploring the role of digital health coaching for men with prostate cancer." Journal of Clinical Oncology 39, no. 15_suppl (May 20, 2021): TPS1586. http://dx.doi.org/10.1200/jco.2021.39.15_suppl.tps1586.

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TPS1586 Background: Toxicity leading to impaired quality of life is common among men receiving treatment for Prostate Cancer (PCa). Digital interventions may be beneficial in enhancing health self-efficacy in managing symptom burden. This study evaluates the feasibility and preliminary outcomes of digital health coaching intervention on men with PCa. Methods: This pilot study aims to recruit up to 100 adult, English-speaking men with PCa who in the last 2 years have required active treatment, defined as cancer management via active surveillance, surgery, radiation, androgen deprivation, chemotherapy, hormonal therapy, immunotherapy or a combination of these modalities. Men will be enrolled across the catchment area of Jefferson Health using social media and a variety of other outreach tools approved by the Institutional Review Board. Consented patients are enrolled in a 3-month digital health coaching program which combines weekly calls with up to 4 nudges of evidence-based content delivered via text or email weekly. The program focuses on a weekly health topic, such as physical, mental, social, or financial health, and managing symptoms, and empowers participants to set health goals of importance to them. Primary endpoints include feasibility, defined as 60% of participants completing the 3-month program. The main secondary endpoints measured are health self-efficacy as measured by the Cancer Behavior Inventory-Brief (CBI-B), quality of life, as measured by the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), financial toxicity as measured by the Comprehensive Score of Financial Toxicity (COST) and physical and mental health as measured by the Patient Reported Outcomes Measurement Information System-Global Health 10 (PROMIS-10). Outcomes are captured on enrollment and monthly through program completion for a total of 4 data points. Summary statistics will be used to describe patient demographic and clinical characteristics of the study population. Summary statistics will also be used to describe CBI, EPIC-CP, PROMIS and COST by assessment time. The change in CBI-B scores from baseline to 3 months will be calculated along with 95% confidence intervals. Additional LMMs will be created to assess the relationship between self-efficacy (CBI) and quality of life (EPIC-CP), financial toxicity (COST) and global health (PROMIS- SF10).

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Ashraf, Nazia, Mudassar Yasin, Ghulam Farid, Shahbaz Ahmad, and Muhammad Tanveer Khaliq. "The Impact of Socio-economic Characteristics of School Teachers on their Job Performance." Journal of Economic Impact 1, no. 2 (May 2, 2019): 59–63. http://dx.doi.org/10.52223/jei0102194.

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The study underhand is aimed to estimate the impact of socioeconomic characteristics of school teachers on their job performance. The data were collected by using well-structured and pre-tested questionnaire. A sample of 200 respondents from ESTs elementary school female teachers were selected through simple random sampling technique from tehsil Vehari. Descriptive statistics i.e. frequency, percentage and mean values were used to analyze the data. The results showed that the teacher performance was depending on many factors i.e. free accommodation, weekly duty allowances, advance payment from the school in case of financial problem, provision of prizes, provision of free medical care and a satisfactory standard of living. The result also showed that the salary and financial benefits have high impact on teachers’ performance. The results also found significant impact of socioeconomic characteristics on teacher’s performance

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Mudahogora, Edmond Kazungu, and Denis Ndanguza. "Modeling the Rwanda Exchange Rates by GARCH Models." African Journal of Applied Statistics 8, no. 1 (January 1, 2021): 1525–44. http://dx.doi.org/10.16929/ajas/2021.1525.261.

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Volatility modeling and forecasts are essential tools to all financial sectors. This paper focuses on weekly exchange rate returns of the FRW versus USD from 2012 until 2018 obtained from the National Bank of Rwanda. The aim of this paper is to formulate an appropriate GARCH model which fits the data. The GARCH(1,1) model has been selected after using required techniques of model selection.Parameters have been estimated using Least Squares method first and then validated using MCMC method. Once the chain of parameters are found, both visual inspection and basic statistics are computed and in this study, they have illustrated a good compatibility between simulation and observations. Diagnostic of convergence of the chains of parameters has been checked and ensured the model to beaccurate. The results obtained from the LSQ and MCMC methods have been compared and found to be almost similar. An agreement between the model solution and actual data is obtained and a forecast is done by concluding that the estimated values are almost similar to the real data. Hence, the identified model is accepted for forecasting and recommended for further applications.

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Ai-Jalodi, Omar, Matthew Sabo, Keyur Patel, Neal Bullock, Laura Serena, Kristy Breisinger, and Thomas E. Serena. "Efficacy and safety of a porcine peritoneum-derived matrix in diabetic foot ulcer treatment: a pilot study." Journal of Wound Care 30, Sup2 (February 1, 2021): S18—S23. http://dx.doi.org/10.12968/jowc.2021.30.sup2.s18.

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Objective: A third of people with diabetes will develop a foot ulcer during their lifetime. The absence of pain secondary to neuropathy often leads to a delay in diagnosis and treatment. Diabetic foot ulcer (DFU) complications, such as infection and amputation, increase mortality and strain the financial resources of health systems across the world. Cellular and/or tissue products (CTPs) have played an important role in the closure of DFUs. Investigators continue to search for new CTPs that facilitate healing. The aim of this study was to assess the efficacy and safety of a porcine peritoneum-derived matrix in DFU treatment. Method: Patients with longstanding DFUs participated in this institutional review board-approved, multicentre, prospective pilot study evaluating the time to healing over 12 weeks. In addition to weekly assessments for wound size, investigators analysed bacterial burden using the MolecuLight procedure (MLiX) and bacterial protease (BPA) testing. Participants received a weekly application of Meso Wound Matrix Scaffold (MWM), a lyophilised porcine peritoneum-derived matrix (DSM Biomedical Inc., Exton, PA, US) for up to eight weeks. Descriptive statistics were chosen for this analysis. Results: A total of 12 male patients and three female patients with an average age of 57 years were enrolled over a two-month period. The average wound duration was 30 weeks. Due to unrelated health issues, four participants were withdrawn. For the study endpoint of complete wound closure at 12 weeks, six (55%) of the remaining 11 patients achieved complete closure, and four (36%) patients healed during the 8-week treatment period. The average number of CTP applications was six. Patients who healed all had negative BPA by nine weeks and no fluorescence on MLiX, indicating low bacterial load. Conclusion: This small pilot study indicates that patients with longstanding DFUs may respond to a porcine peritoneal-derived CTP. In this study, the CTP appears to have inhibited bacterial growth in the wound; however, further research is needed.

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Chikezie, C., A. Henri-Ukoha, O. B. Ibeagwa, E. U. Nwachukwu, and B. C. Onuoha. "Consumption of liquefied petroleum gas and its determinants: A prospect for indiscriminate tree harvesting in Imo State, Nigeria." Journal of Agriculture and Food Sciences 18, no. 1 (August 17, 2020): 93–104. http://dx.doi.org/10.4314/jafs.v18i1.9.

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The study analysed the consumption of liquefied petroleum gas and its determinants as a prospect for indiscriminate tree harvesting in Imo State, Nigeria. A total number of 96 questionnaires were distributed but only 90 of them were returned. Data collected were analysed using both descriptive and inferential statistics. Result shows that the weekly fuel wood and liquefied petroleum gas consumed by the households in the study area were 514.326MJ (37.27KG) and 65.92MJ (1.43KG) respectively. The result also identified indoor pollution, eye defect and loss of biodiversity with weighted means of 2.64, 3.00 and 2.67 respectively as very serious problems of fuel wood use. Result showed that clean fuels (as well as afforestation), ethanol cook stove, crop residue/animal dung and solar/water energy sources which ranked 1st, 2nd, 3rd and 4th respectively were the major prospects for indiscriminate tree harvesting in the study area. Results also indicated that at 1% levels of significance, price of liquefied petroleum gas, price of kerosene, household expenditure, household size and number of times electricity was available per month were the majordeterminants of liquefied petroleum gas consumption in the study areas. Given the urgency of the clean energy access, the paper recommends that relevant stakeholders should prioritize efforts and financial supports geared toward the alleviation of the problems of indiscriminate tree harvesting. It also advocates for LPG subsidization to encourage more users of the fuel. Keywords: Indiscriminate wood harvesting, loss of bio-diversity, clean energy

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Walker, Gary V., Shervin M. Shirvani, Yerko Borghero, Matthew D. Callister, Daniel D. Chamberlain, Emily J. Grade, Mohamed K. Khan, et al. "Palliation or Prolongation? The Impact of a Peer-Review Intervention on Shortening Radiotherapy Schedules for Bone Metastases." Journal of Oncology Practice 14, no. 8 (August 2018): e513-e516. http://dx.doi.org/10.1200/jop.18.00042.

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Purpose: Shorter fractionation radiation regimens for palliation of bone metastases result in lower financial and social costs for patients and their caregivers and have similar efficacy as longer fractionation schedules, although practice patterns in the United States show poor adoption. We investigated whether prospective peer review can increase use of shorter fractionation schedules. Methods: In June 2016, our practice mandated peer review of total dose and fractionation for all patients receiving palliative treatment during our weekly chart rounds. We used descriptive statistics and Fisher’s exact test to compare lengths of treatment of uncomplicated bone metastases before and after implementation of the peer review process. Results: Between July 2015 and December 2016, a total of 242 palliative treatment courses were delivered, including 105 courses before the peer review intervention and 137 after the intervention. We observed greater adoption of shorter fractionation regimens after the intervention. The use of 8 Gy in one fraction increased from 2.8% to 13.9% of cases postadoption. Likewise, the use of 20 Gy in five fractions increased from 25.7% to 32.8%. The use of 30 Gy in 10 fractions decreased from 55.2% to 47.4% ( P = .002), and the use of ≥ 11 fractions decreased from 16.2% before the intervention to 5.8% after ( P = .006). Conclusion: Prospective peer review of palliative regimens for bone metastases can lead to greater adoption of shorter palliative fractionation schedules in daily practice, in accordance with national guidelines. This simple intervention may therefore benefit patients and their caregivers as well as provide value to the health care system.

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Esposito, Michelle Marie, and Anna King. "New York City: COVID-19 quarantine and crime." Journal of Criminal Psychology 11, no. 3 (May 18, 2021): 203–21. http://dx.doi.org/10.1108/jcp-10-2020-0046.

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Purpose In early 2020, the world faced a rapid life-changing pandemic in the form of the Coronavirus Disease of 2019 (COVID-19) crisis. Citywide lockdowns with stay-at-home orders and mass closings quickly became the “new normal.” With these new mandates, routine activity, mental health and financial securities all began to experience major deviations, and it became clear that this could prove to be rather valuable in providing the opportunity for large-scale criminology experiments. This study aims to explore New York City's (NYC) crime patterns during this unique social situation. Specifically, has crime as a whole increased or decreased, and have particular crimes increased or decreased during these stressful fluid times? Design/methodology/approach The authors briefly review previous crises and worldwide trends but focus on NYC crime as collected by the New York Police Department's statistics unit, “CompStat.” An analysis of 13 crime types from March 30 to July 5 was completed, including percent differences and individual weekly incidence rates in citywide crimes compared to the same time in 2019. Findings The analysis demonstrated that all crimes analyzed, except for murder and burglary, exhibited a statistically significant difference during COVID-19 conditions compared to the same time the previous year. Grand larceny auto and gun violence crimes significantly increased during COVID-19 weeks, whereas rape, other sex crimes, robbery, felony assault, grand larceny, transit, housing, misdemeanor assault and petit larceny all significantly decreased. Originality/value Due to the ongoing nature of the pandemic, this is amongst the first studies to examine trends in NYC crime during pandemic mandates. Expanding our knowledge in these situations can inform natural disaster responses, as well as criminal justice policy and practice to better protect the public in future crises.

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Van de Winckel, Ann, Tanjila Nawshin, and Casey Byron. "Combining a Hudl App With Telehealth to Increase Home Exercise Program Adherence in People With Chronic Diseases Experiencing Financial Distress: Randomized Controlled Trial." JMIR Formative Research 5, no. 3 (March 18, 2021): e22659. http://dx.doi.org/10.2196/22659.

