Estramustine Phosphate Versus Placebo as Second Line Treatment After Orchiectomy in Patients With Metastatic Prostate Cancer: Daproca Study 9002

Iversen, Peter; Rasmussen, Finn; Asmussen, Christian; Christensen, Ib Jarle; Eickhoff, J. H.; Klarskov, Peter; Larsen, Erik; Mogensen, Peter; Mommsen, S; Rosenkilde, Per

doi:10.1016/s0022-5347(01)65086-9

Cited by 45 publications

(27 citation statements)

References 20 publications

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“…The combination therapies therefore appear superior for HRPC than EMP monotherapy based on both PSA levels and measurable disease response. A Danish study (DAPROCA study 9002) [12] of EMP versus placebo as second-line treatment after orchiectomy in patients with metastatic HRPC found that 37.2% of 43 patients who showed a PSA reduction of 1 50% were treated with EMP, and that the decrease in PSA correlated signifi cantly with favorable cancer-specifi c survival. However, the median time to subjective progression and median overall survival did not differ signifi cantly between the EMP and placebo groups.…”

Section: Discussionmentioning

confidence: 99%

“…Kelly et al [10] reported the prognostic value of several variables in relation to the survival of patients with HRPC, and found that posttreatment PSA decline was the most important parameter. Monitoring of PSA levels therefore represents a useful and relevant endpoint for clinical studies in this area [11,12] . In light of the paucity of reports on this topic, we carried out a prospective study to assess the effi cacy of EMP on patients with HRPC who showed an elevated PSA level following ADT, using changes in serum PSA as the major endpoint.…”

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confidence: 99%

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Prospective Study of Estramustine Phosphate for Hormone Refractory Prostate Cancer Patients following Androgen Deprivation Therapy

et al. 2005

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Introduction: Estramustine phosphate (EMP) in combination with other cytotoxic agents has been widely used in clinical trials as an anti-tumor agent for the treatment of hormone-refractory prostate cancer (HRPC). However, few prospective studies have considered the efficacy of EMP monotherapy for HRPC patients following androgen-deprivation therapy (ADT), given the availability of methods to measure prostate-specific antigen (PSA) levels in the serum. We therefore initiated a prospective study to determine whether EMP is efficient for HRPC following ADT using changes in PSA levels as the major endpoint. Methods: After a diagnosis of anti-androgen withdrawal syndrome had been excluded, 34 patients with HRPC who showed an elevated serum PSA level in 3 or more sequential tests following ADT were treated orally with 560 mg/day of EMP. The clinical stage and the median PSA value for inclusion in the study were D2 and 25.9 (range 6.5–540.8) ng/ml, respectively. Treatment was continued until evidence of disease progression reappeared or until severe adverse effects appeared. Results: Of the 34 patients enrolled, 29 were evaluated, while the other 5 (15%) patients were discontinued due to severe gastrointestinal side effects. Seven of the 29 patients (24%) showed a decrease of 50% or greater in serum PSA levels from the initially elevated values, with the median duration of PSA response being 8.0 (range 2.2–18.8) months. Baseline PSA, hemoglobin, alkaline phosphatase, lactate dehydrogenase, performance status, and length of time of initial hormonal treatment did not correlate with the PSA response. With a median follow-up time of 20.0 (range 3.2–45.6) months, the cancer-specific survival rate at 2 years was 83% in the PSA responders and 44% in the non-responders. The PSA response was correlated with cancer-specific survival (p = 0.029). Conclusions: Following ADT one quarter of HRPC patients responded to EMP, with more than 50% of patients showing a decrease in PSA levels and an enhanced survival rate.

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Section: Discussionmentioning

confidence: 99%

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Prospective Study of Estramustine Phosphate for Hormone Refractory Prostate Cancer Patients following Androgen Deprivation Therapy

et al. 2005

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“…As a single agent, the radiographic response rate of estramustine is only 5% to 19% [5•,6]. In a double-blind multicenter study, 131 patients with progressing metastatic hormone-refractory prostate cancer were randomized to receive 280 mg of estramustine phosphate twice daily versus placebo [7]. Breast tenderness, gynecomastia, and diarrhea were more frequent among patients in the estramustine phosphate group.…”

Section: Microtubule Antagonists and Estramustine Phosphate Combinationmentioning

confidence: 99%

Chemotherapy of prostate cancer: Present and future

Trump

Lau

2003

Curr Urol Rep

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The role of chemotherapy in prostate cancer continues to evolve. In men with symptomatic androgen-independent prostate cancer, significant reduction in pain and analgesic requirements are achievable with mitoxantrone and glucocorticoid combinations compared with glucocorticoids alone. However, survival rates are not improved. Taxane-based combinations with estramustine phosphate or other new agents show promise. Prostate-specific antigen response rates with these combinations appear to be 1.5 to 2 times more frequent than with mitoxantrone-based combinations. Randomized trials of taxane versus mitoxantrone-based therapies are underway. New agents and applications of current agents in adjuvant settings should be explored if survival in men with prostate cancer is to be improved.

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“…In a randomized multicenter trial the Danish Prostatic Cancer Group [75] compared the effect of estramustine phospate to placebo as a supplement to standard palliative therapy for patients with HRPC. The selected dose of 560 mg/daily was lower than that used by others.…”

Section: Estramustinementioning

confidence: 99%

Role of Chemotherapy in Hormone-Refractory Prostate Cancer

Autorino¹,

Lorenzo

Damiano³

et al. 2003

Urol Int

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Prostate cancer that grows despite castrate levels of testosterone and that no longer responds to any form of hormonal manipulation and for which nonhormonal approaches are required, can be precisely defined as hormone-refractory prostate cancer (HRPC). Until recently, there has been no standard chemotherapeutic approach for HRPC. In this article recent advances in the treatment of HRPC using chemotherapeutic regimens are critically reviewed. We performed a MEDLINE search of the published reports from 1995 to 2002 including chemotherapy in the treatment of HRPC. We critically reviewed a total of 84 clinical trials, of which only 6 were phase III trials, most of the studies being phase II trials. Various chemotherapeutic agents have been used. To date, the major benefits of chemotherapy in the treatment of HRPC are palliative in nature, in terms of reduction of pain and use of analgesics and improvement of performance status, as followed in the most recent trials. There is a promising activity of new drug combinations, such as vinca alkaloids and taxanes in association with estramustine. Mitoxantrone, although with a limited activity, has been shown to provide improvement in pain and quality of life for the patients. Several studies suffer from methodological deficits, such as small number of patients, heterogeneity of enrolled groups or no definitive response criteria. Further phase III studies are necessary to better evaluate the efficacy of the different regimens.

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Estramustine Phosphate Versus Placebo as Second Line Treatment After Orchiectomy in Patients With Metastatic Prostate Cancer: Daproca Study 9002

Cited by 45 publications

References 20 publications

Prospective Study of Estramustine Phosphate for Hormone Refractory Prostate Cancer Patients following Androgen Deprivation Therapy

Prospective Study of Estramustine Phosphate for Hormone Refractory Prostate Cancer Patients following Androgen Deprivation Therapy

Chemotherapy of prostate cancer: Present and future

Role of Chemotherapy in Hormone-Refractory Prostate Cancer

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