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Journal articles on the topic 'Cyfra 21-1'

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Published: 4 June 2021
Last updated: 5 February 2022

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1

Boutten, Anne. "CYFRA 21-1." EMC - Biologie Médicale 1, no. 1 (January 2006): 1–2. http://dx.doi.org/10.1016/s2211-9698(06)76055-1.

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2

Ohlendorf, D., G. M. Oremek, and D. A. Groneberg. "Cyfra 21-1." Zentralblatt für Arbeitsmedizin, Arbeitsschutz und Ergonomie 67, no. 4 (June 22, 2017): 224–25. http://dx.doi.org/10.1007/s40664-017-0194-0.

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3

Song, Keum-Soo, Satish Balasaheb Nimse, Shrikant Dashrath Warkad, Ae-Chin Oh, Taisun Kim, and Young Jun Hong. "Correction: Quantification of CYFRA 21-1 and a CYFRA 21-1–anti-CYFRA 21-1 autoantibody immune complex for detection of early stage lung cancer." Chemical Communications 55, no. 73 (2019): 10984. http://dx.doi.org/10.1039/c9cc90396h.

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Correction for ‘Quantification of CYFRA 21-1 and a CYFRA 21-1–anti-CYFRA 21-1 autoantibody immune complex for detection of early stage lung cancer’ by Keum-Soo Song et al., Chem. Commun., 2019, 55, 10060–10063.
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4

Zhang, Zhen, Chenglin Tian, Qiang Shi, Jing Hao, Na Zhao, and Zhijie Liu. "Diagnostic Value of CYFRA 21-1 in the Cerebrospinal Fluid for Leptomeningeal Metastasis." Disease Markers 2017 (2017): 1–6. http://dx.doi.org/10.1155/2017/2467870.

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Cerebrospinal fluid (CSF) cytology has low sensitivity for leptomeningeal metastasis (LM); thus, new markers are needed to improve the diagnostic accuracy of LM. We measured carcinoembryonic antigen (CEA) and cytokeratin 19 fragments (CYFRA 21-1) in paired samples of CSF and serum from patients with LM and patients with nonmalignant neurological diseases (NMNDs) as controls. Receiver operating curve analysis was performed to assess their diagnostic accuracy for LM. In patients with NMNDs, CEA and CYFRA 21-1 levels in the CSF were significantly lower than the serum levels. In patients with LM, there was no significant difference between the CSF and serum CEA levels, whereas the CYFRA 21-1 levels were significantly higher in the CSF than the serum. CSF/serum quotients of CYFRA 21-1 were higher than those of CEA in patients with LM and patients with NMNDs. CSF CYFRA 21-1 and CSF/serum quotient of CYFRA 21-1 had high accuracy for differentiating LM from NMNDs that was similar to CSF CEA and CSF/serum quotient of CYFRA 21-1, whereas serum CYFRA 21-1 is of poor diagnostic value. Measurement of CSF CYFRA 21-1 should not be overlooked in patients with suspected LM, even if the serum CYFRA 21-1 level is within normal limits.
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5

Song, Keum-Soo, Satish Balasaheb Nimse, Shrikant Dashrath Warkad, Ae-Chin Oh, Taisun Kim, and Young Jun Hong. "Quantification of CYFRA 21-1 and a CYFRA 21-1–anti-CYFRA 21-1 autoantibody immune complex for detection of early stage lung cancer." Chemical Communications 55, no. 68 (2019): 10060–63. http://dx.doi.org/10.1039/c9cc03620b.

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6

Rashid, H., S. Hossain, R. K. Chowdhury, S. Rahman, and M. M. Khan. "Role of Serum CYFRA 21-1 in the Diagnosis of Primary Lung Cancer." Journal of Medical Science & Research 27, Number 2 (July 1, 2017): 13–18. http://dx.doi.org/10.47648/jmsr.2017.v2702.03.

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Majority of the lung cancer occurs in developing countries. In case of Bangladesh it's a burden for health in both serest. A definitive diagnosis of lung cancer can help the surgeons and physicians for making decisions about the plan of treatment. The rapidity of diagnosis also alleviates the patient's anxiety whether the lesion is nonmalignant or malignant Several studies proposed the role of CYFRA 21-1 level in diagnosis of lung cancer and its better management. To find the sensitive, feasible and cost effective test for detection of lung cancer and to evaluate the CYFRA 21-1 with their histopathological findings. This case control study was carried out in the department of Medicine of National Institute of Diseases of the Chest and Hospital (NIDCH) Dhaka and Enam Medical College Hospital, Savar, Dhaka during the period from January 2017 to September 2017. We included a total of 80 subjects among them 40 diagnosed cases of lung cancer and 40 controls with diseases other than lung cancer. The mean normal (< 3.5) serum CYFRA 21-1 level was (Mean *SD) 1.10 t 1.5 with ranging from 0.87 ng /ml — 1.5 ng lint Normal level of CYFRA 21-1 was found in all 40 (100%) of controls. The mean of high (> 3.5) serum CYFRA 21-1 level was (Mean +-SD) 18.20 ± 13.63 with rangingfrom 6.9 ng hnl — 49.30 ng/ml. High level of CYFRA 21-1 level was found in maximum 35(87.5%) cases. High (> 3.5 rig/m1) serum CYFRA 21-1 level was found maximum in squamous cell carcinoma (20), next adenocarcinoma (15). Among 40 cases diagnosed as malignant by histopathology, serum CYFRA 21-1 level was compared with histopathological findings. The sensitivity of serum CYFRA 21-1 level in case of squamous cell carcinoma, adenocarcinoma and combined were 90.90%, 83.33% and 87.5% respectively. The sensitivity and accuracy of serum CYFRA 21-1 for squamous cell carcinoma was more than that of adenocarcinoma. So serum CYFRA 21-1 level was highly sensitive for squamous cell carcinoma.
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7

Szturmowicz, M., A. Sakowicz, P. Rudzinski, J. Zych, E. Wiatr, J. Zalęska, and E. Rowinska-Zakrzewska. "The Clinical Value of Cyfra 21-1 Estimation for Lung Cancer Patients." International Journal of Biological Markers 11, no. 3 (July 1996): 172–77. http://dx.doi.org/10.1177/172460089601100306.

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Cytokeratin-19, one of the cytoskeletal proteins, is expressed both in bronchial epithelium and in lung cancer cells. The aim of our study was to establish the value of serum cytokeratin-19 soluble fragment (Cyfra 21-1) measurement in lung cancer patients. Cyfra 21-1 levels were estimated in 35 patients (pts) with benign lung diseases and in 116 lung cancer patients: 55 pts with squamous cell lung cancer, 38 pts with small cell lung cancer and 23 pts with adenocarcinoma. The cutoff level was set at 4 ng/ml with a specificity of 94% and a sensitivity of 40%. Elevated Cyfra 21-1 values were found in 44% of squamous cell lung cancer, 39% of adenocarcinoma and 34% of small cell lung cancer pts (the difference was not significant). In squamous cell lung cancer and in adenocarcinoma elevated Cyfra 21-1 values were observed more often in patients with advanced disease than in patients with limited disease. There was no significant correlation between the initial Cyfra 21-1 level and the response to chemotherapy. Cyfra 21-1 was hot a prognostic indicator, although in operable squamous cell lung cancer the proportion of survivors in the second year of observation was higher among the patients with normal preoperative Cyfra 21-1 levels.
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8

Kim, Jung Hoon, Joon Cheol Song, Jung Hyun Kwon, Dae Kyun Kim, Dong Wook Jekarl, Jeong Won Jang, and Young Chul Yoon. "CYFRA 21-1 as a novel diagnostic serum biomarker in pancreatic cancer." Journal of Clinical Oncology 32, no. 3_suppl (January 20, 2014): 191. http://dx.doi.org/10.1200/jco.2014.32.3_suppl.191.

