Enriqueta Felip1, Andrea Ardizzoni2, Tudor Ciuleanu3, Manuel Cobo4, Konstantin Laktionov5, Maria Szilasi6, Raffaele Califano7, Enric Carcereny8, Richard Griffiths9, Luis Paz-Ares10, Renata Duchnowska11, Miriam Alonso Garcia12, Dolores Isla13, Jacek Jassem14, Wiebke Appel15, Janusz Milanowski16, Jan P Van Meerbeeck17, Juergen Wolf18, Ang Li19, Angelic Acevedo20, Sanjay Popat21. 1. Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology (VHIO), Barcelona, 8035, Spain. Electronic address: efelip@vhio.net. 2. Division of Medical Oncology, S.Orsola-Malpighi Hospital, University of Bologna, Bologna, 40138, Italy. Electronic address: andrea.ardizzoni@aosp.bo.it. 3. The Oncology Institute Ion Chiricuta and University of Medicine and Pharmacy Iuliu Hatieganu, Cluj-Napoca, RO-400015, Romania. Electronic address: tudor_ciuleanu@hotmail.com. 4. Hospital Regional Universitario de Málaga and IBIMA, Malaga, 29010, Spain. Electronic address: manuelcobodols@yahoo.es. 5. N.N. Blokhin Russian Cancer Research Center, Moscow, 115478, Russia. Electronic address: lkoskos@mail.ru. 6. University of Debrecen, Department for Pulmonology, Debrecen, H-4032, Hungary. Electronic address: mszilasi@med.unideb.hu. 7. Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, M20 4BX, UK. Electronic address: Raffaele.Califano@christie.nhs.uk. 8. 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. 9. The Clatterbridge Cancer Centre, Wirral, CH63 4JY, UK. Electronic address: richard.griffiths1@nhs.net. 10. Hospital Universitario 12 de Octubre, Madrid, 28041, Spain. Electronic address: lpazaresr@seom.org. 11. Military Institute of Medicine, Warsaw, 04-141, Poland. Electronic address: rduchnowska@wim.mil.pl. 12. Virgen Del Rocio University Hospital, Seville, 41013, Spain. Electronic address: miriamag3@hotmail.com. 13. University Hospital Lozano Blesa, Zaragoza, 50009, Spain. Electronic address: lola.isla@gmail.com. 14. Medical University of Gdańsk, Gdańsk, 80-210, Poland. Electronic address: jjassem@gumed.edu.pl. 15. Rosemere Cancer Centre, Preston, PR2 9HT, UK. Electronic address: Wiebke.Appel@lthtr.nhs.uk. 16. Medical University of Lublin, Lublin, 20-059, Poland. Electronic address: janusz.milanowski@umlub.pl. 17. Universitair Ziekenhuis Antwerpen, Antwerp-ERN Lung, 2650, Belgium. Electronic address: jan.van.meerbeeck@uza.be. 18. Center for Integrated Oncology, University Hospital of Cologne, Cologne, 50937, Germany. Electronic address: juergen.wolf@uk-koeln.de. 19. Bristol-Myers Squibb, Princeton, NJ, 08540, USA. Electronic address: angus.lee@bms.com. 20. Bristol-Myers Squibb, Princeton, NJ, 08540, USA. Electronic address: angelic.acevedo@bms.com. 21. Royal Marsden Hospital, London, SW3 6JJ, UK; The Institute of Cancer Research, London, SW7 3RP, UK. Electronic address: Sanjay.Popat@rmh.nhs.uk.
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. CLINICAL TRIAL REGISTRATION: NCT02409368.
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.
Authors: Roberto Ferrara; Diego Signorelli; Claudia Proto; Arsela Prelaj; Marina Chiara Garassino; Giuseppe Lo Russo Journal: Transl Lung Cancer Res Date: 2021-06
Authors: Andrew C Johns; Lai Wei; Madison Grogan; Rebecca Hoyd; John F P Bridges; Sandipkumar H Patel; Mingjia Li; Marium Husain; Kari L Kendra; Gregory A Otterson; Jarred T Burkart; Ashley E Rosko; Barbara L Andersen; David P Carbone; Dwight H Owen; Daniel J Spakowicz; Carolyn J Presley Journal: J Geriatr Oncol Date: 2021-02-21 Impact factor: 3.929