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.