Perioperative chemotherapy and nivolumab in non-small-cell lung cancer (NADIM): 5-year clinical outcomes from a multicentre, single-arm, phase 2 trial - 29/10/24
, Ernest Nadal, MD c, Amelia Insa d, Rosario García Campelo, MD e, Joaquín Casal, MD f, Manuel Dómine, MD g, Bartomeu Massuti, MD h, Margarita Majem, MD i, Delvys Rodríguez-Abreu, MD j, Alex Martínez-Martí, MD k, Javier de Castro, MD l, David Gómez de Antonio, MD b, Iván Macia, MD c, m, n, o, Santiago Figueroa, MD d, Luís Fernández Vago, MD e, Virginia Calvo, MD a, Ramón Palmero, MD c, Belén Sierra-Rodero, MSc a, Cristina Martínez-Toledo, MSc a, Marta Molina-Alejandre, MSc a, Roberto Serna-Blasco, PhD a, Atocha Romero, PhD a, Alberto Cruz-Bermúdez, PhD aSummary |
Background |
Perioperative immunotherapy improves short-term outcomes in resectable non-small-cell lung cancer (NSCLC). We now report 5-year survival from the NADIM trial to assess its long-term benefit.
Methods |
NADIM was a multicentre, single-arm, phase 2 trial conducted across 18 hospitals in Spain. Patients were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status of 0 or 1, and had histologically or cytologically confirmed, treatment-naive, resectable stage IIIA NSCLC (American Joint Committee on Cancer, 7th edition criteria). The neoadjuvant treatment consisted of three cycles of intravenous paclitaxel (200 mg/m2) and carboplatin (area under the curve 6 mg/mL per min) with nivolumab (360 mg). After surgery, 1 year of adjuvant treatment with intravenous nivolumab monotherapy was administered (240 mg every 2 weeks for 4 months, followed by 480 mg every 4 weeks for 8 months). The primary endpoint was 24-month progression-free survival, with 5-year progression-free survival and overall survival as secondary endpoints, assessed in the intention-to-treat population (ie, all patients who received neoadjuvant treatment). Toxicity profile was also assessed as a secondary endpoint. This trial is registered at ClinicalTrials.gov (NCT03081689) and is complete; this is the final report of the trial.
Findings |
Between April 26, 2017, and Aug 25, 2018, 51 patients were assessed for eligibility, of whom 46 comprised the intention-to-treat population (34 [74%] male and 12 [26%] female, median age 63 years [IQR 58–70]). Follow-up was concluded at 60 months (data cutoff July 11, 2023; median follow-up 60·0 months [IQR 60·0–60·0]). 5-year progression-free survival in the intention-to-treat population was 65·0% (95% CI 49·4–76·9), and overall survival was 69·3% (53·7–80·6). Disease progression occurred in 11 (24%) patients; 14 (30%) patients died, including nine (20%) from disease relapse and five (11%) from non-tumour-related causes. Treatment-related adverse events (TRAEs) of grade 3 or worse occurred in 14 (30%) of 46 patients during neoadjuvant treatment and in seven (19%) of 37 during adjuvant treatment. The most common grade 3 or worse TRAEs were increased lipase and febrile neutropenia (three [7%] each) during neoadjuvant treatment, and elevated serum lipase (four [7%]) and elevated serum amylase (three [8%]) during adjuvant treatment. Serious TRAEs included elevated serum lipase and neutropenia (one [2%] each) during neoadjuvant treatment, and elevated serum lipase (one [3%]) during adjuvant treatment. No treatment-related surgery delays, deaths, or unexpected long-term toxicities were reported.
Interpretation |
Perioperative chemoimmunotherapy showed a promising long-term benefit with no concerning safety data, reinforcing its use in resectable stage IIIA NSCLC.
Funding |
Bristol-Myers Squibb, Spanish Ministry of Science, Instituto de Salud Carlos III, European Union.
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Vol 25 - N° 11
P. 1453-1464 - novembre 2024 Retour au numéro
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