Evidence map›Paper›PMID 21306237›Full record

Trial reportThe New England journal of medicine2011

Sunitinib malate for the treatment of pancreatic neuroendocrine tumors.

Eric Raymond, Laetitia Dahan, Jean-Luc Raoul, Yung-Jue Bang, Ivan Borbath, Catherine Lombard-Bohas, Juan Valle, Peter Metrakos, Denis Smith, Aaron Vinik and 10 more

Erratum issued 6 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in The New England journal of medicine, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 6 registered trials, which are not on this map. Cited by 1,058 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
1,058citing papers in PubMed, 4 pooled it
152.3field-weighted citation impact, top 1% 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
NCT04339036 phase2recruitingnot on this mapstarted 2021, after this paper: background citation

UPCC 04219 Phase 2 Study of Capecitabine-Temozolomide(CapTem) With Yttrium-90 Radioembolization in the Treatment of Patients With Unresectable Metastatic Grade 2/3 Neuroendocrine Tumors

TypeinterventionalSponsorAbramson Cancer Center at Penn MedicineRan2021 to 2028Enrolled70ConditionsNeuroendocrine Tumor Grade 2, Neuroendocrine TumorsArmsCapecitabine Oral Product, Temozolomide Oral Product, transarterial radioembolization
NCT04427787 phase2unknown statusnot on this mapstarted 2020, after this paper: background citation

A Phase II Trial Aiming to Assess the Safety and Activity of the Combination of Cabozantinib Plus Lanreotide in Gastroenteropancreatic (GEP) and Thoracic Neuroendocrine Tumor (NET): The LOLA Trial

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2020 to 2023Enrolled69ConditionsMetastatic Well Differentiated Neuroendocrine Neoplasm, Neuroendocrine TumorsArmsCabozantinib, Lanreotide
NCT04790708 naunknown statusnot on this mapstarted 2018, after this paper: background citation

Peptide Receptor Radionuclide Therapy (PRRT) in Tumors With High Expression of Somatostatin Receptors

TypeinterventionalSponsorUniversity Hospital of FerraraRan2018 to 2023Enrolled250ConditionsNeuroendocrine Tumors, Peptide Receptor Radionuclide Therapy (PRRT)ArmsLutetium-177 (177Lu)-DOTATOC, Yttrium-90 (90Y)-DOTATOC, 177Lu-DOTATOC + 90Y-DOTATOC, Re-treatment 177Lu-DOTATOC, Re-treatment 90Y-DOTATOC
NCT05973968 unknown statusnot on this mapstarted 2023, after this paper: background citation

A Real-world Study of Surufatinib in Refractory Metastatic G3 Neuroendocrine Tumors

TypeobservationalSponsorQilu Hospital of Shandong UniversityRan2023 to 2025Enrolled32ConditionsNeuroendocrine Tumor Grade 3ArmsSurufatinib
NCT07471425 not yet recruitingnot on this mapstarted 2026, after this paper: background citation

Survival Without Persistent Limiting Toxicity: a Real Life Prospective Cohort of Advanced Neuroendocrine Tumor Followed in the French ENDOCAN-RENATEN and GTE Networks

Typeobservational_patient_registrySponsorGustave Roussy, Cancer Campus, Grand ParisRan2026 to 2034Enrolled1,100ConditionsNeuroendocrine (NE) TumorsArmsquality of life questionnaire, treatment side effect follow up
3 · Its place in the literature

Who cites it

1,058 citing papers in PubMed, 4 syntheses or guidelines pooled it, 2,525 citations in OpenAlex.

  1. Pooled it
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  9. Cabozantinib plus Atezolizumab in Advanced, Progressive Endocrine Malignancies: A Multicohort, Basket, Phase II Trial (CABATEN/GETNE-T1914).Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
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  11. Randomized Phase II Trial of Pazopanib Versus Placebo in Patients With Advanced Extrapancreatic Neuroendocrine Tumors (Alliance A021202).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
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  12. Sunitinib as Second-Line Treatment in Advanced Intrahepatic Cholangiocarcinoma: Results From the SUN-CK GERCOR Phase II Trial.Liver international : official journal of the International Association for the Study of the Liver · 2025
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998 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 14 institutions in 8 countries.

