A27: Effect of nivolumab (NIVO) on quality of life (QoL) in patients (pts) with treatment-naïve advanced melanoma (MEL): results of a phase III study (CheckMate 066)
1Melanoma Institute Australia, North Sydney, NSW, Australia,2Gallipoli Medical Research Foundation and Princess Alexandra Hospital, Queensland, Australia,3Istituto Nazionale Tumori Fondazione Pascale, Napoli, Italy,4Institut Gustave-Roussy, Paris, France,5University Hospital Heidelberg, Dep. of Dermatology and National Center for Tumor Diseases, Heidelberg, Germany,6Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland,7BC Cancer Agency, University of British Columbia, Vancouver, BC, Canada,8Adelphi Values, Boston, MA, USA,9Bristol-Myers Squibb, Princeton, NJ, USA,10Duke Cancer Institute, Durham, NC, USA
Background: Newer treatments have extended survival in advanced MEL but quality of survival is rarely evaluated. Treatments demonstrating increased survival while preserving long-term QoL are needed. In a phase III, randomized, double-blind study, NIVO (a PD-1 immune checkpoint inhibitor) improved overall survival compared with dacarbazine (DTIC) in treatment-naïve pts with advanced MEL.
Methods: QoL, measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EuroQol-five dimension questionnaire (EQ-5D), was evaluated at baseline (BL) and at treatment cycles Q6W. Mean changes and non-parametric comparisons are reported.
Results: 418 pts were randomized to NIVO (n=210) or DTIC (n=208). Adjusted completion rates at BL for EQ-5D utilities were 69.5% (NIVO) and 64.9% (DTIC), and for EORTC QLQ-C30 were 70.0% (NIVO) and 64.9% (DTIC). While rates remained similar throughout the study, analysis of QoL involving DTIC was not feasible after wk 13 due to a high attrition rate (n?41). Mean BL QoL scores were similar for NIVO versus DTIC (EQ-5D utilities: 0.778 vs 0.711; EQ-5D visual analog scale [VAS] scores: 70.9 vs 69.1; EORTC Global Health: 68.9 vs 66.2). No QoL change was noted for DTIC prior to study dropout. For NIVO, improvements from BL were noted in EQ-5D utilities from wk 7 (0.027; n=132; P=0.011) through wk 49 (0.045; n=38; P=0.034), and in EQ-5D VAS scores at wks 25, 31, 37, 49 and 61 (P?0.03). EORTC subscale scores did not change over time.
Conclusions: Results demonstrate that NIVO does not impair and may enhance QoL compared with BL, while also conferring survival benefits in treatment-naïve pts with advanced MEL. Dropout rates limited QoL data interpretation for DTIC.