Prospective randomized study on inductive chemotherapy plus radiotherapy for patients with upper and middle esophageal carcinoma

Objective: To evaluate the effect of radiotherapy combined with inductive chemotherapy for patients with upper and middle esophageal cancer. Methods: 162 patients with upper and middle esophageal cancer were randomized into two groups, with 82 treated by inductive chemotherapy combined with radiotherapy (C + R) and 80 by radiotherapy alone (R). The chemotherapy regimen included 5-fluorouracil 500 mg/m2 on d1-d5 by continuous infusion for 120 hours, cisplatin 60 mg/m2 on dl and bleomycin A5 8 mg on d1, d3, d5 intravenously. Three to seven days after chemotherapy, the patients were irradiated with anteroposterior (AP) and posteroanterior (PA) fields to a dose of 40-44 Gy in 4.0-4.4 weeks followed by a boost of 24-28 Gy in 2.4-2.8 weeks through oblique fields. Results: The 5- and 10-year survival rates were 22.0%, 15.9% for the C + R group and 13.8%, 8.8% for the R group. The difference was statistically significant (P = 0.034). The toxic and side effects were tolerable and similar in the two groups. Nineteen patients (23%) in the C + R group and thirty-one (39%) in the R group died from distant metastasis and/or lymph node metastasis, even though the difference was not statistically significant (x2 = 3.47, P > 0.05). Conclusions: Inductive chemotherapy with 5-fluorouracil, cisplatin, bleomycin A5 plus radiotherapy may improve the outcome of esophageal cancer, with the toxic and side effects of the combined modality severer than radiation along, but they are well tolerated