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1

Rehman, Bushra, Nida Javaid, Mohammad Zulqarnain Chaudhary, Mohammad Asad Parvaiz, and Amina Khan. "P162: Is complete pathological response truly a complete response?!" European Journal of Surgical Oncology 46, no. 6 (2020): e53. http://dx.doi.org/10.1016/j.ejso.2020.03.201.

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2

Rehman, Bushra, Sara Rehman, Sameen Mohtasham, Toqeer Zahid, Albash Sarwar, and Muhammad Asad Parvaiz. "Is complete pathological response truly a complete response in breast cancer?" Journal of the Pakistan Medical Association 73, no. 2 (2023): 280–89. http://dx.doi.org/10.47391/jpma.5574.

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Objective: To check if complete pathological response in breast cancer is a good prognostic factor. Method: The retrospective study was conducted at the Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore, Pakistan, and comprised data from January 2012 to December 2015 of all patients who received neo-adjuvant chemotherapy and had no distant metastasis at diagnosis. Mastectomy patients were excluded. Complete pathological response was defined as no detectable tumour cell in breast and axilla on pathological examination of the resected specimen. Tumour characteristics and 5-year disease free survival and overall survival were recorded. Data was analysed using SPSS 20. Results: Of the 353 patients whose data was evaluated, 91(25.8%) had complete pathological response. Mean age at diagnosis was 43+/-10 years. Among them, 62(68%) patients had grade III tumour, 39(42.9%) were negative for oestrogen receptor, 58(63.7%) were negative for progesterone receptor, 25(27.5%) were positive for human epidermal growth factor receptor 2, and 26(28.6%) patients were triple negative. Overall, 28((30.7%) patients had recurrence; 20(71.4%) had distant metastasis, 6(21.4%) had local recurrence, and 2(7.14%) had contralateral cancer. The 5-year disease-free survival and overall survival rates (Kaplan-Meier Survial curve) were 70% (28 patients-recurrence) and 87% (15 patients-deaths), respectively. Conclusion: Despite complete disappearance of tumour, a significant number of patients developed recurrences. Key Words: Complete pathological response, Neo-adjuvant chemotherapy, Survival, Metastasis.
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3

Laino, Charlene. "Trastuzumab increases pathological complete response rates." Oncology Times UK 6, no. 3 (2009): 16. http://dx.doi.org/10.1097/01434893-200903000-00015.

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4

Ocana, Alberto, Bostjan Seruga, and Eitan Amir. "Pathological complete response in breast cancer." Lancet 385, no. 9963 (2015): 113. http://dx.doi.org/10.1016/s0140-6736(15)60015-0.

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5

Fujita, Tetsuji. "Pathological complete response in breast cancer." Lancet 385, no. 9963 (2015): 113. http://dx.doi.org/10.1016/s0140-6736(15)60016-2.

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6

Hindié, Elif, and David Groheux. "Pathological complete response in breast cancer." Lancet 385, no. 9963 (2015): 114. http://dx.doi.org/10.1016/s0140-6736(15)60017-4.

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7

Bonneterre, J., A. Mailliez, S. Giard, et al. "Correlation between clinical response according to WHO criteria and pathological response according to Chevallier and Sataloff in inflammatory breast cancer (IBC)." Journal of Clinical Oncology 25, no. 18_suppl (2007): 11033. http://dx.doi.org/10.1200/jco.2007.25.18_suppl.11033.

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11033 Introduction: IBC has a very poor prognosis ; the first treatment is first primary chemotherapy, followed by surgery and radiotherapy. It has been shown that patients experiencing a complete pathological response haved a longer survival . The pathological response has thus to be carefully assessed. Material and Methods: The aim of this retrospective study was to determine whether there islook for a correlation between clinical response with (WHO criteria) and pathological response using Chevallier’s and Sataloff’s classifications. 56 successive patients received an anthracycline- based chemotherapy regimen for IBC before surgery; for all of these patients a pathological analysis had beenwas performed before chemotherapytreatment and after surgery. Alll the specimens werehave been reviewed by the same pathologist. Results: There is a very good correlation between the 2 pathological classifications fAmong the 56 patients, there were 3 complete clinical responses, which were also pathological complete responses according to both classifications.or the complete responders only. In all the other cases, no correlation wascould be found between the 3 classifications . It was particularly striking for all the 41 patients tumours classified grade 3 according to Chevallier who could be classified clinically (with WHO) or pathologically (with Sataloff) in either of the 4 groups from complete responseders to progressive disease . Overall , in this our series , 3 patients according to Chevallier and 11 according to Sataloff were complete pathological responders. Discussion: The lack of correlation between clinical and pathological classifications could be explained , at least in part, by the fibrosis often observed after primary chemotherapy. The differences observed between the 2 pathological classifications highlight the fact that there is no standard and that further research is neede in that perspective. [Table: see text] No significant financial relationships to disclose.
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8

Sorscher, Steven. "Pathological complete response as a surrogate endpoint." Breast 33 (June 2017): 202. http://dx.doi.org/10.1016/j.breast.2016.11.020.

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9

Rodríguez, Mauricio, Diego M. González, Farah El-Sharkawy, Mileny Castaño, and Jorge Madrid. "Respuesta patológica completa de pacientes con cáncer de mama HER2 positivo tratadas con quimioterapia neoadyuvante en Colombia." Biomédica 43, no. 3 (2023): 396–405. http://dx.doi.org/10.7705/biomedica.6665.

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Introduction. Breast cancer is the most common type of cancer and the leading cause of death by cancer in women in Colombia. Approximately 15 to 20% of breast cancers overexpress HER2.Objective. To analyze the relationship between multiple clinical and histological variables and pathological complete response in patients with HER2-positive breast cancer undergoing neoadjuvant therapy in a specialized cancer center in Colombia. Materials and methods. We performed a retrospective analysis of non-metastatic HER2-positive breast cancer patients who received neoadjuvant therapy between 2007 and 2020 at the Instituto de Cancerología Las Americas Auna (Medellín, Colombia). Assessed parameters were tumor grade, proliferation index, estrogen receptor, progesterone receptor, HER2 status, type of neoadjuvant therapy, pathologic complete response rates, and overall survival.Results. Variables associated with low pathologic complete response rates were tumor grades 1-2 (OR = 0.55; 95% CI = 0.37-0.81; p = 0.03), estrogen receptor positivity (OR =0.65; 95%; CI = 0.43-0.97; p=0.04), and progesterone receptor positivity (OR = 0.44; 95% CI = 0.29-0.65; p = 0.0001). HER2 strong positivity (score 3+) was associated with high pathological complete response rates (OR = 3.3; 95% CI = 1.3-8.35; p=0.013). Five-year overall survival was 91.5% (95% CI = 82.6-95.9) in patients with pathological complete response and 73.6% (95% CI = 66.4-79.6) in patients who did not achieve pathological complete response (p = 0.001). Additionally, the pathological complete response rate was three times higher in patients receiving combined neoadjuvant chemotherapy with anti-HER2 therapy than in those with chemotherapy alone (48% versus 16%).Conclusion. In patients with HER2-positive breast cancer, tumor grade 3, estrogen receptor negativity, progesterone receptor negativity, strong HER2 positivity (score 3+), and the use of the neoadjuvant trastuzumab are associated with higher pathological complete response rates.
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10

Rana, Zaker Hamid, Robert Hong, Joon Han, Isaac Chen, Mohammed Nurhussien, and Nadim Munir Nasr. "The effect of MRI or PET fusion in radiotherapy treatment planning on the pathological complete response rate in rectal adenocarcinoma." Journal of Clinical Oncology 33, no. 3_suppl (2015): 523. http://dx.doi.org/10.1200/jco.2015.33.3_suppl.523.

