Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung Cancer
By P. Forde, J. Spicer, Shun Lu, M. Provencio, T. Mitsudomi, M. Awad, E. Felip, S. Broderick, J. Brahmer, S. Swanson and 19 more. New England Journal of Medicine, 2022
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BACKGROUND Neoadjuvant or adjuvant chemotherapy confers a modest benefit over surgery alone for resectable non–small-cell lung cancer (NSCLC). In early-phase trials, nivolumab-based neoadjuvant regimens have shown promising clinical activity; however, data from phase 3 trials are needed to confirm these findings. METHODS In this open-label, phase 3 trial, we randomly assigned patients with stage IB to IIIA resectable NSCLC to receive nivolumab plus platinum-based chemotherapy or platinum-based chemotherapy alone, followed by resection. The primary end points were event-free survival and pathological complete response (0% viable tumor in resected lung and lymph nodes), both evaluated by blinded independent review. Overall survival was a key secondary end point. Safety was assessed in all treated patients. RESULTS The median event-free survival was 31.6 months (95% confidence interval [CI], 30.2 to not reached) with nivolumab plus chemotherapy and 20.8 months (95% CI, 14.0 to 26.7) with chemotherapy alone (hazard ratio for disease progression, disease recurrence, or death, 0.63; 97.38% CI, 0.43 to 0.91; P=0.005). The percentage of patients with a pathological complete response was 24.0% (95% CI, 18.0 to 31.0) and 2.2% (95% CI, 0.6 to 5.6), respectively (odds ratio, 13.94; 99% CI, 3.49 to 55.75; P<0.001). Results for event-free survival and pathological complete response across most subgroups favored nivolumab plus chemotherapy over chemotherapy alone. At the first prespecified interim analysis, the hazard ratio for death was 0.57 (99.67% CI, 0.30 to 1.07) and did not meet the criterion for significance. Of the patients who underwent randomization, 83.2% of those in the nivolumab-plus-chemotherapy group and 75.4% of those in the chemotherapy-alone group underwent surgery. Grade 3 or 4 treatment-related adverse events occurred in 33.5% of the patients in the nivolumab-plus-chemotherapy group and in 36.9% of those in the chemotherapy-alone group. CONCLUSIONS In patients with resectable NSCLC, neoadjuvant nivolumab plus chemotherapy resulted in significantly longer event-free survival and a higher percentage of patients with a pathological complete response than chemotherapy alone. The addition of nivolumab to neoadjuvant chemotherapy did not increase the incidence of adverse events or impede the feasibility of surgery. (Funded by Bristol Myers Squibb; CheckMate 816 ClinicalTrials.gov number, NCT02998528.)
Subfields: Oncology, Pulmonary and Respiratory Medicine, Radiology, Nuclear Medicine and Imaging
View Paper: https://www.semanticscholar.org/paper/84f8c6ac4735c737c9a44ca1000900843c2852c8
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Citations in the corpus
- Cancer statistics, 2024 (2024, background): “83 At the population level, survival gains for lung cancer have largely been confined to nonsmall cell lung cancer, for which 3 ‐ year relative survival increased from 26% in 2004 to 40% in 2017 compared with an increase from 9% to 13% for small cell lung cancer.”
- Cancer statistics, 2023 (2023, background): “6 months with the addition of nivolumab, including a pathologic complete response in one of four patients.(79) At the population level, 3‐year relative survival for all stages of lung cancer combined increased from 22% for diagnoses during 2004 through 2006 to 33% for diagnoses during 2016 through 2”