Abstract
Background. From 1993 to 1996, 38 patients (32 men and 6 women) with T1-4NxM0 esophageal cancer (International Union Against Cancer [UICC], 1987) entered into a phase II study of combination therapy of radiation and local administration of the biological resporse modifier, OK-432. The average age of the patients was 64 years. The average tumor length was 7.9cm. Seven patients were T1; 12, T2-3; and 19, T4.
Methods. OK-432 (0.5mg) was administered endoscopically around the cancerous lesion at the beginning of radiotherapy, and the same dose 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 mean total dose was 62 Gy.
Results. Complete response (CR) was achieved in 23 of the 38 patients (60.5%) and partial response (PR) was achieved in the remaining 15 patients. The 3-year cause-specific survival rate was 39.6% (overall, 29.4%). The 3-year survival rates of CR and PR patients were 74%, and 0.0%, respectively, and the 2-year survival rate of PR patients was 7.8%, a significant difference (P < 0.001). The 3-year survival rates of the T1-3 and T4 patients (UICC, 1987) were 73.0% and 14.0%, respectively, a significant difference (P < 0.001). The 3-year survival rates of the 9 patients with tumors less than 5 cm in length, and of the 18 patients with tumors 5–10cm long were 80% and 54.2%, respectively. In the 11 patients pith tumors more than 10 cm in length, the 2-year survival rate was 9.0%. The 3-year survival rate of the 18 patients with tumors less than 7 cm was 92.3 %, and the 2-year survival rate of the 20 patients with tumors over 7cm long was 16.7%/x, a significant difference (P < 0.001). All 38 patients were discharged in good condition and were able to take food orally.
Conclusion. This combination therapy could contribute not only to improving the survival rate, but also to improving the patients' quality of life.
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Mukai, M., Morita, S. Phase II study of combination therapy of radiation and local administration of OK-432 for esophageal cancer. Int J Clin Oncol 3, 370–373 (1998). https://doi.org/10.1007/BF00539215
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DOI: https://doi.org/10.1007/BF00539215