Docetaxel with prednisone or prednisolone for the treatment of ...

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Appendix 3
patients with HRPC. Patients received docetaxel
(35 mg/m 2 intravenously weekly for six consecutive
weeks followed by 2 weeks of rest) plus
thalidomide (100 mg per day orally) or docetaxel
alone (35 mg/m 2 intravenously weekly for six
consecutive weeks followed by 2 weeks of rest). All
patients in both groups received prophylactic ASA
(200 mg/day throughout the study) to prevent
thrombotic episodes.
Accrual started in October 2001 and is ongoing.
To date 55 patients have been accrued using
standard Phase 2 eligibility criteria. All patients
were chemo-naive but no one was excluded based
on any type of hormone/radiation/radioisotope
treatment. Median age was 65 years and all
patients had ECOG performance status 0–1.
Using the generally accepted consensus criteria,
20 (66%) of 30 patients in the combination arm
showed PSA decline of 50% or more compared
with 8 (32%) of 25 patients receiving docetaxel
alone.
A total of 660 weekly docetaxel infusions were
administered. Severe marrow toxicity was rare.
Grade 2 or more neutropenia was seen in only five
patients. Grade 2 or more thrombocytopenia was
also infrequent and was shown in three patients.
Two patients in the combination arm developed
deep vein thrombosis, which cleared shortly after
anticoagulant therapy started.
The study supports the previous preclinical and
clinical evidence suggesting the synergistic effect
of combining an anti-angiogenic agent with a
cytotoxic drug in the treatment of human prostate
cancer.