ZOLADEX SUMMARY
ZOLADEX®
(goserelin acetate implant)
3.6 MG
ZOLADEX® (goserelin acetate implant), contains a potent synthetic decapeptide analogue of luteinizing hormone-releasing hormone (LHRH), also known as a gonado-tropin releasing hormone (GnRH) agonist analogue.
ZOLADEX® is indicated for the following:
Prostatic Carcinoma: ZOLADEX is indicated in the palliative treatment of advanced carcinoma of the prostate.
Stage B2-C Prostatic Carcinoma: ZOLADEX is indicated for use in combination with flutamide for the management of locally confined Stage T2b-T4 (Stage B2-C) carcinoma of the prostate. Treatment with ZOLADEX and flutamide should start 8 weeks prior to initiating radiation therapy and continue during radiation therapy.
Endometriosis: ZOLADEX is indicated for the management of endometriosis, including pain relief and reduction of endometriotic lesions for the duration of therapy. Experience with ZOLADEX for the management of endometriosis has been limited to women 18 years of age and older treated for 6 months.
Advanced Breast Cancer: ZOLADEX is indicated for use in the palliative treatment of advanced breast cancer in pre- and perimenopausal women.
The estrogen and progesterone receptor values may help to predict whether ZOLADEX therapy is likely to be beneficial. (See CLINICAL PHARMACOLOGY.)
Endometrial Thinning: ZOLADEX is indicated for use as an endometrial-thinning agent prior to endometrial ablation for dysfunctional uterine bleeding.
The automatic safety feature of the syringe aids in the prevention of needlestick injury.
|
NEWS HIGHLIGHTS
Published Studies Related to Zoladex (Goserelin)
Long-term effectiveness of adjuvant goserelin in premenopausal women with early breast cancer. [2009.03.04]
BACKGROUND: Systematic reviews have found that luteinizing hormone-releasing hormone (LHRH) agonists are effective in treating premenopausal women with early breast cancer... CONCLUSIONS: Two years of goserelin treatment was as effective as 2 years of tamoxifen treatment 15 years after starting therapy. In women who did not take tamoxifen, there was a large benefit of goserelin treatment on survival and recurrence, and in women who did take tamoxifen, there was a marginal potential benefit on these outcomes when goserelin was added.
A comparative study of the effect of raloxifene and gosereline on uterine leiomyoma volume changes and estrogen receptor, progesterone receptor, bcl-2 and p53 expression immunohistochemically in premenopausal women. [2007.11]
OBJECTIVE: To compare the mechanism of action of raloxifene and gosereline induced shrinkage of leiomyomas via estrogen receptor, progesterone receptor, bcl-2 and p53 expression immunohistochemically... CONCLUSION: Raloxifene was as effective as gosereline in reducing leiomyoma volumes. Decreased PR expression may be a mechanism for tumor growth reduction in raloxifene treatment. In both treatment modalities, the mechanism of shrinkage of leiomyomas could not be increased apoptosis mediated by bcl-2 and p53 expression and should be investigated by further studies.
Goserelin Acetate 10.8 mg Plus Iron Versus Iron Monotherapy Prior to Surgery in Premenopausal Women with Iron-Deficiency Anemia Due to Uterine Leiomyomas: Results from a Phase III, Randomized, Multicenter, Double-Blind, Controlled Trial. [2007.08]
Background: Women with symptomatic uterine leiomyomas (fibroids) may have iron-deficiency anemia (IDA); therefore, surgery places them at risk of blood-borne morbidity from perioperative transfusions. Such women might benefit from a preoperative treatment that restores hematologic normality and alleviates fibroid symptoms...
Adjuvant chemotherapy followed by goserelin compared with either modality alone: the impact on amenorrhea, hot flashes, and quality of life in premenopausal patients--the International Breast Cancer Study Group Trial VIII. [2007.01.20]
PURPOSE: The purpose of this article is to compare quality of life (QOL) and menopausal symptoms among premenopausal patients with lymph node-negative breast cancer receiving chemotherapy, goserelin, or their sequential combination, and to investigate differential effects by age... CONCLUSION: Age-adjusted risk profiles that consider patient-reported outcomes enable patients to adapt to their disease and treatment, such as considering the trade-offs between delayed endocrine symptoms, but higher risk of permanent menopause with chemotherapy, and immediate but reversible endocrine symptoms with goserelin, in younger premenopausal patients.
Treatment of dysfunctional uterine bleeding in the perimenopause: the effects of adding combined estradiol/norethisterone acetate therapy to goserelin acetate treatment--a randomized, placebo-controlled, double-blind trial. [2006.12]
OBJECTIVE: To assess the effects of adding combined estradiol/norethisterone acetate therapy (CENT) to goserelin acetate treatment (GA) of dysfunctional uterine bleeding (DUB) in perimenopausal women... CONCLUSIONS: Adding CENT to GA treatment for DUB in perimenopausal women initially prevented BMD loss and improved climacteric complaints, while having no negative impact on vaginal bleeding, abdominal pain or BI-RAD scores. However, prolonged treatment did not result in a lasting prevention of bone loss.
Clinical Trials Related to Zoladex (Goserelin)
Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-Menopausal Patients [Active, not recruiting]
The primary purpose of this study is to establish if a 10. 8 mg dose of ZOLADEX given 3
monthly is non-inferior to a 3. 6 mg dose of ZOLADEX given monthly in terms of oestradiol
suppression in patients with oestrogen receptor positive early breast cancer.
Study of Zoladex Given Every 12 Weeks Versus Given Every Month in Advanced Breast Cancer (ABC) Pre-Menopausal Women [Suspended]
The primary objective is to evaluate whether Zoladex 10. 8 mg (12-weekly) is non-inferior to
Zoladex 3. 6 mg (4-weekly) in pre-menopausal women with oestrogen receptor positive advanced
breast cancer by assessment of progression-free survival at 24 weeks.
A temporary halt to patient recruitment was placed on the study on December 24th 2007,
pending confirmation/approval from the Japanese PMDA. The meeting with the PMDA will now take
place in July/August 2008. The study has been halted with a total of 97 patients randomized
and it is anticipated that the study stats and CSR for the primary objective (Data at
6-months) will be based on this patient number. These patients will then be followed to the
secondary endpoint at 2 years, when the final stats and CSR will be produced.
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women [Active, not recruiting]
To evaluate the antitumor activity, toxicity, and effectiveness of the combination of
Arimidex and Zoladex in the treatment of premenopausal women with hormone receptor positive
metastatic carcinoma of the breast.
A Prospective, Single-Arm Study to Evaluate the Efficacy and Safety of Zoladex 3.6mg Combined With CEF Chemotherapy as Neo-Adjuvant Therapy in Hormone Responsive, Premenopausal, Operable Breast Cancer [Recruiting]
It has been found that many breast cancers are hormone dependent and that hormonal therapy
by estrogen suppression such as ovarian ablation, tamoxifen and aromatase inhibitor has
proven beneficial in both adjuvant and neoadjuvant settings. Zoladex, a kind of luitinizing
hormone releasing hormone analogue, can offer efficient estrogen suppression as well. It can
induce reversible amenorrhea and the clinical effect is similar to ovarian ablation. Some
studies have demonstrated the efficacy of zoladex in treating pre and perimenopausal
hormone dependent breast cancer in both adjuvant and metastatic settings. Few data is
available on Zoladex in neoadjuvant treatment for breast cancer In our departments,
neoadjuvant CEF regimen is of general practice, and a preliminary study is designed to
investigate whether adding Zoladex into neoadjuvant CEF could further improve results in
hormone responsive breast cancer.
Goserelin Acetate Study for Ovarian Function in Patients With Primary Breast Cancer [Recruiting]
Primary Objective:
- To determine the effectiveness of goserelin acetate (Zoladex) in preserving ovarian
function in premenopausal women undergoing neoadjuvant and/or adjuvant chemotherapy for
primary invasive breast cancer by documenting persistence or resumption of regular
menses.
Secondary Objectives:
- To determine the incidence of pregnancy and the effect for participants' quality of life
(QOL) after chemotherapy.
- To determine the overall survival and disease-free survival times of study
participants.
|
