title: Going further in the knowledge of Yondelis®; what's new in daily clinical practice?
abstract: The approval of trabectedin in Europe in 2007 for the treatment of advanced soft tissue sarcoma (STS) was based on four Phase II trials. The extensive clinical trials program currently underway with trabectedin indicates clearly the extent to which this novel agent remains a topic of scientific and clinical interest in the treatment of advanced STS. Results of several retrospective studies examining outcomes of patients treated beyond clinical trials and under everyday practice conditions, including compassionate use programs, were disclosed in 2013. These analyses complement the knowledge about trabectedin gained from previous and ongoing clinical studies. Collectively, the results confirm the activity of trabectedin in inoperable/metastatic STS and extend current knowledge about several aspects of its profile, highlighting in particular improved outcomes when trabectedin is used in earlier lines of therapy and when treatment is maintained in the absence of disease progression. Evidence that the safety profile of trabectedin does not differ materially between elderly (≥65 years) and younger patients suggests no need to discriminate on the basis of age; elderly patients who are sufficiently fit to receive chemotherapy and considered by their physicians as unsuited to receive doxorubicin/ifosfamide can be treated with trabectedin in the same manner as younger patients.
authors.affiliation: Department of Medical Oncology, Centre Léon Bérard, 28 Rue Laennec, 69008 Lyon, France. jean-yves.blay@lyon.unicancer.fr.
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Blay
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D017322:Clinical Trials, Phase II as Topic; D004149:Dioxoles / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D012189:Retrospective Studies; D012509:Sarcoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D000077606:Trabectedin; D016896:Treatment Outcome
chemical_list: D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin
keywords: compassionate use programs; elderly patients; maintenance treatment; safety; soft tissue sarcoma; trabectedin