Cisplatin (C) or carboplatin (CBP) plus cyclophosphamide (CTX) was until recently considered standard chemotherapy for advanced ovarian cancer (OC). Attempts to maximize platinum and its analog activity against OC include its administration directly into the peritoneal cavity. In the past we have shown that intraperitoneal (IP) CBP administration is a safe and effective treatment for OC [Polyzos et al: Proc Am Assoc Cancer Res 1990;31: 1120]. In the present study we aimed to compare the effectiveness and toxicity of CBP administration either intravenously (IV) or IP plus CTX IV. Since 1990, 90 evaluable patients with stage III OC were prospectively randomized to receive CBP 350 mg/m² IV or IP plus CTX 600 mg/m² IV (in both groups) every 3–4 weeks for six courses. The randomization incorporated stratification according to performance status and the amount of residual tumor (maximum diameter ≤2 or >2 cm). Clinical assessment was performed with abdominal CT and serum CA-125. Responses were observed in 33/46 = 72% (95/CI 56.5–84.0) of the IV group and in 33/44 = 75% (95/CI 59.7–86.8) of the IP group with 48 and 45% clinical complete responses, respectively. Times to progression were 19 months (8–62+) for the IV group and 18 (6–72+) for the IP group. Median survivals were: 25 months (6–80+) and 26 months (6–72+), respectively. Significantly more patients in the IV group than in the IP group had grade 3 or higher leukopenia (p < 0.01) and grade 3 thrombocytopenia (p < 0.09). Morbidity due to infectious complications in the IP group was minimal. It seems that IP CBP is equally effective to IV administration in terms of response and survival with less myelotoxicity. The favorable results on survival demonstrated in studies with IP C administration in patients with small volume disease [Alberts et al: N Engl J Med 1996;335:1950–1965] could not be repeated in the present study applying CBP in patients with variable tumor size and a relatively small number of patients. The likelihood that patients with large volume disease would benefit from a regional approach compared to systemic administration is small and this explains the inability to detect a difference between the two arms.

Plasma adiponectin levels are almost twice as high in patients with chronic renal failure in comparison with healthy controls, but not different between renal patients on and those not on hemodialysis. In addition, low plasma adiponectin levels are strongly associated with ischemic heart disease, but not with aortic distensibility in chronic renal failure.

No abstract

This phase II trial studied the efficacy and toxicity of full dose paclitaxel plus vinorelbine, as salvage chemotherapy in patients with metastatic breast cancer resistant to anthracyclines. Patients received vinorelbine (30 mg/m2) followed 1 hour later by full dose paclitaxel (175 mg/m2) every 3 weeks for a maximum of 8 cycles or until disease progression. Because of the heavy pretreatment of the patients, prophylactic granulocyte-colony stimulating factor (5 microg/kg) was administered daily for 5-10 days. To minimize potentially cumulative neurotoxicity due to both agents, amifostine was given prior to chemotherapy. Thirty-four patients: 8 with tumors primary resistant and 26 with tumors recurring within 3-6 months after anthracycline treatment, were evaluable for efficacy and toxicity. Objective responses occurred in 11 patients [32%; 95% confidence interval (CI): 16.3-47.7%), all partial responses. Responses were observed in lung and liver. The median response duration was 4 months (range 3-7), median time to progression was 5 months (range 3-9) and median overall survival was 8 months (range 4-24). Neutropenia was dose limiting (35% grade 3-4 toxicity). The left ventricular ejection fraction, measured and followed in 18 patients, fell less than 20% below baseline level in 9 patients (50%), but only one patient developed congestive cardiac failure. The paclitaxel-vinorelbine regimen was moderately tolerated and moderately effective in poor prognosis breast cancer patients with visceral metastases and tumors resistant to anthracyclines. The combination at these doses and schedules should be considered in the design of regimens for advanced breast cancer.

The selection of material of an arteriovenous graft employed for maintenance hemodialysis when natural veins are lacking is of major importance for its patency rate because of rough handling during hemodialysis, because of multiple needling, and because of other risk factors related to the patient's physical condition. The authors studied 148 umbilical vein grafts implanted in the last 7 years in 123 patients for maintenance hemodialysis. During a 3-year follow up, 83 grafts were lost because of a total number of 137 complications in 103 grafts, despite the invasive and noninvasive attempts at graft rescue. The most frequent cause of graft loss was thrombosis, observed in 87 grafts, causing graft loss in 57. The remaining 50 complications observed were bleeding in seven, aneurysm formation in six, infection in 16, and venostasis or steal syndrome in 21 grafts. Twenty-four of these were rescued, while seven patient deaths were seen with functioning graft. The good biocompatibility of the umbilical vein grafts allowed for multiple interventional and surgical procedures toward graft rescue, which prolonged patency rate. The cumulative patency rate was 72.2 ± 5.9%, 54.4 ± 6.2%, and 31.7 ± 9.2% for the first, second, and third year, respectively. The patency rate is considered satisfactory in view of the prolonged time under hemodialysis and the advanced age of the patients of our study.