Conventional treatment of carcinoma of the esophagus by surgery and radiation therapy has had extremely unsatisfactory results. The vast majority of patients die of their disease within one year of diagnosis, and fewer than 5% of all patients are expected to be alive at 5 years. This is due to both the lack of response to conventional cancer therapy as well as the poor nutritional state of the patients because of anorexia and esophogeal obstruction. Recently we have been able to demonstrate a major objective response in 50% of the patients with operable epidermoid carcinoma of the esophagus who were given one course of preoperative chemotherapy with cisplatin, bleomycin and vindesine. Their resectability rate was 76%. This was significantly better than the 54% resectability rate observed with preoperative radiation therapy in a historical control group treated by us. We have expanded into a program with two courses of chemotherapy in hopes of further improving the resectability rate and reducing metastatic disease. Preoperative chemotherapy and preoperative external radiation therapy can only be compared adequately in a randomized trial. We therefore propose to evaluate them in a clinical trial, randomizing patients with operable esophageal carcinoma to receive either two preoperative courses of cisplatin, bleomycin and vindesine or preoperative irradiation. If residual carcinoma is present in patients treated by chemotherapy and surgery, therapeutic external irradiation will be given. Conversely, chemotherapy and surgery, therapeutic external irradiation will be given. Conversely, chemotherapy will be given to patients with residual carcinoma after radiation and surgery. All patients will receive intensive nutritional support, both pre- and postoperatively, to enhance their response to and tolerance of treatment. It is estimated that 100 patients will enter the trial during the first three years of the study. By this intensive multimodel approach we seek to lengthen the disease-free interval, and improve survival in patients with epidermoid carcinoma of the esophagus.
| Kelsen, D P; Minsky, B; Smith, M et al. (1990) Preoperative therapy for esophageal cancer: a randomized comparison of chemotherapy versus radiation therapy. J Clin Oncol 8:1352-61 |
| Safai, B; Sarngadharan, M G; Koziner, B et al. (1985) Spectrum of Kaposi's sarcoma in the epidemic of AIDS. Cancer Res 45:4646s-4648s |
| Safai, B; Johnson, K G; Myskowski, P L et al. (1985) The natural history of Kaposi's sarcoma in the acquired immunodeficiency syndrome. Ann Intern Med 103:744-50 |
