Evidence map›Paper›PMID 25611229›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2015

SWOG S0722: phase II study of mTOR inhibitor everolimus (RAD001) in advanced malignant pleural mesothelioma (MPM).

Sai-Hong Ignatius Ou, James Moon, Linda L Garland, Philip C Mack, Joseph R Testa, Anne S Tsao, Antoniette J Wozniak, David R Gandara

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00770120 (Phase II Trial of mTOR Inhibitor, Everolimus), which is not on this map. Cited by 38 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
38citing papers in PubMed, 1 pooled it
5.5field-weighted citation impact, top 4% 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.

NCT00770120 phase2completednot on this map

Phase II Trial of mTOR Inhibitor, Everolimus (RAD001), in Malignant Pleural Mesothelioma (MPM)

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2008 to 2014Enrolled61ConditionsMalignant MesotheliomaArmseverolimus
3 · Its place in the literature

Who cites it

38 citing papers in PubMed, 1 synthesis or guideline pooled it, 76 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Article
  5. Review
  6. Review
  7. Review
  8. Article
  9. Review
  10. Review
  11. Article
  12. Target Therapy in Malignant Pleural Mesothelioma: Hope or Mirage?International journal of molecular sciences · 2023
    Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. c-MYC-mediated TRIB3/P62Acta pharmaceutica Sinica. B · 2022
    Article
  20. Article
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

8 authors at 6 institutions in 1 country.

Sai-Hong Ignatius Ou*Department of Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, CA; †SWOG Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA; ‡Department of Medicine, Arizona Cancer Center, University of Arizona Tucson School of Medicine, Tucson, AZ; §Department of Medicine, University of California Davis Comprehensive Cancer Center, Sacramento, CA; ║Fox Chase Cancer Center, Philadelphia, PA; ¶Department of Medicine, The University of Texas M.D. Anderson Cancer Center, Houston, TX; and #Department of Medicine, Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI.
James Moon
Linda L Garland
Philip C Mack
Joseph R Testa
Anne S Tsao
Antoniette J Wozniak
David R Gandara
Fox Chase Cancer Center · USUC Davis Comprehensive Cancer CenterFred Hutch Cancer Center · USThe University of Texas MD Anderson Cancer Center · USUniversity of Arizona · USWayne State University · US

Funding

SWOG Network Group Operations Center of the NCTNU10CA180888 · NCI · UNIVERSITY OF CALIFORNIA AT DAVIS · PI PRIMO N. LARA · 2014 to 2026
$152.1M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
SWOG Statistics & Data Management Center complex - extension supplement for GY06U10CA180819 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Catherine M. Tangen · 2014 to 2026
$115.2M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Laura Marcu · 2002 to 2026
$84.9M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
Translational Research Support CoreP30ES013508 · NIEHS · UNIVERSITY OF PENNSYLVANIA · PI Rebecca A Simmons · 2006 to 2026
$35.3M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
DAYTON CLINICAL ONCOLOGY PROGRAMU10CA035090 · NCI · KETTERING MEDICAL CENTER · PI GROSS, HOWARD M · 1985 to 2014
$12.0M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035261 · NCI · GRANT/RIVERSIDE METHODIST HOSPITALS · PI KUEBLER, PHILIP J. · 1985 to 2014
$10.6M
WESTERN ONCOLOGY RESEARCH CONSORTIUMU10CA045377 · NCI · PROVIDENCE PORTLAND MEDICAL CENTER · PI CONLIN, ALISON K · 1987 to 2013
$9.9M
NCI NIH HHS CA105409NCI NIH HHS CA11083NCI NIH HHS CA114047NCI NIH HHS CA14028NCI NIH HHS CA16385NCI NIH HHS CA20319NCI NIH HHS CA35090NCI NIH HHS CA35261NCI NIH HHS CA42777NCI NIH HHS CA45377NCI NIH HHS CA45808NCI NIH HHS CA58723NCI NIH HHS CA63848NCI NIH HHS CA76462NCI NIH HHS CA77429NCI NIH HHS CA86780NCI NIH HHS N01 CA013612NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA067575NCI NIH HHS P01 CA114047NCI NIH HHS P30 CA093373NCI NIH HHS R01 CA077429NCI NIH HHS U10 CA013612NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA016385NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035261NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA042777NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA086780NCI NIH HHS U10 CA105409NCI NIH HHS U10 CA180819NCI NIH HHS U10 CA180846NCI NIH HHS U10 CA180888NCI NIH HHS UG1 CA233340NIEHS NIH HHS P30 ES013508
6 · The paper itself

Abstract

introductionThe PI3K/Akt/mammalian target of rapamycin pathway is activated in a majority of malignant pleural mesotheliomas (MPM). We evaluated the activity of everolimus, an oral mammalian target of rapamycin inhibitor, in patients with unresectable MPM.

methodsMPM patients who had received at least one but no more than two prior chemotherapy regimens, which must have been platinum-based, were treated with 10 mg of everolimus daily. The primary endpoint was 4-month progression-free survival (PFS) by RECIST 1.1.

resultsA total of 59 evaluable patients were included in the analysis. The median duration of treatment was 2 cycles (56 days). Overall response rate was 2% [95% confidence interval (CI): 0-12%] by RECIST 1.1 and 0% (0-10%) by modified RECIST for MPM. The 4-month PFS rate was 29% (95% CI: 17-41%) by RECIST 1.1, and 27% (95% CI: 16-39%) by modified RECIST. The median PFS was 2.8 months (95% CI: 1.8-3.4) by RECIST 1.1. The median overall survival was 6.3 months (95% CI: 4.0-8.0). There was no difference in PFS among patients who received one or two prior chemotherapy regimens (p = 0.74). There was no difference in overall survival between patients with epithelioid histology versus other types (p = 0.47). The most common toxicities were fatigue (59%), hypertriglyceridemia (44%), anemia (42%), oral mucositis (34%), nausea (32%), and anorexia (32%). The most common grade 3 to 4 toxicities were fatigue (10.2%), anemia (6.8%), and lung infection (6.8%).

conclusionEverolimus has limited clinical activity in advanced MPM patients. Additional studies of single-agent everolimus in advanced MPM are not warranted.

Indexed as

AgedAged, 80 and overAntineoplastic AgentsDisease-Free SurvivalEverolimusFemaleHumansLung NeoplasmsMaleMesotheliomaMesothelioma, MalignantMiddle AgedPleural NeoplasmsSirolimusTOR Serine-Threonine KinasesAntineoplastic AgentsEverolimusMTOR protein, humanSirolimusTOR Serine-Threonine Kinases

Identifiers

PMID25611229
PMCPMC4304604
OpenAlexW1981270560

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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.