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. Issue 7 (May 2015)

• Record Type: Journal Article
• Authors: Nishikawa, Kazuhiro; Fujitani, Kazumasa; Inagaki, Hitoshi; Akamaru, Yusuke; Tokunaga, Shinya; Takagi, Masakazu; Tamura, Shigeyuki; Sugimoto, Naotoshi; Shigematsu, Tadashi; Yoshikawa, Takaki; Ishiguro, Tohru; Nakamura, Masato; Morita, Satoshi; Miyashita, Yumi; Tsuburaya, Akira; Sakamoto, Junichi; Tsujinaka, Toshimasa
• Is Part Of: European journal of cancer. Volume 51:Issue 7(2015:May)
• Page Start: 808
• Page End: 816
• Publication Date: 2015-05
• Subjects: Cancer -- Periodicals; Neoplasms -- Periodicals; Cancer -- Périodiques; Cancer; Tumors; Electronic journals; Periodicals; Electronic journals; 616.994
• DOI: 10.1016/j.ejca.2015.02.009
• Languages: English
• ISSNs: 0959-8049

Abstract

<abstract xml:lang="en" abstract-type="author" id="ab005"> <title id="st080">Abstract</title> <sec> <title id="st085">Aim</title> <p id="sp0005">The 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.</p> </sec> <sec> <title id="st090">Methods</title> <p id="sp0010">AGC 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<sup>2</sup>; CDDP, 30 mg/m<sup>2</sup>, q2w) or CPT-11 (150 mg/m<sup>2</sup>, q2w).</p> </sec> <sec> <title id="st095">Results</title> <p id="sp0015">Sixty-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, <italic>P</italic> = 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; <italic>P</italic> = 0.019).</p> </sec> <sec> <title id="st100">Conclusion</title> <p id="sp0020">No survival benefit was observed upon adding CDDP to CPT-11 after S-1 monotherapy failure.</p> </sec> </abstract>