METEOR was a phase 3 trial (NCT01865747) of cabozantinib versus everolimus in adults with advanced or metastatic clear cell RCC previously treated with VEGF receptor (VEGFR) tyrosine kinase inhibitors (TKIs). This post hoc analysis of METEOR compared outcomes for patients recruited from European and non-European countries.
Adults with advanced/metastatic clear cell RCC who had received ≥ 1 prior VEGFR-TKI treatment were randomized 1:1 to receive cabozantinib or everolimus. Patients were categorized by recruitment region: Europe or outside of Europe (rest of world [RoW]). Progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse events (AEs) were compared between regional subgroups.
In total, there were 320 eligible patients from Europe (cabozantinib, 167; everolimus, 153) and 338 from RoW (North America, 240 patients; Asia-Pacific, 86; Latin America, 12; randomized as cabozantinib, 163; everolimus, 175). PFS and OS were longer with cabozantinib than with everolimus and similar for the Europe and RoW subgroups. For PFS, the hazard ratio (HR) for cabozantinib versus everolimus was 0.54 for the Europe subgroup (p < .001) and 0.50 for the RoW subgroup (p < .001). For OS, the HR was 0.75 for the Europe subgroup (p = .034) and 0.69 for the RoW subgroup (p = .006). ORR in the Europe subgroup was 15% for cabozantinib and 3.9% for everolimus (p < .001). For the RoW subgroup, ORR was 20% for cabozantinib and 2.9% for everolimus (p < .001). Incidence of grade 3/4 AEs were similar for the Europe (cabozantinib, 74%; everolimus, 58%) and RoW subgroups (cabozantinib, 69%; everolimus, 64%).
In the METEOR trial, efficacy outcomes for patients recruited from European and non-European countries favored cabozantinib over everolimus. The efficacy and safety results for the regional subgroups were consistent with those of the overall METEOR population.
Acta oncologica (Stockholm, Sweden). 2021 Nov 04 [Epub ahead of print]
Manuela Schmidinger, Robert J Motzer, Frederic Rolland, Michael Straehler, Michael Rink, Margitta Retz, Tibor Csoszi, John A McCaffrey, Ugo De Giorgi, Claudia Caserta, Ignacio Duran, Fawzi Benzaghou, Douglas O Clary, Laurence Albiges, Toni K Choueiri, Nizar M Tannir
Department of Urology, Medical University of Vienna, Vienna, Austria., Memorial Sloan Kettering Cancer Center, New York, NY, USA., Institut de Cancérologie de l'Ouest, Saint-Herblain, France., Department of Urology, Ludwig-Maximilians-Universität München, Munich, Germany., Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany., Jász-Nagykun-Szolnok County Hospital, Szolnok, Hungary., Cancer Trials Ireland, Dublin, Ireland., IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy., Medical and Translational Oncology Unit, Azienda Ospedaliera Santa Maria, Terni, Italy., Medical Oncology Department, Hospital Universitario Marques de Valdecilla (IDIVAL), Santander, Spain., Ipsen Bioscience, Oncology R&D, Cambridge, MA, USA., Exelixis Inc., Alameda, CA, USA., Medical Oncology, Gustave Roussy, Université Paris-Saclay, Villejuif, France., Dana-Farber Cancer Institute, Boston, MA, USA., MD Anderson Cancer Center Hospital, The University of Texas, Houston, TX, USA.