Publication:
Outcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial.

dc.contributor.authorSenan, S
dc.contributor.authorÖzgüroğlu, M
dc.contributor.authorDaniel, D
dc.contributor.authorVillegas, A
dc.contributor.authorVicente, D
dc.contributor.authorMurakami, S
dc.contributor.authorHui, R
dc.contributor.authorFaivre-Finn, C
dc.contributor.authorPaz-Ares, L
dc.contributor.authorWu, Y L
dc.contributor.authorMann, H
dc.contributor.authorDennis, P A
dc.contributor.authorAntonia, S J
dc.date.accessioned2023-05-03T14:58:15Z
dc.date.available2023-05-03T14:58:15Z
dc.date.issued2022-03-02
dc.description.abstractThe phase III PACIFIC trial (NCT02125461) established consolidation durvalumab as standard of care for patients with unresectable, stage III non-small-cell lung cancer (NSCLC) and no disease progression following chemoradiotherapy (CRT). In some cases, patients with stage IIIA-N2 NSCLC are considered operable, but the relative benefit of surgery is unclear. We report a post hoc, exploratory analysis of clinical outcomes in the PACIFIC trial, in patients with or without stage IIIA-N2 NSCLC. Patients with unresectable, stage III NSCLC and no disease progression after ≥2 cycles of platinum-based, concurrent CRT were randomized 2 : 1 to receive durvalumab (10 mg/kg intravenously; once every 2 weeks for up to 12 months) or placebo, 1-42 days after CRT. The primary endpoints were progression-free survival (PFS; assessed by blinded independent central review according to RECIST version 1.1) and overall survival (OS). Treatment effects within subgroups were estimated by hazard ratios (HRs) from unstratified Cox proportional hazards models. Of 713 randomized patients, 287 (40%) had stage IIIA-N2 disease. Baseline characteristics were similar between patients with and without stage IIIA-N2 NSCLC. With a median follow-up of 14.5 months (range: 0.2-29.9 months), PFS was improved with durvalumab versus placebo in both patients with [HR = 0.46; 95% confidence interval (CI), 0.33-0.65] and without (HR = 0.62; 95% CI 0.48-0.80) stage IIIA-N2 disease. Similarly, with a median follow-up of 25.2 months (range: 0.2-43.1 months), OS was improved with durvalumab versus placebo in patients with (HR = 0.56; 95% CI 0.39-0.79) or without (HR = 0.78; 95% CI 0.57-1.06) stage IIIA-N2 disease. Durvalumab had a manageable safety profile irrespective of stage IIIA-N2 status. Consistent with the intent-to-treat population, treatment benefits with durvalumab were confirmed in patients with stage IIIA-N2, unresectable NSCLC. Prospective studies are needed to determine the optimal treatment approach for patients who are deemed operable.
dc.identifier.doi10.1016/j.esmoop.2022.100410
dc.identifier.essn2059-7029
dc.identifier.pmcPMC9058904
dc.identifier.pmid35247871
dc.identifier.pubmedURLhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC9058904/pdf
dc.identifier.unpaywallURLhttp://www.esmoopen.com/article/S205970292200031X/pdf
dc.identifier.urihttp://hdl.handle.net/10668/22213
dc.issue.number2
dc.journal.titleESMO open
dc.journal.titleabbreviationESMO Open
dc.language.isoen
dc.organizationHospital Universitario Virgen Macarena
dc.page.number100410
dc.pubmedtypeJournal Article
dc.pubmedtypeRandomized Controlled Trial
dc.pubmedtypeResearch Support, Non-U.S. Gov't
dc.rightsAttribution 4.0 International
dc.rights.accessRightsopen access
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.subjectchemotherapy
dc.subjectimmunotherapy
dc.subjectmultimodality therapy
dc.subjectradiation therapy
dc.subjectsurgery
dc.subject.meshAntibodies, Monoclonal
dc.subject.meshCarcinoma, Non-Small-Cell Lung
dc.subject.meshChemoradiotherapy
dc.subject.meshDisease Progression
dc.subject.meshHumans
dc.subject.meshLung Neoplasms
dc.titleOutcomes with durvalumab after chemoradiotherapy in stage IIIA-N2 non-small-cell lung cancer: an exploratory analysis from the PACIFIC trial.
dc.typeresearch article
dc.type.hasVersionVoR
dc.volume.number7
dspace.entity.typePublication

Files

Original bundle

Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
PMC9058904.pdf
Size:
448.31 KB
Format:
Adobe Portable Document Format