1. Multicenter phase II study of capecitabine plus oxaliplatin in older patients with advanced gastric cancer: the Tokyo Cooperative Oncology Group (TCOG) GI-1601 study.
- Author
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Kawabata R, Chin K, Takahari D, Hosaka H, Muto O, Shindo Y, Nagata N, Yabusaki H, Imamura H, Endo S, Kashiwada T, Nakamura M, Hihara J, Kobayashi M, Sagawa T, Saito S, Sato A, Yamada T, Okano N, Shimada K, Matsushima M, Kataoka M, Matsumoto S, Goto M, Kotaka M, Shiraishi T, Yamai H, Nagashima F, Ishizuka N, and Yamaguchi K
- Subjects
- Humans, Aged, Capecitabine, Oxaliplatin therapeutic use, Prospective Studies, Tokyo, Antineoplastic Combined Chemotherapy Protocols adverse effects, Fluorouracil, Stomach Neoplasms, Neutropenia chemically induced, Neutropenia drug therapy
- Abstract
Background: Capecitabine plus oxaliplatin (CapeOX) is a standard treatment option for advanced gastric cancer (AGC). We conducted a prospective multicenter phase II study to evaluate the efficacy and safety of CapeOX as a first-line therapy for AGC in older patients., Methods: Chemotherapy-naive patients aged ≥ 70 years with AGC were eligible. Initial treatment comprised capecitabine (2000 mg/m
2 on days 1-14) and oxaliplatin (130 mg/m2 on day 1) every 3 weeks. After the initial feasibility assessment, the dose was reduced considering toxicity (capecitabine, 1500 mg/m2 on days 1-14; and oxaliplatin, 100 mg/m2 on day 1 every 3 weeks). The primary endpoint was overall survival (OS)., Results: In total, 108 patients were enrolled, of whom 104 were evaluated. Thirty-nine patients received the original-dose treatment, whereas 65 received the reduced-dose treatment. The median OS, progression-free survival (PFS), and time to treatment failure (TTF) were 12.9 (95% CI 11.6-14.8), 5.7 (95% CI 5.0-7.0), and 4.3 (95% CI 3.9-5.7) months, respectively, for all patients; 13.4 (95% CI 9.5-16.0), 5.8 (95% CI 4.1-7.8), and 5.3 (95% CI 3.5-7.2) months in the original-dose group; and 12.8 (95% CI 11.3-15.3), 5.7 (95% CI 4.4-7.0), and 4.1 (95% CI 3.7-5.7) months in the reduced-dose group. The most common grade 3/4 toxicities were neutropenia (17.9%), anemia (12.8%), and thrombocytopenia (12.8%) in the original-dose group and neutropenia (13.8%) and anorexia (12.3%) in the reduced-dose group., Conclusions: These findings demonstrate CapeOX's efficacy and safety in older AGC patients., (© 2023. The Author(s).)- Published
- 2023
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