Background We compared a regimen of six chemotherapeutic agentsadministered sequentially at high doses, followed by myeloablativetreatment and bone marrow transplantation, with a regimen ofmethotrexate, doxorubicin, cyclophosphamide, vincristine, prednisone,and bleomycin (MACOP-B) as initial or salvage treatment foradults with diffuse large-cell lymphoma.
Methods Ninety-eight eligible patients with diffuse large-celllymphoma of the B-cell type were randomly assigned to receiveeither MACOP-B (50 patients) or high-dose sequential therapy(48 patients). If the assigned treatment failed, the study designallowed patients to cross over to the other treatment group.
Results After a median follow-up of 55 months, the patientsgiven high-dose sequential therapy, as compared with those treatedwith MACOP-B, had significantly higher rates of complete response(96 percent vs. 70 percent, P = 0.001), freedom from diseaseprogression (84 percent vs. 49 percent, P<0.001), freedomfrom relapse (88 percent vs. 70 percent, P = 0.055), and event-freesurvival (76 percent vs. 49 percent, P = 0.004). The differencein overall survival at seven years, which also favored the groupassigned 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-doseMACOP-B for patients with diffuse large-cell lymphoma of theB-cell type.
Source Information
From the Cristina Gandini Bone Marrow Transplantation Unit, Department of Medical Oncology, Università degli Studi di Milano, and the Department of Radiotherapy, Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy (A.M.G., M.B., S.S., C.B., M.D.N., F.L., L.G., F.R., P.V., G.B.); and Cattedra di Ematologia, Università degli Studi di Torino, Turin, Italy (C.T., A.P.). Other authors were Angelika C. Stern, Ph.D. (Sandoz Clinical Research, Basel, Switzerland); Michele Magni, M.D. (Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan, Italy), and Daniele Caracciolo, M.D. (Cattedra di Ematologia, Università degli Studi di Torino, Turin, Italy).
Address reprint requests to Dr. Gianni at Oncologia Medica, Istituto Nazionale Tumori, Via Venezian 1, 20133 Milan, Italy.
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Grossbard, M. L.
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Schilder, R. J., Johnson, S., Gallo, J., Kindsfather, S., Rogers, B., Bookman, M. A., Millenson, M. M., Boente, M., Rosenblum, N., Litwin, S., Ozols, R. F.
(1999). Phase I Trial of Multiple Cycles of High-Dose Chemotherapy Supported by Autologous Peripheral-Blood Stem Cells. JCO
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Ballestrero, A., Ferrando, F., Garuti, A., Basta, P., Gonella, R., Stura, P., Mela, G. S., Sessarego, M., Gobbi, M., Patrone, F.
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Shipp, M.A., Abeloff, M.D., Antman, K.H., Carroll, G., Hagenbeek, A., Loeffler, M., Montserrat, E., Radford, J.A., Salles, G., Schmitz, N., Symann, M., Armitage, J.O., Philip, T., Coiffier, B.
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Tarella, C., Zallio, F., Caracciolo, D., Cherasco, C., Bondesan, P., Gavarotti, P., Corradini, P., Tassi, V., Pileri, A.
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Weaver, C.H., West, W., Schwartzberg, L., Birch, R., Buckner, C.D.
(1998). The Rationale for Performing Autologous Peripheral Blood Stem Cell Transplants in Community Cancer Centers. The Oncologist
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Clarke, M., Chalmers, I.
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Mach-Pascual, S., Legare, R. D., Lu, D., Kroon, M., Neuberg, D., Tantravahi, R., Stone, R. M., Freedman, A. S., Nadler, L. M., Gribben, J. G., Gilliland, D. G.
(1998). Predictive Value of Clonality Assays in Patients With Non-Hodgkin's Lymphoma Undergoing Autologous Bone Marrow Transplant: A Single Institution Study. Blood
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Nicolaides, C., Dimou, S., Pavlidis, N.
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Ketterer, N., Salles, G., Raba, M., Espinouse, D., Sonet, A., Tremisi, P., Dumontet, C., Moullet, I., Eljaafari-Corbin, A., Neidhardt-Berard, E.-M., Bouafia, F., Coiffier, B.
(1998). High CD34+ Cell Counts Decrease Hematologic Toxicity of Autologous Peripheral Blood Progenitor Cell Transplantation. Blood
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Deeg, H. J., Socie, G.
(1998). Malignancies After Hematopoietic Stem Cell Transplantation: Many Questions, Some Answers. Blood
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Freedman, A., Neuberg, D., Mauch, P., Gribben, J., Soiffer, R., Anderson, K., Robertson, M., Fisher, D. C., Schlossman, R., Kroon, M., Rhuda, C., Kuhlman, C., Ritz, J., Nadler, L.
(1997). Cyclophosphamide, Doxorubicin, Vincristine, Prednisone Dose Intensification With Granulocyte Colony-Stimulating Factor Markedly Depletes Stem Cell Reserve for Autologous Bone Marrow Transplantation. Blood
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Nademanee, A., Molina, A., O'Donnell, M. R., Dagis, A., Snyder, D. S., Parker, P., Stein, A., Smith, E., Planas, I., Kashyap, A., Spielberger, R., Fung, H., Wong, K.K., Somlo, G., Margolin, K., Chow, W., Sniecinski, I., Vora, N., Blume, K. G., Niland, J., Forman, S. J.
(1997). Results of High-Dose Therapy and Autologous Bone Marrow/Stem Cell Transplantation During Remission in Poor-Risk Intermediate- and High-Grade Lymphoma: International Index High and High-Intermediate Risk Group. Blood
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Mok, T. S., Martins, R. G., Seiden, M. V., Gianni, A. M., Valagussa, P., Bonadonna, G.
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