Abstract

4786 Aim: To retrospectively review PSA response rate, and survival following the use of docetaxel (D) for metastatic HRPC. Background: HRPC is associated with poor prognosis and has historically been considered relatively chemo-resistant. Emerging data demonstrate clinical benefit with the use of D in HRPC, culminating in 2 recent published Phase III studies demonstrating survival benefit. Currently, D is not registered or reimbursed through Medicare (Pharmaceutical Benefits Scheme) for the treatment of HRPC in Australia. Methods: Retrospective audit (commenced September 2003) of the use of D for HRPC from January 2001- January 2004 in 3 Medical Oncology practices. Demographic data, baseline PSA, ECOG status, sites of disease, number of cycles received and PSA response rate were collected. Results: 35 patients (pts); median age 71yrs (50–88yrs). ECOG status: 0 (8pts), 1 (20pts), 2 (7pts). Mean duration from initial prostate cancer diagnosis to start of D 5.4yrs (0.2–13.5yrs). Mean baseline PSA doubling time, available for 18/35 pts, was 3.91 months (1–15). Median number of metastatic sites 1 (range 1–4): bone-34 pts, lymph nodes-10, liver-7 and lung-7. Twelve pts were chemo-naïve; 23 pts had received prior chemotherapy (21/23 received mitoxantrone). Twenty pts received D 3 weekly; 15 pts were on weekly schedules. Mean dose density was 23mg/m2/week. Pts received an average of 3.2 months of treatment (0.2–11.8). There were 170 recorded toxicities, of which 13 were grade 3–4, and two likely treatment-related deaths (sepsis). Twelve pts (34%) had >50% PSA response (4 chemo-naïve); of these 12 responders, 7 pts had a >75% PSA response (4 chemo-naïve). Median survival from start of D was 8 months with 37% alive at 12 months and 23% alive at 24 months. Conclusion: Docetaxel is active in HRPC (in both chemotherapy naïve and exposed pts) with a predictable toxicity profile.Our median survival of 8 months compared to a median survival of 18.9 months in the TAX-327 Phase III study is probably due to the fact that our patients on average were slightly older, more heavily pre-treated and more likely to have a poorer performance status. More research is warranted to identify predictors of response and toxicity. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis

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