Background: Treatment of metastatic colorectal cancer (mCRC) with BRAFV600E mutation is challenging.Resistance to treatment is a significant cause of unfavourable clinical outcomes.Aim: This work investigated the effectiveness and safety of bevacizumab (BEV) mFOLFOXIRI as an initial line of treatment of mCRC with BRAF V600E mutation.Materials & Methods: This prospective, phase II, open-label study included 30 participants with mCRC harboring RAS wild-type and BRAF V600E mutation in primary tumors or metastases.Patients received 5 mg/kg BEV plus mFOLFOXIRI biweekly for 12 cycles, until progression of the disease, intolerable toxicity, or resectability.The main end point was to evaluate response, additional end points were progression free survival, overall survival and toxicity.Results: In the current study, 18 patients achieved objective response (6.67% complete responses, 53.33% partial responses).The disease was stable in 8 (26.67%) patients.Progression-Free Survival (PFS) was 76.67% at 6 months, 43.33% at 12 months, and 10% at 36 months.Overall Survival (OS) was 83.33% at 6 months, 73.33% at 12 months, and 26.67% at 36 months.The treatment protocol showed a high incidence of Diarrhea (73.33%).Hematological toxicities were dominated by neutropenia (40%).G-CSF prophylaxis was given to 76.66%, and the dose was reduced in 36.6% of patients.Conclusions: BEV-mFOLFOXIRI combination demonstrates efficacy in treating BRAF mutant V600E mCRC, with a high response and disease control rate.However, the treatment is associated with considerable toxicities, requiring careful monitoring and management.
Elkady et al. (Wed,) studied this question.