Immunostaining with Ki-67 monoclonal antibody was performed on frozen sections of biopsy specimens obtained before and during preoperative radiation therapy from 21 patients with head and neck squamous cell carcinoma. The Ki-67 labeling rates before radiation therapy and at radiation doses of 10 and 20 Gy ranged from 21 to 71% (mean: 35.0%), from 7 to 49% (mean: 25.8%) and from 1 to 44% (mean: 14.8%), respectively. One of the 2 patients whose tumors showing Ki-67 labeling rates of greater than 48% (mean+ 1 SD) before radiation therapy suffered local relapse shortly after the treatment. Moreover, tumors with rapidly decreased Ki-67 labeling rates (lower than 3%) at radiation doses of 20 Gy were related to poor clinical outcome: 4 out of 6 patients whose tumors showed Ki-67 labeling rates below 3% (mean-1 SD) at 20 Gy of irradiation had local relapses or showed distant metastases. These findings indicate that immunostaining with Ki-67 monoclonal antibody of biopsy specimens of head and neck squamous cell carcinoma, before and during radiation therapy, is very useful in assessing the clinical outcome of the patients.

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