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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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CLINICAL TRIALS AND OBSERVATIONS

Brief Report

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 Robak1, Krzysztof Jamroziak1, Joanna Gora-Tybor1, Jerzy Z. Blonski1, Marek Kasznicki1, Jadwiga Dwilewicz-Trojaczek2, Elzbieta Wiater2, Andrzej Zdunczyk3, Jacek Dybowicz3, Anna Dmoszynska4, Maria Wojtaszko4, Barbara Zdziarska5, Malgorzata Calbecka6, Aleksandra Kostyra6, Andrzej Hellmann7, Krzysztof Lewandowski7, Beata Stella-Holowiecka8, Kazimierz Sulek9, Krzysztof Gawronski9, Aleksander B. Skotnicki10, Wieslaw Nowak10, Krystyna Zawilska11, Lucyna Molendowicz-Portala11, Janusz Kloczko12, Jaroslaw Sokolowski12, Krzysztof Warzocha13, Ilona Seferynska13, Bernardeta Ceglarek13, Lech Konopka13, for the Polish Adult Leukemia Group

1 Department of Hematology, Medical University of Lodz; 2 Department of Hematology, Oncology and Internal Medicine, Medical University of Warsaw; 3 Department of Hematology, City Hospital, Krakow; 4 Department of Hematology and Bone Marrow Transplantation, Medical University of Lublin; 5 Department of Hematology, Pomeranian Medical University, Szczecin; 6 Department of Hematology, City Hospital, Torun; 7 Department of Hematology, Medical University of Gdansk; 8 Department of Hematology and Bone Marrow Transplantation, Medical University, Katowice; 9 Department of Internal Medicine, Military Institute of Medicine, Warsaw; 10 Department of Hematology, Jagiellonian University, Krakow; 11 Department of Hematology, Medical University of Poznan; 12 Department of Hematology, Medical University of Bialystok; 13 Institute of Hematology and Transfusiology, Warsaw, Poland

Cladribine (2-chlorodeoxyadenosine, 2-CdA) treatment-associated infections may shorten potentially long-term survival in hairy cell leukemia (HCL). In search of the optimal mode of 2-CdA administration, 132 patients with untreated HCL were randomized to receive either standard 5-day 2-CdA protocol or a novel schedule of 6 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 in the weekly schedule. Of special interest, no significant differences were found in the rate of grade 3/4 infections (18% for daily and 26% for weekly protocol, difference –8.2%; 95% confidence interval [CI] –23.2% to 6.9%; P = .28) and the rate of septic deaths (3% for daily and 2% for weekly protocol, difference 1.4%; 95% CI –4.3% to 7.0%; P = .64). In conclusion, HCL treatment with weekly 2-CdA infusions is equally effective but no safer than the standard 5-day 2-CdA protocol.


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JWatch Oncology and HematologyHome page
Cladribine Therapy for Hairy Cell Leukemia: Does Schedule Matter?
Journal Watch Oncology and Hematology, May 25, 2007; 2007(525): 1 - 1.
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