Efficacy and safety analysis of dose-modified FOLFOXIRI as first-line chemotherapy in advanced gastric cancer / 中国肿瘤临床

ABSTRACT

Objective: To evaluate the efficacy and safety of dose-modified FOLFOXIRI as first-line chemotherapy in advanced gastric cancer patients. Methods: Twenty patients without prior chemotherapy were enrolled between July 2016 and March 2019 at the Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Treatment consisted of oxaliplatin 85 mg/m2 on day 1, irinotecan 120 mg/m2 on day 1, leucovorin 200 mg/m2 on day 1, and 5-fluorouracil 2400 mg/m2 as a 44-h continuous infusion starting on day 1; treatment was repeated every two weeks. The primary endpoint was objective response rate (ORR). The secondary endpoints were progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety. Results: The median number of treatment cycles was eight. ORR and DCR were 50% and 95%, respectively. The median time to response was 1.6 months, and the median DOR reached 8.7 months. The median follow-up was 19.5 months, the median PFS was 9.5 months (95% CI 7.309-11.691), and the median OS was 19.9 months (95% CI 9.754-30.046). The most common adverse enents (AEs) were leukopenia, elevation of ALT and AST, and diarrhea. Grade 3 neutropenia, diarrhea, and elevation of ALT occurred in 50%, 10%, and 5% patients, respectively. No Grade 4/5 AEs were observed. Conclusion: The dose-modified FOLFOXIRI showed promising antitumor activity and was well tolerated by advanced gastric cancer patients without previous treatment.