Neoadjuvant nivolumab plus chemotherapy increases event-free survival in resectable non-small cell lung cancer

1. Neoadjuvant nivolumab plus chemotherapy resulted in longer event-free survival and a higher percentage of patients with pathologic complete response than chemotherapy alone.

2. Adding nivolumab as a neoadjuvant did not increase the incidence or severity of adverse events, or impact the feasibility of surgery.

Level of evidence assessment: 1 (Excellent)

Summary of the study: Adding neoadjuvant immunotherapy to a chemotherapy or surgery regimen has been shown to be effective in some cancers. This study explored the efficacy and safety of nivolumab (an anti-programmed death 1 antibody) as a neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC). These patients were randomized to receive neoadjuvant nivolumab and chemotherapy, or chemotherapy alone, both followed by surgery. The median event-free survival (EFS) in the nivolumab group was longer and the percentage of patients with a pathological complete response was higher. These results were consistent across most subgroups, with the greatest magnitude of EFS benefit being in patients with stage IIIA disease. More patients in the nivolumab group underwent permanent surgery than the chemotherapy group. In the nivolumab group, the median duration of surgery was shorter, minimally invasive procedures were more frequent, and pneumonectomies were less frequent. The incidence of adverse events was not increased with the addition of neoadjuvant nivolumab, and the occurrence of grade 3 or 4 treatment-related adverse events was not significantly different between the two groups. The most common grade 3 or 4 adverse events in both groups include neutropenia and neutrophil count decreased. The limitations of this study are its predominantly male patients and the fact that it does not discuss the need for adjuvant therapy in this treatment regimen. The strengths of this study are that it has limited bias given its design and that it was able to demonstrate the clinical benefit of neoadjuvant nivolumab in lung cancer. Overall, the addition of neoadjuvant nivolumab is a viable treatment option in resectable NSCLC.

Click to read the study in the NEJM

Click to read an accompanying editorial in: NEJM

Relevant reading: Early-stage resectable non-small cell lung cancer: is neoadjuvant immunotherapy the right way forward?

In depth [randomized control trial]: This international phase III trial randomly divided 358 patients with resectable stage IB to IIIA NSCLC into two groups before having them undergo resection: 179 in the neoadjuvant nivolumab plus chemotherapy group and 179 in the chemotherapy alone group. The median SSE was 31.6 months in the nivolumab group and 20.8 months in the chemotherapy group (relative risk [HR] for disease progression, disease recurrence, or death, 0.63; 97.38% confidence interval [CI], 0.43 to 0.91; P=0.005). The percentage of patients with a pathological complete response was 24.0% in the nivolumab group and 2.2% in the chemotherapy group (odds ratio, 13.94; 99% CI, 3.49 to 55.75; P

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