Chemohormonal therapy as primary treatment for metastatic prostate cancer: A randomized study of estramustine phosphate plus luteinizing hormone‐releasing hormone agonist versus flutamide plus luteinizing hormone‐releasing hormone agonist

Abstract

Background: The present study was undertaken mainly to investigate whether chemohormonal therapy with estramustine phosphate plus luteinizing hormone-releasing hormone (LHRH) agonist has a more beneficial effect than the hormonal therapy with flutamide plus LHRH agonist for newly diagnosed patients with metastatic prostate cancer. Methods: A total of 57 patients with metastatic prostate cancer aged 59-80 years (median 74 years) were entered in the study and were randomized to the treatment of estramustine phosphate (560 mg/ day) plus LHRH agonist (estramustine group) or flutamide (375 mg/day) plus LHRH agonist (flutamide group) with stratification for the degree of performance status, histological differentiation and bone metastasis. Results: Both of the treatment regimens were well tolerated with similar incidences of adverse drug reactions. The overall response rates (complete response plus partial response) at 12 weeks after treatment in the estramustine and flutamide groups were 76 and 55%, respectively. The median time to objective progression for the estramustine group (25.4 months) was longer than that of the flutamide group (14.6 months). The serum levels of follicle stimulating hormone and testosterone were significantly lower in the estramustine group. Conclusions: Chemohormonal therapy with estramustine phosphate plus LHRH agonist showed longer clinical progression-free survival than the hormonal therapy with flutamide plus LHRH agonist (P = 0.03), although there was no significant difference in the overall survival. A largerscaled trial with more statistical power is required to clarify that the former regimen is more beneficial than the latter for newly diagnosed patients with advanced prostate cancer.

Safety and effectiveness of neoadjuvant luteinizing hormone-releasing hormone agonist plus low-dose estramustine phosphate in high-risk prostate cancer: a prospective single-arm study

“…In fact some authors reported the superiority of combination of EMP and LHRH agonist to orchiectomy alone or androgen deprivation therapy for the patients with advanced Pca. 15,16,30 In this study, 4.9% of patients achieved pT0, which can be acceptable antitumor effect. No serious adverse events occurred and there were no toxicity-related deaths.…”

“…13,14 We have reported the active effect of luteinizing hormone-releasing hormone (LHRH) plus EMP for the patients with advanced Pca. 15,16 We expected that this combination may be applicable to neoadjuvant therapy for the patients with high-risk Pca.…”

A randomized comparative study of endocrine monotherapy and a combination of estramustine phosphate with the endocrine therapy in patients with untreated stage D prostate cancer

“…Noguchi et al 13 conducted a randomized trial of combination therapy with an LH-RH agonist and flutamide vs EMP in patients with stage D2 progressive prostate cancer; they reported that there was no significant difference between the groups in overall survival, but that progression-free survival was significantly prolonged in the EMP + endocrine therapy group. We defined progression-free survival as three consecutive PSA measurements that did not show an increase.…”

Long-term control or possible cure? Treatment of stage D2 prostate cancer under chemotherapy using cisplatin and estramustine phosphate followed by maximal androgen blockade

“…Several studies have suggested that EMP offers better efficacy than standard hormonal therapy for high-grade, high-stage PC [7]. In addition, chemohormonal therapy with EMP plus castration has been recommended over MAB with antiandrogen plus castration in suppression of FSH and testosterone for metastatic PC [7].…”