Randomized comparison of ACVBP and m-BACOD in the treatment of patients with low-risk aggressive lymphoma: The LNH87-1 study

Purpose: To compare ct short intensified regimen followed by sequential con solidation therapy (doxorubicin, cyclophosphamide, vindesine, bleomycin, an d prednisone [ACVBP]) to the standard regimen of methotrexate, bleomycin, c yclophosphamide, and etoposide (m-BACOD) in patients with low-risk aggressi ve lymphoma. Patients and Methods: A total of 752 patients with intermediate or high-gra de lymphoma and no adverse prognostic factors (Eastern Cooperative Oncology Group performance status of 2 to 4, greater than or equal to two extranoda l sites of disease, tumor burden greater than or equal to 10 cm in largest dimension, bone marrow or CNS involvement, Burkitt's or lymphoblastic subty pes) were registered. Of 673 eligible patients, 332 received ACVBP and 341 received m-BACOD. Results: The complete remission rate wets identical (86%) in the two groups . With a median follow-up duration of 7 years, the 5-year failure-free surv ival (FFS) rate wets 65% in the ACVBP group and 61% in the m-BACOD group (P = .16), The 5-year overall survival rate wets 75% in the ACVBP group and 7 3% in the m-BACOD group (P = .47). ACVBP was responsible for more severe an d life-threatening infections (P < .01), but m-BACOD caused more pulmonary toxicity (P < .001). The number of treatment-related deaths did not differ between the two regimens. A multivariate analysis indicated that ACVBP wets associated with a longer FFS in patients with two or three risk factors of the International Prognostic Index. Conclusion: In this population of patients with low-risk aggressive lymphom a, toxicities of the regimens are different, but the rates of response and survival are identical. The survival advantage of ACVBP over standard regim en in patients with advanced disease is suggested by this analysis but rema ins to be assessed in prospective studies specifically designed for this pu rpose. (C) 2000 by American Society of Clinical Oncology,