5-Year Outcomes From NADIM Trial Support Perioperative Chemoimmunotherapy in NSCLC

By: Julia Cipriano, MS
Posted: Friday, November 22, 2024

According to Mariano Provencio, MD, of Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, and colleagues, in the multicenter phase II NADIM trial, perioperative nivolumab plus standard chemotherapy showed a “promising” long-term benefit and no concerning safety data in patients with resectable stage IIIA non–small cell lung cancer (NSCLC). These final 5-year clinical outcomes results, which were published in The Lancet Oncology, reinforce this strategy as the standard of care. 

Previously untreated patients were administered three neoadjuvant cycles of intravenous paclitaxel at 200 mg/m² plus carboplatin at AUC of 6 mg/mL/min and nivolumab at 360 mg. After surgery, they underwent adjuvant intravenous nivolumab monotherapy (240 mg every 2 weeks for 4 months, followed by 480 mg every 4 weeks for 8 months). A total of 46 and 37 patients comprised the intention-to-treat (ie, all who received neoadjuvant treatment) and per-protocol (ie, all who underwent tumor resection and at least one cycle of adjuvant treatment) populations, respectively.

Follow-up data were provided for a median of 60 months. The 5-year progression-free and overall survival rates were 65.0% and 69.3%, respectively, in the intention-to-treat population. Disease progression was reported in 24% of patients.

Treatment-related adverse events of grade 3 or higher were documented in 30% of the intention-to-treat population and 19% of the per-protocol population in the neoadjuvant and adjuvant settings, respectively. Of these events, during neoadjuvant treatment, the most frequently reported were increased lipase levels (7%) and febrile neutropenia (7%); elevated levels of serum lipase (7%) and serum amylase (8%) were common with adjuvant treatment. Serious treatment-related adverse events included elevated serum lipase levels (2%) and neutropenia (2%) in the neoadjuvant setting and elevated serum lipase levels (3%) in the adjuvant setting. The investigators reported no treatment-related surgery delays, deaths, or unexpected long-term toxicities.

Disclosure: For full disclosures of the study authors, visit thelancet.com.

The Lancet Oncology

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