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The initial biopsy Gleason score as a predictive marker for docetaxel survival benefit in patients with prostate cancer: Data from the TAX 327 study.

44 Background: The TAX 327 study was conducted in 1,006 men with metastatic castration-resistant prostate cancer (mCRPC) who were randomized to receive 3-weekly docetaxel (D3), weekly docetaxel (D1) or 3-weekly mitoxantrone (M), each with prednisone. Survival and symptom control were superior following D3 as compared to M. In this post-hoc analysis we aimed to identify factors that could characterize subgroups of patients who obtained the greatest benefit from the use of D3 as compared to M.


METHODS
The TAX 327 database was used to investigate if patients with poorly differentiated tumors (Gleason 7-10) at diagnosis had greater benefit from D3 as compared to M, than patients with better differentiated tumors (Gleason ≤6). Using a Cox model, we compared overall survival (OS) between the treatment groups within each subgroup of Gleason score.


RESULTS
Baseline characteristics known to predict OS including visceral metastasis and time from first hormonal treatment to the start of chemotherapy were well balanced between patient groups, except for an imbalance in the small group of patients with impaired Karnofsky performance score (PS) (see table). The TAX 327 data showed that the OS benefit of D3 versus M is greater in patients with high grade tumors (median OS 18.9 vs 14.5 months) than in patients with low grade tumors (median OS 21.6 vs 20.7 months).


CONCLUSIONS
The survival benefit obtained with docetaxel as compared to mitoxantrone is greater in patients with high Gleason score tumors. Although this finding is hypothesis-generating and needs confirmation in other trials, it may provide additional guidance in treatment decisions regarding the use of chemotherapy as first line treatment for patients with mCRPC. [Table: see text].