dc.creator | Paz Ares, Luis | es |
dc.creator | Ramalingam, Suresh S. | es |
dc.creator | Ciuleanu, Tudor Eliade | es |
dc.creator | Lee, Jong Seok | es |
dc.creator | Urban, Laszlo | es |
dc.creator | Bernabé-Caro, Reyes | es |
dc.creator | Reck, Martin | es |
dc.date.accessioned | 2022-10-10T18:31:07Z | |
dc.date.available | 2022-10-10T18:31:07Z | |
dc.date.issued | 2022 | |
dc.identifier.citation | Paz Ares, L., Ramalingam, S.S., Ciuleanu, T.E., Lee, J.S., Urban, L., Bernabé-Caro, R. y Reck, M. (2022). First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 4-Year Outcomes From the Randomized, Open-Label, Phase 3 CheckMate 227 Part 1 Trial. Journal of Thoracic Oncology, 17 (20), 289-308. https://doi.org/10.1016/j.jtho.2021.09.010. | |
dc.identifier.issn | 1556-0864 | es |
dc.identifier.issn | 1556-1380 | es |
dc.identifier.uri | https://hdl.handle.net/11441/137788 | |
dc.description.abstract | Introduction: In CheckMate 227, nivolumab plus ipilimu mab prolonged overall survival (OS) versus chemotherapy
in patients with tumor programmed death-ligand 1 (PD-L1)
greater than or equal to 1% (primary end point) or less
than 1% (prespecified descriptive analysis). We report re sults with minimum 4 years’ follow-up.
Methods: Adults with previously untreated stage IV or
recurrent NSCLC were randomized (1:1:1) to nivolumab
plus ipilimumab, nivolumab, or chemotherapy (PD-L1
1%); or to nivolumab plus ipilimumab, nivolumab plus
chemotherapy, or chemotherapy (PD-L1 <1%). Efficacy
included OS and other measures. Safety included timing and
management of immune-mediated adverse events (AEs). A
post hoc analysis evaluated efficacy in patients who dis continued nivolumab plus ipilimumab due to treatment related AEs (TRAEs).
Results: After 54.8 months’ median follow-up, OS remained
longer with nivolumab plus ipilimumab versus chemo therapy in patients with PD-L1 greater than or equal to 1%
(hazard ratio ¼ 0.76; 95% confidence interval: 0.65–0.90)
and PD-L1 less than 1% (0.64; 0.51–0.81); 4-year OS rate
with nivolumab plus ipilimumab versus chemotherapy was
29% versus 18% (PD-L1 1%); and 24% versus 10% (PD L1 <1%). Benefits were observed in both squamous and
nonsquamous histologies. In a descriptive analysis, efficacy
was improved with nivolumab plus ipilimumab relative to
nivolumab (PD-L1 1%) and nivolumab plus chemotherapy
(PD-L1 <1%). Safety was consistent with previous reports.
The most common immune-mediated AE with nivolumab
plus ipilimumab, nivolumab, and nivolumab plus chemo therapy was rash; most immune-mediated AEs (except
endocrine events) occurred within 6 months from start of
treatment and resolved within 3 months after, mainly with
systemic corticosteroids. Patients who discontinued nivo lumab plus ipilimumab due to TRAEs had long-term OS
benefits, as seen in the all randomized population.
Conclusions: At more than 4 years’ minimum follow-up,
with all patients off immunotherapy treatment for at least
2 years, first-line nivolumab plus ipilimumab continued to
demonstrate durable long-term efficacy in patients with
advanced NSCLC. No new safety signals were identified.
Immune-mediated AEs occurred early and resolved quickly with guideline-based management. Discontinuation of nivolumab
plus ipilimumab due to TRAEs did not have a negative impact
on the long-term benefits seen in all randomized patients. | es |
dc.format | application/pdf | es |
dc.format.extent | 20 p. | es |
dc.language.iso | eng | es |
dc.publisher | ELSEVIER SCIENCE INC | es |
dc.relation.ispartof | Journal of Thoracic Oncology, 17 (20), 289-308. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | PD-1 checkpoint inhibitor | es |
dc.subject | Immunotherapy | es |
dc.subject | First-line | es |
dc.subject | Metastatic non–small cell lung cancer | es |
dc.subject | CTLA-4 | es |
dc.title | First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 4-Year Outcomes From the Randomized, Open-Label, Phase 3 CheckMate 227 Part 1 Trial | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://www.sciencedirect.com/science/article/pii/S155608642103207X?via%3Dihub | es |
dc.identifier.doi | 10.1016/j.jtho.2021.09.010 | es |
dc.journaltitle | Journal of Thoracic Oncology | es |
dc.publication.volumen | 17 | es |
dc.publication.issue | 20 | es |
dc.publication.initialPage | 289 | es |
dc.publication.endPage | 308 | es |