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191 Background: CYFRA 21-1 is a fragment of cytokeratin 19, a structure protein and part of intermediate filament proteins contributing to stability of epithelial cells. Serum concentration of CYFRA 21-1 is known to be elevated in many types of epithelial malignancies, and especially it has a prognostic and predictive value in patients with non-small cell lung cancer. We assessed serum CYFRA 21-1 and studied its clinical significance in patients with pancreatic cancer. Methods: The sera from 52 patients diagnosed with pancreatic cancer was collected between May 2012 and August 2013 at Incheon St. Mary’s hospital, Catholic University of Korea, School of Medicine and was measured for CYFRA 21-1 and CA 19-9. 48 patients had an advanced disease at presentation, 2 patients had a locally advanced disease, and 2 patients presented with a local disease. Control blood samples were obtained from 31 healthy individuals and 48 patients with nonmalignant hepatic or pancreatobiliary disease. We measured CYFRA 21-1 using two-step sandwich, chemiluminescent microparticle immunoassay, Architect i2000SR (Abbott Laboratories, Ltd., Il, USA). Results: Serum concentration of CYFRA 21-1 was significantly elevated in patients with pancreatic cancer compared with control group. (p=.000) CYFRA 21-1 ( >1.96 ng/ml as determined by the ROC curve) had a sensitivity, specificity, positive predictive value, and negative predictive value of 86.5%, 79.7%, 73.8%, 90% for the diagnosis of pancreatic cancer. Additionally, CA 19-9 ( >35 U/ml determined by our institute’s criteria) had a sensitivity, specificity, positive predictive value, and negative predictive value of 67.3%, 89.9%, 69.1%, 81.6%. The area under curve for CYFRA 21-1 and CA 19-9 was 86.3% and 81.5%, respectively. Conclusions: CYFRA 21-1 has a potential to become a novel serum biomarker for the diagnosis of pancreatic cancer. Serum concentration of CYFRA 21-1 in combination with CA 19-9 can be useful in clinical practice to diagnose pancreatic cancer.
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9

Deng, Yan Fei, Ping Chen, Yong Zhi Lin, Jia Zhen Le, Xiao Li Wu, Ming Qiang Yu, Pei Yun Zhuang, and Ming Hua Gao. "Analytical and clinical evaluation of CYFRA 21-1 by electrochemiluminescent immunoassay in head and neck squamous cell carcinoma." Journal of Laryngology & Otology 117, no. 3 (March 2003): 190–94. http://dx.doi.org/10.1258/002221503321192485.

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This paper attempts to evaluate the clinical usefulness of CYFRA 21-1 as a serum tumour marker in patients with head and neck squamous cell carcinoma (HNSCC).The serum concentration of CYFRA 21-1 was measured utilizing a new electrochemiluminescent immunoassay (ECLIA) in 142 patients with HNSCC before and after treatment, 68 patients with benign tumours of the head and neck, and 50 healthy controls.Serum levels of CYFRA 21-1 in patients with HNSCC were significantly higher than those of benign tumours and healthy controls (p < 0.001). The diagnostic sensitivity and specificity of CYFRA 21-1 for HNSCC were 62 per cent and 100 per cent, respectively. The positive rates of CYFRA 21-1 increased with progression of HNSCC, serum CYFRA 21-1 levels were related to the tumour stage expressed by primary tumour (T) and nodal status (N) (p < 0.001), but not related to patient age, gender, smoking and drinking habit, or histopathological grade (p > 0.05). Post-treatment levels of CYFRA 21-1 in HNSCC decreased significantly (p < 0.001). Among 38 patients with clinical or radiological evidence of a recurrence during follow-up, 78.9 per cent (30 of 38) showed an increase in CYFRA 21-1.The analytical ECLIA performance for serum CYFRA 21-1 provides a new means of clinical assessment for HNSCC. The results of ECLIA suggest that the serum marker CYFRA 21-1 is valuable not only for diagnosis but also for close monitoring of patients with HNSCC.
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10

Gadducci, A., M. Ferdeghini, S. Cosio, A. Fanucchi, R. Cristofani, and A. R. Genazzani. "The clinical relevance of serum CYFRA 21-1 assay in patients with ovarian cancer." International Journal of Gynecologic Cancer 11, no. 4 (2001): 277–82. http://dx.doi.org/10.1136/ijgc-00009577-200107000-00004.

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Abstract.Gadducci A, Ferdeghini M, Cosio S, Fanucchi A, Cristofani R, Genazzani AR. The clinical relevance of serum CYFRA 21-1 assay in patients with ovarian cancer.CYFRA 21-1 assay, which detects serum fragments of cytokeratin 19, has been widely assessed as a serum marker of several malignancies. Preoperative serum CYFRA 21-1 levels were retrospectively measured in 60 patients with ovarian cancer and in 59 control patients with benign ovarian disease. CYFRA 21-1 levels were also serially measured in 90 serum samples drawn from patients with advanced (FIGO stage III-IV) ovarian cancer followed after surgery and chemotherapy. Preoperative serum CYFRA 21-1 levels were higher in patients with ovarian cancer compared with controls (median, range = 2.6, 0.1–51.4 ng/ml versus 0.4, 0.0–3.6 ng/ml, P < 0.0001), and among the former, antigen values were higher in the 39 patients with advanced-stage than in the 21 patients with early (FIGO stage I-II) disease (P < 0.0001). In advanced ovarian cancer patients, the 25%, 50%, and 75% quantiles of preoperative CYFRA 21-1 levels were 1.9, 4.8 and 14.4 ng/ml, respectively. Preoperative CYFRA 21-1 levels were lower in the 11 patients who achieved a pathologic complete response at second-look compared with those who had clinically or surgically detectable persistent disease after first-line chemotherapy (median, range 1.9, 0.6–9.2 ng/ml versus 10.2, 0.1–51.4 ng/ml, P = 0.007). The pathologic complete response rate was significantly greater in patients with low preoperative CYFRA 21-1 levels compared with those with elevated CYFRA 21-1 levels at any cut-off limit for the antigen (1.9, 4.8 and 14.4 ng/ml). However, Cox regression analysis failed to detect a significant association between preoperative CYFRA 21-1 assay and survival. As for the follow-up of advanced ovarian cancer patients, CYFRA 21-1 levels were higher in the 42 samples drawn from patients with clinically detectable disease compared with the 48 specimens collected from patients with no clinical evidence of disease (median, range = 1.15, 0.3–40.7 ng/ml versus 0.4, 0.1–9.1 ng/ml, P < 0.0001). In conclusion, preoperative serum CYFRA 21-1 assay appears to be predictive of response to chemotherapy, but not prognostic of survival, for patients with advanced ovarian cancer. Moreover, the serial measurement of CYFRA 21-1 levels might have a potential clinical relevance for the assessment of disease status in patients followed after surgery and chemotherapy.
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11

Sánchez-Carbayo, Marta, Antonia Espasa, Virtudes Chinchilla, Enrique Herrero, Julián Megías, Antonio Mira, and Federico Soria. "New Electrochemiluminescent Immunoassay for the Determination of CYFRA 21-1: Analytical Evaluation and Clinical Diagnostic Performance in Urine Samples of Patients with Bladder Cancer." Clinical Chemistry 45, no. 11 (November 1, 1999): 1944–53. http://dx.doi.org/10.1093/clinchem/45.11.1944.

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Abstract Background: A new electrochemiluminescent immunoassay (ECLIA) has been developed for the determination of cytokeratin 19 (CYFRA 21-1) in the Elecsys 2010 immunoassay system. Urinary CYFRA 21-1 might have a role in the diagnosis of bladder cancer. Methods: We performed an analytical evaluation of the CYFRA 21-1 ECLIA for serum and urine samples. The clinical value of urinary CYFRA 21-1 for the detection of bladder cancer was evaluated through its measurement in 226 urine samples from symptomatic and asymptomatic controls. Results: At concentrations of 2–30 μg/L, within-assay imprecision (CV) was below 2.1% for sera and 3.3% for urines, with interassay CVs below 3.3% for sera and 4.9% for urines. The day-to-day CV was &lt;20% at concentrations &gt;0.2 μg/L (functional sensitivity). Measurement of diluted samples showed that the assay estimated CYFRA 21-1 between 98% and 103% for sera and 98% and 105% for urines. Recovery of added CYFRA 21-1 was 99–105% for sera and 96–115% for urines. We separately compared serum and urine CYFRA 21-1 ECLIA results with those obtained with an IRMA (CIS bio international). Regression analysis for sera was: CYFRA 21-1 (ECLIA) = 0.520 + 1.018 CYFRA 21-1 (IRMA); [95% confidence interval (CI) (y-intercept), −0.260 to 1.309]; 95% CI (slope), 0.978–1.060; n = 100; Sy|x = 3.242; r2 = 0.987. For urine samples it was: CYFRA 21-1 (ECLIA) = 0.716 + 0.966 CYFRA 21-1 (IRMA); 95% CI (y-intercept), 0.009–1.422; 95% CI (slope), 0.956–0.976; n = 100; Sy|x = 4.136; r2 = 0.986. In urine samples voided by patients with and without bladder cancer, the best ROC analysis discrimination provided 81.0% (95% CI, 72.7–87.7%) sensitivity and 97.2% (95% CI, 90.2–99.6%) specificity at a threshold value of 5.7 μg/L. Conclusions: Our initial evaluation showed reliable analytical performance for urinary CYFRA 21-1, which might assist urologists in the detection of bladder cancer as a noninvasive adjunct to cystoscopy.
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12

Li, Zhong-Qian, Robert J. Smalley, Curtis L. Glover, Savitha Raju, Katherine Falcone, Maryellen Fegely, Kuanglin He, Rachel R. Radwan, and Timothy R. Kettlety. "Comparison of serum CYFRA 21-1 and ROMA in distinguishing ovarian cancer from benign pelvic masses." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e15565-e15565. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e15565.

