title: The preventive effect of antineoplaston AS2-1 on HCC recurrence.
abstract: Once hepatocellular carcinoma (HCC) develops, it repeats intrahepatic metastasis and has multicentric occurrence, which requires frequent treatment. We designed a phase II clinical trail to clarify whether antineoplaston AS2-1, a mixture of sodium salts of phenylacetylglutamine and phenylacetic acid at a ratio of 1:4, prolongs the recurrence-free interval of HCC patients who undergo frequent treatments for recurrence. Ten patients were enrolled in this trial, 2 in stage I, 6 in stage II, 1 in stage III, 1 in stage IV-B at initial diagnosis. Ten patients experienced 35 recurrence-free intervals. Recurrence-free intervals during antineoplaston AS2-1 administration were significantly longer than those without antineoplaston AS2-1 (16.19+/-15.916 versus 5.05+/-2.897 months: p<0.01). Patients who experienced recurrence-free intervals with and without antineoplaston AS2-1 showed longer intervals during antineoplaston AS2-1 administration than those before and after antineoplaston AS2-1 administration (14.47+/-13.821 versus 5.07+/-2.989 versus 5.02+/-3.009 months: p<0.05). Two patients in stage I showed longer recurrence-free intervals than those in more advanced stages. In conclusion, antineoplaston AS2-1 could not prevent recurrence of HCC but prolonged the recurrence-free interval between regional treatments and improved survival rate of these patients.
authors.affiliation: Department of Anesthesiology, Kurume Daiichi Social Insurance Hospital, Kushihara Kurumeshi, Fukuoka 830-0013, Japan.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Tsuda
authors.forename: Michio
authors.initials: M
authors.lastname: Sata
authors.forename: Tutomu
authors.initials: T
authors.lastname: Kumabe
authors.forename: Masafumi
authors.initials: M
authors.lastname: Uchida
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Hara
mesh_terms: D000284:Administration, Oral; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D006528:Carcinoma, Hepatocellular / Q000401:mortality / Q000517:prevention & control*; D004338:Drug Combinations; D005260:Female; D005973:Glutamine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D006801:Humans; D008113:Liver Neoplasms / Q000401:mortality / Q000517:prevention & control*; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D009367:Neoplasm Staging; D010648:Phenylacetates / Q000008:administration & dosage / Q000627:therapeutic use*; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D004338:Drug Combinations; D010648:Phenylacetates; D005973:Glutamine; C092038:antineoplaston AS 2-1