Evidence map›Paper›PMID 25897676›Full record

Trial reportBritish journal of cancer2015

A randomised phase II trial of selumetinib vs selumetinib plus temsirolimus for soft-tissue sarcomas.

Z Eroglu, H A Tawbi, J Hu, M Guan, P H Frankel, N H Ruel, S Wilczynski, S Christensen, D R Gandara, W A Chow

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 3 pooled it
3.6field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 3 syntheses or guidelines pooled it, 37 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. SARC031: A Phase II Trial of Selumetinib and Sirolimus for Patients with Unresectable or Metastatic Malignant Peripheral Nerve Sheath Tumors (MPNST).Clinical cancer research : an official journal of the American Association for Cancer Research · 2026
    Trial
  5. Trial
  6. Review
  7. Article
  8. Review
  9. Mucocutaneous toxicities from MEK inhibitors: a scoping review of the literature.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
    Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Targeted therapy in sarcomas other than GIST tumors.Journal of surgical oncology · 2015
    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

10 authors at 4 institutions in 1 country.

Z ErogluCity of Hope National Medical Center, Duarte, CA, USA.
H A TawbiUniversity of Pittsburgh Cancer Institute and University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
J HuNorris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.
M GuanCity of Hope National Medical Center, Duarte, CA, USA.
P H FrankelCity of Hope National Medical Center, Duarte, CA, USA.
N H RuelCity of Hope National Medical Center, Duarte, CA, USA.
S WilczynskiCity of Hope National Medical Center, Duarte, CA, USA.
S ChristensenUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.
D R GandaraUniversity of California Davis Comprehensive Cancer Center, Sacramento, CA, USA.
W A ChowCity of Hope National Medical Center, Duarte, CA, USA.
City Of Hope National Medical Center · USUniversity of California, Davis · USUniversity of Southern California · USUPMC Hillman Cancer Center · US

Funding

Transgenic Mouse FacilityP30CA033572 · NCI · CITY OF HOPE/BECKMAN RESEARCH INSTITUTE · PI STANLEY R. HAMILTON · 1985 to 2026
$86.3M
NCI NIH HHS N01-CM-2011-00038NCI NIH HHS P30 CA033572
6 · The paper itself

Abstract

backgroundThe MEK inhibitor, selumetinib, suppresses soft-tissue sarcoma (STS) cell proliferation in vitro. Mammalian target of rapamycin inhibitors possess modest activity against STS; however, resistance develops via MAPK pathway feedback activation. The combination of selumetinib and temsirolimus synergistically inhibits STS cell line growth. Therefore, a randomized phase II trial of selumetinib vs selumetinib plus temsirolimus was conducted.

methodsSeventy-one adults with advanced STS who received ⩽ 2 prior chemotherapeutics were randomized to selumetinib 75 mg p.o. bid and allowed to crossover upon progression, or to selumetinib 50 mg p.o. bid plus temsirolimus 20 mg i.v. weekly, with primary endpoint of progression-free survival (PFS).

resultsThere was no difference in PFS between the two arms for the overall cohort (median 1.9 vs 2.1 months); an improved median PFS was observed in the combination arm (N = 11) over single agent (N = 10) in the prespecified leiomyosarcoma stratum (median 3.7 vs 1.8 months; P = 0.01). Four-month PFS rate was 50% (95% confidence interval 0.19-0.81) with the combination vs 0% with selumetinib alone in the leiomyosarcoma cohort. Most common grade 3/4 adverse events with the combination were mucositis (29%), lymphopenia (26%), neutropenia and anaemia (20% each).

conclusionsWhile single-agent selumetinib has no significant activity in STS, the combination may be active for leiomyosarcomas.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzimidazolesDisease-Free SurvivalDrug Administration ScheduleFemaleHumansMaleMiddle AgedSarcomaSirolimusTreatment OutcomeYoung AdultAZD 6244BenzimidazolesSirolimustemsirolimus

Identifiers

PMID25897676
PMCPMC4430716
OpenAlexW2003619378

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-SA
Read underepoch 390

Registered trials

None linked

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.