Comparison of a Standard Regimen (CHOP) with Three Intensive Chemotherapy Regimens for Advanced Non-Hodgkin's Lymphoma
Richard I. Fisher, Ellen R. Gaynor, Steve Dahlberg, Martin M. Oken, Thomas M. Grogan, Evonne M. Mize, John H. Glick, Charles A. Coltman, and Thomas P. Miller
Background CHOP is a first-generation, combination-chemotherapyregimen consisting of cyclophosphamide, doxorubicin, vincristine,and prednisone that has cured approximately 30 percent of patientswith advanced stages of intermediate-grade or high-grade non-Hodgkin'slymphoma in national cooperative-group trials. However, studiesat single institutions have suggested that 55 to 65 percentof such patients might be cured by third-generation regimenssuch as ones consisting of low-dose methotrexate with leucovorinrescue, bleomycin, doxorubicin, cyclophosphamide, vincristine,and dexamethasone (m-BACOD); prednisone, doxorubicin, cyclophosphamide,and etoposide, followed by cytarabine, bleomycin, vincristine,and methotrexate with leucovorin rescue (ProMACE-CytaBOM); andmethotrexate with leucovorin rescue, doxorubicin, cyclophosphamide,vincristine, prednisone, and bleomycin (MACOP-B).
Methods To make a valid comparison of these regimens, the SouthwestOncology Group and the Eastern Cooperative Oncology Group initiateda prospective, randomized phase III trial. The study end pointswere the response rate, time to treatment failure, overall survival,and incidence of severe or life-threatening toxicity. Dose intensitywas calculated and analyzed.
Results Of the 1138 patients registered for the trial, 899 wereeligible. Each treatment group contained at least 218 patients.Known prognostic factors were equally distributed among thegroups. There were no significant differences among the groupsin the rates of partial and complete response. At three years,44 percent of all patients were alive without disease; therewere no significant differences between the groups (41 percentin the CHOP and MACOP-B groups and 46 percent in the m-BACODand ProMACE-CytaBOM groups; P = 0.35). Overall survival at threeyears was 52 percent (50 percent in the ProMACE-CytaBOM andMACOP-B groups, 52 percent in the m-BACOD group, and 54 percentin the CHOP group; P = 0.90). There was no subgroup of patientsin which survival was improved by a third-generation regimen.Fatal toxic reactions occurred in 1 percent of the CHOP group,3 percent of the ProMACE-CytaBOM group, 5 percent of the m-BACODgroup, and 6 percent of the MACOP-B group (P = 0.09).
Conclusions CHOP remains the best available treatment for patientswith advanced-stage intermediate-grade or high-grade non-Hodgkin'slymphoma.
Source Information
From the Stritch School of Medicine, Loyola University, Maywood, Ill. (R.I.F., E.R.G.); Southwest Oncology Group Statistical Center, Seattle (S.D., E.M.M.); Virginia Piper Cancer Institute, Abbott Northwestern Hospital, Minneapolis (M.M.O.); the University of Arizona, Tucson (T.M.G., T.P.M.); the University of Pennsylvania, Philadelphia (J.H.G.); and the University of Texas Health Science Center, San Antonio (C.A.C.).
Address reprint requests to the Southwest Oncology Group (SWOG-8516), Operations Office, 5430 Fredericksburg Rd., Suite No. 618, San Antonio, TX 78229-6197.
Observational Studies and Randomized Trials
Kunz R., Khan K. S., Neumayer H.-H., Sacks H. S., Liu P.-Y., Anderson G., Crowley J. J., Friedman H. S., Smith R. P., Meier P., Benson K., Hartz A. J., Concato J., Shah N., Horwitz R. I.
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N Engl J Med 2000;
343:1194-1197, Oct 19, 2000.
Correspondence
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(2005). FDG PET in the Evaluation of Treatment for Lymphoma: Clinical Usefulness and Pitfalls. RadioGraphics
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Mounier, N., Gisselbrecht, C., Briere, J., Haioun, C., Feugier, P., Offner, F., Recher, C., Stamatoullas, A., Morschhauser, F., Macro, M., Thieblemont, C., Sonet, A., Fabiani, B., Reyes, F., On behalf of the Groupe d'Etude des Lymphomes de l,
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(2004). Prolonged Clinical and Molecular Remission in Patients With Low-Grade or Follicular Non-Hodgkin's Lymphoma Treated With Rituximab Plus CHOP Chemotherapy: 9-Year Follow-Up. JCO
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(2004). Plasma Glutathione S-Transferase P1-1 as a Prognostic Factor in Patients with Advanced Non-Hodgkin's Lymphoma (Stages III and IV). Clin. Cancer Res.
