Adverse drug reaction: a comparative analysis of protocols used for treatment of colorectal cancer

Abstract

Study design: Cohort study Objective: Analyze the adverse reactions that occurred in Brazilian patients with colorectal cancer submitted to chemotherapy with two different protocols, in order to identify the types and severity of those most frequent recorded. Methods: Sixty-three patients, who started treatment from June 2014 to May 2015, were separated into two groups: mFOLFOX6 (protocol containing oxaliplatin, folinic acid and 5-fluorouracil in bolus and continuous infusion, n= 40) and FOLFIRI (protocol containing irinotecan, folinic acid and 5-fluorouracil in bolus and continuous infusions, n= 23). Data related to the demographic and clinical profile of the patients were collected from the medical record, as well as information about the treatment performed and the adverse reactions manifested. The reactions were classified according to their severity (grades 1, 2, 3 and 4) and causality (definite, probable, possible and doubtful). Results: A high frequency of adverse reactions was observed in both groups, reaching 92.5% of patients with mFOLFOX6 protocol and 95.6% with FOLFIRI protocol. Gastrointestinal and neurological toxicities were the most frequent among the groups. When comparing the occurrence of intergroup reactions, there was difference only for gastrointestinal toxicities (p= 0.035). In 17.5% of patients mFOLFOX6 group (n= 7) and in 8.7% of patients FOLFIRI group (n= 2), grades 3 and 4 adverse reactions were observed and classified as probable. Conclusion: The adverse reactions were more diversified and frequent in the mFOLFOX6 group compared to the FOLFIRI group. However, no difference was observed in the severity and causality of reactions in both groups.