دورية أكاديمية
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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| المساهمون: | Robert Motzer, Boris Alekseev, Sun-Young Rha, Camillo Porta, Masatoshi Eto, Thomas Powles, Viktor Grünwald, Thomas E Hutson, Evgeny Kopyltsov, María J Méndez-Vidal, Vadim Kozlov, Anna Alyasova, Sung-Hoo Hong, Anil Kapoor, Teresa Alonso Gordoa, Jaime R Merchan, Eric Winquist, Pablo Maroto, Jeffrey C Goh, Miso Kim, Howard Gurney, Vijay Patel, Avivit Peer, Giuseppe Procopio, Toshio Takagi, Bohuslav Melichar, Frederic Rolland, Ugo De Giorgi, Shirley Wong, Jens Bedke, Manuela Schmidinger, Corina E Dutcus, Alan D Smith, Lea Dutta, Kalgi Mody, Rodolfo F Perini, Dongyuan Xing, Toni K Choueiri, Rha, Sun Young |
| بيانات النشر: | Massachusetts Medical Society |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Aged, 80 and over, Antibodies, Monoclonal, Humanized / administration & dosage, Humanized / adverse effects, Antineoplastic Agents / adverse effects, Antineoplastic Agents / therapeutic use, Antineoplastic Combined Chemotherapy Protocols / adverse effects, Antineoplastic Combined Chemotherapy Protocols / therapeutic use, Carcinoma, Renal Cell / drug therapy, Renal Cell / mortality, Everolimus / administration & dosage, Everolimus / adverse effects, Female, Humans, Kidney Neoplasms / drug therapy, Kidney Neoplasms / mortality, Male, Middle Aged, Phenylurea Compounds / administration & dosage, Phenylurea Compounds / adverse effects, Programmed Cell Death 1 Receptor / antagonists & inhibitors, Progression-Free Survival, Protein Kinase Inhibitors / therapeutic use, Quinolines / administration & dosage, Quinolines / adverse effects, Sunitinib / adverse effects |
| الوصف: | Background: 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. Methods: 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. Results: 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; P<0.001) 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; P<0.001). 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0028-4793 1533-4406 |
| العلاقة: | NEW ENGLAND JOURNAL OF MEDICINE; J02371; OAK-2021-06182; https://ir.ymlib.yonsei.ac.kr/handle/22282913/185460Test; T202104165; NEW ENGLAND JOURNAL OF MEDICINE, Vol.384(14) : 1289-1300, 2021-04 |
| DOI: | 10.1056/NEJMoa2035716 |
| الإتاحة: | https://doi.org/10.1056/NEJMoa2035716Test https://ir.ymlib.yonsei.ac.kr/handle/22282913/185460Test |
| حقوق: | CC BY-NC-ND 2.0 KR |
| رقم الانضمام: | edsbas.AE689981 |
| قاعدة البيانات: | BASE |
| تدمد: | 00284793 15334406 |
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| DOI: | 10.1056/NEJMoa2035716 |