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Background Patients with chronic diseases often need to adhere to long-term individualized home exercise programs (HEPs). Limited adherence to long-term exercise given during physical therapy (PT) visits reduces the capacity of exercise to manage or improve symptoms related to chronic disease. In addition, a lower socioeconomic status negatively impacts exercise adherence. To mitigate this, apps that motivate people to exercise could be a viable option. Using an app through telehealth may help adults with chronic diseases to achieve long-term HEP adherence. However, because apps for rehabilitation are an emerging field, the feasibility of the app needs to be evaluated. Objective To address HEP adherence in participants with chronic diseases who are experiencing financial distress, we aim to evaluate the feasibility of and satisfaction with the Hudl Technique app and telehealth and satisfaction with PT care and to monitor HEP adherence and compliance (ie, percentage of participant-recorded videos sent) in participants using the app with telehealth compared with those using standard HEPs on paper. Methods We recruited patients scheduled for outpatient PT. We performed a randomized controlled trial in which the experimental group received weekly HEP demonstrations through app videos on a tablet with feedback on their self-recorded HEP video performance from the telehealth physical therapist. The control group received HEPs on paper without feedback, as is customary in PT practice. Demographic, clinical, and health coverage information was collected for screening and baseline measurements. Adherence and compliance were evaluated. Both groups completed surveys at 8 and 24 weeks on their satisfaction with PT care, and the experimental group also completed a survey on their satisfaction with the app with telehealth use. Descriptive and nonparametric statistics were used for within-group and between-group comparisons and analyzed with JMP, version 13. Results Overall, 45 adults with chronic diseases who were experiencing financial distress were randomized into experimental (23/45, 51%) and control (22/45, 49%) groups, with 74% (17/23) and 86% (19/22) participants completing the 24-week HEP, respectively. The experimental group had an HEP adherence frequency of 4 (SD 2) to 5 (SD 2) times per week at 8 and 24 weeks (P=.14), whereas HEP adherence decreased in the control group from 4 (SD 2) to 3 (SD 2) times per week (P=.07), with a significant difference (P=.01) between groups at 24 weeks. Of the total participants, 68% (15/22) sent videos. They sent 68% (16/24) of the requested number of videos on average. The average score for PT care satisfaction was maintained at 87% in the experimental group (P=.99), whereas it decreased from 89% at 8 weeks to 74% at 24 weeks (P=.008) in the control group. App-related adverse events were not observed. Conclusions The Hudl app/telehealth platform is feasible for delivering HEPs and maintaining HEP adherence in participants with chronic diseases who are experiencing financial distress. Trial Registration ClinicalTrials.gov NCT02659280; https://clinicaltrials.gov/ct2/show/NCT02659280

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Lee, Cheng-Wen, and Dolgion Gankhuyag. "Portfolio Optimization in Post Financial Crisis of 2008-2009 in the Mongolian Stock Exchange." Jurnal METRIS 21, no. 01 (June 1, 2020): 47–58. http://dx.doi.org/10.25170/metris.v21i01.2432.

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In this study, we present the Mongolian stock market’s performance post phenomenal financial crisis of 2008-2009, opportunities to invest and the risks problems. For analysis of the study, we used financial portfolio optimization models with restricted structure, mathematical statistic methods and financial methods. First, we considered about portfolio optimization in the Mongolian Stock Exchange using Markowitz’s modern portfolio theory and Telser’s safety first model. We used MSE weekly trading data chosen 50 most traded stocks out of 237 stocks listed at the MSE between 2009 and 2013. We generated 50 weeks mean-variance portfolio and safety first portfolio for 2014 and discussed. We considered weekly investment in the MSE using mean-variance portfolio andsafety first portfolio. The mean-variance portfolio has the best performance of weekly portfolio return with average weekly return and cumulative return. We found stable portfolio against investing risk and did back-test the result. For prospect investors in the MSE, we suggest invest and earn high return in the MSE.

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Spindler, K. G., D. Olsen, I. Brandslund, and A. Jakobsen. "Treatment related changes of the serum epidermal growth factor receptor in advanced colorectal cancer." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e22096-e22096. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e22096.

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e22096 Background: The epidermal growth factor receptor (EGFR) is an established target for therapy in colorectal cancer. The extracellular domain of the receptor is shed into circulation and detectable by ELISA. We investigated the changes in sEGFR levels during preoperative chemoradiation (CRT) in rectal cancer patients and third-line treatment with cetuximab and irinotecan (CETIRI) in advanced disease, to elucidate the predictive or prognostic value in these settings. Methods: We included 126 healthy controls and 118 patients with chemorefractory mCRC treated with cetuximab (initial 400/m2 mg followed by weekly 250mg/m2) and irinotecan (350 mg/m2 q3w). Response was evaluated according to RECIST. Furthermore, 114 patients with locally advanced rectal tumours were treated with CRT (60 Gy/30 fractions and concomitant uftoral (300 mg/m2)/leukovorin (22.5 mg) on treatment days, followed by surgery 8 weeks post-treatment and pathological tumour regression evaluation. Pre-treatment and consecutive samples were drawn at each visit. sEGFR was measured by ELISA. Median statistics and Kaplain-Mayer curves with log-rank testing for comparison of survival rates were performed. Results: There were significant differences between the median pre-treatment sEGFR levels in controls, rectal cancer and mCRC (58 ng/ml(56–59 95% C-I), 53 ng/ml(51–55 95% C-I) and 51 ng/ml(49–53 95% C-I), respectively, p<0.000). We detected a rapid increase in sEGFR by the first on- treatment values during CETIRI (p<0.001), and a correlation between the magnitude of increase and a higher degree of skin toxicity, a well known indicator of clinical benefit to EGFR inhibitors. sEGFR in rectal cancer patients displayed a decreasing tendency during CRT (p<0.001), but no correlation to local tumour response. Patients with baseline pre-treatment level > 43.4 ng/ml (mean sEGFR of control group-2xSD) had a significantly higher OS rate than patients with low baseline levels (93% and 59% respectively, HR 0.15, P=0.002). Conclusions: We report a rapid increase in sEGFR by the onset of CETIRI, which may indicate development of skin toxicity and thereby a better change of response. Furthermore, we suggest a potential prognostic value of sEGFR measurement during CRT in locally advanced rectal cancer. No significant financial relationships to disclose.

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Hanis Aminuddin, Nurul, Ruzanna Ab Razak, and Noriszura Ismail. "Dependence Measure of Daily versus Weekly Returns." International Journal of Engineering & Technology 7, no. 3.20 (September 1, 2018): 329. http://dx.doi.org/10.14419/ijet.v7i3.20.19268.

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The copula method has been popular among researchers, especially in measuring the overall dependence and extreme dependence of multivariate data. Many copula studies have been focusing on examining the correlation of bivariate daily, monthly or weekly returns to explain the co-movement between financial markets and possible financial implications on portfolio management. Differently from past studies, this paper investigates whether different frequency of bivariate data (daily and weekly returns) possesses different dependence structures. The data from Kuala Lumpur Composite Index (KLCI) and Bursa Malaysia Hijrah Shariah Index (FBMHS) for the sample period of 2008 Q1 to 2017 Q1 are used for studying the dependency. The findings from this study reveal that both daily and weekly bivariate returns have the same dependence structure but different degree of dependence. Bivariate weekly returns showed stronger dependence compared to bivariate daily returns. This paper also highlights the statistical properties of weekly and daily data. The evidence from this research draws inferences for further study that lower frequency data such as monthly or quarterly returns data may have higher degree of dependence while higher frequency data may have lower degree of dependence and different copula structure.

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YANG, CHUNXIA, HONGFA WU, and YINGCHAO ZHANG. "PERIODIC COMPONENTS AND CHARACTERISTIC TIME SCALES IN THE FINANCIAL MARKET." Modern Physics Letters B 22, no. 26 (October 20, 2008): 2571–78. http://dx.doi.org/10.1142/s0217984908017151.

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Based on six large empirical data sets, the financial data sequences are decomposed by Empirical Mode Decomposition (EMD) into various quasi-periodic fluctuation modes, including weekly, half-month, seasonal, about-four-years and so on, which may indicate some abnormal return oscillation patterns. The corresponding average periods are calculated by Fast Fourier Transform Algorithm (FFT), about 6 days for the weekly, about 10 days for the half-month, about 60 days for the seasonal and 1020 days or so for the about-four-years. These obtained results show that the mode periods may be universal for different markets.

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Brotman, Billie Ann. "San Francisco: rental restrictions and pre-restriction host listing motivation." Journal of Property Investment & Finance 38, no. 2 (March 21, 2020): 147–55. http://dx.doi.org/10.1108/jpif-09-2019-0128.

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PurposeSan Francisco started regulating short-term vacation rentals on rooms/apartments/houses located within city limits in September 2019. The objectives of this conceptual-scenario and regression study are to calculate the present value of the net earnings for a short-term residential rental property located in San Francisco pre-regulation and post-regulation, and consider a financial reason motivating households to list properties as short-term rentals.Design/methodology/approachA present value approach is used to estimate the value of rental space to tourists prior to the passage of San Francisco's short-term rental regulations compared to post-rental rules. Table 2 shows pre- and post-income scenarios. Price increases of +20, +40 and +60 percent over the initial base rate failed to restore host earnings to pre-registration levels. The present value model calculates the net revenue less net cost associated with listing a property. The regression model uses the number of listings as the dependent variable, and housing prices divided by weekly wages as independent variables.FindingsThe short-term rental regulations significantly reduce the profitability associated with short-term tourist stays offered by hosts and listed by online platforms. A host earns pre-regulation income when average daily rents increase by approximately 71.5 percent. It will likely limit income earned by hosts and Airbnb and other shared housing website platforms due to the reduced number of rental days allowed for shared housing caused by ordinances and host enrollment restrictions. The regression model results suggest that homeowners were listing properties for rent to help cover higher priced property purchases.Research limitations/implicationsAirbnb, VRBO, Booking.com, and HomeAway are all private companies; this means that financial information is not publicly available. HomeAway, VRBO, and Booking.com are companies owned by Expedia. FlipKey is owned by TripAdvisor. Due to limited public information regarding income statements and property listing trends, regression analysis and descriptive statistics cannot be generated using audited financial statements.Practical implicationsRent control restriction frequently sets the maximum price below the market-clearing price, which results in limited supply but increase in demand for housing. The San Francisco regulations outlaw second-home rentals and seriously limit the availability of other rentals to tourists. FlipKey and HomeAway tend to rent second homes, which San Francisco now bars from being rented for short-term.Social implicationsThe San Francisco restrictions were enacted with the goal of increasing the supply of rental housing available to permanent residents by restricting short-term rentals. This may have limited short-term benefits to permanent residents, but in the long term lowers income associated with single-family housing which will encourage housing arrangements that would avoid leasing restrictions and lower the number of new houses built. Other cities also have a history of rent controls, and are experiencing housing shortages and at the same time attracting large numbers of tourists. These cities may be motivated to enact similar rental restrictions as those approved in San Francisco.Originality/valueThese short-term rental restrictions just started being implemented and enforced. A court decision upheld them. There were media reports outlining the restrictions, but enforcement has just started, so no research papers have been written about San Francisco. Prior research studies have not used net present value analysis to calculate the loss to the host by enacted ordinances restricting tourists’ length of stay and have neither tried to explain why homeowners are listing properties for short-term rentals.

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Halyard, M. Y., T. M. Pisansky, L. J. Solin, L. B. Marks, L. J. Pierce, A. Dueck, and E. A. Perez. "Adjuvant radiotherapy (RT) and trastuzumab in stage I-IIA breast cancer: Toxicity data from North Central Cancer Treatment Group Phase III trial N9831." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 523. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.523.

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523 Background: Adjuvant trastuzumab (Herceptin [H]) with chemotherapy improves outcome in HER2+ breast cancer (BC). Preclinical studies suggest H may enhance RT. We herein assess if H given with adjuvant RT increases adverse events (AE) after breast conserving surgery or mastectomy. Methods: N9831 randomized 3505 women with pT1–3N1–2M0, pT2–3N0M0, or pT1cN0M0 (ER/PR negative) HER2+ BC to doxorubicin (A) and cyclophosphamide (C) followed by weekly paclitaxel (T), AC→T→H, or AC→TH→H. Post-lumpectomy breast ± nodal RT was recommended, as was post-mastectomy chest wall + nodal RT (>3 nodes +); internal mammary RT was prohibited. RT started within 5 weeks of completion of T and allowed concurrently with H. 2324 eligible patients were enrolled on study prior to April 25, 2004: 1460 patients receiving RT are available for analysis of RT-associated AEs. Also, 1286 patients on +H arms who completed T (908 +RT and 378 -RT) are available for analysis of clinical cardiac events (CE). Rates of RT-associated AEs were compared across treatment arms, and rates of CE were compared for +RT vs -RT patients within +H arms. All reported p-values are for chi-squared statistics. Results: With a median follow-up of 1.5 years, significant differences among arms in RT-associated AEs were not identified. No significant differences across arms in +RT patients existed in the incidence of skin reaction (p=0.78), pneumonitis (p=0.78), dyspnea (p=0.87), cough (p=0.54), esophageal dysphagia (p=0.26), or neutropenia (p=0.16). There was a significant difference in +RT patients in the incidence of leukopenia (p=0.02) with higher incidence rates in the arms receiving H. RT did not increase the frequency of CE. In the AC→T→H arm, the incidence of CE was 2.2% in +RT patients versus 2.9% in -RT patients. In the AC→TH→H arm, the incidence of CE was 1.5% in +RT patients versus 6.3% in -RT patients. No difference in CE was seen between left- and right-sided RT fields in +RT patients in either +H arm. Conclusion: Concurrent administration of adjuvant RT with H in early stage breast cancer patients is not associated with an increased incidence of acute RT AEs. Further follow-up is required to assess late AEs. No significant financial relationships to disclose.

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Petrucci, Maria Teresa, Xavier Leleu, Charalampia Kyriakou, Isabelle Vande Broek, Philip T. Murphy, Philip Lewis, Pamela Bacon, Benoit Arnould, and Manfred Welslau. "Continued Treatment Duration, Drug dosing and Health-Related Quality Of Life (HRQoL) Of Patients With Relapsed/Refractory Multiple Myeloma (RRMM) Receiving 2nd and 3rd Line Treatments: Results From a European Multicentre Study." Blood 122, no. 21 (November 15, 2013): 5368. http://dx.doi.org/10.1182/blood.v122.21.5368.5368.

