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


CONCLUSIONS
Single-agent trabectedin displayed minimal antitumor activity in this pretreated population of women with persistent or recurrent endometrial cancer.
McMeekin
D S
DS
Division of Gynecologic Oncology, University of Oklahoma Health Sciences Center, Oklahoma City, OK 73190, USA. scott-mcmeekin@ouhsc.edus
Lisyanskaya
A
A
Crispens
M
M
Oza
A M
AM
Braly
P
P
Doering
D
D
Bayever
E
E
Michiels
B
B
Markman
M
M
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects / Q000627:therapeutic use*; D004149:Dioxoles / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D016889:Endometrial Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D044005:Tetrahydroisoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D000077606:Trabectedin; D055815:Young Adult
D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin