頭頸部扁平上皮癌に対するベスタチン療法

多施設によるrandomized controlled study

抄録

In order to evaluate the adjuvant effect of Bestatin, an immunomodulator, on cancer, a randomized controlled study was performed in 365 cases with squamous cell carcinoma of the head and neck. Patients were initially divided into 2 groups, i. e. one for curative cancer therapy alone and the other for curative cancer therapy plus adjuvant Bestatin therapy. Bestatin (30mg/day) was given for 2 years together with curative cancer therapy. The number of evaluable cases was 325 in total; 165 in the Bestatin adjuvant group and 160 in the control group. The prognoses were followed up during the period of 2 years after initiation of therapy. The percentage of absolute 2-year survivals in the Bestatin adjuvant group was 80.5%, while 70.9% in the control group. There was a tendency toward difference between 2 groups (p<0.1). The survival time and relapse free period were prolonged in the Bestatin adjuvant group when compared with the control group. Mild reversible side effects were observed in 6 patients in 181 cases of the Bestatin group (3.3%). Bestatin therapy was considered to be a useful adjuvant treatment for the head and neck cancer.