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In Reply:

Center for Cancer Research, National Cancer Institute, Bethesda, MD

We appreciate the comments of Dr Ozkan et al, who accurately note the antitumor activity being observed with low-molecular-weight heparin (LMWH). The results they report are early and warrant further evaluation. However, the results we reported from our trial comparing docetaxel plus thalidomide versus docetaxel alone in patients with prostate cancer, do not change substantially when considering the coadministration of LMWH.¹ Only 10 individuals in the combination arm received LMWH as a prophylactic therapy, so any comparisons made will have low power. Although there was not a statistically significant improvement in survival when comparing the 37 patients who received the combination without LMWH, with the 10 patients receiving docetaxel and thalidomide plus LMWH, a modest trend toward some benefit associated with LMWH was identified. Two patients who went several months without LMWH and then developed a thrombosis and commenced LMWH were excluded from this analysis (because of concerns that the documented long time to progression before LMWH would unfairly impact the results). Finally, when we remove the 10 individuals receiving prophylactic LMWH from the combination arm and compare the remaining 37 patients against those in the docetaxel arm, the data still suggest a potential survival benefit for the combination of docetaxel plus thalidomide.

We have recently updated our overall survival data from this trial, and the current difference between survival in the combination arm (docetaxel plus thalidomide: median survival, 25.9 months) and the single-agent arm (docetaxel: median survival, 14.7 months) continues to indicate a benefit for thalidomide (P2 = .0407; see Fig 1). The median potential follow-up is 46.7 months. These data further support the need to continue to evaluate docetaxel plus thalidomide in this disease setting.

View larger version (12K): [in this window] [in a new window]   Fig 1. Thalidomid plus docetaxel trial survival. (*), single agent (22 of 25 failed); (), combination (34 of 49 failed).

The authors indicated no potential conflicts of interest.

REFERENCE

1. Dahut WL, Gulley JL, Arlen PM, et al: Randomized phase II trial of docetaxel plus thalidomide in androgen-independent prostate cancer. J Clin Oncol 22:2532-2539, 2004[Abstract/Free Full Text]

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Related Correspondence

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This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Figg, W. D. Articles by Dahut, W. L. Search for Related Content PubMed Articles by Figg, W. D. Articles by Dahut, W. L. Related Articles Related Correspondence Social Bookmarking                            What's this?