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e15565 Background: CYFRA 21-1 is a known lung cancer biomarker. In subjects with ovarian cancer (OC) versus those with benign gynecological diseases, serum CYFRA 21-1 was reported sensitivities (SN) of 44% and 41% at specificity (SP) of 95% for OC detection using an ELISA assay by Hasholzner U (1994) and Tempfer C (1998), respectively. Nolen B (2010) reported a SN of 84.1% and 85.8% and a SP of 85% and 79.3% with a combination of CYFRA 21-1, CA 125 and HE4 using a multiplex bead-based immunoassay in a training and validation set, respectively. We carried out a cohort study to evaluate the serum CYFRA 21-1 as an ovarian cancer biomarker and compared it with ROMA (Risk of Ovarian Malignancy Algorithm), an FDA-cleared ovarian cancer algorithm. Methods: ARCHITECT CYFRA 21-1 assay was used to measure the levels of serum CYFRA 21-1. Single point serum samples from 170 female subjects with a pelvic mass were randomly selected from an archive cohort of female subjects. Among the 170 subjects, 47 had OC (42 with epithelial OC and 5 with low malignant potential tumor) and 123 with benign gynecological diseases. ROMA values were obtained with HE4 EIA and ARCHITECT CA 125 II. Results: For ARCHITECT CYFRA 21-1, the ROC-AUC, cut-off, SN, SP, PPV and NPV were 86%, 1.8 ng/mL, 70.2% (95% CI: 55.1% to 82.7%), 95.1% (95% CI: 89.7% to 98.2%), 84.6% and 89.3%, repectively. For ROMA algorithm, the ROC-AUC, cut-off, SN, SP, PPV and NPV were 92%, 2.44, 89.4% (95% CI: 76.9% to 96.5%), 84.6% (95% CI: 76.9% to 90.4%), 68.9% and 95.4%, repectively. Chi-square test showed an SN for ROMA was significantly higher than that of ARCHITECT CYFRA 21-1 (p < 0.05), and SP for ARCHITECT CYFRA 21-1 was significantly higher than that of ROMA (p < 0.01). Conclusions: In distinguishing OC from benign gynecological diseases, ROMA algorithm appears to be more sensitive than serum ARCHITECT CYFRA 21-1 (p < 0.05), and serum ARCHITECT CYFRA 21-1 appears to be more specific than (p < 0.01) in this cohort study.
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13

Mady, Essam A. "Cytokeratins as Serum Markers in Egyptian Bladder Cancer. A Comparison of CYFRA 21–1, TPA and TPS." International Journal of Biological Markers 16, no. 2 (January 2001): 130–35. http://dx.doi.org/10.1177/172460080101600208.

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Cytokeratins (CKs) have been shown to be overexpressed in bladder cancer and to be valuable as tumor markers. The present study was designed to evaluate the single and combined use of three cytokeratin fragments, CYFRA 21–1, TPA, and TPS, in serum of Egyptian bladder cancer patients. The study subjects comprised 40 healthy controls, 30 patients with benign bladder diseases, and 60 patients with histologically confirmed primary bladder cancer. The cutoff was set at 95% specificity versus benign bladder diseases, resulting in cutoff values of 2.93 ng/mL for CYFRA 21–1, 158 U/L for TPA and 143.7 ng/mL for TPS. With 41% true positive results CYFRA 21-1 had a higher sensitivity than TPA (32%) and TPS (27%). Evaluation by histological findings revealed a highest sensitivity of CYFRA 21-1 (46%) in transitional cell carcinoma (TCC) followed by TPA (27%) and TPS (21%). Also in adenocarcinoma CYFRA 21-1 showed the highest sensitivity (38%) followed by TPA (32%) and TPS (28%). A high percentage (41.6%) of Egyptian bladder cancers is represented by squamous cell carcinoma (SCC). In this population TPS showed the highest sensitivity (69%), followed by CYFRA 21-1 (54%) and TPA (41%). The sensitivity of each of the three markers increased with advancing tumor stage and increasing tumor grade. Combined use of two of the three markers did not raise the sensitivities obtained by single determination of CYFRA 21-1. The present study suggests that serum CYFRA 21-1 could be a marker of choice in bladder cancer.
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Céruse, Philippe, Muriel Rabilloud, Anne Charrié, Christian Dubreuil, and François Disant. "Study of Cyfra 21–1, a Tumor Marker, in Head and Neck Squamous Cell Carcinoma." Annals of Otology, Rhinology & Laryngology 114, no. 10 (October 2005): 768–76. http://dx.doi.org/10.1177/000348940511401006.

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Objectives: We performed a prospective study to determine the cutoff value and the prognostic value of Cyfra 21–1, a serum tumor marker, in head and neck squamous cell carcinoma (HNSCC). Methods: The serum concentration of Cyfra 21–1 was measured in a group of 300 patients (group 1) with HNSCC, in a control group of 71 healthy subjects (group 2), and in a group of 73 patients with a nonmalignant tumor or inflammatory disease (group 3). The concentrations were compared between the various groups and subgroups; the cutoff value was calculated with a receiver operating characteristic curve. Furthermore, the serum concentrations of Cyfra 21–1 before treatment in the group of 300 patients were compared with the stage of the disease and with the evolution of the overall survival rate and the disease-free survival rate. Finally, to determine whether Cyfra 21–1 is an independent prognostic factor, we compared the concentrations, by a Cox model, with the classic prognostic factors of HNSCC. Results: At the cutoff value of 1 ng/mL, the specificity was 94% and the sensitivity was 72%. The serum concentrations of Cyfra 21–1 were statistically correlated with the stage of the disease. The overall survival rate and the disease-free survival rate were lower in patients with high serum concentrations, and these differences were statistically significant (p <.001). The Cox model allows us to conclude that Cyfra 21–1 is a prognostic marker that is independent of other classic prognostic factors. Conclusions: Cyfra 21–1 is an interesting tumor marker that could be proposed for the early detection of HNSCC with a cutoff value of 1 ng/mL. Furthermore, Cyfra 21–1 can be considered an independent prognostic marker.
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Shirasu, Hiromichi, Akira Ono, Katsuhiro Omae, Kazuhisa Nakashima, Shota Omori, Kazushige Wakuda, Hirotsugu Kenmotsu, et al. "CYFRA 21-1 predicts the efficacy of nivolumab in patients with advanced lung adenocarcinoma." Tumor Biology 40, no. 2 (February 2018): 101042831876042. http://dx.doi.org/10.1177/1010428318760420.

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CYFRA 21-1 is a prognostic marker for non–small cell lung cancer. The serum CYFRA 21-1 level is also known as an adjunct for the diagnosis of lung squamous cell carcinoma. This study aimed to examine whether CYFRA 21-1 has predictive implications for nivolumab therapy in patients with advanced lung adenocarcinoma. Of the 79 patients who were treated with nivolumab therapy at the Shizuoka Cancer Center between December 2015 and September 2016, we retrospectively reviewed the data of 50 patients. The patient characteristics were as follows: age <70/≥70 years: 43 (86%)/7; male/female: 31 (62.0%)/19; Eastern Cooperative Oncology Group performance status 0–1/2: 43 (86%)/7; smoking status: no/yes: 18 (36%)/32; epidermal growth factor receptor mutation status negative/positive: 36 (72%)/14; CYFRA 21-1 ≥2.2/<2.2 ng/mL: 28 (56%)/22; carcinoembryonic antigen ≥5/<5 ng/mL: 29 (58%)/21; and number of prior regimens 2–3/≥4: 16 (32%)/34. With a median follow-up of 263.5 (range, 64–352) days, the median progression-free survival was 70 days. The clinical variables investigated using univariate analysis were as follows: age (p = 0.423), carcinoembryonic antigen (p = 0.888), epidermal growth factor receptor mutation status (p = 0.105), performance status (p = 0.968), sex (p = 0.210), number of prior regimens (p = 0.146), CYFRA 21-1 (p = 0.026), and smoking status (p = 0.041). A multivariate analysis identified a serum CYFRA 21-1 level ≥2.2 ng/mL as an independent predictor of a favorable outcome (hazard ratio, 0.44; 95% confidence interval, 0.23–0.85; p = 0.015; median progression-free survival, 155 vs 51.5 days). In conclusion, CYFRA 21-1 might be an independent predictor of outcome for patients with advanced lung adenocarcinoma treated with nivolumab.
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Mrochem-Kwarciak, Jolanta, Tomasz Rutkowski, Andrzej Wygoda, Regina Deja, Agata Hajduk, and Krzysztof Składowski. "Early diagnosis of radiotherapy failure for patients with head and neck cancer: the role of biochemical markers." Tumori Journal 104, no. 4 (May 8, 2018): 273–79. http://dx.doi.org/10.5301/tj.5000639.

