Oral estramustine and oral etoposide for hormone-refractory prostate cancer

Dimopoulos, Meletios A.; Panopoulos, C; Bamia, Christina; Deliveliotis, Charalambos; Alivizatos, Gerasimos; Pantazopoulos, D; Constantinidis, C.; Kostakopoulos, A.; Kastriotis, Ioannis; Zervas, Anastasios; Aravantinos, G.; Dimopoulos, C

doi:10.1016/s0090-4295(97)00323-3

Cited by 73 publications

(30 citation statements)

References 12 publications

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“…In these combination trials, PSA response rates, defi ned as the percent of patients with a greater than 50% decline in PSA for a minimum of 3 biweekly or monthly measurements, ranged from 31 to 54% [23][24][25][26] . In more recent trials, Kelly et al [27] reported on the effi cacy of paclitaxel combined with EMP and carboplatin.…”

Section: Discussionmentioning

confidence: 99%

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%

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

et al. 2005

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“…The combination of EMP and VP16 was adopted for the first time by Pienta et al [6,9] in 1993, demonstrating objective response and PSA decrease in 50% of patients with HRPC. Dimopoulos et al [10] , adopting the same combination, reported PSA decrease of at least 50% and greater than 80% in 59% and 39% of HRPC patients, respectively. No further studies on this combination were carried out.…”

Section: Discussionmentioning

confidence: 92%

“…The maximum tolerated dose was determined to be 50 mg/ m 2 /day for 21 days in a 28-day cycle [8] . A synergic therapeutic activity between EMP and VP16 both in vitro and in vivo has been demonstrated [6,[9][10] . Both drugs can be administered orally and their combination could permit a significant dose reduction.…”

Section: Introductionmentioning

confidence: 97%

Oral Chemotherapy in Hormone-Refractory Prostate Carcinoma Patients Unwilling to Be Admitted to Hospital

Serretta

Altieri²,

Morgia³

et al. 2009

Urol Int

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Objectives: To investigate the safety and efficacy in terms of PSA response of a low-dose oral combination of estramustine phosphate (EMP) and etoposide (VP16) in hormone- refractory prostate cancer (HRPC) patients. Well-tolerated outpatient chemotherapy regimens for patients unfit and/or unwilling to be admitted to hospital are needed. Methods: Fifty-six HRPC patients with metastatic disease (median age 75 years) were randomized between arm A (daily oral EMP 10 mg/kg, in 3 doses) and arm B (28-day cycle with low-dose EMP 3 mg/kg once daily plus VP16 25 mg/m² once daily on days 1 through 14). Baseline characteristics between the two groups were similar. LHRH therapy was maintained. Anti- androgen was stopped 1 month before entry. Results: The low-dose combination was better tolerated, with a significant advantage in terms of time to treatment interruption for any reason (p = 0.01) or toxicity (6 vs. 12 months, p = 0.02). A trend in favour of arm B was evident in terms of PSA reduction (41.4 vs. 15%), performance status and pain improvement. Hospital admission due to toxicity was never required for arm B patients and there were no treatment-related deaths. Conclusions: Low-dose oral combination of EMP and VP16 might represent a treatment option for patients unfit for i.v. chemotherapy. This regimen requires minimal toxicity monitoring when administered at home for prolonged periods.

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“…More recently, the same group of investigators from the University of Michigan [78] presented the results of another phase II trial, showing the toxicity of estramustine delivered in high dose. To confirm the results of these studies, Dimopoulos et al [79] treated 56 patients with HRPC who had failed flutamide withdrawal, obtaining response rates in 45% of the patients with measurable lesions and documenting >50% decrease of the PSA levels in 59%.…”

Section: Estramustinementioning

confidence: 88%

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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Oral estramustine and oral etoposide for hormone-refractory prostate cancer

Cited by 73 publications

References 12 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

Oral Chemotherapy in Hormone-Refractory Prostate Carcinoma Patients Unwilling to Be Admitted to Hospital

Role of Chemotherapy in Hormone-Refractory Prostate Cancer

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