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Bertz, H., Zeiser, R., Lange, W., Fetscher, S., Waller, C. F., Finke, J.
(2004). Long-term follow-up after high-dose chemotherapy and autologous stem-cell transplantation for high-grade B-cell lymphoma suggests an improved outcome for high-risk patients with respect to the age-adjusted International Prognostic Index. Ann Oncol
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Friedberg, J. W.
(2004). Developing New Monoclonal Antibodies for Aggressive Lymphoma: A Challenging Road in the Rituximab Era. Clin. Cancer Res.
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Leonard, J. P., Coleman, M., Ketas, J. C., Chadburn, A., Furman, R., Schuster, M. W., Feldman, E. J., Ashe, M., Schuster, S. J., Wegener, W. A., Hansen, H. J., Ziccardi, H., Eschenberg, M., Gayko, U., Fields, S. Z., Cesano, A., Goldenberg, D. M.
(2004). Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive Non-Hodgkin's Lymphoma: Phase I/II Clinical Trial Results. Clin. Cancer Res.
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Pfreundschuh, M., Trumper, L., Kloess, M., Schmits, R., Feller, A. C., Rudolph, C., Reiser, M., Hossfeld, D. K., Metzner, B., Hasenclever, D., Schmitz, N., Glass, B., Rube, C., Loeffler, M., the German High-Grade Non-Hodgkin's Lymphoma Study,
(2004). Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of young patients with good-prognosis (normal LDH) aggressive lymphomas: results of the NHL-B1 trial of the DSHNHL. Blood
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Pfreundschuh, M., Trumper, L., Kloess, M., Schmits, R., Feller, A. C., Rube, C., Rudolph, C., Reiser, M., Hossfeld, D. K., Eimermacher, H., Hasenclever, D., Schmitz, N., Loeffler, M., the German High-Grade Non-Hodgkin's Lymphoma Study,
(2004). Two-weekly or 3-weekly CHOP chemotherapy with or without etoposide for the treatment of elderly patients with aggressive lymphomas: results of the NHL-B2 trial of the DSHNHL. Blood
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Mounier, N., Gisselbrecht, C., Briere, J., Haioun, C., Feugier, P., Offner, F., Recher, C., Stamatoullas, A., Morschhauser, F., Macro, M., Thieblemont, C., Sonet, A., Fabiani, B., Reyes, F.
(2004). Prognostic Factors in Patients With Aggressive Non-Hodgkin's Lymphoma Treated by Front-Line Autotransplantation After Complete Remission: A Cohort Study by the Groupe d'Etude des Lymphomes de l'Adulte. JCO
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Tobinai, K., Hotta, T.
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Spina, M., Tirelli, U.
(2004). HIV-related non-Hodgkin's lymphoma (HIV-NHL) in the era of highly active antiretroviral therapy (HAART): some still unanswered questions for clinical management. Ann Oncol
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Kewalramani, T., Zelenetz, A. D., Nimer, S. D., Portlock, C., Straus, D., Noy, A., O'Connor, O., Filippa, D. A., Teruya-Feldstein, J., Gencarelli, A., Qin, J., Waxman, A., Yahalom, J., Moskowitz, C. H.
(2004). Rituximab and ICE as second-line therapy before autologous stem cell transplantation for relapsed or primary refractory diffuse large B-cell lymphoma. Blood
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Bendandi, M., Pileri, S. A., Zinzani, P. L.
(2004). Challenging paradigms in lymphoma treatment. Ann Oncol
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Tobinai, K., Igarashi, T., Itoh, K., Kobayashi, Y., Taniwaki, M., Ogura, M., Kinoshita, T., Hotta, T., Aikawa, K., Tsushita, K., Hiraoka, A., Matsuno, Y., Nakamura, S., Mori, S., Ohashi, Y.
(2004). Japanese multicenter phase II and pharmacokinetic study of rituximab in relapsed or refractory patients with aggressive B-cell lymphoma. Ann Oncol
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Milpied, N., Deconinck, E., Gaillard, F., Delwail, V., Foussard, C., Berthou, C., Gressin, R., Lucas, V., Colombat, P., Harousseau, J.-L., the Groupe Ouest-Est des Leucemies et des Autres M,
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