Sunitinib effectiveness and safety as first line treatment in metastatic renal cell carcinoma, in the Costa Rican population

Aim: Tyrosine kinase inhibitors are part of the armamentarium to treat metastatic renal cell carcinomas (mRCC). Costa Rica has approved sunitinib in the first line setting. The authors conducted a retrospective study to address the effectiveness and safety profile of sunitinib in our population in terms of overall survival (OS) and progression free survival (PFS). Methods: The authors analyzed all patients who were treated with sunitinib diagnosed with mRCC in the three National Hospitals (Hospital Mexico, Hospital San Juan de Dios, and Hospital Calderon Guardia) from February 2007 to June 2015. Demographics, safety profile, and efficacy (OS and PFS) were obtained from medical records. OS and PFS were calculated using the Kaplan Meier method and a Cox Proportional Model Analysis was used when OS and PFS were compared in subset of patients. Results: Seventy-seven patients were included; mean age was 58.9 years. Fifty-four patients were male (70.1%). The most common histologic type was clear cell carcinoma (87%), followed by papillary (9.1%) and chromophobe (2.0%) types. Median OS was 21.0 months [95% confidence interval (CI): 13.42-28.58]. Median PFS was 13.7 months (95% CI: 11.24-16.16). Patients aged 65 years or older experienced worse PFS and OS than younger patients (median PFS: 8.2 vs. 17.6 months; P = 0.011) (median OS: 19.0 vs. 29.0 months; P = 0.022). Sunitinib was well tolerated and no serious side effects were reported. Conclusion: This is the first study in Central America showing that sunitinib, first line, in mRCC is as effective as reported in pivotal clinical trials and expanded use studies in terms of PFS and OS.