Cited 144 times in
Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451
DC Field | Value | Language |
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dc.contributor.author | 김혜련 | - |
dc.date.accessioned | 2022-09-14T01:19:39Z | - |
dc.date.available | 2022-09-14T01:19:39Z | - |
dc.date.issued | 2021-04 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190401 | - |
dc.description.abstract | Purpose: In extensive-disease small-cell lung cancer (ED-SCLC), response rates to first-line platinum-based chemotherapy are robust, but responses lack durability. CheckMate 451, a double-blind phase III trial, evaluated nivolumab plus ipilimumab and nivolumab monotherapy as maintenance therapy following first-line chemotherapy for ED-SCLC. Methods: Patients with ED-SCLC, Eastern Cooperative Oncology Group performance status 0-1, and no progression after ≤ 4 cycles of first-line chemotherapy were randomly assigned (1:1:1) to nivolumab 1 mg/kg plus ipilimumab 3 mg/kg once every 3 weeks for 12 weeks followed by nivolumab 240 mg once every 2 weeks, nivolumab 240 mg once every 2 weeks, or placebo for ≤ 2 years or until progression or unacceptable toxicity. Primary end point was overall survival (OS) with nivolumab plus ipilimumab versus placebo. Secondary end points were hierarchically tested. Results: Overall, 834 patients were randomly assigned. The minimum follow-up was 8.9 months. OS was not significantly prolonged with nivolumab plus ipilimumab versus placebo (hazard ratio [HR], 0.92; 95% CI, 0.75 to 1.12; P = .37; median, 9.2 v 9.6 months). The HR for OS with nivolumab versus placebo was 0.84 (95% CI, 0.69 to 1.02); the median OS for nivolumab was 10.4 months. Progression-free survival HRs versus placebo were 0.72 for nivolumab plus ipilimumab (95% CI, 0.60 to 0.87) and 0.67 for nivolumab (95% CI, 0.56 to 0.81). A trend toward OS benefit with nivolumab plus ipilimumab was observed in patients with tumor mutational burden ≥ 13 mutations per megabase. Rates of grade 3-4 treatment-related adverse events were nivolumab plus ipilimumab (52.2%), nivolumab (11.5%), and placebo (8.4%). Conclusion: Maintenance therapy with nivolumab plus ipilimumab did not prolong OS for patients with ED-SCLC who did not progress on first-line chemotherapy. There were no new safety signals. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ONCOLOGY | - |
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 | Antineoplastic Combined Chemotherapy Protocols / therapeutic use* | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Ipilimumab / administration & dosage* | - |
dc.subject.MESH | Ipilimumab / adverse effects | - |
dc.subject.MESH | Lung Neoplasms / drug therapy* | - |
dc.subject.MESH | Lung Neoplasms / mortality | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Nivolumab / administration & dosage* | - |
dc.subject.MESH | Nivolumab / adverse effects | - |
dc.subject.MESH | Small Cell Lung Carcinoma / drug therapy* | - |
dc.subject.MESH | Small Cell Lung Carcinoma / mortality | - |
dc.title | Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Taofeek K Owonikoko | - |
dc.contributor.googleauthor | Keunchil Park | - |
dc.contributor.googleauthor | Ramaswamy Govindan | - |
dc.contributor.googleauthor | Neal Ready | - |
dc.contributor.googleauthor | Martin Reck | - |
dc.contributor.googleauthor | Solange Peters | - |
dc.contributor.googleauthor | Shaker R Dakhil | - |
dc.contributor.googleauthor | Alejandro Navarro | - |
dc.contributor.googleauthor | Jerónimo Rodríguez-Cid | - |
dc.contributor.googleauthor | Michael Schenker | - |
dc.contributor.googleauthor | Jong-Seok Lee | - |
dc.contributor.googleauthor | Vanesa Gutierrez | - |
dc.contributor.googleauthor | Ivor Percent | - |
dc.contributor.googleauthor | Daniel Morgensztern | - |
dc.contributor.googleauthor | Carlos H Barrios | - |
dc.contributor.googleauthor | Laurent Greillier | - |
dc.contributor.googleauthor | Sofia Baka | - |
dc.contributor.googleauthor | Miten Patel | - |
dc.contributor.googleauthor | Wen Hong Lin | - |
dc.contributor.googleauthor | Giovanni Selvaggi | - |
dc.contributor.googleauthor | Christine Baudelet | - |
dc.contributor.googleauthor | Jonathan Baden | - |
dc.contributor.googleauthor | Dimple Pandya | - |
dc.contributor.googleauthor | Parul Doshi | - |
dc.contributor.googleauthor | Hye Ryun Kim | - |
dc.identifier.doi | 10.1200/JCO.20.02212 | - |
dc.contributor.localId | A01166 | - |
dc.relation.journalcode | J01331 | - |
dc.identifier.eissn | 1527-7755 | - |
dc.identifier.pmid | 33683919 | - |
dc.contributor.alternativeName | Kim, Hye Ryun | - |
dc.contributor.affiliatedAuthor | 김혜련 | - |
dc.citation.volume | 39 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | 1349 | - |
dc.citation.endPage | 1359 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, Vol.39(12) : 1349-1359, 2021-04 | - |
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