Eric RaymondService Inter-Hospitalier de Cancérologie et Service de Gastroenteropancréatologie, Hôpital Beaujon, Clichy, France. eric.raymond@bjn.aphp.fr
Laetitia Dahan
Jean-Luc Raoul
Yung-Jue Bang
Ivan Borbath
Catherine Lombard-Bohas
Juan Valle
Peter Metrakos
Denis Smith
Aaron Vinik
Jen-Shi Chen
Dieter Hörsch
Pascal Hammel
Bertram Wiedenmann
Eric Van Cutsem
Shem Patyna
Dongrui Ray Lu
Carolyn Blanckmeister
Richard Chao
Philippe Ruszniewski
Pfizer (United States) · USHôpital Beaujon · FRCentre Eugène Marquis · FRChang Gung Memorial Hospital · TWCharité - Universitätsmedizin Berlin · DECliniques Universitaires Saint-Luc · BEEastern Virginia Medical School · USHôpital Saint-André · FRHospices Civils de Lyon · FRMcGill University Health Centre · CANational Health Service · GBSeoul National University Hospital · KRUniversitair Ziekenhuis Leuven · BEZentralklinik Bad Berka · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe multitargeted tyrosine kinase inhibitor sunitinib has shown activity against pancreatic neuroendocrine tumors in preclinical models and phase 1 and 2 trials.

methodsWe conducted a multinational, randomized, double-blind, placebo-controlled phase 3 trial of sunitinib in patients with advanced, well-differentiated pancreatic neuroendocrine tumors. All patients had Response Evaluation Criteria in Solid Tumors-defined disease progression documented within 12 months before baseline. A total of 171 patients were randomly assigned (in a 1:1 ratio) to receive best supportive care with either sunitinib at a dose of 37.5 mg per day or placebo. The primary end point was progression-free survival; secondary end points included the objective response rate, overall survival, and safety.

resultsThe study was discontinued early, after the independent data and safety monitoring committee observed more serious adverse events and deaths in the placebo group as well as a difference in progression-free survival favoring sunitinib. Median progression-free survival was 11.4 months in the sunitinib group as compared with 5.5 months in the placebo group (hazard ratio for progression or death, 0.42; 95% confidence interval [CI], 0.26 to 0.66; P<0.001). A Cox proportional-hazards analysis of progression-free survival according to baseline characteristics favored sunitinib in all subgroups studied. The objective response rate was 9.3% in the sunitinib group versus 0% in the placebo group. At the data cutoff point, 9 deaths were reported in the sunitinib group (10%) versus 21 deaths in the placebo group (25%) (hazard ratio for death, 0.41; 95% CI, 0.19 to 0.89; P=0.02). The most frequent adverse events in the sunitinib group were diarrhea, nausea, vomiting, asthenia, and fatigue.

conclusionsContinuous daily administration of sunitinib at a dose of 37.5 mg improved progression-free survival, overall survival, and the objective response rate as compared with placebo among patients with advanced pancreatic neuroendocrine tumors. (Funded by Pfizer; ClinicalTrials.gov number, NCT00428597.).

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDisease ProgressionDouble-Blind MethodFemaleHumansIndolesIntention to Treat AnalysisKaplan-Meier EstimateMaleMiddle AgedNeuroendocrine TumorsPancreatic NeoplasmsProportional Hazards ModelsAntineoplastic AgentsIndolesProtein Kinase InhibitorsPyrrolesReceptors, Vascular Endothelial Growth FactorSunitinib

Identifiers

PMID21306237
OpenAlexW2158474413

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.