A pilot study of combination therapy of radiation and local administration of OK-432 for esophageal cancer. Five-year survival and local control rate.

Abstract

Combination therapy consisting of radiation and local administration of OK-432 was administered to 73 patients with esophageal cancer without distant metastases. Seventy patients were examined. The average age was 71 years. There were 60 males and 10 females. The mean tumor length was 7.0 cm. One mg of OK-432 was administered endoscopically to and around the cancerous lesion at the beginning of radiotherapy and a second dose of 0.5 mg of OK-432 was given in the same manner 2 weeks later. X-ray irradiation was given at a daily dose of 1.6-1.8 Gy, five fractions a week. The average total dose was 61.1 Gy. Complete responses were obtained in 49 of the 70 patients (70.0%), and partial responses (PR) in the remaining 21. The 5-year cause-specific survival rate of the 70 patients was 33.1%. The 5-year survival rate of the 49 patients with CR was 44.9%, and there were no patients with PR who survived more than 2 years. The 5-year survival rate of the 13 patients with T1 (UICC, 1987) was 79.6%, of the 24 patients with T2/3 41.1%, and of the 33 patients with T4 11.6%. The 5-year survival rates of the 18 patients with tumors less than 5 cm in length and the 40 patients with tumors 5 to 10 cm were 59.9 and 37.9%, respectively. In the patients with tumors more than 10 cm in length, the 4-year survival rate was 14.6%. Sixty-nine of the 70 patients were discharged in good condition and were able to take food orally. This combination therapy may contribute not only to the survival rate, but also to patients' quality of life.