Aflibercept Plus FOLFIRI for Second-line Treatment of Metastatic Colorectal Cancer: Observations from the Global Aflibercept Safety and Health-Related Quality-of-Life Program (ASQoP)
Rachel P Riechelmann, Vichien Srimuninnimit, Roberto Bordonaro, Petr Kavan, Maria Di Bartolomeo, Evaristo Maiello, Irfan Cicin, Pilar García-Alfonso, Ian Chau, Mikhail Y Fedyanin, Carlos Fernández Martos, Mikhail Ter-Ovanesov, Marc Peeters, Yoo-Joung Ko, Suayib Yalcin, Meinolf Karthaus, Jorge Aparicio, Volker Heinemann, Pascaline Picard, Denise Bury, Edward Drea, Alberto Sobrero, Rachel P Riechelmann, Vichien Srimuninnimit, Roberto Bordonaro, Petr Kavan, Maria Di Bartolomeo, Evaristo Maiello, Irfan Cicin, Pilar García-Alfonso, Ian Chau, Mikhail Y Fedyanin, Carlos Fernández Martos, Mikhail Ter-Ovanesov, Marc Peeters, Yoo-Joung Ko, Suayib Yalcin, Meinolf Karthaus, Jorge Aparicio, Volker Heinemann, Pascaline Picard, Denise Bury, Edward Drea, Alberto Sobrero
Abstract
Background: The objectives of this study were to evaluate the safety profile of aflibercept and health-related quality of life (HRQL) in patients with metastatic colorectal cancer (mCRC) provided with aflibercept access before marketing authorization.
Patients and methods: Patients received aflibercept followed by FOLFIRI (fluorouracil, leucovorin, irinotecan) on day 1 of a 2-week cycle until disease progression, unacceptable toxicity, death, or patient/investigator decision to discontinue. Treatment-emergent adverse events (TEAEs) were evaluated, and HRQL was assessed at baseline, cycle 3, and every other cycle using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, EORTC QLQ-CR29, and EuroQol 5-Dimensions 3-Levels questionnaires (NCT01571284).
Results: Overall, 779 adult patients with mCRC, who received ≥ 1 prior oxaliplatin-based regimen and had disease progression during or following their last administration of oxaliplatin-based chemotherapy, were enrolled. At data cutoff, all patients had discontinued treatment, mainly owing to disease progression (51.7%). The most common TEAEs of any grade were diarrhea (61.6%), hypertension (48.4%), and nausea (43.3%). The most common grade 3/4 TEAEs were hypertension (24.1%), neutropenia (23.1%), and diarrhea (15.3%). Clinically meaningful changes in HRQL were reported for all measures. Most patients either had an improvement in their HRQL scores or remained stable during the treatment period based on patient-reported outcomes.
Conclusion: The data from this study support the tolerability of the combination of aflibercept and FOLFIRI in a setting that more closely approximates real life in patients with mCRC who failed to respond to oxaliplatin-based chemotherapy, and also suggest an improvement in HRQL.
Keywords: Antiangiogenic; Colorectal neoplasms; Patient-reported outcome measures; Receptors; Vascular endothelial growth factor.
Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed