# Neoadjuvant nivolumab plus chemotherapy in resectable non-small-cell lung cancer in Japanese patients from CheckMate 816.

**Tumor:** CPNM (cáncer de pulmón)
**Autores:** Mitsudomi T, Ito H, Okada M et al
**Revista:** Cancer Sci (2023)
**PMID:** 38098261 | **PMCID:** PMC10859619
**DOI:** [10.1111/cas.16030](https://doi.org/10.1111/cas.16030)
**Fuente:** PubMed Central (open access)

## Relevancia
CPNM resecable tras quimio-inmunoterapia neoadyuvante (CheckMate-816, NADIM, KEYNOTE-671): downstaging mediastínico (ypN0/N1), tasas de pCR ganglionar y supervivencia. Paralelo importante con mama: la conversión nodal patológica predice EFS/OS y orienta la extensión de la disección ganglionar.

## Abstract
In the open-label, phase III CheckMate 816 study (NCT02998528), neoadjuvant nivolumab plus chemotherapy demonstrated statistically significant improvements in event-free survival (EFS) and pathological complete response (pCR) versus chemotherapy alone in patients with resectable non-small-cell lung cancer (NSCLC). Here we report efficacy and safety outcomes in the Japanese subpopulation. Patients with stage IB-IIIA, resectable NSCLC were randomized 1:1 to nivolumab plus chemotherapy or chemotherapy alone for three&#x2009;cycles before undergoing definitive surgery within 6&#x2009;weeks of completing neoadjuvant treatment. The primary end-points (EFS and pCR) and safety were assessed in patients enrolled at 16 centers in Japan. Of the Japanese patients randomized, 93.9% (31/33) in the nivolumab plus chemotherapy arm and 82.9% (29/35) in the chemotherapy arm underwent surgery. At 21.5&#x2009;months' minimum follow-up, median EFS was 30.6&#x2009;months (95% confidence interval [CI], 16.8-not reached [NR]) with nivolumab plus chemotherapy versus 19.6&#x2009;months (95% CI, 8.5-NR) with chemotherapy; hazard ratio, 0.60 (95% CI, 0.30-1.24). The pCR rate was 30.3% (95% CI, 15.6-48.7) versus 5.7% (95% CI, 0.7-19.2), respectively; odds ratio, 7.17 (95% CI, 1.44-35.85). Grade 3/4 treatment-related adverse events were reported in 59.4% versus 42.9% of patients, respectively, with no new safety signals identified. Neoadjuvant nivolumab plus chemotherapy resulted in longer EFS and a higher pCR rate versus chemotherapy alone in Japanese patients, consistent with findings in the global population. These data support nivolumab plus chemotherapy as a neoadjuvant treatment option in Japanese patients with resectable NSCLC.

## Acceso
Disponible en PMC: https://pmc.ncbi.nlm.nih.gov/articles/PMC10859619/

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*Datos de PubMed. Citar: doi 10.1111/cas.16030*