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Abstract Introduction The use of novel therapeutic agents has significantly improved both progression-free and overall survival in multiple myeloma (MM) patients. In this context, evaluating health-related quality of life (HRQoL) gains in importance. The objective of this analysis is to explore patients’ HRQoL associated with 2nd and 3rdline treatments for Relapsed/Refractory MM (RRMM) and to compare HRQoL in those patients that completed 6 months of treatment vs. patients who discontinued from the study earlier. Methods A multicenter observational study is being conducted in 34 sites in Italy, Germany, France, UK, Ireland and Belgium in RRMM patients starting 2nd or 3rd line bortezomib- or lenalidomide-based treatment. HRQoL and symptoms of patients are assessed at baseline, month 3, and month 6 or discontinuation visit using two EORTC questionnaires: 1) Quality-of-Life Core Questionnaire (QLQ-C30) including 15 domains (Global Health Status/QoL, Physical, Role, Emotional, Cognitive and Social Functioning; Fatigue, Nausea and Vomiting, Pain, Dyspnea, Insomnia, Appetite Loss, Constipation, Diarrhea and Financial Difficulties); 2) and QLQ-Multiple Myeloma (QLQ-MY20) including four domains (Disease Symptoms, Side Effects of Treatment, Body Image and Future Perspective). All EORTC scores range 0-100. Higher HRQoL scores indicate better HRQoL, higher symptom scores indicate worse symptoms. Descriptive statistics and paired t-tests were used in this interim analysis to evaluate changes in scores from baseline. Results As of June 2013, 206 patients (mean age: 69; 51% male) were enrolled in the study and included in this interim analysis. The average time since diagnosis was 3.4 years, with 90% of patients starting 2nd line and 10% starting 3rdline treatment. Overall, EORTC questionnaires were completed by 197, 130, 84 and 34 patients at baseline, month 3, month 6 and discontinuation, respectively. A total of 84 patients received bortezomib and 117 received lenalidomide. Out of 84 bortezomib patients, 54 had already completed their final visit, split about evenly between month 6 (29 patients) and early discontinuation (25 patients, 46%). Out of 117 lenalidomide patients, 64 had completed their final visit assessment, 55 with continued treatment until month 6 and nine patients discontinuing earlier (14%). A substantial and often clinically meaningful decline in HRQoL (Minimal Important Difference, MID > 6, based on 1 standard error measurement, SEM, as calculated from study patients’ baseline QoL), was observed within the patient group discontinuing treatment (see Table 1). The average dosage of lenalidomide treatment was 17.0 mg/day. Bortezomib patients received vial injections at an average of 1.2 mg/m2/day, close to the pre-specified starting dose of 1.3 mg/m2/day. Bortezomib patients who discontinued early had an average number of 3.2 vials per cycle (closer to bi-weekly dosing) and continuers up to month 6 an average of 2.3 vials per cycle, closer to weekly dosing. Conclusions First results of this multicenter observational study show a strong association between treatment discontinuation and HRQoL in RRMM. While HRQoL is maintained in patients who pursue treatment, early treatment discontinuation is significantly associated with worsened HRQoL. Higher discontinuation rates were observed amongst bortezomib treated patients as compared to lenalidomide treated patients. A direct comparison by treatment group will be performed when final data is available. Disclosures: Petrucci: Celgene: Consultancy, Honoraria; Janssen-Cilag: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria. Leleu:Janssen: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Onyx: Consultancy, Honoraria; Leopharma: Consultancy, Honoraria; Millennium : Honoraria; Amgen: Honoraria; Novartis: Honoraria. Lewis:Celgene GmbH : Employment, Equity Ownership. Bacon:Celgene International : Employment, Equity Ownership. Arnould:Celgene: Consultancy. Welslau:Celgene: Membership on an entity’s Board of Directors or advisory committees; Janssen: Membership on an entity’s Board of Directors or advisory committees.

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Handika, Rangga, and Dony Abdul Chalid. "The predictive power of log-likelihood of GARCH volatility." Review of Accounting and Finance 17, no. 4 (November 12, 2018): 482–97. http://dx.doi.org/10.1108/raf-01-2017-0006.

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Purpose This paper aims to investigate whether the best statistical model also corresponds to the best empirical performance in the volatility modeling of financialized commodity markets. Design/methodology/approach The authors use various p and q values in Value-at-Risk (VaR) GARCH(p, q) estimation and perform backtesting at different confidence levels, different out-of-sample periods and different data frequencies for eight financialized commodities. Findings They find that the best fitted GARCH(p,q) model tends to generate the best empirical performance for most financialized commodities. Their findings are consistent at different confidence levels and different out-of-sample periods. However, the strong results occur for both daily and weekly returns series. They obtain weak results for the monthly series. Research limitations/implications Their research method is limited to the GARCH(p,q) model and the eight discussed financialized commodities. Practical implications They conclude that they should continue to rely on the log-likelihood statistical criteria for choosing a GARCH(p,q) model in financialized commodity markets for daily and weekly forecasting horizons. Social implications The log-likelihood statistical criterion has strong predictive power in GARCH high-frequency data series (daily and weekly). This finding justifies the importance of using statistical criterion in financial market modeling. Originality/value First, this paper investigates whether the best statistical model corresponds to the best empirical performance. Second, this paper provides an indirect test for evaluating the accuracy of volatility modeling by using the VaR approach.

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Střelec, Luboš. "Searching for long memory effects in time series of central Europe stock market indices." Acta Universitatis Agriculturae et Silviculturae Mendelianae Brunensis 56, no. 3 (2008): 187–200. http://dx.doi.org/10.11118/actaun200856030187.

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This article deals with one of the important parts of applying chaos theory to financial and capital markets – namely searching for long memory effects in time series of financial instruments. Source data are daily closing prices of Central Europe stock market indices – Bratislava stock index (SAX), Budapest stock index (BUX), Prague stock index (PX) and Vienna stock index (ATX) – in the period from January 1998 to September 2007. For analysed data R/S analysis is used to calculate the Hurst exponent. On the basis of the Hurst exponent is characterized formation and behaviour of analysed financial time series. Computed Hurst exponent is also statistical compared with his expected value signalling independent process. It is also operated with 5-day returns (i.e. weekly returns) for the purposes of comparison and identification nonperiodic cycles.

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Bărbulescu, Alina, and Cristian Ștefan Dumitriu. "On the Connection between the GEP Performances and the Time Series Properties." Mathematics 9, no. 16 (August 5, 2021): 1853. http://dx.doi.org/10.3390/math9161853.

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Artificial intelligence (AI) methods are interesting alternatives to classical approaches for modeling financial time series since they relax the assumptions imposed on the data generating process by the parametric models and do not impose any constraint on the model’s functional form. Even if many studies employed these techniques for modeling financial time series, the connection of the models’ performances with the statistical characteristics of the data series has not yet been investigated. Therefore, this research aims to study the performances of Gene Expression Programming (GEP) for modeling monthly and weekly financial series that present trend and/or seasonality and after the removal of each component. It is shown that series normality and homoskedasticity do not influence the models’ quality. The trend removal increases the models’ performance, whereas the seasonality elimination results in diminishing the goodness of fit. Comparisons with ARIMA models built are also provided.

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Nwohiri, A. M., and F. T. Sonubi. "Deploying data mining techniques to gain deeper insight into Nigerian customers' financial activities." Nigerian Journal of Technology 39, no. 2 (July 16, 2020): 553–61. http://dx.doi.org/10.4314/njt.v39i2.26.

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Presently, Nigerian banks issue account statements in a tabular flat form. These statements mainly show basic logs of credit and debit transactions. They do not offer a deeper insight into the pure nature of transactions. Moreover, they lack rich mine-able data, and rather contain basic data tables that do not provide enough insights into customers' monthly/weekly/yearly expenses and earnings. In today’s fast-paced digital world, where information processing methods are rapidly changing, customers need not just a basic table of transactions but deeper analysis and detail report of their finances. This paper aims at identifying and addressing these problems by deploying data mining techniques and practices in building an application that helps customers gain a deeper insight and understanding of their spending and earnings over a particular period. Some of the techniques used are classification, statistical analysis, visualization, report generation and summarization. Keywords: Data mining, API, Anomaly Detection, GTBank, CBN, Bank statements, Nigeria

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Miyazaki, Takashi. "Clarifying the Response of Gold Return to Financial Indicators: An Empirical Comparative Analysis Using Ordinary Least Squares, Robust and Quantile Regressions." Journal of Risk and Financial Management 12, no. 1 (February 14, 2019): 33. http://dx.doi.org/10.3390/jrfm12010033.

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In this study, I apply a quantile regression model to investigate how gold returns respond to changes in various financial indicators. The model quantifies the asymmetric response of gold return in the tails of the distribution based on weekly data over the past 30 years. I conducted a statistical test that allows for multiple structural changes and find that the relationship between gold return and some key financial indicators changed three times throughout the sample period. According to my empirical analysis of the whole sample period, I find that: (1) the gold return rises significantly if stock returns fall sharply; (2) it rises as the stock market volatility increases; (3) it also rises when general financial market conditions tighten; (4) gold and crude oil prices generally move toward the same direction; and (5) gold and the US dollar have an almost constant negative correlation. Looking at each sample period, (1) and (2) are remarkable in the period covering the global financial crisis (GFC), suggesting that investors divested from stocks as a risky asset. On the other hand, (3) is a phenomenon observed during the sample period after the GFC, suggesting that it reflects investors’ behavior of flight to quality.

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Sabetti, Leonard, David T. Jacho-Chávez, Robert Petrunia, and Marcel C. Voia. "Tail Risk in a Retail Payments System." Jahrbücher für Nationalökonomie und Statistik 238, no. 3-4 (July 26, 2018): 353–69. http://dx.doi.org/10.1515/jbnst-2018-0024.

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Abstract In this paper, we study a credit risk (collateral) management scheme for the Canadian retail payment system designed to cover the exposure of a defaulting member. We estimate ex ante the size of a collateral pool large enough to cover exposure for a historical worst-case default scenario. The parameters of the distribution of the maxima are estimated using two main statistical approaches based on extreme value models: Block-Maxima for different window lengths (daily, weekly and monthly) and Peak-over-Threshold. Our statistical model implies that the largest daily net debit position across participants exceeds roughly $1.5 billion once a year. Despite relying on extreme-value theory, the out of sample forecasts may still underestimate an actual exposure given the absence of observed data on defaults and financial stress in Canada. Our results are informative for optimal collateral management and system design of pre-funded retail-payment schemes.

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Lenka, Sanjaya Kumar, and Rajesh Barik. "A discourse analysis of financial inclusion: post-liberalization mapping in rural and urban India." Journal of Financial Economic Policy 10, no. 3 (August 6, 2018): 406–25. http://dx.doi.org/10.1108/jfep-11-2015-0065.

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Purpose The purpose of this study is to measure the availability, accessibility and usability of financial products and services in both rural and urban India from 1991 to 2014. Design/methodology/approach This paper uses principal component analysis (PCA) method to construct financial inclusion index that serves as a proxy variable for indicating the inclusiveness of financial products and services among the rural and urban people. To fulfill this objective, the study proposes separate indexes of financial inclusion for both rural and urban India from 1991 to 2014. The paper uses annual time series data from 1991 to 2014 to construct the rural-urban financial inclusion index. The used data have been collected from the basic statistical returns of Reserve Bank of India and Economic Political Weekly research foundation. Findings The study inferences that though there is a remarkable increase in financial inclusion in India from 1991 onwards, it does not result in sizeable growth of financial access to rural masses in comparison to urban masses. The rural India does not substantiate an equivalent growth to that of urban India, contrasting a perceptible increase in financial inclusion. The finding of this study will help the researchers and policymakers to understand the status of financial inclusion in the context of both rural and urban India. Furthermore, policymakers can take appropriate policy initiatives to fulfill the financial inclusion gap that exists between rural and urban people. Additionally, the proposed index is easy to compute and can be used to make comparison across countries for further studies. Originality/value The present paper attempts to include all possible dimensions (and indicators within a dimension) that have been considered so far by various authors. Therefore, the authors hope that this index will be more indicative and accurate than previous index. Again, the authors propose to use PCA for the first time to assign the weight of factors in the financial inclusion index for rural and urban India separately.

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Bouillet, T., D. Nizri, A. Zawadi, D. Herman, D. Cupissol, H. Demaux, E. Touboul, J. Cretin, and J. F. Morere. "A randomized phase II study of concomitant CT (docetaxel±cisplatin) and (RT) in first-line treatment of locally advanced head and neck cancer (LAHNC)." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 6047. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.6047.

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6047 Background: 4 randomized trials demonstrated superiority of concomitant CT and radiotherapy (CRT) versus RT. Radiosensitizing effect of docetaxel showed in vitro, phase I recommended docetaxel dose as weekly 20 mg/m2 with concomitant RT. Methods: (pts) with inoperable LAHNC (T3/T4); PS < 2.RT in both arms was 70 Gy. In arm A, pts received 7 cycles of weekly Docetaxel 20 mg/m2 before RT and cisplatin 20 mg/m2 D1–3 every three weeks (3 cycles). In arm B, docetaxel alone at the same dose as in arm A.G-CSF secondary prophylaxis and ciprofloxacin recommended in both arms. Primary objective was WHO objective response rate (ORR). Statistical analysis: 2 steps according to a Simon plan authorized early interruption in case of insufficient efficacy. Results: 82 pts treated (Arms A/B:35/47); Arm A stopped in the first step. 47 pts treated in arm B. M/F (%) (83/17), median age 56.6 y, PS 0/1 (%) 54/46, T2/T3/T4 (%) 2/36/62, N0–1/N2/N3 (%) 30/55/15, primary site (%): buccal cavity (38), hypo-oropharynx (47), larynx (11). Median nbr of cycles 7 (3–7), 85% of pts completed planned CRT. ITT ORR: 89 % [75–96], median TTP 31.3 [19.3 –42.4], median OS 36.8 [21.2–49.5] months. Main grade 3–4 toxicities were mucositis (31.9%),skin toxicity (21.3%). Grade 3–4 hematological, GI and neurological toxicities were not observed. Conclusions: In this study, concomitant RT and weekly 20 mg/m2 docetaxel is effective and well tolerated in LAHNC. The docetaxel/cisplatin arm was prematurely discontinued for insufficient efficacy. No significant financial relationships to disclose.

