|Title:||Gemcitabine plus cisplatin for patients with recurrent or metastatic nasopharyngeal carcinoma in Taiwan: A multicenter prospective Phase II trial||Authors:||Hsieh J.C.
|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.
|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
|Appears in Collections:||腫瘤醫學研究所|
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.