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523 Background: A pathological complete response rate of 10% to 30% has been noted to occur following preoperative chemoradiation with CT-based treatment planning in patients with rectal cancer. Fusion of the treatment planning CT with other imaging modalities like MRI or PET may help identify tumor location and improve tumor coverage. This retrospective study sought to evaluate the effect of adding MRI or PET imaging to CT-based treatment planning and its impact on pathological complete response rates in patients with rectal cancer. Methods: A retrospective analysis was performed on 39 patients, who received neoadjuvant chemoradiation for rectal adenocarcinoma from February 2009 to September 2013. Patients were divided into two groups. The first group was treated using CT-only based treatment 3D-Conformal or IMRT planning (n=9) and the second was treated using either PET or MRI fusion with the simulation CT scan (n=30). Patients were treated to a total of 5,040 cGy in 28 fractions. Pathological complete response rates (ypT0N0M0) were assessed using postoperative pathologic reports following resection. Results: 39 patients with a median age of 62 received preoperative chemoradiation with an interval to surgery ranging from 34-162 days and a median of 70 days. Patients treated with PET or MRI fusion treatment planning showed a complete pathological response rate at the primary site of 60% and a complete lymph node pathological response rate of 70.83% compared to 22.22% at the primary site and 66.66% at lymph node sites in patients with CT-only treatment planning. In patients treated using MRI or PET fusion, middle rectal cancer showed the best complete pathological response rate at 80%, followed by lower rectal cancer at 41.66%, and upper rectal cancer at 37.5%. Conclusions: Although the sample size was small, utilization of MRI or PET fusion resulted in a higher pathological complete response rate when compared to CT-only based treatment planning, especially in middle rectal cancers. Further studies are needed to accurately identify those patients with a complete pathologic response which may ultimately alter their treatment course.
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11

Ulusoy, Cemal, Gülçin Harman Kamalı, and Andrej Nikolovski. "Analysis of Survival in Complete Pathological Response after Long-Course Chemoradiotherapy in Patients with Advanced Rectal Cancer." Current Oncology 30, no. 1 (2023): 1054–64. http://dx.doi.org/10.3390/curroncol30010081.

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Background: Neoadjuvant chemoradiotherapy prior to surgery is the standard treatment for locally advanced rectal cancer. This consists in the patient’s complete pathological response being achieved with no residual tumor presence in the resected specimen, which results in survival improvement. Methods: This retrospective study aimed to examine the rate of complete pathological response in patients with advanced rectal cancer treated with neoadjuvant long-course chemoradiotherapy and to examine the survival differences between the different tumor regression grade (TRG) scores. Results: A total of 154 patients were operated prior to long-course chemoradiotherapy with a total of 50 Gy plus FOLFOX protocol. Complete pathologic response was achieved in 29 (18.8%) patients. There was no statistical difference for the different pathologic responses according to gender, type of surgery, and number of harvested lymph nodes. Mean survival for all the groups was 37.2 months. Survival within a different TRG score exhibited statistical significance (p = 0.006). Overall, the survival rate during the follow-up period was of 81.8%. Conclusions: The complete pathological response rate in this study was of 18.8%. High tumor regression grade scores (TRG0 and TRG1) had a survival rate of over 90% during follow-up. Multivariate analysis identified perineural invasion and tumor regression grade as independent factors that affect survival.
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12

Nikas, Jason B., Walter C. Low, and Paul A. Burgio. "Prognosis of Treatment Response (Pathological Complete Response) in Breast Cancer." Biomarker Insights 7 (January 2012): BMI.S9387. http://dx.doi.org/10.4137/bmi.s9387.

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Pertaining to the female population in the USA, breast cancer is the leading cancer in terms of annual incidence rate and, in terms of mortality, the second most lethal cancer. There are currently no biomarkers available that can predict which breast cancer patients will respond to chemotherapy with both sensitivity and specificity > 80%, as mandated by the latest FDA requirements. In this study, we have developed a prognostic biomarker model (complex mathematical function) that–-based on global gene expression analysis of tumor tissue collected during biopsy and prior to the commencement of chemotherapy–-can identify with a high accuracy those patients with breast cancer (clinical stages I–III) who will respond to the paclitaxel-fluorouracil-doxorubicin-cyclophosphamide chemotherapy and will experience pathological complete response (Responders), as well as those breast cancer patients (clinical stages I–III) who will not do so (Non-Responders). Most importantly, both the application and the accuracy of our breast cancer prognostic biomarker model are independent of the status of the hormone receptors ER, PR, and HER2, as well as of the ethnicity and age of the subjects. We developed our prognostic biomarker model with 50 subjects [10 responders (R) and 40 non-responders (NR)], and we validated it with 43 unknown (new and different) subjects [10 responders (R) and 33 non-responders (NR)]. All 93 subjects were recruited at five different clinical centers around the world. The overall sensitivity and specificity of our prognostic biomarker model were 90.0% and 91.8%, respectively. The nine most significant genes identified, which comprise the input variables to the mathematical function, are involved in regulation of transcription; cell proliferation, invasion, and migration; oncogenesis; suppression of immune response; and drug resistance and cancer recurrence.
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13

Miličević, Ozana, Ines Trkulja, Andrija Matijević, et al. "Complete pathological response following neoadjuvant chemoradiotherapy in locally advanced colorectal carcinoma." Libri Oncologici Croatian Journal of Oncology 50, no. 2-3 (2022): 81–86. http://dx.doi.org/10.20471/lo.2022.50.02-03.13.

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Background: The prognosis of rectal cancer has improved with neoadjuvant treatment for locally advanced disease. Twenty percent of patients respond to treatment with complete pathological regression, which is clinically estimated with magnetic resonance imaging. Aim: describe the properties of the pathological complete response group of patients at our institution Materials and methods: All selected patients received LCCRT at the University Hospital for Tumors Sestre milosrdnice University Hospital Center, Zagreb, between January 2014 and December 2019 and were later surgically treated at the same facility. Results: We identified 23 patients with complete pathological responses, of which, despite surgery, seven progressed. We recorded a higher proportion of female patients in that group and younger age of onset. MRI preoperatively was not yet predictive of a complete pathological response. Conclusion: The proportion of patients with a complete pathological response is 16% in this cohort. All patients underwent surgery but did not receive consolidating therapy. About 30% progressed during the observed period.
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14

Younger, Alexander Frost, Ross McLean, Petros Amorginos, Andrew Pieri, Henry Cain, and Sunil Amonkar. "P136. Does complete radiological response correlate with a complete pathological response following neoadjuvant chemotherapy?" European Journal of Surgical Oncology 45, no. 5 (2019): 919–20. http://dx.doi.org/10.1016/j.ejso.2019.01.156.

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15

Herrera Kok, Johnn Henry, Antonio Álvarez Martínez, Manuela Pedraza Lorenzo, et al. "Gastric Remnant Cancer: Complete Pathological Response - Case report." European Journal of Surgical Oncology 48, no. 2 (2022): e175. http://dx.doi.org/10.1016/j.ejso.2021.12.363.

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16

Huerta, Sergio. "Predicting a pathological complete response in rectal cancer." Anti-Cancer Drugs 27, no. 8 (2016): 709–10. http://dx.doi.org/10.1097/cad.0000000000000403.

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17

Burki, Talha Khan. "Pathological complete response is no surrogate for survival." Lancet Oncology 15, no. 3 (2014): e111. http://dx.doi.org/10.1016/s1470-2045(14)70086-5.

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18

Groheux, David. "Predicting pathological complete response in breast cancer early." Lancet Oncology 15, no. 13 (2014): 1415–16. http://dx.doi.org/10.1016/s1470-2045(14)71020-4.

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19

Cortazar, Patricia, Charles E. Geyer, Luca Gianni, David Cameron, and Gunter von Minckwitz. "Pathological complete response in breast cancer – Authors' reply." Lancet 385, no. 9963 (2015): 114–15. http://dx.doi.org/10.1016/s0140-6736(15)60018-6.

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20

Mynard, J. N., R. M. Conry, J. De Los Santos, J. B. Gordetsky, and C. M. Contreras. "Pathological complete response after neoadjuvant pembrolizumab and radiation." Clinical and Experimental Dermatology 44, no. 5 (2018): 570–73. http://dx.doi.org/10.1111/ced.13820.

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21

Cabral, F., A. Cruz, R. Casaca, et al. "Complete pathological response (pCR) in gastroesophageal cancer: Correlation with metabolic response." Cancer/Radiothérapie 24, no. 8 (2020): 834–41. http://dx.doi.org/10.1016/j.canrad.2020.05.013.