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Bollina, R., G. Beretta, P. Belloni, D. Toniolo, C. Cozzi, S. Brigida, and G. A. Beretta. "Choice of chemotherapy (CT) for advanced/metastatic lung carcinoma, WHO types I - III - IV (NSCLC)." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 17132. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.17132.

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17132 For NSCLC optimal CT has not been established so far, while many equivalent moderately active schemes are used. The present 40-month study randomized 71 consecutively accrued patients (pts) with parametrable disease between platinum(P)-based three-weekly combinations and non-P monoCT (weekly gemcitabine, vinorelbine or taxane). 68 evaluable pts characteristic were well balanced between treatments: median age 67 years (r. 40–82y), median P Status < 2 WHO scale (r. 0–2),male predominant 82.3%, ratio of IIIb/IV = 1.34 and squamous/non squamous histotype = 1.19, pathologies 26% (only mild to moderate, not contraindicating CT). Objective/subjective response (RECIST/MILAN criteria, JNCI 92:180; P.ASCO 19:642a) after poliCT (PCT) or monoCT (MCT) are reported in the descriptive table . Tolerance was good for both treatment, MCT resulting less deeply toxic and more easily accepted by the majority of pts. This study is still ongoing to achieve the total pts accrual in order to explore statistical significant in the principal determinant subgroup, to determine the subjective response to CT, and to confirm a possible difference in survival. The role of a programmed second line CT vs supportive care alone, and the impact of adding new biomolecular therapies (combined with CT) are the short-term challenges of the second part of this prospective study for advanced NSCLC. [Table: see text] No significant financial relationships to disclose.

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Saroha, S., S. Litwin, and M. von Mehren. "Retrospective review of treatment for angiosarcoma at Fox Chase Cancer Center over the past 15 years." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 10034. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.10034.

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10034 Background: Angiosarcoma is a rare vascular neoplasm that may arise in a variety of anatomic locations. There is limited published data on chemotherapy treatment in angiosarcoma and data on taxane therapy does not utilize contemporary schedules. We present a retrospective analysis of our institution's experience with angiosarcoma over the past 15 years. We reviewed patient characteristics, overall survival and response to various chemotherapeutic agents. We specifically compared the response to weekly paclitaxel with all other chemotherapeutic agents used over the study period. Methods: Medical records of all the patients treated with the diagnosis of angiosarcoma at Fox Chase Cancer Center between January 1990 and June 2005 were reviewed. Overall survival was determined by the Kaplan-Meier method. Response to chemotherapy was determined at two-month follow-up after starting treatment. Clinician judgment was used to define response for superficial lesions. We compared the response to weekly paclitaxel with all other chemotherapy regimens using Fisher's exact test. p <0.10 was considered significant. Results: A total of 39 patients were identified. Most common sites for angiosarcoma were head and neck (including scalp) and breast. Median overall survival was 21 months. Since many patients received several lines of chemotherapy, 40 chemotherapy administrations were identified for analysis. 10 of 13 patients showed response to weekly paclitaxel versus 14 of 27 for non-paclitaxel regimens, which was not statistically significant by Fisher's exact test (2-tail, p=0.18). We also analyzed the response with respect to different anatomic locations of angiosarcoma and individual chemotherapy regimens used, however the numbers were too small for statistical comparisons. Conclusions: Angiosarcoma is an aggressive malignancy with poor survival rates. Our study demonstrated that paclitaxel has efficacy in angiosarcoma, although not statistically superior to non-taxane containing regimens. No significant financial relationships to disclose.

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Dueker, Jeffrey M., Jacob Luty, D. Alexander Perry, Seiko Izumi, Erik K. Fromme, and Matthew DiVeronica. "A Resident-Led Initiative to Increase Documentation of Surrogate Decision Makers for Hospitalized Patients." Journal of Graduate Medical Education 11, no. 3 (June 1, 2019): 295–300. http://dx.doi.org/10.4300/jgme-d-18-00812.1.

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ABSTRACT Background Identification of surrogate decision makers (SDMs) is an important part of advance care planning for hospitalized patients. Despite its importance, the best methods for engaging residents to sustainably improve SDM documentation have not been identified. Objective We implemented a hospital-wide quality improvement initiative to increase identification and documentation of SDMs in the electronic health record (EHR) for hospitalized patients, utilizing a Housestaff Quality and Safety Council (HQSC). Methods EHR documentation of SDMs for all adult patients admitted to a tertiary academic hospital, excluding psychiatry, were tracked and grouped by specialty in a weekly run chart during the intervention period (July 2015 through April 2016). This also continued postintervention. Interventions included educational outreach for residents, monthly plan-do-study-act cycles based on performance feedback, and a financial incentive of a one-time payment of 0.75% of a resident's salary put into the retirement account of each resident, contingent on meeting an SDM documentation target. Comparisons were made using statistical process control and chi-square tests. Results At baseline, SDMs were documented for 11.1% of hospitalized adults. The intervention period included 9146 eligible admissions. Hospital-wide SDM documentation increased significantly and peaked near the financial incentive deadline at 48% (196 of 407 admissions, P < 001). Postintervention, hospital-wide SDM documentation declined to 30% (134 of 446 admissions, P < .001), but remained stable. Conclusions This resident-led intervention sustainably increased documentation of SDMs, despite a decline from peak rates after the financial incentive period and notable differences in performance patterns by specialty admitting service.

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Butler, M. B., H. Gu, T. Kenney, and S. G. Campbell. "P017: Does a busy day predict another busy day? A time-series analysis of multi-centre emergency department volumes." CJEM 18, S1 (May 2016): S83—S84. http://dx.doi.org/10.1017/cem.2016.193.

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Introduction: Variations of patient volumes in the ED according to days of the week and month of the year are well-established. Anecdotally, ED volumes follow ‘waves’ that correlate with previous days. Time-series models have traditionally been used in econometrics to develop financial models, but have been adapted in other fields, such as health informatics. This study uses a time-series approach to assess whether these impressions are valid. Methods: The daily volume of patients presenting to four emergency departments (ED) at the Nova Scotia Health Authority from Jan 2010 to May 2015 were analyzed to assess for the effect of previous volumes on future volumes. Parameters were selected using the auto-correlation (ACF) and partial auto-correlation functions (PACF) for a Seasonal Auto-regressive Integrated Moving Average (SARIMA) model. The Box-Jenkins statistic was assessed for model suitability. To assess for accuracy, a forecast of the model was evaluated with a year of volumes set aside for testing. Results: The EDs saw an average of 365.1 patients per day, with a minimum of 188 patients and a maximum of 479. The increasing trend in volumes consistent with the increasing number of ED presentations nation-wide was detrended using linear regression. There was a significant correlation in ACF with the previous day (ρ1 = 0.297). A seasonal, periodic trend was seen weekly. Significant correlations occurred annually (ρ365 = 0.279) and at 29 days (ρ29 = 0.339), consistent with the lunar cycle. A seasonal model was postulated incorporating an auto-regressive (AR) coefficient, and a moving average (MA) coefficient for the previous day’s volume. An AR and MA seasonal coefficient were each incorporated using the weekly period. When using the model on the test data, the model predicted 4 more patient presentations on average than the true value, with 90% of the values within 37 presentations of the true volume. The Box-Jenkins statistic was non-significant, indicating no problems with model specification. Conclusion: The volume of patients presenting to an ED system is correlated with that of the previous day. A weekly seasonal variation was confirmed. Auto-correlations also occur annually and possibly associated with the lunar cycle. Previous ED volumes may be useful in forecasting patient volumes. The time-series approach may discover further ways to predict ED volumes.

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Syrigos, K. N., C. Bacoyiannis, T. Makatsoris, A. Bamias, G. Klouvas, C. Nicolaides, I. Boukovinas, E. Linardou, G. Fountzilas, and P. Kosmidis. "Paclitaxel versus oral vinorelbine in patients with advanced non-small cell lung cancer (NSCLC) with performance status (PS) 2: A randomized phase II study." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e19035-e19035. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e19035.

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e19035 Background: The optimal treatment of patients with advanced NSCLC and PS 2 is not well established. Our group has shown that single agent is equally effective to doublets. Purpose of this study was to compare efficacy and toxicity of two single agents Paclitaxel and oral Vinorelbine. Methods: 75 stage IIIb wet and IV chemotherapy-naïve for metastatic disease patients with PS 2 were randomized to either Paclitaxel 90mg/m2 weekly (group A: 36pts) or Vinorelbine 60mg/m2 weekly (group B: 34pts). Both agents were given for three weeks on and one week off. Results: A total of 70 out of 75 patients were eligible for analysis. All patient and disease characteristics were well balanced. Partial response rate (PR) was 14% (95% CI, 4.7%-29.5%) and 6% (95% CI, 0.7%- 19.7%) for groups A and B respectively. Stable disease (SD) was 17% (95% CI, 6.4%-32.8%) and 12% (95% CI, 3.3%-27.5%) respectively. These rates did not differ significantly. Median survival (OS) was 5.3m (95% CI, 3.1–7.5 m) and 3.5m (95% CI, 1.6 - 5.4 m) respectively (P=0.6). Progression free survival (PFS) was 3.2m (95% CI, 1.9 - 4.6 m) and 2.1m (95% CI, 1.8 - 2.3 m) respectively (P=0.2). There was a non-statistically significant trend for more myelotoxicity in the vinorelbine group. Conclusions: A trend for higher efficacy and less toxicity of Paclitaxel in comparison to oral Vinorelbine was observed, without however reaching statistical significance. No significant financial relationships to disclose.

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Vincenzi, B., D. Santini, A. Russo, G. Dicuonzo, G. Michele, F. Battistoni, G. Avvisati, L. Rocci, N. Gebbia, and G. Tonini. "Angiogenesis modifications are predictive of response and outcome in heavily pretreated advanced colorectal cancer patients during therapy with cetuximab plus irinotecan." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 3562. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.3562.

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3562 Background: Angiogenesis has been correlated with increased invasion and metastases in a variety of human neoplasms. Inadequate inhibition of the growth of tumor microvessels by anticancer agents may result in treatment failure, rated clinically as progressive or stable disease. We designed this trial to investigate if Vascular Endothelial Growth Factor (VEGF) circulating levels modifications may be related with clinical response and outcome in advanced colorectal cancer patients during treatment with a weekly combination of cetuximab plus irinotecan. Methods: 45 heavily pretreated metastatic colorectal cancer patients were prospectively evaluated for circulating levels of VEGF during the treatment with cetuximab (initial dose of 400 mg per square meter, followed by weekly infusions of 250 mg per square meter) plus weekly irinotecan (90 mg per square meter). VEGF circulating levels were assessed at the following time-points: just before and at 1, 21, 50 and 92 days after the start of cetuximab plus irinotecan treatment. Results: Basal serum VEGF median levels were significantly decreased just at the first day (after the first treatment infusion (P=0.016). The VEGF persisted at the following time points reaching the highest statistical significance 92 days after the first infusion (P<0.0001). Twenty-two patients showed a reduction in median VEGF circulating levels of at least 50% 92 days after the first infusion respect to the basal time point. In the group of patients with at least 50% reduction of VEGF levels the response rate was 59.1% vs 21.7% in the non reduced VEGF group (P=0.024). Moreover, the median time to progression was 6.12 months (95% C.I.: 3.9 - 7.1) in the reduced VEGF group vs 2.3 months (95% C.I.: 1.6 - 3.5) in the other patients (P=0.001). Finally, also overall survival was longer in patients who developed VEGF reduction (12.3 months; 95% C.I.: 8.65 - 15.9) than this recorded in patients without the reduction (6.4 months; 95% C.I.: 5.6 - 8.4) (P=0.05). Conclusions: The present data represent the first evidence that suggest a role of VEGF reduction in the prediction of efficacy of treatment with cetuximab plus weekly irinotecan in heavily pretreated advanced colorectal cancer patients. No significant financial relationships to disclose.

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Darwish, S., G. Bronte, A. Ignoto, D. Piazza, S. Rizzo, S. Russo, and I. Carreca. "Efficacy of weekly low-dose chemotherapy in elderly women with advanced ovarian cancer: is there an antiangiogenic effect?" Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 13133. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.13133.