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Purpose: There is a lack of effective diagnostic tools for early assessment of radiotherapy (RT) outcome in patients with head and neck cancer (HNC). The timely diagnosis of treatment failure may facilitate use of salvage procedures to prevent disease progression. We assessed squamous cell carcinoma antigen and CYFRA 21-1 as early markers of radiotherapy failure in patients with HNC. Methods: Between January 2009 and February 2012, 185 patients (median age 59 years) with squamous cell carcinoma were treated with curative intent with RT alone or combined with chemotherapy (ChT). Markers were estimated in the serum 2 times: before RT and after completion of treatment. Results: The median of follow-up was 40 months. Locoregional control (LRC) was 53% and locoregional failure (LRF) was 31%. When comparing LRC and LRF, there were no significant differences between markers concentration obtained before RT. After RT, CYFRA 21-1 (p = 0.018) was significantly elevated in the LRF group. Patients with CYFRA 21-1 <1.79 ng/mL had a higher disease-free survival rate compared to patients with CYFRA 21-1 ≥1.79 ng/mL (74% vs 53%, respectively). After RT, CYFRA 21-1 was significantly related to the overall survival ratio in both univariate (p = 0.049) and multivariate analysis (p = 0.019). Conclusions: CYFRA 21-1 assessed at the end of RT or ChT seems to be a prognostic marker for tumor response. A high concentration of CYFRA 21-1 after treatment increases the risk of death. CYFRA 21-1 might be suggested in the monitoring of carcinomas of HNC.
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Lee, Jeongmin, Hye Lim Park, Chan-Wook Jeong, Jeonghoon Ha, Kwanhoon Jo, Min-Hee Kim, Jeong-Sun Han, et al. "CYFRA 21-1 in Lymph Node Fine Needle Aspiration Washout Improves Diagnostic Accuracy for Metastatic Lymph Nodes of Differentiated Thyroid Cancer." Cancers 11, no. 4 (April 5, 2019): 487. http://dx.doi.org/10.3390/cancers11040487.

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Fine needle aspiration cytology (FNAC) and washout thyroglobulin (Tg) measurements are the standard for evaluating a metastatic lymph node (LN) in thyroid cancer. However, patients rarely benefit from these procedures due to false results. This study aims to identify a reliable biomarker that significantly improves the diagnosis of metastatic LNs, in addition to FNAC and washout Tg. This study analyzed 130 LNs that were suspected to have metastases on thyroid ultrasonography, from June 2016 to December 2017. All subjects underwent FNAC, washout Tg measurements and a new biomarker, washout Cytokeratin fragment 21-1 (CYFRA 21-1) measurement. The final LN outcomes were confirmed by surgical histology, repeat FNAC, or follow-up image. The diagnostic values of the presence of washout CYFRA 21-1 for diagnosing metastatic LNs were evaluated according to final LN outcomes. Among the 130 LNs, 42 were metastatic lesions and 88 were benign. The washout CYFRA 21-1 levels were significantly higher in metastatic LNs than in benign LNs. In contrast to the findings of washout Tg, washout CYFRA 21-1 showed little overlap between benign and malignant LNs, and its diagnostic cutoff values were not affected by surgery. The combinations of FNAC and washout CYFRA 21-1 showed higher sensitivity (91.9%), specificity (96.5%), negative predictive value (98.8%), and diagnostic accuracy (94.2%) than FNAC with washout Tg. The combination of FNAC, washout Tg, and washout CYFRA 21-1 showed the best sensitivity (98.8%). When washout CYFRA 21-1 was applied to the discordant results that were observed between FNAC and washout Tg, 20 of 22 LNs were correctly diagnosed. Washout CYFRA 21-1 measurements in thyroid LNs provide a diagnostic modality.
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Molina, R., C. Agusti, J. M. Mañe, X. Filella, J. Jo, J. Joseph, N. Giménez, J. Estapé, and A. M. Ballesta. "Cyfra 21–1 in Lung Cancer: Comparison with Cea, Ca 125, Scc and Nse Serum Levels." International Journal of Biological Markers 9, no. 2 (April 1994): 96–101. http://dx.doi.org/10.1177/172460089400900206.

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CYFRA 21–1, CEA, CA 125, SCC and NSE serum levels were determined in 50 healthy subjects and in 189 patients with primary lung cancer (101 with locoregional disease, 68 with recurrence and 20 patients with no evidence of residual disease (NED). Abnormal CYFRA 21–1 serum levels were found in 53.6% (90/168) of the patients with active cancer. Neither healthy subjects nor NED patients had abnormal serum levels. CYFRa 21–1 serum concentrations were significantly higher in patients with active cancer than in healthy subjects or in NED patients (p < 0.0001). CYFRA 21–1 sensitivity was related to tumor histology with abnormal levels in 64.7% of patients with NSCLC and in 30% of patients with SCLC (P <0.0001). In NSCLC, serum CYFRA 21–1 concentrations were also related to histological type, the highest values being found in squamous cell carcinomas and LCLC and the lowest in adenocarcinomas (p < 0.04). There was also a clear relationship between CYFRA 21–1 and tumor extension, with significantly higher values in patients with metastases than in those without metastases (p < 0.0001). Abnormal CEA values were found in 49.1%, CA 125 in 39%, SCC in 27.8% and NSE in 21.3% of the patients with active cancer. With respect to histological type, CYFRA was elevated in 68.3% of squamous cell carcinomas (CEA: 46.7%, SCC: 50%, CA 125:31.7%, NSE: 11.7%), in 54.8% of adenocarcinomas (CEA: 62%, SCC: 26.2%, CA 125: 59.5%, NSE: 9.5%), in 78.6% of LCLC (CEA: 64.3%, SCC: 28.6%, CA 125: 78.6%, NSE: 7.1%) and in 30% of SCLC (CEA: 37.7%, SCC: 3.8%, CA 125:20.8%, NSE: 45.3%). In summary, CYFRA 21–1 is the most sensitive tumor marker in patients with lung cancer, especially in NSCLC patients.
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Lai, Ruay-Sheng, Hon-Ki Hsu, Jau-Yeong Lu, Luo-Ping Ger, and Ning-Sheng Lai. "CYFRA 21–1 Enzyme-Linked Immunosorbent Assay." Chest 109, no. 4 (April 1996): 995–1000. http://dx.doi.org/10.1378/chest.109.4.995.

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20

Bombardieri, E., E. Seregni, A. Bogni, S. Ardit, S. Belloli, A. Busetto, B. Caniello, et al. "Evaluation of Cytokeratin 19 Serum Fragments (Cyfra 21–1) in Patients with Lung Cancer: Results of a Multicenter Trial." International Journal of Biological Markers 9, no. 2 (April 1994): 89–95. http://dx.doi.org/10.1177/172460089400900205.

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Recently, a new immunometric assay (Cyfra 21–1) was developed to measure serum concentrations of a soluble fragment of cytokeratin subunit 19. With this method, supplied by Boehringer Mannheim (EIA Test Cyfra 21–1), an Italian multicenter trial was performed in patients with lung cancer. Cyfra 21–1 serum levels were determined in 568 normal subjects (blood donors), 607 patients with non-malignant diseases (491 respiratory diseases) and 730 patients with malignancies. In the latter group 584 had lung cancer. All these 584 patients had pathologically confirmed disease; 314 were epidermoid tumors, 166 adenocarcinomas, 88 small cell cancers and 16 large cell cancers. In the 568 healthy blood donors the mean Cyfra 21–1 value was 0.91 ng/ml (SD 0.47 ng/ml; range 0.05–2.90 ng/ml). A threshold of 1.9 ng/ml was chosen as the upper limit of normality. High levels of Cyfra21–1 were observed in patients with chronic hepatitis (positivity rate: 17/51–33.3%) and with pancreatitis (positivity rate 5/16 - 31.3%). In 114 out of 491 (23.2%) patients with respiratory diseases Cyfra 21–1 showed values greater than 1.9 ng/ml. The overall sensitivity (all stages) of Cyfra 21–1 in lung cancer was 65.6% (383/584). When the histology was considered the highest positivity rates were found in patients with squamous cell tumors (226/314; 72%) followed by adenocarcinomas (105/166; 63%). In patients with SCLC the global sensitivity was 52.3% (46/88). Higher sensitivity of Cyfra 21–1 was observed from stage I to stage IV (53.9% vs 85.7%; Chisquare: p < 0.01). When comparing patients in whom curative resections were possible (up to stage IIIa) with patients suffering from inoperable tumors, a significant difference in Cyfra 21–1 positivies was found (59% vs 81.5%; Chi square p < 0.01).
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21

Stieber, P., H. Dienemann, U. Hasholzner, P. G. Fabricius, C. Schambeck, M. Weinzierl, S. Poley, et al. "Comparison of Cyfra 21–1, Tpa and Tps in Lung Cancer, Urinary Bladder Cancer and Benign Diseases." International Journal of Biological Markers 9, no. 2 (April 1994): 82–88. http://dx.doi.org/10.1177/172460089400900204.

