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

Meeting: 2004 ASCO Annual Meeting
Category: Genitourinary cancer
Subcategory: Prostate cancer
Phase II randomized trial of docetaxel plus
estramustine (DE) versus docetaxel (D) in
patients (pts) with hormone-refractory prostate
cancer (HRPC): a final report
Abstract no: 4603
Citation: Proc Am Soc Clin
Oncol;22(14S):4603.
Authors: JC Eymard, F Joly, F Priou, A Zannetti, A
Ravaud, P. Kerbrat et al.
The study evaluated docetaxel in combination
with estramustine versus docetaxel alone in
patients with HRPC. To be eligible for the study,
patients had to have WHO performance status
≤ 2, appropriate renal, hepatic, and
haematological function, no prior chemotherapy
and withdrawal of anti-androgen therapy. Patients
received docetaxel (70 mg/m 2 intravenously over
1 hour on day one every 3 weeks) plus
estramustine (560 mg per day orally starting 1 day
prior to docetaxel infusion, for five consecutive
days) or docetaxel alone (75 mg/m 2 intravenously
over 1 hour on day one every 3 weeks) for a
maximum of six cycles. Prophylactic warfarin
(1 mg/day orally) was given continuously in the
docetaxel plus estramustine group. Corticosteroid
was given before and after docetaxel infusion in
both groups. Outcomes of interest were PSA
decline, safety and QoL.
A total of 92 patients were randomised, but one
patient did not receive treatment. Median age was
68 years (range: 46–86), performance status 0/1/2
(32/50/9 patients), median PSA was 115 ng/ml
(range: 0.3–1585) and 40 patients (22 in the
docetaxel plus estramustine group and 18 in the
docetaxel alone group) had measurable disease.
With a median number of six treatment cycles in
both arms, cycle delays >7 days were more
frequent in the docetaxel plus estramustine group
(15% of patients) than the docetaxel alone group
(11% of patients); dose reduction was similar, 4.3%
versus 4.5% of patients, respectively. Median
follow-up was 12.8 months.
Appendix 3
Health Technology Assessment 2007; Vol. 11: No. 2
Trials only available in abstract form
© Queen’s Printer and Controller of HMSO 2007. All rights reserved.
Response in the docetaxel plus estramustine group
versus the docetaxel group, respectively, was as
follows: PSA decline >50%, 68 versus 29%; PSA
decline >75%, 36 versus 16%; median PSA
response duration, 6 months in both groups. Of
40 patients with measurable disease, partial
response was observed in 18.2% (docetaxel plus
estramustine group) versus 16.7% (docetaxel alone
group). Median time to progression in the
docetaxel plus estramustine group was 5.7 months
(range: 4.7–5.8) versus 2.8 months (range: 2–6.9)
in the docetaxel alone group.
The main grade 3–4 haematological toxicities
among patients in the docetaxel plus estramustine
group versus the docetaxel alone group,
respectively, were neutropenia 25.5 versus 27.3%
and anaemia 10.6 versus 2.3%. The main grade
3–4 treatment toxicities were thrombophlebitis
(one patient in the docetaxel plus estramustine
group), allergic reaction (one patient in the
docetaxel plus estramustine group), febrile
neutropenia (one patient in each group) and fatal
acute pulmonary edema (one patient in the
docetaxel alone group).
There was no worsening in QoL using the FACT-P
instrument and the pain score was stable
throughout treatment in both groups.
Conclusion: docetaxel-based regimens are active
in hormone-refractory prostate cancer with
predictable and manageable toxicity profiles.
Meeting: 39th Annual Meeting of the American
Society of Clinical Oncology
Category: Genitourinary Cancer
Combining angiogenesis inhibitors with
cytotoxic chemotherapy enhances PSA response
in hormone-refractory prostate cancer (HRPC), a
randomized study of weekly docetaxel alone or
in combination with thalidomide
Abstract No: 1725
Author: M Salimichokami
The study evaluated docetaxel in combination
with thalidomide versus docetaxel alone in
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