Multicenter phase II study of capecitabine plus oxaliplatin in older patients with advanced gastric cancer: the Tokyo Cooperative Oncology Group (TCOG) GI-1601 study.

Autor: Kawabata R; Department of Surgery, Osaka Rosai Hospital, Nagasone-cho, Kita-ku, Sakai, Osaka, 1179-35918025, Japan. r-kawabata@umin.ac.jp., Chin K; Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan., Takahari D; Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan., Hosaka H; Department of Gastroenterology, Gunma Prefectural Cancer Center, Gunma, Japan., Muto O; Department of Medical Oncology, Japanese Red Cross Akita Hospital, Akita, Japan., Shindo Y; Department of Gastroenterological Surgery, Nakadori General Hospital, Akita, Japan., Nagata N; Department of Gastroenterological Surgery, Kitakyushu General Hospital, Kitakyushu, Fukuoka, Japan., Yabusaki H; Department of Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan., Imamura H; Department of Gastroenterological Surgery, Toyonaka Municipal Hospital, Toyonaka, Osaka, Japan., Endo S; Department of Gastroenterological Surgery, Yao Municipal Hospital, Yao, Osaka, Japan., Kashiwada T; Department of Internal Medicine, Division of Hematology, Respiratory Medicine and Oncology, Faculty of Medicine, Saga University, Saga, Japan., Nakamura M; Aizawa Comprehensive Cancer Center, Aizawa Hospital, Matsumoto, Nagano, Japan., Hihara J; Department of Gastroenterological Surgery, Hiroshima City North Medical Center Asa Citizens Hospital, Hiroshima, Japan., Kobayashi M; Cancer Treatment Center, Kochi Medical School Hospital, Nankoku, Kochi, Japan., Sagawa T; Department of Gastroenterology, National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, Japan., Saito S; Department of Gastroenterology, Misawa Citi Hospital, Misawa, Aomori, Japan., Sato A; Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Aomori, Japan., Yamada T; Department of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Ibaragi, Japan., Okano N; Department of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Tokyo, Japan., Shimada K; Department of Internal Medicine, Division of Medical Oncology, Showa University Koto-Toyosu Hospital, Tokyo, Japan., Matsushima M; Department of Gastroenterology, Tokai University School of Medicine, Tokyo, Japan., Kataoka M; Department of Surgery, National Hospital Organization Nagoya Medical Center, Tokyo, Japan., Matsumoto S; Department of Clinical Oncology, Kyoto University Hospital, Kyoto, Japan., Goto M; Cancer Chemotherapy Center, Osaka Medical and Pharmaceutical University Hospital, Suita, Osaka, Japan., Kotaka M; Gastrointestinal Cancer Center, Sano Hospital, Tokyo, Japan., Shiraishi T; Department of Medical Oncology, Japanese Red Cross Matsuyama Hospital, Matsuyama, Ehime, Japan., Yamai H; Department of Gastroenterological Surgery, Japanese Red Cross Kochi Hospital, Kochi, Japan., Nagashima F; Department of Medical Oncology, Kyorin University Faculty of Medicine, Mitaka, Tokyo, Japan., Ishizuka N; Clinical Planning and Strategy Department Center for Development of Advanced Cancer Therapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan., Yamaguchi K; Department of Gastroenterological Chemotherapy, Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Jazyk: angličtina
Zdroj: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association [Gastric Cancer] 2023 Nov; Vol. 26 (6), pp. 1020-1029. Date of Electronic Publication: 2023 Aug 23.
DOI: 10.1007/s10120-023-01423-z
Abstrakt: 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/m 2 on day 1) every 3 weeks. After the initial feasibility assessment, the dose was reduced considering toxicity (capecitabine, 1500 mg/m 2 on days 1-14; and oxaliplatin, 100 mg/m 2 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).)
Databáze: MEDLINE