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Twenty-three women with chronic heavy anovulatory uterine bleeding and severe iron-deficiency anemia received six months' treatment with goserelin, a gonadotropin releasing hormone agonist, administered as a monthly subcutaneous depot. After two months of treatment, all patients were amenorrheic and subsequent spotting was reported on only nine occasions. Laboratory results showed the following values: mean hemoglobin before treatment, 7.9 g/dL-13.8 g/dL at six months (+75%); mean hematocrit, 26.3%-41.6% (+58); mean serum iron, 19.8 micrograms/dL-63.3 micrograms/dL (+134%) and mean serum ferritin, 6.2 ng/mL-35.3 ng/mL (+469%). The endometrial hyperplasia observed in 11 subjects showed regression at follow-up suction biopsy. Gonadotropin releasing hormone agonists administered in a depot formulation for a few months in highly selected patients with severe anemia associated with heavy anovulatory uterine bleeding are practical, safe and effective, may avoid blood transfusions and could be used as a first line of treatment.

Eighteen consecutive patients with measurable locally advanced or metastatic pancreatic adenocarcinoma were treated with goserelin (Zoladex) 3.6 mg subcutaneously every 4 weeks. Hydrocortisone 20 milligrams twice daily was commenced with the second injection of goserelin. Objective tumour response was monitored by computerised tomography of the abdomen. There was no objective remission in disease sites. Serial measurements of serum tumour markers showed no reduction in serum CA 19-9 and CA 195 concentrations. The median duration of survival of all cases was 5 months. Administration of goserelin resulted in significant reductions in oestradiol, testosterone, androstenedione in males and reductions in FSH and LH in both males and females. The addition of hydrocortisone resulted in further reductions of androstenedione and testosterone levels in males. Thus goserelin showed no anti-tumour effect, but concentrations required for direct inhibitory effects may be higher than those required to produce effects on hormone suppression.

Objective: To determine whether the addition of a low dose of oral estrogen replacement therapy (ERT) taken daily can prevent the bone loss associated with continuous GnRH analogue use., Methods: In a double-blind, placebo-controlled study, 60 women aged 21-45 years were randomized to one of three treatment groups: placebo implant every 4 weeks plus placebo ERT tablets daily, Zoladex (goserelin 3.6 mg) implant every 4 weeks plus placebo ERT tablets daily, or Zoladex (3.6 mg) implant every 4 weeks plus estradiol valerate, 2 mg/day, with norethisterone 5 mg from days 22-28. A dual x-ray bone density scan was performed before treatment and again after six treatment cycles. The percentage bone change with respect to the initial bone density was calculated., Results: There was a significant loss of bone density at both the lumbar spine and proximal femur in the group receiving Zoladex plus placebo after 6 months compared with both pre-treatment values and with the group receiving placebo plus placebo. The addition of estrogen "add-back" therapy to GnRH analogue treatment (Zoladex plus ERT) resulted in no significant change in bone density compared with either pre-treatment values or the group receiving placebo plus placebo. The study had a dropout rate of 32%., Conclusion: The addition of "add-back" estrogen therapy to continuous GnRH analogue use can prevent bone loss.

Glandular Hyperplasia is commonly associated with meno and/or metrorrhagia. We treated 84 patients suffering from meno and/or metrorrhagia associated with simple glandular hyperplasia with a gonadotropin releasing hormone agonist, goserelin, (Zoladex, ICI Pharmaceuticals, Macclesfield. Cheshire, England), available in a depot formulation. Subcutaneous administration of goserelin 3.6 mg was repeated every 28 days for 6 months. Within the first 4 weeks from the start of therapy 45% of the patients became amenorrhoeic, within 12 weeks 100%. Only 3 patients reported continued spotting. Hysteroscopic evaluation and biopsy have shown in the 84 evaluable patients, a positive result in 76 (90.4%), demonstrating the validity of the use of this analogue in this indication. In the future it would be of value to increase the period of treatment in selected cases as well as increasing the length of the follow-up period.

Subjective quality-of-life assessments obtained from investigators and patients were compared in a subset of 76 patients from an EORTC study (protocol 30853) on metastatic prostatic carcinoma. In this study the therapeutic effect of orchiectomy was compared with a luteinizing hormone-releasing hormone analogue depot preparation and flutamide in 327 patients in total. Pretreatment, 6- and 12-month quality-of-life assessments revealed large variations between the patients' and the investigators' evaluation of performance status and sexual status (potency). Correlation analysis showed that reduced social life, impaired sexual potency and fatigue played important roles in overall psychological well-being. It was concluded that quality-of-life assessments obtained by self-administration questionnaires is a feasible approach and provides a tool to evaluate the benefits of treatment in prostate cancer.

589 patients from 10 countries are recruited into a multicentre randomised trial comparing Zoladex with a combination of Zoladex-Depot + flutamide. Zoladex was administered as a depot injection every 28 days and flutamide was given as 3 x 250 mg tablets daily. Patients with histologically confirmed locally advanced (T3/T4) or metastatic (M1) carcinoma were included. Patients with previous hormonal manipulation and/or chemotherapy were excluded. 65% of patients had metastatic disease. Both treatment groups were balanced (T-category, histology, metastases, performance status). An analysis of subjective and objective response, time to response and time to progression has shown no statistically significant difference. A survival analysis after a median follow-up of 24 months has shown no statistically significant difference between the two treatment groups (p = 0.47).

The Authors report their experience with the use of GnRH analogue (Goserelin) in 35 women with abnormal uterine bleeding due to low-risk hyperplasia of the endometrium. A hysteroscopic and histopathological follow-up was performed at 2 months and 6 months after treatment. The results show a significantly effectiveness of Goserelin in treating dysfunctional uterine bleeding.