Phase II trial of tamoxifen and interferon alpha in patients with metastatic or recurrent soft tissue sarcoma

Abstract

9031 Background: Management of patients with advanced soft tissue sarcoma (STS) is difficult and often disappointing. We evaluated the role of Tamoxifen (T) and Interferon alpha 2b (I) for their anti-angiogenic properties in metastatic or recurrent STS. Methods: Patients with advanced STS who had failed at least one prior systemic therapy, with performance status of 0–2 on ECOG scale, and adequate organ functions were enrolled on this study between October 1999 and June 2003.Patients received 20 mg of Tamoxifen daily and subcutaneous Interferon alpha 2b (Schering-Plough) 3 million-unit/square meters three times weekly .Patients were evaluated for response at 8 weeks and at 6 months, and those with stable or responsive disease continued treatment up to 26 weeks after which treatment was discontinued and patients were followed. Results: Seventeen patients were enrolled on the study. All patients had received at east one prior chemotherapy regimen and 8 patients had received prior radiotherapy. Median age 56 years (27–76), Male/Female 11/6, 12 Caucasians. Median follow-up was 24 weeks (2–126 weeks). Two of the seventeen patients were not started on treatment due to rapidly deteriorating condition, 4 patients developed early severe toxicity and eventually were taken off protocol. Out of the 11 evaluable study patients, There was 1(7%) Complete remission with 70 weeks duration of response, no partial responses, and 2(13%) stable disease of 84 and 45 weeks duration, 8(53%) had progressive disease. Encountered Grade 3 and 4 toxicities included thrombocytopenia (1), neutropenia (1), abnormal LFTs (1) and non-Q wave myocardial infarction. No treatment related deaths were encountered. Conclusions: The combination of interferon and tamoxifen has activity in advanced STS, which warrants further evaluation. No significant financial relationships to disclose.