RT Journal Article
T1 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.
A1 Felip, Enriqueta
A1 Ardizzoni, Andrea
A1 Ciuleanu, Tudor
A1 Cobo, Manuel
A1 Laktionov, Konstantin
A1 Szilasi, Maria
A1 Califano, Raffaele
A1 Carcereny, Enric
A1 Griffiths, Richard
A1 Paz-Ares, Luis
A1 Duchnowska, Renata
A1 Alonso-Garcia, Miriam
A1 Isla, Dolores
A1 Jassem, Jacek
A1 Appel, Wiebke
A1 Milanowski, Janusz
A1 Van-Meerbeeck, Jan P
A1 Wolf, Juergen
A1 Li, Ang
A1 Acevedo, Angelic
A1 Popat, Sanjay
K1 Comorbidity
K1 Elderly
K1 Health status indicators
K1 Nivolumab
K1 Non-small cell lung cancer
AB 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. 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. 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. 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. NCT02409368.
PB Elsevier
YR 2020
FD 2020-02-03
LK http://hdl.handle.net/10668/15061
UL http://hdl.handle.net/10668/15061
LA en
NO Felip E, Ardizzoni A, Ciuleanu T, Cobo M, Laktionov K, Szilasi M, et al. 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. Eur J Cancer. 2020 Mar;127:160-172
DS RISalud
RD Apr 18, 2025