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Recently CYFRA 21–1, a new tumor marker measuring a fragment of cytokeratin 19, was introduced and proved to be suitable for therapy monitoring and follow-up of non-small cell lung carcinomas (NSCLC), in particular squamous cell carcinomas. Besides CYFRA 21–1 there are two other tumor markers, tissue polypeptide antigen (TPA) and tissue polypeptide-specific antigen (TPS), which also measure various cytokeratins in serum. In a retrospective study we investigated the clinical significance of these three cytokeratin markers in lung cancer and in carcinoma of the urinary bladder. For this purpose we investigated the sera of 50 healthy persons, 273 patients with various benign diseases, 218 patients with histologically proven lung cancer and 88 patients with carcinoma of the urinary bladder. In a first step the specificity was established for the different reference groups and the cutoff values were fixed at a specificity of 95%. In lung cancer the single and combined sensitivities were calculated versus benign lung diseases (n = 58) as reference group. With single determinations CYFRA 21–1 proved to have the highest sensitivity in lung cancer in general (61%), in non-small cell lung carcinomas (64%), in squamous cell carcinomas (79%), in adenocarcinomas (54%) and in large cell carcinomas (65%). In small cell lung carcinomas (SCLC) NSE was confirmed to be the marker of choice (55%). With combined determinations a clear increase in sensitivity could only be reached in large cell carcinomas (CYFRA 21–1 + TPA: 77%) and in small cell carcinomas (CYFRA 21–1 + NSE: 62%). In cancer of the urinary bladder the sensitivities were established versus benign urological diseases (n = 73). CYFRA 21–1 showed with 38% true positive test results the highest sensitivity compared to TPA (27%) and TPS (23%). From our investigations it was evident that TPA detects at least partially the same substance as CYFRA 21–1 (the sensitivities compared to the markers TPS, CEA, SCC and NSE were rather high, but not as high as for CYFRA 21–1) whereas TPS represents a completely different parameter of clinical chemistry (lowest number of true positive test results over the whole investigation), which apparently measures something completely different. These findings cleary correspond with the very recent results of immunoblotting comparing CYFRA 21–1, TPA and TPS.
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22

Rychlik, Urszula, Jadwiga Nowak-Sadzikowska, Jerzy Jakubowicz, Jadwiga Tarapacz, Zofia Stasik, Ewa Wójcik, and Jan Kanty Kulpa. "CYFRA 21-1, CEA, and selected inflammatory markers in patients with muscle invasive bladder cancer." Diagnostyka Laboratoryjna 51, no. 1 (April 13, 2015): 15–22. http://dx.doi.org/10.5604/01.3001.0004.1256.

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Aim: Evaluation of diagnostic utility of CYFRA 21-1, CEA, C-reactive protein and cancer serum index (CSI) defined by the ratio of 1alpha acid glycoprotein to prealbumin, in respect of basic clinical parameters was performed in patients with muscle invasive bladder cancer treated with bladder sparing approach including TRUB followed by radio(chemo)therapy, or TURB followed by palliative radiotherapy. Material and methods: Serum CYFRA 21-1, CEA, C-reactive protein, alpha-1 acid glycoprotein, prealbumin and urine CYFRA 21-1, CEA levels were measured in 131 patients with muscle invasive bladder cancer after TURB as well as in the healthy controls. Results: Serum and urine CYFRA 21-1, CEA and serum CRP, alpha-1 acid glycoprotein levels and CSI were significantly higher, with significantly lower serum prealbumin concentration in the bladder cancer group than in healthy controls. Correlations between concentration of tested markers and performance status, clinical stage of disease, presence of hydronephrosis, macroscopic TURB resection margin status and inflammatory state assessed by CRP and CSI were observed. Conclusion: Serum and urine CYFRA 21-1 levels can be useful in diagnosis of muscle invasive bladder cancer. Elevated levels of CRP and CSI confirm the role of inflamation in etiology of bladder cancer and these tests could be used as potential prognostic factors.
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23

Rosenblatt, P. Y., M. J. Edelman, R. H. Christenson, L. Hodgson, X. Wang, R. Kratzke, and E. Vokes. "CYFRA 21–1 (CYFRA) as a prognostic and predictive marker in advanced non-small cell lung cancer (NSCLC): CALGB 150304." Journal of Clinical Oncology 27, no. 15_suppl (May 20, 2009): 11020. http://dx.doi.org/10.1200/jco.2009.27.15_suppl.11020.

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11020 Background: Cytokeratin 19 and its soluble fragment CYFRA have been studied as markers that may correlate with response to therapy and survival in NSCLC. As part of CALGB 30203, a randomized trial of carboplatin/gemcitabine with eicosanoid modulators (celecoxib, zileuton or both) in advanced NSCLC (Edelman JCO 2008), serum CYFRA levels were obtained prior to and during treatment. The objective of this study was to evaluate the possible correlation of CYFRA as a predictive and prognostic marker and to confirm a previous finding that a 27% reduction in CYFRA after one cycle (21 days) of treatment correlated with a longer survival (Vollmer Clin Ca Res, 2003). Methods: Paired specimens were available from 88 patients. CYFRA was measured at baseline and after cycles 1 and 2 using an electrochemoluminescent assay (Roche Diagnostics) on the ElecSys 2010 system as previously described. Using logarithm of the initial concentration and logarithm of the difference in concentrations, we analyzed these in relation to overall survival (OS) and failure free survival (FFS). Results: 1. Lower baseline CYFRA levels were associated with both longer overall survival and failure free survival (p = <0.0001 and p=0.0045). 2. Larger reductions in CYFRA levels correlated to longer overall survival and failure-free survival (p=0.0254 and p=0.0298). 3.We failed to replicate that a drop of >27% in CYFRA levels had statistical significance in overall or failure free survival (p=0.6489 and p=0.9636). Conclusions: CYFRA and change in CYFRA appear to be reliable markers in predicting the response to chemotherapy for nonsmall cell lung cancer; however, a precise threshold to mark response has yet to be determined. No significant financial relationships to disclose.
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24

Szturmowicz, M., W. Tomkowski, A. Fijalkowska, W. Kupis, A. Cieślik, U. Demkow, R. Langfort, A. Wiechecka, T. Orlowski, and A. Torbicki. "Diagnostic Utility of Cyfra 21-1 and Cea Assays in Pericardial Fluid for the Recognition of Neoplastic Pericarditis." International Journal of Biological Markers 20, no. 1 (January 2005): 43–49. http://dx.doi.org/10.1177/172460080502000107.

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A positive cytology result in pericardial fluid is the gold standard for recognition of malignant pericardial effusion. Unfortunately, in 30–50% of patients with malignant pericardial effusion cytological examination of the pericardial fluid is negative. Tumor marker assessment in pericardial fluid may help to recognize malignant pericardial effusion. The aim of our study was to estimate the value of CYFRA 21-1 and CEA measurement in pericardial fluid for the recognition of malignant pericardial effusion. To our knowledge this is the first study on CYFRA 21-1 assessment in pericardial effusion. The examined group consisted of 50 patients with malignant pericardial effusion and 34 patients with non-malignant pericardial effusion. Median CEA concentrations in malignant pericardial effusion and non-malignant pericardial effusion were 80 ng/mL (0–317) and 0.5 ng/mL (0–18.4), respectively (p<0.001). Median CYFRA 21-1 concentrations in malignant pericardial effusion and non-malignant pericardial effusion were 260 ng/mL (5.3–10080) and 22.4 ng/mL (1.87–317.6), respectively (p<0.001). The optimal cutoff value for CYFRA 21-1 in pericardial effusion was 100 ng/mL. CYFRA 21-1 >100 ng/mL or CEA >5 ng/mL were found in 14/15 patients with malignant pericardial effusion and negative pericardial fluid cytology. We therefore strongly recommend the use of CYFRA 21-1 and/or CEA in addition to pericardial fluid cytology for the recognition of malignant pericardial effusion.
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25

Kulpa, Jan, Ewa Wójcik, Marian Reinfuss, and Leszek Kołodziejski. "Carcinoembryonic Antigen, Squamous Cell Carcinoma Antigen, CYFRA 21-1, and Neuron-specific Enolase in Squamous Cell Lung Cancer Patients." Clinical Chemistry 48, no. 11 (November 1, 2002): 1931–37. http://dx.doi.org/10.1093/clinchem/48.11.1931.

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Abstract Background: Carcinoembryonic antigen (CEA), squamous cell carcinoma antigen (SCC-Ag), and CYFRA 21-1 are the most useful markers for non-small cell lung cancer (NSCLC), but neuron-specific enolase (NSE) is a tumor maker of choice for SCLC. The determination of NSE in NSCLC could allow selection of patients with neuroendocrine features. NSCLC patients whose tumors have neuroendocrine properties may be more responsive to chemotherapy; however, these tumors have been reported to be more aggressive. Tumor markers are not suitable for diagnosis; their principal applications are in monitoring of therapy and prognosis. Methods: Tumor markers were measured in 200 untreated patients with squamous cell lung cancer (SQC) and a reference group (n = 220; 124 healthy persons and 96 patients with nonmalignant lung disease). CEA and SCC-Ag were measured by microparticle enzyme immunoassays on Abbott AxSYM and IMx analyzers. CYFRA 21-1 and NSE were measured by electrochemiluminescence immunoassays on the Roche Elecsys 2010. Results: CEA, SCC-Ag, CYFRA 21-1, and NSE were increased above the cutoffs in 26%, 32%, 67%, and 28% of tested patients, respectively. The area under the ROC curve for CYFRA 21-1 was higher than those for CEA, SCC-Ag, and NSE (SQC vs controls). CYFRA 21-1 and CEA were significantly higher in advanced SQC than in early stages of disease (P &lt;0.0001 and P &lt;0.0004, respectively). In multivariate analysis of survival, CYFRA 21-1 was an independent but nonspecific prognostic factor in the operable group of SQC patients, whereas NSE was an independent prognostic factor in the advanced stages of disease. Conclusion: CYFRA 21-1 is an independent prognostic factor in earlier stages and NSE in the advanced stages of SQC.
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26

Bodenmüller, H., F. Donié, M. Kaufmann, and D. Banauch. "The Tumor Markers Tpa, Tps, TpaCyk and Cyfra 21–1 React Differently with the Keratins 8, 18 and 19." International Journal of Biological Markers 9, no. 2 (April 1994): 70–74. http://dx.doi.org/10.1177/172460089400900202.

