| |
|
|
|
|
|
|
|||
|
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.
CLINICAL TRIALS AND OBSERVATIONS 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 aw Sokolowski12 ska131 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.
This article has been cited by other articles:
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Copyright © 2007 by American Society of Hematology Online ISSN: 1528-0020 | |||||||||