Single-agent trabectedin as second-line therapy of persistent or recurrent endometrial cancer: results of a multicenter phase II study.

McMeekin DS, Lisyanskaya A, Crispens M, Oza AM, Braly P, Doering D, Bayever E, Michiels B, Markman M
Gynecol Oncol. 2009 114 (2): 288-92

PMID: 19476988 · DOI:10.1016/j.ygyno.2009.04.034

OBJECTIVE - To assess the efficacy and safety of single-agent trabectedin in women with persistent or recurrent endometrial cancer.

METHODS - In this open-label, phase II multicenter trial, women with persistent or recurrent endometrial carcinoma were administered trabectedin as a 3-hour intravenous infusion every 21 days at a starting dose of 1.3 mg/m(2) with dexamethasone pretreatment. Clinical objective response was the primary efficacy endpoint. Secondary endpoints were time to progression (TTP), progression-free survival (PFS), overall survival (OS), and safety.

RESULTS - The median age of the 50 women entering the study was 63 years (range, 22-87), with all having history of prior chemotherapy (92% combination regimens) and the majority having undergone surgery (92%) or radiation therapy (68%). Patients received trabectedin for a median duration of 6.8 weeks (range, 3-20). A median of 2 cycles (range, 1-6) was administered, with a median dose intensity of 0.4 mg/m(2) per week (range, 0.27-0.43) and a median relative dose intensity of 92% (range, 61.5-100.2%). One patient exhibited a complete response for an objective response rate of 2.2% (95% confidence interval [CI]: 0.1%, 11.5%). Median TTP and PFS were both 1.8 months (95% CI: 1.4, 2.9), and median OS was 6.7 months (95% CI: 5.2, 13.9). Most frequent adverse events were nausea (62%), asthenia (50%), vomiting (42%), and increased alanine aminotransferase (40%).

CONCLUSION - Single-agent trabectedin displayed minimal antitumor activity in this pretreated population of women with persistent or recurrent endometrial cancer.

MeSH Terms (15)

Adult Aged Aged, 80 and over Antineoplastic Agents, Alkylating Dioxoles Disease-Free Survival Endometrial Neoplasms Female Humans Infusions, Intravenous Middle Aged Neoplasm Recurrence, Local Tetrahydroisoquinolines Trabectedin Young Adult

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