Abstract
10040 Background: T is a formerly marine-derived agent which is active in human cancers, such as ovarian cancer and adult soft tissue sarcomas (STS). Efficacy of T in pts with unresectable/metastatic pretreated advanced STS was demonstrated in phase II settings. Leiomyosarcoma and liposarcoma were shown to be sensitive, with myxoid liposarcoma being exceedingly responsive. Data are lacking on “small round blue cell” sarcomas, including EFT. In 2000 a phase II study was launched by SENDO in a sarcoma population including EFT. At Istituto Nazionale Tumori, Milano, Italy, some EFT pts were treated after the completion of this study. We analyzed treatment efficacy in EFT pts treated within these two settings. Methods: Overall 15/29 of the pts were female, and age ranged from 15 to 55 years. Pts received T at a starting dose between 1,650 and 1,100 mcg/sqm every 3 weeks as 24-hour or 3-hour infusion. Each pt received at least 2 cycles of treatment, except in case of disease progression or unacceptable toxicity. Tumor response was assessed by RECIST criteria after the first 2 cycles and then every other cycle. Dose reductions were based on the worst toxicity (hematological or non-hematological) in the previous cycle. Results: As of December 2006, 20 pts were treated in the Phase II study, and 9 on a compassionate use basis. Two pts were still on therapy. A total of 79 treatment cycles (2–14 per pt) were administered. Three pts (10.3%) demonstrated a partial response, 3 had a minor response (10.3%), and 4 (13.7%) stable disease. PFS rate at 6 months was 25%. The most common all-causality AEs were acute reversible liver toxicity, fatigue, and myelosuppression. Following the introduction of steroid pre-medication, thrombocytopenia and fatigue were less frequent. Conclusions: In this cohort, T was overall well tolerated and showed antitumor activity in pts with advanced EFT. This calls for further evaluation of this compound, alone or in combination, in pts suffering from EFT. No significant financial relationships to disclose.
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