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13133 Background: In elderly patients decreased functionality of multiple organ systems may affect pharmacokinetics and pharmacodynamics of drugs. For this reason elderly cancer patients experience enhanced susceptibility to common chemotherapy-related adverse events. A way to prevent these effects could be metronomic chemotherapy, which is a variation of dose-dense therapy, with a cumulative dose significantly lower than maximum tolerated dose. Methods: 27 advanced ovarian cancer patients, median age 67 (range 60–86), received low dose weekly continuous chemotherapy until disease progression. All patients were treated with CBDCA AUC 2 mg/ml/min and Docetaxel 35 mg/sqm (adjusted according with Kintzel & Dorr formula) i.v. weekly. Primary endpoints were response rate (RR) and time to treatment failure (TTF). Moreover we considered as secondary endpoints toxicity profile, VEGF values and Quality of Life (QoL) score. RR and TTF were evaluated with RECIST criteria and Kaplan-Meyer formula respectively, toxicity was assessed according to the NCI-CTC. VEGF concentrations were analyzed by ELISA, QoL score was determined using the ADL/IADL and EORTC QLQ-C30 questionnaires, at baseline (T0) and at the end of therapy (T1). Results: median duration of treatment was 39 weeks. 2 Complete Responses (CR) and 5 Partial Responses (PR) were achieved for a 26% RR. Stable Disease was achieved in 18 pts (67%) with a total Clinical Benefit (CB) of 93%. Overall toxicity was very low: haematological G1/2 - 6 pts; gastrointestinal G1 - 8 pts; neurological G1/2 - 5 pts; cutaneous G3 - 1 pt; renal G1 - 1 pt. A mean TTF of 17.4 months was reached. Mean VEGF values (T0): 527 ± 35 pg/ml, (T1): 335 ± 18 pg/ml (p = 0,003). QoL score (T0): 45.2 ± 12, (T1): 47.5 ± 25 (p = 0,06). Conclusions: first results seem to be very encouraging, even if the number of responses is too small and we need to enrol more pts to reach a good statistical evaluation. Nevertheless the use of this “metronomic” schedule shows that VEGF values decrease strongly during the treatment and is maintained also when treatment is discontinued. Thus it suggests a preminent antiangiogenic role of this schedule according with the most recent preclinical and clinical studies. No significant financial relationships to disclose.

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Nugent, E., A. S. Case, I. Zighelboim, L. DeWitt, P. H. Thaker, L. S. Massad, M. A. Powell, D. G. Mutch, K. Trinkhaus, and J. S. Rader. "Chemoradiation in locally advanced cervical carcinoma: An analysis of cisplatin administration and other clinical prognostic factors." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e16525-e16525. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e16525.

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e16525 Background: The standard treatment for locally advanced cervical cancer is combination weekly cisplatin and radiotherapy (RT). Toxicity and compliance issues often result in failure to complete the recommended six cycles of weekly chemotherapy. Our objective was to retrospectively evaluate the effect of number of chemotherapy cycles and other clinical and pathologic factors on progression-free (PFS) and overall survival (OS). Methods: Between January 2004 and May 2007 we identified 118 patients at our institution with locally advanced cervical cancer (stage 1B2-IVA) treated with combined weekly cisplatin (40 mg/m2) and RT from chemotherapy log records. PFS and OS were evaluated for associations with number of chemotherapy cycles as well as other clinical and pathologic factors. Kaplan-Meier and Cox proportional hazard models were utilized for statistical analyses. Results: The median age and BMI were 51 years (25–86) and 29.2 kg/m2 (15–69). The majority of patients had stage IB2 or II disease (70%), squamous histology (91%), and size <6 cm (65%). Median RT duration was 50 days and 95% received brachytherapy. 30% of patients completed fewer than 6 cycles of chemotherapy and estimated PFS and OS were 63% and 75% respectively. 32 recurrences were detected with a median time to progression of 27 months. In multivariate analyses, number of chemotherapy cycles was independently predictive of PFS and OS. Patients that received <6 cycles of cisplatin had a worse PFS (HR 2.65; 95%CI 1.35–5.17; p = 0.0045) and OS (HR 4.47; 95% CI 1.83–10.9; p = 0.001). Additionally, advanced stage, longer time to RT completion, and absence of brachytherapy were associated with decreased OS and PFS (p < 0.05). Higher grade was associated with decreased PFS (p = 0.03) but not OS. Age, race, BMI, tumor size, smoking, histology, and IMRT were not statistically significant for OS or PFS. Conclusions: Number of cisplatin cycles, stage, grade, time to radiotherapy completion, and brachytherapy, are prognostic of PFS and OS in patients with cervical cancer undergoing treatment with combined cisplatin and RT. Efforts to decrease toxicity and improve compliance allowing for completion of six cycles of cisplatin may be associated with increased progression free and overall survival. No significant financial relationships to disclose.

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Chung, Hyungchul, Yueming Yang, Chia-Lin Chen, and Roger Vickerman. "Exploring the Association of the Built Environment, Accessibility and Commuting Frequency with the Travel Times of High-Speed Rail Commuters: Evidence from China." Built Environment 46, no. 3 (October 1, 2020): 342–61. http://dx.doi.org/10.2148/benv.46.3.342.

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This paper explores door-to-door commuting pa erns and the way commuting time is associated with three factors: the built environment, transport mode (from residence and workplace to HSR stations), and commute frequency. Econometric and statistical analyses are employed to examine evidence from China that draws on a survey targeting Suzhou-based HSR commuters who travel to work in Shanghai. The findings present three major points. First, a dense urban environment around residence and workplace is associated with reduced commuting time to high-density healthcare facilities (Suzhou and Shanghai) and financial institutions (Shanghai only). However, the density of public transport facilities near both residence and workplace has no association with commuting time. Second, taking the metro to and from HSR stations shows signi ficant association with increased commuting time for the first and last miles, while walking from HSR stations to the workplace shows signi ficant reduction of commuting time. Third, daily commuting is associated with reduced commuting time in the first mile, while weekly commuting is reversely related to longer commuting time in the last mile, which is coupled with a shorter commuting time for the first mile than the last mile. These findings lead us to conclude that reducing the total commuting time for a door-to-door journey is a key factor in associated commuting pa erns, commuting frequency, and travel mode choice. This re flects the choices commuters make in relation to where they live rather than where they work, which off ers fewer options. A longer last mile relates to a weekly commuting pa ern rather than a daily commuting. The current public metro systems in both home and work cities appear to be lengthy and inefficient. Transitoriented and integrated development is required to provide more efficient experiences for commuters.

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Sanil, Siddartha, and Phadindra Kumar Paudel. "Determinants of bank selection among working people in Kathmandu Valley." International Research Journal of Management Science 2 (December 4, 2017): 118–34. http://dx.doi.org/10.3126/irjms.v2i0.28050.

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The major objective of the study is to know the determinant of bank selection among working people in Kathmandu Valley. The study has explored seven factors which are core service delivery, external and internal aesthetics of bank, convenience, financial benefit, technology, recommendation by peers and staff. The study developed the questionnaire considering these seven factors and to confirm the reliability, questionnaire was distributed to 10 people which revealed questionnaire was fairly reliable for research administration. Arithmetic Mean, ANOVA and correlation analysis are basis for statistical analysis. The study finds that convenience significantly impacts the banking decisions among working people in Kathmandu Valley which includes item like convenient location, close to home, adequate number of location, security, convenience, reputation of organization and proximity. Bank should focus more on items like accurate account information and pleasant bank atmosphere. Working people are more sensitive in cost rather than benefit and they are more sensitive to interest rate in fixed deposit to saving in banking decision. Correlation analysis in study asserts that recommendation by peers is weekly correlated with other factor which research found that banks need to improve in faster service, queue management, front desk employee, ATM and mobile service and information sharing.

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Beard, C., E. Dean-Clower, J. Dusek, W. B. Stason, S. DeCristofaro, A. Keshaviah, I. Purevjal, D. Rosenthal, A. Webster, and H. Benson. "A study of complementary therapies in men receiving radiation therapy for prostate cancer: A randomized feasibility trial." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 15638. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.15638.

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15638 Background: Prostate-cancer patients suffer from substantial distress with both their diagnosis and treatment. Several studies have looked at the use of complementary and alternative medicine (CAM) in patients with prostate cancer to alleviate their stress and effects of therapy. We elected to study Reiki and Relaxation Response Therapy (RRT) in prostate-cancer patients. Methods: Patients receiving an eight-week course of radiation for prostate cancer were eligible. Consented participants were randomly assigned to RRT, to Reiki, or to no CAM therapy during radiotherapy. Reiki was given twice weekly, RRT once weekly. The feasibility of enrolling 60 patients, their compliance with physiologic and psychological testing, and preliminary assessment of the effect of CAM are the study endpoints. Statistical analysis of feasibility is based on the assumption that at least 80% of patients would complete 14/16 Reiki sessions or 7/8 RRT sessions. Patients were tested for outcome measures at baseline, at randomization, halfway through radiation, at completion of radiation and 2 months later. The psychosocial outcome measures used were the STAI, CES-D, FACT-G, FACIT: Fatigue Scale, and EPIC: Hormone Section. Physiological assessment included salivary cortisol, blood samples for interleukin-6, tumor necrosis factor alpha, CD8, natural killer cells, heat shock protein 70 and a validated bowel-and-bladder-symptom questionnaire. Results: We have enrolled 62 of 108 eligible patients (60%) within 18 months. The number of enrollment has been increased to 62 as two patients changed their treatment location. To date five patients dropped out short of completion, 1 became ineligible, 32 have completed the study, 20 are still receiving CAM therapy or are in active follow-up and 2 are awaiting randomization and radiotherapy. Conclusions: Complementary therapy appears to be of much interest to prostate-cancer patients. At the completion of the trial, we will have more data on feasibility, compliance and preliminary results on the effect of CAM intervention in this population. No significant financial relationships to disclose.

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Ragni, Margaret, Roshni Kulkarni, K. John Pasi, Kathelijn Fischer, Johnny Mahlangu, Amy Shapiro, Beatrice Nolan, et al. "B-YOND Final Results Confirm Established Safety, Sustained Efficacy, and Extended Dosing Interval for Up to 4 Years of Treatment With rFIXFc in Previously Treated Subjects With Severe Hemophilia B." Blood 132, Supplement 1 (November 29, 2018): 1214. http://dx.doi.org/10.1182/blood-2018-99-110100.

