The following is a summary of “Perioperative chemotherapy and nivolumab in non-small-cell lung cancer (NADIM): 5-year clinical outcomes from a multicentre, single-arm, phase 2 trial,” published in the October 2024 issue of Oncology by Provencio et al.     

Perioperative immunotherapy improves short-term outcomes for patients with resectable non-small-cell lung cancer (NSCLC). The long-term benefits of such treatment remain unclear.  

Researchers conducted a prospective study assessing the long-term clinical outcomes of perioperative chemotherapy and nivolumab in patients with resectable NSCLC.  

They conducted the NADIM trial, a multicenter, single-arm, phase 2 study across 18 hospitals in Spain. Patients aged 18 years or older with treatment-naive, histologically confirmed, resectable stage IIIA NSCLC (American Joint Committee on Cancer, 7th edition criteria) received 3 cycles of intravenous paclitaxel (200 mg/m²) and carboplatin (area under the curve 6 mg/mL per min) alongside nivolumab (360 mg). Following surgery, patients underwent 1 year of adjuvant nivolumab monotherapy (240 mg every 2 weeks for 4 months, followed by 480 mg every 4 weeks for 8 months).  

The results showed 46 patients in the intention-to-treat population, the 5-year progression-free survival (PFS) was 65.0% (95% CI 49.4–76.9), and OS was 69.3% (53.7–80.6). Disease progression occurred in 11 (24%) patients and 14 (30%) patients died, including 9 (20%) from disease relapse and 5 (11%) from non-tumor-related causes. Treatment-related adverse events (TRAEs) of grade 3 or worse occurred in 14 (30%) of 46 patients during neoadjuvant treatment and in 7 (19%) of 37 patients during adjuvant treatment. The standard grade 3 or worse TRAEs included increased lipase and febrile neutropenia (3[7%] each) during neoadjuvant treatment, elevated serum lipase (4[7%]), and elevated serum amylase (3[8%]) during adjuvant treatment. Serious TRAEs included elevated serum lipase and neutropenia (1[2%] each) during neoadjuvant treatment and elevated serum lipase (1[3%]) during adjuvant treatment. No treatment-related surgery delays, deaths, or unexpected long-term toxicities were reported.  

They concluded that perioperative chemotherapy and nivolumab provide promising long-term benefits for patients with resectable stage IIIA NSCLC without significant safety concerns.  

Source: thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00498-4/fulltext