Abstract
10026 Background: AS represent an aggressive subtype of sarcoma. Preclinical data and limited clinical experience suggest that SORA has some antitumor activity against AS. Methods: We had conducted a stratified phase II trial. The primary endpoint was progression- free rate (PFR) at 9 months according to RECIST. A 2-stage design (Optimal Simon Design) was used. Patients received for 9 months SORA 400 mg b.i.d until unacceptable toxicity or tumor progression. Central pathological review was performed. Data of strata A (superficial AS) and strata B (visceral AS) are currently available. Results: [Strata A] From 06/2008 to 07/2009, 23 pts with superficial AS (8 scalp and skin/10 breast/6 soft tissue) have been enrolled (16 women/median age: 63 [31-82]). Twelve (52%) cases arose in irradiated fields. Sixteen tumors were metastatic (74%) and 7 locally advanced (26%). Eighteen patients (78%) have previously received chemotherapy (anthracyclines in 15 cases and taxanes in 8 cases). Grade-3 toxicities occurred in 5 pts (21%, mainly skin toxicities). Transient discontinuation and dose reduction were necessary in 9 (39%) and 10 (43%) cases, respectively. The best responses were: 2 CR (8%), 2 PR (8%), 4 SD (17%) and 15 PD (67%). The 4-month and 6-month PFR were 6/23 (26%) and 4/23 (17%). All pts experiencing SD at 6 month had had breast radio-induced AS. [Strata B] From 06/2008 to 11/2009, 15 pts with visceral AS have been enrolled (7 women/ median age: 49 [19-67]). One case arose in irradiated field. Metastases were present in 8 cases. Eight pts have received previous chemotherapy (anthracyclines in 7 cases and taxanes in 3 cases). Nine pts experienced at least one episode of grade-3 toxicity. Transient discontinuation and dose reduction were necessary in 3 and 4 cases. 7 pts are currently assessable for response. Best responses were: 4 SD and 3 PD. The 4-month and 6-month PFR were both 2/7. Conclusions: SORA provides a 6-month PFR of about 20% of pts with AS. Exploration of biological predictive factors is ongoing. Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Bayer
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.
