BENEFIT OF ABIRATERONE ACETATE PLUS PREDNISONE (AA+P) ADDED TO ANDROGEN DEPRIVATION THERAPY (ADT) IN PATIENTS WITH HIGH-RISK, NEWLY DIAGNOSED METASTATIC HORMONE-SENSITIVE PROSTATE CANCER (MHSPC)- POST HOC ANALYSIS OF EQ-5D-5L FROM THE LATIT ...

Author(s)

Metin H1, McQuarrie K2, Thilakarathne P3, Diels J4, Ito T5, Li T6, Sulur G7, Chi KN8, Fizazi K9
1Janssen-Cilag GmbH, North Rhine-Westphalia, Germany, 2Janssen Research & Development, Spring House, PA, USA, 3Janssen-Cilag, Beerse, Belgium, 4Janssen Pharmaceutica EMEA HEMAR, Beerse, Belgium, 5Janssen-Cilag, UK, High Wycombe, UK, 6Janssen Global Services, Raritan, NJ, USA, 7Janssen Research & Development, Los Angeles, CA, USA, 8BC Cancer Agency-Vancouver Centre, Vancouver, BC, Canada, 9Gustave Roussy, University of Paris Sud, Villejuif Cedex, France

OBJECTIVES: To determine benefit of AA+P when added to ADT by evaluating EQ-5D-5L visual analog scale (VAS) time to deterioration, assessing clinically relevant minimally important differences (MIDs), in the LATITUDE study of patients with mHSPC. METHODS: Patients were randomized 1:1 to ADT+AA+P (n = 597) or ADT+placebos (PBOs) (n = 602). EQ-5D-5L responses were collected at baseline, Day 1 (Cycles 2-13), and then bimonthly (Cycles 14+) until radiographic or clinical disease progression, and then every 4 months for 12 months post-progression. Time-to-event analyses were performed using Kaplan-Meier and Cox proportional hazards model to evaluate AA+P treatment effect. Subgroup analysis was done by baseline characteristics including age, Eastern Cooperative Oncology Group performance status, Gleason score at initial diagnosis, bone lesion number, prostate-specific antigen, lactate dehydrogenase, region, and use of bone-modifying or analgesic concomitant medication. Clinically relevant MIDs for EQ-5D-5L VAS—seven (T7) and ten (T10) points—as estimated by Pickard et al. (Health Qual Life Outcomes

Conference/Value in Health Info

2018-05, ISPOR 2018, Baltimore, MD, USA

Value in Health, Vol. 21, S1 (May 2018)

Code

PCN171

Topic

Patient-Centered Research

Topic Subcategory

Patient-reported Outcomes & Quality of Life Outcomes

Disease

Oncology

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