Clinical Outcomes by Nephrectomy Status In METEOR, A Randomized Phase 3 Trial of Cabozantinib Versus Everolimus in Patients with Advanced Renal Cell Carcinoma

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Tannir , N M , Powles , T , Escudier , B , Donskov , F , Gruenwald , V , Sternberg , C N , Schmidinger , M , Schoeffski , P , Szczylik , C , Peltola , K , Nosov , D , Melichar , B , Clary , D , Scheffold , C , Motzer , R J & Choueiri , T K 2020 , ' Clinical Outcomes by Nephrectomy Status In METEOR, A Randomized Phase 3 Trial of Cabozantinib Versus Everolimus in Patients with Advanced Renal Cell Carcinoma ' , Kidney cancer , vol. 4 , no. 1 , pp. 29-39 . https://doi.org/10.3233/KCA-190080

Title: Clinical Outcomes by Nephrectomy Status In METEOR, A Randomized Phase 3 Trial of Cabozantinib Versus Everolimus in Patients with Advanced Renal Cell Carcinoma
Author: Tannir, Nizar M.; Powles, Thomas; Escudier, Bernard; Donskov, Frede; Gruenwald, Viktor; Sternberg, Cora N.; Schmidinger, Manuela; Schoeffski, Patrick; Szczylik, Cezary; Peltola, Katriina; Nosov, Dmitry; Melichar, Bohuslav; Clary, Douglas; Scheffold, Christian; Motzer, Robert J.; Choueiri, Toni K.
Contributor: University of Helsinki, HUS Comprehensive Cancer Center
Date: 2020
Language: eng
Number of pages: 11
Belongs to series: Kidney cancer
ISSN: 2468-4562
URI: http://hdl.handle.net/10138/333879
Abstract: Background: We investigated outcomes with cabozantinib versus everolimus in patients with advanced renal cell carcinoma (RCC) with or without prior nephrectomy in the phase 3 METEOR trial (NCT01865747). Methods: Patients (N = 658) with advanced clear cell RCC and prior treatment with >= 1 VEGFR tyrosine kinase inhibitor (TKI) were randomized to cabozantinib 60 mg/day or everolimus 10 mg/day. Pre-specified subgroup analyses of progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were conducted by prior nephrectomy status. Response was assessed by independent radiology committee. Results: Most enrolled patients (85%) had prior nephrectomy. Baseline prognostic factors (e.g. MSKCC risk group) were less favorable for patients without prior nephrectomy. Cabozantinib improved outcomes versus everolimus in the subgroups with and without nephrectomy-hazard ratios (95% CIs) of 0.51 (0.41-0.64) and 0.51 (0.30-0.86), respectively, for PFS, and 0.66 (0.52-0.84) and 0.75 (0.44-1.27), respectively, for OS. Median OS was numerically longer in patients with versus those without prior nephrectomy in both treatment arms. ORR for cabozantinib versus everolimus was 17% versus 4% for the prior nephrectomy subgroup and 21% versus 2% for the subgroup without prior nephrectomy. Among evaluable patients without prior nephrectomy, reductions of renal target lesions occurred in 94% (16/17) of patients in the cabozantinib arm versus 44% (8/18) in the everolimus arm. The safety profiles of both subgroups were generally consistent with that of the overall study population. Conclusion: Cabozantinib improved PFS, ORR, and OS compared with everolimus in patients with advanced RCC irrespective of nephrectomy status.
Subject: Nephrectomy
renal cell carcinoma
cabozantinib
everolimus
ENDOTHELIAL GROWTH-FACTOR
CYTOREDUCTIVE NEPHRECTOMY
TARGETED THERAPY
INTERFERON-ALPHA
2ND-LINE TREATMENT
OPEN-LABEL
SURVIVAL
SUNITINIB
EFFICACY
AXITINIB
3122 Cancers
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