title: Ecteinascidin-743: evidence of activity in advanced, pretreated soft tissue and bone sarcoma patients.
abstract: Purpose. To evaluate the activity and safety of ecteinascidin (ET-743) in pretreated patients with advanced or metastatic soft tissue and bone sarcoma. Patients or subjects. Eighty-nine patients received ET-743 as a 24-hour continuous infusion at a dose of 900-1500 mug/m(2) every 3 weeks. Results. We observed one complete remission, 5 partial remissions, one minimal response, and 16 patients with a disease stabilization of 6 months or more. The objective response rate was 6.7% and the clinical benefit rate at 3 and 6 months was 37.7% and 23.4%, respectively. Responses were noted in patients with lipo-, leiomyo-, osteo-, and myogenic sarcoma, with a median duration of 9.85 months. Toxicity mainly involved an asymptomatic elevation of transaminases and neutropenia. Estimated 1- and 2-year survival rates were 39.4% and 15.8%. Median overall survival was 8.25 months. Discussion. This retrospective analysis confirms that ET-743 induces objective responses and progression arrest in a clinically relevant proportion of patients.
authors.affiliation: Leuven Cancer Institute, Department of General Medical Oncology, University Hospital Gasthuisberg, Herestraat 49, 3000 Leuven, Belgium.
authors.forename: G
authors.initials: G
authors.lastname: Huygh
authors.forename: Paul M J
authors.initials: PM
authors.lastname: Clement
authors.forename: H
authors.initials: H
authors.lastname: Dumez
authors.forename: P
authors.initials: P
authors.lastname: Schöffski
authors.forename: H
authors.initials: H
authors.lastname: Wildiers
authors.forename: J
authors.initials: J
authors.lastname: Selleslach
authors.forename: J M
authors.initials: JM
authors.lastname: Jimeno
authors.forename: I De
authors.initials: ID
authors.lastname: Wever
authors.forename: R
authors.initials: R
authors.lastname: Sciot
authors.forename: L
authors.initials: L
authors.lastname: Duck
authors.forename: A T
authors.initials: AT
authors.lastname: Van Oosterom