Introduction: To assess the risk factors associated with regorafenib-related adverse events (AEs) in metastatic colorectal cancer (mCRC) and gastrointestinal stromal tumors (GIST). We also evaluated different measures of combatting AEs and their success rate to aid physicians in early identification and management of reported AEs.
Methods: A literature search was conducted through the electronic databases PubMed, Embase, and Cochrane Central Register of Controlled Trials up to May 2018 according to the pre-specified inclusion and exclusion criteria. Pooled estimates with Pearson correlation were obtained with fixed or random-effects models.
Results: From our analysis, it was evident that AEs were more common in patients aged less than 65 years compared to those aged at least 65 years (71.3% vs. 27.6%, p = 0.001). A statistically significant correlation was observed between the occurrence of AEs and a dose of 160 mg (r = 0.967; p = 0.001) while no significant correlation was found at 120 mg and 80 mg. The common measures used to manage AEs included lowering the regorafenib dose (41%), intermittent drug withdrawal (66.7%), and complete drug withdrawal (19%). About 57% of patients recovered from AE after their initiating dose was lowered.
Conclusion: Regorafenib-associated AEs are more common at an initiating dose of 160 mg. Considering that the efficacy depends on the dosage, 120 mg might be a better choice for mCRC and GIST patients; further studies are needed to validate the results of our analysis. Further prompt identification and management of AEs are required to help the patients continue with drug therapy.
Keywords: AEs; Adverse events; Correlation; Follow-up; Intermittent withdrawal; Lowering the dose; Regorafenib.