CheckMate 171: A phase 2 trial of nivolumab in patients with previously treated advanced squamous non-small cell lung cancer, including ECOG PS 2 and elderly populations

Felip, E. ; Ardizzoni, A. ; Ciuleanu, T. ; Cobo, M. ; Laktionov, K. ; Szilasi, M. ; Califano, R. ; Carcereny, E. ; Griffiths, R. ; Paz-Ares, L. ; Duchnowska, R. ; Garcia, M. A. ; Isla, D. ; Jassem, J. ; Appel, W. ; Milanowski, J. ; Van Meerbeeck, J. P. ; Wolf, J. ; Li, A. ; Acevedo, A. ; Popat, S.

Resumen: Background: CheckMate 171 (NCT02409368) is an open-label, multicentre, phase 2 trial of nivolumab in previously treated advanced squamous non-small cell lung cancer (NSCLC), conducted as part of a post-approval commitment to the European Medicines Agency (EMA). We report outcomes from this trial. Methods: Patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 0–2 and disease progression during/after =1 systemic treatment (=1 being platinum-based chemotherapy) for advanced or metastatic disease were treated with nivolumab 3 mg/kg every 2 weeks until progression or unacceptable toxicity. The primary end-point was incidence of grade 3–4 treatment-related select adverse events (AEs). Other end-points included overall survival (OS) and safety. Results: Of 811 patients treated, 103 had ECOG PS 2; 278 were aged =70 years and 125 were =75 years of age. Minimum follow-up was ~18 months. Safety was similar across populations; the most frequent grade 3–4 treatment-related select AEs in all treated patients were diarrhoea (1%), increased alanine aminotransferase (ALT, 1%), pneumonitis (0.7%), colitis (0.6%) and increased aspartate aminotransferase (AST, 0.5%). Median OS was similar in all treated patients and those aged =70 and =75: 10.0 months, 10.0 months and 11.2 months, respectively. Median OS was 5.2 months in patients with ECOG PS 2. Conclusion: These results suggest that nivolumab is well tolerated and active in patients with advanced, relapsed squamous NSCLC, including the elderly, with OS outcomes consistent with phase 3 data. In patients with ECOG PS 2, nivolumab had similar tolerability, but outcomes were worse, as expected in this difficult-to-treat, poor prognosis population. Clinical trial registration: NCT02409368.

Idioma: Inglés

DOI: 10.1016/j.ejca.2019.11.019

Año: 2020

Publicado en: European Journal of Cancer 127 (2020), 160-172
ISSN: 0959-8049

Originalmente disponible en: Texto completo de la revista

Factor impacto JCR: 9.162 (2020)

Categ. JCR: ONCOLOGY rank: 33 / 241 = 0.137 (2020) - Q1 - T1

Factor impacto SCIMAGO: 3.354 - Oncology (Q1) - Cancer Research (Q1)

Tipo y forma: Artículo (Versión definitiva)