Evidence map›Paper›PMID 25592632›Full record

Trial reportThe Lancet. Oncology2015

Sunitinib in patients with chemotherapy-refractory thymoma and thymic carcinoma: an open-label phase 2 trial.

Anish Thomas, Arun Rajan, Arlene Berman, Yusuke Tomita, Christina Brzezniak, Min-Jung Lee, Sunmin Lee, Alexander Ling, Aaron J Spittler, Corey A Carter and 8 more

Erratum issued 2 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Oncology, 2015. 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 2 registered trials, which are not on this map. Cited by 164 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
164citing papers in PubMed, 2 pooled it
18.0field-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.

NCT01621568 phase2completednot on this map

A Phase II Study of Sunitinib in Patients With Advanced Relapsed or Refractory Thymoma or Thymic Carcinoma With at Least One Prior Line of Platinum-Based Systemic Chemotherapy

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2012 to 2024Enrolled56ConditionsThymoma, Thymus NeoplasmsArmsSunitinib
NCT03449173 phase2unknown statusnot on this mapstarted 2017, after this paper: background citation

Phase II Trial of Sunitinib in Patients With Type B3 Thymoma or Thymic Carcinoma in Second and Further Lines (Style Trial)

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2017 to 2022Enrolled56ConditionsType B3 Thymoma, Thymic CarcinomaArmsSunitinib
3 · Its place in the literature

Who cites it

164 citing papers in PubMed, 2 syntheses or guidelines pooled it, 296 citations in OpenAlex.

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104 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 6 institutions in 1 country.

Anish ThomasThoracic and GI Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Arun RajanThoracic and GI Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Arlene BermanThoracic and GI Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Yusuke TomitaDevelopmental Therapeutics Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Christina BrzezniakDepartment of Hematology and Oncology, Walter Reed National Military Medical Center, Bethesda, MD, USA.
Min-Jung LeeDevelopmental Therapeutics Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Sunmin LeeDevelopmental Therapeutics Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Alexander LingRadiology and Imaging Sciences, Warren Grant Magnuson Clinical Center, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Aaron J SpittlerDivision of Hematology/Oncology, Indiana University Medical Center, Indianapolis, IN, USA.
Corey A CarterDepartment of Hematology and Oncology, Walter Reed National Military Medical Center, Bethesda, MD, USA.
Udayan GuhaThoracic and GI Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Yisong WangDivision of Hematology/Oncology, Lombardi Cancer Center, Georgetown University, Washington, DC, USA.
Eva SzaboDivision of Cancer Prevention, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Paul MeltzerGenetics Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Seth M SteinbergBiostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Jane B TrepelDevelopmental Therapeutics Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
Patrick J LoehrerDivision of Hematology/Oncology, Indiana University Medical Center, Indianapolis, IN, USA.
Giuseppe GiacconeDivision of Hematology/Oncology, Lombardi Cancer Center, Georgetown University, Washington, DC, USA. Electronic address: gg496@georgetown.edu.
National Cancer Institute · USNational Institutes of Health · USGeorgetown University · USUniversity Medical Center · USWalter Reed National Military Medical Center · USCenter for Cancer Research · US

Funding

Cancer Genomics Technology DevelopmentZIABC011091 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI MELTZER, PAUL S. · 2009 to 2025
$16.9M
Signal Transduction Events and the Regulation of Cell GrowthZICSC006743 · NCI · DIVISION OF CLINICAL SCIENCES - NCI · PI TREPEL, JANE B · 2009 to 2023
$13.8M
Pharmacokinetic and Pharmacodynamic Modeling of Anticancer AgentsZ01BC010548 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI FIGG, WILLIAM DOUGLAS · 2003 to 2008
$815k
Intramural NIH HHS Z01 BC010548
6 · The paper itself

Abstract

backgroundNo standard treatments are available for advanced thymic epithelial tumours after failure of platinum-based chemotherapy. We investigated the activity of sunitinib, an orally administered tyrosine kinase inhibitor.

methodsBetween May 15, 2012, and Oct 2, 2013, we did an open-label phase 2 trial in patients with histologically confirmed chemotherapy-refractory thymic epithelial tumours. Patients were eligible if they had disease progression after at least one previous regimen of platinum-containing chemotherapy, an Eastern Cooperative Oncology Group performance status of two or lower, measurable disease, and adequate organ function. Patients received 50 mg of sunitinib orally once a day, in 6-week cycles (ie, 4 weeks of treatment followed by 2 weeks without treatment), until tumour progression or unacceptable toxic effects arose. The primary endpoint was investigator-assessed best tumour response at any point, which we analysed separately in thymoma and thymic carcinoma cohorts. Patients who had received at least one cycle of treatment and had their disease reassessed were included in the analyses of response. The trial was registered with ClinicalTrials.gov, number NCT01621568.

findings41 patients were enrolled, 25 with thymic carcinoma and 16 with thymoma. One patient with thymic carcinoma was deemed ineligible after enrolment and did not receive protocol treatment. Of patients who received treatment, one individual with thymic carcinoma was not assessable because she died. Median follow-up on trial was 17 months (IQR 14.0-18.4). Of 23 assessable patients with thymic carcinoma, six (26%, 90% CI 12.1-45.3, 95% CI 10.2-48.4) had partial responses, 15 (65%, 95% CI 42.7-83.6) achieved stable disease, and two (9%, 1.1-28.0) had progressive disease. Of 16 patients with thymoma, one (6%, 95% CI 0.2-30.2) had a partial response, 12 (75%, 47.6-92.7) had stable disease, and three (19%, 4.1-45.7) had progressive disease. The most common grade 3 and 4 treatment-related adverse events were lymphocytopenia (eight [20%] of 40 patients), fatigue (eight [20%]), and oral mucositis (eight [20%]). Five (13%) patients had decreases in left-ventricular ejection fraction, of which three (8%) were grade 3 events. Three (8%) patients died during treatment, including one individual who died of cardiac arrest that was possibly treatment-related.

interpretationSunitinib is active in previously treated patients with thymic carcinoma. Further studies are needed to identify potential biomarkers of activity.

fundingNational Cancer Institute (Cancer Therapy Evaluation Program).

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsDrug Resistance, NeoplasmFemaleFollow-Up StudiesHumansIndolesMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingNeuroendocrine TumorsPrognosisPyrrolesAntineoplastic AgentsIndolesPyrrolesSunitinib

Identifiers

PMID25592632
PMCPMC4401497
OpenAlexW2168558240

What OpenQuestion holds

Textmetadata
LicenceTDM
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.