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Published on: February 12, 2017
Perioperative Outcomes and Pathological Response After Neoadjuvant Nivolumab Plus Platinum Chemotherapy in Clinically
Takuya Watanabe1,2, Kotaro Nomura3, Shinkichi Takamori4,5
1Division of Thoracic Surgery, Respiratory Disease Center, Seirei Mikatahara General Hospital, Hamamatsu, Japan. watanabechoke@gmail.com.
Purpose:
The role of neoadjuvant chemoimmunotherapy in clinically node-negative (cN0) non-small cell lung cancer (NSCLC) remains unclear. This study aimed to evaluate perioperative outcomes and pathological response in patients with cN0.
Methods:
This was a pre-specified secondary analysis of the CReGYT-04 Neo-Venus registry, a nationwide multicenter retrospective study in Japan. A total of 129 patients with stage IIA-IIIB NSCLC who received neoadjuvant nivolumab plus platinum-doublet chemotherapy were included. Patients were stratified by clinical nodal status (cN0 vs. cN1-2), and clinical characteristics, perioperative outcomes, and pathological responses were compared.
Results:
The analysis included 31 patients with cN0 and 98 with cN1-2. Preoperative treatment discontinuation was more frequent in the cN0 group (22.6% vs. 9.2%), primarily due to immune-related adverse events (irAEs) or disease progression. The surgical cancellation rate was 6.5% in the cN0 group and 9.2% in the cN1-2 group. Postoperative outcomes, including complication rates and hospital stay, were comparable between the groups, with no 30-day mortality observed in the cN0 group. Pathological complete response was achieved in 34.5% of the cN0 group and 36.1% of the cN1-2 group; major pathological response was observed in 48.3% and 62.7%, respectively. R0 resection was achieved in all cN0 patients.
Conclusions:
In patients with resectable cN0 NSCLC, nivolumab-based neoadjuvant chemoimmunotherapy was associated with perioperative outcomes and pCR rates similar to those observed in patients with cN1-2. These findings suggest that this regimen may represent a treatment option for patients with cN0, with careful attention to irAEs and disease progression.