Multicenter-Studie mit Enantone® Monats-Depot — Langzeitverlaufskontrolle

Fornara, P

doi:10.1007/978-3-642-76866-8_10

Cited by 2 publications

(3 citation statements)

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“…Coexistent or previous malignancy except Leuprorelin 3-Month Depot in PCA Urol Int 1996;56(suppl 1): [18][19][20][21][22] basal cell carcinoma of the skin. Central nervous system disease, except brain metastasis of PCA.…”

Section: Clinical Multicenter Studymentioning

confidence: 99%

“…The most commonly occurring side effects were hot flushes, excessive perspiration, decreased libido, impo tence, testicular hypoplasia, weight increase, musculoskel etal disorders and micturition disorders, which seemed to be related to hormone deprivation. Rare side effects Leuprorelin 3-Month Depot in PCA Urol Int 1996:56(suppl 1): [18][19][20][21][22] included headaches, depression, sleep disturbances and peripheral edema. Isolated side effects included gastroin testinal, metabolic and nutritional, vascular, extracardiac, respiratory' and other disorders.…”

Section: Adverse Eventsmentioning

confidence: 99%

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Clinical Study Results of the New Formulation Leuprorelin Acetate Three-Month Depot for the Treatment of Advanced Prostate Carcinoma

Fornara¹,

Jocham²

1996

Urol Int

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Androgen suppression, using gonadotrophin-releasing hormone analogues (leuprorelin), is being developed as an effective treatment of advanced prostate carcinoma. Treatment with leuprorelin acetate 1-month depot is already well established all over the world. In order to increase patients’ acceptability of this treatment, by reducing frequency of administration, a 3-month depot formulation has been developed in Takeda’s research laboratories. A single-shot pharmacokinetic study was conducted to confirm efficacy in terms of hormone suppression and safety of the 3-month depot formulation. Thereafter, a parallel-group, open-labelled, randomized trial was performed to compare clinical efficacy and safety profiles of the 1- and 3-month depot formulations. Patients with a histologically and/or cytologically confirmed advanced prostate carcinoma, without prior hormonal or surgical androgen deprivation, are included. According to 1:2 randomization, patients are treated with either the 1- or 3-month depot for 9 months. To prevent initial flare-up, a concomitant antiandrogen therapy might be administered within 2 weeks prior to first injection and continued for up to 3 weeks. The clinical efficacy of the formulations is assessed by both objective response, EORTC and NPCTG response criteria, and subjective response by using WHO performance status. In addition, the level of prostate-specific antigen is determined every 3 months. The efficacy of the two formulations is also evaluated by determination of serum testosterone, dihydrotestosterone, luteinizing hormone and follicle stimulating hormone. To date, 106 patients have been treated with the 3-month depot and 53 patients with the 1-month depot. Preliminary evaluation shows a satisfying level of testosterone suppression with both the 3- and 1-month depot formulations. Therapeutic equivalence was assumed. The 3-month depot is tolerated as well as the 1-month depot.

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Section: Clinical Multicenter Studymentioning

confidence: 99%

Section: Adverse Eventsmentioning

confidence: 99%

Clinical Study Results of the New Formulation Leuprorelin Acetate Three-Month Depot for the Treatment of Advanced Prostate Carcinoma

Fornara¹,

Jocham²

1996

Urol Int

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“…About 80% of prostate cancers respond primarily to endocrine manipulation. The mainstay of hormone deprivation was, until recently, orchiectomy in addition to estrogen treat ment -although the psychological problems associated with orchiectomy and the potential cardiovascular ad verse effects of estrogens are well known [2,3], Following the initial observation in 1976 that the gonadotropin-releasing hormone (GnRH) analogue, leuprorelin, could be used for the treatment of hormonedependent tumors [4], many of these analogues have been synthesized and tested in the treatment of prostatic cancer [5,6] and other hormone-dependent benign [7,8] and malignant diseases [16]. 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.…”

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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Multicenter-Studie mit Enantone® Monats-Depot — Langzeitverlaufskontrolle

Cited by 2 publications

References 0 publications

Clinical Study Results of the New Formulation Leuprorelin Acetate Three-Month Depot for the Treatment of Advanced Prostate Carcinoma

Clinical Study Results of the New Formulation Leuprorelin Acetate Three-Month Depot for the Treatment of Advanced Prostate Carcinoma

Efficacy and Safety of Leuprorelin Acetate Depot for Prostate Cancer

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