title: Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial.
abstract: 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.
authors.affiliation: Strelitz Diabetes Research Center and Neuroendocrine Unit, Eastern Virginia Medical School, Strelitz Diabetes Center, Norfolk, VA, USA. vinikai@evms.edu.
authors.forename: Aaron
authors.initials: A
authors.lastname: Vinik
authors.affiliation: Quality of Life Department, European Organization for Research and Treatment of Cancer, Brussels, Belgium.
authors.forename: Andrew
authors.initials: A
authors.lastname: Bottomley
authors.affiliation: Pfizer Inc, New York, NY, USA.
authors.forename: Beata
authors.initials: B
authors.lastname: Korytowsky
authors.affiliation: Seoul National University College of Medicine, Seoul, Korea.
authors.forename: Yung-Jue
authors.initials: YJ
authors.lastname: Bang
authors.affiliation: Paoli-Calmettes Institute, Marseille, France.
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Raoul
authors.affiliation: The University of Manchester/The Christie NHS Foundation Trust, Manchester, UK.
authors.forename: Juan W
authors.initials: JW
authors.lastname: Valle
authors.affiliation: McGill University Hospital Center, Montreal, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Metrakos
authors.affiliation: Bad Berka Central Clinic, Bad Berka, Germany.
authors.forename: Dieter
authors.initials: D
authors.lastname: Hörsch
authors.affiliation: Pfizer Inc, New York, NY, USA.
authors.forename: Rajiv
authors.initials: R
authors.lastname: Mundayat
authors.affiliation: Pfizer Inc, New York, NY, USA.
authors.forename: Arlene
authors.initials: A
authors.lastname: Reisman
authors.affiliation: Pfizer Inc, New York, NY, USA.
authors.forename: Zhixiao
authors.initials: Z
authors.lastname: Wang
authors.affiliation: Pfizer Oncology, La Jolla, CA, USA.
authors.forename: Richard C
authors.initials: RC
authors.lastname: Chao
authors.affiliation: Hôpital Beaujon, Clichy, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Raymond
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D008297:Male; D018358:Neuroendocrine Tumors / Q000188:drug therapy* / Q000523:psychology; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000523:psychology; D000071066:Patient Reported Outcome Measures; D011758:Pyrroles / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D011788:Quality of Life / Q000523:psychology*; D012189:Retrospective Studies; D000077210:Sunitinib
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib