000153633 001__ 153633 000153633 005__ 20251017144554.0 000153633 0247_ $$2doi$$a10.1016/j.ejca.2019.11.019 000153633 0248_ $$2sideral$$a116851 000153633 037__ $$aART-2020-116851 000153633 041__ $$aeng 000153633 100__ $$aFelip, E. 000153633 245__ $$aCheckMate 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 000153633 260__ $$c2020 000153633 5060_ $$aAccess copy available to the general public$$fUnrestricted 000153633 5203_ $$aBackground: 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. 000153633 540__ $$9info:eu-repo/semantics/openAccess$$aby-nd$$uhttps://creativecommons.org/licenses/by-nd/4.0/deed.es 000153633 590__ $$a9.162$$b2020 000153633 591__ $$aONCOLOGY$$b33 / 241 = 0.137$$c2020$$dQ1$$eT1 000153633 592__ $$a3.354$$b2020 000153633 593__ $$aOncology$$c2020$$dQ1 000153633 593__ $$aCancer Research$$c2020$$dQ1 000153633 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000153633 700__ $$aArdizzoni, A. 000153633 700__ $$aCiuleanu, T. 000153633 700__ $$aCobo, M. 000153633 700__ $$aLaktionov, K. 000153633 700__ $$aSzilasi, M. 000153633 700__ $$aCalifano, R. 000153633 700__ $$aCarcereny, E. 000153633 700__ $$aGriffiths, R. 000153633 700__ $$aPaz-Ares, L. 000153633 700__ $$aDuchnowska, R. 000153633 700__ $$aGarcia, M. A. 000153633 700__ $$aIsla, D. 000153633 700__ $$aJassem, J. 000153633 700__ $$aAppel, W. 000153633 700__ $$aMilanowski, J. 000153633 700__ $$aVan Meerbeeck, J. P. 000153633 700__ $$aWolf, J. 000153633 700__ $$aLi, A. 000153633 700__ $$aAcevedo, A. 000153633 700__ $$aPopat, S. 000153633 773__ $$g127 (2020), 160-172$$pEur. j. cancer$$tEuropean Journal of Cancer$$x0959-8049 000153633 85641 $$uhttps://www.scopus.com/inward/record.uri?eid=2-s2.0-85078797835&doi=10.1016%2fj.ejca.2019.11.019&partnerID=40&md5=d90498e7e3709fe9df09277eb7a465b2$$zTexto completo de la revista 000153633 8564_ $$s514002$$uhttps://zaguan.unizar.es/record/153633/files/texto_completo.pdf$$yVersión publicada 000153633 8564_ $$s2278058$$uhttps://zaguan.unizar.es/record/153633/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000153633 909CO $$ooai:zaguan.unizar.es:153633$$particulos$$pdriver 000153633 951__ $$a2025-10-17-14:12:36 000153633 980__ $$aARTICLE