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
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
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DOI：
10.1200/jco.2012.48.5805
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发表时间：
2013-12-10
影响因子：
45.3
通讯作者：
Hyodo, Ichinosuke
中科院分区：
文献类型：
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作者：
Hironaka, Shuichi;Ueda, Shinya;Hyodo, Ichinosuke
目的：这项III期研究比较了每周一次的紫杉醇和两周一次的伊立替康对氟嘧啶加铂治疗无效的进展期胃癌患者的疗效。患者和方法将患者随机分为紫杉醇(80 mg/m(2)，第1、8、15天，每4周一次)和伊立替康(150 mg/m(2)，第1、15天，每4周一次)。主要终点为总生存期(OS)，次要终点为无进展生存期(PFS)、有效率、不良事件和接受三线化疗的患者比例。紫杉醇组108名患者的中位OS为9.5个月，伊立替康组111名患者的中位OS为8.4个月(风险比[HR]，1.13；95%CI，0.86至1.49；P=.38)。紫杉醇组和伊立替康组的中位PFS分别为3.6个月和2.3个月(HR，1.14；95%CI，0.88至1.49；P=.33)。紫杉醇组有效率为20.9%，伊立替康组有效率为13.6%(P=0.24)。常见的3~4级不良反应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%)、厌食(7.4%；17.3%)。伊立替康组有2名患者(1.8%)发生了与治疗相关的死亡。紫杉醇三线化疗97例(89.8%)，伊立替康治疗80例(72.1%)(P=.001)。结论紫杉醇与伊立替康治疗OS无统计学差异。两者都是进展期胃癌合理的二线治疗选择。
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.