6533b856fe1ef96bd12b1ed1

RESEARCH PRODUCT

A randomized phase II study of estramustine phosphate versus estramustine phosphate plus etoposide in hormone refractory prostate cancer (HRPC)

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20632 Background: Docetaxel-based regimens represent the treatment of choice of HRPC. However, in some patients toxicity may be a concern and the quality of life may be compromised. The aim of this phase II randomized study is to investigate the efficacy and safety of low-dose chemotherapy regimen adopting a combination of EMP and VP16 in patients affected by HRPC. Methods: 54 HRPC patients were randomized between: arm A, daily oral standard dose EMP (10mg/kg) and arm B, low-dose EMP (3mg/kg) plus VP16 (25mg/mq) for 2 weeks followed by 2-weeks’rest. Systemic toxicity and hematologic exams were monitored every 2 weeks. Performance status, pain and analgesic use were evaluated according to WHO scales. Quality of Life (QoL) was evaluated through a self-administered visual analog scale (VAS). Results: Median age was 75 years (range 65–83).The most common adverse event was mild to moderate gastrointestinal toxicity. No grade 4 toxicity was registered. Treatment interruption due to grade 3 toxicity was necessar...