This randomized, phase III trial by the Gynecologic Oncology Group (GOG) was designed to compare treatment with intravenous paclitaxel plus cisplatin with intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel in patients with stage III ovarian cancer. study. End points were the progression-free and overall survival. Eligibility criteria included a primary diagnosis of stage III ovarian cancer with no residual mass greater than 1.0 cm after surgical treatment, at least a moderate activity level, normal blood counts, and adequate renal and hepatic function. Patients randomized to the intravenous therapy group received 135 mg intravenous paclitaxel per square meter of body surface area over a 24-hour period on day 1 and 75 mg intravenous cisplatin per square meter on day 2. Patients in the intraperitoneal therapy group were given 135 mg intravenous paclitaxel per square meter of body surface for 24 hours followed by 100 mg intraperitoneal cisplatin per square meter on day 2 and 60 mg intraperitoneal paclitaxel per square meter on day 8. New cycles were not started until neutrophil counts were greater than 1500 cells/mm 3 , platelet counts were ≥1,000,000 cells/mm 3 , and creatinine levels were ≤2.0 mg/dL. Participants were removed from the study when new cycles were delayed for more than 3 weeks. In the intraperitoneal group, patients who experienced grade 2 abdominal pain were given lower doses of the intraperitoneal drug. Persistent grade 2 abdominal pain, or grade 3 abdominal pain, or complications involving the intraperitoneal catheter resulted in a conversion to intravenous therapy for the remaining cycles. Carboplatin replaced cisplatin if severe toxicity resulting from cisplatin developed. Of the 415 women who met all eligibility criteria, 210 were randomized to the intravenous group, and 205 were assigned to the intraperitoneal group. Ninety percent of patients in the intravenous group completed six cycles of chemotherapy, and 83% received six cycles of the assigned intravenous therapy. In comparison, 83% of women in the intraperitoneal group completed six cycles of chemotherapy, but only 42% received all six cycles of the assigned intraperitoneal therapy. Compared with the intravenous group, the intraperitoneal therapy group had significantly more grade 3 or 4 adverse events, the most severe of which were fatigue, pain, or hematologic, gastrointestinal, metabolic, or neurologic toxic effects (P ≤.001 for all). After a median follow up of 48.2 months for the intravenous group and 52.6 months for the intraperitoneal therapy group, the median progression-free survivals were 18.3 months and 23.8 months, respectively (Fig. 1). The median overall survival was 49.7 months in the intravenous group compared with 65.6 months for the intraperitoneal group (Fig. 2). Quality-of-life assessments were made at baseline, before the fourth cycle, 3 to 6 weeks after the sixth cycle, and 12 months after the sixth cycle. After adjustments for confounding factors, the patients receiving intraperitoneal therapy reported lower quality-of-life scores at the prefourth cycle assessment (P <.001) and 3 to 6 weeks after completion of therapy (P =.009) compared with the patients in the intravenous group. However, 12 months after treatment, there were no differences in quality of life between the two groups.

Intraperitoneal cisplatin and paclitaxel in ovarian cancer

BACKGROUNDEndothelium-dependent vasodilation is abnormal in experimental models of diabetes mellitus. We postulated that abnormalities of endothelial function are also present in patients with insulin-dependent diabetes mellitus and may contribute to the pathogenesis of vascular disease in these individuals.METHODS AND RESULTSVascular reactivity was measured in the forearm resistance vessels of 15 patients with insulin-dependent diabetes mellitus and 16 age-matched normal subjects. No patient had hypertension or dyslipidemia. Each subject was pretreated with aspirin to inhibit endogenous production of prostanoids. Methacholine chloride (0.3 to 10 micrograms/min) was administered via the brachial artery to assess endothelium-dependent vasodilation. Sodium nitroprusside (0.3 to 10 micrograms/min) and verapamil (10 to 300 micrograms/min) were infused intra-arterially to assess endothelium-independent vasodilation; phenylephrine (0.3 to 3 micrograms/min) was administered to examine vasoconstrictor responsiven...

Impaired endothelium-dependent vasodilation in patients with insulin-dependent diabetes mellitus.

Impaired nitric oxide-mediated vasodilation in patients with non-insulin-dependent diabetes mellitus☆

Platelet-Active Drugs: The Relationships Among Dose, Effectiveness, and Side Effects

The past 10 years have witnessed major changes in our understanding of the pathophysiologic mechanisms underlying vascular occlusion1,2 and considerable progress in the clinical assessment of aspirin and other antiplatelet agents3–5. The purpose of this review is to describe a rational basis for antithrombotic prophylaxis and treatment with aspirin. Basic information on the molecular mechanism of action of aspirin in inhibiting platelet function will be integrated with the appropriate clinical pharmacologic data and the results of randomized clinical trials. Mechanism of Action Aspirin induces a long-lasting functional defect in platelets, clinically detectable as a prolongation of the . . .

https://www.nejm.org/doi/pdf/10.1056/NEJM199405053301808?listPDF=true

Aspirin as an antiplatelet drug.

We studied the ability of a single oral dose of aspirin to inhibit prostacyclin synthesis by human arterial and venous tissue and to inhibit thromboxane A2 synthesis by platelets in 70 patients who were undergoing aortocoronary bypass. A dose of 40, 80, or 325 mg of aspirin was administered 12 to 16 hours before surgery. The generation of thromboxane in serum--which provides an estimate of platelet thromboxane production--was reduced from the control value by 77, 95, and 99 per cent after single doses of 40, 80, and 325 mg of aspirin, respectively. By contrast, prostacyclin production in aortic tissue that was removed at operation was reduced by only 35, 38, and 75 per cent, respectively, in response to these doses. Production of prostacyclin in saphenous-vein tissue (not tested after 40 mg of aspirin) fell only slightly and not significantly after 80 mg but was reduced by 85 per cent after 325 mg. These findings indicate that a low dose of aspirin (40 to 80 mg) can largely inhibit platelet aggregation and thromboxane synthesis but has much less effect on prostacyclin production in arterial and venous endothelium.

Differential Inhibition by Aspirin of Vascular and Platelet Prostaglandin Synthesis in Atherosclerotic Patients

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Differential Inhibition by Aspirin of Vascular and Platelet Prostaglandin Synthesis in Atherosclerotic Patients