Comparison of leuprolide and diethylstilbestrol for stage D2 adenocarcinoma of prostate

Sharifi, Roohollah; Lee, Mary; Ojeda, Larry; Ray, Paul S.; Stobnicki, Marek; Guinan, Patrick

doi:10.1016/0090-4295(85)90042-1

Cited by 33 publications

(7 citation statements)

References 13 publications

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“…In patients with advanced prostate cancer, GnRH analogues proved to have activi ties comparable to those of established endocrine thera pies including orchiectomy and oral estrogens. In terms of tumor responsiveness, time to progression and me dian survival time, results were equivalent to orchiecto my and diethylstilbestrol [3,[9][10][11][12], To enhance com pliance and to avoid the necessity of daily injections, a depot of leuprorelin acetate was developed. For this depot formulation, leuprorelin acetate was incorporated into a biodegradable copolymer of lactic and glycolic acid [13,14], The compound is supplied as lyophilized microsphercs.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Leuprorelin Acetate Depot for Prostate Cancer

Kienle¹,

Lübben²

1996

Urol Int

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In an open, prospective clinical trial enrolling 205 patients, efficacy and safety of the gonadotropin-releasing hormone agonist leuprorelin acetate depot (LAD) in the treatment of patients with advanced prostatic carcinoma were assessed. 3.75 mg of the LAD formulation was injected subcutaneously in monthly intervals. The primary objective of this study was to evaluate the efficacy of the analogue in producing and maintaining castration levels of testosterone over a > 3-year follow-up period and to determine its safety profile. Median pretreatment serum testosterone levels fell from 350 to 21 ng/dl after 4 weeks and 20 ng/dl after 45 months. The long-term clinical efficacy of the LAD formulation can be expressed by best treatment response over time. These respective figures read as follows: 10.7% complete response; 49.8% partial response; 34.1% no change; 1.5% progression, and 3.9% no data available. The median time to progression was 12(15 ± 11) months. Median survival time calculated by Kaplan-Meier exceeded 42.5 months for patients on monotherapy and 30.9 months for those on combination therapy. Hot flushes which were related to androgen deprivation were the most common side effects. Patients and treating physicians judged tolerability of LAD in more than 90% as good. Androgen deprivation remains the mainstay of hormone-dependent advanced carcinoma of the prostate. Up to now, surgical castration has been considered the standard method. LAD is an advantage in the endocrine treatment of advanced prostatic carcinoma and is a good alternative to castration.

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Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Leuprorelin Acetate Depot for Prostate Cancer

Kienle¹,

Lübben²

1996

Urol Int

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“…Objective and subjective responses, and survival and duration of response were comparable 42,43 . However, leuprorelin was better tolerated, 42,43 leading to fewer treatment withdrawals than with DES 43 . Fewer adverse cardiovascular events occurred with leuprorelin than with DES 42 .…”

Section: Pharmacokineticsmentioning

confidence: 90%

“…DES (3 mg daily) and leuprorelin (1 mg daily s.c. injection) have been shown to be equally effective in reducing serum testosterone below castrate levels in patients with metastatic prostate cancer 42,43 . Objective and subjective responses, and survival and duration of response were comparable 42,43 . However, leuprorelin was better tolerated, 42,43 leading to fewer treatment withdrawals than with DES 43 .…”

Section: Pharmacokineticsmentioning

confidence: 99%

Leuprorelin Acetate in Prostate Cancer: A European Update

Persad

2002

Int J Clinical Practice

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SUMMARYThis review provides an update on leuprorelin acetate, the world's most widely prescribed depot luteinising hormone‐releasing hormone analogue. Leuprorelin acetate has been in clinical use in the palliative treatment of prostate cancer for more than 20 years, but advances continue to be made in terms of convenience and flexibility of administration, and in the incorporation of leuprorelin acetate into novel treatment regimens. The drug is administered in the form of a depot injection containing leuprorelin acetate microspheres, and is at least as effective in suppressing testosterone secretion as orchiectomy. In patients with prostate cancer, serum testosterone levels are reduced to castrate levels (≤50 ng/dl) within 2–3 weeks of the first one‐month depot injection of 3.75 mg or three‐month depot injection of 11.25 mg. Both the one‐month and three‐month formulations are effective in delaying tumour progression and alleviating symptoms of locally advanced and metastatic prostate cancer. Tolerability is generally good, with side‐effects reflecting effective testosterone suppression. Recent studies have investigated the place of leuprorelin acetate as part of continuous or intermittent maximal androgen blockade (MAB) and in neoadjuvant therapy (i.e. to reduce the size of the prostate and downsize the tumour before radiotherapy). Additional formulations and presentations are in development, including a six‐month injection, with the aim of adding to the clinical flexibility and patient acceptability of this important palliative treatment for prostate cancer.

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“…Long-term use of these potent hormones eventually desensitises the pituitary to hormonal stimulation, paradoxically but effectively down-regulating the production of testicular testosterone. Numerous studies have shown therapy with LHRH analogues such as leuprolide (Lupron, TAP Pharmaceuticals, Bannockburn, USA) or goserelin (Zoladex, ICI Pharma, Wilmington, USA) to be as effective as orchiectomy or oestrogen therapy in reducing testosterone levels (Warner et al, 1983;Sharifi, 1985;Ahmann et al, 1987;Murphy et al, 1987;Seely, 1987;Beacock, 1988;Borgmann et al, 1988;Debruyne et al, 1988;Kotake et al, 1988;Solowayet al, 1988;Waxman, 1988;Peeling, 1989). Surgery is avoided, and many of the serious side effects of oestrogen therapy, including cardiovascular effects, are significantly reduced.…”

Section: Overview Of Treatment Methodsmentioning

confidence: 99%

Challenges in the Management of Prostate Cancer

Crawford

1992

British Journal of Urology

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An estimated 32,000 American men will die of prostate cancer this year. Local prostate cancer may be successfully treated by radical prostatectomy or radiotherapy. Advanced cases may necessitate the use of hormonal ablation with bilateral orchiectomy, an approach that is regarded as the gold standard of therapy but not always the preferred treatment of patients. Oestrogen therapy is an alternative but is associated with side effects, such as hot flushes and gynaecomastia, which frequently lead to treatment cessation. Luteinising hormone-releasing hormone (LHRH) analogues work by initially producing a surge of androgen, followed by a down-regulation in hormone production to effect a medical castration. Various groups have studied the effects of androgen blockade administered as monotherapy and as combination therapy (LHRH analogue plus antiandrogen). The National Cancer Institute intergroup protocol 0036, which is the largest cooperative study to date of patients with advanced prostatic cancer, showed that combination therapy with leuprolide and flutamide offered greater benefit in both time to disease progression and median survival while circumventing tumour flare and its associated symptoms. Thus, combination therapy for total androgen ablation may become the new treatment standard for advanced prostatic cancer, pending further studies in the efficacy and cost-effectiveness of all available treatments.

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Comparison of leuprolide and diethylstilbestrol for stage D2 adenocarcinoma of prostate

Cited by 33 publications

References 13 publications

Efficacy and Safety of Leuprorelin Acetate Depot for Prostate Cancer

Efficacy and Safety of Leuprorelin Acetate Depot for Prostate Cancer

Leuprorelin Acetate in Prostate Cancer: A European Update

Challenges in the Management of Prostate Cancer

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