PMID- 34736367 OWN - NLM STAT- MEDLINE DCOM- 20220121 LR - 20220808 IS - 1651-226X (Electronic) IS - 0284-186X (Print) IS - 0284-186X (Linking) VI - 61 IP - 1 DP - 2022 Jan TI - Analysis by region of outcomes for patients with advanced renal cell carcinoma treated with cabozantinib or everolimus: a sub-analysis of the METEOR study. PG - 52-57 LID - 10.1080/0284186X.2021.1995041 [doi] AB - INTRODUCTION: 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. MATERIAL AND METHODS: 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. RESULTS: 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%). CONCLUSION: 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. FAU - Schmidinger, Manuela AU - Schmidinger M AD - Department of Urology, Medical University of Vienna, Vienna, Austria. FAU - Motzer, Robert J AU - Motzer RJ AD - Memorial Sloan Kettering Cancer Center, New York, NY, USA. FAU - Rolland, Frederic AU - Rolland F AD - Institut de Cancerologie de l'Ouest, Saint-Herblain, France. FAU - Staehler, Michael AU - Staehler M AD - Department of Urology, Ludwig-Maximilians-Universitat Munchen, Munich, Germany. FAU - Rink, Michael AU - Rink M AD - Department of Urology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. FAU - Retz, Margitta AU - Retz M AD - Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany. FAU - Csoszi, Tibor AU - Csoszi T AD - Jasz-Nagykun-Szolnok County Hospital, Szolnok, Hungary. FAU - McCaffrey, John A AU - McCaffrey JA AD - Cancer Trials Ireland, Dublin, Ireland. FAU - De Giorgi, Ugo AU - De Giorgi U AD - IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy. FAU - Caserta, Claudia AU - Caserta C AD - Medical and Translational Oncology Unit, Azienda Ospedaliera Santa Maria, Terni, Italy. FAU - Duran, Ignacio AU - Duran I AD - Medical Oncology Department, Hospital Universitario Marques de Valdecilla (IDIVAL), Santander, Spain. FAU - Benzaghou, Fawzi AU - Benzaghou F AD - Ipsen Bioscience, Oncology R&D, Cambridge, MA, USA. FAU - Clary, Douglas O AU - Clary DO AD - Exelixis Inc., Alameda, CA, USA. FAU - Albiges, Laurence AU - Albiges L AD - Medical Oncology, Gustave Roussy, Universite Paris-Saclay, Villejuif, France. FAU - Choueiri, Toni K AU - Choueiri TK AD - Dana-Farber Cancer Institute, Boston, MA, USA. FAU - Tannir, Nizar M AU - Tannir NM AD - MD Anderson Cancer Center Hospital, The University of Texas, Houston, TX, USA. LA - eng GR - P30 CA008748/CA/NCI NIH HHS/United States PT - Journal Article PT - Randomized Controlled Trial DEP - 20211104 PL - Sweden TA - Acta Oncol JT - Acta oncologica (Stockholm, Sweden) JID - 8709065 RN - 0 (Anilides) RN - 0 (Antineoplastic Agents) RN - 0 (Protein Kinase Inhibitors) RN - 0 (Pyridines) RN - 1C39JW444G (cabozantinib) RN - 9HW64Q8G6G (Everolimus) SB - IM MH - Anilides/adverse effects MH - *Antineoplastic Agents/adverse effects MH - *Carcinoma, Renal Cell/drug therapy MH - Everolimus/adverse effects MH - Humans MH - *Kidney Neoplasms/drug therapy MH - Protein Kinase Inhibitors/adverse effects MH - Pyridines PMC - PMC9357268 MID - NIHMS1825572 OTO - NOTNLM OT - *Cabozantinib OT - *METEOR regional sub-analysis OT - *everolimus OT - *renal cell carcinoma COIS- Disclosure statement No potential conflict of interest was reported by the author(s). EDAT- 2021/11/06 06:00 MHDA- 2022/01/22 06:00 PMCR- 2022/08/07 CRDT- 2021/11/05 05:28 PHST- 2021/11/06 06:00 [pubmed] PHST- 2022/01/22 06:00 [medline] PHST- 2021/11/05 05:28 [entrez] PHST- 2022/08/07 00:00 [pmc-release] AID - 10.1080/0284186X.2021.1995041 [doi] PST - ppublish SO - Acta Oncol. 2022 Jan;61(1):52-57. doi: 10.1080/0284186X.2021.1995041. Epub 2021 Nov 4.