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22

YETİŞİR, Abdullah Evren, Mahmut BÜYÜKŞİMŞEK, Ali OĞUL, Timuçin ÇİL, and Berna BOZKURT DUMAN. "A new prognostic index associated with pathological complete response in rectal cancer." Cukurova Medical Journal 48, no. 2 (2023): 575–82. http://dx.doi.org/10.17826/cumj.1279880.

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Purpose: Approximately half of rectal cancer cases are diagnosed at a locally advanced stage. It is important to identify biomarkers that can predict pathological complete response in patients undergoing surgery following neoadjuvant chemoradiotherapy.
 Materials and Methods: This retrospective study included 205 patients with locally advanced rectal cancer who underwent surgery and adjuvant chemotherapy following neoadjuvant chemoradiotherapy. Inflammatory biomarkers were assayed in the complete blood count before neoadjuvant therapy.
 Results: A pathological complete response was detected in 20.5% of the patients. The neutrophil-lymphocyte ratio, platelet-lymphocyte ratio, and pan-immune inflammation value were significantly lower in the pathological complete response (+) group than in the pathological complete response (-) group. The cut-off of the pan-immune inflammation value was ≤ 331.2, and this parameter had the best diagnostic performance of 90.4%.
 Conclusion: Neoadjuvant chemoradiotherapy followed by surgery and adjuvant chemotherapy remains the standard treatment approach for rectal cancer. Since pathological complete response improves oncological outcomes, it is important to identify biomarkers that can predict pathological complete response in rectal cancer
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23

Bayramgil, Ayberk, Ahmet Bilici, Ali Murat Tatlı, et al. "Comparison of Standard Neoadjuvant Therapy and Total Neoadjuvant Therapy in Terms of Effectiveness in Patients Diagnosed with Locally Advanced Rectal Cancer." Medicina 61, no. 2 (2025): 340. https://doi.org/10.3390/medicina61020340.

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Background/Objectives: The study aimed to compare the treatment effectiveness of patients with locally advanced rectal cancer undergoing standard neoadjuvant therapy or total neoadjuvant therapy. It also sought to identify prognostic factors for disease-free survival and overall survival and parameters predictive of pathological complete response. Materials and Methods: A retrospective analysis was conducted on 239 patients diagnosed with locally advanced rectal cancer between 2016 and 2022 at several medical centers in Turkey. Clinical data, including neoadjuvant chemoradiotherapy types, chemotherapy regimens, surgical outcomes, and survival metrics, were collected. Statistical analyses included chi-square tests, Kaplan–Meier survival analysis, and Cox proportional hazard models to evaluate prognostic factors for disease-free survival and overall survival and logistic regression to identify predictors of pathological complete response. Results: Among 239 patients, 46.9% received total neoadjuvant therapy, while 53.1% underwent standard neoadjuvant therapy. Total neoadjuvant therapy was associated with a significantly higher pathological complete response rate (45.5% vs. 14.9% in standard neoadjuvant therapy; p < 0.001) and longer disease-free survival (median 124.2 vs. 72.4 months). The 3-year overall survival rate for all patients was 90.7%, and disease-free survival was 76.8%. Multivariate analysis identified pathological complete response (HR: 2.34), total neoadjuvant therapy (HR: 5.12), and type of surgery (HR: 8.12) as independent prognostic factors for disease-free survival, and pathological complete response and absence of lymphovascular invasion as independent prognostic factors for overall survival. Logistic regression analysis showed that total neoadjuvant therapy (OR: 4.40) and initial neoadjuvant chemotherapy (OR: 2.02) were independent predictors of achieving pathological complete response. Conclusions: Total neoadjuvant therapy significantly improves pathological complete response rates, disease-free survival, and overall survival in patients with locally advanced rectal cancer compared to standard neoadjuvant therapy. Total neoadjuvant therapy and achieving pathological complete response are strong independent prognostic factors for both disease-free survival and overall survival, suggesting that a more intensive neoadjuvant approach may lead to better outcomes in locally advanced rectal cancer. The increased pathological complete responses rate with total neoadjuvant therapy has created an opportunity for the development of new treatment modalities and the advancement of non-surgical management strategies in the future.
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Alter, Mareike. "Kutanes Plattenepithelkarzinom: Fortschritte in der neoadjuvanten Immuntherapie mit Cemiplimab." Kompass Dermatologie 12, no. 3 (2024): 153–54. http://dx.doi.org/10.1159/000539925.

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<b>Background:</b> In a pilot study involving patients with cutaneous squamous-cell carcinoma, a high percentage of patients had a pathological complete response with the use of two doses of neoadjuvant cemiplimab before surgery. Data from a phase 2 study are needed to confirm these findings. <b>Methods:</b> We conducted a phase 2, confirmatory, multicenter, nonrandomized study to evaluate cemiplimab as neoadjuvant therapy in patients with resectable stage II, III, or IV (M0) cutaneous squamous-cell carcinoma. Patients received cemiplimab, administered at a dose of 350 mg every 3 weeks for up to four doses, before undergoing surgery with curative intent. The primary end point was a pathological complete response (the absence of viable tumor cells in the surgical specimen) on independent review at a central laboratory, with a null hypothesis that a pathological complete response would be observed in 25% of patients. Key secondary end points included a pathological major response (the presence of viable tumor cells that constitute ≤10% of the surgical specimen) on independent review, a pathological complete response and a pathological major response on investigator assessment at a local laboratory, an objective response on imaging, and adverse events. <b>Results:</b> A total of 79 patients were enrolled and received neoadjuvant cemiplimab. On independent review, a pathological complete response was observed in 40 patients (51%; 95% confidence interval [CI], 39 to 62) and a pathological major response in 10 patients (13%; 95% CI, 6 to 22). These results were consistent with the pathological responses determined on investigator assessment. An objective response on imaging was observed in 54 patients (68%; 95% CI, 57 to 78). Adverse events of any grade that occurred during the study period, regardless of whether they were attributed to the study treatment, were observed in 69 patients (87%). Grade 3 or higher adverse events that occurred during the study period were observed in 14 patients (18%). <b>Conclusions:</b> Neoadjuvant therapy with cemiplimab was associated with a pathological complete response in a high percentage of patients with resectable cutaneous squamous-cell carcinoma.
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Zargham, Anum, Riaz Ahmad, Mussavir Hussain Bangash, Umair Tufail, Ibtisam ., and Anil Babar. "Association of Various Factors in Terms of Pathological Response in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy." Pakistan Armed Forces Medical Journal 73, no. 2 (2023): 561–64. http://dx.doi.org/10.51253/pafmj.v73i2.6651.

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Objective: To analyze the association of various factors in terms of pathological response among breast cancer patients.
 Study Design: Cross-sectional study.
 Place and Duration of Study: Oncology Department, Combined Military Hospital, Rawalpindi Pakistan, from Jan 2019 to Jun 2020.
 Methodology: This study was conducted on 82 female patients with advanced breast cancer who required neo-adjuvant chemotherapy followed by surgical tumour resection. The pathological response was classed as complete, partial, and no response based on histological findings on resected tumour sample. In addition, the age of the patient, stage of disease at presentation, intrinsic (molecular) subtypes and pathological subtype were the factors correlated with response to treatment in the target population.
 Results: A total of 82 female patients were included in the final analysis. The mean age of the patients was 47.421±8.857 years. 27(32.9%) had a complete pathological response, 34(41.5%) had partial, and 21(25.6%) had no response to the neoadjuvant therapy. Intrinsic subtypes of the tumour were statistically significantly associated with pathological response to neoadjuvant therapy (p-value<0.05) in our study participants.
 Conclusion: Considerable number of patients with advanced breast cancer showed pathological responses to neoadjuvant chemotherapy. In addition, intrinsic subtyping significantly predicted pathological response to therapy in our patients, with triple-negative patients having more chances of complete response to neoadjuvant chemotherapy.
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Santos, Elizabeth S., Felipe D'Almeida Costa, Stephania Bezerra, et al. "Correlation of TOP2A expression in HER2-positive breast cancer with pathologic response and clinical outcomes in patients undergoing neoadjuvant treatment based on anthracycline." Journal of Clinical Oncology 30, no. 15_suppl (2012): 643. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.643.

