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Blood, 15 July 2006, Vol. 108, No. 2, pp. 473-479. Prepublished online as a Blood First Edition Paper on March 21, 2006; DOI 10.1182/blood-2005-12-4828. This Article Full Text (PDF) All Versions of this Article: 2005-12-4828v1 108/2/473    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Robak, T. Articles by Kasznicki, M. Search for Related Content PubMed PubMed Citation Articles by Robak, T. Articles by Kasznicki, M. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted December 6, 2005 Accepted March 10, 2006 Cladribine alone and in combination with cyclophosphamide or cyclophosphamide plus mitoxantrone in the treatment of progressive chronic lymphocytic leukemia: report of prospective, multicenter, randomized trial of the Polish Adult Leukemia Group (PALG CLL2) Tadeusz Robak*, Jerzy Z Blonski, Joanna Gora-Tybor, Krzysztof Jamroziak, Jadwiga Dwilewicz-Trojaczek, Agnieszka Tomaszewska, Lech Konopka, Bernadetta Ceglarek, Anna Dmoszynska, Malgorzata Kowal, Janusz Kloczko, Beata Stella-Holowiecka, Kazimierz Sulek, Malgorzata Calbecka, Krystyna Zawilska, Kazimierz Kuliczkowski, Aleksander B Skotnicki, Krzysztof Warzocha, and Marek Kasznicki Department of Hematology, Medical University of Lodz, Lodz, Poland Department of Hematology and Oncology, Medical University of Warsaw, Warsaw, Poland Institute of Hematology and Transfusiology, Warsaw, Poland Department of Hematology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland Department of Hematology, Medical Uiversity, Bialystok, Poland Department of Hematology and Bone Marrow Transplantation, Medical University of Katowice, Katowice, Poland Department of Internal Medicine, Military Institute of Medicine, Warsaw, Poland City Hospital, Torun, Poland Department of Hematology, Medical University of Poznan, Poznan, Poland Department of Hematology, Medical University, Wroclaw, Poland Department of Hematology, Jagiellonian University, Krakow, Poland * Corresponding author; email: robaktad{at}csk.umed.lodz.pl. In this prospective randomized trial we compared the efficacy and toxicity of cladribine (2-CdA) alone to 2-CdA combined with cyclophosphamide (CC) or cyclophosphamide and mitoxantrone (CMC) in untreated progressive CLL. Study end points were complete response (CR), overall response, minimal residual disease (MRD), progression-free survival, overall survival and toxicity. From January 1st 1998 to December 31st 2003, 508 patients from 15 hematology departments were randomized. Compared to 2-CdA, CMC induced higher CR rate (36% vs. 21%, p=0.004), whilst only trend for higher CR rate with CC was observed (29% vs. 21%, p=0.08). Furthermore, percentage of patients in CR and MRD negative were higher in CMC compared to 2-CdA (23% vs 14% p=0.042). There were no differences in overall response, progression-free survival and overall survival among treatment groups. Grade 3/4 neutropenia occurred more frequently in CC (32%) and CMC (38%) than in 2-CdA (20%) (p=0.01 and p=0.004, respectively). Infections were more frequent in CMC compared to 2-CdA (40% vs. 27%, p=0.02). In conclusion, CMC used in first-line treatment of CLL gives higher CR rate and suppresses MRD more efficiently than 2-CdA monotherapy, although associates with increased toxicity. No important differences in efficacy and toxicity were found between CC and 2-CdA regimens. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

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