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Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma
DC Field | Value | Language |
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dc.contributor.author | 라선영 | - |
dc.date.accessioned | 2021-10-21T00:17:25Z | - |
dc.date.available | 2021-10-21T00:17:25Z | - |
dc.date.issued | 2021-04 | - |
dc.identifier.issn | 0028-4793 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/185460 | - |
dc.description.abstract | 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 hypertension, diarrhea, and elevated lipase levels. Conclusions: 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.). | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Massachusetts Medical Society | - |
dc.relation.isPartOf | NEW ENGLAND JOURNAL OF MEDICINE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized / administration & dosage* | - |
dc.subject.MESH | Antibodies, Monoclonal, Humanized / adverse effects | - |
dc.subject.MESH | Antineoplastic Agents / adverse effects | - |
dc.subject.MESH | Antineoplastic Agents / therapeutic use | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / therapeutic use* | - |
dc.subject.MESH | Carcinoma, Renal Cell / drug therapy* | - |
dc.subject.MESH | Carcinoma, Renal Cell / mortality | - |
dc.subject.MESH | Everolimus / administration & dosage* | - |
dc.subject.MESH | Everolimus / adverse effects | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Kidney Neoplasms / drug therapy* | - |
dc.subject.MESH | Kidney Neoplasms / mortality | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Phenylurea Compounds / administration & dosage* | - |
dc.subject.MESH | Phenylurea Compounds / adverse effects | - |
dc.subject.MESH | Programmed Cell Death 1 Receptor / antagonists & inhibitors* | - |
dc.subject.MESH | Progression-Free Survival | - |
dc.subject.MESH | Protein Kinase Inhibitors / therapeutic use | - |
dc.subject.MESH | Quinolines / administration & dosage* | - |
dc.subject.MESH | Quinolines / adverse effects | - |
dc.subject.MESH | Sunitinib / adverse effects | - |
dc.subject.MESH | Sunitinib / therapeutic use | - |
dc.subject.MESH | Survival Analysis | - |
dc.title | Lenvatinib plus Pembrolizumab or Everolimus for Advanced Renal Cell Carcinoma | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Robert Motzer | - |
dc.contributor.googleauthor | Boris Alekseev | - |
dc.contributor.googleauthor | Sun-Young Rha | - |
dc.contributor.googleauthor | Camillo Porta | - |
dc.contributor.googleauthor | Masatoshi Eto | - |
dc.contributor.googleauthor | Thomas Powles | - |
dc.contributor.googleauthor | Viktor Grünwald | - |
dc.contributor.googleauthor | Thomas E Hutson | - |
dc.contributor.googleauthor | Evgeny Kopyltsov | - |
dc.contributor.googleauthor | María J Méndez-Vidal | - |
dc.contributor.googleauthor | Vadim Kozlov | - |
dc.contributor.googleauthor | Anna Alyasova | - |
dc.contributor.googleauthor | Sung-Hoo Hong | - |
dc.contributor.googleauthor | Anil Kapoor | - |
dc.contributor.googleauthor | Teresa Alonso Gordoa | - |
dc.contributor.googleauthor | Jaime R Merchan | - |
dc.contributor.googleauthor | Eric Winquist | - |
dc.contributor.googleauthor | Pablo Maroto | - |
dc.contributor.googleauthor | Jeffrey C Goh | - |
dc.contributor.googleauthor | Miso Kim | - |
dc.contributor.googleauthor | Howard Gurney | - |
dc.contributor.googleauthor | Vijay Patel | - |
dc.contributor.googleauthor | Avivit Peer | - |
dc.contributor.googleauthor | Giuseppe Procopio | - |
dc.contributor.googleauthor | Toshio Takagi | - |
dc.contributor.googleauthor | Bohuslav Melichar | - |
dc.contributor.googleauthor | Frederic Rolland | - |
dc.contributor.googleauthor | Ugo De Giorgi | - |
dc.contributor.googleauthor | Shirley Wong | - |
dc.contributor.googleauthor | Jens Bedke | - |
dc.contributor.googleauthor | Manuela Schmidinger | - |
dc.contributor.googleauthor | Corina E Dutcus | - |
dc.contributor.googleauthor | Alan D Smith | - |
dc.contributor.googleauthor | Lea Dutta | - |
dc.contributor.googleauthor | Kalgi Mody | - |
dc.contributor.googleauthor | Rodolfo F Perini | - |
dc.contributor.googleauthor | Dongyuan Xing | - |
dc.contributor.googleauthor | Toni K Choueiri | - |
dc.identifier.doi | 10.1056/NEJMoa2035716 | - |
dc.contributor.localId | A01316 | - |
dc.relation.journalcode | J02371 | - |
dc.identifier.eissn | 1533-4406 | - |
dc.identifier.pmid | 33616314 | - |
dc.identifier.url | https://www.nejm.org/doi/10.1056/NEJMoa2035716 | - |
dc.contributor.alternativeName | Rha, Sun Young | - |
dc.contributor.affiliatedAuthor | 라선영 | - |
dc.citation.volume | 384 | - |
dc.citation.number | 14 | - |
dc.citation.startPage | 1289 | - |
dc.citation.endPage | 1300 | - |
dc.identifier.bibliographicCitation | NEW ENGLAND JOURNAL OF MEDICINE, Vol.384(14) : 1289-1300, 2021-04 | - |
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