PubMed · 7257351
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F L Iber. 1981. Ascites.. https://pubmed.ncbi.nlm.nih.gov/7257351/
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PURPOSE: Previous phase I and II studies of intraperitoneal recombinant human tumor necrosis factor-alpha (rhTNF-alpha) 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-alpha 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/m2 rhTNF-alpha (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-alpha. RESULTS: None of 18 evaluable rhTNF-alpha 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 < or = 1000 ml of fluid ultrasound). There were no CRs or PRs in the 17 evaluable patients who received drainage alone. The intraperitoneal infusion of rhTNF-alpha 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-alpha. CONCLUSION: rhTNF-alpha, as given in this study, was not effective in preventing recurrence of ascites in this patient population.
Intractable ascites carries great morbidity by affecting appetite, mobility, and quality of life. Peritoneovenous shunts (PVSs) are utilized to abate intractable ascites, although long-term efficacy is unestablished. Thirty male and 18 female cirrhotics, 55 +/- 12 (standard deviation) years of age, failed multiple large-volume paracenteses and diuretic therapy before undergoing PVS. Data were collected until death or the present time. Nine patients (19%) are alive and palliated, four with working shunts [average follow-up (ave. f/u), 30 months] and five without shunts (ave. f/u, 19 months). Thirty-two (67%) patients died: 18 palliated with functional shunts (survival time, 4.4 +/- 5.7 months), 8 unpalliated with dysfunctional shunts (ave. f/u, 3.9 +/- 4.5 months), 4 unpalliated with shunts removed (ave. f/u 5.5 +/- 4.7 months), and 2 with unknown shunt function at death. Function was lost to occlusion in 26 patients, infection in 9, and ligation for disseminated intravascular coagulation in 3. Thirteen patients underwent 18 shunt replacements. At death/present time, 22 (46%) patients were palliated with functioning shunts. Seven patients were lost to follow-up. PVSs provide palliation for intractable ascites short term, but commonly occlude within 1 year. Despite palliation, complications with PVSs are high, and survival is limited.