A VM 26‐based regimen for patients with previously untreated non‐Hodgkin lymphoma. Prolonged disease‐free survival in patients younger than 60 years of age: A phase II trial of the eastern cooperative oncology group

Background. The epidophyllotoxin VM 26 has been shown to have single‐agent activity in patients with diffuse aggressive lymphoma. In an attempt to determine its activity in combination with other agents known to be effective in lymphoma, a Phase II trial of a novel chemotherapy regimen was conducted. Methods. Forty‐two patients with Stages II, III, and IV diffuse aggressive lymphoma were treated with teniposide, doxorubicin, prednisone, cyclophosphamide, vincristine, and bleomycin (PATen‐CPOB) as part of a Phase II trial of the Eastern Cooperative Oncology Group. Fifty‐five percent of patients had Stage IV disease, 21% Stage III, and 24% Stage II. Results. The overall complete response rate was 64%. Of the 27 patients who had complete response, 19 (70% [45% of the entire group]) are still alive without disease (median follow‐up, 5.7 years). No patient had a follow‐up time of less than 5 years. On examination of factors that were predictive of survival and relapse, it was found that age younger than 60 years was predictive of long‐term survival, as 76% of patients younger than 60 years of age were alive without disease. Forty patients were evaluable for toxicity. There were four (10%) early deaths, and six patients (15%) had Grade 4 hematologic toxicity. Conclusions. This alternating combination chemotherapy regimen (PATen‐CPOB) results in a complete response rate comparable to what has been reported previously in the literature, but 45% of patients in this series demonstrated long‐term disease‐free survival. When patients younger than 60 years of age with follow‐up times of at least 5 years were considered, disease‐free survival was 76%.