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The commercially available tumor marker tests TPA, TPS, TPACYK and CYFRA 21–1 react with simple epithelium keratins. From clinical studies it can be deduced that the pattern of keratin recognition must be different for each of these tests. We therefore studied the reactivity of the keratin fragment combinations K8/K18 and K8/K19 in the different tests and determined the reactivity of the corresponding soluble antibodies with purified keratin 8, 18 and 19 in immunoblots. TPS and CYFRA 21–1 were found to distinguish clearly between the keratin fragment combinations K8/K18 (TPS) and K8/K19 (CYFRA 21–1). TPA and TPACYK reacted with both combinations, however, with different intensities. On immunoblots the CYFRA 21–1 antibodies reacted exclusively with K19, whereas the antibodies of the other assays reacted with at least 2 of the keratins investigated.
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27

Ebert, W., H. Bodenmüller, and W. Hölzel. "CYFRA 21—1 - clinical applications and analytical requirements." Scandinavian Journal of Clinical and Laboratory Investigation 55, sup221 (January 1995): 72–80. http://dx.doi.org/10.3109/00365519509090568.

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28

Blasco, R. F., M. Melgarejo, E. M. A. Barbero, P. La Banda, L. Callol, and F. J. Gomez De Terreros. "Cyfra 21-1 in Bronchoalveolar Lavage: Preliminary Results." International Journal of Biological Markers 10, no. 1 (January 1995): 55–57. http://dx.doi.org/10.1177/172460089501000110.

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29

Stieber, Petra, Ch Müller, Ute Hasholzer, H. Dienemann, Maren Fiebig, and A. Fateh-Moghadam. "CYFRA 21-1 - Ein neuer Marker beim Bronchialkarzinom." LaboratoriumsMedizin 17, no. 7-8 (January 1993): 328–32. http://dx.doi.org/10.1515/labm.1993.17.7-8.328.

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30

Felletti, R., L. Chessa, E. Cerri, F. Ropolo, G. Ratto, E. Spessa, G. Giorgi, and M. Onetto. "CYFRA 21-1: A marker of lung cancer." Lung Cancer 11 (June 1994): 37. http://dx.doi.org/10.1016/0169-5002(94)93912-8.

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31

Pierga, J. Y., L. Deneux, C. Bonneton, A. Vincent-Salomon, C. Nos, P. Anract, H. Magdelénat, P. Pouillart, and J. P. Thiery. "Prognostic Value of Cytokeratin 19 Fragment (CYFRA 21–1) and Cytokeratin-Positive Cells in Bone Marrow Samples of Breast Cancer Patients." International Journal of Biological Markers 19, no. 1 (January 2004): 23–31. http://dx.doi.org/10.1177/172460080401900103.

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The aim of this study was to investigate the relationship between the detection of micrometastatic cells by immunocytochemistry (ICC) with an anticytokeratin antibody and cytokeratin fragment (CYFRA 21–1) expression detected by an immunofluorescent assay in bone marrow of breast cancer patients. Micrometastatic CK+ cells were screened with a pancytokeratin antibody A45 B/B3 from bone marrow aspiration samples of 102 breast cancer patients (65 primary tumors, 10 local recurrences and 27 distant metastases). CYFRA 21-1 levels were assessed in bone marrow supernatant of these patients before collection of the mononucleated interface cells on a Ficoll-Hypaque density gradient and in 20 control patients. CYFRA 21-1 and CK+ cell detection by ICC were both correlated with clinical stage. CYFRA 21-1 was significantly elevated in patients with micrometastatic disease detected by ICC: 4.77 ng/mL (± 10.87 SD) versus 1.00 ng/mL (± 1.36 SD) in patients with negative ICC (p=0.01). In univariate analysis, a CYFRA 21-1 value ≥1 ng/mL and the presence of CK+ cells were associated with a poorer survival for patients with stage I to III breast cancer (n=65). On multivariate analysis, only pathological nodal status and presence of CK+ cells in bone marrow were independent prognostic factors for overall survival. In conclusion, in this series CYFRA 21-1 was correlated with detection of CK+ cells by ICC in bone marrow, but cannot replace ICC. The presence of CK+ cells in bone marrow remains a strong independent prognostic factor in primary breast cancer.
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32

Alm El-Din, Mohamed A., Gihan Farouk, Hala Nagy, Ayman Abd Elzaher, and Gehan H. Abo El-Magd. "Cytokeratin-19 fragments, nucleosomes and neuron-specific enolase as early measures of chemotherapy response in non-small cell lung cancer." International Journal of Biological Markers 27, no. 2 (April 2012): 139–46. http://dx.doi.org/10.5301/jbm.2012.9141.

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Aim To investigate the reduction in the serum level of cytokeratin-19 fragments (CYFRA 21–1), nucleosomes and neuron-specific enolase (NSE) as early measures of the response to chemotherapy in non-small cell lung cancer (NSCLC). Methods Forty-two consecutive patients with locally advanced NSCLC were included. All patients received platinum-based chemotherapy. Staging investigations and quantification of CYFRA 21–1, nucleosomes and NSE (using enzyme-linked immunosorbent assay, ELISA) were performed before the start of treatment and after the second cycle of chemotherapy. According to the response to chemotherapy, patients were classified into 3 groups: (I) disease regression, (II) stable disease, and (III) progressive disease. The reduction in the levels of tumor markers was correlated with the response to chemotherapy. Results After the second cycle of chemotherapy, groups I and II had significantly decreased serum levels of CYFRA 21–1 (p<0.05). Similarly, the concentration of nucleosomes was significantly lower than the baseline levels in groups I (p=0.0008) and II (p=0.003). The reduction of both CYFRA 21–1 and nucleosome levels was not significant for patients in group III. In all groups the reduction of NSE levels in response to chemotherapy was not significant. As a marker of response to chemotherapy, CYFRA 21–1 showed the highest sensitivity (88.9%) and specificity (77.4%) compared with nucleosomes (77.8% and 58.1% respectively) and NSE (66.7% and 51.8% respectively). Conclusion The reduction in the serum level of CYFRA 21–1 and nucleosomes may be used for early identification of NSCLC patients with good response to chemotherapy.
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Merle, P., H. Janicot, M. Filaire, D. Roux, C. Bailly, C. Vincent, F. Gachon, et al. "Early CYFRA 21-1 Variation Predicts Tumor Response to Chemotherapy and Survival in Locally Advanced Non-Small Cell Lung Cancer Patients." International Journal of Biological Markers 19, no. 4 (October 2004): 310–15. http://dx.doi.org/10.1177/172460080401900409.

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We have evaluated CYFRA 21-1 serum level variations as an indicator of tumor response and survival in 44 consecutive patients with locally advanced non-small cell lung cancer (NSCLC) treated with induction chemotherapy (IC). Irrespective of the initial CYFRA 21-1 serum concentration, a more than 65% decrease in the serum level after the first chemotherapy course was significantly predictive of an objective tumor response (p=0.0022). In addition, a more than 80% decrease in this level significantly predicted a better disease-free survival (p=0.039). In patients with initial CYFRA 21-1 serum levels >3.3 ng/mL (n=29), a more than 80% decrease after the first IC course was the most significant predictor of overall survival (p=0.025) in a Cox analysis including initial staging, tumor response and surgery. We conclude that early monitoring of CYFRA 21-1 serum levels may be a useful prognostic tool for tumor response and survival in stage III NSCLC patients treated by induction chemotherapy.
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Kanaji, Nobuhiro, Kyuichi Kadota, Akira Tadokoro, Takuya Inoue, Naoki Watanabe, Reiji Haba, Norimitsu Kadowaki, and Tomoya Ishii. "Serum CYFRA 21-1 but not Vimentin is Associated with Poor Prognosis in Advanced Lung Cancer Patients." Open Respiratory Medicine Journal 13, no. 1 (July 9, 2019): 31–38. http://dx.doi.org/10.2174/1874306401913010031.

