https://scholars.lib.ntu.edu.tw/handle/123456789/543479| Title: | Gemcitabine plus cisplatin for patients with recurrent or metastatic nasopharyngeal carcinoma in Taiwan: A multicenter prospective Phase II trial | Authors: | Hsieh J.C. Hsu C.-L. Ng S.-H. Wang C.-H. Lee K.-D. Lu C.-H. Chang Y.-F. Hsieh R.-K. KUN-HUEI YEH Hsiao C.-H. Chen S.-Y. Shiau C.-Y. Wang H.-M. |
Keywords: | Chemo-phase I-II-III; Clinical trials; H & N-Med; Head and neck; Palliative care; Supportive care | Issue Date: | 2015 | Publisher: | Oxford University Press | Journal Volume: | 45 | Journal Issue: | 9 | Start page/Pages: | 819-827 | Source: | Japanese Journal of Clinical Oncology | Abstract: | Objective: This multicenter Phase II trial evaluated the toxicity/efficacy of gemcitabine plus cisplatin as first-line chemotherapy in patients with recurrent/metastatic nasopharyngeal carcinoma. Methods: Gemcitabine 1250 mg/m2 on Days 1 and 8 and cisplatin 75 mg/m2 on Day 1 were administered at a 3-week interval. The primary endpoint was the response rate. Secondary endpoints included progression-free survival, overall survival, response duration and safety. Results: Fifty-two patients were recruited between 2004 and 2008. The response rate was 51.9% (complete remission rate, 9.6%) in the intent-to-treat group. The median progression-free and overall survivals were 9.8 and 14.6 months, respectively. The major Grade III/IV adverse event was leucopenia (61.6%). The mean number of cycleswas 6.63 ± 0.40. The regimenwaswell-tolerated, although one treatment-related death occurred after severe sepsis from aspiration pneumonia. Conclusions: Gemcitabine plus cisplatin is an effective, well-tolerated regimen as a first-line treatment for recurrent/metastatic nasopharyngeal carcinoma. ? The Author 2015. Published by Oxford University Press. All rights reserved. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-84942310951&doi=10.1093%2fjjco%2fhyv083&partnerID=40&md5=7460b66c0e2011bc7017636c8a4ba8df https://scholars.lib.ntu.edu.tw/handle/123456789/543479 |
ISSN: | 0368-2811 | DOI: | 10.1093/jjco/hyv083 | SDG/Keyword: | cisplatin; creatinine; gemcitabine; cisplatin; deoxycytidine; gemcitabine; adult; aged; alopecia; anemia; anorexia; Article; aspiration pneumonia; asthenia; cancer chemotherapy; cancer combination chemotherapy; death; diarrhea; distant metastasis; drug efficacy; drug response; drug safety; drug tolerability; drug withdrawal; female; human; hypertransaminasemia; hyponatremia; infection; leukopenia; major clinical study; male; mucosal disease; multicenter study; multiple cycle treatment; nasopharynx carcinoma; nausea; overall survival; patient compliance; phase 2 clinical trial; progression free survival; prospective study; sepsis; side effect; Taiwan; thrombocytopenia; vomiting; analogs and derivatives; cancer staging; clinical trial; disease free survival; drug administration; drug combination; metastasis; middle aged; mortality; Nasopharyngeal Neoplasms; pathology; proportional hazards model; risk; survival; treatment outcome; tumor recurrence; Adult; Aged; Cisplatin; Deoxycytidine; Disease-Free Survival; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Nasopharyngeal Neoplasms; Neoplasm Metastasis; Neoplasm Recurrence, Local; Neoplasm Staging; Odds Ratio; Proportional Hazards Models; Prospective Studies; Survival Analysis; Taiwan; Treatment Outcome [SDGs]SDG3 |
| Appears in Collections: | 腫瘤醫學研究所 |
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