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 regim...

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Autores: Argilés Martínez, Guillem|||0000-0002-1487-7108, Mulet, N., Valladares-Ayerbes, M.|||0000-0002-7950-9584, Viéitez, J.M.|||0000-0003-1823-8773, Grávalos, Cristina|||0000-0001-9239-6505, García-Alfonso, Pilar|||0000-0002-4373-9978, Santos Vivas, Cristina|||0000-0002-9854-5097, Tobeña, María, García Paredes, B., Benavides Orgaz, Manuel, Cano, M.T., Loupakis, F., Rodríguez-Garrote, M., Rivera, Fernando|||0000-0001-8915-226X, Goldberg, R.M., Cremolini, Chiara, Bennouna, J., Ciardiello, Fortunato, Tabernero, Josep|||0000-0002-2495-8139, Aranda Aguilar, Enrique|||0000-0002-5471-2842, Falcone, Alfredo, Goldberg, R., Argilés, None, Limón, M.L., Valladares, M., Jiménez, P., Vieitez, J.M., Grávalos, C., Paez, David|||0000-0002-5596-6588, Sastre Valera, Javier|||0000-0001-6538-0065, Rguez Garrote, M., Guillén, C., Rivera, M.F., Safont, J., Hiret, S., Pannier, D., Malka, D.
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:275167
Acceso en línea:https://ddd.uab.cat/record/275167
https://dx.doi.org/urn:doi:10.1016/j.ejca.2022.09.037
Access Level:acceso abierto
Palabra clave:Colorectal cancer
Drug administration schedule
Metastasis
Regorafenib
Descripción
Sumario: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: population 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 patients), 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 numerical improvement on the most clinically relevant AEs in the intermittent dosing arm, particularly during the relevant first two cycles. Clinicaltrials.gov identifier: NCT02835924.

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