Efficacy and safety of lenvatinib plus pembrolizumab vs sunitinib in the East Asian subset of patients with advanced renal cell carcinoma from the CLEAR trial.

Autor: Rha SY; Department of Medical Oncology, Yonsei Cancer Center, Yonsei University Health System, Seoul, South Korea., Choueiri TK; Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA., Matveev VB; Department of Urology, Federal State Budgetary Institution 'N.N. Blokhin National Medical Research Center of Oncology' of the Ministry of Health of the Russian Federation, Moscow, Russia., Alyasova A; Department of Oncology, Prevoljskiy Region Medical Centre, Novgorod, Russia., Hong SH; Department of Urology, Seoul St. Mary's Hospital, Seoul, South Korea., Gordoa TA; Department of Medical Oncology, Hospital Universitario Ramón y Cajal, Madrid, Spain., Gurney H; Department of Medical Oncology, Macquarie University, Sydney, New South Wales, Australia., Bjarnason GA; Division of Medical Oncology, Department of Medicine, Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada., Buchler T; Department of Oncology, First Faculty of Medicine, Charles University and Thomayer University Hospital, Prague, Czech Republic., Pedrazzoli P; Department of Internal Medicine and Medical Therapy, University of Pavia and Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy., Takagi T; Department of Urology, Tokyo Women's Medical University Hospital, Tokyo, Japan., Park SH; Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea., Lee JL; Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea., Perini RF; Clinical Research, Merck & Co., Inc., Rahway, New Jersey, USA., He CS; Biostatistics, Oncology Business Group, Eisai Inc., Nutley, New Jersey, USA., McKenzie JA; Clinical Research, Oncology Business Group, Eisai Inc., Nutley, New Jersey, USA., Eto M; Department of Urology, Kyushu University, Fukuoka, Japan.
Jazyk: angličtina
Zdroj: International journal of cancer [Int J Cancer] 2023 Sep 15; Vol. 153 (6), pp. 1241-1250. Date of Electronic Publication: 2023 Jun 09.
DOI: 10.1002/ijc.34608
Abstrakt: In the CLEAR trial, lenvatinib plus pembrolizumab met study endpoints of superiority vs sunitinib in the first-line treatment of patients with advanced renal cell carcinoma. We report the efficacy and safety results of the East Asian subset (ie, patients in Japan and the Republic of Korea) from the CLEAR trial. Of 1069 patients randomly assigned to receive either lenvatinib plus pembrolizumab, lenvatinib plus everolimus or sunitinib, 213 (20.0%) were from East Asia. Baseline characteristics of patients in the East Asian subset were generally comparable with those of the global trial population. In the East Asian subset, progression-free survival was considerably longer with lenvatinib plus pembrolizumab vs sunitinib (median 22.1 vs 11.1 months; HR 0.38; 95% CI: 0.23-0.62). The HR for overall survival comparing lenvatinib plus pembrolizumab vs sunitinib was 0.71; 95% CI: 0.30-1.71. The objective response rate was higher with lenvatinib plus pembrolizumab vs sunitinib (65.3% vs 49.2%; odds ratio 2.14; 95% CI: 1.07-4.28). Dose reductions due to treatment-emergent adverse events (TEAEs) commonly associated with tyrosine kinase inhibitors occurred more frequently than in the global population. Hand-foot syndrome was the most frequent any-grade TEAE with lenvatinib plus pembrolizumab (66.7%) and sunitinib (57.8%), a higher incidence compared to the global population (28.7% and 37.4%, respectively). The most common grade 3 to 5 TEAEs were hypertension with lenvatinib plus pembrolizumab (20%) and decreased platelet count with sunitinib (21.9%). Efficacy and safety for patients in the East Asian subset were generally similar to those of the global population, except as noted.
(© 2023 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)
Databáze: MEDLINE
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