A phase I-II trial of mitoxantrone by hepatic arterial infusion in patients with hepatocellular carcinoma or colorectal carcinoma metastatic to the liver

摘要: Background. Mitoxantrone is an anthraquinone derivative that has demonstrated encouraging preclinical and clinical activity against a variety of human carcinoma cell lines malignancies. Three Phase II studies systemically administered mitoxantrone in patients with colorectal failed to demonstrate any therapeutic activity, as did four intravenous hepatocellular carcinoma. Two additional trials limited when intravenously However, because this drug exhibits steep dose-response curve, I-II trial by hepatic arterial infusion was initiated. Methods. Patients metastatic liver only or liver-predominant disease were eligible for therapy. All underwent the placement percutaneous catheter before each course therapy, first cohort treated at 10 mg/m2/ on day 1 28-day cycle. Dosages escalated increments 2 mg/m2/course based side effects tolerance. Results. Twenty-eight bidimensionally measurable unresectable, entered into trial. The therapy well tolerated, 5 courses 55 being complicated neutropenia none associated fever. Only one patient required dosage reduction basis toxicity (neutropenia). No complete partial responses observed. Conclusion. These data are consistent lack treatment cancer.