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This study shows the effect of a long-term treatment (60 cycles) with the ethinyl oestradiol/cyproterone acetate pill, and the follow-up after 6 months from cessation, in polycystic ovarian syndrome. The 140 studied women had polycystic ovaries and moderate or severe acne, 108 also presented hirsutism. The endocrine profile significantly modified after six cycles (P < 0.001), with a further significant decrease of gonadotrophins, oestrogens and androgens after 12 cycles, and a greater increase of sex hormone-binding globulins and insulin-like growth factor-binding globulins. Between the 12th and 60th cycle there was only a significant reduction of dehydroepiandrosterone sulphate (P < 0.05). Acne disappeared in all patients within 12-24 cycles, but hirsutism was still present in 30.6% after 60 cycles. Mild-moderate hirsutism disappeared in 36-60 cycles, whereas severe hirsutism substantially decreased, but persisted. Ovarian volume, microcyst numbers and stroma percentage significantly decreased (P < 0.01). After 6 months from the end of the therapy, endocrine parameters were identical to the starting ones, acne and hirsutism reappeared, whereas ovarian morphology was between the initial and final condition. Ovaries were polycystic in 42 (30%) patients and multifolliculars in 98 (70%). Our results show the effectiveness of this combination on androgenic symptoms, especially on acne, and suggest that acne and hirsutism are induced by different peripheral mechanisms.

Background: A prospective phase II study was conducted to evaluate the efficacy and toxicity of oral gimatecan in patients with recurrent epithelial ovarian, fallopian tube or peritoneal cancer.Patients and methods: Patients had a maximum of three prior chemotherapy lines with no more than two prior platinum-containing regimens and a progression-free interval after the last dose of platinum <12 months. A total dose of 4 mg/m2/cycle (0.8 mg/m2/day from day 1 to day 5) was administered, repeated every 28 days.Results: From June 2005 to December 2005, 69 assessable patients were enrolled. The best overall response to study treatment by combined CA-125 and RECIST criteria was partial response in 17 patients (24.6%) and disease stabilization in 22 patients (31.9%). The median time to progression and overall survival were 3.8 and 16.2 months, respectively. A total of 312 cycles were administered. Neutropenia grade 4 and thrombocytopenia grade 4 occurred in 17.4% and 7.2% of patients, respectively. Diarrhea grade 4 was never observed. Asthenia and fatigue were reported by 36.2% and 18.8% of patients, but were all grade 2 or less.Conclusion: Gimatecan is a new active agent in previously treated ovarian cancer with myelosuppression as main toxicity.

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