Adjuvant Nivolumab vs Observation in Resected Non–Small Cell Lung Cancer
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Le résumé fourni par la source
Importance: Preoperative and perioperative nivolumab improve event-free survival in resectable non-small cell lung cancer. The role of adjuvant nivolumab after upfront surgery is unknown. Objective: To determine whether adjuvant nivolumab improves disease-free survival and overall survival in patients with resected non-small cell lung cancer with any tumor programmed death-ligand 1 (PD-L1) expression and in those with at least 50% PD-L1 expression. Design, Setting, and Participants: This open-label, randomized phase 3 study enrolled participants from May 2016 through September 2019, with median follow-up of 72.6 months at the data cutoff in December 2025. The study was conducted at 378 centers in the US National Clinical Trials Network. Patients were identified through a screening trial. Those with resected tumors at least 4 cm and/or who were lymph node positive (N1/N2) were eligible for inclusion after completion of planned standard adjuvant therapy if the tumor was adenocarcinoma without sensitizing sequence variants in EGFR and ALK or squamous cell carcinoma. Intervention: Patients were randomized in a 1:1 ratio to receive nivolumab 480 mg intravenously every 4 weeks for up to 1 year or standard care observation. Main Outcomes and Measures: Co-primary end points were disease-free survival in the intention-to-treat population and in those with tumoral PD-L1 expression at least 50%. Overall survival was examined if the corresponding test of disease-free survival was statistically significant. Results: A total of 466 patients (median age, 66 years; 241 [52%] male) were assigned to receive nivolumab and 469 (median age, 67 years; 245 [52%] male) to undergo standard care observation. The median duration of follow-up was 72.6 months. The trial was stopped for futility at 75% information. In the intention-to-treat population, median disease-free survival was 71.3 months with nivolumab and 68.8 months with observation (hazard ratio for progression or death, 0.97 [97% CI, 0.79-1.20]; [95% CI, 0.81-1.17]; 1-sided P = .39). In the subset of participants with PD-L1 of at least 50%, median disease-free survival was 89.8 months with nivolumab and 78.5 months with observation (hazard ratio for progression or death, 0.86 [98% CI, 0.55-1.34]; [95% CI, 0.59-1.25]; 1-sided P = .22). Conclusions and Relevance: Adjuvant nivolumab was not associated with improved disease-free survival in patients with resected non-small cell lung cancer without sensitizing EGFR and ALK alterations when given after planned adjuvant chemotherapy and/or radiotherapy. Trial Registration: Clinicaltrials.gov Identifier: NCT02595944.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Adjuvant Nivolumab vs Observation in Resected Non–Small Cell Lung Cancer
- Date Crossref
- 11/08/2026
- Éditeur
- American Medical Association (AMA)
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Memorial Sloan Kettering Cancer Center pays non établi dans la noticeÉtablissement de santé
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Cornell University pays non établi dans la noticeUniversité ou école supérieure
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Harvard University pays non établi dans la noticeUniversité ou école supérieure
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Dana-Farber Cancer Institute pays non établi dans la noticeStructure de recherche
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Emory University pays non établi dans la noticeUniversité ou école supérieure
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Winship Cancer Institute pays non établi dans la noticeÉtablissement de santé
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Gundersen Lutheran Hospital pays non établi dans la noticeÉtablissement de santé
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Heartland Cancer Research pays non établi dans la noticeÉtablissement de santé
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Minnesota Oncology pays non établi dans la noticeÉtablissement de santé
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Wellmont Health Systems pays non établi dans la noticeÉtablissement de santé
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Kaiser Permanente pays non établi dans la noticeOrganisation à but non lucratif
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Duke Medical Center pays non établi dans la noticeÉtablissement de santé
Memorial Sloan Kettering Cancer Center, Cornell University et Harvard University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.