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Previous Volume 343:1750-1757 December 14, 2000 Number 24 Next

	Full Text PDF Editorial by Dighiero, G. Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited PubMed Citation

ABSTRACT

Background Fludarabine is an effective treatment for chronic lymphocytic leukemia that does not respond to initial treatment with chlorambucil. We compared the efficacy of fludarabine with that of chlorambucil in the primary treatment of chronic lymphocytic leukemia.

Methods Between 1990 and 1994, we randomly assigned 509 previously untreated patients with chronic lymphocytic leukemia to one of the following treatments: fludarabine (25 mg per square meter of body-surface area, administered intravenously daily for 5 days every 28 days), chlorambucil (40 mg per square meter, given orally every 28 days), or fludarabine (20 mg per square meter per day for 5 days every 28 days) plus chlorambucil (20 mg per square meter every 28 days). Patients with an additional response at each monthly evaluation continued to receive the assigned treatment for a maximum of 12 cycles.

Results Assignment of patients to the fludarabine-plus-chlorambucil group was stopped when a planned interim analysis revealed excessive toxicity and a response rate that was not better than the rate with fludarabine alone. Among the other two groups, the response rate was significantly higher for fludarabine alone than for chlorambucil alone. Among 170 patients treated with fludarabine, 20 percent had a complete remission, and 43 percent had a partial remission. The corresponding values for 181 patients treated with chlorambucil were 4 percent and 33 percent (P< 0.001 for both comparisons). The median duration of remission and the median progression-free survival in the fludarabine group were 25 months and 20 months, respectively, whereas both values were 14 months in the chlorambucil group (P<0.001 for both comparisons). The median overall survival among patients treated with fludarabine was 66 months, which was not significantly different from the overall survival in the other two groups (56 months with chlorambucil and 55 months with combined treatment). Severe infections and neutropenia were more frequent with fludarabine than with chlorambucil (P=0.08), although, overall, toxic effects were tolerable with the two single-drug regimens.

Conclusions When used as the initial treatment for chronic lymphocytic leukemia, fludarabine yields higher response rates and a longer duration of remission and progression-free survival than chlorambucil; overall survival is not enhanced.

Source Information

From the Cancer and Leukemia Group B, Chicago (K.R.R., B.L.P., J.K., G.A.T., R.A.L., C.A.S.); the Southwest Oncology Group, San Antonio, Tex. (F.R.A., L.E.); National Cancer Institute Canada, Clinical Trials Group, Kingston, Ont. (L.S.); the Eastern Cooperative Oncology Group, Brookline, Mass. (J.H.); and the National Cancer Institute, Rockville, Md. (B.D.C.). Presented in part at the plenary session of the 38th Annual Meet-ing of the American Society of Hematology, Orlando, Fla., December 6–10, 1996.The contents of this report are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Address reprint requests to Dr. Rai at the Long Island Jewish Medical Center, 270-05 76th Ave., New Hyde Park, NY 11040, or at rai{at}lij.edu.

