Evidence map›Paper›PMID 26371143›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2016

Efficacy and Safety of Trabectedin or Dacarbazine for Metastatic Liposarcoma or Leiomyosarcoma After Failure of Conventional Chemotherapy: Results of a Phase III Randomized Multicenter Clinical Trial.

George D Demetri, Margaret von Mehren, Robin L Jones, Martee L Hensley, Scott M Schuetze, Arthur Staddon, Mohammed Milhem, Anthony Elias, Kristen Ganjoo, Hussein Tawbi and 9 more

3 registry-linked trialsOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 420 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
420citing papers in PubMed, 8 pooled it
56.4field-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.

NCT03138161 phase1 / phase2recruitingnot on this mapstarted 2017, after this paper: background citation

SAINT: A Phase 1/2 Study of Safe Amounts of IPLIMUMAB, NIVOLUMAB and TRABECTEDIN for Previously Treated Advanced Soft Tissue Sarcoma (STS)

TypeinterventionalSponsorSarcoma Oncology Research Center, LLCRan2017 to 2031Enrolled250ConditionsAdvanced Soft Tissue Sarcoma, Metastatic Soft Tissue SarcomaArmsTrabectedin, Ipilimumab, Nivolumab
NCT03773510 phase3withdrawnnot on this mapstarted 2019, after this paper: background citation

Time to Secondary Resistance to Trabectedin After Interruption Versus Continuation in Responding Patients With Liposarcoma, Leiomyosarcoma and Synovial Sarcoma

TypeinterventionalSponsorItalian Sarcoma GroupRan2019 to 2025Enrolled0ConditionsLeiomyosarcoma, Liposarcoma, Synovial SarcomaArmsTrabectedin discontinuation, Trabectedin continuation
NCT06263231 phase3recruitingnot on this mapstarted 2024, after this paper: background citation

A Multicenter, Randomized, Phase 3 Study to Assess the Efficacy and Safety of INtratumorally Administered INT230-6 (SHAO, VINblastine, CIsplatin) Compared With US Standard of Care in Adults With Locally Recurrent, InoperaBLE, or Metastatic Soft Tissue Sarcomas (INVINCIBLE-3)

TypeinterventionalSponsorIntensity Therapeutics, Inc.Ran2024 to 2028Enrolled333ConditionsSarcoma,Soft TissueArmsINT230-6, Eribulin, Trabectedin, Pazopanib
3 · Its place in the literature

Who cites it

420 citing papers in PubMed, 8 syntheses or guidelines pooled it, 817 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. SEOM-GEIS Spanish clinical guidelines for the management of soft‑tissue sarcomas (2024).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025
    Guideline
  5. Guideline
  6. Pooled it
  7. Soft Tissue Sarcoma, Version 2.2022, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2022
    Guideline
  8. Pooled it
  9. Trial
  10. Trial
  11. Trial
  12. Trial
  13. Trial
  14. 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
  15. Letetresgene Autoleucel in Advanced/Metastatic Myxoid/Round Cell Liposarcoma.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025
    Trial
  16. Trial
  17. Trial
  18. Trial
  19. Trial
  20. A First-in-Human Phase I Study of Milademetan, an MDM2 Inhibitor, in Patients With Advanced Liposarcoma, Solid Tumors, or Lymphomas.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023
    Trial

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 1 institution in 1 country.