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Background: Cytokeratins and Vimentin are intermediate filament proteins. Vimentin expression in tissue samples has been reported to be associated with a poor prognosis in non-small cell lung cancer patients who underwent surgery. CYFRA 21-1 (Cytokeratin 19 Fragment) is a well known tumor marker. Objective: This study aimed to investigate the usefulness of serum vimentin as a tumor marker and significance of CYFRA 21-1 and vimentin expression on prognosis of advanced lung cancer patients. Methods: One hundred and four advanced lung cancer patients and 19 non-lung cancer patients were included. A total of 157 clinical samples obtained from 113 patients was used for immunostaining of vimentin and measurements of CYFRA 21-1 and vimentin concentrations. Results: Compared to low concentration, high concentration of serum CYFRA 21-1 was associated with shorter overall survival in lung cancer patients. However, there was no difference in the serum vimentin concentration between the patients with lung cancer and those with non-lung cancer. No difference in vimentin concentration was observed between the malignant and non-malignant pleural effusions. Immunostaining revealed that of the 43 tumor samples, 21 were positive and 22 were negative for vimentin. No significant difference was found in overall survival between patients with positive and negative for vimentin. Conclusion: An elevated serum CYFRA 21-1 concentration was associated with shorter overall survival in advanced lung cancer patients. However, serum vimentin was not as useful as a tumor marker of lung cancer. The vimentin positivity in tumor samples might not predict patients’ prognosis in patients with advanced lung cancer.
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Sunpaweravong, Somkiat, Patrapim Sunpaweravong, Puttisak Puttawibul, Pleumjit Boonyaphiphat, and Anupong Nitiruangjaras. "Correlation between serum tumor markers, tissue proliferative activity, and clinicopathologic factors in patients with locally advanced esophageal squamous cell carcinoma." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e14639-e14639. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e14639.

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e14639 Background: Squamous cell carcinoma antigen (SCCA) and CYFRA 21-1 have been reported as useful tumor markers for esophageal squamous cell carcinoma (ESCC), but no information has yet been reported about the relationship between these serum tumor markers and tissue proliferative activity (Ki-67). The aim of this study was to compare SCCA, CYFRA 21-1 and Ki-67 with clinicopathological factors and survival in locally advanced ESCC patients. Methods: Pre-treatment SCCA and CYFRA 21-1 serum levels were measured by enzyme-linked immunoassays while the expression of tissue Ki-67 activity was calculated by immunohistochemical nuclear staining on paraffin-embedded tumor samples of locally advanced ESCC patients. The association between these biomarkers, clinicopathological factors, and overall survival were analyzed by Cox proportional hazards model. Results: 166 locally advanced ESCC patients from our institution (2002-6) were evaluated. Their median age was 62 years (39-90), M:F 144:22, location of tumor (upper:middle:lower 31:83:53) and histological grade (well:moderate:poor 50:73:43). 43% had received surgery, 22% chemoradiation and 35% best supportive care. Follow-up times ranged from 2 months to 38 months, and the median survival was 11.0 months. Elevated SCCA (>1.5 ng/mL) and CYFRA 21-1 (>3.5 ng/mL) before treatment were found in 79.1% and 50.4% of the patients, respectively, while 42.6% had both serum markers elevated. The SCCA and CYFRA 21-1 levels were not correlated (p=0.128) to each other, nor either to age, sex, T, N, M, location, grade or Ki-67. High Ki-67 expression levels were significantly correlated with T4 (p=0.010), M1 (p=0.010) and poor grade (p=0.015) but not to age, sex, N or location. Levels of SCCA, CYFRA 21-1 and Ki-67, alone or in any combination, were not correlated to survival of patients. Conclusions: This study suggests that the evaluation of SCCA and CYFRA 21-1 are of no particular correlation to clinicopathological factors and survival in locally advanced ESCC, but Ki-67 is correlated with T, M and grade.
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Dall’Olio, Filippo G., Francesca Abbati, Francesco Facchinetti, Maria Massucci, Barbara Melotti, Anna Squadrilli, Sebastiano Buti, Francesca Formica, Marcello Tiseo, and Andrea Ardizzoni. "CEA and CYFRA 21-1 as prognostic biomarker and as a tool for treatment monitoring in advanced NSCLC treated with immune checkpoint inhibitors." Therapeutic Advances in Medical Oncology 12 (January 2020): 175883592095299. http://dx.doi.org/10.1177/1758835920952994.

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Aims: To assess prognostic value of pre-therapy carcinoembryonic antigen (CEA) and cytokeratin-19 fragments (CYFRA 21-1) blood levels in non-small cell lung cancer (NSCLC) patients treated with immune-checkpoint inhibitors (ICIs) and their early change as predictor of benefit. Materials and methods: This is a retrospective cohort study including patients with stage IIIB–IV NSCLC who received anti PD-1/PD-L1 in first or advanced lines of therapy in two institutions. A control cohort of patients treated only with chemotherapy has been enrolled as well. Results: A total of 133 patients treated with nivolumab or atezolizumab were included in the test set, 74 treated with pembrolizumab first line in the validation set and 89 in the chemotherapy only cohort. CYFRA 21-1 >8 ng/mL was correlated with overall survival (OS) in the test set, validation set and in univariate and multivariate analysis (pooled cohort hazard ratio (HR) 1.90, 95% confidence interval (CI) 1.24–2.93, p 0.003). Early 20% reduction after the third cycle was correlated with OS for CEA (HR 0.12; 95% CI 0.04–0.33; p < 0.001), and for CYFRA 21-1 (HR 0.19; 95% CI 0.07–0.55; p 0.002) Conclusions: CYFRA 21-1 pre-therapy assessment provides clinicians with relevant prognostic information about patients treated with ICI. CEA and CYFRA 21-1 repeated measures could be useful as an early marker of benefit.
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37

Sakatani, Toshio, Fumiyoshi Ohyanagi, Azusa Tanimoto, Yuko Kawano, Ryota Saito, Kyohei Kaburaki, Noriko Yanagitani, et al. "Serum CYFRA 21-1 as a biomarker of pemetrexed plus cisplatin treatment in nonsquamous non-small cell lung cancer." Journal of Clinical Oncology 30, no. 15_suppl (May 20, 2012): e18014-e18014. http://dx.doi.org/10.1200/jco.2012.30.15_suppl.e18014.

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e18014 Background: Pemetrexed (P) is a key drug in the treatment of advanced non-squamous (N-Sq) non-small cell lung cancer (NSCLC). Although differential efficacies of P between squamous (Sq) and N-sq subtypes have been reported, it is difficult to get a clear histological diagnosis from a small biopsy sample. Therefore, a more objective, yet simple, biomarker for histology-based treatment is needed. Previously, we reported that serum Cytokeratin fragment 21-1 (CYFRA) was related to the outcome of P monotherapy. In this study, we examined whether serum CYFRA could predict the efficacy of the cisplatin-pemetrexed (CP) combination regimen as well as it did for P monotherapy. Methods: Pre-treatment serum concentrations of CYFRA, carcinoembryonic antigen (CEA), squamous cell carcinoma (SCC) antigen, and sialyl Lewis X-I antigen (SLX) were measured in 50 N-sq NSCLC patients who were enrolled in a phase II study of C (75 mg/m2 and 500 mg/m2) against N-Sq NSCLC. Eligibility criteria consisted of histologically or cytologically confirmed recurrent or metastatic N-Sq NSCLC previously untreated with chemotherapy, ECOG performance status (PS) 0-1. The primary endpoint was response rate, which was evaluated with RECIST. The planned sample size was 50 patients. We analyzed possible associations between these NSCLC marker levels and the efficacy of the CP regimen. Results: From April 2010 to June 2011, 50 N-sq NSCLC patients (male/female, 34/16; median age 60 y (28-74 y)) were enrolled in this study. Patients’ histological characteristics were: adeno/large/not otherwise specified (NOS), 39/5/6; PS: 0/1, 31/19. In these 50 patients, elevated levels of serum CYFRA, CEA, SCC and SLX were found in 25, 32, 5 and 32 patients, respectively. CYFRA was significantly associated with progression-free survival (PFS) (median PFS: 5.53 vs. 3.29 months; p < 0.05), whereas no significant associations were observed between PFS and CEA, SCC or SLX. In addition, multivariate analysis showed that higher CYFRA and PS levels were significant factors associated with a shorter PFS. (p < 0.05) Conclusions: Serum CYFRA is related to the outcome of CP treatment; our results suggest that serum CYFRA is a promising predictive marker of CP therapy.
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38

Kumar, Panwar, Kumar, Augustine, and Malhotra. "Biofunctionalized Nanostructured Yttria Modified Non-Invasive Impedometric Biosensor for Efficient Detection of Oral Cancer." Nanomaterials 9, no. 9 (August 22, 2019): 1190. http://dx.doi.org/10.3390/nano9091190.