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Abstract Introduction: Recombinant factor IX Fc fusion protein (rFIXFc) is an extended half-life therapy for severe hemophilia B. The safety, efficacy, and prolonged half-life of rFIXFc were demonstrated in previously treated pediatric, adolescent, and adult subjects with severe hemophilia B in the Phase 3 B-LONG and Kids B-LONG trials (NCT01027364 and NCT01440946, respectively) (Fischer et al, Lancet Haematol, 2017; Powell et al, N Engl J Med, 2013). Here, the final results are reported from B-YOND (NCT01425723), the long-term extension of those 2 studies. Methods: This was an open-label, multicenter, long-term trial of previously treated subjects of all ages with severe hemophilia B. Dosing regimens included weekly prophylaxis (WP; 20-100 IU/kg every 7 days), individualized prophylaxis (IP; 100 IU/kg every 8-16 days or twice monthly), modified prophylaxis (MP; for subjects not achieving optimal dosing on IP or WP), or episodic treatment (ET; on-demand dosing based on type and severity of bleeding episodes). Subjects <12 years of age could only enroll in the prophylactic groups (WP, IP, or MP). Investigators were permitted to change treatment groups for a subject at any point in B-YOND; thus, subjects may be included in >1 group for analyses. The primary endpoint was development of inhibitors. Other endpoints included annualized bleeding rates (ABRs), joint ABRs, spontaneous joint ABRs, exposure days (ED), and factor consumption. Descriptive statistics were used for analysis. Analyses were performed separately based on parent study. Results: A total of 120 subjects (93 from B-LONG and 27 from Kids B-LONG) enrolled in B-YOND, and 98 subjects (75 from B-LONG and 23 from Kids B-LONG) completed the study. Of the 93 subjects from B-LONG, the median (range) age was 29 (13‒63) years and most were prescribed WP (WP, n=51; IP, n=31; MP, n=17; ET, n=15). Subjects from Kids B-LONG had a median (range) age of 7 (3‒12) years. Among subjects <6 years of age, 13 were prescribed WP and 1 MP. Ten subjects 6 to <12 years of age received WP, 5 received IP, and 1 received MP. No subject developed an inhibitor during B-YOND. The overall safety profile of rFIXFc was consistent with the parent studies and prior interim analyses. ABRs remained low and stable throughout B-YOND (Table 1). The overall median (range) number of ED in B-YOND for subjects from B-LONG was 146.0 (8.0-462.0) days, with an overall median (range) duration of 208 (4 years; 13.9-280.0) weeks. For subjects from the Kids B-LONG study, the median (range) number of ED was 55.0 (8.0-204.0) days and 149.0 (53.0-202.0) days for those aged <6 years and 6 to <12 years, respectively. Median (range) exposure to rFIXFc was 55.0 (1.1 years; 7.9‒177.0) weeks for subjects <6 years of age and 175.66 (3.4 years; 47.0‒201.1) weeks for subjects 6 to <12 years of age. The median dosing interval ranged from 7 to 14 days for B-LONG subjects and 7 to 10 days for Kids B-LONG subjects (Table 1). Most subjects (79% and 78% from B-LONG and Kids B-LONG, respectively) had maintained their dosing interval during the extension trial (Table 2), although the dosing interval was lengthened for 6% of B-LONG subjects and 15% of Kids B-LONG subjects. Median weekly dose was low (Table 1) and ranged from 48.46 IU/kg to 68.23 IU/kg for B-LONG subjects and 59.96 IU/kg to 67.70 IU/kg for Kids B-LONG subjects. There was no change in median weekly factor consumption from the end of either parent study through the B-YOND extension. Conclusions: During up to 4 years of treatment with rFIXFc in the B-YOND study, no inhibitors were reported. The low ABRs, low consumption, and extended dosing intervals of up to 14 days that were observed during the parent studies were sustained for the duration of the long-term extension trial. These data confirm the consistent, well-characterized safety profile, and durable efficacy of rFIXFc prophylaxis in subjects of all ages with severe hemophilia B. Disclosures Ragni: Alnylam: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; American Academy of CME: Honoraria; Baxalta/ Shire: Research Funding; Baxter Bioscience: Research Funding; Bayer: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Biogen/Bioverativ: Consultancy, Research Funding; Biomarin: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; CSL Behring: Research Funding; Foundation for Women and Girls with Blood Disorders: Membership on an entity's Board of Directors or advisory committees; Institute for Cost Effectiveness Research (ICER): Consultancy; NovoNordisk: Research Funding; OPKO Biologics: Research Funding; Pfizer: Research Funding; Shire Development LL: Consultancy, Other: Non-financial support (study Drug); SPARK: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; MOGAM(Green Cross Corporation: Membership on an entity's Board of Directors or advisory committees. Kulkarni:Bioverativ: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bayer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; NovoNordisk: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Shire: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Octa Pharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Kedrion: Honoraria, Membership on an entity's Board of Directors or advisory committees; Genetech: Honoraria, Membership on an entity's Board of Directors or advisory committees; BPL: Honoraria, Membership on an entity's Board of Directors or advisory committees. Pasi:Biomarin: Honoraria, Research Funding; NovoNordisk: Speakers Bureau; Alnylam: Honoraria, Research Funding; Catalyst Bio: Honoraria; Shire: Speakers Bureau; Octapharma: Honoraria; Pfizer: Speakers Bureau; Apcintex: Honoraria; Bioverativ: Honoraria, Research Funding; Sobi: Honoraria; Bayer: Speakers Bureau. Mahlangu:Sanofi: Research Funding, Speakers Bureau; Roche: Consultancy, Research Funding, Speakers Bureau; LFB: Consultancy; NovoNordisk: Consultancy, Research Funding, Speakers Bureau; CSL Behring: Consultancy, Research Funding, Speakers Bureau; Chugai: Consultancy; Catalyst Biosciences: Consultancy, Research Funding; Biomarin: Research Funding, Speakers Bureau; Biogen: Research Funding, Speakers Bureau; Bayer: Research Funding; Amgen: Consultancy; Alnylam: Consultancy, Research Funding, Speakers Bureau; Shire: Consultancy, Research Funding, Speakers Bureau; Sobi: Research Funding, Speakers Bureau; Spark: Consultancy, Research Funding. Shapiro:Bioverativ, a Sanofi Company: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Daiichi Sankyo: Research Funding; BioMarin: Research Funding; Bayer Healthcare: Other: International Network of Pediatric Hemophilia; Shire: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau; Prometic Life Sciences: Consultancy, Research Funding; Octapharma: Research Funding; Kedrion Biopharma: Consultancy, Research Funding; Sangamo Biosciences: Consultancy; Novo Nordisk: Membership on an entity's Board of Directors or advisory committees, Research Funding; OPKO: Research Funding; Bio Products Laboratory: Consultancy; Genetech: Membership on an entity's Board of Directors or advisory committees, Research Funding, Speakers Bureau. Nolan:Bayer: Research Funding; CSL Behring: Research Funding; Sobi: Research Funding. Oldenburg:Chugai: Honoraria, Membership on an entity's Board of Directors or advisory committees; Grifols: Honoraria, Membership on an entity's Board of Directors or advisory committees; Pfizer: Honoraria, Membership on an entity's Board of Directors or advisory committees; Roche: Honoraria, Membership on an entity's Board of Directors or advisory committees; Biogen Idec: Honoraria, Membership on an entity's Board of Directors or advisory committees; Shire: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Octapharma: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novo Nordisk: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; CSL Behring: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Biotest: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Bayer: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Swedish Orphan Biovitrum: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau. Matsushita:Bioverativ: Honoraria; Bayer: Honoraria, Research Funding; NovoNordisk: Honoraria, Research Funding; JB: Honoraria, Research Funding; Shire: Honoraria; CSL: Honoraria. Willemze:SOBI: Employment. Rudin:Bioverativ: Employment, Equity Ownership.

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Jaysheelan, N., R. Hariharan, and G. P. Dinesh. "Has it Pierced or Yet To Pierce? A Critical Analysis of E-Retailing’s Penetration into Rural India using Extended Technology Acceptance [TAM2]." IRA-International Journal of Management & Social Sciences (ISSN 2455-2267) 6, no. 2 (February 27, 2017): 155. http://dx.doi.org/10.21013/jmss.v6.n2.p4.

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<div>Genesis: Gone are those days when markets were associated with transactions involving physical cash; due to demonetization of high value currency notes India is now witnessing a giant leap of transformation towards digital economy. Cash transactions get replaced by mobile wallets, e-payments, bank transfers, online payments etc. this brings in greater degree of transparency into the system through high degree accountability of transactions.Cashless economy needs adoption of technology [mobile internet] to proceed smoothly; urban India is positively skewed towards digital economy, but rural India is not well equipped and educated to adopt, use and substitute the physical transaction mechanisms with digital transaction mechanisms. Major stake holders of rural weekly markets are farmers whose literacy rates and financial status are often scaled below par. Access to smart phone is certainly increasing among rural consumers, but to what extent they are willing to adopt the mobile internet technology as a means for executing financial transactions is a debatable question. In order to steer the rural consumer’s trajectory towards digital payment mode in rural India, it is important to understand the factors/forces influencing the acceptance of technology among rural consumers, thereby strategies can be devised to sail over the tide of resistance easily.Approach: A survey was conducted using The Extended Technology Acceptance Model [TAM2] to ascertain the various factors/forces that are responsible for resistance towards acceptance of mobile internet technology as a means for executing their financial transactions, particularly in the rural weekly markets of Ballari district.Methods: Measurement of the facets of TAM2 such as (intention to use, perceived usefulness, perceived ease of use, subjective norms, voluntariness, image) was done and subjected to rigorous data processing and analysis using the relevant statistical tools such as, KMO Test, Bartlett’s Test, cronbach’s alpha, Factor Analysis, mean, standard deviation and percentage analysis. Results: The assessment unearthed the various factors/forces affecting the rural consumer’s intentions towards acceptance of mobile internet technology as a means for executing their financial transactions, among which, safety, security, intangibility aspect, credibility and accessibility of money in electronic form were prominent.Conclusion/Recommendations: Rural consumers lack necessary equipments [smart phones] and knowledge of usage which act as a major bottleneck blocking the inroads of digital economy in rural markets; along with many factors/forces result in resistance towards adoption of mobile internet technology for executing their financial transactions. Recommendations include all those initiatives that results in acceptance of technology among rural consumers such as, ensuring security, safety, credibility of transactions, accessibility of digital money etc. </div>The rest of the paper is maneuvered with following sequence, Part 1: Introduction to the concept of digital economy; Part 2: Review of literature; Part 3: Gap Analysis; Part 4: Objectives of the study; Part 5: Research methodology; Part 6: Data analysis; Part 7: Findings; Part 8: Conclusion & Recommendations.

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Haritha, C., and V. Shankar. "Oral morphine gargles: A cost effective approach for pain relief in patients with chemoradiation induced acute oral mucositis in head and neck cancers." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e20504-e20504. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e20504.

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e20504 Background: Painful oral mucositis is the most significant dose-limiting toxicity in head & neck cancer patients treated with conc. CT-RT protocol. The purpose of this study is to evaluate the efficacy of oral morphine gargles in reducing the severity of chemoradiation induced mucositis pain & thus, its impact on nutrition, quality of life & cost of supportive care, during the treatment period. Methods: 106 consecutive patients, recruited between May 2006 through Dec. 2007, with adv. head and neck cancers (54 oropharynx, 42 hypopharynx & 10 nasopharynx) were included in the study. All patients underwent treatment under conc. CT-RT (Inj.CDDP 40mg/m2 weekly, RT: 66–70gy/33–35# @200cgy/# delivered by 3D- CRT). Patients who had painful mucositis (RTOG Grade 3 or more) not controlled with magic mouthwash, Tab. Acetaminophen 500mg qds or Tab.Tramdol 50–100 mg tds were randomized into 2 groups: morphine group (MOP) -53 patients & Control group (CON) - 53 patients. Patients in both groups received adjusted doses of oral steroids based on the severity of oral mucositis. While CON group patients were given adjusted doses of tramadol, MOP group patients were assigned to 15ml of 2% morphine gargles administered every 4th hourly. Patients were instructed not to swallow the rinses and to hold the solution in the mouth for 3mins duration. All patients underwent weekly recording of (1) response to pain rated on VAS (2) weight (3) morphine systemic side-effects (4) QOL Questionnaire. Mann-Whitney test and ’T’ Test are used for statistical analysis of the data. Results: Patients in the MOP group had significant lower pain intensity scores, better QOL scores & less weight loss compared to patients in the CON group. The duration of the severe pain was atleast 1 week shorter in the MOP group. Systemic side-effects secondary (nausea, vomiting, constipation) to opiod use were significantly lower in the MOP group. The Cost of supportive care for pain management was less in the MOP group, with greater compliance for the treatment. Conclusions: Morphine gargles, in our experience, is an effective approach for pain relief in patients with CT-RT induced acute mucositis in head and neck cancers thus leading to better nutrition & compliance in the treatment. No significant financial relationships to disclose.

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Venner, Christopher P., Richard Leblanc, Irwindeep Sandhu, Darrell J. White, Andrew R. Belch, Donna E. Reece, Christine I. Chen, et al. "MCRN¯003/MYX·1: A Single Arm Phase II Study of High-Dose Weekly Carfilzomib Plus Cyclophosphamide and Dexamethasone in the Treatment of Relapsed Multiple Myeloma after 1-3 Prior Therapies." Blood 132, Supplement 1 (November 29, 2018): 1984. http://dx.doi.org/10.1182/blood-2018-99-117824.

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Abstract Background: Carfilzomib, a second generation proteosome inhibitor, is effective in the treatment of relapsed and refractory multiple myeloma (RRMM). Recent phase II and phase III trials have demonstrated the efficacy of weekly dosing strategies. The aim of this study was to examine high dose once weekly carfilzomib in combination with weekly dexamethasone and low dose weekly cyclophosphamide (wCCD) in RRMM. It was hypothesized that this may offer a potent yet convenient and more financially viable triplet-based treatment option than existing combinations. Methods: The MCRN-003/MYX.1 multi-centre single arm phase II clinical trial is run through the Myeloma Canada Research Network (MCRN) with support from the Canadian Cancer Trials Group (CCTG). Patients who had at least one but not more than three prior lines of therapy and who did not have proteosome inhibitor (PI) refractory disease were eligible. Treatment consists of carfilzomib (20 mg/m2 day 1 of first cycle then escalated to 70 mg/m2 for all subsequent doses) given on days 1, 8, and 15 of a 28-day cycle, plus weekly oral dexamethasone 40 mg and cyclophosphamide 300 mg/m2 capped at 500 mg on days 1, 8, 15 and 22. Treatment continues until progression or intolerance, except for cyclophosphamide which is discontinued after 12 cycles. The total sample size of 76 patients includes a 6 patient lead-in phase where safety at 70 mg/m2 was evaluated. The primary objective was to observe an overall response rate (ORR) ≥ 80% after 4 cycles of protocol therapy. Secondary endpoints include safety, toxicity, kinetics of and maximal response depth and overall survival. This analysis is based on the locked data base of 2018 July 13. Results: Of the 76 patients accrued 1 was subsequently determined to be ineligible on the basis of bortezomib refractory disease, and 1 did not receive any protocol therapy due to a cardiac event occurring post-study registration but prior to treatment commencement. All patients who received therapy were included in the analysis as per protocol inclusive of the bortezomib exposed patient. Among these 75 patients, median age was 66 years with 33% being > 70 years of age. Thirty-seven percent were female. Thirty-nine percent received 1 prior line, 44% received 2 prior lines and 17% received 3 prior lines of therapy. High risk cytogenetics [(t4;14), t(14;16) and del P53] were identified in 32%. Twenty percent had ISS stage III disease and 11% had R-ISS stage III disease. Prior PI and immunomodulatory drug exposure was noted in 87% and 81% respectively. Within the first 4 cycles of therapy 84% (95% CI, 76-92%) of patients achieved PR or better, with ≥ VGPR achieved in 52% and ≥ CR in 9% (table 1, p = 0.0006). There was a trend toward a better ORR after 4 cycles based on the presence or absence of high-risk cytogenetics (75% vs 94% respectively, p = 0.051) not meeting statistical significance. The median duration of follow-up at the time of data analysis was 13.9 months (range 0.2 to 22.8 months). 18 patients have died with an estimated 1-year OS of 80%. The cause of death as assessed by the investigator was myeloma in 13 patients with 3 dying from a cause possibly or probably related to the study intervention. During the first 4 cycles of treatment, non-hematologic toxicity ≥ grade 3 occurred in 33% of patients; most commonly infection (16%) and fatigue (7%). Grade 3/4 anemia was observed in 17%, thrombocytopenia in 33% and neutropenia in 20%. Grade 3 or greater hypertension was seen in 4%, dyspnea in 1%, pulmonary edema in 1% and thrombotic microangiopathy in 4%; all resolved with no long-term sequelae. To date 37 (49%) patients have discontinued carfilzomib, 11 due to toxicity and 16 due to disease progression. Conclusion: This prospective phase II study demonstrates that wCCD is a safe and effective regimen in the treatment of RRMM. The study met its primary endpoint demonstrating a ≥ 80% ORR after 4 cycles of therapy. These results compare favourably to published phase III data examining weekly carfilzomib and dexamethasone as well as the established twice-weekly dosing strategies. This regimen will be a useful triplet-based option for RRMM especially in patients refractory to immunomodulatory agents who would otherwise be ineligible for the carfilzomib-lenalidomide-dexamethasone combination. Disclosures Venner: Janssen: Honoraria, Research Funding; Celgene: Honoraria, Research Funding; Amgen: Honoraria; Takeda: Honoraria. Leblanc:Celgene Canada: Membership on an entity's Board of Directors or advisory committees; Janssen Inc.: Membership on an entity's Board of Directors or advisory committees; Amgen Canada: Membership on an entity's Board of Directors or advisory committees; Takeda Canada: Membership on an entity's Board of Directors or advisory committees. Sandhu:Celgene: Honoraria; Janssen: Honoraria; Amgen: Honoraria; Novartis: Honoraria; Bioverativ: Honoraria. White:Amgen, Celgene, Janssen, Takeda: Honoraria. Chen:Amgen: Honoraria. Louzada:Celgene: Honoraria; Janssen: Honoraria; amgen: Honoraria; pfizer: Honoraria. Hay:Amgen: Research Funding; Novartis: Research Funding; Janssen: Research Funding; Roche: Research Funding; Seattle Genetics: Research Funding; Kite: Research Funding.

