Please use this identifier to cite or link to this item:
Title: A randomised phase 2 study comparing different dose approaches of induction treatment of regorafenib in previously treated metastatic colorectal cancer patients (REARRANGE trial)
Author: Argilés, Guillem
Mulet, Nuria
Valladares Ayerbes, Manuel
Viéitez, José M.
Grávalos, Cristina
García Alfonso, Pilar
Santos, Cristina
Tobeña, María
García Paredes, Beatriz
Benavides, Manuel
Cano, María T.
Loupakis, Fotios
Rodríguez Garrote, Mercedes
Rivera, Fernando
Goldberg, Richard M.
Cremolini, Chiara
Bennouna, Jaafar
Ciardiello, Fortunato
Tabernero Caturla, Josep
Aranda, Enrique
Falcone, Alfredo
Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)
The REARRANGE investigators
Keywords: Càncer colorectal
Administració de medicaments
Colorectal cancer
Administration of drugs
Issue Date: 1-Dec-2022
Publisher: Elsevier BV
Abstract: Purpose: The purpose of this article is to evaluate the safety of two regorafenib dose-escalation approaches in refractory metastatic colorectal cancer (mCRC) patients.Patients and methods: Patients with mCRC and progression during or within 3 months following their last standard chemotherapy regimen were randomised to receive the approved dose of regorafenib of 160 mg QD (arm A) or 120 mg QD (arm B) administered as 3 weeks of treatment followed by 1 week off, or 160 mg QD 1 week on/1 week off (arm C). The primary end-point was the percentage of patients with G3/G4 treatment-related adverse events (AEs) in each arm.Results: There were 299 patients randomly assigned to arm A (n = 101), arm B (n = 99), or arm C (n = 99); 297 initiated treatments (arm A n = 100, arm B n = 98, arm C n = 99: pop-ulation for safety analyses). G3/4 treatment-related AEs occurred in 60%, 55%, and 54% of patients in arms A, B, and C, respectively. The most common G3/4 AEs were hypertension (19, 12, and 20 patients), fatigue (20, 14, and 15 patients), hypokalemia (11, 7, and 10 pa-tients), and hand-foot skin reaction (8, 7, and 3 patients). Median overall survival was 7.4 (IQR 4.0-13.7) months in arm A, 8.6 (IQR 3.8-13.4) in arm B, and 7.1 (IQR 4.4-12.4) in arm C.Conclusions: The alternative regorafenib dosing schedules were feasible and safe in patients with mCRC who had been previously treated with standard therapy. There was a higher nu-merical improvement on the most clinically relevant AEs in the intermittent dosing arm, particularly during the relevant first two cycles.
Note: Reproducció del document publicat a:
It is part of: European Journal of Cancer, 2022, vol. 177, p. 154-163
Related resource:
ISSN: 0959-8049
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

Files in This Item:
File Description SizeFormat 
PIIS0959804922007808.pdf1.25 MBAdobe PDFView/Open

This item is licensed under a Creative Commons License Creative Commons