CEOP-B ALTERNATED WITH VIMB IN INTERMEDIATE-GRADE AND HIGH-GRADE NON-HODGKINS-LYMPHOMA - A PILOT-STUDY

Purpose: To improve response and toxicity in treatment of non-Hodgkin' s lymphomas (NHLs), a prospective single-arm trial was initiated using cyclophosphamide, epirubicin, vincristine, prednisone, and bleomycin (CEOP-B) alternated with etoposide (VP-16), ifosfamide, mitoxantrone, and bleomycin (VIMB). Patients and Methods: From December 1988 to Apri l 1992, 60 consecutive previously untreated patients with intermediate - or high-grade NHL were admitted to the study and were assessable. Pa tient characteristics were as follows: 32% greater than 60 years of ag e, 63% with stage III to IV disease, 42% with a performance status (PS ) of 2 or 3, 23% with high lactate dehydrogenase (LDH) levels, and 22% with two or more extranodal disease sites. Stage I and II patients re ceived three cycles of CEOP-B/VIMB plus radiotherapy (RT) to involved fields; stage III and IV patients received four cycles of chemotherapy alone. Results: The complete remission (CR) rate was 77%; actuarial 4 8-month overall survival (OS) and time to treatment failure (TTF) rate s were 70% and 59%, respectively. With univariate analysis, CR, OS, an d TTF rates were significantly influenced by serum LDH levels (P = .04 85, P = .0017, and P = .0064, respectively) and performance status (P = .0005, P < .00005, and P = .0001, respectively). The actuarial 48-mo nth disease-free survival (DFS) rate was 83% and was negatively influe nced only by high-grade histology (P < .004). Toxicity was mild. A low er epirubicin dose-intensity (DI) wets found in patients older than 60 years of age, with a borderline P value. Patients were divided into f our groups according to the International Prognostic Factor Project; l ow-risk and low-intermediate-risk groups had similar OS and TTF rates; when considered together, they showed superior, but not statistically significant, OS and TTF rates as compared with the high-intermediate- risk group, which in turn had significantly superior OS and TTF rates when compared with the high-risk group. Conclusion: CEOP-B/VIMB compar es favorably with third-generation regimens and results in lower toxic ity. J Clin Oncol 13:953-960. (C) 1995 by American Society of Clinical Oncology.