Evidence map›Paper›PMID 27924459›Full record

Trial reportTargeted oncology2016

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

Aaron Vinik, Andrew Bottomley, Beata Korytowsky, Yung-Jue Bang, Jean-Luc Raoul, Juan W Valle, Peter Metrakos, Dieter Hörsch, Rajiv Mundayat, Arlene Reisman and 3 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Targeted oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00428597 (A Phase III Randomized, Double-Blind Study Of Sunitinib), which is not on this map. Cited by 27 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 7 pooled it
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00428597 phase3terminatednot on this map

A Phase III Randomized, Double-Blind Study Of Sunitinib (SU011248, SUTENT) Versus Placebo In Patients With Progressive Advanced/Metastatic Well-Differentiated Pancreatic Islet Cell Tumors

TypeinterventionalSponsorPfizerRan2007 to 2009Enrolled171ConditionsCarcinoma, Islet Cell, Carcinoma, PancreasArmssunitinib malate, Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 7 syntheses or guidelines pooled it, 52 citations in OpenAlex.

  1. Pooled it
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  6. Time to deterioration in cancer randomized clinical trials for patient-reported outcomes data: a systematic review.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2020
    Pooled it
  7. Pooled it
  8. Trial
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  13. [European journal of nuclear medicine and molecular imaging · 2022
    Article
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  18. Can the peptide receptor radionuclide therapy [EJC supplements : EJC : official journal of EORTC, European Organization for Research and Treatment of Cancer ... [et al.] · 2021
    Article
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  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 7 countries.

Aaron VinikStrelitz Diabetes Research Center and Neuroendocrine Unit, Eastern Virginia Medical School, Strelitz Diabetes Center, Norfolk, VA, USA. vinikai@evms.edu.
Andrew BottomleyQuality of Life Department, European Organization for Research and Treatment of Cancer, Brussels, Belgium.
Beata KorytowskyPfizer Inc, New York, NY, USA.
Yung-Jue BangSeoul National University College of Medicine, Seoul, Korea.
Jean-Luc RaoulPaoli-Calmettes Institute, Marseille, France.
Juan W ValleThe University of Manchester/The Christie NHS Foundation Trust, Manchester, UK.
Peter MetrakosMcGill University Hospital Center, Montreal, Canada.
Dieter HörschBad Berka Central Clinic, Bad Berka, Germany.
Rajiv MundayatPfizer Inc, New York, NY, USA.
Arlene ReismanPfizer Inc, New York, NY, USA.
Zhixiao WangPfizer Inc, New York, NY, USA.
Richard C ChaoPfizer Oncology, La Jolla, CA, USA.
Eric RaymondHôpital Beaujon, Clichy, France.
Pfizer (United States) · USEastern Virginia Medical School · USEuropean Organisation for Research and Treatment of Cancer · BEHôpital Beaujon · FRInstitut Paoli-Calmettes · FRMcGill University Health Centre · CASeoul National University · KRUniversity of Manchester · GBZentralklinik Bad Berka · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe 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

methodsPatients 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.

resultsSunitinib 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.

conclusionWith 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.

Indexed as

Patient Reported Outcome MeasuresAntineoplastic AgentsFemaleHumansIndolesMaleNeuroendocrine TumorsPancreatic NeoplasmsPyrrolesQuality of LifeRetrospective StudiesSunitinibAntineoplastic AgentsIndolesPyrrolesSunitinib

Identifiers

PMID27924459
OpenAlexW2560844514

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.