Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma
| العنوان: | Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma |
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| المؤلفون: | Motzer, R, Alekseev, B, Rha, SY, Porta, C, Eto, M, Powles, T, Grunwald, V, Hutson, TE, Kopyltsov, E, Mendez-Vidal, MJ, Kozlov, V, Alyasova, A, Hong, SH, Kapoor, A, Gordoa, TA, Merchan, JR, Winquist, E, Maroto, P, Goh, JC, Kim, M, Gurney, H, Patel, V, Peer, A, Procopio, G, Takagi, T, Melichar, B, Rolland, F, De Giorgi, U, Wong, S, Bedke, J, Schmidinger, M, Dutcus, CE, Smith, AD, Dutta, L, Mody, K, Perini, RF, Xing, DY, Choueiri, TK, CLEAR Trial Investigators |
| المصدر: | NEW ENGLAND JOURNAL OF MEDICINE r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau instname |
| بيانات النشر: | MASSACHUSETTS MEDICAL SOC, 2021. |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Oncology, Male, Programmed Cell Death 1 Receptor, Medizin, Pembrolizumab, 030204 cardiovascular system & hematology, urologic and male genital diseases, chemistry.chemical_compound, 0302 clinical medicine, Renal cell carcinoma, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Sunitinib, Medicine, 030212 general & internal medicine, Humanized, Aged, 80 and over, General Medicine, Middle Aged, female genital diseases and pregnancy complications, Kidney Neoplasms, Progression-Free Survival, Quinolines, Female, Lenvatinib, medicine.drug, Adult, medicine.medical_specialty, Antineoplastic Agents, Antibodies, Monoclonal, Humanized, Antibodies, 03 medical and health sciences, Internal medicine, Carcinoma, Humans, Progression-free survival, Everolimus, Carcinoma, Renal Cell, Protein Kinase Inhibitors, Aged, business.industry, Phenylurea Compounds, Renal Cell, medicine.disease, Survival Analysis, chemistry, business |
| الوصف: | Lenvatinib in combination with pembrolizumab or everolimus has activity against advanced renal cell carcinoma. The efficacy of these regimens as compared with that of sunitinib is unclear.In this phase 3 trial, we randomly assigned (in a 1:1:1 ratio) patients with advanced renal cell carcinoma and no previous systemic therapy to receive lenvatinib (20 mg orally once daily) plus pembrolizumab (200 mg intravenously once every 3 weeks), lenvatinib (18 mg orally once daily) plus everolimus (5 mg orally once daily), or sunitinib (50 mg orally once daily, alternating 4 weeks receiving treatment and 2 weeks without treatment). The primary end point was progression-free survival, as assessed by an independent review committee in accordance with Response Evaluation Criteria in Solid Tumors, version 1.1. Overall survival and safety were also evaluated.A total of 1069 patients were randomly assigned to receive lenvatinib plus pembrolizumab (355 patients), lenvatinib plus everolimus (357), or sunitinib (357). Progression-free survival was longer with lenvatinib plus pembrolizumab than with sunitinib (median, 23.9 vs. 9.2 months; hazard ratio for disease progression or death, 0.39; 95% confidence interval [CI], 0.32 to 0.49; P0.001) and was longer with lenvatinib plus everolimus than with sunitinib (median, 14.7 vs. 9.2 months; hazard ratio, 0.65; 95% CI, 0.53 to 0.80; P0.001). Overall survival was longer with lenvatinib plus pembrolizumab than with sunitinib (hazard ratio for death, 0.66; 95% CI, 0.49 to 0.88; P = 0.005) but was not longer with lenvatinib plus everolimus than with sunitinib (hazard ratio, 1.15; 95% CI, 0.88 to 1.50; P = 0.30). Grade 3 or higher adverse events emerged or worsened during treatment in 82.4% of the patients who received lenvatinib plus pembrolizumab, 83.1% of those who received lenvatinib plus everolimus, and 71.8% of those who received sunitinib. Grade 3 or higher adverse events occurring in at least 10% of the patients in any group included hypertension, diarrhea, and elevated lipase levels.Lenvatinib plus pembrolizumab was associated with significantly longer progression-free survival and overall survival than sunitinib. (Funded by Eisai and Merck Sharp and Dohme; CLEAR ClinicalTrials.gov number, NCT02811861.). |
| تدمد: | 0028-4793 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0334f0faf7037f77f5c4cb15439bd9c2Test https://iibsantpau.fundanetsuite.com/Publicaciones/ProdCientif/PublicacionFrw.aspx?id=4803Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....0334f0faf7037f77f5c4cb15439bd9c2 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 00284793 |
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