PS4-18 ASSOCIATION OF DISEASE PROGRESSION, HEALTH-RELATED QUALITY OF LIFE, AND UTILITY IN PATIENTS WITH ADVANCED, NONFUNCTIONAL, WELL-DIFFERENTIATED GASTROINTESTINAL OR LUNG NEUROENDOCRINE TUMORS IN THE PHASE 3 RADIANT-4 TRIAL

Tuesday, June 14, 2016
Exhibition Space (30 Euston Square)
Poster Board # PS4-18

Simron Singh, MD1, Marianne E. Pavel, MD2, Jonathan Strosberg, MD3, Lida Bubuteishvili-Pacaud, MD4, Evgeny Degtyarev, MSc4, Maureen P. Neary, PhD5, Matthias Hunger, PhD6, Jennifer Eriksson, MSc7, Nicola Fazio, MD8, Matthew Kulke, MD9 and James C. Yao, MD10, (1)Sunnybrook Health Sciences Centre, Toronto, ON, Canada, (2)Charité Berlin Campus Virchow-Klinikum, Berlin, Germany, (3)Department of Medicine, Moffitt Cancer Center, Tampa, FL, (4)Novartis Pharma AG, Basel, Switzerland, (5)Novartis Pharmaceuticals Corporation, East Hanover, NJ, (6)Mapi, Munich, Germany, (7)Mapi, Stockholm, Sweden, (8)Istituto Europeo di Oncologia IRCCS, Milan, Italy, (9)Dana Farber Cancer Institute, Boston, MA, (10)University of Texas MD Anderson Cancer Center, Houston, TX

Purpose:

Post hoc analyses were performed to determine if disease progression is associated with decline in health-related quality of life (HRQoL) and utility scores using data from RADIANT-4, a phase 3 trial that showed significantly prolonged progression-free survival (PFS) with everolimus + best supportive care (BSC) vs placebo + BSC in patients (pts) with advanced, progressive, nonfunctional gastrointestinal (GI) or lung neuroendocrine tumors (NET).

 

Method(s):

Pooling data from both arms, 284 patients were analyzed from baseline to study end. HRQoL was measured with FACT-G, a validated questionnaire with 4 domains: physical (PWB), social/family (SWB), emotional (EWB), and functional wellbeing (FWB). FACT-G was completed at baseline, every 8 weeks until month 12 after randomization, and every 12 weeks thereafter. Association between disease progression and HRQoL outcomes was assessed by fitting linear mixed models. Based on a review of existing mapping functions and relevance for the RADIANT-4 population, 2 mapping algorithms were selected to translate FACT-G scores into EQ-5D utility scores: Young, Med Decis Making 2015 (UK value set); Teckle, Health Qual Life Outcomes 2013 (US value set). 

 

Result(s):

The difference in FACT-G total score pre- vs post-progression was significant: 79.7 vs 74.8 (difference: 4.91; 95% CI: 3.71, 6.11). This difference may also be clinically relevant based on published ranges for minimal important difference (Yost & Eton, Eval Health Prof 2005). Differences in subscale scores were: PWB 22.4 vs 20.9 (1.5; 95% CI: 1.05, 1.95); EWB 17.6 vs 16.4 (1.14; 95% CI: 0.78, 1.49); SWB 21.6 vs 20.9 (0.69; 95% CI: 0.24, 1.14); and FWB 18.2 vs 16.9 (1.34; 95% CI: 0.86, 1.82). Mean “Teckle” utility was 0.826 (95% CI: 0.815, 0.836) pre-progression and 0.795 (95% CI: 0.783, 0.807) post-progression; mean “Young” utility was 0.779 (95% CI: 0.763, 0.796) pre-progression and 0.725 (95% CI: 0.706, 0.744) post-progression.

 

Conclusion(s):

Disease progression in patients with advanced, nonfunctional, well-differentiated GI or lung NET is associated with a significant decline in HRQoL and utility scores. Effective therapy to prolong PFS may delay a decline in HRQoL and utility.