Cabozantinib for the treatment of advanced renal cell carcinoma in treatment-naïve adults

• Autores: Alba Salguero Olid, M. J. Martínez Bautista, S. Fénix Caballero
• Localización: European journal of clinical pharmacy: atención farmacéutica, ISSN 2385-409X, Vol. 21, Nº. 3, 2019, págs. 160-163
• Idioma: inglés
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• Resumen

  • Cabozantinib is a multi-targeted inhibitor tyrosine kinase. EMA authorization (September 2018) includes the treatment of naïve patients with advanced renal cell carcinoma (RCC) and intermediate- or poor-risk, defined by the ,International Metastatic Renal Cell Carcinoma Database Consortium criteria. The efficacy and safety of cabozantinib for the treatment-naïve RCC were evaluated in a randomized, open-label and multicenter phase II study. Patients, (No. = 157) with intermediate- or poor-risk disease, previously untreated, locally advanced or metastatic renal cell carcinoma with a clear cell component, were randomized (1:1) to receive cabozantinib (No. = 79) or sunitinib (No. = 78). Compared with sunitinib, cabozantinib treatment significantly increased median progression-free survival (P)S), 8.2 versus 5.6 months (HR = 0.66; 95% confidence interval, 95% C,: 6.2-8.8, p = 0.012), without statistically significant differences in overall survival (difference in median survival was 8.5 months, HR 0.8; 95% C,: 0.5-1.26). Objective response rate (ORR) was 33% (95% C,: 23-44%) for cabozantinib versus 12% (95% C,: 5.4-21%) for sunitinib. All-causality grade 3 or 4 adverse events were 67% for cabozantinib and 68% for sunitinib, and included diarrhea (cabozantinib, 10% versus sunitinib, 11%), fatigue (6% versus 15%), hypertension (28% versus 22%), palmar-plantar erythrodysesthesia (8% versus 4%) and hematologic adverse events (3% versus 22%). 7he results of pivotal trial are insufficient to consider cabozantinib as first-line treatment. More studies are needed (phase III trial) to support its inclusion in the first-line therapeutic arsenal of advanced or metastatic RCC