PMID- 28651159 OWN - NLM STAT- MEDLINE DCOM- 20170907 LR - 20190118 IS - 1879-0852 (Electronic) IS - 0959-8049 (Print) IS - 0959-8049 (Linking) VI - 82 DP - 2017 Sep TI - Health-related quality of life results from the phase III CheckMate 067 study. PG - 80-91 LID - S0959-8049(17)30995-4 [pii] LID - 10.1016/j.ejca.2017.05.031 [doi] AB - BACKGROUND: Nivolumab, a monoclonal antibody of immune checkpoint programmed death 1 on T cells (PD-1), combined with ipilimumab, an immune checkpoint cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor, as combination therapy on the one hand and nivolumab as monotherapy on the other, have both demonstrated improved efficacy compared with ipilimumab alone in the CheckMate 067 study. However, the combination resulted in a higher frequency of grade 3/4 adverse events (AEs), which could result in diminished health-related quality of life (HRQoL). Here we report analyses of HRQoL for patients with advanced melanoma in clinical trial CheckMate 067. PATIENTS AND METHODS: HRQoL was assessed at weeks 1 and 5 per 6-week cycle for the first 6 months, once every 6 weeks thereafter, and at two follow-up visits using the European Organization for Research and Treatment of Care Core Quality of Life Questionnaire and the EuroQoL Five Dimensions Questionnaire. In addition to the randomised population, patient subgroups, including BRAF mutation status, partial or complete response, treatment-related AEs of grade 3/4, and those who discontinued due to any reason and due to an AE, were investigated. RESULTS: Nivolumab and ipilimumab combination and nivolumab alone both maintained HRQoL, and no clinically meaningful deterioration was observed over time compared with ipilimumab. In addition, similar results were observed across patient subgroups, and no clinically meaningful changes in HRQoL were observed during follow-up visits for patients who discontinued due to any cause. CONCLUSION: These results further support the clinical benefit of nivolumab monotherapy and nivolumab and ipilimumab combination therapy in patients with advanced melanoma. The finding that the difference in grade 3/4 AEs between the arms did not translate into clinically meaningful differences in the reported HRQoL may be relevant in the clinical setting. STUDY NUMBER: NCT01844505. CI - Copyright (c) 2017 The Authors. Published by Elsevier Ltd.. All rights reserved. FAU - Schadendorf, Dirk AU - Schadendorf D AD - Department of Dermatology, University of Essen, Essen, Germany; German Cancer Consortium, Heidelberg, Germany. FAU - Larkin, James AU - Larkin J AD - Royal Marsden Hospital, London, UK. FAU - Wolchok, Jedd AU - Wolchok J AD - Memorial Sloan Kettering Cancer Center, New York, NY, USA. FAU - Hodi, F Stephen AU - Hodi FS AD - Dana-Farber Cancer Institute, Boston, MA, USA. FAU - Chiarion-Sileni, Vanna AU - Chiarion-Sileni V AD - Istituto Oncologico Veneto, Veneto, Italy. FAU - Gonzalez, Rene AU - Gonzalez R AD - University of Colorado, Denver, CO, USA. FAU - Rutkowski, Piotr AU - Rutkowski P AD - Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland. FAU - Grob, Jean-Jacques AU - Grob JJ AD - Hospital de la Timone, Marseille, France. FAU - Cowey, C Lance AU - Cowey CL AD - Texas Oncology-Baylor Cancer Center, Dallas, TX, USA. FAU - Lao, Christopher AU - Lao C AD - University of Michigan, Ann Arbor, MI, USA. FAU - Wagstaff, John AU - Wagstaff J AD - The College of Medicine, Swansea University, Swansea, UK. FAU - Callahan, Margaret K AU - Callahan MK AD - Memorial Sloan Kettering Cancer Center, New York, NY, USA. FAU - Postow, Michael A AU - Postow MA AD - Memorial Sloan Kettering Cancer Center, New York, NY, USA; Weill Cornell Medical College, New York, NY, USA. FAU - Smylie, Michael AU - Smylie M AD - Cross Cancer Institute, Edmonton, Alberta, Canada. FAU - Ferrucci, Pier Francesco AU - Ferrucci PF AD - Istituto Europeo di Oncologia, Milan, Italy. FAU - Dummer, Reinhard AU - Dummer R AD - University of Zurich, Zurich, Switzerland. FAU - Hill, Andrew AU - Hill A AD - Tasman Oncology Research, Brisbane, QLD, Australia. FAU - Taylor, Fiona AU - Taylor F AD - Adelphi Values, Boston, MA, USA. FAU - Sabater, Javier AU - Sabater J AD - Bristol-Myers Squibb, Princeton, NJ, USA. FAU - Walker, Dana AU - Walker D AD - Bristol-Myers Squibb, Princeton, NJ, USA. FAU - Kotapati, Srividya AU - Kotapati S AD - Bristol-Myers Squibb, Princeton, NJ, USA. FAU - Abernethy, Amy AU - Abernethy A AD - Duke University Medical Center, Durham, NC, USA. FAU - Long, Georgina V AU - Long GV AD - Melanoma Institute Australia, The University of Sydney, Sydney, NSW, Australia; Royal North Shore and Mater Hospitals, Sydney, NSW, Australia. Electronic address: georgina.long@sydney.edu.au. LA - eng SI - ClinicalTrials.gov/NCT01844505 SI - ClinicalTrials.gov/NCT01844505 GR - P30 CA008748/CA/NCI NIH HHS/United States PT - Clinical Trial, Phase III PT - Journal Article PT - Randomized Controlled Trial DEP - 20170623 PL - England TA - Eur J Cancer JT - European journal of cancer (Oxford, England : 1990) JID - 9005373 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antineoplastic Agents) RN - 0 (Ipilimumab) RN - 31YO63LBSN (Nivolumab) SB - IM MH - Adult MH - Aged MH - Antibodies, Monoclonal/administration & dosage/*therapeutic use MH - Antineoplastic Agents/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/therapeutic use MH - Double-Blind Method MH - Female MH - Health Status MH - Humans MH - Ipilimumab MH - Male MH - Melanoma/*drug therapy MH - Middle Aged MH - Nivolumab MH - *Quality of Life PMC - PMC5737813 MID - NIHMS926889 OTO - NOTNLM OT - Advanced melanoma OT - Checkpoint inhibitors OT - Health-related quality of life OT - Ipilimumab OT - Nivolumab EDAT- 2017/06/27 06:00 MHDA- 2017/09/08 06:00 PMCR- 2017/12/20 CRDT- 2017/06/27 06:00 PHST- 2017/05/08 00:00 [received] PHST- 2017/05/18 00:00 [accepted] PHST- 2017/06/27 06:00 [pubmed] PHST- 2017/09/08 06:00 [medline] PHST- 2017/06/27 06:00 [entrez] PHST- 2017/12/20 00:00 [pmc-release] AID - S0959-8049(17)30995-4 [pii] AID - 10.1016/j.ejca.2017.05.031 [doi] PST - ppublish SO - Eur J Cancer. 2017 Sep;82:80-91. doi: 10.1016/j.ejca.2017.05.031. Epub 2017 Jun 23.