As reported in The Lancet Oncology by Provencio et al, analysis of a Spanish phase II trial (NADIM) showed good long-term outcomes with preoperative chemotherapy and perioperative nivolumab in patients with stage IIIA non-small cell lung cancer (NSCLC).
Study Details
In the multicenter trial, 46 patients enrolled between April 2017 and August 2018 received neoadjuvant therapy consisting of paclitaxel at 200 mg/m² and carboplatin at AUC 6 plus nivolumab at 360 mg every 3 weeks for three cycles. After surgery, patients received adjuvant nivolumab for 1 year at 240 mg every 2 weeks for 4 months and then 480 mg every 4 weeks for 8 months. The current report analyzes the secondary endpoints of 5-year progression-free and overall survival.
Key Findings
Follow-up was concluded at 60 months (median follow-up = 60.0 months; interquartile range [IQR] = 60.0–60.0 months). At 5 years, progression-free survival was 65.0% (95% confidence interval [CI] = 49.4%–76.9%). Post hoc analysis showed that median time to disease progression among patients experiencing progression was 22.5 months (IQR = 13.5–28.7 months). At 5 years, overall survival was 69.3% (95% CI = 53.7%–80.6%).
In the per-protocol population of 37 patients who had tumor resection and received at least one cycle of adjuvant treatment, 5-year progression-free survival was 75.4% (95% CI = 58.0%–86.4%) and 5-year overall survival was 78.0% (95% CI = 60.8%–88.4%).
Treatment-related grade ≥ 3 adverse events occurred in 30% of patients during neoadjuvant treatment and in 19% during adjuvant treatment; the most common were increased lipase and febrile neutropenia (7% each) during neoadjuvant treatment and elevated amylase (8%) and elevated lipase (7%) during adjuvant treatment. No treatment-related deaths or unexpected long-term toxicities were reported.
The investigators concluded: “Perioperative chemoimmunotherapy showed a promising long-term benefit with no concerning safety data, reinforcing its use in resectable stage IIIA NSCLC.”
Mariano Provencio, MD, of Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was supported by the Spanish Ministry of Science, Instituto de Salud Carlos III, Bristol Myers Squibb, and others. For full disclosures of the study authors, visit www.thelancet.com.
