![]() ![]() 5 Moreover, few patients have a pathological complete response (median, 4% range, 0 to 16), a potential early predictor of survival. ![]() However, the absolute difference in 5-year recurrence-free survival and overall survival with neoadjuvant chemotherapy as compared with surgery alone is only 5 to 6 percentage points. 2,3 Neoadjuvant chemotherapy can be used for the treatment of patients whose disease is at stages that warrant adjuvant chemotherapy (see the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology 4 full citation provided in the Supplementary Appendix, available with the full text of this article at ). Neoadjuvant Nivolumab plus Chemotherapy in Resectable Lung CancerĪpproximately 20 to 25% of patients who receive a diagnosis of non–small-cell lung cancer (NSCLC) have resectable disease 1 however, 30 to 55% of patients who undergo curative surgery have recurrence and ultimately die of their disease. (Funded by Bristol Myers Squibb CheckMate 816 number, NCT02998528.) Introduction The addition of nivolumab to neoadjuvant chemotherapy did not increase the incidence of adverse events or impede the feasibility of surgery. 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. 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. 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. ![]() 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. Results for event-free survival and pathological complete response across most subgroups favored nivolumab plus chemotherapy over chemotherapy alone. The median event-free survival was 31.6 months (95% confidence interval, 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). Safety was assessed in all treated patients. Overall survival was a key secondary end point. 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. 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. 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. Neoadjuvant or adjuvant chemotherapy confers a modest benefit over surgery alone for resectable non–small-cell lung cancer (NSCLC). The most trusted, influential source of new medical knowledge and clinical best practices in the world. Information and tools for librarians about site license offerings. Valuable tools for building a rewarding career in health care. The authorized source of trusted medical research and education for the Chinese-language medical community. The most advanced way to teach, practice, and assess clinical reasoning skills. Information, resources, and support needed to approach rotations - and life as a resident. ![]() The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. NEW! Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery.Ĭoncise summaries and expert physician commentary that busy clinicians need to enhance patient care. NEW! A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making. ![]()
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