![]() Prior to surgery, patients in the investigative arm received nivolumab at 360 mg, paclitaxel at 200 mg/m2, and carboplatin at an area under the curve 5 every 21 days for 3 cycles. ![]() Patients were randomly assigned in a 2:1 fashion. Those with nodal stage N3 disease or EGFR/ ALK mutations were excluded. Patients also needed to have measurable disease per RECIST v1.1 criteria and an ECOG performance status of 0 or 1. NADIM II was conducted at 21 hospitals in Spain and enrolled adult patients with histologically documented, previously untreated, surgically resectable stage IIIA/B NSCLC from June 2019 through February 2021. Relapses at the central nervous system occurred in 3 patients in the experimental group and in 4 patients in the control group,” lead study author Mariano Provencio, MD, PhD, the head of the Medical Oncology Department at Puerta de Hierro University Hospital and professor of the School of Medicine at Autonomous University of Madrid in Spain, and colleagues, wrote. Locoregional recurrence occurred in 7 patients and 9 patients, respectively. “Distant recurrence occurred as the first event in 10 patients in the experimental group and in 8 patients in the control group. There were 12 deaths in the doublet arm, with 1 due to surgical complications, and 11 deaths in the chemotherapy arm at data cutoff. In the doublet arm, 93% of patients underwent surgery compared with 69% in the paclitaxel/carboplatin group (relative risk, 1.35 95% CI, 1.05-1.74) and both arms experienced a median time from the end of neoadjuvant treatment to surgery of 7 weeks (range, 2-9).Īdditionally, a benefit with the addition of nivolumab was seen regarding overall response rate (ORR), with 75% (95% CI, 62%-86%) of patients in combination arm experiencing a response compared with 48% (95% CI, 29%-67%) in the chemotherapy group (relative risk, 1.56 95% CI, 1.04-2.34).įurther, at a median follow-up of 26.1 months (interquartile range, 17.4-30.9), 17 patients in each arm experienced disease progression. 02), with benefit seen across all subgroups. Neoadjuvant treatment with nivolumab (Opdivo) plus platinum-based chemotherapy followed by adjuvant nivolumab increased pathological complete response (pCR) rates and prolonged survival compared with neoadjuvant chemotherapy alone in patients with resectable stage IIIA/B non–small cell lung cancer (NSCLC), according to data from the phase 2 NADIM II trial (NCT03838159) published in The New England Journal of Medicine.ĭata from the open-label, randomized, trial demonstrated that 37% (95% CI, 24%-51%) of patients in the neoadjuvant nivolumab plus chemotherapy arm (n = 57) experienced a pCR vs 7% (95% CI, 1%-23%) in the chemotherapy alone arm (n = 29 relative risk, 5.34 95% CI, 1.34-21.23 P =. ![]()
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