Evidence map›Paper›PMID 31173362›Full record

Trial reportCancer2019

Overall survival and histology-specific subgroup analyses from a phase 3, randomized controlled study of trabectedin or dacarbazine in patients with advanced liposarcoma or leiomyosarcoma.

Shreyaskumar Patel, Margaret von Mehren, Damon R Reed, Pamela Kaiser, John Charlson, Christopher W Ryan, Daniel Rushing, Michael Livingston, Arun Singh, Rahul Seth and 10 more

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

Trial report in Cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 3% 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

39 citing papers in PubMed, 1 synthesis or guideline pooled it, 63 citations in OpenAlex.

  1. Soft Tissue Sarcoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
  2. Trial
  3. A Phase II Multicenter Trial of Trabectedin in Combination with Olaparib in Patients with Advanced Unresectable or Metastatic Sarcoma.Clinical cancer research : an official journal of the American Association for Cancer Research · 2025
    Trial
  4. Letetresgene Autoleucel in Advanced/Metastatic Myxoid/Round Cell Liposarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  5. Review
  6. How I treat soft tissue sarcomas.Future oncology (London, England) · 2026
    Review
  7. Leiomyosarcoma Therapeutic Approaches and Future Directions.Hematology/oncology clinics of North America · 2025
    Review
  8. Article
  9. Article
  10. Review
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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

20 authors at 17 institutions in 1 country.

Shreyaskumar PatelThe University of Texas MD Anderson Cancer Center, Houston, Texas.
Margaret von MehrenFox Chase Cancer Center, Philadelphia, Pennsylvania.
Damon R ReedMoffitt Cancer Center, Tampa, Florida.ORCID 0000-0002-8238-2465
Pamela KaiserLutheran General Advanced Care Center, Park Ridge, Illinois.
John CharlsonMedical College of Wisconsin, Milwaukee, Wisconsin.
Christopher W RyanKnight Cancer Institute, Oregon Health and Science University, Portland, Oregon.
Daniel RushingSimon Cancer Center, Indiana University, Indianapolis, Indiana.
Michael LivingstonBlumenthal Cancer Center, Carolinas HealthCare System, Charlotte, North Carolina.
Arun SinghUCLA Medical Center, Los Angeles, California.
Rahul SethSUNY Upstate University Hospital, Syracuse, New York.
Charles ForscherCedars-Sinai Medical Center, Los Angeles, California.
Gina D'AmatoGeorgia Cancer Specialists, Northside Hospital Cancer Institute, Atlanta, Georgia.
Sant P ChawlaSarcoma Oncology Center, Santa Monica, California.
Sharon McCarthyJanssen Research & Development, LLC, Raritan, New Jersey.
George WangJanssen Research & Development, LLC, Raritan, New Jersey.
Trilok ParekhJanssen Research & Development, LLC, Raritan, New Jersey.
Roland KnoblauchJanssen Research & Development, LLC, Raritan, New Jersey.
Martee L HensleyMemorial Sloan Kettering Cancer Center, New York, New York.
Robert G MakiMount Sinai Medical Center, New York, New York.ORCID 0000-0002-9853-2528
George D DemetriCenter for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Harvard Medical School, Boston, Massachusetts.
Janssen (United States) · USAdvocate Lutheran General Hospital · USCarolinas Healthcare System · USCedars-Sinai Medical Center · USFox Chase Cancer Center · USHarvard University · USIndiana University Health · USMedical College of Wisconsin · USMemorial Sloan Kettering Cancer Center · USMoffitt Cancer Center · USMount Sinai Medical Center · USNorthside Hospital · USOregon Health & Science University · USRonald Reagan UCLA Medical Center · USSarcoma Oncology Center · USSUNY Upstate Medical University · USThe University of Texas MD Anderson Cancer Center · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

backgroundWe performed a randomized phase 3 study of trabectedin versus dacarbazine in previously-treated patients with liposarcoma/leiomyosarcoma (LPS/LMS).

methodsPatients were randomized 2:1 to trabectedin (n = 384) or dacarbazine (n = 193) administered intravenously every 3 weeks. The primary objective was overall survival (OS). Secondary objectives were progression-free survival, objective response rate, safety, and patient-reported outcomes, all previously reported and demonstrating superior disease control with trabectedin. Results of the final OS analysis in preplanned subgroups of patients with LPS/LMS are presented.

resultsAt the time of the final OS analysis, 577 patients had been assigned randomly, including 423 (73%) with LMS and 154 (27%) with LPS. The median duration of treatment exposure was higher in the trabectedin arm compared with the dacarbazine arm (4 vs 2 cycles), as was the proportion of patients receiving an extended number of therapy courses (≥6 cycles: 42% vs 22%). This pattern was consistent across histological subgroups: the median number of treatment cycles (4 vs 2 for both subgroups) and proportion of patients with ≥6 treatment cycles (LMS, 43% vs 24%; LPS, 40% vs 16%). Despite improved disease control by trabectedin, no improvement in OS was observed; the final median OS for trabectedin versus dacarbazine was 13.7 versus 13.1 months (P = .49). Sensitivity analyses of OS suggest confounding by post-study anticancer therapies, which were utilized in most patients in both treatment arms (71% vs 69%, respectively).

conclusionThe final OS results demonstrated comparable survival between LPS/LMS patients receiving trabectedin or dacarbazine, which is consistent with the interim analysis results. Both LPS and LMS demonstrated improved disease control with trabectedin.

Indexed as

AgedAntineoplastic Agents, AlkylatingDacarbazineFemaleHumansLeiomyosarcomaLiposarcomaMaleSurvival AnalysisTrabectedinAntineoplastic Agents, AlkylatingDacarbazineTrabectedindacarbazineleiomyosarcomaliposarcomasoft tissue sarcomatrabectedin

Identifiers

PMID31173362
PMCPMC6771856
OpenAlexW2962135113

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.