Academic Journal
Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451
| العنوان: | Nivolumab and Ipilimumab as Maintenance Therapy in Extensive-Disease Small-Cell Lung Cancer: CheckMate 451 |
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| المساهمون: | Taofeek K Owonikoko, Keunchil Park, Ramaswamy Govindan, Neal Ready, Martin Reck, Solange Peters, Shaker R Dakhil, Alejandro Navarro, Jerónimo Rodríguez-Cid, Michael Schenker, Jong-Seok Lee, Vanesa Gutierrez, Ivor Percent, Daniel Morgensztern, Carlos H Barrios, Laurent Greillier, Sofia Baka, Miten Patel, Wen Hong Lin, Giovanni Selvaggi, Christine Baudelet, Jonathan Baden, Dimple Pandya, Parul Doshi, Hye Ryun Kim, Kim, Hye Ryun |
| بيانات النشر: | American Society of Clinical Oncology |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Adult, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols / therapeutic use, Double-Blind Method, Female, Humans, Ipilimumab / administration & dosage, Ipilimumab / adverse effects, Lung Neoplasms / drug therapy, Lung Neoplasms / mortality, Male, Middle Aged, Nivolumab / administration & dosage, Nivolumab / adverse effects, Small Cell Lung Carcinoma / drug therapy, Small Cell Lung Carcinoma / mortality |
| الوصف: | 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. ; open |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0732-183X 1527-7755 |
| Relation: | JOURNAL OF CLINICAL ONCOLOGY; J01331; OAK-2022-04168; https://ir.ymlib.yonsei.ac.kr/handle/22282913/190401; T202126019; JOURNAL OF CLINICAL ONCOLOGY, Vol.39(12) : 1349-1359, 2021-04 |
| DOI: | 10.1200/JCO.20.02212 |
| الاتاحة: | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190401 https://doi.org/10.1200/JCO.20.02212 |
| Rights: | CC BY-NC-ND 2.0 KR |
| رقم الانضمام: | edsbas.858BD713 |
| قاعدة البيانات: | BASE |
| تدمد: | 0732183X 15277755 |
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| DOI: | 10.1200/JCO.20.02212 |