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BACKGROUND: We compared the combination plus Carboplatin plus paclitaxel, which is considered the treatment of choice for initial chemotherapy of advanced ovarian cancer (AOC) with a regimen combining alternating carboplatin and cisplatin plus paclitaxel. The two platinum derivatives have been previously combined as they are not totally cross-resistant and as they share no overlapping toxicities. PATIENTS AND METHODS: Patients with AOC, after the initial cytoreductive surgery were randomized to either 6 courses of paclitaxel at 175 mg/m2 as 3 h infusion plus Carboplatin at 7 AUC (Arm A) or Paclitaxel at the same dose plus Carboplatin again at 7 AUC for cycles 1,3,5, while for cycles 2,4,6 Cisplatin at 75 mg/m2 substituted for Carboplatin (Arm B). RESULTS: 247 patients are analyzed. Significant differences were not found, both in terms of PFS (38 vs 39 months, p=0.95) and overall survival (40.6 vs 38.6 months, p=0.79). There was not also difference in 5-year survival rate (35% vs 39%) or 5-year PFS rate (23% vs 28%). Age >60, PS 2, stage IV disease and presence of residual disease were adversely related to the overall survival. CONCLUSION: Both regimens are well tolerated and effective. Alternating cisplatin with carboplatin does not improve the results compared with the standard combination.

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OBJECTIVES: Both paclitaxel and cisplatin have moderate activity in patients with metastatic or recurrent carcinoma of the endometrium, and the combination of these two agents has shown activity in a variety of solid tumors. We administered this combination to patients with metastatic or recurrent carcinoma of the endometrium to evaluate its activity and to define its toxicity. METHODS: Twenty-four consecutive patients were treated on an outpatient basis with paclitaxel 175 mg/m(2) administered intravenously over a 3-h period followed by cisplatin 75 mg/m(2) administered intravenously with granulocyte colony-stimulating factor (G-CSF) support. The chemotherapy was repeated every 3 weeks for a maximum of six courses. RESULTS: Sixteen patients (67%; 95% confidence interval, 45-84%) achieved an objective response, including seven complete responses and nine partial responses. The median duration of response was 7 months, and the median times to progression and survival for all patients were 8.4 and 17.6 months, respectively. Some degree of neurotoxicity occurred in 44% of patients. Grade 3 or 4 toxicity included granulocytopenia in 22% of patients and peripheral neuropathy in 9%. CONCLUSION: The combination of paclitaxel with cisplatin with G-CSF support appears active in patients with metastatic or recurrent carcinoma of the endometrium. The significant incidence of neurotoxicity is of concern and alternative methods of administration of the two agents could be evaluated.

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The efficacy of colpopexy using an autograft is assessed. The method was used in patients with post-hysterectomy vaginal vault prolapse and/or suffering from uterine prolapse complicated by ovarian pathology. Thirty-five patients were subjected to a modified operative procedure based on Shaw's original method and completed with a posterior colporrhaphy. All patients are now free of urinary and/or pelvic symptoms with a functional vagina, after a 48 to 60 months post-operative follow-up. Pelvic cellulitis was observed in two patients and low abdominal pain in three others for a period of 1 month.

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Paclitaxel was administered at a dose of 175 mg/m2 in a 3-hour infusion every 3 weeks in platinum pretreated patients with ovarian cancer. 51 patients with a median age of 57 years entered the study. 33 (65%) presented with stage III and 18 (35%) with stage IV disease. 39 patients (76%) were previously treated with only one and 12 (24%) with two regimens. The median interval from the last previous chemotherapy was 4 months (range, 1-65). Ninety-eight per cent of the planned dose of paclitaxel was actually delivered. Overall and complete response rate was 26% (13/51) and 16% (8/51), respectively. All complete responses were observed among patients previously treated with only one regimen. Median time to progression was 10.26 months (range, 4.9-25.2+) and median survival 15.6 months (range, 1.3-27.1+). Factors influencing survival were performance status and the number of previous regimens.

