A phase I study of chemoembolization with cisplatin, thiotepa, and lipiodol for primary and metastatic liver cancer

Thirty patients with primary hepatocellular carcinoma or liver metastases w ere entered into a program of chemoembolization with cisplatin, lipiodol, a nd escalating doses of thiotepa. Doses of cisplatin were 100/m(2), and thio tepa doses ranged from 9 mg/m(2) to 24 mg/m(2). Two of three patients with ocular melanoma had partial responses in the liver metastases for 3+ and 16 months. In patients with either hepatocellular carcinoma (15 patients) or primary cholangiocarcinoma of the liver (three patients), there were two pa rtial responses, for 22 and 33 months. Five patients had minor responses: f our with a 40% reduction in tumor and one with a mixed response. There were four early deaths, which involved sepsis in two patients, respiratory fail ure in one, and acute myocardial infarction in one. Otherwise, toxicity was tolerable and reversible and included abdominal pain and transient elevati on of serum creatinine, bilirubin, and transaminases. Less common toxicitie s included ototoxicity and peripheral neuropathy. Chemoembolization of the liver with cisplatin, thiotepa, and lipiodol can produce responses, but tox icity can be significant. The recommended starting phase II dose for future studies is thiotepa 24 mg/m(2) and cisplatin 100 mg/m(2).