A New Long Acting Formulation of the Luteinizing Hormone-Releasing Hormone Analogue, Goserelin: Results of Studies in Prostate Cancer

Debruyne, F.M.J.; Dijkman, G.A.; Lee, D.C.H.; Witjes, Wim P.J.

doi:10.1016/s0022-5347(01)66264-5

Cited by 35 publications

(30 citation statements)

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“…[2][3][4] In the study reported here, the anti-androgen bicalutamide was used in conjunction with the goserelin acetate. We found no difference in the incidence of adverse events between two groups, and thus we consider that the safety of treatment initiated with the 3-month depot is comparable to that of treatment initiated with the 1-month depot.…”

Section: Discussionmentioning

confidence: 99%

“…Osamu Ishizuka 1), 2) , Osamu Nishizawa 1), 2) , Shuji Nishizawa 2) , Tomoya Satoh 2) , Masahisa Wajiki 2) , Hideo Kiyokawa 2) , Yoshihiro Inoue 2) , Shinya Kobayashi 2) , Hiroya Mizusawa 2) , Tatsuo Nakagawa Two such agonists, goserelin acetate and leuprorelin acetate, are now approved for clinical use in Japan, and 1-month and 3-month depots are currently available. Advantages of the 3-month depot include reductions of (1) hospital visits by one-third, (2) physical and/or psychological burden with the injections, (3) and drug costs.…”

Section: Comparison Of Efficacy and Safety Of One-and Three-month Lutmentioning

confidence: 99%

“…Because of these benefits, use of the 3-month depot from the start of treatment is ideal. However, while reports are available on the efficacy and safety of the 3-month depot administered as the initial treatment in Western patients, 2,3 there is only one report, based on a very small population, that evaluated the efficacy and safety in Japanese patients. 4 Because of this minimal substantiation, many Japanese physicians start treatment with the 1-month depot and then switch to the 3-month depot after confirming its efficacy and safety.…”

Section: Comparison Of Efficacy and Safety Of One-and Three-month Lutmentioning

confidence: 99%

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Comparison of efficacy and safety of 1- and 3-month luteinizing hormone-releasing hormone agonist depots as initial therapies for prostate cancer

Ishizuka

Nishizawa

Nishizawa³

et al. 2012

Int J Clin Oncol

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Section: Discussionmentioning

confidence: 99%

Section: Comparison Of Efficacy and Safety Of One-and Three-month Lutmentioning

confidence: 99%

Section: Comparison Of Efficacy and Safety Of One-and Three-month Lutmentioning

confidence: 99%

See 1 more Smart Citation

Comparison of efficacy and safety of 1- and 3-month luteinizing hormone-releasing hormone agonist depots as initial therapies for prostate cancer

Ishizuka

Nishizawa

Nishizawa³

et al. 2012

Int J Clin Oncol

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“…Effective suppression of serum tes tosterone below the castrate level w ithin 3 weeks and m aintenance of suppression for the duration of therapy was achieved w ith both the 10.8-and 3.6-mg depot formulations. The 10.8-mg depot was well tolerated both locally and systemically.5, 6 In this report, we update the pharm acodynam ic and safety results of these two Phase III studies and present an analysis of prostate-specific antigen (PSA) response, time to progression, and survival.…”

