The New England Journal of MedicinePerioperative Nivolumab in Resectable Lung Cancer

Does perioperative treatment with nivolumab further improve clinical outcomes?

Perioperative treatment with nivolumab significantly enhances event-free survival in patients with resectable non-small-cell lung cancer (NSCLC), according to a phase 3 randomized trial. This treatment regimen, combining neoadjuvant nivolumab with chemotherapy followed by surgery and adjuvant nivolumab, demonstrated superior clinical outcomes and manageable safety profiles compared to traditional chemotherapy alone.

Key Points:

• Study Design: Phase 3, randomized, double-blind trial.
• Participants: Adults with resectable stage IIA to IIIB non-small-cell lung cancer (NSCLC).
• Intervention: Neoadjuvant nivolumab plus chemotherapy vs. neoadjuvant chemotherapy plus placebo, followed by surgery and adjuvant nivolumab or placebo.
• Primary Outcome: Event-free survival.
• Secondary Outcomes: Pathological complete response, major pathological response, overall survival, and safety.

Findings:

• Event-Free Survival: 70.2% at 18 months for the nivolumab group vs. 50.0% for the chemotherapy group (HR, 0.58; 97.36% CI, 0.42 to 0.81; P<0.001).
• Pathological Complete Response: 25.3% for the nivolumab group vs. 4.7% for the chemotherapy group (OR, 6.64; 95% CI, 3.40 to 12.97).
• Major Pathological Response: 35.4% for the nivolumab group vs. 12.1% for the chemotherapy group (OR, 4.01; 95% CI, 2.48 to 6.49).
• Safety: Grade 3 or 4 treatment-related adverse events in 32.5% of the nivolumab group vs. 25.2% of the chemotherapy group.

HCN Medical Memo
Perioperative nivolumab significantly improves event-free survival compared to chemotherapy in resectable NSCLC without introducing new safety concerns.

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