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Clinical Trial
. 2015 May;51(7):808-16.
doi: 10.1016/j.ejca.2015.02.009. Epub 2015 Mar 18.

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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Clinical Trial

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

Kazuhiro Nishikawa et al. Eur J Cancer. .
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Abstract

Aim: 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.

Methods: 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(2); CDDP, 30 mg/m(2), q2w) or CPT-11 (150 mg/m(2), q2w).

Results: 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, 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).

Conclusion: No survival benefit was observed upon adding CDDP to CPT-11 after S-1 monotherapy failure.

Keywords: Cisplatin; Combination chemotherapy; Fluoropyrimidine; Gastric cancer; Irinotecan; Phase III; S-1; Second-line.

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