Background <p>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.</p> Methods <p>This prospective, multicenter, observational cohort study included all consecutive patients with resectable programmed cell death ligand-1(PD-L1) ≥&#xa0;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.</p> Results <p>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 ≥&#xa0;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%; <i>p </i>= 0.003).</p> Conclusions <p>In this first nationwide cohort from a European country, early adoption of neoadjuvant chemo-immunotherapy with nivolumab in patients with resectable PD-L1&#xa0;≥&#xa0;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.</p>

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Nationwide Implementation of Neoadjuvant Nivolumab-Based Chemo-Immunotherapy for Resectable NSCLC: Surgical Outcomes from a Prospective Multicenter Study

  • Jiri Vachtenheim Jr,
  • Fernando Casas-Mendez,
  • Rene Novysedlak,
  • Janis Tavandzis,
  • Linda Capkova,
  • Jaromir Vajter,
  • Marek Szkorupa,
  • Juraj Kultan,
  • Alice Taskova,
  • Martina Koziar Vasakova,
  • Martin Skala,
  • Martin Svaton,
  • Vilem Maly,
  • David Sulc,
  • Ivo Hanke,
  • Michal Hrnciarik,
  • Ladislav Mitas,
  • Monika Bratova,
  • Lubomir Tulinsky,
  • Radoslava Cernekova,
  • Zuzana Ozaniak Strizova,
  • Matyas Kuhn,
  • Boris Sepesi,
  • Jitka Palich Fucikova,
  • Robert Lischke

摘要

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.