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643 Background: Factors predictive of response to anthracyclines can help selecting patients who really benefit from its use. TOP2A (a target of anthracyclines) and HER2 genes are both amplified in 40% of breast cancers. Data from literature are conflicting regarding the potential of TOP2A as a predictor of response to anthracyclines. Methods: We retrospectively analyzed data on the outcome of patients undergoing neoadjuvant anthracycline-based chemotherapy and evaluated nuclear TOP2A protein expression in breast cancer biopsies by immunohistochemistry (IHC) and reviewed the pathological responses after completion of neoadjuvant treatment. Results: From 2002 to 2011, data from 82 patients was reviewed. Forty nine patients had the paraffin blocks corresponding to the pre-treatment biopsy. All biopsies had some degree of TOP2A IHC expression. Patients were considered positive for TOP2A if the level of expression in IHC was higher than 10%. This was found in 77.6% of cases. Forty percent of the patients achieved pathologic complete response in pos-treatment surgical specimens. Correlation was observed between TOP2A IHC expression and tumor pathological response (p0.02). It was observed a difference in pathological complete response in favour of the group positive for TOP2A (47.4% vs. 22.7%), although not significant (p=0.09). No difference in PFS and OS was observed between patients with complete response after median follow-up of 34 months. Conclusions: The expression of TOP2A seems to be a promising marker to predict pathological response to antracycline-based neoadjuvant chemotherapy in HER2 breast cancer; however these findings would be better evaluated in prospective trials.
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Shintani, Hiroshi, Shoji Oura, and Shinichiro Makimoto. "Hepatocellular Carcinoma Showing Pathological Complete Response to Lenvatinib Monotherapy." Case Reports in Oncology 14, no. 2 (2021): 772–77. http://dx.doi.org/10.1159/000515507.

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A 61-year-old man was referred to our hospital due to the liver dysfunction without hepatitis B or C infection. In addition to the elevated levels of α-fetoprotein (AFP) and protein induced by vitamin K absence or antagonist-II, a large tumor, 10.8 cm in size, and multiple small tumors, up to 1.6 cm in size, in the liver on computed tomography (CT) led to the diagnosis of unresectable advanced hepatocellular carcinoma (HCC). Levatinib monotherapy resulted in complete disappearance of the small liver tumors and marked shrinkage of the largest tumor with complete disappearance of intratumoral enhancement on CT and normalization of serum AFP levels. After 2 months’ cessation of lenvatinib monotherapy due to side effects, the patient underwent residual tumor resection. The pathological findings showed no viable tumor cells, i.e. pathological complete response. The patient was discharged from the hospital on the twelfth day after the operation without any complication. Lenvatinib monotherapy appears to be more effective for HCC than other conventional treatments. In addition, oncologists should take into consideration the possibility of pathological complete response with newly developed anticancer agents including lenvatinib to develop therapeutic strategies to avoid unnecessary overtreatment.
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Cortazar, Patricia, and Charles E. Geyer. "Pathological Complete Response in Neoadjuvant Treatment of Breast Cancer." Annals of Surgical Oncology 22, no. 5 (2015): 1441–46. http://dx.doi.org/10.1245/s10434-015-4404-8.

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29

Reddy, Laxma. "Pathological complete response and its relevance in current times." Cancer Research, Statistics, and Treatment 6, no. 3 (2023): 470–71. http://dx.doi.org/10.4103/crst.crst_258_23.

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30

Fessas, Petros, Linda Charalambous, Sarah Morgan, and Anand Sharma. "Pathological complete response with cocktail chemotherapy in mediastinal seminoma." BMJ Case Reports 18, no. 3 (2025): e261999. https://doi.org/10.1136/bcr-2024-261999.

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A mediastinal mass can present a diagnostic challenge, especially when symptoms necessitate urgent treatment. Mediastinal seminoma, a rare extragonadal germ cell tumour, shares clinical features with testicular seminoma, such as slow growth and high sensitivity to chemotherapy and radiotherapy. This case is of a man in his 40s presenting with cough and chest discomfort, with imaging revealing a large anterior mediastinal mass that was causing left diaphragmatic paralysis due to phrenic nerve involvement. Urgent CT of chest, abdomen and pelvis and tissue biopsy supported the diagnosis of mediastinal seminoma, prompting the immediate initiation of chemotherapy with an induction dose of etoposide and cisplatin, followed by the cisplatin, vincristine, methotrexate, bleomycin alternating with actinomycin D, cyclophosphamide, etoposide regimen. This approach led to significant tumour reduction, facilitating complete surgical resection and sparing of the right phrenic nerve. Despite early fluorodeoxyglucose-positron emission tomography suggesting residual activity, resection histopathology confirmed no malignant cells. The patient achieved a favourable outcome, underscoring the importance of rapid treatment initiation, effective chemotherapy regimens and multidisciplinary management in mediastinal seminoma cases.
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Dr, Himal Aziz Khan Dr Arooj Zafar Dr Muhammad Usama Akram. "PATHOLOGICAL COMPLETE REMISSION OF PANCREATIC CANCER FOLLOWING NEOADJUVANT CHEMORADIATION THERAPY." INDO AMERICAN JOURNAL OF PHARMACEUTICAL SCIENCES o6, no. 04 (2019): 8778–82. https://doi.org/10.5281/zenodo.2658536.

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<em>Neoadjuvant chemoradiotherapy followed by esophagogastrectomy has become the standard of care for patients with locally advanced esophageal cancer. This report analyses our experience with this treatment approach. </em> <em>All patients from a single institution receiving neoadjuvant chemoradiotherapy followed by esophagogastrectomy were reviewed for operative mortality, morbidity, long-term survival, and factors affecting survival. Only patients preoperatively staged with both computed tomographic scans and endoscopic ultrasound were included. </em> <em>There were 162 patients (142 men, 20 women), and the median age was 61 years (range, 22 to 81 years). Histopathology was adenocarcinoma in 143 patients and squamous cell in 19. Pretreatment clinical stage was II in 28 patients (17%), III in 111 (68%), and IV (M1a) in 23 (14%). Ivor Lewis esophagogastrectomy was the most common procedure, occurring in 132 patients. Operative mortality and morbidity was 4.9% and 37%, respectively. Pathologic response was complete in 42 patients (26%), near complete in 27 (17%), partial in 88 (54%), and unresectable in 5 (3%). Five-year survival for overall, complete, near complete, and partial response patients was 34%, 55%, 27%, and 27%, respectively (p = 0.013). Patients whose lymph nodes were rendered free of cancer showed improved overall and disease-free survival compared with patients having persistently positive lymph nodes (p = 0.019). </em> <em>Esophagogastrectomy after neoadjuvant chemoradiotherapy can be performed with low mortality and morbidity. Patients with complete pathologic response have significantly improved long-term survival compared with patients with near complete and partial responses. Future efforts should be directed at understanding determinants of complete responses.</em> <strong>Key Words: </strong><em>Pathological Remission; Panceratic Cancer; Neoadjuvant Chemoradiation Therapy.</em>
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Bai, Ravisha, Ghulam Haider, Kanwal Satyawan, Ammara Manzoor, Shahid Hussain, and Muhammad Hayat Sasoli. "Pathological response rate in patients who achieve clinical response after neoadjuvant concurrent chemoradiotherapy in localized esophageal cancer." Journal of Fatima Jinnah Medical University 14, no. 03 (2020): 114–18. http://dx.doi.org/10.37018/qsqy1921.

