두경부 편평세포암종에 대한 UFT 투여 후 항종양효과에 관한 제2상 임상 연구

A Phase n Study on UFT Therapy for Head and Neck Squamous Cell Carcinoma

두경부에 발생한 편평세포암종 68례(재발암 32례 포함)에 대하여 UFT(400mg/m²)를 6∼8주간 경구투여한 후 항종양효과를 관찰한 제2상 임상시험결과 다음파 같은 성적을 얻었다. 1) 치료 경험이 없었던 두경부 편평세포암종 32례에 대한 주효융은 38.89%, 재발암종 32례에 대한 주효율은 21.88%로서, 평균 주효율은 30.88% 이었다. 2) 암종의 병기에 따른 주효융은 임상적으로 초기병기에서 높았으며, 병리조직학적으로 분화도가 좋은 경우에 높았고, 치료효과의 발현시기는 4주와 5주째가 높은 경향올 보였다. 3) 부작용은 식욕부진, 오심 및 구토가 다수 있었으나 용량을 반으로 감량하거나 일시 중단함으로써 극복이 가능하였으며 중증 부작용은 없었다. 이상의 성적에서 UFT는 두경부 편평세포암종에서 항암효과가 있으며, 투여방법이 간편하고 부작용이 적어 병합항암화학요법이나 고식적 항암화학요법으로 널리 이용될 수 있을 것으로 생각되었다.

A Phase II study of UFT which is a mixture of Tegafur and Uracil was conducted in two institutions during past two years. Ninty-four patients of head and neck squamous cell carcinoma entered this trial, of which sixty-eight were evaluated. Among those, thirty-six cases were previously untreated and thirty-two cases were recurrent. UFT was administrated orally at a daily dose of 400mg/m² for eight weeks. The results were as following: 1) Overall response was 30.88%, but for 38.36% for 36 cases of the untreated cases, 21.88% for 32 cases of recurrent cases. 2) UFT was more effective in early stage and well differentiated squamous cell carcinoma and UFT tended to reduce the tumor size maximally at fourth or fifth week 3) There was no serious side effects except mild gastrointestinal disturbances such as nausea and vomiting, which were recovered immediately after stop or reducing a daily dose. Therefore, UFT therapy is clinically effective for head and neck squamous cell carcinoma and also may be useful for combination or palliative chemotherapy because of mild side effects.