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P-123 Outcomes and predictive factors of regorafenib benefit in patients with metastatic colorectal cancer in a real-life setting

2020; Elsevier BV; Volume: 31; Linguagem: Inglês

10.1016/j.annonc.2020.04.205

1569-8041

Nieves Martínez Lago, B. Carnero Lopez, J. de la Cámara Gómez, Francisca Vázquez-Rivera, Ana Fernández Montés, Nataly de Dios, Ana Maseda, M. Pellón Augusto, Sonia Candamio Folgar, M. Reboredo-Lopez, Mercedes Salgado Fernández, Elena Gallardo Martín, M. Covela-Rúa, Begoña Graña, Marta Campos, E. Brozos Vázquez, C. Reboredo Rendo, G. Quintero Aldana, C. Grande Ventura, Yolanda Vidal Insua, J. Méndez Méndez,

Economic and Financial Impacts of Cancer

After regorafenib (REG) was approved due to a survival benefit in refractory metastatic colorectal cancer (mCRC), some predictive markers such as the FAS and FAS-CORRECT scores have been proposed to improve patient selection. We have explored the survival and safety outcomes of REG in a real-life setting and tried to find and validate predictive markers. We conducted a retrospective, multicentre, observational study of pts with mCRC treated with REG after failure to standard therapies as part of routine clinical practice at seven hospitals from the Galician Research Group on Digestive Tumors (GITuD). We recorded 130 pts treated with REG between September 2013 to December 2019. Median age was 63 years (range 27-79 years), 65.4% male, ECOG PS0/1/2 19.2/75.4/4.6%, 45.4% left-sided location, 78.5% low grade, 55.4% RASmt and 1.5% BRAFmt, 58.5% synchronous presentation, 76.2% primary tumor resection, 32.3% >3 metastatic locations and 75% liver metastases. Median prior lines of treatment were 3 (range 2-8) including TAS-102 in 29.2% of pts. Initial dose: 53.1% pts full standard dose, 14.6% dose level -1, 16.9% dose level -2. 15.4% pts used a dose-escalation strategy (ReDOS strategy). Dose selection 60 (OS 5.2 vs 9.1; p 85 (OS 6.4 vs 9.0; p= 0.016) achieved prognostic significance. Median of weeks until reimbursement approval was 3.1 weeks. Patients who had to wait longer to start treatment had lower OS (5.2 vs 7.8; p=0.006) despite having similar clinical characteristics. The results of our series corroborate that REG offers and modest survival benefit in all patients with refractory mCRC, which can be significant in selected patients. Although we have not been able to validate the FAS and FAS-correct algorithms, our results suggest that they could be useful and some important parameters that reflect disease burden are confirmed to be predictors of poor prognosis. Finally, we have identified for the first time in our study, that delay of treatment due to reimbursement reasons is an independent prognostic factor.