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Phase 3 CLEAR study in patients with advanced renal cell carcinoma: outcomes in subgroups for the lenvatinib-plus-pembrolizumab and sunitinib arms
V. Grünwald, T. Powles, M. Eto, E. Kopyltsov, SY. Rha, C. Porta, R. Motzer, TE. Hutson, MJ. Méndez-Vidal, SH. Hong, E. Winquist, JC. Goh, P. Maroto, T. Buchler, T. Takagi, JE. Burgents, R. Perini, C. He, CE. Okpara, J. McKenzie, TK. Choueiri
Status neindexováno Jazyk angličtina Země Švýcarsko
Typ dokumentu časopisecké články
Grantová podpora
P30 CA008748
NCI NIH HHS - United States
NLK
Directory of Open Access Journals
od 2011
Free Medical Journals
od 2011
PubMed Central
od 2011
Europe PubMed Central
od 2011
Open Access Digital Library
od 2011-01-01
Open Access Digital Library
od 2011-01-01
ROAD: Directory of Open Access Scholarly Resources
od 2011
- Publikační typ
- časopisecké články MeSH
INTRODUCTION: The phase 3 CLEAR study demonstrated that lenvatinib plus pembrolizumab significantly improved efficacy versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma (RCC). Prognostic features including presence and/or site of baseline metastases, prior nephrectomy, and sarcomatoid features have been associated with disease and treatment success. This subsequent analysis explores outcomes in patients with or without specific prognostic features. METHODS: In CLEAR, patients with clear cell RCC were randomly assigned (1:1:1) to receive either lenvatinib (20 mg/day) plus pembrolizumab (200 mg every 3 weeks), lenvatinib (18 mg/day) plus everolimus (5 mg/day), or sunitinib alone (50 mg/day, 4 weeks on, 2 weeks off). In this report, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were all assessed in the lenvatinib-plus-pembrolizumab and the sunitinib arms, based on baseline features: lung metastases, bone metastases, liver metastases, prior nephrectomy, and sarcomatoid histology. RESULTS: In all the assessed subgroups, median PFS was longer with lenvatinib-plus-pembrolizumab than with sunitinib treatment, notably among patients with baseline bone metastases (HR 0.33, 95% CI 0.21-0.52) and patients with sarcomatoid features (HR 0.39, 95% CI 0.18-0.84). Median OS favored lenvatinib plus pembrolizumab over sunitinib irrespective of metastatic lesions at baseline, prior nephrectomy, and sarcomatoid features. Of interest, among patients with baseline bone metastases the HR for survival was 0.50 (95% CI 0.30-0.83) and among patients with sarcomatoid features the HR for survival was 0.91 (95% CI 0.32-2.58); though for many groups, median OS was not reached. ORR also favored lenvatinib plus pembrolizumab over sunitinib across all subgroups; similarly, complete responses also followed this pattern. CONCLUSION: Efficacy outcomes improved following treatment with lenvatinib-plus-pembrolizumab versus sunitinib in patients with RCC-irrespective of the presence or absence of baseline lung metastases, baseline bone metastases, baseline liver metastases, prior nephrectomy, or sarcomatoid features. These findings corroborate those of the primary CLEAR study analysis in the overall population and support lenvatinib plus pembrolizumab as a standard of care in 1L treatment for patients with advanced RCC. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT02811861.
Biostatistics Eisai Inc Nutley NJ United States
Clinic for Medical Oncology and Clinic for Urology University Hospital Essen Essen Germany
Clinical Research Eisai Inc Nutley NJ United States
Clinical Research Eisai Ltd Hatfield United Kingdom
Clinical Research Merck and Co Inc Rahway NJ United States
Department of Biomedical Sciences and Human Oncology University of Bari 'A Moro' Bari Italy
Department of Medical Oncology Dana Farber Cancer Institute Boston MA United States
Department of Medical Oncology Hospital de la Santa Creu i Sant Pau Barcelona Spain
Department of Medicine Memorial Sloan Kettering Cancer Center New York NY United States
Department of Oncology Charles University and Thomayer University Hospital Prague Czechia
Department of Oncology University of Western Ontario London ON Canada
Department of Urology Kyushu University Fukuoka Japan
Department of Urology Tokyo Women's Medical University Tokyo Japan
Global Clinical Development Merck and Co Inc Rahway NJ United States
ICON Research South Brisbane and University of Queensland St Lucia QLD Australia
Medical Oncology Texas Oncology Dallas TX United States
State Institution of Healthcare Regional Clinical Oncology Dispensary Omsk Russia
Citace poskytuje Crossref.org
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- $a Phase 3 CLEAR study in patients with advanced renal cell carcinoma: outcomes in subgroups for the lenvatinib-plus-pembrolizumab and sunitinib arms / $c V. Grünwald, T. Powles, M. Eto, E. Kopyltsov, SY. Rha, C. Porta, R. Motzer, TE. Hutson, MJ. Méndez-Vidal, SH. Hong, E. Winquist, JC. Goh, P. Maroto, T. Buchler, T. Takagi, JE. Burgents, R. Perini, C. He, CE. Okpara, J. McKenzie, TK. Choueiri
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- $a INTRODUCTION: The phase 3 CLEAR study demonstrated that lenvatinib plus pembrolizumab significantly improved efficacy versus sunitinib as first-line treatment for patients with advanced renal cell carcinoma (RCC). Prognostic features including presence and/or site of baseline metastases, prior nephrectomy, and sarcomatoid features have been associated with disease and treatment success. This subsequent analysis explores outcomes in patients with or without specific prognostic features. METHODS: In CLEAR, patients with clear cell RCC were randomly assigned (1:1:1) to receive either lenvatinib (20 mg/day) plus pembrolizumab (200 mg every 3 weeks), lenvatinib (18 mg/day) plus everolimus (5 mg/day), or sunitinib alone (50 mg/day, 4 weeks on, 2 weeks off). In this report, progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were all assessed in the lenvatinib-plus-pembrolizumab and the sunitinib arms, based on baseline features: lung metastases, bone metastases, liver metastases, prior nephrectomy, and sarcomatoid histology. RESULTS: In all the assessed subgroups, median PFS was longer with lenvatinib-plus-pembrolizumab than with sunitinib treatment, notably among patients with baseline bone metastases (HR 0.33, 95% CI 0.21-0.52) and patients with sarcomatoid features (HR 0.39, 95% CI 0.18-0.84). Median OS favored lenvatinib plus pembrolizumab over sunitinib irrespective of metastatic lesions at baseline, prior nephrectomy, and sarcomatoid features. Of interest, among patients with baseline bone metastases the HR for survival was 0.50 (95% CI 0.30-0.83) and among patients with sarcomatoid features the HR for survival was 0.91 (95% CI 0.32-2.58); though for many groups, median OS was not reached. ORR also favored lenvatinib plus pembrolizumab over sunitinib across all subgroups; similarly, complete responses also followed this pattern. CONCLUSION: Efficacy outcomes improved following treatment with lenvatinib-plus-pembrolizumab versus sunitinib in patients with RCC-irrespective of the presence or absence of baseline lung metastases, baseline bone metastases, baseline liver metastases, prior nephrectomy, or sarcomatoid features. These findings corroborate those of the primary CLEAR study analysis in the overall population and support lenvatinib plus pembrolizumab as a standard of care in 1L treatment for patients with advanced RCC. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, identifier NCT02811861.
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