Abstract
Purpose: Previous phase I and II studies of intraperitoneal recombinant human tumor necrosis factor-α (rhTNF-α) suggested a high degree of efficacy in reducing or eliminating ascitic fluid. To more accurately determine the efficacy of this agent, the role of paracentesis versus paracentesis plus intraperitoneal rhTNF-α was studied in a randomized trial. Patients and methods: Thirty-nine patients with symptomatic ascites with a volume of >1000 ml from recurrent epithelial ovarian carcinoma or primary peritoneal carcinoma, which was refractory to standard therapy, were randomized either to receive 0.06 mg/m2rhTNF-α (Knoll, Canada) (the dose determined optimal from phase I and II studies) intraperitoneally after drainage of fluid or to receive drainage alone. A maximum of three treatments were given at weekly intervals. Eighteen patients were randomized to receive rhTNF-α. Results: None of 18 evaluable rhTNF-α patients had either a complete response (CR) (no clinical evidence of ascites and <400 ml of fluid on ultrasound) or a partial response (PR) (asymptomatic ascites and ≤1000 ml of fluid on ultrasound). There were no CRs or PRs in the 17 evaluable patients who received drainage alone. The intraperitoneal infusion of rhTNF-α was generally well tolerated. Moderate to severe toxicity consisted of pain/discomfort in 42.1%, fever/chills in 36.9%, nausea/vomiting in 10.5%, edema in 10.5%, and hypotension in 5.3% of patients receiving rhTNF-α. Conclusion: rhTNF-α, as given in this study, was not effective in preventing recurrence of ascites in this patient population.
Published Version
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