PMID- 32028209 OWN - NLM STAT- MEDLINE DCOM- 20200731 LR - 20200731 IS - 1879-0852 (Electronic) IS - 0959-8049 (Linking) VI - 127 DP - 2020 Mar TI - 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. PG - 160-172 LID - S0959-8049(19)30859-7 [pii] LID - 10.1016/j.ejca.2019.11.019 [doi] AB - 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. CI - Copyright (c) 2019 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Felip, Enriqueta AU - Felip E AD - Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, 8035, Spain. Electronic address: efelip@vhio.net. FAU - Ardizzoni, Andrea AU - Ardizzoni A AD - Division of Medical Oncology, S.Orsola-Malpighi Hospital, University of Bologna, Bologna, 40138, Italy. Electronic address: andrea.ardizzoni@aosp.bo.it. FAU - Ciuleanu, Tudor AU - Ciuleanu T AD - The Oncology Institute Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, RO-400015, Romania. Electronic address: tudor_ciuleanu@hotmail.com. FAU - Cobo, Manuel AU - Cobo M AD - Hospital Regional Universitario de Malaga and IBIMA, Malaga, 29010, Spain. Electronic address: manuelcobodols@yahoo.es. FAU - Laktionov, Konstantin AU - Laktionov K AD - N.N. Blokhin Russian Cancer Research Center, Moscow, 115478, Russia. Electronic address: lkoskos@mail.ru. FAU - Szilasi, Maria AU - Szilasi M AD - University of Debrecen, Department for Pulmonology, Debrecen, H-4032, Hungary. Electronic address: mszilasi@med.unideb.hu. FAU - Califano, Raffaele AU - Califano R AD - Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, M20 4BX, UK. Electronic address: Raffaele.Califano@christie.nhs.uk. FAU - Carcereny, Enric AU - Carcereny E AD - Medical Oncology Department (B-ARGO Group) and Catalan Institute of Oncology-Badalona (Germans Trias I Pujol Hospital), Barcelona, 08916, Spain. Electronic address: ecarcereny@iconcologia.net. FAU - Griffiths, Richard AU - Griffiths R AD - The Clatterbridge Cancer Centre, Wirral, CH63 4JY, UK. Electronic address: richard.griffiths1@nhs.net. FAU - Paz-Ares, Luis AU - Paz-Ares L AD - Hospital Universitario 12 de Octubre, Madrid, 28041, Spain. Electronic address: lpazaresr@seom.org. FAU - Duchnowska, Renata AU - Duchnowska R AD - Military Institute of Medicine, Warsaw, 04-141, Poland. Electronic address: rduchnowska@wim.mil.pl. FAU - Garcia, Miriam Alonso AU - Garcia MA AD - Virgen Del Rocio University Hospital, Seville, 41013, Spain. Electronic address: miriamag3@hotmail.com. FAU - Isla, Dolores AU - Isla D AD - University Hospital Lozano Blesa, Zaragoza, 50009, Spain. Electronic address: lola.isla@gmail.com. FAU - Jassem, Jacek AU - Jassem J AD - Medical University of Gdansk, Gdansk, 80-210, Poland. Electronic address: jjassem@gumed.edu.pl. FAU - Appel, Wiebke AU - Appel W AD - Rosemere Cancer Centre, Preston, PR2 9HT, UK. Electronic address: Wiebke.Appel@lthtr.nhs.uk. FAU - Milanowski, Janusz AU - Milanowski J AD - Medical University of Lublin, Lublin, 20-059, Poland. Electronic address: janusz.milanowski@umlub.pl. FAU - Van Meerbeeck, Jan P AU - Van Meerbeeck JP AD - Universitair Ziekenhuis Antwerpen, Antwerp-ERN Lung, 2650, Belgium. Electronic address: jan.van.meerbeeck@uza.be. FAU - Wolf, Juergen AU - Wolf J AD - Center for Integrated Oncology, University Hospital of Cologne, Cologne, 50937, Germany. Electronic address: juergen.wolf@uk-koeln.de. FAU - Li, Ang AU - Li A AD - Bristol-Myers Squibb, Princeton, NJ, 08540, USA. Electronic address: angus.lee@bms.com. FAU - Acevedo, Angelic AU - Acevedo A AD - Bristol-Myers Squibb, Princeton, NJ, 08540, USA. Electronic address: angelic.acevedo@bms.com. FAU - Popat, Sanjay AU - Popat S AD - Royal Marsden Hospital, London, SW3 6JJ, UK; The Institute of Cancer Research, London, SW7 3RP, UK. Electronic address: Sanjay.Popat@rmh.nhs.uk. LA - eng SI - ClinicalTrials.gov/NCT02409368 PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't DEP - 20200203 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 31YO63LBSN (Nivolumab) RN - BG3F62OND5 (Carboplatin) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use MH - Carboplatin/administration & dosage MH - Carcinoma, Non-Small-Cell Lung/*drug therapy/pathology MH - Carcinoma, Squamous Cell/*drug therapy/pathology MH - Female MH - Follow-Up Studies MH - Humans MH - Lung Neoplasms/*drug therapy/pathology MH - Male MH - Middle Aged MH - Nivolumab/administration & dosage MH - Prognosis MH - Retrospective Studies MH - Survival Rate OTO - NOTNLM OT - Comorbidity OT - Elderly OT - Health status indicators OT - Nivolumab OT - Non-small cell lung cancer COIS- Conflict of interest statement E.F. reports receiving personal fees from AbbVie, AstraZeneca, Blueprint medicines, Boehringer Ingelheim, Bristol-Myers Squibb, Eli Lilly, Guardant Health, Janssen, Medscape, Merck KGaA, Merck Sharp & Dohme, Novartis, Pfizer, priME Oncology, Roche, Samsung, Springer, Takeda, and Touchtime, outside the submitted work. A.A. reports receiving personal fees from Boehringer Ingelheim, Eli Lilly, MSD, and Pfizer, grants from Celgene, and grants and personal fees from Bristol-Myers Squibb and Roche, outside the submitted work. T.C. reports receiving personal fees from Amgen, Astellas, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Ipsen, Janssen, MSD, Novartis/GSK, Pfizer, Roche, Sanofi, and Servier, outside the submitted work. M.C., K.L., M.S., E.C., M.A.G., D.I., and J.M. have nothing to disclose. R.C. reports receiving grants from Bristol-Myers Squibb during the conduct of the study, and personal fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, Lilly Oncology, MSD, Novartis, Pfizer, Roche, and Takeda, outside the submitted work. R.G. reports receiving personal fees from Bristol-Myers Squibb, outside the submitted work. L. P-A. reports receiving personal fees from Amgen, Bayer, Blueprint, Eli Lilly, Incyte, Merck, MSD, Novartis, Roche, and Takeda, and grants and personal fees from AstraZeneca and Bristol-Myers Squibb, outside the submitted work. R.D. reports receiving travel grants from Amgen and Roche, receiving travel grants and holding advisory position for Pfizer, and acting in an advisory role for Ely Lilly and Novartis, outside the submitted work. J.J. reports receiving personal fees from AstraZeneca, Bristol-Myers Squibb, MSD, Pfizer, Roche, and Takeda, and receiving travel support from Roche, outside the submitted work. W.A. reports receiving non-financial support from Boehringer Ingelheim and Bristol-Myers Squibb, personal fees from AstraZeneca and Pfizer, personal fees and non-financial support from Amgen and Roche, outside the submitted work. J.P.V.M. reports receiving travel support from Bristol-Myers Squibb and institutional grants from Pfizer, outside the submitted work. J.W. reports receiving personal fees from AbbVie, AstraZeneca, Blueprint, Boehringer Ingelheim, Chugai, Eli Lilly, Ignyta, Loxo, Roche, and Takeda, and grants and personal fees from Bristol-Myers Squibb, Janssen, MSD, Novartis, and Pfizer, outside the submitted work. A.L. and A.A. were employees of Bristol-Myers Squibb during the conduct of the study and A.A. has received company stock from Bristol-Myers Squibb. S.P. reports receiving personal fees from Bristol-Myers Squibb during the conduct of the study; personal fees from AbbVie, AstraZeneca, Boehringer Ingelheim, Elsevier, EMD Serono, Guardant Health, Medscape, MSD, Novartis, OncLive, Pfizer, Roche, Takeda, and Tesaro, outside the submitted work. EDAT- 2020/02/07 06:00 MHDA- 2020/08/01 06:00 CRDT- 2020/02/07 06:00 PHST- 2019/11/08 00:00 [received] PHST- 2019/11/21 00:00 [accepted] PHST- 2020/02/07 06:00 [pubmed] PHST- 2020/08/01 06:00 [medline] PHST- 2020/02/07 06:00 [entrez] AID - S0959-8049(19)30859-7 [pii] AID - 10.1016/j.ejca.2019.11.019 [doi] PST - ppublish SO - Eur J Cancer. 2020 Mar;127:160-172. doi: 10.1016/j.ejca.2019.11.019. Epub 2020 Feb 3.