Clinical outcomes and safety with trabectedin therapy in patients with advanced soft tissue sarcomas following failure of prior chemotherapy: results of a worldwide expanded access program study

This expanded access program (EAP) was designed to provide trabectedin access for patients with incurable soft tissue sarcoma (STS) following progression of disease with standard therapy. The outcomes of trial participants accrued over approximately 5 years are reported. Adult patients with advanced...

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Bibliographic Details
Published in:	Annals of oncology Vol. 24; no. 6; pp. 1703 - 1709
Main Authors:	Samuels, B.L., Chawla, S., Patel, S., von Mehren, M., Hamm, J., Kaiser, P.E., Schuetze, S., Li, J., Aymes, A., Demetri, G.D.
Format:	Journal Article
Language:	English
Published:	Oxford Elsevier Ltd 01-06-2013 Oxford University Press
Subjects:	Adolescent Adult Aged Aged, 80 and over Antineoplastic agents Antineoplastic Agents, Alkylating - administration & dosage Antineoplastic Agents, Alkylating - adverse effects Biological and medical sciences Compassionate Use Trials - mortality Compassionate Use Trials - trends Dermatology Dioxoles - administration & dosage Dioxoles - adverse effects Disease Progression expanded access program Female Global Health - trends Health Services Accessibility - trends Humans Kaplan-Meier Estimate L-sarcoma Male Medical sciences Middle Aged Multiple tumors. Solid tumors. Tumors in childhood (general aspects) objective response rate overall survival Pharmacology. Drug treatments Sarcoma - drug therapy Sarcoma - mortality Sarcoma - pathology soft tissue sarcoma Tetrahydroisoquinolines - administration & dosage Tetrahydroisoquinolines - adverse effects Trabectedin Treatment Failure Treatment Outcome Tumors Tumors of the skin and soft tissue. Premalignant lesions Young Adult World overall survival objective response rate soft tissue sarcoma trabectedin L-sarcoma expanded access program Antineoplastic agent Human Program Prognosis Accessibility Toxicity Soft tissue sarcoma Response rate Patient Malignant tumor Trabectedin Survival Chemotherapy Treatment Advanced stage Safety Cancer
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Summary:	This expanded access program (EAP) was designed to provide trabectedin access for patients with incurable soft tissue sarcoma (STS) following progression of disease with standard therapy. The outcomes of trial participants accrued over approximately 5 years are reported. Adult patients with advanced STS of multiple histologies, including leiomyosarcoma and liposarcoma (L-sarcomas), following relapse or disease progression following standard-of-care chemotherapy, were enrolled. Trabectedin treatment cycles (1.5 mg/m2, intravenously over 24 h) were repeated q21 days. Objective response, overall survival (OS), and safety were evaluated. Of 1895 patients enrolled, 807 (43%) had evaluable objective response data, with stable disease reported in 343 (43%) as best response. L-sarcoma patients exhibited longer, OS compared with other histologies [16.2 months (95% confidence interval (CI) 14.1–19.5) versus 8.4 months (95% CI 7.1–10.7)], and a slightly higher objective response rate [6.9% (95% CI 4.8–9.6) versus 4.0% (95% CI 2.1–6.8)]. The median treatment duration was 70 days representing a median of three treatment cycles; 30% of patients received ≥6 cycles. Safety and tolerability in this EAP were consistent with prior clinical trial data. Results of this EAP are consistent with previous reports of trabectedin, demonstrating disease control despite a low incidence of objective responses in advanced STS patients after failure of standard chemotherapy. NCT00210665.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	0923-7534 1569-8041
DOI:	10.1093/annonc/mds659