Background: Mitoxantrone has demonstrable clinical activity when administered intravenously in a wide range of malignancies. The feasibility and toxicity of intra-peritoneal administration was ...established in a phase I study. The optimal dose from the phase I was subsequently evaluated in a phase II study. Patients and methods: 19 patients with refractory malignancies and extensive abdominal disease (13 ovarian cancer, 4 breast cancer, 2 mesothelioma) were entered in a phase I study. The dose of intraperitoneal mitoxantrone was escalated from 10 mg/m2, administered in 21 of fluid via a Tenkhoff catheter, to 55 mg/m2, in increments of 5 mg/m2. Cycles were repeated every three weeks. Sixty-seven cycles of mitoxantrone were administered, the maximum tolerable dose being 25 mg/m2. A phase II study at this dose was conducted in 14 patients with refractory ovarian cancer, all of whom had previously received systemic platinum based therapy. Five of the 14 had also previously been treated with intraperitoneal carboplatin. Fifty-one cycles were administered. Results: The dose limiting toxicity in the phase I study was peritoneal irritation and pain. Leucopenia was frequent at doses equal or greater than 30 mg/m2. Three complete remissions were documented in the phase I study (2 breast cancer and 1 ovarian cancer). There was no significant haematological toxicity in the phase II assessment, though local toxicity precluded further therapy in 2 patients. No objective responses were seen in the phase II evaluation. Conclusions: These studies demonstrate the feasibility of intra-peritoneal mitoxantrone therapy in patients with peritoneal disease, but do not support its routine use in ovarian cancer.
Twenty-three patients with serious irradiation damage of the rectum underwent surgical treatment. Patients were classified according to the level of the lesion and the presence of stenosis. Patients ...with high lesions (Type I) (n = 5), were treated by resection with end to end anastomosis. Patients with low lesions, with stenosis (Type II) (n = 6), were treated by resection with descending colon flap repair. Patients with low lesions, without stenosis (Type III) (n = 7) were treated by gracilis muscle repair. The remaining patients (n = 5) with miscellaneous, often complex problems (Type IV) were treated by a variety of techniques. Results in Type I, II, and III patients were encouraging with 80% of the reconstructed patients obtaining normal faecal continence.
Between 1967 and 1981, 213 patients with carcinoma of the uterine cervix Stage I and IIA underwent an abdominovaginal radical hysterectomy with transperitoneal lymphadenectomy. In 1987 the overall ...5-year survival rate was 87.5% and the 10-year survival 85%. Recurrences were seen in 29 patients (13.7%). Lymph node metastases occurred in 39 patients (18%). Five-year survival decreased from 94% without positive nodes to 65% with positive nodes. The median blood loss was 2100 cc. Fistulas were seen in 6.7% of the patients. Long-term voiding problems were encountered in 40.8%. In 25% of the women intercourse was impeded postoperatively because of shortening of the vagina. The results obtained with this type of radical surgery in cervical cancer Stages I-IIA are good and do not differ from other methods reported in the literature. However this also means that this more difficult and time-consuming approach does not improve survival rates. For this reason there are no reasons to change from the Wertheim operation to this combined approach.
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