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Blood, 1 May 2007, Vol. 109, No. 9, pp. 3672-3675.
Prepublished online as a Blood First Edition Paper on January 5, 2007; DOI 10.1182/blood-2006-08-042929.
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Submitted August 21, 2006
Accepted December 30, 2006
Cladribine in a weekly versus daily schedule for untreated active hairy cell leukemia: final report from the Polish Adult Leukemia Group (PALG) of a prospective, randomized, multicenter trial
Tadeusz Robak*, Krzysztof Jamroziak, Joanna Gora-Tybor, Jerzy Z. Blonski, Marek Kasznicki, Jadwiga Dwilewicz-Trojaczek, Elzbieta Wiater, Andrzej Zdunczyk, Jacek Dybowicz, Anna Dmoszynska, Maria Wojtaszko, Barbara Zdziarska, Malgorzata Calbecka, Aleksandra Kostyra, Andrzej Hellmann, Krzysztof Lewandowski, Beata Stella-Holowiecka, Kazimierz Sulek, Krzysztof Gawronski, Aleksander B. Skotnicki, Wieslaw Nowak, Krystyna Zawilska, Lucyna Molendowicz-Portala, Janusz Kloczko, Jaroslaw Sokolowski, Krzysztof Warzocha, Ilona Seferynska, Bernardeta Ceglarek, and Lech Konopka
Department of Hematology, Medical University of Lodz, Lodz, Poland
Department of Hematology, Oncology and Internal Medicine, Medical University of Warsaw, Warsaw, Poland
Department of Hematology, City Hospital, Krakow, Poland
Department of Hematology and Bone Marrow Transplantation, Medical University of Lublin, Lublin, Poland
Department of Hematology, Pomeranian Medical University, Szczecin, Poland
Department of Hematology, City Hospital, Torun, Poland
Department of Hematology, Medical University of Gdansk, Gdansk, Poland
Department of Hematology and Bone Marrow Transplantation, Medical University, Katowice, Poland
Department of Internal Medicine, Military Institute of Medicine, Warsaw, Poland
Department of Hematology, Jagiellonian University, Krakow, Poland
Department of Hematology, Medical University of Poznan, Poznan, Poland
Department of Hematology, Medical University of Bialystok, Bialystok, Poland
Institute of Hematology and Transfusiology, Warsaw, Poland and Polish Adult Leukemia Group, Warsaw, Poland
* Corresponding author; email: robaktad{at}csk.umed.lodz.pl.
Cladribine (2-chlorodeoxyadenosine, 2-CdA) treatment-associated infections may shorten potentially long-term survival in hairy cell leukemia (HCL). In search of optimal mode of 2-CdA administration, 132 patients with untreated HCL were randomized to receive either standard 5-day 2-CdA protocol or novel schedule of six weekly 2-CdA infusions suggested to be less toxic. Analysis of treatment response confirmed similar complete remission rates, overall response rates, progression-free survival and overall survival in both 2-CdA protocols. However, we did not observe lower toxicity of weekly schedule. Of special interest, no significant differences were found in rate of grade 3/4 infections (18% for daily and 26% for weekly protocol, difference=-8.2% (95%confidence interval -23.2 to 6.9%), p=0.28) and rate of septic deaths (3% for daily and 2% for weekly protocol, difference=1.4% (95% confidence interval -4.3 to 7.0%), p=0.64). In conclusion, HCL treatment with weekly 2-CdA infusions is equally effective, but no safer than standard 5-day 2-CdA protocol.

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