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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
biochemistry, genetics and molecular biology
Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial
Targeted Oncology, Volume 11, No. 6, Year 2016
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Description
Objective: 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 and Methods: 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. Results: 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. Conclusion: 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. [Figure not available: see fulltext.] © 2016, Springer International Publishing Switzerland.
Authors & Co-Authors
Vinik, Aaron I.
United States, Norfolk
Eastern Virginia Medical School
Bottomley, Andrew D.
Belgium, Brussels
European Organisation for Research and Treatment of Cancer
Bang, Yung–Jue
South Korea, Seoul
Seoul National University College of Medicine
Raoul, Jean Luc
France, Marseille
Institut Paoli-calmettes
Valle, Juan W.
United Kingdom, Manchester
The University of Manchester
Metrakos, Peter P.
Canada, Montreal
Centre Universitaire de Santé Mcgill
Raymond, Éric
France, Clichy
Hôpital Beaujon
Statistics
Citations: 41
Authors: 7
Affiliations: 9
Identifiers
Doi:
10.1007/s11523-016-0462-5
ISSN:
17762596
Research Areas
Cancer
Disability
Health System And Policy