[Phase III controlled studies of bestatin in malignant tumors of the skin--results of treatment of squamous cell carcinoma and genital Paget's disease].
We have performed a co-operative controlled clinical study of Bestatin in the treatment of malignant tumors of the skin at 18 research institutions in Japan. Twenty-seven Bestatin-treated cases of stage I and II squamous cell carcinoma and 24 control cases were followed up for a maximum of 46 months, to compare disease-free and survival rates in the 2 groups. There was no significant difference in either rate between the groups, though each rate was slightly higher for the Bestatin-treated group. Eight Bestatin-treated cases of genital Paget's disease and 8 control cases were similarly followed up. The survival rate was slightly higher for the Bestatin-treated group, but each group consisted of too small a number of cases to demonstrate the utility of Bestatin. The data obtained up to now only suggest the future potentiality of Bestatin treatment for these types of malignancy. For this reason, the data from phase III studies of Bestatin, including previously reported findings on malignant melanoma, proved Bestatin to be useful in treating stage Ib and II malignant melanoma, but were only suggestive of its potential indication in the treatment of other malignant tumors of the skin. Although Bestatin was administered for long periods (a mean of 21.5 months), only mild gastrointestinal disturbances were observed as adverse reactions to the drug in 4.5% of cases.
Ikeda
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S
Ishihara
K
K
Taguchi
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G
D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D004334:Drug Administration Schedule; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy*; D005834:Genital Neoplasms, Male / Q000188:drug therapy*; D006801:Humans; D007930:Leucine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010145:Paget Disease, Extramammary / Q000188:drug therapy*; D012878:Skin Neoplasms / Q000188:drug therapy*
D000903:Antibiotics, Antineoplastic; D007930:Leucine; C012211:ubenimex