VELOUR trial compared FOLFIRI+/-aflibercept in 1226 mCRC patients after progression to oxaliplatin-based treatment, regardless of biological previous therapies. mOS (13.50 vs 12.06 months) and mPFS (6.90 vs 4.67 months) were increased, which led to aflibercept approval. We do not have yet enough information on aflibercept after anti-EGFR treatment. Our goal was to analyze efficacy and safety data of aflibercept in this specific context.
Retrospective analysis of clinical, therapeutic, and survival data collected from 120 consecutive RASwt mCRC patients treated from 2012 to 2017 with FOLFIRI-aflibercept after progression to standard chemotherapy + anti-EGFR in 12 Spanish hospitals.
Median age was 60, 62.5% male, 37.5% female. 24% were right-sided tumours and 76% left-sided, with primary tumour resection in 41%. 100% RASwt, 5% BRAFmt. All patients received prior anti-EGFR therapy and 96% had ECOG 0/1. Median of FOLFIRI-Aflibercept cycles was 12, with 33% ORR. mPFS was 6.9 months (95% CI 6.0-7.7). BRAF, ECOG, primary tumour resection and nº of metastatic sites had statistical significance in univariate analysis; and primary tumour resection was also significant in multivariate analysis. mOS was 14.5 months (95% CI 9.7-19.3), with statistical significance in univariate for primary tumour resection, ECOG, and nº of metastatic sites. ECOG and nº of metastatic sites reached significance in multivariate analysis. As for toxicity, only 18.3% needed aflibercept dose reduction. 2nd line treatment was discontinued in 71.8% (mostly due to progression: 51.7%, 6.7% toxicity,1.7% surgery). 37% reached G3-4 toxicity (16.6% hematologic, 7.5% HTN, 5.9% asthenia, 2.5% perforation) 59% received a 3rd line therapy: 23% TAS-102, 18% regorafenib, 9% capecitabine.
RASwt mCRC patients reached similar results to those reported in VELOUR trial. The efficacy of subsequent aflibercept-containing 2nd line was maintained regardless of prior anti-EGFR. The efficacy of subsequent aflibercept-containing 2nd line was maintained regardless of prior anti-EGFR. Our results suggest that FOLFIRI-aflibercept, after 1st line with anti-EGFR, is a good treatment strategy for RASwt mCRC.
Clinical trial identification
Legal entity responsible for the study
Ruth Vera García.
Has not received any funding.
All authors have declared no conflicts of interest.