Schadendorf, D., Larkin, J., Wolchok, J., Hodi, F. S., Chiarion-Sileni, V., Gonzalez, R., Rutkowski, P., Grob, J. J., Cowey, C. L., Lao, C., Wagstaff, J., Callahan, M. K., Postow, M. A., Smylie, M., Ferrucci, P. F., Dummer, R., Hill, A., Taylor, F., Sabater, J., Walker, D., Kotapati, S., Abernethy, A., Long, G. V. (2017) Health-related quality of life results from the phase III CheckMate 067 study. EUROPEAN JOURNAL OF CANCER, 82. pp. 80-91. ISSN 0959-8049

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Abstract

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. (C) 2017 The Authors. Published by Elsevier Ltd.

Item Type:	Article
Authors (ICR Faculty only):	Larkin, James
All Authors:	Schadendorf, D., Larkin, J., Wolchok, J., Hodi, F. S., Chiarion-Sileni, V., Gonzalez, R., Rutkowski, P., Grob, J. J., Cowey, C. L., Lao, C., Wagstaff, J., Callahan, M. K., Postow, M. A., Smylie, M., Ferrucci, P. F., Dummer, R., Hill, A., Taylor, F., Sabater, J., Walker, D., Kotapati, S., Abernethy, A., Long, G. V.
Additional Information:	ISI Document Delivery No.: FC2TS Times Cited: 0 Cited Reference Count: 26 Schadendorf, Dirk Larkin, James Wolchok, Jedd Hodi, F. Stephen Chiarion-Sileni, Vanna Gonzalez, Rene Rutkowski, Piotr Grob, Jean-Jacques Cowey, C. Lance Lao, Christopher Wagstaff, John Callahan, Margaret K. Postow, Michael A. Smylie, Michael Ferrucci, Pier Francesco Dummer, Reinhard Hill, Andrew Taylor, Fiona Sabater, Javier Walker, Dana Kotapati, Srividya Abernethy, Amy Long, Georgina V. Schadendorf, Dirk/0000-0003-3524-7858 Bristol-Myers Squibb We thank the patients and investigators who participated in the CheckMate 067 trial. Professional medical writing and editorial assistance were provided by Melissa Kirk, PhD, and Cara Hunsberger at StemScientific, an Ashfield Company, funded by Bristol-Myers Squibb. 0 Elsevier sci ltd Oxford 1879-0852
Uncontrolled Keywords:	Health-related quality of life Checkpoint inhibitors Advanced melanoma Nivolumab Ipilimumab advanced melanoma untreated melanoma clinical-trials metastatic melanoma combined nivolumab ipilimumab monotherapy cancer pembrolizumab combination Oncology
Research teams:	ICR divisions > Clinical Studies > Melanoma and Kidney Cancer Clinical Units > Renal & Melanoma Unit
Depositing User:	Barry Jenkins
Date Deposited:	29 Aug 2017 09:53
Last Modified:	29 Aug 2017 09:53
URI:	http://publications.icr.ac.uk/id/eprint/16187

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