dc.contributor | Vall d'Hebron Barcelona Hospital Campus |
dc.contributor.author | Felip Font, Enriqueta |
dc.contributor.author | Ardizzoni, Andrea |
dc.contributor.author | Ciuleanu, Tudor |
dc.contributor.author | Laktionov, Konstantin |
dc.contributor.author | Szilasi, Maria |
dc.contributor.author | Cobo, Manuel |
dc.date.accessioned | 2021-10-22T08:01:22Z |
dc.date.available | 2021-10-22T08:01:22Z |
dc.date.issued | 2020-03-01 |
dc.identifier.citation | 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 1;127:160–72. |
dc.identifier.issn | 0959-8049 |
dc.identifier.uri | https://hdl.handle.net/11351/6443 |
dc.description | Elderly; Nivolumab; Non-small cell lung cancer |
dc.description.abstract | 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. |
dc.language.iso | eng |
dc.publisher | Elsevier |
dc.relation.ispartofseries | European Journal of Cancer;127 |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 International |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ |
dc.source | Scientia |
dc.subject | Persones grans |
dc.subject | Pulmons - Càncer - Quimioteràpia |
dc.subject.mesh | Carcinoma, Non-Small-Cell Lung |
dc.subject.mesh | /drug therapy |
dc.subject.mesh | Aged |
dc.title | 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 |
dc.type | info:eu-repo/semantics/article |
dc.identifier.doi | 10.1016/j.ejca.2019.11.019 |
dc.subject.decs | carcinoma de pulmón de células no pequeñas |
dc.subject.decs | /farmacoterapia |
dc.subject.decs | anciano |
dc.relation.publishversion | https://doi.org/10.1016/j.ejca.2019.11.019 |
dc.type.version | info:eu-repo/semantics/publishedVersion |
dc.audience | Professionals |
dc.contributor.organismes | Institut Català de la Salut |
dc.contributor.authoraffiliation | [Felip E] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Ardizzoni A] Division of Medical Oncology, S. Orsola-Malpighi Hospital, University of Bologna, Bologna, 40138, Italy. [Ciuleanu T] The Oncology Institute Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, RO-400015, Romania. [Cobo M] Hospital Regional Universitario de Málaga and IBIMA, Malaga, 29010, Spain. [Laktionov K] N.N. Blokhin Russian Cancer Research Center, Moscow, 115478, Russia. [Szilasi M] University of Debrecen, Department for Pulmonology, Debrecen, H-4032, Hungary |
dc.identifier.pmid | 32028209 |
dc.identifier.wos | 000514572100017 |
dc.rights.accessrights | info:eu-repo/semantics/openAccess |