Abstract 2398
Background
Although emerging treatments have been introduced to patients with metastatic or recurrent gastric cancer (MRGC) as second-line therapy, paclitaxel or irinotecan are still viable options. This phase III study compared the efficacy and safety of paclitaxel versus irinotecan in patients with MRGC who failed to first-line chemotherapy.
Methods
Patients were randomized to receive either paclitaxel (70 mg/m2; days 1, 8, 15, every 4 weeks) or irinotecan (150 mg/m2 biweekly). The primary endpoint was progression-free survival (PFS).
Results
This study was stopped early due to low accrual rate. A total of 112 patients were enrolled, of which 54 were allocated to paclitaxel, and 58 to irinotecan. Median PFS of paclitaxel or irinotecan group were 3.5 and 2.1 months, respectively [hazard ratio (HR) 1.27; 95% confidence interval (CI), 0.86-1.88; p = 0.234]. Non-inferiority of irinotecan to paclitaxel was not proven according to the predefined upper margin of non-inferiority (1.32). Median overall survival (OS) was 8.6 months in the paclitaxel group, and 7.0 months in the irinotecan group (HR, 1.39; 95% CI, 0.91-2.11; p = 0.126). There was no difference in response rate (p = 0.783) between paclitaxel (15.8%) and irinotecan (13.6%). Among toxicities of ≥ grade 3, neutropenia (11.5%) was the most common toxicity, followed by peripheral neuropathy (7.7%) in the paclitaxel group, and neutropenia (34.5%) followed by nausea, vomiting and anemia (8.6%, respectively) in the irinotecan group.
Conclusions
Although paclitaxel showed numerically longer PFS and OS compared with irinotecan, this was statistically insignificant. Both irinotecan and paclitaxel are valid second-line treatment options in MRGC.
Clinical trial identification
Legal entity responsible for the study
Korean Cancer Study Group (KCSG).
Funding
Boryung Pharmaceutical, CJ HealthCare Corp.
Editorial Acknowledgement
This study was partly funded by Boryung Pharmaceutical and CJ HealthCare Corp. The research was supported in part by the Korean Cancer Study Group (KCSG) and KCSG data center (Study Number: KCSG ST10-01).
Disclosure
All authors have declared no conflicts of interest.
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