Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial
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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.
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.
KeywordsSunitinib Peptide Receptor Radionuclide Therapy Functional Scale HRQoL Scale Sunitinib Malate
The authors wish to thank all of the participating patients and their families, as well as the global network of investigators, research nurses, study coordinators, and operations staff. The views expressed in this manuscript reflect those of the authors and do not necessarily reflect the official views of the authors’ institutions. Medical writing assistance was provided by Nicola Crofts and Susanne Gilbert at ACUMED® (New York, NY, USA), an Ashfield company, part of UDG Healthcare plc, and by Vardit Dror, PhD, of Engage Scientific Solutions, with funding from Pfizer Inc.
Compliance with Ethical Standards
This study was funded by Pfizer Inc.
Conflicts of Interest
Dr Vinik is a board member at Medscape and has received consultancy fees from Pfizer, Merck, Pamlab, NeuroMetrix and ISIS Pharmaceuticals; research funding from Pfizer, the American Diabetes Association, the National Institutes of Health, Impeto Medical, Daiichi Sankyo, Tercica, ViroMed, Intarcia Therapeutics and Novo Nordisk; and honoraria from Merck and Pamlab. Dr Bottomley has reported no potential conflicts of interest. Ms Korytowsky was an employee of Pfizer at the time the study was conducted. Dr Bang has received consultancy fees and research funding from Pfizer. Dr Raoul has reported no potential conflicts of interest. Dr Valle has received honoraria from Pfizer, Novartis and Ipsen and research funding from Novartis. Dr Metrakos has received consulting fees from Novartis, Ipsen and Pfizer, and research funding from Novartis and Pfizer. Dr Hörsch has received honoraria and travel support from Pfizer, Novartis, Ipsen and Lexicon and research funding from Novartis, ITG, Eckart and Ziegler, Covidien and MSD. Mr Mundayat is an employee of Pfizer. Ms Reisman is an employee of Pfizer. Dr Wang was an employee of Pfizer at the time the study was conducted. Dr Chao was an employee of Pfizer at the time the study was conducted and owns Pfizer stock. Dr Raymond has received consulting fees and research funding from Pfizer, Novartis and Ipsen.
Presented in part at the American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, Illinois, USA, June 4–8, 2010, and the North American Neuroendocrine Tumor Society (NANETS) Neuroendocrine Tumor Symposium, Santa Fe, New Mexico, USA, October 29–30, 2010.
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