1. Eficacia y Seguridad de Regorafenib en Pacientes con Características de Buen Pronóstico en Tratamiento del Cáncer Colorrectal Metastásico: Análisis de Subgrupo del Estudio CORRECT
- Author
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Palhares, Rodrigo Resende, Britto, Glauco do Canto, Su, Yun, Le Berre, Marie-Aude, Henriques, Ricardo Saad, Navachi, Fabricio Volpato, Pereira, Daniela Cristina Foli, Ostojic, Helene, Azevedo, Graziella Agostini, and Van Cutsem, Eric
- Subjects
protein kinase inhibitors ,neoplasm metastasis ,neoplasias colorrectales ,inibidores de proteínas quinases ,análisis de supervivência ,inhibidores de proteínas quinasas ,neoplasias colorretais ,metástase neoplásica ,análise de sobrevida ,colorectal neoplasms ,metástasis de la neoplasia ,survival analysis - Abstract
Introduction: Colorectal cancer (CRC) is the second most common and when metastatic, it has a five-year survival rate of 14%. Regorafenib is an approved TKI for metastatic colorectal cancer (mCRC) with a proven increase in overall survival (OS). Objective: To investigate the efficacy and safety results of regorafenib in patients with mCRC and good prognostic characteristics (GPC). Method: Subgroup analysis of the CORRECT study, with participants divided according to GPC, following the criteria: Eastern Cooperative Oncology Group (ECOG) 0, duration of metastatic disease greater than 18 months, up to three metastatic sites and absence of liver metastasis. Efficacy compared with stratified log-rank test and hazard ratios (HR) calculated with the Cox model. Results: Of the 760 participants randomized, 292 (34.5%) had GPC; 185 (63.4%) received regorafenib; and 107 (35.6%) received placebo. For the GPC group, the median OS was 10.9 months (95%CI:8.8-12.3) for regorafenib and 7.3 months (95%CI:5.6-9.1) for placebo, with 39% of reduction of the risk of death (HR 0.61; 95% CI:0.43-0.88; p=0.0069). The median progression-free survival (PFS) was 3.5 months (95%CI:3.0-3.9) versus 1.8 months (95%CI:1.7-1.8) respectively, with 61% of reduced risk of disease progression or death (HR 0.39; 95%CI:0.30-0.52; p
- Published
- 2022