Investigational New Drugs

, Volume 28, Issue 4, pp 529–530 | Cite as

Inadequacy of size-based response criteria to assess the efficacy of trabectedin among metastatic sarcoma patients

  • Antoine Hollebecque
  • Antoine Adenis
  • Sophie Taieb
  • Claudia Lebedinsky
  • Nicolas Penel

To the Editor

Trabectedin is a tetrahydro-isoquinoline alkaloid isolated from a tunicate (Ecteinascidia turbinata) that binds and alkylates N2 of guanines located in the 5′-PuGC-3′ or 5'-PyrGG-3' sequences of the minor groove of DNA. It is currently in phase II/III clinical evaluation for ovarian and breast cancers, and has been approved by the European Medicines Agency (EMEA) for the treatment of soft tissue sarcomas (STS) after failure of standard therapy [1]. According to the Response Evaluation Criteria In Solid Tumours (RECIST), the response rate in STS is about 8% and the non-progression-rate is about 40%, including 25% of stable diseases lasting more than 6 months [1]. However, we herein report a case that demonstrates the difficulty assessing the efficacy of trabectedin using only RECIST.

A 52-years-old man with bulky pelvic recurrence of peritoneal grade II leiomyosarcoma not amenable to surgery received 6 cycles of doxorubicin and 6 cycles of a gemcitabine-docetaxel...


Morphine Imatinib Soft Tissue Sarcoma Imatinib Mesylate Soft Tissue Sarcoma 
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  1. 1.
    Le Cesne A, Jy B, Judson I et al (2005) Phase II study of ET-743 in advanced soft-tissue sarcomas: an European organisation for the research and treatment of cancer (EORTC) soft tissue and bone group trial. J Clin Oncol 23:576–584. doi: 10.1200/JCO.2005.01.180 CrossRefPubMedGoogle Scholar
  2. 2.
    Choi H, Charnsangavej C, Faria SC et al (2007) Correlation of computed tomography and positron emission tomography in patients with metastatic gastrointestinal stromal tumor treated at a single institution with imatinib mesylate: proposal of new computed tomography response criteria. J Clin Oncol 25:1753–1759. doi: 10.1200/JCO.2006.07.3049 CrossRefPubMedGoogle Scholar
  3. 3.
    James K, Eisenhauer E, Christian M et al (1999) Measuring response in solid tumors: unidimensional versus bidimensional measurement. J Natl Cancer Inst 91:523–528. doi: 10.1093/jnci/91.6.523 CrossRefPubMedGoogle Scholar
  4. 4.
    Grosso F, Jones RL, Demetri GD et al (2007) Efficacy of trabectedin (estenascidin 743) in advanced pretreated myxoid liposarcoma: a retrospective study. Lancet Oncol 8:595–602. doi: 10.1016/S1470-2045(07)70175-4 CrossRefPubMedGoogle Scholar
  5. 5.
    Fayette J, Ray-Coquard I, Alberti L, Ranchère D, Boyle H, Blay JY (2005) ET-743: a novel agent with activity in soft tissue sarcoma. Oncologist 10:827–832. doi: 10.1634/theoncologist.10-10-827 CrossRefPubMedGoogle Scholar
  6. 6.
    Verweij J (2008) Other endpoints in screening studies for soft tissue sarcomas. Oncologist 13(suppl 2):S27–S31. doi: 10.1634/theoncologist.13-S2-27 CrossRefGoogle Scholar

Copyright information

© Springer Science+Business Media, LLC 2009

Authors and Affiliations

  • Antoine Hollebecque
    • 1
    • 5
  • Antoine Adenis
    • 1
  • Sophie Taieb
    • 2
  • Claudia Lebedinsky
    • 3
  • Nicolas Penel
    • 1
    • 4
  1. 1.Département d’Oncologie MédicaleCentre Oscar LambretLilleFrance
  2. 2.Département d’ImagerieCentre Oscar LambretLilleFrance
  3. 3.PharmaMarColmenar ViejoMadridSpain
  4. 4.Equipe d’Accueil 2694: Santé Publique, Epidémiologie et modélisation des maladies chroniquesUniversité Lille IILilleFrance
  5. 5.Département de Cancérologie GénéraleCentre Oscar LambretLilleFrance

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