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Related Collections Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  Blood, 1 November 2001, Vol. 98, No. 9, pp. 2640-2644 CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS Multicenter, randomized comparative trial of fludarabine and the combination of cyclophosphamide-doxorubicin-prednisone in 92 patients with Waldenström macroglobulinemia in first relapse or with primary refractory disease Véronique Leblond, Vincent Lévy, Frédéric Maloisel, Bruno Cazin, Jean-Paul Fermand, Jean-Luc Harousseau, Liliane Remenieras, Raphaël Porcher, Martine Gardembas, Gérald Marit, Eric Deconinck, Bernard Desablens, François Guilhot, Guilaine Philippe, Aspasia Stamatoullas, and Odile Guibon for the French Cooperative Group on Chronic Lymphocytic Leukemia and Macroglobulinemia From Département d'hématologie, Hôpital Pitié-Salpétrière, AP-HP, Paris; Département de biostatistique et informatique médicale, Hôpital Saint-Louis, U 444 INSERM, Paris; Centre Hospitalier Régional Universitaire, Hôpital Hautepierre, Strasbourg; Centre Hospitalier Régional Universitaire, Hôpital Claude Huriez, Lille; Service d'immuno-hématologie, Hôpital Saint-Louis, AP-HP Paris; Centre Hospitalier Universitaire, Hôtel-Dieu, Nantes; Centre Hospitalier Universitaire, Limoges; Centre Hospitalier Universitaire, Angers; Centre Hospitalier Universitaire, Bordeaux; Centre Hospitalier Universitaire, Besançon; Centre Hospitalier Universitaire, Amiens; Centre Hospitalier Universitaire, Poitiers; Centre Hospitalier, Pontoise; Centre anti-cancéreux Becquerel, Rouen; and Laboratoire Schering, Lys-lez-Lannoy, France. Few reports are available on the treatment of patients with Waldenström macroglobulinemia (WM) and primary or secondary resistance to alkylating-agent-based regimens. From December 1993 through December 1997, 92 patients with WM resistant to first-line therapy (42) or with first relapse (50) after alkylating-agent therapy were randomly assigned to receive fludarabine (25 mg/m2 of body-surface area on days 1-5) or cyclophosphamide, doxorubicin (Adriamycin), and prednisone (CAP; 750 mg/m2 cyclophosphamide and 25 mg/m2 doxorubicin on day 1 and 40 mg/m2 prednisone on days 1-5). The first end point evaluated was the response rate after 6 treatment courses. Forty-five patients received CAP and 45 received fludarabine. Two patients died before the first course of chemotherapy. No statistical differences were observed between the 2 treatment arms with respect to hematologic toxicity or infections. Mucositis and alopecia occurred significantly more often in patients treated with CAP. Partial responses were obtained in 14 patients (30%) treated with fludarabine and 5 patients (11%) treated with CAP (P = .019). Responses were more durable in patients treated with fludarabine (19 months versus 3 months), and the event-free survival rate was significantly higher in this group (P < .01). Forty-four patients died, 22 in the fludarabine group and 22 in the CAP group. There was no statistical difference in the median overall survival time in the 2 study arms. Fludarabine was thus more active than CAP in salvage therapy of WM and should be tested as first-line therapy in a randomized comparison with alkylating agents. © 2001 by The American Society of Hematology.   CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: X. Leleu, J. Soumerai, A. Roccaro, E. Hatjiharissi, Z. R. Hunter, R. Manning, B. T. Ciccarelli, A. Sacco, L. Ioakimidis, S. Adamia, et al. Increased Incidence of Transformation and Myelodysplasia/Acute Leukemia in Patients With Waldenstrom Macroglobulinemia Treated With Nucleoside Analogs J. Clin. Oncol., January 10, 2009; 27(2): 250 - 255. [Abstract] [Full Text] [PDF] A. Vijay and M. A. Gertz Waldenstrom macroglobulinemia Blood, June 15, 2007; 109(12): 5096 - 5103. [Abstract] [Full Text] [PDF] C. I. Chen, C. T. Kouroukis, D. White, M. Voralia, E. Stadtmauer, A. K. Stewart, J. J. Wright, J. Powers, W. Walsh, and E. Eisenhauer Bortezomib Is Active in Patients With Untreated or Relapsed Waldenstrom's Macroglobulinemia: A Phase II Study of the National Cancer Institute of Canada Clinical Trials Group J. Clin. Oncol., April 20, 2007; 25(12): 1570 - 1575. [Abstract] [Full Text] [PDF] M. A. Dimopoulos, R. A. Kyle, A. Anagnostopoulos, and S. P. Treon Diagnosis and Management of Waldenstrom's Macroglobulinemia J. Clin. Oncol., March 1, 2005; 23(7): 1564 - 1577. [Abstract] [Full Text] [PDF] C. I. 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