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• Baldini, L., Brugiatelli, M., Luminari, S., Lombardo, M., Merli, F., Sacchi, S., Gobbi, P., Liberati, M., Cavanna, L., Colombi, M., Stelitano, C., Goldaniga, M., Morabito, F., Federico, M., Silingardi, V. (2003). Treatment of Indolent B-Cell Nonfollicular Lymphomas: Final Results of the LL01 Randomized Trial of the Gruppo Italiano per lo Studio dei Linfomi. JCO 21: 1459-1465 [Abstract] [Full Text]  
• Weiss, M. A., Maslak, P. G., Jurcic, J. G., Scheinberg, D. A., Aliff, T. B., Lamanna, N., Frankel, S. R., Kossman, S. E., Horgan, D. (2003). Pentostatin and Cyclophosphamide: An Effective New Regimen in Previously Treated Patients With Chronic Lymphocytic Leukemia. JCO 21: 1278-1284 [Abstract] [Full Text]  
• Keating, M. J., Chiorazzi, N., Messmer, B., Damle, R. N., Allen, S. L., Rai, K. R., Ferrarini, M., Kipps, T. J. (2003). Biology and Treatment of Chronic Lymphocytic Leukemia. ASH Education Book 2003: 153-175 [Abstract] [Full Text]  
• O'Brien, S. N., Blijlevens, N. M.A., Mahfouz, T. H., Anaissie, E. J. (2003). Infections in Patients with Hematological Cancer: Recent Developments. ASH Education Book 2003: 438-472 [Abstract] [Full Text]  
• Byrd, J. C., Peterson, B. L., Morrison, V. A., Park, K., Jacobson, R., Hoke, E., Vardiman, J. W., Rai, K., Schiffer, C. A., Larson, R. A. (2003). Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712). Blood 101: 6-14 [Abstract] [Full Text]  
• Klasa, R. J., Meyer, R. M., Shustik, C., Sawka, C. A., Smith, A., Guevin, R., Maksymiuk, A., Rubinger, M., Samosh, M., Laplante, S., Grenier, J.-F. (2002). Randomized Phase III Study of Fludarabine Phosphate Versus Cyclophosphamide, Vincristine, and Prednisone in Patients With Recurrent Low-Grade Non-Hodgkin's Lymphoma Previously Treated With an Alkylating Agent or Alkylator-Containing Regimen. JCO 20: 4649-4654 [Abstract] [Full Text]  
• Schulz, H., Klein, S. K., Rehwald, U., Reiser, M., Hinke, A., Knauf, W.-U., Aulitzky, W.-E., Hensel, M., Herold, M., Huhn, D., Hallek, M., Diehl, V., Engert, A. (2002). Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia. Blood 100: 3115-3120 [Abstract] [Full Text]  
• Morrison, V. A., Rai, K. R., Peterson, B. L., Kolitz, J. E., Elias, L., Appelbaum, F. R., Hines, J. D., Shepherd, L., Larson, R. A., Schiffer, C. A. (2002). Therapy-Related Myeloid Leukemias Are Observed in Patients With Chronic Lymphocytic Leukemia After Treatment With Fludarabine and Chlorambucil: Results of an Intergroup Study, Cancer and Leukemia Group B 9011. JCO 20: 3878-3884 [Abstract] [Full Text]  
• Helman, D. L. Jr, Byrd, J. C., Ales, N. C., Shorr, A. F. (2002). Fludarabine-Related Pulmonary Toxicity* : A Distinct Clinical Entity in Chronic Lymphoproliferative Syndromes. Chest 122: 785-790 [Abstract] [Full Text]  
• Hegde, U. P., Wilson, W. H., White, T., Cheson, B. D. (2002). Rituximab treatment of refractory fludarabine-associated immune thrombocytopenia in chronic lymphocytic leukemia. Blood 100: 2260-2262 [Abstract] [Full Text]  
• Stilgenbauer, S., Dohner, H. (2002). Campath-1H-Induced Complete Remission of Chronic Lymphocytic Leukemia despite p53 Gene Mutation and Resistance to Chemotherapy. NEJM 347: 452-453 [Full Text]  
• Lundin, J., Kimby, E., Bjorkholm, M., Broliden, P.-A., Celsing, F., Hjalmar, V., Mollgard, L., Rebello, P., Hale, G., Waldmann, H., Mellstedt, H., Osterborg, A. (2002). Phase II trial of subcutaneous anti-CD52 monoclonal antibody alemtuzumab (Campath-1H) as first-line treatment for patients with B-cell chronic lymphocytic leukemia (B-CLL). Blood 100: 768-773 [Abstract] [Full Text]  
