Long-term follow-up of overall survival for cabozantinib versus everolimus in advanced renal cell carcinoma

Mené sur 658 patients atteints d'un carcinome à cellules rénales de stade avancé, cet essai de phase III compare l'efficacité sur le long terme, du point de vue de la survie globale, du cabozantinib et de l'évérolimus après l'échec d'une thérapie anti-angiogénique de première ligne (430 décès au total)

British Journal of Cancer, sous presse, 2018, article en libre accès

Résumé en anglais

Background : In the phase 3 METEOR trial (NCT01865747), cabozantinib significantly improved progression-free survival, overall survival, and objective response rate compared with everolimus in patients with advanced renal cell carcinoma (RCC) after prior antiangiogenic therapy. A statistically significant improvement in overall survival was observed at a second interim analysis with 320 recorded deaths.

Methods : 658 patients with advanced RCC who had received at least one prior VEGFR tyrosine kinase inhibitor were randomised 1:1 to cabozantinib (60 mg daily) or everolimus (10 mg daily). Survival follow-up continued to reach the 408 deaths that were pre-specified for the final analysis.

Results : With 430 deaths (198 for cabozantinib and 232 for everolimus), median overall survival was 21.4 months with cabozantinib and 17.1 months with everolimus (HR 0.70, 95% CI 0.58–0.85; P = 0.0002). Safety profiles of cabozantinib and everolimus were consistent with those reported previously.

Conclusions : Cabozantinib significantly improved overall survival compared with everolimus in previously treated patients with advanced RCC with consistent results after long-term follow-up.