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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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/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
Volume31
Issue number35
DOIs
Publication statusPublished - 2013 Dec 10
Externally publishedYes

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irinotecan
Paclitaxel
Combination Drug Therapy
Platinum
Stomach Neoplasms
Neoplasm Metastasis
Disease-Free Survival
Survival
Therapeutics
Drug Therapy

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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

In: Journal of Clinical Oncology, Vol. 31, No. 35, 10.12.2013, p. 4438-4444.

Research output: Contribution to journalArticle

Hironaka, S, Ueda, S, Yasui, H, Nishina, T, Tsuda, M, Tsumura, T, Sugimoto, N, Shimodaira, H, Tokunaga, S, Moriwaki, T, Esaki, T, Nagase, M, Fujitani, K, Yamaguchi, K, Ura, T, Hamamoto, Y, Morita, S, Okamoto, I, Boku, N & Hyodo, I 2013, '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', Journal of Clinical Oncology, vol. 31, no. 35, pp. 4438-4444. https://doi.org/10.1200/JCO.2012.48.5805
Hironaka, Shuichi ; Ueda, Shinya ; Yasui, Hirofumi ; Nishina, Tomohiro ; Tsuda, Masahiro ; Tsumura, Takehiko ; Sugimoto, Naotoshi ; Shimodaira, Hideki ; Tokunaga, Shinya ; Moriwaki, Toshikazu ; Esaki, Taito ; Nagase, Michitaka ; Fujitani, Kazumasa ; Yamaguchi, Kensei ; Ura, Takashi ; Hamamoto, Yasuo ; Morita, Satoshi ; Okamoto, Isamu ; Boku, Narikazu ; Hyodo, Ichinosuke. / 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. In: Journal of Clinical Oncology. 2013 ; Vol. 31, No. 35. pp. 4438-4444.
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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/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.",
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TY - JOUR

T1 - 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

T2 - WJOG 4007 trial

AU - Hironaka, Shuichi

AU - Ueda, Shinya

AU - Yasui, Hirofumi

AU - Nishina, Tomohiro

AU - Tsuda, Masahiro

AU - Tsumura, Takehiko

AU - Sugimoto, Naotoshi

AU - Shimodaira, Hideki

AU - Tokunaga, Shinya

AU - Moriwaki, Toshikazu

AU - Esaki, Taito

AU - Nagase, Michitaka

AU - Fujitani, Kazumasa

AU - Yamaguchi, Kensei

AU - Ura, Takashi

AU - Hamamoto, Yasuo

AU - Morita, Satoshi

AU - Okamoto, Isamu

AU - Boku, Narikazu

AU - Hyodo, Ichinosuke

PY - 2013/12/10

Y1 - 2013/12/10

N2 - 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.

AB - 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.

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