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Phase II trial of capecitabine plus cisplatin as first‐line therapy in patients with metastatic nasopharyngeal cancer
Author(s) -
Chua Daniel T. T.,
Yiu Harry HoYin,
Seetalarom Kasan,
Ng Alice WanYing,
Kurnianda Johan,
Shotelersuk Kanjana,
Krishnan Gopala,
Hong RueyLong,
Yang MuhHwa,
Wang ChengHsu,
Sze WingKin,
Ng WaiTong
Publication year - 2012
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.21884
Subject(s) - capecitabine , medicine , nasopharyngeal carcinoma , neutropenia , nausea , clinical endpoint , adverse effect , phases of clinical research , vomiting , cisplatin , oncology , tolerability , radiation therapy , chemotherapy , surgery , cancer , clinical trial , colorectal cancer
Background Capecitabine is an oral fluoropyrimidine with single‐agent activity in metastatic nasopharyngeal carcinoma (NPC). This multicenter phase II study was conducted to investigate the efficacy and safety of capecitabine plus cisplatin as a first‐line treatment for metastatic NPC. Methods Patients with metastatic NPC received cisplatin 100 mg/m 2 day 1 plus capecitabine 1000 mg/m 2 twice daily on days 1 to 14 every 3 weeks for 6–8 cycles. The primary endpoint was overall response rate. Results Forty‐four patients were enrolled; 39 patients were evaluable for efficacy. The overall response rate was 53.8% (95% confidence interval [CI], 37%–70%), including 1 complete response. Median time to tumor progression was 7.3 months (95% CI, 5.6–9.9 months) and median overall survival was 28.0 months (95% CI, 14.5 months—not reached). Common grade 3/4 adverse events were neutropenia (50%), vomiting (11%), thrombocytopenia (9%), and nausea (7%). Conclusions Capecitabine plus cisplatin is an active first‐line combination in metastatic NPC that requires a short hospital stay. © 2011 Wiley Periodicals, Inc. Head Neck, 2012