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Background: The incidence of esophagus carcinoma is raising and it is the 6th leading cause of mortality. The objective of this study is to determine pathological response rate in patients who achieve clinical response after neo-adjuvant concurrent chemoradiotherapy in locally advanced esophageal cancer presented at a single tertiary care centre in Karachi.&#x0D; Patients and methods: It was a longitudinal study conducted at the Department of Oncology of Jinnah Postgraduate Medical College from May 2017 to July 2018. Thirty five patients with locally advanced carcinoma involving lower and middle esophagus had concurrent chemoradiotherapy. Induction of concurrent chemoradiotherapy with radiations in which carboplatin and paclitaxel was given weekly. After 6 weeks at the end of irradiation, the clinical response was assessed on CT scan. All patients who had achieved stable, partial and complete clinical response after completion of concurrent chemoradiotherapy (CCRT) underwent surgery within 6-8 weeks. After surgery, pathologist evaluated resected specimen and staging was done on the basis of residual tumor. To grade the response to therapy, the degree of histomorphologic regression classified into four categories as Pathological complete response (pCR), pathological partial response, stable disease as no pathological response and progression of disease. Statistical analysis was performed using SPSS version 23. Chi-square test was applied to assess association between effect modifiers and complete pathological response. &#x0D; Results: Total of 35 patients were included in the study. Mean age of the patients was 42.42±14.16 years. There was female preponderance (57.4%) with male to female ratio of 17:18. Eleven patients (31%) achieved complete clinical response and 2 patients (6%) had stable disease. After surgery, complete pathological response was observed in 21 (60%) patients. However, 10 (28.6%) patients achieved partial pathological response, 1 (2.9%) patient had stable disease and 3 (8.6%) patients showed progression of disease.&#x0D; Conclusion: The achievement of complete pathological response was comparatively higher than partial response among locally advanced EC patients who had neoadjuvant CCRT followed by surgery.
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Shigematsu, Hideo, Tomomi Fujisawa, Tadahiko Shien, and Hiroji Iwata. "Omitting surgery for early breast cancer showing clinical complete response to primary systemic therapy." Japanese Journal of Clinical Oncology 50, no. 6 (2020): 629–34. http://dx.doi.org/10.1093/jjco/hyaa055.

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Abstract Breast cancer is highly sensitive to systemic therapy. High probability of pathological complete response suggests a clinical question that omitting surgery is an effective alternative to surgery in breast cancer showing clinical complete response to primary systemic therapy. However, the validity of omitting surgery for early breast cancer after primary systemic therapy has not been sufficiently established; thus, even if pathological complete response is expected in patients showing clinical complete response, excision of the primary tumor site remains the standard treatment of breast cancer. Inappropriate omitting surgery increases the incidence of local recurrence, which can be the risk of a subsequent distant metastasis and reduced overall survival. To achieve acceptable local control rate, omitting surgery should be investigated in patients with early breast cancer where a high percentage of pathological complete response, a high concordance rate between clinical complete response and pathological complete response and an acceptable local control rate are expected. This review presents concept and ongoing clinical trials for omitting surgery for patients with breast cancer showing clinical complete response to primary systemic therapy.
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Sakina Abidi, Syeda, Lubna Vohra, Asad Ali Kerawala, Annam Kafeel, Muhammad Umair Tahseen, and Saad Javed. "Frequency of axillary nodal complete pathological response of breast cancer patients in neoadjuvant chemotherapy setting: A cross-sectional study." Turkish Journal of Surgery 39, no. 2 (2023): 136–44. http://dx.doi.org/10.47717/turkjsurg.2023.5708.

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Objective: Pathological complete response (pCR) occurs in about 20-30% of patients undergoing systemic neoadjuvant therapy. This leads to the idea of sparing the patient the morbidity associated with axillary surgery. “Wait and watch” policy for cancers which achieve complete pathological response on neoadjuvant systemic therapy is a well-established practice in various cancers like the esophagus, rectum and larynx. This has led to organ preservation protocols being practiced worldwide for these cancers without affecting the overall survival of the patient. We believe patients undergoing a complete pathological response in the breast may be spared axillary surgery. Axillary surgery leads to morbidity and extra financial burden with no added advantage in survival. Material and Methods: A total of 326 patients with breast cancer who had received neoadjuvant systemic chemotherapy from 2015 to 2020 were included in our retrospective study. Final histopathology of the breast and axillary surgery was noted to report the frequency of complete pathological response. The frequency of positive nodal disease with respect to stage, grade and type of cancer was measured. Results: Among 326 patients, our study showed that 53% of patients with complete pathological response in breast also had complete response in the axilla compared to 43% with incomplete pathological response. No significant difference was found for age, menopausal status, initial tumor size when patients with complete pathological response were compared to non or partial responders. The rate of complete pathological response was higher in patients with clinically node negative patients after NACT, hormone negative, HER2 positive and triple negative population. Conclusion: Our results indicated that 53% of the patients who developed complete pathological response in the breast underwent needless axillary procedure. Axillary surgery can be staged after the breast surgery if residual tumor is present on the histopathological specimen. In case of pCR, omission of axillary surgery can be considered. However, a larger population, multi-centric studies are needed for treatment guidelines.
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Skoropad, V. Yu, D. D. Kudriavtsev, L. N. Titova, et al. "PATHOLOGICAL COMPLETE RESPONSE TO NEOADJUVANT CHEMORADIOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED GASTRIC CANCER." Siberian journal of oncology 19, no. 3 (2020): 38–46. http://dx.doi.org/10.21294/1814-4861-2020-19-3-38-46.

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The impact of pathological complete response (pCR) on long-term treatment outcomes was analyzed in patients with locally advanced gastric cancer, who received prolonged neoadjuvant chemoradiotherapy.Material and Methods. The study included 45 patients with locally advanced gastric cancer. Neoadjuvant hyperfractionated accelerated radiotherapy at a total dose of 45 Gy was given concurrently with capecitabine and oxaliplatin chemotherapy. There were more men than women. The median age of the patients was 62 years. Tumors were most commonly located in the upper (46 %) and middle (38 %) thirds of the stomach. Low-grade adenocarcinoma and signet-ring cell carcinoma were the most common (65 %). According to a comprehensive examination, including CT and laparoscopy, tumors which invaded the subserous layer of the stomach wall were diagnosed in 17 (37.8 %) patients, and tumors which penetrated the serous layer or surrounding structures were found in 28 (62.2 %) patients. Regional lymph node metastases were detected in 38 (84.4 %) cases.Results. The absolute majority of patients underwent gastrectomy (43 patients, 96 %). Grade IaIb pathological response occurred in almost half of the patients (45.4 % of cases). Peritoneal metastases were found to be the most common mode of cancer dissemination; they were mostly observed in patients with poorly differentiated gastric cancer. Multivariate analysis revealed no effect of any of the factors characterizing the patient, tumor and completeness of treatment on the pathological response grade. However, a correlation between the clinical and morphological assessments of tumor regression was observed. In cases with complete or partial responses of the primary tumor and regional lymph nodes to chemoradiotherapy, 1aIb grades of pathological response were more frequently observed. It was also demonstrated a direct correlation between the pathological response grade and pathomorphological stage of the tumor (yp), as well as ypT and ypN categories. Analysis of long-term treatment outcomes showed that the overall and relapse-free 5-year survival rates were significantly higher in patients with 1a and Ib grades of pathological response. The overall 3-year survival rates were 70 ± 10 % and 41 ± 11 %, respectively (p=0.003). Multivariate analysis using the Cox regression model confirmed a statistically significant independent effect of the pathological response grade on the overall survival (p=0.015).Conclusion. Grade IaIb pathological response was observed in almost half of the patients, who received neoadjuvant chemoradiotherapy for locally advanced gastric cancer. No clinical and morphological factors influencing the pathological response grade were found. A correlation between the clinical and morphological assessments of tumor regression was observed. Patients with Ia-Ib pathological response had significantly higher overall and disease-free survival rates.
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Shanmugam, S. Subbiah, and Aravind Shivakumar. "Pathological Response Patterns to Preoperative Chemoradiation and the Factors Determining Pathological Complete Response in Locally Advanced Carcinoma Rectum." Indian Journal of Colo-Rectal Surgery 7, no. 2 (2024): 19–24. https://doi.org/10.4103/ijcs.ijcs_10_23.