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We report results of the studies relating to the development of an efficient biosensor for non-invasive detection of CYFRA-21-1 cancer biomarker. We used a low dielectric constant material (nanostructured yttrium oxide, nY2O3) for the fabrication of the biosensing platform. The nY2O3 was synthesized via solvothermal process and functionalized using 3-aminopropyl triethoxy silane (APTES). Electrophoretic deposition (EPD) of the functionalized nanomaterial (APTES/nY2O3) onto an indium tin oxide (ITO)-coated glass electrode was conducted at a DC potential of 50V for 60s. The EDC-NHS chemistry was used for covalent immobilization of −COOH bearing monoclonal anti-CYFRA-21-1 onto −NH2 groups of APTES/nY2O3/ITO electrode. To avoid the non-specific interaction on the anti-CYFRA-21-1/APTES/nY2O3/ITO immunoelectrode, bovine serum albumin (BSA) was used. X-ray diffraction (XRD), transmission electron microscopy (TEM), and field emission scanning electron microscopy (FESEM) were utilized for structural and morphological studies, whereas Fourier-transform infrared spectroscopy (FTIR) was used for the bonding analysis. Cyclic voltammetry (CV) and electrochemical impedance spectroscopy (EIS) techniques were used for electrochemical characterization and response studies of fabricated electrodes. The fabricated immunosensor (BSA/anti-CYFRA-21-1/APTES/nY2O3/ITO) exhibited linearity in the range of 0.01–50 ng·mL−1, sensitivity of 226.0 Ω·mL·ng−1, and lower detection limit of 0.01·ng·mL−1. A reasonable correlation was observed between the results obtained using this biosensor and concentration of CYFRA-21-1 measured through ELISA (enzyme-linked immunosorbent assay) technique in salivary samples of oral cancer patients.
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39

Prisadov, G., L. Grigorov, P. Utchikov, G. Paskalev, Botushanova, K. Tchepileva, and A. Utchikov. "Cyfra 21-1 in the diagnosis of lung cancer." Lung Cancer 21 (September 1998): S48. http://dx.doi.org/10.1016/s0169-5002(98)90115-5.

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40

KINOSHITA, MASAHARU, HISASHI WATANABE, MASAO ICHIKI, SHINYA SUMITA, YO OKUBO, MICHIYA MATSUNAMI, HIROAKI FURUNO, TSUNEAKI SHIRAISHI, TORU RIKIMARU, and KOTARO OIZUMI. "Cyfra 21-1 as a Marker of Lung Cancer." Kurume Medical Journal 45, no. 1 (1998): 7–9. http://dx.doi.org/10.2739/kurumemedj.45.7.

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41

Morita, Tatsuo, Takao Kikuchi, Shinichi Hashimoto, Yutaka Kobayashi, and Akihiko Tokue. "Cytokeratin-19 Fragment (CYFRA 21-1) in Bladder Cancer." European Urology 32, no. 2 (1997): 237–44. http://dx.doi.org/10.1159/000480865.

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42

Stieber, Petra, Ute Hasholzner, Heinz Bodenmüller, Dorothea Nagel, Ludger Sunder-Plassmann, Hendrik Dienemann, Werner Meier, and Ahmad Fateh-Moghadam. "CYFRA 21-1: A new marker in lung cancer." Cancer 72, no. 3 (August 1, 1993): 707–13. http://dx.doi.org/10.1002/1097-0142(19930801)72:3<707::aid-cncr2820720313>3.0.co;2-x.

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43

Muraki, Masato, Yuji Tohda, Takashi Iwanaga, Hisao Uejima, Yukio Nagasaka, and Shigenori Nakajima. "Assessment of serum CYFRA 21-1 in lung cancer." Cancer 77, no. 7 (April 1, 1996): 1274–77. http://dx.doi.org/10.1002/(sici)1097-0142(19960401)77:7<1274::aid-cncr7>3.0.co;2-i.

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44

Yazigi, R., R. Castillo, G. Aliste, J. Garrido, A. Opazo, S. Prado, C. Navarro, E. Altieri, and G. Del Campo. "Cyfra 21-1 marker in carcinoma of the cervix." International Journal of Gynecological Cancer 10, no. 3 (May 7, 2000): 203–6. http://dx.doi.org/10.1046/j.1525-1438.2000.010003203.x.

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45

Kashihara, Takeshi, Atsushi Ohki, Tomoko Kobayashi, Tomomi Sato, Hitoshi Nishizawa, Kohei Ogawa, Hajime Tako, Fusao Kawakami, Motomu Tsuji, and Koichi Tamaoka. "Intrahepatic cholangiocarcinoma with increased serum CYFRA 21-1 level." Journal of Gastroenterology 33, no. 3 (May 20, 1998): 447–53. http://dx.doi.org/10.1007/s005350050112.

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46

Grenier, J., J. L. Pujol, F. Guilleux, J. P. Daures, H. Pujol, and F. B. Michel. "Cyfra 21-1, a new marker of lung cancer." Nuclear Medicine and Biology 21, no. 3 (April 1994): 471–76. http://dx.doi.org/10.1016/0969-8051(94)90070-1.

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47

Nakamura, H., H. Nakahama, O. Kitada, and M. Sugita. "Primary mediastinal choriocarcinoma with elevated serum CYFRA 21-1." International Journal of Clinical Oncology 4, no. 5 (November 1, 1999): 315–17. http://dx.doi.org/10.1007/s101470050076.

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48

Park, Yongjung, Yoonjung Kim, Jong-Han Lee, Eun Young Lee, and Hyon-Suk Kim. "Usefulness of Serum Anti-p53 Antibody Assay for Lung Cancer Diagnosis." Archives of Pathology & Laboratory Medicine 135, no. 12 (December 1, 2011): 1570–75. http://dx.doi.org/10.5858/arpa.2010-0717-oa.

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Context.—Some tumor markers, including carcinoembryonic antigen (CEA) and cytokeratin 19 fragment (CYFRA 21-1), are used for the detection of lung cancer; however, their use is limited because of low sensitivities and high false-positive rates. Objectives.—To investigate the usefulness of an anti-p53 assay in detecting lung cancer and to compare the anti-p53 to CEA and CYFRA 21-1 tumor markers. Design.—Serum samples were collected from 82 patients with lung cancer. Sera were also collected from 79 patients with or without benign pulmonary disease for the control group. All 161 specimens were assayed for CEA, CYFRA 21-1, and anti-p53. The diagnostic performances of these markers were compared using receiver operating characteristic analysis. Results.—The receiver operating characteristic area under the curve values of CYFRA 21-1, CEA, and anti-p53 for discriminating lung cancers from benign or healthy conditions were 0.79, 0.81, and 0.79, respectively. Area under the curve for the 3 markers in combination was 0.90. The sensitivities of those markers for lung cancer detection were respectively 39.0%, 53.7%, and 34.1% at 94.9% specificity, and the cutoff levels at those sensitivities and specificities were 4.5 ng/mL for CYFRA 21-1, 5.4 ng/mL for CEA, and 2.7 U/mL for anti-p53. We found 79.3% positive results for patients with lung cancer by any of the 3 markers, and 12.2% were positive only for anti-p53. All patients without cancer had negative results for 2 or all 3 markers. Conclusions.—Anti-p53 combined with other conventional markers is helpful in increasing the sensitivity and specificity for detecting lung cancer.
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Choi, Hong Woo, Heyjin Kim, Ae-chin Oh, Jin Kyung Lee, and Young Jun Hong. "Diagnostic Significance of the Ratio of Plasma CYFRA 21-1 Autoantibody Immune Complex to Free CYFRA 21-1 in Patients with Colon Cancer." Journal of Laboratory Medicine and Quality Assurance 42, no. 4 (December 31, 2020): 218–23. http://dx.doi.org/10.15263/jlmqa.2020.42.4.218.

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50

Caviglia, Gian Paolo, Michela Ciruolo, Antonella Olivero, Patrizia Carucci, Emanuela Rolle, Chiara Rosso, Maria Lorena Abate, et al. "Prognostic Role of Serum Cytokeratin-19 Fragment (CYFRA 21-1) in Patients with Hepatocellular Carcinoma." Cancers 12, no. 10 (September 28, 2020): 2776. http://dx.doi.org/10.3390/cancers12102776.

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Keratin 19 (K19) is a cancer stem cell marker expressed by a subpopulation of hepatocellular carcinoma (HCC), associated with tumor aggressiveness. We evaluated the prognostic value of serum K19 fragment (CYFRA 21-1), in comparison or in combination with alpha-fetoprotein (AFP) and protein induced by vitamin-K absence or antagonist-II (PIVKA-II), in patients with HCC. A total of 160 patients (28F/132M; median age 62, range 44–86 years) with a new diagnosis of HCC and available serum samples collected at tumor diagnosis were analyzed retrospectively. Median overall survival (OS) after HCC diagnosis was 35.1, 95% CI 27.1–70.5 months. Multivariate Cox regression analysis showed that CYFRA 21-1 > 2.7 ng/mL (hazard ratio (HR) = 3.39, p < 0.001), AFP > 20 ng/mL (HR = 2.27, p = 0.007), and PIVKA-II > 200 mAU/mL (HR = 2.17, p = 0.020) were independent predictors of OS. The combination of biomarkers positivity allowed us to stratify patients with HCC into four risk categories associated with a progressively lower survival probability (log-rank test, p < 0.001). CYFRA 21-1 resulted an independent prognostic factor of patients with HCC and its combination with AFP and PIVKA-II might be useful to tailor personalized treatment strategies.
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