Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markers

• DOI: 10.1002/cam4.1903
• Publication Date: 2019-01-28T23:32:56Z
• Authors: Ana Fernández Montes; Nieves Martínez Lago; Marta Covela Rúa; Juan de la Cámara...; Paula González Vi...; José Carlos Ménde...; Mónica Jorge Fern...; Mercedes Salgado ...; Margarita Rebored...; Guillermo Quinter...; María Luz Pellón ...; Begoña Graña Suárez; Jesús García Gómez
• Keywords: FOLFIRI; Aflibercept; Mucositis

Abstract Purpose The phase III VELOUR trial demonstrated efficacy with combined FOLFIRI‐aflibercept in patients metastatic colorectal cancer previously treated oxaliplatin or without bevacizumab versus placebo. effect of routine clinical practice was evaluated. Methods/Patients Overall survival (OS), progression‐free (PFS), response and safety were analysed for 78 at six GITuD institutions. Exploratory analyses prognostic predictive markers performed. Results Patients had good general status (PS 0‐1 96.2%), tumours mostly RAS ‐mutant (75.6%), synchronous (71.8%), left‐sided (71.8%). Prior therapy included (47.4%) anti‐EGFR agents (12.8%). PFS longer metachronous than (11.0 vs 5.0 months, P = 0.028), left‐colon (7.0 3.0 0.044). RAS‐ mutant status, first‐line treatment primary tumour surgery did not impact PFS. disease control rate 70.5%. most common grade 3/4 toxicities neutropenia (15.3%), asthenia (10.3%), diarrhea mucositis (6.4% each). Dysphonia reported 39.7% patients, 3 hypertension 3.8%. Development (any grade) significantly associated a reduced risk progression by multivariate analysis (HR 2.7; 95%CI 1.3‐5.4; 0.001). Conclusions Efficacy real‐life population line results from the pivotal toxicity manageable adaptation. Survival outcomes impacted location, surgery. Hypertension may be surrogate marker this patient population.