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ABSTRACT Background: Rectal cancer is a formidable health problem worldwide. It is the third most common cancer in men (663,000 cases, 10.0% of all cancer cases) and the second most common in women (571,000 cases, 9.4% of all cancer cases). Rectal cancer accounts for 8% of all cancer deaths, making it the fourth most common cause of death due to cancer. Objectives: The aim of our study is to try to identify the factors that might predict a pathological complete response (pCR) and to analyze the response to preoperative chemoradiation in locally advanced carcinoma rectum using tumor regression analysis scoring. Materials and Methods: We conducted a retrospective analysis that included 64 patients of locally advanced carcinoma rectum (Stage II [T3–4, node-negative] or Stage III [node-positive]) who underwent treatment at our institution from January 2017 to December 2021. Patient data were collected from medical records and survival data were analyzed. Biopsy-proven patients were included and were appropriately staged with a magnetic resonance imaging (MRI) abdomen and pelvis, carcinoembryonic antigen (CEA), and colonoscopy. All of them underwent preoperative chemoradiation with 50 Gy radiation delivered by intensity modulated radiotherapy technique with concurrent oral capecitabine 875 mg/m2 twice daily for 14 days. Patients were then reassessed with MRI and CEA after 6–8 weeks and subjected to appropriate surgery. Upper and middle third rectum patients underwent low anterior resection. Tumors involving the lower third rectum were treated with low anterior resection and abdominoperineal resection. Patients with adjacent organ involvement underwent exenteration as indicated. Postoperative tumor regression analysis was calculated using AJCC/CAP Modified Ryan scheme scoring (Score 0 – complete response, Score 1 – near complete response, Score 3 – partial response, and Score 4 – no response). Patients underwent adjuvant chemotherapy with 6 months of FOLFOX. Statistical data were calculated using SPSS software version 21. P values were obtained with a Chi-square test. Results: Out of 64 patients, 19 patients achieved a complete response with a tumor regression grading (TRG) score of 0 suggesting a complete response. Fourteen patients had a TRG score of 1 indicating a near-complete response. Twenty-two patients had a TRG score of 2 suggesting a partial response and eight patients had a TRG score of 3, indicating no response. After hypothesis, testing with a Chi-square test and analyzing age, sex, site of the tumor, T stage, N stage, type of surgery, lymphovascular invasion, and preoperative biopsy between the pCR and non-pCR, we identified that tumor location (middle third) and T stage (T2) were statistically significant with P = 0.016 and P = 0.002, respectively. Preoperative-CEA levels were also statistically significant in the subgroup which achieved a pCR with a mean value of 3.17 ng/ml. Conclusion: Amongst the various factors that could determine a pCR, we were able to identify a lower T stage (T2), middle rectal tumor location, and pretreatment CEA level of &lt;5 as statistically significant.
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Vera, Ruth, María Luisa Gómez, Juan Ramón Ayuso, et al. "Correlation of RECIST, Computed Tomography Morphological Response, and Pathological Regression in Hepatic Metastasis Secondary to Colorectal Cancer: The AVAMET Study." Cancers 12, no. 8 (2020): 2259. http://dx.doi.org/10.3390/cancers12082259.

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Background: The prospective phase IV AVAMET study was undertaken to correlate response evaluation criteria in solid tumors (RECIST)-defined response rates with computed tomography-based morphological criteria (CTMC) and pathological response after liver resection of colorectal cancer metastases. Methods: Eligible patients were aged ≥18 years, with Eastern Cooperative Oncology Group (ECOG) performance status 0/1 and histologically-confirmed colon or rectal adenocarcinoma with measurable liver metastases. Preoperative treatment was bevacizumab (7.5 mg on day 1) + XELOX (oxaliplatin 130 mg/m2, capecitabine 1000 mg/m2 bid on days 1–14 q3w). After three cycles, response was evaluated by a multidisciplinary team. Patients who were progression-free and metastasectomy candidates received one cycle of XELOX before undergoing surgery 3–5 weeks later, followed by four cycles of bevacizumab + XELOX. Results: A total of 83 patients entered the study; 68 were eligible for RECIST, 67 for CTMC, and 51 for pathological response evaluation. Of these patients, 49% had a complete or partial RECIST response, 91% had an optimal or incomplete CTMC response, and 81% had a complete or major pathological response. CTMC response predicted 37 of 41 pathological responses versus 23 of 41 responses predicted using RECIST (p = 0.008). Kappa coefficients indicated a lack of correlation between the results of RECIST and morphological responses and between morphological and pathological response rates. Conclusion: CTMC may represent a better marker of pathological response to bevacizumab + XELOX than RECIST in patients with potentially-resectable CRC liver metastases.
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Gupta, Ankit, Monalisa Banerjee, Shehnaz Kantharia, and Rajesh Kantharia. "Neoadjuvant Chemotherapy Followed by Surgery in Advanced Oral Squamous Cell Carcinoma-Pathological Response as a Prognostic Indicator?" Journal of Advances in Medicine and Medical Research 35, no. 20 (2023): 205–17. http://dx.doi.org/10.9734/jammr/2023/v35i205191.

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Objective: To analyze the pathological response and clinical outcomes in patients receiving Neoadjuvant chemotherapy followed by surgery in locally advanced oral squamous cell carcinoma.&#x0D; Methods: Retrospective study of prospectively collected data of 87 patients who received Neoadjuvant chemotherapy followed by surgery in locally advanced oral squamous cell carcinoma from 2018 to 2021 was done in the department of head and neck surgery. The pathological response to Neoadjuvant chemotherapy was assessed and classified into complete response, partial response and no response. Pathological response and its prognostic importance with various parameters were evaluated.&#x0D; Results: Total number of 87 patients received Neoadjuvant chemotherapy followed by surgery for locally advanced oral squamous cell carcinoma, 58 cases were of buccoalveolar complex, 27 were of tongue and 2 were of metastasis of unknown origin , complete response to Neoadjuvant chemotherapy was seen in 4 tongue and 2 buccoalveolar complex and 2 metastasis of unknown origin cases, partial response to Neoadjuvant chemotherapy was seen in 35 buccoalveolar complex and 11 tongue cases. Out of total 87 patients 25 patients defaulted adjuvant therapy and did not completed prescribed treatment and were lost to follow up. 62 patients who completed treatment and follow up, 38 (61.2%) patients were present in the complete (6) and partial response (32) group, rest (24) in no response group. In the median follow up period of 42 months, the complete and partial response group patients showed better overall survival (P = 0.058) and disease-free survival (P = 0.174) then the no response group overall survival (P = 0.058) and disease-free survival (P = 0.174) but statistically no significant changes amongst group were observed.&#x0D; Conclusion: The lesions of the tongue are better responding to buccoavleolar complex lesions in complete response groups. disease-free survival and overall survival are higher in the complete response group compared to no response group.
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Shaikh, Sooma Hafeez, Muhammad Umair, Ummarah Zafar Farid, Amaar Talib, Yusra Ashraf, and Laiba Binte Saleem. "Impact of Neo-Adjuvant Chemotherapy in Triple Negative Breast Cancers." Pakistan Armed Forces Medical Journal 75, SUPPL-2 (2025): S340—S344. https://doi.org/10.51253/pafmj.v75isuppl-2.13111.

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Objective: To evaluate the impact of Neo-Adjuvant Chemotherapy on Pathological Complete Response rates, in patients with Triple-Negative Breast Cancer, focusing on the relationship between tumor size, nodal involvement, type of surgery, and treatment outcomes. Study Design: Prospective cohort study. Place and Duration of Study: Pakistan Navy Station Shifa Hospital, Karachi Pakistan, from Feb 2023 to Feb 2025. Methodology: A total of 88 patients with triple-negative breast cancer who received neoadjuvant chemotherapy were included. Baseline characteristics, including tumor size, nodal involvement, and type of surgery, were recorded. The chi-square test was used to compare pathological complete response rates between subgroups. A p-value of &lt;0.05 was considered statistically significant. Results: The overall Pathological Complete Response rate was 43.18%. Nodal involvement was significantly associated with Pathological Complete Response (p=0.01), with N0 patients achieving higher response rates compared to N1 and N2 patients. Tumor size and type of surgery were not significantly associated with Pathological Complete Response (p=0.13 and p=0.30, respectively). Tumor size and type of surgery did not significantly affect outcomes. Adverse effects were observed in 21.59% of patients, with no significant impact. Conclusion: Neo-Adjuvant Chemotherapy is effective in achieving Pathological Complete Response in Triple-Negative Breast Cancer patients, particularly in those without nodal involvement.
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Gronchi, A., A. Le Cesne, N. B. Bui, et al. "A phase II clinical trial of neoadjuvant trabectedin in patients with nonmetastatic advanced myxoid/round cell liposarcoma (MRCL)." Journal of Clinical Oncology 27, no. 15_suppl (2009): 10525. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.10525.

