A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials

Le Cesne, A., Yovine, A., Blay, J. Y., Delaloge, S., Maki, R. G., Misset, J. L., Frontelo, P., Nieto, A., Jiao, J. J., Demetri, G. D. (June 2012) A retrospective pooled analysis of trabectedin safety in 1,132 patients with solid tumors treated in phase II clinical trials. Invest New Drugs, 30 (3). pp. 1193-202. ISSN 1573-0646 (Electronic)0167-6997 (Linking)

URL: https://www.ncbi.nlm.nih.gov/pubmed/21484250
DOI: 10.1007/s10637-011-9662-0


PURPOSE: To summarize the safety experience obtained from phase II clinical trials conducted with trabectedin as single-agent therapy in patients with advanced solid tumors. METHODS: This retrospective analysis includes 1,132 patients exposed to trabectedin in 19 phase II trials carried out between February 1999 and April 2008. Trabectedin was administered intravenously as 1 of 3 schedules: 24-hour infusion every 3 weeks (q3wk 24-h; n = 570/2,818 cycles), 3-hour infusion every 3 weeks (q3wk 3-h; n = 258/1,003 cycles), and 3-hour infusion for three consecutive weeks every 4 weeks (qwk 3-h; n = 304/1,198 cycles). RESULTS: The majority of patients (90%) had received previous chemotherapy. Patients were given a median of three treatment cycles of trabectedin (range, 1-59). Nausea, fatigue and vomiting were the most common trabectedin-related adverse events, reported in >/=20% of patients. Reversible myelosuppression (mainly neutropenia) and transient reversible transaminase increases were the most common laboratory abnormalities seen with trabectedin, with a very low incidence of relevant clinical consequences. Deaths associated with drug-related adverse events were infrequent, occurring in 19 (1.7%) patients. CONCLUSION: Single-agent trabectedin treatment was reasonably well tolerated. Trabectedin can be administered for prolonged periods to patients with sustained clinical benefit (induction of disease stability or shrinkage) without cumulative toxicities over time.

Item Type: Paper
Uncontrolled Keywords: Adolescent Adult Aged Aged, 80 and over Alanine Transaminase/blood Antineoplastic Agents, Alkylating/*administration & dosage/adverse effects Child Dioxoles/*administration & dosage/adverse effects Female Humans Male Middle Aged Neoplasms/*drug therapy Neutropenia/chemically induced Rhabdomyolysis/chemically induced Tetrahydroisoquinolines/*administration & dosage/adverse effects Young Adult
Subjects: diseases & disorders > cancer
diseases & disorders > cancer > drugs and therapies
CSHL Authors:
Communities: CSHL labs > Maki lab
Depositing User: Matt Covey
Date: June 2012
Date Deposited: 20 Oct 2016 16:56
Last Modified: 20 Oct 2016 16:56
Related URLs:
URI: https://repository.cshl.edu/id/eprint/33740

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