George D DemetriGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX. george_demetri@dfci.harvard.edu.
Margaret von MehrenGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Robin L JonesGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Martee L HensleyGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Scott M SchuetzeGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Arthur StaddonGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Mohammed MilhemGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Anthony EliasGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Kristen GanjooGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Hussein TawbiGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Brian A Van TineGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Alexander SpiraGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Andrew DeanGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Nushmia Z KhokharGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Youn Choi ParkGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Roland E KnoblauchGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Trilok V ParekhGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Robert G MakiGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Shreyaskumar R PatelGeorge D. Demetri, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Boston, MA; Margaret von Mehren, Fox Chase Cancer Center; Arthur Staddon, University of Pennsylvania, Philadelphia; Hussein Tawbi, University of Pittsburgh Cancer Institute, Pittsburgh, PA; Robin L. Jones, Seattle Cancer Care Alliance, Seattle, WA; Martee L. Hensley, Memorial Sloan Kettering Cancer Center; Robert G. Maki, Mount Sinai Medical Center, New York, NY; Scott M. Schuetze, University of Michigan, Ann Arbor, MI; Mohammed Milhem, University of Iowa Hospitals and Clinics, Iowa City, IA; Anthony Elias, University of Colorado Cancer Center, Aurora, CO; Kristen Ganjoo, Stanford Hospital and Clinics, Stanford, CA; Brian A. Van Tine, Washington University in St Louis, St Louis, MO; Alexander Spira, Virginia Cancer Specialists, Fairfax, VA; Andrew Dean, St John of God Hospital-Bendat Cancer Centre, Subiaco, Western Australia, Australia; Nushmia Z. Khokhar, Youn Choi Park, Roland E. Knoblauch, and Trilok V. Parekh, Janssen Research & Development, Raritan, NJ; and Shreyaskumar R. Patel, The University of Texas MD Anderson Cancer Center, Houston, TX.
Janssen (Belgium) · BE

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
WORD PROCESSING CENTER--COREP30CA006927 · NCI · RESEARCH INST OF FOX CHASE CAN CTR · PI Margaret von Mehren · 1985 to 2026
$138.8M
Tumor Microenvironment and Cancer ImmunologyP30CA030199 · NCI · SANFORD BURNHAM PREBYS MEDICAL DISCOVERY INSTITUTE · PI Michael Jackson · 1985 to 2026
$107.2M
Viral VectorP30CA086862 · NCI · UNIVERSITY OF IOWA · PI Douglas Robert Spitz · 2000 to 2026
$70.0M
NCI NIH HHS P30 CA006927NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA086862
6 · The paper itself

Abstract

purposeThis multicenter study, to our knowledge, is the first phase III trial to compare trabectedin versus dacarbazine in patients with advanced liposarcoma or leiomyosarcoma after prior therapy with an anthracycline and at least one additional systemic regimen. PATIENTS AND

methodsPatients were randomly assigned in a 2:1 ratio to receive trabectedin or dacarbazine intravenously every 3 weeks. The primary end point was overall survival (OS), secondary end points were disease control-progression-free survival (PFS), time to progression, objective response rate, and duration of response-as well as safety and patient-reported symptom scoring.

resultsA total of 518 patients were enrolled and randomly assigned to either trabectedin (n = 345) or dacarbazine (n = 173). In the final analysis of PFS, trabectedin administration resulted in a 45% reduction in the risk of disease progression or death compared with dacarbazine (median PFS for trabectedin v dacarbazine, 4.2 v 1.5 months; hazard ratio, 0.55; P < .001); benefits were observed across all preplanned subgroup analyses. The interim analysis of OS (64% censored) demonstrated a 13% reduction in risk of death in the trabectedin arm compared with dacarbazine (median OS for trabectedin v dacarbazine, 12.4 v 12.9 months; hazard ratio, 0.87; P = .37). The safety profiles were consistent with the well-characterized toxicities of both agents, and the most common grade 3 to 4 adverse effects were myelosuppression and transient elevation of transaminases in the trabectedin arm.

conclusionTrabectedin demonstrates superior disease control versus conventional dacarbazine in patients who have advanced liposarcoma and leiomyosarcoma after they experience failure of prior chemotherapy. Because disease control in advanced sarcomas is a clinically relevant end point, this study supports the activity of trabectedin for patients with these malignancies.

Indexed as

AdolescentAdultAgedAged, 80 and overAntineoplastic Agents, AlkylatingDacarbazineDioxolesDisease-Free SurvivalDrug Administration ScheduleFemaleHumansLeiomyosarcomaLiposarcomaMaleMiddle AgedSurvival RateAntineoplastic Agents, AlkylatingDacarbazineDioxolesTetrahydroisoquinolinesTrabectedin

Identifiers

PMID26371143
PMCPMC5070559
OpenAlexW1955072209

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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.