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In a prospective clinical trial, 39 patients with advanced hepatocellular carcinoma were randomized to receive either Adriamycin (20 patients) or a combination of 5-fluorouracil, methotrexate, cyclophosphamide, and vincristine (19 patients). Five patients receiving Adriamycin and none receiving quadruple chemotherapy responded (P less than 0.05 in favor of Adriamycin). A further 25 patients were treated with Adriamycin, making a total of 45. The overall objective response rate was 24% (11 patients), with 3 complete remissions and 8 partial remissions. The median survival for Adriamycin-treated patients (13.0 weeks for the first 20 patients and 14.4 weeks for all patients) was longer than those treated by quadruple chemotherapy (6.5 weeks). The difference, however, was not significant by the Wilcoxan test as modified by Gehan. Patients with positive HbsAg had a significantly higher chance of having a response, while serum alpha-fetoprotein levels did not correlate with response.
Choi et al. (1984) studied this question.
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