A randomised phase 2 study comparing different dose approaches of induction treatment of regorafenib in previously treated metastatic colorectal cancer patients (REARRANGE trial)

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 regime...

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Detalhes bibliográficos
Autores: 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), UNICANCER GI, The REARRANGE investigators
Tipo de documento: artigo
Estado:Versão publicada
Data de publicação:2022
País:España
Recursos:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)
Repositório:Recercat. Dipósit de la Recerca de Catalunya
OAI Identifier:oai:recercat.cat:2445/192003
Acesso em linha:https://hdl.handle.net/2445/192003
Access Level:Acceso aberto
Palavra-chave:Càncer colorectal
Metàstasi
Administració de medicaments
Colorectal cancer
Metastasis
Administration of drugs
Descrição
Resumo: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.

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