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

Shuichi Hironaka, Shinya Ueda, Hirofumi Yasui, Tomohiro Nishina, Masahiro Tsuda, Takehiko Tsumura, Naotoshi Sugimoto, Hideki Shimodaira, Shinya Tokunaga, Toshikazu Moriwaki, Taito Esaki, Michitaka Nagase, Kazumasa Fujitani, Kensei Yamaguchi, Takashi Ura, Yasuo Hamamoto, Satoshi Morita, Isamu Okamoto, Narikazu Boku, Ichinosuke Hyodo

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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/m2 on days 1, 8, and 15, every 4 weeks) or irinotecan (150 mg/m2 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.

Original languageEnglish
Pages (from-to)4438-4444
Number of pages7
JournalJournal of Clinical Oncology
Issue number35
Publication statusPublished - Dec 10 2013


All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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