High-Dose Chemotherapy and Autologous Bone Marrow Transplantation Compared with MACOP-B in Aggressive B-Cell Lymphoma

Alessandro M. Gianni(Fondazione IRCCS Istituto Nazionale dei Tumori), Marco Bregni(Fondazione IRCCS Istituto Nazionale dei Tumori), Salvatore Siena(Fondazione IRCCS Istituto Nazionale dei Tumori), Cristina Brambilla(Fondazione IRCCS Istituto Nazionale dei Tumori), Massimo Di Nicola(Fondazione IRCCS Istituto Nazionale dei Tumori), Fabrizio Lombardi(Fondazione IRCCS Istituto Nazionale dei Tumori), Lorenza Gandola(Fondazione IRCCS Istituto Nazionale dei Tumori), Corrado Tarella(University of Turin), Alessandro Pileri(University of Turin), Fernando Ravagnani(Fondazione IRCCS Istituto Nazionale dei Tumori), Pinuccia Valagussa(Fondazione IRCCS Istituto Nazionale dei Tumori), Gianni Bonadonna(Fondazione IRCCS Istituto Nazionale dei Tumori)
New England Journal of Medicine
May 1, 1997
Cited by 478Open Access
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Abstract

BACKGROUND: We compared a regimen of six chemotherapeutic agents administered sequentially at high doses, followed by myeloablative treatment and bone marrow transplantation, with a regimen of methotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin (MACOP-B) as initial or salvage treatment for adults with diffuse large-cell lymphoma. METHODS: Ninety-eight eligible patients with diffuse large-cell lymphoma of the B-cell type were randomly assigned to receive either MACOP-B (50 patients) or high-dose sequential therapy (48 patients). The study design allowed for patients in whom the assigned treatment failed to cross over to the other treatment group. RESULTS: After a median follow-up of 55 months, the patients given high-dose sequential therapy, as compared with those treated with MACOP-B, had significantly higher rates of complete response (96 percent vs. 70 percent, P=0.001), freedom from disease progression (84 percent vs. 49 percent, P<0.001), freedom from relapse (88 percent vs. 70 percent, P=0.055), and event-free survival (76 percent vs. 49 percent, P=0.004). The difference in overall survival at seven years, which also favored the group assigned to high-dose sequential therapy, was marginally significant (81 percent vs. 55 percent, P=0.09). CONCLUSIONS: High-dose sequential therapy is superior to standard-dose MACOP-B for patients with diffuse large-cell lymphoma of the B-cell type.


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