Evidence map›Paper›PMID 21752435›Full record

Trial reportGynecologic oncology2011

Phase II trial of the mTOR inhibitor, temsirolimus and evaluation of circulating tumor cells and tumor biomarkers in persistent and recurrent epithelial ovarian and primary peritoneal malignancies: a Gynecologic Oncology Group study.

Kian Behbakht, Michael W Sill, Kathleen M Darcy, Stephen C Rubin, Robert S Mannel, Steven Waggoner, Russell J Schilder, Kathy Q Cai, Andrew K Godwin, R Katherine Alpaugh

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 96 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
96citing papers in PubMed, 5 pooled it
20.5field-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.

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

96 citing papers in PubMed, 5 syntheses or guidelines pooled it, 210 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Treatment-related fatigue with everolimus and temsirolimus in patients with cancer-a meta-analysis of clinical trials.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015
    Pooled it
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  6. Trial
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  13. Review
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  17. Diagnostic biomarkers in ovarian cancer: advances beyond CA125 and HE4.Therapeutic advances in medical oncology · 2024
    Review
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  19. Article
  20. Review

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

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 8 institutions in 1 country.

Kian BehbakhtUniversity of Colorado Denver, Aurora, CO 80045, USA. kian.behbakht@ucdenver.edu
Michael W Sill
Kathleen M Darcy
Stephen C Rubin
Robert S Mannel
Steven Waggoner
Russell J Schilder
Kathy Q Cai
Andrew K Godwin
R Katherine Alpaugh
Fox Chase Cancer Center · USUniversity of Kansas Medical Center · USRoswell Park Comprehensive Cancer Center · USUniversity at Buffalo, State University of New York · USUniversity Hospitals Case Medical Center · USUniversity of Colorado Denver · USUniversity of Oklahoma Health Sciences Center · USUniversity of Pennsylvania · US

Funding

GYNECOLOGIC ONCOLOGY GROUP HEADQUARTERSU10CA027469 · NCI · GYNECOLOGIC ONCOLOGY GROUP · PI DISAIA, PHILIP J. · 1985 to 2013
$132.6M
GYNECOLOGIC ONCOLOGY GROUP STATISTICAL OFFICEU10CA037517 · NCI · ROSWELL PARK CANCER INSTITUTE CORP · PI BLESSING, JOHN A · 1985 to 2013
$67.4M
Therapeutic Micro RNA Strategies for Ovarian CancerP50CA083638 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI GODWIN, ANDREW K., GOLEMIS, ERICA A. · 1999 to 2013
$33.6M
Exploiting Biological Networks to Improve Clinical Treatment of Ovarian CancerR01CA140323 · NCI · UNIVERSITY OF KANSAS MEDICAL CENTER · PI GODWIN, ANDREW K. · 2010 to 2014
$2.1M
NCI NIH HHS CA 11479NCI NIH HHS CA 140323NCI NIH HHS CA 27469NCI NIH HHS CA 37517NCI NIH HHS P50 CA083638NCI NIH HHS R01 CA140323NCI NIH HHS U10 CA027469NCI NIH HHS U10 CA037517
6 · The paper itself

Abstract

objectivePatients with persistent/recurrent epithelial ovarian cancer/primary peritoneal cancer (EOC/PPC) have limited treatment options. AKT and PI3K pathway activation is common in EOC/PPC, resulting in constitutive activation of downstream mTOR. The GOG conducted a phase II evaluation of efficacy and safety for the mTOR inhibitor, temsirolimus in EOC/PPC and explored circulating tumor cells (CTC) and AKT/mTOR/downstream tumor markers.

methodsEligible women with measurable, persistent/recurrent EOC/PPC who had received 1-3 prior regimens were treated with 25mg weekly IV temsirolimus until progression or intolerable toxicity. Primary endpoints were progression-free survival (PFS) ≥6-months, tumor response, and toxicity. CellSearch® system was used to examine CTC, and AKT/mTOR/downstream markers were evaluated by archival tumor immunohistochemistry. Kendall's tau-b correlation coefficient (r) and Cox regression modeling were used to explore marker associations with baseline characteristics and outcome.

resultsSixty patients were enrolled in a two-stage sequential design. Of 54 eligible and evaluable patients, 24.1% (90% CI 14.9%-38.6%) had PFS ≥6 months (median 3.1 months), 9.3% (90% CI 3.7%-23.4%) experienced a partial response. Grade 3/4 adverse events included metabolic (8), gastrointestinal (8), pain (6), constitutional (5) and pulmonary (4). Suggested associations were between cyclin D1 and PFS ≥6 months, PFS or survival; positive CTC pre-treatment and lack of response; and high CTC expression of M30 and PFS ≥6 months/longer PFS.

conclusionsTemsirolimus appears to have modest activity in persistent/recurrent EOC/PPC; however, PFS is just below that required to warrant inclusion in phase III studies in unselected patients. Cyclin D1 as a selection marker and CTC measures merit further study.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsBiomarkers, TumorCarcinoma, Ovarian EpithelialCyclin D1Disease-Free SurvivalFemaleHumansMiddle AgedNeoplasms, Glandular and EpithelialNeoplastic Cells, CirculatingOvarian NeoplasmsPeritoneal NeoplasmsProto-Oncogene Proteins c-aktAntineoplastic AgentsBiomarkers, TumorCCND1 protein, humanCyclin D1MTOR protein, humanProto-Oncogene Proteins c-aktSirolimustemsirolimusTOR Serine-Threonine Kinases

Identifiers

PMID21752435
PMCPMC3336961
OpenAlexW1996193504

What OpenQuestion holds

Textmetadata
LicenceTDM
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.