A randomized trial of high dose cyclophosphamide, vincristine, and prednisone plus or minus doxorubicin (CVP versus CAVP with long-term follow-up in advanced non-Hodgkin's lymphoma

Ninety-three stage III and IV patients with non-Hodgkin's lymphoma were randomized to either high dose CVP (cyclophosphamide 1500 mg/m² 1.v. day 1, vincristine 1.4 mg/m² day 1, and prednisone 40 mg/m² orally days 1-10) or high dose CAVP (cyclophosphamide 1000 mg/m² i.v. day 1, doxorubicin 45 mg/m² i.v. day 1, vincristine and prednisone as above). Overall, the complete response (CR) rates were similar (CVP 51%, CAVP 51%). Patients with the International Working Formulation diffuse large cell lymphoma had significantly higher CR with CAVP. No difference in CR duration was detected between the two regimens. CRs were durable with 68% of diffuse and 86% of diffuse large cell complete responders alive and disease free at 7 years. Survival was similar with both regimens except for patients with diffuse large cell lymphoma who survived longer with CAVP. Both regimens were equitoxic with neutropenia <1.0 x 10⁹/liter in 36% of courses, infections in 15% of courses, and fatal infections in three patients. These intermittent high dose cyclophosphamide equitoxic regimens produce durable responses. However, the doxorubicin-containing regimen is superior in diffuse large cell lymphoma.