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%.