Abstract 2414
Background
Biweekly CPT-11 plus CDDP (BIRIP) and CPT-11 alone are both expectable options for treating advanced gastric cancer (AGC) in second-line setting. Recently, two randomized phase III trials (TCOG GI-0801 and ECRIN TRICS) employing the same regimens have been reported. Both trials did not demonstrate the survival benefit of BIRIP due to underpowered. Therefore, we conducted a meta-analysis to compare the efficacy and safety of these two regimens in patients who have been enrolled in these two randomized trials.
Methods
Individual patient–level data from these two trials were collected for this study. In these two trials, patients with metastatic or recurrent gastric cancer refractory to S-1-based chemotherapy were randomly allocated to BIRIP (CPT-11, 60 mg/m2; CDDP, 30 mg/m2, q2w) or CPT-11 (150 mg/m2, q2w). Overall survivals (OS) and progression-free survival (PFS) were described using Kaplan-Meier methods. Tumor responses were evaluated using RECIST ver. 1.0. Adverse events were evaluated using CTCAE ver. 3.0.
Results
Cumulative data from eligible 290 patients from these two trials were evaluated. OS were 12.3 (95% confidence interval [CI]: 10.5–14.1) in BIRIP group and 11.3 (95% CI: 10.0–13.2) months in CPT-11 group (hazard ratio 0.87; 95% CI: 0.68–1.12, P = 0.272). PFS was significantly longer in BIRIP group (4.3months [95% CI: 3.5–5.1]) than in CPT-11 group (3.3months [2.9–4.1]; HR 0.77; 95% CI: 0.61–0.98, P = 0.035). The response rate was 20.5% [95% CI: 13.3–27.7] in BIRIP group and 16.0% [95% CI: 9.6–22.4] in CPT-11 group (P = 0.361). The disease control rate was significantly better in BIRIP group (72.1% [95% CI: 64.2–80.1]) than in CPT-11 group (59.2% [95% CI: 50.6–67.8]) (P = 0.032). The incidences of grade 3 or worse adverse events did not differ between the two groups, for example neutropenia (35.9% vs. 32.4%) and elevation of serum creatinine (0.7% vs. 0.7%). The incidences of anemia (16.6% vs. 10.3%) was higher for BIRIP than for CPT-11. But diarrhea (1.4% versus 4.1%) was more common in CPT-11 group.
Conclusions
BIRIP significantly prolonged PFS as compared with CPT-11 alone and was tolerated as second-line treatment for AGC, but did not demonstrate the survival benefit.
Clinical trial identification
UMIN 000025367.
Legal entity responsible for the study
The non-profit organization Epidemiological & Clinical research Information Network (ECRIN).
Funding
Has not received any funding.
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
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