东京协作肿瘤学组(TCOG)在晚期胃癌患者中进行的卡培他滨加奥沙利铂的多中心二期研究：GI-1601研究。
Multicenter phase II study of capecitabine plus oxaliplatin in older patients with advanced gastric cancer: the Tokyo Cooperative Oncology Group (TCOG) GI-1601 study.
发表日期：2023 Aug 23
作者：
Ryohei Kawabata, Keisho Chin, Daisuke Takahari, Hisashi Hosaka, Osamu Muto, Yoshiaki Shindo, Naoki Nagata, Hiroshi Yabusaki, Hiroshi Imamura, Shunji Endo, Tomomi Kashiwada, Masato Nakamura, Jun Hihara, Michiya Kobayashi, Tamotsu Sagawa, Soh Saito, Atsushi Sato, Takeshi Yamada, Naohiro Okano, Ken Shimada, Masashi Matsushima, Masato Kataoka, Shigemi Matsumoto, Masahiro Goto, Masahito Kotaka, Takeshi Shiraishi, Hiromichi Yamai, Fumio Nagashima, Naoki Ishizuka, Kensei Yamaguchi
来源：
Gastric Cancer
摘要：
卡培他滨加奥沙利铂（CapeOX）是晚期胃癌（AGC）的标准治疗选择。我们进行了一项前瞻性的多中心Ⅱ期研究，评估CapeOX作为AGC老年患者的一线治疗的疗效和安全性。符合条件的化疗未经患者年龄≥70岁的AGC患者可以参与研究。初始治疗包括每3周一次的卡培他滨（第1-14天每天2000 mg/m2）和奥沙利铂（第1天130 mg/m2）。在初始可行性评估后，根据毒性降低剂量（卡培他滨，第1-14天每天1500 mg/m2；奥沙利铂，第1天100 mg/m2，每3周一次）。主要终点是总生存期（OS）。共有108名患者参与研究，其中有104名患者进行了评估。39名患者接受了原剂量治疗，而65名患者接受了降低剂量治疗。对于所有患者，中位OS、无进展生存期（PFS）和治疗失败时间（TTF）分别为12.9个月（95% CI 11.6-14.8）、5.7个月（95% CI 5.0-7.0）和4.3个月（95% CI 3.9-5.7）。原剂量组分别为13.4个月（95% CI 9.5-16.0）、5.8个月（95% CI 4.1-7.8）和5.3个月（95% CI 3.5-7.2）；降低剂量组分别为12.8个月（95% CI 11.3-15.3）、5.7个月（95% CI 4.4-7.0）和4.1个月（95% CI 3.7-5.7）。原剂量组最常见的3/4级毒性为中性粒细胞减少（17.9%）、贫血（12.8%）和血小板减少（12.8%），而降低剂量组最常见的为中性粒细胞减少（13.8%）和食欲不振（12.3%）。这些发现表明CapeOX在老年AGC患者中具有良好的疗效和安全性。 ©2023. 作者。
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.Chemotherapy-naive patients aged ≥ 70 years with AGC were eligible. Initial treatment comprised capecitabine (2000 mg/m2 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).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.These findings demonstrate CapeOX's efficacy and safety in older AGC patients.© 2023. The Author(s).