Randomised phase III trial of second-line irinotecan plus cisplatin versus irinotecan alone in patients with advanced gastric cancer refractory to S-1 monotherapy: TRICS trial |
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| Institution: | 1. Department of Surgery, Osaka National Hospital, 2-1-14, Houenzaka, Chuo-ku, Osaka 540-0006, Japan;2. Department of Surgery, Osaka General Medical Center, 3-1-56, Bandaihigashi, Sumiyoshi-ku, Osaka 558-0056, Japan;3. Department of Surgery, Gifu Central Hospital, 3-25, Kawabe, Gifu 501-1151, Japan;4. Department of Surgery, Osaka Kose-Nenkin Hospital, 4-2-78, Fukushima, Fukushima-ku, Osaka 553-0007, Japan;5. Department of Clinical Oncology, Osaka City General Hospital, 2-13-22, Miyakojimahondori, Miyakojima-ku, Osaka 534-0021, Japan;6. Department of Surgery, Shizuoka General Hospital, 4-27-1, Kitaando, Aoi-ku, Shizuoka 420-0881, Japan;7. Department of Surgery, Kansai Rosai Hospital, 3-1-69, Inabaso, Amagasaki 537-0025, Japan;8. Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, 1-3-3, Nakamichi, Higashinari-ku, Osaka 537-0025, Japan;9. Department of Gastroenterology, Saiseikai Shiga Prefectural Hospital, 2-4-1, Ohashi, Ritto 520-3046, Japan;10. Department of Gastrointestinal Surgery, Kanagawa Cancer Center, 2-3-2, Nakao, Asahi-ku, Yokohama 241-0815, Japan;11. Department of Digestive Tract and General Surgery, Saitama Medical Center, 1981, Kamoda, Kawagoe 350-0844, Japan;12. Comprehensive Cancer Center, Aizawa Hospital, 2-5-1, Honjo, Matsumoto 390-0814, Japan;13. Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, 54, Shogoinkawaharacho, Sakyo-ku, Kyoto 606-8397, Japan;14. Date Center, Epidemiological & Clinical Research Information Network, 21-7, Shogoinsannocho, Sakyo-ku, Kyoto 606-8392, Japan;15. Department of Gastroenterological Center, Yokohama City University Medical Center, 4-57, Urafunecho, Minami-ku, Yokohama 232-0024, Japan;p. Tokai Central Hospital, 4-6-2, Higashijimacho Sohara, Kakamigahara 504-8601, Japan;q. Kaizuka City Hospital, 3-10-20, Hori, Kaizuka 597-0015, Japan |
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| Abstract: | 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/m2; CDDP, 30 mg/m2, q2w) or CPT-11 (150 mg/m2, 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. |
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| Keywords: | Phase III Gastric cancer Combination chemotherapy Second-line Irinotecan Cisplatin Fluoropyrimidine S-1 |
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