Universität zu Köln

Felip, Enriqueta, Ardizzoni, Andrea, Ciuleanu, Tudor, Cobo, Manuel, Laktionov, Konstantin, Szilasi, Maria, Califano, Raffaele, Carcereny, Enric, Griffiths, Richard, Paz-Ares, Luis, Duchnowska, Renata, Alonso Garcia, Miriam, Isla, Dolores, Jassem, Jacek ORCID: 0000-0002-8875-6747, Appel, Wiebke, Milanowski, Janusz, Van Meerbeeck, Jan P., Wolf, Juergen, Li, Ang, Acevedo, Angelic and Popat, Sanjay ORCID: 0000-0003-2087-4963 (2020). 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, 127. S. 160 - 173. OXFORD: ELSEVIER SCI LTD. ISSN 1879-0852

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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) 0e2 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 similar to 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. (C) 2019 The Authors. Published by Elsevier Ltd.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Felip, Enriqueta UNSPECIFIED UNSPECIFIED UNSPECIFIED Ardizzoni, Andrea UNSPECIFIED UNSPECIFIED UNSPECIFIED Ciuleanu, Tudor UNSPECIFIED UNSPECIFIED UNSPECIFIED Cobo, Manuel UNSPECIFIED UNSPECIFIED UNSPECIFIED Laktionov, Konstantin UNSPECIFIED UNSPECIFIED UNSPECIFIED Szilasi, Maria UNSPECIFIED UNSPECIFIED UNSPECIFIED Califano, Raffaele UNSPECIFIED UNSPECIFIED UNSPECIFIED Carcereny, Enric UNSPECIFIED UNSPECIFIED UNSPECIFIED Griffiths, Richard UNSPECIFIED UNSPECIFIED UNSPECIFIED Paz-Ares, Luis UNSPECIFIED UNSPECIFIED UNSPECIFIED Duchnowska, Renata UNSPECIFIED UNSPECIFIED UNSPECIFIED Alonso Garcia, Miriam UNSPECIFIED UNSPECIFIED UNSPECIFIED Isla, Dolores UNSPECIFIED UNSPECIFIED UNSPECIFIED Jassem, Jacek UNSPECIFIED orcid.org/0000-0002-8875-6747 UNSPECIFIED Appel, Wiebke UNSPECIFIED UNSPECIFIED UNSPECIFIED Milanowski, Janusz UNSPECIFIED UNSPECIFIED UNSPECIFIED Van Meerbeeck, Jan P. UNSPECIFIED UNSPECIFIED UNSPECIFIED Wolf, Juergen UNSPECIFIED UNSPECIFIED UNSPECIFIED Li, Ang UNSPECIFIED UNSPECIFIED UNSPECIFIED Acevedo, Angelic UNSPECIFIED UNSPECIFIED UNSPECIFIED Popat, Sanjay UNSPECIFIED orcid.org/0000-0003-2087-4963 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-343123
DOI:	10.1016/j.ejca.2019.11.019
Journal or Publication Title:	Eur. J. Cancer
Volume:	127
Page Range:	S. 160 - 173
Date:	2020
Publisher:	ELSEVIER SCI LTD
Place of Publication:	OXFORD
ISSN:	1879-0852
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language DOCETAXEL; SAFETY; PEMBROLIZUMAB; ADULTS Multiple languages Oncology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/34312