Capecitabine/cisplatin versus 5-fluorouracil/cisplatin as first-line therapy in patients with advanced gastric cancer: a randomised phase III noninferiority trial
| Autor: | Rustem Khasanov, J. Wang, W. K. Kang, L. Zheng, Yoon-Koo Kang, J. Chen, P. I. McCloud, Mikhail Lichinitser, J. Xiong, D. B. Shin, G. Forster, M. Philco-Salas, J. Santamaria, T. Suarez, Zhongzhen Guan |
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| Rok vydání: | 2009 |
| Předmět: |
Adult
Male medicine.medical_specialty Neutropenia Deoxycytidine Gastroenterology Disease-Free Survival Capecitabine Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Adverse effect Stomatitis Aged business.industry Hazard ratio Hematology Middle Aged medicine.disease Survival Analysis Confidence interval Surgery Oncology Fluorouracil Vomiting Female Cisplatin medicine.symptom business medicine.drug |
| Zdroj: | Annals of Oncology. 20:666-673 |
| ISSN: | 0923-7534 |
| DOI: | 10.1093/annonc/mdn717 |
| Popis: | To compare capecitabine/cisplatin with 5-fluorouracil/cisplatin as first-line treatment for advanced gastric cancer (AGC).In this randomised, open-label, phase III study, patients received cisplatin (80 mg/m(2) i.v. day 1) plus oral capecitabine (1000 mg/m(2) b.i.d., days 1-14) (XP) or 5-FU (800 mg/m(2)/day by continuous infusion, days 1-5) (FP) every 3 weeks. The primary end point was to confirm noninferiority of XP versus FP for progression-free survival (PFS).A total of 316 patients were randomised to XP (n = 160) or FP (n = 156). In the per-protocol population, median PFS for XP (n = 139) versus FP (n = 137) was 5.6 versus 5.0 months. The primary end point was met with an unadjusted hazard ratio (HR) of 0.81 [95% confidence interval (CI) 0.63-1.04, P0.001 versus noninferiority margin of 1.25]. Median overall survival was 10.5 versus 9.3 months for XP versus FP (unadjusted HR = 0.85, 95% CI 0.64-1.13, P = 0.008 versus noninferiority margin of 1.25). The most common treatment-related grade 3/4 adverse events in XP versus FP patients were as follows: neutropenia (16% versus 19%), vomiting (7% versus 8%), and stomatitis (2% versus 6%).XP showed significant noninferiority for PFS versus FP in the first-line treatment of AGC. XP can be considered an effective alternative to FP. |
| Databáze: | OpenAIRE |
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