A Phase II Trial of Triamcinolone Hexacetanide for Symptomatic Recurrent Malignant Ascites

Abstract

Ascites is a common complication of advanced cancer and frequently requires paracentesis to reduce symptoms of pain, anorexia, and dyspnea. For many patients repeat paracenteses are required at short intervals. We prospectively studied 15 patients with recurrent ascites of malignancy to determine if intraperitoneal triamcinolone hexacetonide, a slowly metabolized corticosteroid, produced objective and symptomatic responses. After biochemical, radiological, and symptom assessment and the establishment of the interval between paracenteses, patients underwent large-volume paracentesis followed by intraperitoneal triamcinolone hexacetonide 10 mg/kg. Patients were followed after treatment for assessment of symptoms and physical signs of ascites. Repeat paracentesis was performed when symptomatic ascites recurred. Symptomatic ascites recurred in 13 of 15 patients, but the interval between paracenteses was extended from 9.5 ± 1.6 days to 17.5 days (P = 0.0086). Symptom questionnaire scores assessing well-being, nausea, abdominal pain, dyspnea, appetite, appearance, and change in abdominal size on a scale from 0 to 6 averaged 3.2 ± 0.3 at entry and 2.5 ± 0.2 at the 2-week assessment (P = 0.026). Self-assessed symptoms, feeling of well-being, abdominal distention, and physical appearance improved significantly. The mean serum cortisol decreased from baseline, suggesting that some systemic corticosteroid absorption occurred. Thirteen of 15 patients have died, with a median survival of 42 days. Potential adverse effects included 1 episode each of transient abdominal pain, bacterial peritonitis, and localized herpes zoster infection. In patients with ascites of malignancy, intraperitoneal triamcinolone hexacetonide appears to postpone the requirement for repeat paracentesis and improve symptoms of malignant ascites.