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10525 Background: Trabectedin (ET-743, Yondelis), a marine-derived alkaloid has demonstrated significant activity in the treatment of soft tissue sarcomas (STS) in phase III trials, and has recently received EMEA approval in this indication. A subtype that accounts for 10% of STS, MRCL, displays the fusion FUS-CHOP in 95% of all cases. Preliminary results of neoadjuvant trabectedin (T) in advanced MRCL show reduction in the radiological density of the tumor, clinical improvement, and a pathological complete response (pCR) in the resected tumor mass. A phase II study to further determine the response to T in the MRCL population is presented. Methods: In this multicenter Phase II trial, patients (pts) with locally advanced (stage III) or locally recurrent MRCL were treated for 3 - 6 cycles with T (1.5 mg/m2 q3wk) in the neoadjuvant setting. Main endpoints were: pCR rate, objective response rate by RECIST, and correlation of molecular parameters from tissue samples with clinical outcomes. Results: Twenty-five pts with locally advanced MRCL have been recruited, of whom 20 are evaluable. All had the translocation (t12q13, 16p11) which causes the chimeric FUS-CHOP. Median age was 53 (23–75) and male:female ratio was 1. Thirteen pts completed therapy and underwent curative surgery. Pathological assessment was performed in 10 pts: 2 achieved pCR, 1 as per central pathology review and 1 by local pathology assessment. In addition, 1 pt had a very good pathological response. Ten patients remain to be histologically evaluated. Response rate by RECIST from pts who completed therapy was: 6 partial responses (46%) and 7 disease stabilizations. Remarkably, pathological response does not entirely correlate with response by RECIST since the pts with pCR still had radiological disease but no malignant component was found in the excised tumor mass (only connective and reactive tissue). Two serious adverse reactions of severe rhabdomyolysis, and asthenia, nausea and transaminase elevation were reported. Most common toxicities were liver enzyme elevation, neutropenia and thrombocytopenia. Conclusions: These preliminary results in terms of objective and complete pathologic responses, strongly suggest that T may have a role in the neoadjuvant setting in pts with MRCL. [Table: see text]
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Fernandez Sagarra, A. J., C. Alvarenga, M. Alvarenga, M. L. Kraft, and L. C. Teixeira. "Relationship between tumor characteristics and HER2/neu overexpression with response and outcome in locally advanced breast cancer (LABC) patients (pts) treated with neoadjuvant anthracycline-based chemotherapy (CHT)." Journal of Clinical Oncology 24, no. 18_suppl (2006): 10698. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.10698.

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10698 Objectives: To retrospectively evaluate the relationship between HER2/neu status, pts’ characteristics, prognostic factors and clinical outcome in LABC women treated with neoadjuvant anthracycline-based CHT. Patients and Methods: 118 pts. with stage IIIA-B LABC, excluding inflammatory cancer, were included. HER2 overexpression was evaluated by immunohistochemistry (IHC), only IHC 3+ were defined as positive. The disease-free survival (DFS) was calculated according to Kaplan-Meier method. Fisher test, hazard ratios with 95% interval confidence, and Cox or Wilcoxon models were used. Kruskall-Wallis was used for comparison between medians. Results: Median age was 49 y (range: 31–69); 66 were pre-menopausal, 43 were stage IIIA and 77 IIIB; 59 pts. were N2. Primary tumor average size was 70 mm; 44 tumors were ER+, 43 PR+, 26 (22%) HER 3+, 104 histological grade III, 57 nuclear grade III. Seventy-four pts. (62.7%) achieved objective responses, with 7 complete clinical remissions. There was 1 progressive disease and only 3 pts. (2.5%) didn’t undertake mastectomy. After surgery, four pts. (3.5%) were evaluated as pathological complete remission, 6 (5.2%) with microscopic residual disease and 105 with macroscopic residual tumor. The median DFS was 19 months for the whole group and 39,6 and 31,6 for those achieving complete pathological remission and microscopic residual disease, respectively. There was no association between HER2/neu overexpression and pts’ characteristics, tumor prognostic factors nor with clinical or pathological responses. Negative PR, high tumor nuclear grade, clinical stage IIIA and complete clinical response were predictive factors for pathological response. In multivariate analysis, only pathological lymph node status was prognostic factor for DFS. Conclusions: There was no significant association between HER2 overexpression, tumor prognostic factors and clinical or pathological response to neoadjuvant CHT. Negative PR, high nuclear tumor grade, clinical stage IIIA and clinical complete response were associated to complete pathological response. Lymph node status was a strong prognostic factor for DFS. No significant financial relationships to disclose.
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Margelí, M., B. Cirauqui, V. Vallejos, et al. "Monitorization of primary therapy (PT) by additional imaging methods in locally advanced breast cancer (LABC)." Journal of Clinical Oncology 24, no. 18_suppl (2006): 10580. http://dx.doi.org/10.1200/jco.2006.24.18_suppl.10580.

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10580 Introduction: The response of locally advanced breast cancer (LABC) to Primary therapy (PT) may be monitored clinically and by mammography (MG). Magnetic resonance (MR) and 99mTc-sestamibi scintimammography (SMM) are increasingly being used. The aim of this study was to determine whether MG, MR and SMM are accurate indicators of tumour response to PT and whether they are predictors of histological response. Patients and Methods: A prospective observational study was approved at our institution and 52 patients( p) with core biopsy diagnostic of LABC and written consent were enrolled (mean age 52 years, SD 13) All p had clinical, MG, MR, SM assessment pre- and post- PT. Primary chemotherapy based on anthracyclines was administered as follows: 19 p FEC, 17 p AC-Docetaxel, 8 p Gemcitabine- Doxorubicine- Paclitaxel, 1 p FEC- Docetaxel and 1 p Carboplatin- VP16. 6 p were treated with hormone-therapy. RECIST criteria were considered for clinical response assessment and the same criteria was adapted for imaging and pathologic response. Results: After PT 33 tumours were considered not suitable for breast-conserving surgery. Based on histopathological findings, 10 (19%) lesions showed complete pathologic response, 30 (58%) partial response, 12 (23%) stabilization. No progression was detected. Clinical assessment of tumour complete response agreed with pathology in 40 of 52 tumours (78%), and with MG in 39 (78%). Correlation between MG and pathological findings was observed in 42 p (84%). Correlation between MR and pathological findings was observed in 42 p (82%). Correlation between SMM and pathological findings was observed in 31 p (66%). Among patients with complete pathologic remission, 9 of ten patients achieve a complete response by MR and SMM. Conclusion: In conclusion, our results don’t show that MR and SMM add any benefit to the diagnostic arsenal for predicting histopathological complete response to PT. However these new diagnostic methods should be considered in selected cases. No significant financial relationships to disclose.
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Resende, Uanderson, César Cabello, Susana Oliveira Botelho Ramalho, and Luiz Carlos Zeferino. "Predictors of Pathological Complete Response in Women with Clinical Complete Response to Neoadjuvant Chemotherapy in Breast Carcinoma." Oncology 95, no. 4 (2018): 229–38. http://dx.doi.org/10.1159/000489785.

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De La Fouchardiere, Christelle, Aziz Zaanan, Romain Cohen, et al. "Immunotherapy for localized dMMR/MSI tumors: First interim analysis of the IMHOTEP trial." Journal of Clinical Oncology 41, no. 16_suppl (2023): 2591. http://dx.doi.org/10.1200/jco.2023.41.16_suppl.2591.