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Akoto, S. D. "Market Survey of Non-Timber Forest Products in the Sunyani Municipality." Journal of Energy and Natural Resource Management 3, no. 2 (February 24, 2018): 44–53. http://dx.doi.org/10.26796/jenrm.v3i2.58.

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This study sought to: (1) identify the types and sources of Non-Timber Forest Products (NTFPs) traded; (2) find the frequencyof the NTFPs trade and (3) identify the challenges in NTFPs trading in the Sunyani Municipality. The survey was carried outfrom February, 2014 to April, 2014 mainly at the Sunyani Central and Nana Bosoma Markets in the Sunyani Municipality. Thetarget population comprised NTFPs collectors (gatherers), sellers and consumers. Respondents were purposively sampled. Atotal of 100 respondents were engaged in this study. The NTFPs were grouped into six categories namely; food, medicine,building materials, packaging materials, artefacts and domestic utensils. Key informants’ interviews were also conducted atthe Sunyani Forest Services Division to triangulate the data already gathered. Statistical Package for Social Sciences was usedto analyze the data obtained. The study demonstrated that domestic utensils (37%), food (33%), medicinal products (12%),packaging materials (9%), artefacts (6%) and building materials (3%) were the types of NTFPs traded in the two market centers.The results also showed that majority of the respondents (77%) harvest their NTFPs from forest lands as against 23% whoharvest from communal lands. A significant proportion of the respondents (52%) traded in above 40 kg of NTFPs and only 4%were seen trading in 10 kg of NTFPs. The study further highlighted that food (28%) and domestic utensils (26%) were regularlybrought to the market centers on weekly basis whilst significant proportions of medicinal products (9%), building materials(3%) and artefacts (4%) were brought to the market venues on monthly basis. Cumbersome permit procedure (40%), increasedmarket demand (15%) and financial constraints (20%) were identified as some of the challenges encountered in NTFPs tradingin the Sunyani Municipality. To ensure strict monitoring and sustainability of the resource, there is the need for sensitizationprogramme on the importance of NTFPs in rural livelihood and why their conservation is vital in meeting the needs of thepresent generation whilst not undermining their potential in supplying the needs of future generations.

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van der Bol, J. M., J. Verweij, F. A. de Jong, W. J. Loos, M. H. Lam, E. van Meerten, and R. H. Mathijssen. "Effects of omeprazole on the pharmacokinetics and toxicities of irinotecan in cancer patients: A prospective open-label cross-over drug-interaction study." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 2502. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.2502.

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2502 Background: The proton pump inhibitor omeprazole (Losec) is one of the most extensively prescribed medications worldwide and within its class, omeprazole is most frequently associated with drug interactions. In vitro studies have shown that omeprazole can alter the function of metabolic enzymes and efflux transporters that are involved in the metabolism of irinotecan, such as UGT1A1, CYP3A, and ABCC2. In this open-label cross-over study we investigated the effects of omeprazole on the pharmacokinetics and toxicities of irinotecan. Methods: Fourteen patients were treated with one course (C1) of single agent irinotecan (600 mg i.v., 90 min) followed three weeks later by a second course (C2) with concurrent use of omeprazole 40 mg once daily, which was started 2 weeks prior to C2. Plasma samples were obtained up to 55 hours after infusion and analyzed for irinotecan, and its metabolites SN-38, SN-38 glucuronide (SN-38G), NPC, and APC by reversed-phase high-performance liquid chromatography with fluorescence detection. Non-compartmental modelling of pharmacokinetic data was performed with WinNonLin. Toxicities were monitored during both courses and graded according to the CTCAE criteria v3.0. Paired statistical tests were performed with SPSS. Results: The mean AUCs of irinotecan and all metabolites were not significantly different between both courses (p>.151; see table). In addition, no differences were seen in Cmax and clearance of irinotecan and all metabolites between C1 and C2 (p>.072). The nadir ANC and WBC and the percentage decrease in ANC and WBC from baseline were not different between both courses (p>.529). Neither were there significant differences in the severity of neutropenia, febrile neutropenia, diarrhea, nausea, and vomiting. Conclusions: Omeprazole 40 mg did not alter the pharmacokinetics and toxicities of irinotecan. This widely used drug can therefore be safely administered during a 3-weekly single agent irinotecan schedule. [Table: see text] No significant financial relationships to disclose.

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Rucinska, M., and S. T. Langkjer. "Correlation between fatigue level and irradiated volume of the whole body, lung and heart in breast cancer patients receiving adjuvant radiotherapy after breast-conserving surgery." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 19608. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.19608.

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19608 Background: Fatigue - an unpleasant, persistent, subjective sense of tiredness - is one of the most common symptoms experienced by cancer patients. It is multidimensional and is associated with both - malignancy itself and the anti-neoplastic treatment. The aim of the study was to assess the level of fatigue during and after adjuvant postoperative radiotherapy in breast cancer patients and evaluate its correlation with the irradiated volume of the whole body, lung and heart. Methods: 48 patients (age 33–76 years, mean 57 years) with early breast cancer after breast-conserving surgery were treated with adjuvant radiotherapy (48Gy/24fractions/5weeks; 12 patients received boost 10Gy/5fractions/1week to the tumor-bed). The patients′ subjective feeling of fatigue intensity was measured according to 10- score visual analog scale (VAS) before the start and weekly during radiotherapy, as well as 14 days and 3 months after radiotherapy. Results: Fatigue intensity increased gradually during radiotherapy (mean fatigue-VAS before and in the last week of treatment was 1.21 and 2.31 respectively; p=0.004). 14 days after the end of radiotherapy, the fatigue intensity was still higher than before treatment (1.88 and 1.21 respectively; p=0.04), but 3 months later, fatigue was lower than at the pretreatment level (n.s.). Irradiation of the large volume of the whole body was correlated with higher fatigue level during and after radiotherapy. If 15% or more of the unilateral lung volume received 20Gy, patients reported higher fatigue level than patients receiving 20Gy for less than 15% of the unilateral lung volume. There were no statistical differences in fatigue level between patients with different percentage of the heart volume receiving irradiation. Patients with boost did not manifest higher fatigue level. Conclusions: Fatigue increased over the course of radiotherapy, but 3 months after the end of therapy it was reduced to lower than at the preliminary level. There was a positive correlation between fatigue level during and after radiotherapy and the irradiated whole body and lung volume, but not heart volume. No significant financial relationships to disclose.

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Nishimura, T., S. Matsumoto, M. Kanai, H. Ishiguro, T. Kitano, K. Yanagihara, and M. Fukushima. "Hepatic arterial infusion chemotherapy using low-dose cisplatin and 5-fluorouracil (5-FU) in the treatment of patients with advanced hepatocellular carcinoma with portal vein tumor thrombus or refractory to transarterial chemoembolization: A single institute outcome analysis." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e15563-e15563. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e15563.

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e15563 Background: Although sorafenib has been reported to prolong survival of patients with advanced hepatocellular carcinoma (HCC), the prognosis of those who did not respond to or are not candidate to transarterial chemoembolization (TACE) remains poor. The aim of this outcome analysis is to evaluate the safety and efficacy of hepatic arterial infusion chemotherapy (HAIC) via a subcutaneously implanted injection port in the treatment of such patients. Methods: From the prospective cohot database of Outpatient Oncology Unit, Kyoto University Hospital, patients with HCC who had been treated with HAIC using low dose cisplatin and 5-FU (cisplatin 10mg and 5-FU 250mg for day 1–5, repeated serially for three or four weeks, then repeated once weekly) between October 2003 and December 2008 were searched for. All adverse events were assessed according to Common Terminology Criteria for Adverse Events v3.0. Survival analysis was performed by using Kaplan-Meier method. Prognostic factors were assessed using Log-rank test. Results: Forty-one patients were identified. The indications of HAIC were: (1) the presence of portal vein tumor thrombus (20/41 cases, 49%), (2) failure to TAE (19/41, 46%) or (3) not candidate for TAE due to the presence of extrahepatic disease (2/41 case, 5%). One complete response and 7 partial responses were observed, overall response rate being 19.5% (95%CI, 7.4–31.6%). Median overall survival was 26.1 month (95%CI: 9.6–45.6). Commonly observed grade 3/4 adverse events were thrombocytopenia (10 cases, 16.3%) and neutropenia (10 cases, 16.3%). There was a trend that fewer death occur in patients who responded to HAIC (1/8 cases, 12.5%) as compared to patients who did not (11/33, 33.3%), but log-rank test failed to detect a statistical significance (P=.145). Conclusions: HAIC for patients with advanced HCC who are not candidate for TACE warrants randomized controlled trial. No significant financial relationships to disclose.

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Barata, F., B. Parente, E. Teixeira, A. Costa, A. Fernandes, F. L. Pimentel, and L. Carvalho. "A phase II trial of adding cetuximab to cisplatin and gemcitabine as first-line therapy in advanced non-small cell lung cancer (NSCLC)." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): e19043-e19043. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.e19043.

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e19043 Background: Phase II and III studies have demonstrated that the EGFR-antibody, cetuximab (Erbitux), improves efficacy parameters when added to a platinum-based chemotherapy in the 1st-line treatment of patients with advanced NSCLC. This study assessed the efficacy and tolerability of cetuximab in combination with cisplatin and gemcitabine in this setting. Methods: Patients in this multicenter, single-arm, phase II Portuguese study received cetuximab (400 mg/m2 initial dose then 250 mg/m2 weekly) in combination with cisplatin (40 mg/m2) and gemcitabine (1,200 mg/m2) for 6 cycles (21 days). Main eligibility criteria included metastatic NSCLC of any histological subtype, ECOG PS 0/1, and measurable disease. Patients with brain metastases were excluded. The primary endpoint was the overall response rate (ORR) during treatment, according to RECIST criteria. Secondary endpoints included time to progression (TTP), overall survival, and adverse events. Statistical analyses were performed for the intention to treat (ITT) and per protocol populations. ORRs and the corresponding 95% confidence intervals (CIs) were estimated and Kaplan-Meier curves were computed for TTP. Results: A total of 48 patients were enrolled between December 2006 and March 2008. Seventy five percent of the patients were men and the median age was 62.5 years (range 34–75). Median TTP was 5.0 months (95% CI 3.9–6.1 months). Best ORR were 35.4% (95% CI 22.2–50.5%) and 38.1% (95% CI 23.6–54.4%) for the ITT and PP populations, respectively. No differences in response rates were observed when EGFR status (as determined by FISH and immunohistochemistry) was taken into consideration. Ninety-six grade III/V adverse events were reported; the most common were neutropenia and thrombocytopenia (36 and 18 events, respectively). Conclusions: Adding cetuximab to cisplatin and gemcitabine demonstrated high efficacy (ORR and TTP) with acceptable toxicities in a nonselected population of patients in 1st-line treatment of NSCLC. No significant financial relationships to disclose.

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Kendall, A., I. Smith, E. Folkerd, and M. Dowsett. "Aromatase inhibition and very low dose estradiol add-back: A pilot study for novel breast cancer prevention." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 1014. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.1014.

