Räth U, Kaufmann M, Schmid H, Hofmann J, Wiedenmann B, Kist A, Kempeni J, Schlick E, Bastert G, Kommerell B
Medizinische Klinik, Ruprecht-Karls-Universität, Heidelberg, Germany.
Eur J Cancer. 1991;27(2):121-5. doi: 10.1016/0277-5379(91)90467-r.
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.
29例因卵巢、胃肠道、肝脏、乳腺和子宫来源的腺癌腹膜转移导致难治性恶性腹水的患者，参与了一项腹腔内输注重组人肿瘤坏死因子α（rhTNF-α）的I期试验。患者每周一次腹腔内接受40 - 350微克/平方米的rhTNF-α，共2个月；若腹水早期消退，则治疗时间较短。全身副作用与静脉注射rhTNF-α时报告的类似。未发现剂量限制性毒性，因此未确定腹腔内rhTNF-α的最大耐受剂量。29例患者中，22例腹水完全（16例）或部分（6例）消退。4例腹水减少不到50%，1例腹水未增加。1例患者出现进行性腹水形成，另1例患者因与治疗无关的早期死亡而不符合条件。有必要对肿瘤负荷较小的患者进行试验。
