A combination docetaxel-capecitabine in patients (pts) with hormone refractory advanced prostate cancer

Abstract

4624 Background: Docetaxel monotherapy is active in hormone refractory metastatic prostate cancer. Pre-clinical models indicate a synergistic cytotoxicity between capecitabine and docetaxel. Recently, this association has proven survival benefits in advanced breast cancer. This multicenter phase II study reports on preliminary efficacy and safety data of docetaxel-capecitabine combination in hormone-refractory prostate cancer with metastases (HRPC). Methods: Eligible pts had histologically and biologically confirmed HRPC. Other requirements included a Karnofsky index of more than 50% and no prior chemotherapy except estramustine. Treatment consisted of 4 cycles of docetaxel 35mg/m2 on day 1, day 8, day 15 and capecitabine 1250mg/m2/day in 2 divided doses from day 5 to day 18 of each 28 days cycle. A minimum of 2 treatment cycles were required for response assessment. Biological efficacy was defined as a decline of >50% from baseline PSA levels. Clinical response was evaluated using RECIST criteria. Results: 23/50 planned pts were enrolled between June to November 2003. Patient baseline characteristics were: median age 69.5 years (range 51.4–81.3), median Gleason score: 8 (range 6–9), median PSA 73.2 ng/ml (range 0.93–2010.9). Sixty-height percent had prior radiation and 52.3% had prior surgical treatment. Disease related pain was present in 82.3% of pts. Pts received a median of 2 courses of treatment (range 1–4). A total of 54 cycles of treatment were administered. The most common grade (G) 3–4 toxicities included 1 G-3 anemia, 4 G-3 digestive toxicities and 1 G-3 stomatitis. Biological response was observed in 17 pts after the 2nd cycle and in 7 pts after the 4th cycle. Seven pts (41.2%) exhibited a PSA decrease of >50% after the 2nd cycle and 5 pts (71.4%) after the 4th cycle. Conclusions: This combination appears to be a very promising regimen with a favorable toxicity profile. These early encouraging data have to be confirmed with the analysis of the next 27 planned patients and final results will be presented at the meeting. No significant financial relationships to disclose.