随机、开放标签、III 期研究比较了伊立替康与紫杉醇在氟嘧啶加铂类化疗失败后无严重腹膜转移的晚期胃癌患者中的疗效：WJOG4007 试验。

Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 trial.

机构信息

Shuichi Hironaka, Chiba Cancer Center, Chiba; Shinya Ueda and Isamu Okamoto, Kinki University, Osakasayama; Hirofumi Yasui, Shizuoka Cancer Center, Shizuoka; Tomohiro Nishina, National Hospital Organization Shikoku Cancer Center, Matsuyama; Masahiro Tsuda, Hyogo Cancer Center, Akashi; Takehiko Tsumura, Osaka Red Cross Hospital; Naotoshi Sugimoto, Osaka Medical Center for Cancer and Cardiovascular Diseases; Shinya Tokunaga, Osaka City General Hospital; Kazumasa Fujitani, Osaka National Hospital, Osaka; Hideki Shimodaira, Tohoku University Hospital, Sendai; Toshikazu Moriwaki and Ichinosuke Hyodo, University of Tsukuba, Tsukuba; Taito Esaki, National Kyushu Organization Kyushu Cancer Center, Fukuoka; Michitaka Nagase, Jichi Medical University, Shimono; Kensei Yamaguchi, Saitama Cancer Center, Saitama; Takashi Ura, Aichi Cancer Center Hospital, Nagoya; Yasuo Hamamoto, Tochigi Cancer Center, Utsunomiya; Satoshi Morita, Yokohama City University Graduate School of Medicine, Yokohama; and Narikazu Boku, St Marianna University School of Medicine, Kawasaki, Japan.

出版信息

J Clin Oncol. 2013 Dec 10;31(35):4438-44. doi: 10.1200/JCO.2012.48.5805. Epub 2013 Nov 4.

DOI:10.1200/JCO.2012.48.5805

PMID:24190112

Abstract

PURPOSE

This phase III study compared treatment with weekly paclitaxel and biweekly irinotecan in patients with advanced gastric cancer refractory to treatment with fluoropyrimidine plus platinum.

PATIENTS AND METHODS

Patients were randomly assigned to receive either paclitaxel (80 mg/m(2) on days 1, 8, and 15, every 4 weeks) or irinotecan (150 mg/m(2) on days 1 and 15, every 4 weeks). Primary end point was overall survival (OS), and secondary end points were progression-free survival (PFS), response rate, adverse events, and proportion of patients who received third-line chemotherapy.

RESULTS

Of 223 patients, 219 were eligible for analysis. Median OS was 9.5 months in 108 patients allocated to the paclitaxel group and 8.4 months in 111 patients allocated to the irinotecan group (hazard ratio [HR], 1.13; 95% CI, 0.86 to 1.49; P = .38). Median PFS was 3.6 months in the paclitaxel group and 2.3 months in the irinotecan group (HR, 1.14; 95% CI, 0.88 to 1.49; P = .33). Response rate was 20.9% in the paclitaxel group and 13.6% in the irinotecan group (P = .24). Common grade 3 to 4 adverse events were neutropenia (paclitaxel group, 28.7%; irinotecan group, 39.1%), anemia (21.3%; 30.0%), and anorexia (7.4%; 17.3%). Treatment-related deaths occurred in two patients (1.8%) in the irinotecan group. Third-line chemotherapy was administered in 97 patients (89.8%) after paclitaxel treatment and in 80 patients (72.1%) after irinotecan treatment (P = .001).

CONCLUSION

No statistically significant difference was observed between paclitaxel and irinotecan for OS. Both are reasonable second-line treatment options for advanced gastric cancer.

摘要

目的

本 III 期研究比较了每周紫杉醇和每 2 周伊立替康治疗氟嘧啶加铂类药物治疗后进展的晚期胃癌患者的疗效。

患者和方法

患者被随机分配接受紫杉醇（80mg/m2，第 1、8 和 15 天，每 4 周）或伊立替康（150mg/m2，第 1 和 15 天，每 4 周）。主要终点是总生存期（OS），次要终点是无进展生存期（PFS）、缓解率、不良事件和接受三线化疗的患者比例。

结果

223 例患者中，219 例符合分析条件。108 例接受紫杉醇治疗的患者中位 OS 为 9.5 个月，111 例接受伊立替康治疗的患者中位 OS 为 8.4 个月（HR，1.13；95%CI，0.86 至 1.49；P =.38）。紫杉醇组的中位 PFS 为 3.6 个月，伊立替康组为 2.3 个月（HR，1.14；95%CI，0.88 至 1.49；P =.33）。紫杉醇组的缓解率为 20.9%，伊立替康组为 13.6%（P =.24）。常见的 3 级至 4 级不良事件为中性粒细胞减少症（紫杉醇组 28.7%，伊立替康组 39.1%）、贫血（21.3%，30.0%）和厌食症（7.4%，17.3%）。伊立替康组有 2 例（1.8%）患者发生与治疗相关的死亡。紫杉醇治疗后有 97 例（89.8%）患者和伊立替康治疗后有 80 例（72.1%）患者接受了三线化疗（P =.001）。