[Results of clinical study with epirubicin hydrochloride injectable solution in hepatoma].
A 10-center cooperative clinical study with a new formulation of epirubicin hydrochloride injectable solution (Epirubicin-RTU) was conducted in patients with hepatocellular carcinoma. Epirubicin-RTU 60 mg/m2 was injected into the hepatic artery and a three-week drug-free interval followed. Of 15 patients with hepatocellular carcinoma registered in this study, 14 patients were eligible, and they all completed the entire course. The objective was to investigate the safety of treatment with Epirubicin-RTU in 14 eligible patients. The adverse drug reactions frequently observed in these 14 eligible cases were leukopenia, neutropenia, thrombocytopenia, alopecia, and fever. They were all reversible and tolerable. With these results. Epirubicin-RTU was considered to be a safe pharmaceutical product to inject into the hepatic artery.
Dept. of Surgery II, Osaka University Medical School.
M
M
Monden
H
H
Nakamura
E
E
Yayoi
T
T
Monden
H
H
Ohi
J
J
Arisawa
M
M
Masuzawa
T
T
Shimizu
N
N
Tomono
K
K
Seki
N
N
Nakao
A
A
Todo
Y
Y
Inoue
M
M
Sakon
Y
Y
Ohsaki
T
T
Hosoki
D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D006528:Carcinoma, Hepatocellular / Q000188:drug therapy*; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005334:Fever / Q000139:chemically induced; D006499:Hepatic Artery; D006801:Humans; D007269:Injections, Intra-Arterial; D007970:Leukopenia / Q000139:chemically induced; D008113:Liver Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D013921:Thrombocytopenia / Q000139:chemically induced
D000903:Antibiotics, Antineoplastic; D015251:Epirubicin