Quality of life (QOL) of patients (pts) with metastatic hormone refractory prostate cancer (mHRPC) following treatment with docetaxel or mitoxantrone in the TAX-327 study

4557 Background: The TAX-327 study compared 3-weekly docetaxel (D3), weekly docetaxel (D1) or mitoxantrone (M), each with prednisone (P) for 1006 pts with mHRPC. Survival and symptom control were superior for treatment with D3+P as compared to M+P (Tannock et al, NEJM 2004;351;1502–12). Here we investigate QOL and its relation to pain, and effects of treatment on QOL in pts with minimal symptoms. Methods: Pts were assessable for pain response if Present Pain Intensity (PPI) ≥ 2 (range 0–5) or Analgesic Score (AS) ≥ 10. QOL was measured by the FACT-Prostate (FACT-P) self-report score (range 0–156, higher scores indicate better QOL). QOL response required a 16-point increase in FACT-P score maintained on 2 occasions; here deterioration of QOL was defined by a 16-point decrease from baseline in FACT-P score. Pts with minimal symptoms were defined at baseline by a FACT-P score > 128 or by PPI < 2 and AS < 10. Results: QOL was substantially impaired at baseline (FACT-P score ≤128) in 92% and 75% of pts who were and were not assessable for pain (p < 0.001). Correlation of FACT-P score with PPI and AS will be presented. QOL response and deterioration for all assessable pts, and for those with minimal symptoms are shown in the table (p-values compared with M+P). Time-dependent analysis of QOL and its relation to duration of treatment will be presented at the meeting. Conclusions: Most pts had impaired QOL at baseline regardless of pain. There was greater improvement in QOL following treatment with D+P compared to M+P for all pts and for pts with minimal symptoms. With the caveat that unequal withdrawal of pts might bias the data, there was greater probability of decline in QOL for pts receiving weekly docetaxel. [Table: see text] [Table: see text]