Radiotherapy versus combined therapy in early stages with bulky disease aggressive malignant lymphoma.

The purpose of this study was to evaluate the use of radiotherapy compared with combined therapy (radiotherapy followed by chemotherapy) in early stages (I and II) in patients with diffuse large cell lymphoma and bulky disease. One hundred and thirty patients were randomly assigned to receive either radiotherapy involved field doses range from 40 to 48 Gy (median 44.5 Gy) or the same radiation therapy following chemotherapy (cyclophosphamide, doxorubicin, vincristine and prednisone, by six cycles. Complete response (CR) was achieved in 58 out of 61 patients (95%) of the patients whose received radiotherapy, that was no different to 91% (63 out of 69 patients) in the combined therapy arm. However, at 10-years event-free survival (EFS) was 68% (95% confidence interval (CI): 61-73%) in the radiotherapy arm that was statistical different to 90% (95% CI: 86-94%) in the combined therapy group (p < 0.01). Overall survival (OS) showed statistical differences: 72% (95% CI 67-76%) in the radiotherapy group compared to 89% (95% CI: 84-93%) in the combined therapy arm (p < 0.01). Toxicity was mild in both groups, at this time, no second neoplasm or acute leukemia has been observed. We conclude that combined therapy appear to be superior in patients with early stages and bulky disease in patients with aggressive malignant lymphoma.