Buscar

Estamos realizando la búsqueda. Por favor, espere...

 Detalle_Publicacion

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

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: 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.

Otras publicaciones de la misma revista o congreso con autores/as de la Universidad de Cantabria

 Fuente: European Journal of Cancer 177 (2022) 154-63

Editorial: Elsevier

 Fecha de publicación: 01/12/2022

Nº de páginas: 10

Tipo de publicación: Artículo de Revista

 DOI: 10.1016/j.ejca.2022.09.037

ISSN: 0959-8049

Url de la publicación: https://doi.org/10.1016/j.ejca.2022.09.037

Autoría

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

FERNANDO RIVERA HERRERO

GOLDBERG, RICHARD M.

CREMOLINI, CHIARA

BENNOUNA, JAAFAR

CIARDIELLO, FORTUNATO

TABERNERO, JOSEP M.

ARANDA, ENRIQUE