[A Study of the Safety of Chemotherapy with Generic Oxaliplatin for the Treatment of Colorectal Cancer].

ABSTRACT

BACKGROUND: Generic oxaliplatin is widely used in colorectal cancer chemotherapy; however, studies on the adverse events of generic drugs are limited. We investigated the safety of brand-name and generic oxaliplatin used in capecitabine plus oxaliplatin(plus bevacizumab Bmab)for colorectal cancer treatment. PARTICIPANTS AND METHODS: A total of 86 patients who newly started CAPOX(plus Bmab)between January 2018 and January 2022 were included in this retrospective study, excluding those who changed to generic from the brand-name drug during the chemotherapy course. RESULTS: Forty-seven patients(54.6%)were in the generic drug(GE)group, while 39 patients(45.4%)were in the brand drug(EP)group. No significant difference was observed in the patient characteristics between the GE and EP groups. The median number of oxaliplatin administrations were 4 and 5 cycles in the GE and EP groups, respectively. Neutropenia of Grade 2 or higher was observed in 51.1%(24 patients)and 33.3%(13 patients)in the GE and EP groups, respectively. Hypersensitivity was observed in 14.9%(7 patients)and 7.7%(3 patients)in the GE and EP groups, respectively. CONCLUSION: There were no statistically significant differences between generic and brand-name oxaliplatin in the frequency of adverse events.