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Background: The addition of antiangiogenic therapies, such as bevacizumab and aflibercept, resulted in overall survival (OS) gain for patients with metastatic colorectal (mCRC). Recently the CORRECT trial demonstrated that regorafenib, an oral multi-kinase inhibitor, also led to improved OS in patients with refractory mCRC. However, the efficacy and safety of regorafenib has not been described in our region, as neither the outcomes following treatment with aflibercept. Objective: To evaluate the overall treatment outcomes of Brazilian patients treated with regorafenib as well as according to type of prior antiangiogenic agent, aflibercept (Group A) or bevacizumab (Group B). Methods: Retrospective unicenter study of mCRC patients treated with regorafenibe within an Expanded Access Program. Results: We included 24 patients: 14 received B and 10, received A. Most patients had colon cancer and all had ECOG 0 or 1. Wild type RAS mCRC was present in 30% of Group A and in 42.8% of Group B. The best response by RECIST 1.1 was stable disease. Median OS times were 8.15 months in Group A, 5.8 months in Group B and 6.16 months for the whole group. Cavitation of pulmonary metastases (45% in Group B and 66%% in Group A) did not influence OS. Nearly 80% of Group A patients received post-progression treatments versus 35.7% in Group B. Fatigue, hand-foot skin reactions, elevated liver enzymes and arterial hypertension were the most common adverse events related to regorafenib, with grade 2/3 occurring in 90% of Group A and in 78.50% of Group B. There were no grade 4 toxicities. Conclusion: In this retrospective series, the median OS of patients treated with regorafenib after bevacizumab was similar to that reported by phase III trials. For those previously treated with aflibercept, the median OS was numerically longer in comparison with the bevacizumab group, although this could be explained by selection bias. The toxicity profile of regorafenibe was also similar to that described in the literature except for less diarrhea, which was rare among Brazilian patients.

revista brasileira de oncologia clínica

Use of regorafenibe in patients with metastastic colorretal cancer previously treated with bevacizumab or aflibercept: uni-institutional clinical experience