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Published on: April 22, 2019
Nationwide Implementation of Neoadjuvant Nivolumab-Based Chemo-Immunotherapy for Resectable NSCLC: Surgical Outcomes
Jiri Vachtenheim1, Fernando Casas-Mendez2, Rene Novysedlak3
13rd Department of Surgery, First Faculty of Medicine, Charles University and University Hospital Motol and Homolka, Prague, Czech Republic. jiri.vachtenheim@fnmotol.cz.
Background:
Neoadjuvant chemo-immunotherapy has transformed the treatment landscape for resectable non-small-cell lung cancer (NSCLC). However, real-world surgical data from nationwide European cohorts remain limited. This study evaluated surgical outcomes and practice patterns during the first year of nationwide implementation of neoadjuvant chemo-immunotherapy with nivolumab in the Czech Republic.
Methods:
This prospective, multicenter, observational cohort study included all consecutive patients with resectable programmed cell death ligand-1(PD-L1) ≥ 1% NSCLC treated according to the CheckMate 816 protocol (platinum-based chemotherapy plus nivolumab) at all eight accredited thoracic oncology centers in the Czech Republic between August 2023 and August 2024. Surgical and pathological outcomes were assessed.
Results:
Sixty-four patients initiated neoadjuvant therapy and 56 (87.5%) underwent resection. Minimally invasive surgery was attempted in 46.4% of cases, with an 11.5% conversion rate. Clavien-Dindo grade ≥ III complications occurred in 14.3%, with grade IIIb representing the highest severity. 30-day mortality was 0%. Although 90-day mortality was 5.4%, none of the deaths were directly attributable to surgery. R0 resection was achieved in 98.2%. In the intention-to-treat population, pathological complete response and major pathological response rates were 40.6% and 48.4%, respectively. Pathological complete response was significantly higher in squamous than in non-squamous NSCLC (66.7% vs. 27.6%; p = 0.003).
Conclusions:
In this first nationwide cohort from a European country, early adoption of neoadjuvant chemo-immunotherapy with nivolumab in patients with resectable PD-L1 ≥ 1% NSCLC was associated with acceptable perioperative outcomes, high R0 resection rates, and substantial pathological response. These results demonstrate the successful adoption of a novel NSCLC treatment modality across a nationwide healthcare system.
