title: Effect of intraperitoneal recombinant human tumour necrosis factor alpha on malignant ascites.
abstract: 29 patients with refractory malignant ascites due to metastatic peritoneal spread of adenocarcinomas originating from the ovary, gastrointestinal tract, liver, breast and uterus were treated in a phase I trial of intraperitoneal infusions of recombinant human tumour necrosis factor alpha (rhTNF-alpha). Patients received 40-350 micrograms/m2 rhTNF-alpha intraperitoneally once weekly for 2 months or for a shorter period in case of early resolution of ascites. Systemic side-effects resembled those reported for rhTNF-alpha given intravenously. No dose-limiting toxicities were found and thus a maximum tolerated dose of intraperitoneal rhTNF-alpha was not established. Out of 29 patients, 22 responded with a complete (16) or partial (6) resolution of their ascites. There was a less than 50% reduction in 4, and no increase in ascites in 1. 1 patient showed progressive ascites formation, and another patient was not eligible because of early death unrelated to treatment. Trials in patients with smaller tumour burden are warranted.
authors.affiliation: Medizinische Klinik, Ruprecht-Karls-Universität, Heidelberg, Germany.
authors.forename: U
authors.initials: U
authors.lastname: Räth
authors.forename: M
authors.initials: M
authors.lastname: Kaufmann
authors.forename: H
authors.initials: H
authors.lastname: Schmid
authors.forename: J
authors.initials: J
authors.lastname: Hofmann
authors.forename: B
authors.initials: B
authors.lastname: Wiedenmann
authors.forename: A
authors.initials: A
authors.lastname: Kist
authors.forename: J
authors.initials: J
authors.lastname: Kempeni
authors.forename: E
authors.initials: E
authors.lastname: Schlick
authors.forename: G
authors.initials: G
authors.lastname: Bastert
authors.forename: B
authors.initials: B
authors.lastname: Kommerell
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000556:secondary*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001201:Ascites / Q000628:therapy*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D010534:Peritoneal Neoplasms / Q000556:secondary*; D011994:Recombinant Proteins / Q000627:therapeutic use; D014409:Tumor Necrosis Factor-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D011994:Recombinant Proteins; D014409:Tumor Necrosis Factor-alpha