PMID- 27924459
OWN - NLM
STAT- MEDLINE
DCOM- 20171030
LR  - 20181202
IS  - 1776-260X (Electronic)
IS  - 1776-2596 (Linking)
VI  - 11
IP  - 6
DP  - 2016 Dec
TI  - Patient-Reported Outcomes and Quality of Life with Sunitinib Versus Placebo for 
      Pancreatic Neuroendocrine Tumors: Results From an International Phase III Trial.
PG  - 815-824
AB  - 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.
FAU - Vinik, Aaron
AU  - Vinik A
AD  - Strelitz Diabetes Research Center and Neuroendocrine Unit, Eastern Virginia 
      Medical School, Strelitz Diabetes Center, Norfolk, VA, USA. vinikai@evms.edu.
FAU - Bottomley, Andrew
AU  - Bottomley A
AD  - Quality of Life Department, European Organization for Research and Treatment of 
      Cancer, Brussels, Belgium.
FAU - Korytowsky, Beata
AU  - Korytowsky B
AD  - Pfizer Inc, New York, NY, USA.
FAU - Bang, Yung-Jue
AU  - Bang YJ
AD  - Seoul National University College of Medicine, Seoul, Korea.
FAU - Raoul, Jean-Luc
AU  - Raoul JL
AD  - Paoli-Calmettes Institute, Marseille, France.
FAU - Valle, Juan W
AU  - Valle JW
AD  - The University of Manchester/The Christie NHS Foundation Trust, Manchester, UK.
FAU - Metrakos, Peter
AU  - Metrakos P
AD  - McGill University Hospital Center, Montreal, Canada.
FAU - Horsch, Dieter
AU  - Horsch D
AD  - Bad Berka Central Clinic, Bad Berka, Germany.
FAU - Mundayat, Rajiv
AU  - Mundayat R
AD  - Pfizer Inc, New York, NY, USA.
FAU - Reisman, Arlene
AU  - Reisman A
AD  - Pfizer Inc, New York, NY, USA.
FAU - Wang, Zhixiao
AU  - Wang Z
AD  - Pfizer Inc, New York, NY, USA.
FAU - Chao, Richard C
AU  - Chao RC
AD  - Pfizer Oncology, La Jolla, CA, USA.
FAU - Raymond, Eric
AU  - Raymond E
AD  - Hopital Beaujon, Clichy, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT00428597
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - France
TA  - Target Oncol
JT  - Targeted oncology
JID - 101270595
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Indoles)
RN  - 0 (Pyrroles)
RN  - V99T50803M (Sunitinib)
SB  - IM
MH  - Antineoplastic Agents/administration & dosage/pharmacology/*therapeutic use
MH  - Female
MH  - Humans
MH  - Indoles/administration & dosage/pharmacology/*therapeutic use
MH  - Male
MH  - Neuroendocrine Tumors/*drug therapy/psychology
MH  - Pancreatic Neoplasms/*drug therapy/psychology
MH  - *Patient Reported Outcome Measures
MH  - Pyrroles/administration & dosage/pharmacology/*therapeutic use
MH  - Quality of Life/*psychology
MH  - Retrospective Studies
MH  - Sunitinib
EDAT- 2016/12/08 06:00
MHDA- 2017/10/31 06:00
CRDT- 2016/12/08 06:00
PHST- 2016/12/08 06:00 [pubmed]
PHST- 2017/10/31 06:00 [medline]
PHST- 2016/12/08 06:00 [entrez]
AID - 10.1007/s11523-016-0462-5 [pii]
AID - 10.1007/s11523-016-0462-5 [doi]
PST - ppublish
SO  - Target Oncol. 2016 Dec;11(6):815-824. doi: 10.1007/s11523-016-0462-5.