Key result
Adriamycin increased median survival to 10.6 weeks versus 7.5 weeks with no antitumor therapy in inoperable HCC (P=0.036), but caused fatal complications in 25% of patients.
Why the study?
Does doxorubicin improve survival in patients with inoperable hepatocellular carcinoma?
RCT (n=106)
randomized
Does doxorubicin improve survival in patients with inoperable hepatocellular carcinoma?
Although doxorubicin slightly prolonged median survival in inoperable HCC, its clinical utility is severely limited by a 25% rate of fatal complications, including unpredictable cardiotoxicity and septicemia.
Doxorubicin's toxicity precludes routine use in inoperable HCC; challenges its adoption and extends need for safer alternatives.
To assess the efficacy and safety of Adriamycin (Adria Laboratories, Columbus, OH) in inoperable hepatocellular carcinoma (HCC), 60 patients were randomized to receive Adriamycin 60 to 75 mg/m2 at 3-week intervals and 46 patients to receive no antitumor therapy. The median survival rate of the Adriamycin group was 10.6 weeks; that of the group receiving no antitumor therapy was 7.5 weeks (P = 0.036). Adriamycin induced tumor regression of 25% to 50% in 5% of patients and of over 50% in only 3.3% of patients. It caused fatal complications (septicemia and cardiotoxicity) in 25% of patients. The severity of neutropenia leading to septicemia for a particular dose was unpredictable. Four of eight patients who developed cardiotoxicity received less than 500 mg/m2 of Adriamycin. We conclude that Adriamycin is not an ideal drug for the treatment of inoperable HCC.
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Lai et al. (1988) conducted an RCT in inoperable hepatocellular carcinoma (n=106). Adriamycin vs. no antitumor therapy was evaluated on median survival (weeks) (p=0.036). Adriamycin increased median survival to 10.6 weeks versus 7.5 weeks with no antitumor therapy in inoperable HCC (P=0.036), but caused fatal complications in 25% of patients.
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