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We compared, in a multicentric randomised prospective study, the efficacy and toxicity of carboplatin 400 mg/m2 as a single agent (CB) to a combination of carboplatin 300 mg/m2, epirubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (CB-EC) in advanced ovarian cancer patients. The treatment was scheduled to be administered every 3 weeks for six courses. Following initial laparotomy and cytoreductive surgery, 130 previously untreated patients entered the study. 73 patients were treated with carboplatin alone while 57 received the combination chemotherapy. In the majority of the patients, the regimens had to be given every 4 weeks due to myelosuppression. Nausea, vomiting and alopecia were more severe in the CB-EC arm. Overall, clinical complete response was observed in 73 (56%) and partial response in 20 (15%) patients. The median time to progression was 16.89 months and median survival was 29.54 months. No significant differences in response rate, time to progression, disease-free survival and overall survival were observed between the two treatment arms. The prognostic role of residual disease after initial surgery, complete remission at second-look laparotomy, tumour stage and performance status was confirmed.

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The results of a 1-year placebo-controlled study in 25 women who had hysterectomy and bilateral oophorectomy receiving a daily oral dose of 2.5 mg of Tibolone (Org OD 14) are presented. Tibolone is a steroid compound with mild oestrogenic in additional to progestagenic effects. Post-oophorectomy bone loss has been reported to accelerate, at least during the first year after surgery. The efficacy of Tibolone to prevent this accelerated bone loss is questionable. All patients were scheduled to participate in the study before oophorectomy. Patients had a detailed pre-operative examination, including measurement of forearm bone density with an SP2 Lunar single photon absorptiometer and haematological and biochemical investigation. After surgery, patients were randomly allocated in two groups; 15 women received an oral dose of 2.5 mg of Tibolone and 1000 mg of Calcium, while 10 women had only 1000 mg of calcium daily. Patients were examined at the end of 6 and 12 months of observation. Bone density of the radial shaft was found to decrease significantly in the calcium group up to 6.12% (P < 0.01) at the end of 6 months and 12.4% (P < 0.001) at the end of 12 months. On the other hand, bone density of the radial shaft remained unchanged in the Tibolone-treated group during the 12 months of treatment. Bone density of the distal radius was found to decrease in the calcium-treated group up to 10.2% (P < 0.014) at the end of 6 months and up to 15.8% (P < 0.002) at the end of 12 months. Bone density of the distal radius remained almost unchanged in the Tibolone-treated group during the whole period of treatment. Urine hydroxyproline/creatinine ratio was found to increase in the calcium group at the end of 6 and 12 months (P < 0.009) and to decrease significantly (P < 0.05) in the Tibolone-treated group. It is concluded that Tibolone is effective in the prevention of the post-ovariectomy accelerated bone loss and in retaining the initial premenopausal bone mass, at least during the first post-oophorectomy year. As this period is the most crucial in developing osteoporosis, it seems that Tibolone is effective in preventing the post-oophorectomy bone loss. HRT is not obligatory in these patients, as Tibolone seems to cover the whole spectrum of post-oophorectomy consequences.

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An unusual case of a full-term pregnancy in a patient with a uterus didelphys is presented. The main complication was the formation of pyocolpos in a blind hypoplastic hemivagina observed early in gestation. The therapeutic approach and the related problems are discussed.

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The post-operative morbidity of 70 patients who underwent total abdominal hysterectomy five to thirteen days after punch-biopsy of the cervix uteri and diagnostic curettage was compared of that of a control group of patients, with hysterectomy alone. It was observed that the sequence punch-biopsy hysterectomy presented a significantly higher post-operative morbidity. This increase was mainly due to higher parametritis, excessive vaginal discharge and wound infections rates. The interval between the two operations was also found to influence the post-hysterectomy morbidity, which seems to decrease with longer intervals.

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Sixteen cases of benign cystic ovarian neoplasms (13 serous cystadenomas and 3 dermoids) were discovered among 5,616 pregnancies. The only serious complication was torsion of the ovary containing the tumor in one case.

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Thirteen cases of pyometra without preoperative diagnosis in which vaginal or abdominal surgery was performed, are analysed in the present paper. The histologic examination revealed endocervicitis in all cases, while positive cultures for bacteria were found preoperatively in only eight of the above cases, thus, pyometra was considered to be a symptom of obstruction of the cervical canal.

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