mentioning

confidence: 99%

Three-month depot of goserelin acetate: clinical efficacy and endocrine profile

Moral

Dijkman

Debruyne

et al. 1996

Urology

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Objectives. To com pare the pharmacodynamics and tolerabiiity of the new goserelin acetate 10.8-mg depot with the 3.6-m g depot in patients with advanced prostate cancer during the first 3 months of therapy. Methods. One hundred sixty patients were randomized in two comparative studies to receive either the 10.8-m g goserelin acetate depot every 12 weeks or the 3.6-mg goserelin acetate depot every 4 weeks for 12 weeks and then the 10.8-m g depot every 12 weeks thereafter. Data for pharmacodynamic assessments were collected prospectively, whereas clinical response data were collected retrospectively. Results. Serum testosterone profiles of the 10.8-mg goserelin acetate depot and the 3.6-mg goserelin ac etate depot were sim ilar; testosterone levels in both groups fell below castrate levels by day 21 after ad ministration. D ecreases in serum prostate-specific antigen level after 3 months of therapy were also similar in both groups: 94% with the 10.8-m g depot and 9 2 .5 % with the 3.6-mg depot. For all patients, the median time to progression was 1 5 2 .7 weeks and the median time to death was 213.6 weeks. The safety profile of the 10.8-m g goserelin acetate depot was similar to that of the 3.6-mg depot; hot flashes was the most common adverse event. The incidence of injection site reactions was very low (2 [0.3% ] of 614 administra tions). Conclusions. The new 10.8-m g depot was pharmacodynamically equivalent to the current 3.6-mg depot and was well tolerated, both locally and system ically. The observed times to progression and survival were as expected in this patient population. The 10.8-mg gosereiin-acetate depot provided a dosing schedule that was convenient for the patient and the physician, and it has the potential to reduce health care costs while maintaining the quality of life in patients being treated for advanced prostate cancer.Copyright 1996 by Elsevier Science Inc. UROLOGY 48: 8 9 4 -9 0 0 , 1996. Since their in tro d u ctio n over a decade ago as a treatm en t for advanced prostate cancer, lu tein izing horm one-releasing horm one (LHRH) ago nist analogues have displaced estrogens as the leading alternative to orchiectom y for patients u n dergoing m o n o th e ra p y ,1 an d they have em erged as a co m p o n en t of com bination therapy w ith antian drogens in patients receiving com bined androgen

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“…Goserelin acetate, leuprolide and triptorelin are all available as monthly intramuscular or subcutaneous injections. Goserelin acetate is now also available in a 12-weekly depot preparation for subcutaneous injection (Dijkman et al, 1995;Debruyne et al, 1996a), and leuprolide is also available as a 3-month depot in some countries (Fernandez Del Moral et al, 1996). These controlled-release preparations have obvious advantages in terms of patient compliance and acceptability.…”

Section: Medical Castrationmentioning

confidence: 99%

Controversies in the management of advanced prostate cancer

1998

Br J Cancer

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For advanced prostate cancer, the main hormone treatment against which other treatments are assessed is surgical castration. It is simple, safe and effective, however it is not acceptable to all patients. Medical castration by means of luteinizing hormone-releasing hormone (LH-RH) analogues such as goserelin acetate provides an alternative to surgical castration. Diethylstilboestrol, previously the only non-surgical alternative to orchidectomy, is no longer routinely used. Castration reduces serum testosterone by around 90%, but does not affect androgen biosynthesis in the adrenal glands. Addition of an anti-androgen to medical or surgical castration blocks the effect of remaining testosterone on prostate cells and is termed combined androgen blockade (CAB). CAB has now been compared with castration alone (medical and surgical) in numerous clinical trials. Some trials show advantage of CAB over castration, whereas others report no significant difference. The author favours the view that CAB has an advantage over castration. No study has reported that CAB is less effective than castration. Of the anti-androgens which are available for use in CAB, bicalutamide may be associated with a lower incidence of side-effects compared with the other non-steroidal anti-androgens and, in common with nilutamide, has the advantage of once-daily dosing. Only one study has compared anti-androgens within CAB: bicalutamide plus LH-RH analogue and flutamide plus LH-RH analogue. At 160-week follow-up, the groups were equivalent in terms of survival and time to progression. However, bicalutamide caused significantly less diarrhoea than flutamide. Withdrawal and intermittent therapy with anti-androgens extend the range of treatment options. © 1999 Cancer Research Campaign

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A New Long Acting Formulation of the Luteinizing Hormone-Releasing Hormone Analogue, Goserelin: Results of Studies in Prostate Cancer

Abstract: The following full text is a publisher's version. For additional information about this publication click this link.

Cited by 35 publications

References 7 publications

Comparison of efficacy and safety of 1- and 3-month luteinizing hormone-releasing hormone agonist depots as initial therapies for prostate cancer

Comparison of efficacy and safety of 1- and 3-month luteinizing hormone-releasing hormone agonist depots as initial therapies for prostate cancer

Three-month depot of goserelin acetate: clinical efficacy and endocrine profile

Controversies in the management of advanced prostate cancer

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