title: A random phase II study of mitoxantrone and cisplatin in patients with hepatocellular carcinoma. An ECOG study.
abstract: Of 86 patients entered in an Eastern Cooperative Oncology Group (ECOG) random Phase II study of mitoxantrone (DHAD) and cisplatin (DDP) in primary liver cancer, 69 were eligible. Nine of the 13 ineligible patients were excluded after a pathology review. Sixty-one percent of the patients were North American, and 39% were South African. The most common severe or the worst toxicity on DHAD was hematologic; and to DDP, hematologic and vomiting. Of the 69 eligible patients, 21 experienced severe, life-threatening or fatal toxic reactions. Two patients treated with DDP had partial responses. With a 95% confidence interval, the true response rate to DHAD was less than 8%, and to DDP, less than 17%. The median survival time was 14 weeks on both drugs. Assuming a proportional hazards model, factors that are significantly associated with survival are patient performance status, the presence of the symptoms, raised bilirubin and hepatomegaly, and clinical evidence of cirrhosis. Any differences between survival rates for South African and North American patients were largely explainable by these factors.
authors.affiliation: Department of Medical Oncology, University of Pretoria, South Africa.
authors.forename: G
authors.initials: G
authors.lastname: Falkson
authors.forename: L M
authors.initials: LM
authors.lastname: Ryan
authors.forename: L A
authors.initials: LA
authors.lastname: Johnson
authors.forename: I W
authors.initials: IW
authors.lastname: Simson
authors.forename: B J
authors.initials: BJ
authors.lastname: Coetzer
authors.forename: P P
authors.initials: PP
authors.lastname: Carbone
authors.forename: R H
authors.initials: RH
authors.lastname: Creech
authors.forename: A J
authors.initials: AJ
authors.lastname: Schutt
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage / Q000009:adverse effects; D011379:Prognosis; D011897:Random Allocation
chemical_list: D008942:Mitoxantrone; D002945:Cisplatin