Association of pain and quality of life (QOL) response with PSA response and survival of patients (pts) with metastatic hormone refractory prostate cancer (mHRPC) treated with docetaxel or mitoxantrone in the TAX-327 study

4516 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 following D3+P as compared to M+P (Tannock et al, NEJM 2004;351;1502–12). Here we investigate associations between pain and QOL response with PSA response and survival. Methods: Pts were evaluated for pain, PSA and QOL at baseline and 3 weekly during treatment. Pain response (pts with initial pain) was defined by ≥ 2-point reduction in Present Pain Intensity (PPI) with no increase in analgesic score (AS) or ≥ 50% in AS with no increase in PPI. PSA response required ≥ 50% reduction in PSA from baseline. QOL response required ≥ 16-point reduction in FACT-P score (range: 0–156). Responses were confirmed ≥ 3 weeks later. Results: There were414 pts assessable for both pain and PSA response: PSA response was seen in 52.4% of 124 pts with pain response and 28.3% of 290 pts without pain response (p < 0.001). There were 704 pts evaluable for both QOL and PSA response: PSA response occurred in 56.5% of 147 pts with QOL response and 37.5% of 557 pts without QOL response (p < 0.001). The table shows associations of pain or QOL response and survival. Landmark analysis will be presented at the meeting. After adjustment for PSA and QOL response, pain response was an independent predictor of survival (HR = 0.47, p = 0.003). Conclusions: Pain and QOL response were associated with PSA response and pain response was an independent predictor of survival. [Table: see text] [Table: see text]