• Kazuhiro Nishikawa, Kazumasa Fujitani, Hitoshi Inagaki, Yusuke Akamaru, Shinya Tokunaga, Masakazu Takagi, Shigeyuki Tamura, Naotoshi Sugimoto, Tadashi Shigematsu, Takaki Yoshikawa, Tohru Ishiguro, Masato Nakamura, Satoshi Morita, Yumi Miyashita, Akira Tsuburaya, Junichi Sakamoto, and Toshimasa Tsujinaka.
• Department of Surgery, Osaka National Hospital, 2-1-14, Houenzaka, Chuo-ku, Osaka 540-0006, Japan. Electronic address: kazuno13@hotmail.co.jp.
• Eur. J. Cancer. 2015 May 1; 51 (7): 808-16.

AimThe optimal second-line regimen for treating advanced gastric cancer (AGC) remains unclear. While irinotecan (CPT-11) plus cisplatin (CDDP) combination therapy and CPT-11 monotherapy have been explored in the second-line setting, the superiority of second-line platinum-based therapies for AGC patients initially treated with S-1 monotherapy has not yet been evaluated; therefore, we aimed to examine the survival benefit of CPT-11/CDDP combination over CPT-11 monotherapy.MethodsAGC patients showing progression after S-1 monotherapy for advanced cancer or recurrence within 6 months after completion of S-1 adjuvant therapy were randomly allocated to CPT-11/CDDP (CPT-11, 60 mg/m(2); CDDP, 30 mg/m(2), q2w) or CPT-11 (150 mg/m(2), q2w).ResultsSixty-eight advanced and 95 recurrent cases were evaluated. The median overall survivals were 13.9 (95% confidence interval [CI]: 10.8-17.6) and 12.7 (95% CI: 10.3-17.2) months for CPT-11/CDDP and CPT-11, respectively (hazard ratio: 0.834; 95% CI: 0.596-1.167, P = 0.288). No significant differences were observed in the secondary end-points, including progression-free survival (4.6 [95% CI: 3.4-5.9] versus 4.1 [95% CI: 3.3-4.9]months) and response rate (16.9% [95% CI: 8.8-28.3] versus 15.4% [95% CI: 7.6-26.5]). The incidences of grade 3-4 anaemia (16% versus 4%) and elevated serum lactate dehydrogenase levels (5% versus 0%) were higher for CPT-11/CDDP than for CPT-11. Exploratory subgroup analysis revealed that CPT-11/CDDP was significantly more effective for intestinal-type AGC, compared with CPT-11 (overall survival: 15.8 versus 14.0 months; P = 0.019).ConclusionNo survival benefit was observed upon adding CDDP to CPT-11 after S-1 monotherapy failure.Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

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