Cancers, Vol. 16, Pages 1515: First-Line LV5FU2 with or without Aflibercept in Patients with Non-Resectable Metastatic Colorectal Cancer: A Randomized Phase II Trial (PRODIGE 25-FFCD-FOLFA)

Cancers, Vol. 16, Pages 1515: First-Line LV5FU2 with or without Aflibercept in Patients with Non-Resectable Metastatic Colorectal Cancer: A Randomized Phase II Trial (PRODIGE 25-FFCD-FOLFA) Cancers doi: 10.3390/cancers16081515 Authors: Jean-Louis Legoux Roger Faroux Nicolas Barrière Karine Le Malicot David Tougeron Véronique Lorgis Véronique Guerin-Meyer Vincent Bourgeois David Malka Thomas Aparicio Matthieu Baconnier Valérie Lebrun-Ly Joëlle Egreteau Faïza Khemissa Akouz Magali Terme Côme Lepage Valérie Boige Fluropyrimidine monotherapy is an option for some patients with inoperable metastatic colorectal cancer. Unlike bevacizumab, the addition of aflibercept, an antibody acting as an anti-angiogenic agent, has never been evaluated in this context. The aim of the study was to determine whether aflibercept could increase the efficacy of fluoropyrimidine monotherapy without increasing toxicity. This multicenter phase II non-comparative trial evaluated the addition of aflibercept to infusional 5-fluorouracil/folinic acid (LV5FU2 regimen) as first-line treatment in patients unfit to receive doublet cytotoxic chemotherapy. The primary endpoint was 6-month progression-free survival (PFS). The clinical hypotheses expected a PFS rate at 6 months of over 40% (60% expected). A total of 117 patients, with a median age of 81 years, were included: 59 in arm A (LV5FU2-aflibercept) and 58 in arm B (LV5FU2 alone). Six-month PFS was 54.7% in bo...
Source: Cancers - Category: Cancer & Oncology Authors: Tags: Article Source Type: research