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1014 Background: Aromatase inhibitors (AIs) are important agents for the treatment of hormone receptor positive breast cancer in post menopausal women. They are being assessed as chemopreventives of breast cancer in large clinical trials, but there are known issues of tolerability notably affecting bone. It is possible that decreasing, but not abolishing, circulating estradiol levels may reduce breast cancer risk without such side effects. We have undertaken a novel pilot study to establish whether healthy volunteers on an AI could be delivered very low dose estradiol replacement to a predictable serum level of 10–20 pmol/L using a transdermal patch, and whether this would reverse changes in the bone resorption biomarker CTx. Methods: Ten healthy postmenopausal women with normal estradiol levels received letrozole 2.5mg/day for 16 weeks. From weeks 6–16 they were also given a quarter of Estraderm MX25 transdermal patch (6.25 μg of estradiol) replaced, twice weekly. Fasting blood samples were taken at baseline, 6, 10, 12, 14 and 16 weeks for estradiol, FSH, LH, SHBG and CTx. Results: Serum estradiol levels fell to <3pmol/L at 6 weeks consistent with AI therapy. The quarter patch successfully replaced estradiol levels to a median of 12pmol/L although there was marked inter and intrasubject variability. FSH rose significantly with AI therapy with no appreciable change in SHBG or LH. There is encouraging evidence that CTx levels which increased with AI (p=0.076) can be corrected with low dose estradiol replacement although this did not reach statistical significance in this initial group. We continue to collect data on a further 8 subjects already recruited into the study. Conclusions: A quarter of Estraderm MX25 transdermal patch can be used to provide a serum estradiol level of 10–20 pmol/l in postmenopausal women given an AI. Further data will confirm whether this novel approach to chemoprevention can reverse the negative impact of AIs on bone metabolism and be suitable for extending to a full chemoprevention trial. [Table: see text] No significant financial relationships to disclose.

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Horisberger, K. E., R. D. Hofheinz, B. Muessle, P. Findeisen, A. Hochhaus, S. Post, and F. Willeke. "Topoisomerase I expression in locally advanced rectal cancer as predictive marker for response to preoperative chemoradiation." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 14566. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.14566.

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14566 Background: In locally advanced rectal cancer combined modality treatment has become the standard therapeutical intervention. Preoperative downstaging is known as a predictor concerning lower local recurrence rate and probably better overall-survival. However, efficacy of neoadjuvant chemoradiation is compromised in some patients by so far unknown factors. The aim of the present study was to investigate topoisomerase I expression as a potential parameter for predicting response to irinotecan-based chemoradiation. Methods: 15 patients with rectal cancer clinical stages T3/4 Nx or N+ were recruited to receive weekly neoadjuvant irinotecan (1 hour before radiation) and capecitabine as well as cetuximab with a concurrent RT dose of 50.4 Gy (45+5.4 Gy). Surgery was scheduled 4–6 weeks after the completion of chemoradiation. Samples of normal and tumor tissues of all patients were collected before neoadjuvant treatment. Initially, RNA-oligonucleotid-array of three patients (one good responder and two non-responders) was accomplished to show qualitatively different gene expression. To quantify the differences, real-time PCR of topoisomerase I was performed. Results: The differences of gene expression in the RNA-oligonucletoidarray were correlated to the clinical response to neoadjuvant chemoradiation as topoisomerase I showed a significant higher expression in the tumor tissue of the good responder before treatment (p<0.0001). PCR-analysis showed a relatively higher median expression of topoisomerase I in normal tissue (1.7 vs. 0.9; p=0.85) and in tumor tissue (1.5 vs. 1.3; p=0.36) of the subsequent good responding patients (n=10). Conclusion: Patients respond differentially to chemoradiation in terms of clinical response and gene expression shifts. The oligonucleotidarray results leads us to assume that response may be predictable. The preliminary results of PCR demonstrate that TopoI expression describes a valuable parameter for prediction of efficiency of irinotecan in advanced rectal cancer. The small number of patients may have caused the missing of the statistical significance. We are intending an extension of the PCR analysis to more powerful series based on the achievements of the current investigation results. No significant financial relationships to disclose.

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Haas, Michael, Ayad Abdul-Ahad, Robert Snijder, Dirk Thomas Waldschmidt, Michael Stahl, Anke C. Reinacher-Schick, Jens Freiberg-Richter, et al. "Implementing a novel method to estimate the "Burden of Therapy" (BOTh) for patients with metastatic pancreatic cancer treated with gemcitabine plus afatinib vs. gemcitabine in the AIO ACCEPT trial." Journal of Clinical Oncology 38, no. 15_suppl (May 20, 2020): e16786-e16786. http://dx.doi.org/10.1200/jco.2020.38.15_suppl.e16786.

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e16786 Background: The phase II ACCEPT trial included 119 patients (pts) with histologically proven pancreatic cancer without any previous systemic treatment for metastatic disease. Pts were randomized in a 2:1 ratio to receive either afatinib 40mg orally once daily + gemcitabine (1000mg/m2 iv weekly for three weeks followed by one week of rest, repeated every four weeks) or gemcitabine alone. The addition of afatinib did not lead to improved efficacy (7.3 vs. 7.4 months, HR 1.06, p = 0.80; data previously shown). The traditional analysis of adverse events was not able to reveal the actual patient´s burden in each of the treatment arms. Methods: BOTh is a highly sensitive, novel methodology utilizing patient-level data to derive a quantitative estimate for the “Burden of Therapy/Toxicity” (BOTh) that all or individual pts experience on each day of a clinical study*. The daily burden estimate is based on number and severity of adverse events (AEs) that occur contemporaneously and consecutively, in a combination of incidence and severity resulting in a major advantage over current methods. A chart displays the total burden experienced by pts on each day throughout the study and statistical analyses are performed with the area under curve. Results: The BOTh analysis revealed that the daily burden of toxicity for pts in the gemcitabine-alone arm was 6.8 compared to 11.5 in the combination treatment arm (p = 0.0005). However, the day to day variation in burden was higher in the gemcitabine-alone arm. The higher burden in the combination arm was already visible at a very early stage of the trial when most pts were still on treatment. Conclusions: Whereas the traditional analysis of AEs only gave a static interpretation, BOTh revealed a more dynamic view on burden of toxicity on pts taking single vs combination medication in a 200 day time frame. BOTh can facilitate better informed treatment selection. *Abdulahad A. et.al, Contemporary Clinical Trials Communications 4 (2016) 186-191. Funding: The ACCEPT trial was funded by an unrestricted financial grant by Boehringer Ingelheim. Clinical trial information: NCT01728818 .

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Posner, M., K. J. Chang, A. Rosemurgy, J. Stephenson, M. Khan, T. Reid, W. E. Fisher, I. Waxman, D. Von Hoff, and R. Hecht. "Multi-center phase II/III randomized controlled clinical trial using TNFerade combined with chemoradiation in patients with locally advanced pancreatic cancer (LAPC)." Journal of Clinical Oncology 25, no. 18_suppl (June 20, 2007): 4518. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.4518.

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4518 Background: TNFerade is a replication-deficient adenoviral vector carrying the transgene for human TNF-a protein, regulated by the radiation-inducible promoter Egr-1. A 50 patient (pt) phase II dose-escalation study in LAPC showed a possible dose-dependent improvement in survival. To confirm these findings, the randomized Pancreatic Cancer Clinical Trial with TNFerade (PACT) study was developed. PACT is a 330 pt study, powered to detect a 20% absolute increase in the primary efficacy endpoint (overall survival at 1 year) compared to standard of care (SOC) chemoradiation. An interim analysis of safety and efficacy was planned after the first 51 pts were randomized. Survival data to 11/15/06 has been evaluated and are reported here. Methods: The TNFerade arm pts received a five- wk treatment of weekly injections of 4 x 1011 pu TNFerade, continuous infusion 5-FU (200 mg/m2/day x 5 days/wk) and 50.4 Gy radiation. TNFerade was administered by percutaneous CT-guided transabdominal injection. The SOC arm received the same regimen, without TNFerade injections. Patients were randomized 2:1 to the TNFerade and SOC arms. The first 51 randomized pts were assessed for evidence of objective response (OR) and overall survival Results: Assessment of response data is still ongoing. TNFerade + SOC was well tolerated. One year survival, the primary endpoint of the study, was 70.5% in the TNFerade + SOC arm versus 28.0% in the SOC arm, an absolute increase of 42.5%. The median survival for TNFerade + SOC pts was 515 days compared to 335 days for the SOC pts. The logrank statistic for comparison between the two arms is X2 = 2.014 (p=0.16). Conclusions: The interim survival data is preliminary. The magnitude of the difference in survival in favor of the TNFerade + SOC arm, however, is encouraging. The data appears to corroborate previous findings from the dose-escalation study, which showed an apparent survival advantage in the 4×1011 pu dose group compared to 4 x 109 pu group. A second interim analysis is planned with larger patient numbers to determine whether this early positive trend is confirmed. No significant financial relationships to disclose.

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Baka, S., S. Mullamitha, L. Ashcroft, S. Nagel, R. Board, and P. Lorigan. "Randomized phase III study of carboplatin and paclitaxel versus vincristine, doxorubicin and cyclophosphamide chemotherapy in intermediate and poor prognosis small cell lung cancer: Preliminary results." Journal of Clinical Oncology 24, no. 18_suppl (June 20, 2006): 7059. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.7059.

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7059 Background: The combination of paclitaxel and carboplatin has been found to be effective in lung cancer and well tolerated. Method: This is a phase III randomized trial of paclitaxel and carboplatin (PC) versus vincristine, doxorubicin and cyclophosphamide (CAV) chemotherapy in limited or extensive stage disease patients but with a prognostic score in the intermediate or poor prognosis range.The aim of the study is to determine the one year survival rate, the objective response rate and toxicity. Patients were randomized to: four cycles of PC (paclitaxel 200mg/m2 by IV 3 hour infusion), followed by carboplatin (AUC of 6) by IV injection, 3-weekly or four cycles of CAV (cyclophosphamide 750mg/ m2, doxorubicin 40mg/ m2, vincristine 1.3mg/ m2 by IV injection) every 3-weeks. Thoracic radiotherapy was considered for appropriate patients. Results: 219 patients (110 for CAV and 109 for PC) patients were randomized. Pre-treatment characteristics were well balanced for stage, performance status, and age. There was significantly more grade 3/4 neutropenia in the CAV arm than the PC arm, 67% vs 38% (p < 0.005), whereas the PC arm, had more grade 3/4 thrombocytopenia (19% versus 8% p = 0.012). The PC arm had more grade 2 and 3 neuropathy. 56% grade 3 and 4 infections were observed on CAV arm and 35% on the PC arm (p < 0.005). Hospitalization required for severe neutropenia and infections was less with PC, compared to CAV (146 days for IV antibiotics compared to 308 days for CAV, p < 0.005). Response rates for CAV and PC were 59% and 61% respectively. One-year survival rates for the CAV arm was 6% and 13% for the PC arm. The intention to treat analysis concluded that there is statistical difference on the overall survival time in favor of PC (P = 0.014). Median survival was 94 days (CAV) and 154 (PC). Conclusions: CAV chemotherapy in SCLC patients is associated with higher risk of neutropenic sepsis than taxane based PC chemotherapy with no significant difference on the response rate. The overall survival was better for the PC arm. Final results will follow. No significant financial relationships to disclose.

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Martinez-Balibrea, E., A. Abad, M. Valladares, M. Martinez-Villacampa, E. Aranda, E. Marcuello, M. Benavides, A. Martinez-Cardús, A. Ginés, and J. L. Manzano. "Pharmacogenetic analysis of TS and UGT1A polymorphisms predictive for response and toxicity in Spanish patients with advanced colorectal cancer treated with first-line irinotecan and 5-fluorouracil." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 4066. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.4066.

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4066 Background: The possible role of uridine diphosphate-glucuronosyltransferase 1A (UGT1A) and Thymidylate Synthase (TS) gene polymorphisms in predicting toxicity and outcomes in irinotecan/ 5-Fluorouracil (5FU)-treated patients is still controversial. The aim of this work was to determine whether UGT1A1, UGT1A7, and UGT1A9 as well as TS polymorphisms affect toxicities and/or outcomes of Spanish patients with advanced colorectal cancer (mCRC) Methods: A total of 149 patients with mCRC were treated either with weekly irinotecan plus high-dose 5FU (FUIRI) or biweekly irinotecan plus 5FU/Leucovorin (FOLFIRI) as first-line chemotherapy (Aranda E; Ann Oncol. 2008 Aug 20). Genomic DNA was extracted from peripheral blood and genotyped using allelic discrimination and direct sequencing. Chi-square test, Fisher's exact test and logistic regression were used to study the association of genotypes with toxicity and response. Log rank and cox regression were used in survival analysis. All statistical tests were two-sided. Results: According to TS 5’TRP genotypes, 79.3% of the 2R/2R patients responded to therapy while only 52.5% of 2R/3R or 3R/3R patients do so (HR=3.5; 95% CI=1.3- 9.1; p=0.009). TS genotypes were not associated with toxicity. UGT1A1*28 TA7/TA7 genotype was clearly associated with severe toxicity (HR=12.7; 95% CI=3.1–51.3; p=0.001) and diarrhea (HR=4; 95% CI=1.3–12; p=0.016) when compared to TA6/TA7 and TA6/TA6 genotypes. These patients also experienced more severe neutropenia (40% vs. 18.8%, p=0.087) and more frequent dose reductions (53.3% vs. 38.1%, p=ns). UGT1A7*3/*3 and UGT1A9–118(dT)9/9 were associated with severe diarrhea (50% vs. 27% p=0.032 and 43% vs. 23% p=0.012). When all non-favourable genotypes (TA7/TA7, *3/*3 and 9/9) were taken into account, there was a statistically significant association with severe diarrhea (HR=4.5; 95% CI 1.3–16.3; p=0.021), neutropenia (HR=3.5; 95% CI=1–12.7; p=0.047) and both (HR=12.4; 95% CI=2.8–54.2; p=0.001). Conclusions: Our data clearly link UGT1A genotypes with irinotecan-related severe toxicity. TS 5’TRP genotypes are predictive of response to irinotecan/5FU first-line chemotherapy. No significant financial relationships to disclose.

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