• Kantarjian, H. M. (2002). Treatment of Myelodysplastic Syndrome: Questions Raised by the Azacitidine Experience. JCO 20: 2415-2416 [Full Text]  
• Keating, M. J., Flinn, I., Jain, V., Binet, J.-L., Hillmen, P., Byrd, J., Albitar, M., Brettman, L., Santabarbara, P., Wacker, B., Rai, K. R. (2002). Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood 99: 3554-3561 [Abstract] [Full Text]  
• Nardella, F. A., LeFevre, J. A. (2002). Enhanced clearance of leukemic lymphocytes in B-cell chronic lymphocytic leukemia with etodolac. Blood 99: 2625-2626 [Full Text]  
• Kay, N. E., Hamblin, T. J., Jelinek, D. F., Dewald, G. W., Byrd, J. C., Farag, S., Lucas, M., Lin, T. (2002). Chronic Lymphocytic Leukemia. ASH Education Book 2002: 193-213 [Abstract] [Full Text]  
• Boogaerts, M. A., Van Hoof, A., Catovsky, D., Kovacs, M., Montillo, M., Zinzani, P. L., Binet, J. L., Feremans, W., Marcus, R., Bosch, F., Verhoef, G., Klein, M. (2001). Activity of Oral Fludarabine Phosphate in Previously Treated Chronic Lymphocytic Leukemia. JCO 19: 4252-4258 [Abstract] [Full Text]  
• Yamauchi, T., Nowak, B. J., Keating, M. J., Plunkett, W. (2001). DNA Repair Initiated in Chronic Lymphocytic Leukemia Lymphocytes by 4-Hydroperoxycyclophosphamide Is Inhibited by Fludarabine and Clofarabine. Clin. Cancer Res. 7: 3580-3589 [Abstract] [Full Text]  
• Leblond, V., Levy, V., Maloisel, F., Cazin, B., Fermand, J.-P., Harousseau, J.-L., Remenieras, L., Porcher, R., Gardembas, M., Marit, G., Deconinck, E., Desablens, B., Guilhot, F., Philippe, G., Stamatoullas, A., Guibon, O. (2001). Multicenter, randomized comparative trial of fludarabine and the combination of cyclophosphamide-doxorubicin-prednisone in 92 patients with Waldenstrom macroglobulinemia in first relapse or with primary refractory disease. Blood 98: 2640-2644 [Abstract] [Full Text]  
• Leporrier, M., Chevret, S., Cazin, B., Boudjerra, N., Feugier, P., Desablens, B., Rapp, M.-J., Jaubert, J., Autrand, C., Divine, M., Dreyfus, B., Maloum, K., Travade, P., Dighiero, G., Binet, J.-L., Chastang, C. (2001). Randomized comparison of fludarabine, CAP, and ChOP in 938 previously untreated stage B and C chronic lymphocytic leukemia patients. Blood 98: 2319-2325 [Abstract] [Full Text]  
• Morrison, V. A., Rai, K. R., Peterson, B. L., Kolitz, J. E., Elias, L., Appelbaum, F. R., Hines, J. D., Shepherd, L., Martell, R. E., Larson, R. A., Schiffer, C. A. (2001). Impact of Therapy With Chlorambucil, Fludarabine, or Fludarabine Plus Chlorambucil on Infections in Patients With Chronic Lymphocytic Leukemia: Intergroup Study Cancer and Leukemia Group B 9011. JCO 19: 3611-3621 [Abstract] [Full Text]  
• Petryk, M., Grossbard, M. L. (2001). Hematologic Malignancies. The Oncologist 6: 317-326 [Abstract] [Full Text]  
• Copur, M. S., Ledakis, P., Muhvic, J., Erman, M., Celik, I., Tekuzman, G., Marchetti, M., Barosi, G., Liberato, L. N., Proctor, S. J., Mounter, P., Summerfield, G. P., Rai, K. R., The Chronic Lymphocytic Leukemia Inter-Group Study, (2001). Fludarabine for Chronic Lymphocytic Leukemia. NEJM 344: 1166-1168 [Full Text]  
• Rai, K. R., Dohner, H., Keating, M. J., Montserrat, E. (2001). Chronic Lymphocytic Leukemia: Case-Based Session. ASH Education Book 2001: 140-156 [Abstract] [Full Text]  
• Dighiero, G., Binet, J.-L. (2000). When and How to Treat Chronic Lymphocytic Leukemia. NEJM 343: 1799-1801 [Full Text]