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2591 Background: Immune checkpoint inhibitors (ICI) have demonstrated their efficacy in advanced dMMR/MSI (deficient mismatch repair/microsatellite instability) tumors and increasing data are also accumulating in localized resectable stages with about 60% of pathological complete response rate. The goal of the IMHOTEP trial is to assess the safety and efficacy of peri-operative pembrolizumab in localized dMMR/MSI tumors independently of their anatomical origin. Methods: IMHOTEP is a prospective, multicenter, phase II study aimed to include 120 patients (pts) with localized resectable dMMR/MSI tumors, eligible for curative surgery. Pembrolizumab 400 mg flat dose is administered as a perioperative treatment with 1 or 2 doses every 6 weeks before surgery and thereafter every 6 weeks for one year. Primary objective is to evaluate the pathological complete response (pCR) rate defined as ypT0N0 stage. Secondary objectives are to assess major pathological response, centralized pathological review, safety, clinical response rate, recurrence-free survival and overall survival. Here, we present the interim analysis of safety and pathologic response data for the first 70 treated pts. Results: Median age was 67.5 years (26-89), 54.3% were males, and 42.0% were ECOG-PS 0. Surgery was performed in 54/70 pts including 27/35 colorectal (CRC), 16/21 oesogastric (OGC), 4/5 endometrial (EC) and 7/9 other (6 small intestine, 1 bile duct) (OC) cancers. 16 pts (22.9%) were not operated, mainly due to patient’s decision following complete clinical response (n=7). Only one patient was not submitted to surgery because of disease progression. Focusing on the 54 operated pts, 31 and 23 pts received 1 and 2 neoadjuvant pembrolizumab doses respectively. The pCR rate was 38.9% (40.7%, 25.0%, 0.0% and 85.7% in CRC, OGC, EC and OC respectively). Grade 3-4 immune-related adverse events were observed in 4 (5.7%) patients including transaminases increase (n=1), arthritis (n=1), acute kidney injury (n=1) and pneumonitis (n=1). Conclusions: In this IMHOTEP interim analysis, we observed a limited complete pathologic response rate to short-course neoadjuvant pembrolizumab. If we add patients in clinical complete response who chose not to be operated to those with pCR, our results compare with those previously reported. But we can also hypothesize that preoperative treatment duration should be prolonged to obtain more pCR. Overall, tolerance of pembrolizumab was acceptable without new safety signal. Centralized pathological review, major pathological response evaluation and clinical response rate analysis are ongoing. IMHOTEP trial has been registered (first post: March 12th, 2021). Clinical trial information: NCT04795661 .
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Taglietti, Paula Mendonca, Samuel Aguiar, Paulo Henrique Amor Divino, et al. "Role of clinical variables for predicting pathologic response to neoadjuvant chemoradiation in locally advanced rectal cancer." Journal of Clinical Oncology 31, no. 15_suppl (2013): e14691-e14691. http://dx.doi.org/10.1200/jco.2013.31.15_suppl.e14691.

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e14691 Background: pathologic response to neoadjuvant chemoradiation is a strong prognostic factor for rectal cancer. Some studies have suggesting a wait and see approach for rectal cancer after clinical complete response to chemoradiation. In this study, we tried to identify clinical predictive factors of pathologic response to neoadjuvant chemoradiation. Methods: we retrospectively reviewed data of 129 patients from a prospective database, treated between January, 2008 and December, 2012. Patients with mid and low rectal adenocarcinoma, clinically staged (MRI) as T3,T4 any N or any T, N+, received pre-operative chemoradiation, which consists in 5040 cGy, concomitant to 5-FU-based chemotherapy. All patients were operated, by radical TME procedures. The clinical variables analyzed were: age, gender, distance from dentate line, cT stage, cN stage, pre-treatment CEA level, NIH toxicity during chemoradiation, endoscopic assessment of response, and interval between the end of radiation and surgery. We investigate associations between these variables with complete pathological response (cPR) and “good” pathological response (gPR), defined as ypT0orT1 N0. Results: the rate of cPR was 20.2%. The rate of gPR was 31.8%. For predicting cPR, only the endoscopic assessment of response showed significant association with cPR. Among 18 patients with complete endoscopic response, 8 (44.4%) confirmed cPR after resection. Among 93 patients with endoscopic findings suggesting residual disease, 14 (15.1%) presented cPR (p=0.008). 55.6% (10/18) of patients with complete endoscopic response still have microscopic residual disease in the resected specimen. For predicting gPR, only the cN staging was significantly associated with ypT0orT1 N0 (23.9% of gPR among cN+ patients against 41.3% among cN0 patients; p=0.038). Conclusions: clinical tools are very poor for predicting pathological response to neoadjuvant chemoradiation therapy in patients with locally advanced rectal carcinomas. Despite endoscopic assessment of response by retoscopy have showed significant association with cPR, the predictive value was weak.
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Hardik Ponkiya, Sandeep Rao. "Comparison of Clinico-pathological and Radiological Parameters of Response to Neoadjuvant Chemotherapy in Breast Cancer." International Journal of Contemporary Surgery 7, no. 1 (2019): 16–19. http://dx.doi.org/10.37506/ijocs.v7i1.291.

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Complete histological response following neo-adjuvant chemotherapy (NACT) for breast cancer has great prognostic value. This study would access rates of complete clinical, radiological and pathological response in patients of breast cancer treated with neo-adjuvant chemotherapy. To Access Rates of Complete Clinical, radiological And Pathological Response in Patients of Breast Carcinoma Being Treated with NACT.
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Kivuyo, Nashivai, Larry Akoko, John of God Mutajwaha, et al. "Dismal pathological response to neoadjuvant chemotherapy in stage III breast cancer patients in Tanzania: A retrospective review." PLOS One 20, no. 4 (2025): e0321187. https://doi.org/10.1371/journal.pone.0321187.

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Response to neoadjuvant treatment in breast cancer has been associated with good oncological outcomes. In Tanzania, a majority of breast cancer patients are diagnosed at stage III; hence, they almost always require neoadjuvant therapy. However, the response to neoadjuvant therapy in these patients remains unknown. This study examined the pathological responses in women with stage III breast cancer who underwent neoadjuvant therapy and identified sociodemographic and clinical predictors of the pathological response in this cohort. This hospital-based retrospective cohort study was conducted between December 2021 and April 2022. It included women with breast cancer who received neoadjuvant therapy and underwent surgery for breast cancer at Muhimbili National Hospital in Tanzania, from January 2018 through December 2021. Data analysis was performed using SPSS version 25. A complete pathological response was identified upon pathological review of the mastectomy specimen. Chi-square tests and Fischer’s exact tests were used to evaluate the factors associated with a complete pathological response, with a p value of less than 0.05 indicating statistical significance. Ethical approval was obtained from the Muhimbili University of Health and Allied Sciences Institutional Review Board. The study complied with the Helsinki Declaration on studies involving human subjects. A total of 181 breast cancer patients were recruited for the study, with a mean age of 51±12.6 (28–89) years. A complete pathological response to neoadjuvant therapy was observed in 40 (22.1%) patients which is relatively lower compared to studies from Western countries. Disease stage at diagnosis was associated with response to neoadjuvant therapy, with those at stage IIIA showing better complete response than those at stages IIIB and IIIC indicating a need to improve diagnostic strategies to capture patients in the earlier stages to improve outcomes.
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Tazi, Fadl Mohammed, Youness Ahallal, Amal Benlemlih, Abdelhak Khallouk, Mohammed Jamal Elfassi, and Moulay Hassan Farih. "Urinary bladder carcinosarcoma: a complete pathological response after neoadjuvant chemotherapy." Türk Üroloji Dergisi/Turkish Journal of Urology 38, no. 2 (2012): 114–16. http://dx.doi.org/10.5152/tud.2012.025.

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Mbanu, P., E. Vasquez Osorio, H. Mistry, et al. "Clinico-pathological predictors of clinical complete response in rectal cancer." Cancer Treatment and Research Communications 31 (2022): 100540. http://dx.doi.org/10.1016/j.ctarc.2022.100540.

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Kołacińska, Agnieszka, Justyna Chałubińska, Maria Błasińska-Morawiec, et al. "Pathological complete response in younger and older breast cancer patients." Archives of Medical Science 2 (2012): 310–15. http://dx.doi.org/10.5114/aoms.2012.28559.

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