Brostallicin versus doxorubicin as first-line chemotherapy in patients with advanced or metastatic soft tissue sarcoma: An EORTC Soft Tissue and Bone Sarcoma Group randomized phase II study.

10037 Background: Brostallicin (B) is a DNA minor groove binder which showed activity in a recent phase II study in patients with soft tissue sarcoma (STS) failing first line therapy (Leahy et al, Eur J Cancer 2007;43:308-15). The present study assessed the safety and efficacy of first line B compared to doxorubicin (D) in patients with advanced or metastatic STS older than 60 or not fit enough to receive combination chemotherapy. Methods: Patients (pts) with progressive advanced (metastatic or locally advanced and inoperable) intermediate to high grade STS were randomized in a 2:1 ratio between IV B 10mg/m2 and D 75 mg/m2 once every 3 weeks for a maximum of 6 cycles. The primary endpoint was documented disease stabilization (RECIST) at 26 weeks, and 35+/72 successes were required to consider results as positive. Results: 118 pts were included (B 79 pts and D 39 pts). Median age was 66 years (range 27-88), male/female ratio 50/50, WHO 0/1 ratio 51/49. Primary tumour or recurrence was present in 39% of pat...