Survival benefit of high-dose therapy in poor-risk aggressive non-Hodgkin's lymphoma: Final analysis of the prospective LNH87-2 protocol - A Groupe d'Etude des Lymphomes de l'Adulte Study

Purpose: To present the final analysis, with a median follow-up of 8 years, of the LNH87-2 randomized study, which compares consolidative sequential c hemotherapy (ifosfamide plus etoposide, asparaginase, and cytarabine) with high-dose therapy (HDT) using cyclophosphamide, carmustine, and etoposide ( CBV regimen) followed by stem-cell transplantation in patients with aggress ive non-Hodgkin's lymphoma in first complete remission after induction, foc using on high/intermediate- and high-risk patients identified by the age-ad justed international prognostic index. Patients and Methods: Among the 916 eligible patients, 451 presented with t wo (n = 318) or three (n = 133) risk factors. After reaching complete remis sion to induction therapy, 236 of these higher risk patients were assessabl e for the consolidation phase, with 125 patients in the HDT arm and 111 in the sequential chemotherapy arm. Results: Among these 451 higher risk patients, 277 (61%) achieved complete remission after induction treatment. In the population of 236 randomized pa tients, HDT wets superior to sequential chemotherapy, with I-year disease-f ree survival rates of 55% (95% confidence interval [CI], 46% to 64%) and 39 % (95% CI, 30% to 48%), respectively (P = .02; relative risk, 1.56). The 8- year survival rate was significantly superior in the HDT arm (64%; 95% CI, 55% to 73%) compared with the sequential chemotherapy arm (49%; 95% CI, 39% to 59%) (P = .04: relative risk, 1.51). Conclusion.. On the basis of the final analysis of this prospectively treat ed series of patients, retrospectively analyzed on the basis of the Interna tional Prognostic Index, we hypothesize that HDT benefits patients at highe r risk who achieve complete remission after induction treatment. (C) 2000 b y American Society of Clinical Oncology.