Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial

• DOI: 10.1007/s11523-016-0462-5
• Publication Date: 2016-12-06T16:26:24Z
• Authors: Aaron Vinik; Andrew Bottomley; Beata Korytowsky; Yung-Jue Bang; Jean-Luc Raoul; Juan W. Valle; Peter Metrakos; Dieter Hörsch; Rajiv Mundayat; Arlene Reisman; Zhixiao Wang; Richard C. Chao; Eric Raymond
• Keywords: Male; 0301 basic medicine; Indoles; Antineoplastic Agents; ResearchInstitutes_Networks_Beacons/mcrc; name=Manchester Cancer Research Centre; 3. Good health; Pancreatic Neoplasms; Neuroendocrine Tumors; 03 medical and health sciences; Quality of Life; Sunitinib; Humans; Female; Pyrroles; Patient Reported Outcome Measures; Retrospective Studies

The objective of this analysis was to compare patient-reported outcomes and health-related quality of life (HRQoL) in a pivotal phase III trial of sunitinib versus placebo in patients with progressive, well-differentiated pancreatic neuroendocrine tumors (NCT00428597).Patients received sunitinib 37.5 mg (n = 86) or placebo (n = 85) on a continuous daily-dosing schedule until disease progression, unacceptable adverse events (AEs), or death. Patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 at baseline, Day 1 of every 4-week cycle, and end of treatment or withdrawal. Changes ≥10 points on each scale or item were deemed clinically meaningful.Sunitinib had anti-tumor effects and improved progression-free survival (PFS) compared with placebo. The study was terminated early for this reason and because of more serious AEs and deaths with placebo. Baseline HRQoL scores were well balanced between study arms, and were generally maintained over time in both groups. In the first 10 cycles, there were no significant differences between groups in global HRQoL, cognitive, emotional, physical, role, and social functioning domains, or symptom scales, except for worsening diarrhea with sunitinib (p < 0.0001 vs. placebo). Insomnia also worsened with sunitinib (p = 0.0372 vs. placebo), but the difference was not clinically meaningful.With the exception of diarrhea (a recognized side effect), sunitinib had no impact on global HRQoL, functional domains, or symptom scales during the progression-free period. Hence, in patients with pancreatic neuroendocrine tumors, sunitinib provided a benefit in PFS without adversely affecting HRQoL.