title: 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.
abstract: 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.
authors.affiliation: Department of Hematology, Medical University of Lodz, 93-513 Lodz, Poland. robaktad@csk.umed.lodz.pl
authors.forename: Tadeusz
authors.initials: T
authors.lastname: Robak
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Jamroziak
authors.forename: Joanna
authors.initials: J
authors.lastname: Gora-Tybor
authors.forename: Jerzy Z
authors.initials: JZ
authors.lastname: Blonski
authors.forename: Marek
authors.initials: M
authors.lastname: Kasznicki
authors.forename: Jadwiga
authors.initials: J
authors.lastname: Dwilewicz-Trojaczek
authors.forename: Elzbieta
authors.initials: E
authors.lastname: Wiater
authors.forename: Andrzej
authors.initials: A
authors.lastname: Zdunczyk
authors.forename: Jacek
authors.initials: J
authors.lastname: Dybowicz
authors.forename: Anna
authors.initials: A
authors.lastname: Dmoszynska
authors.forename: Maria
authors.initials: M
authors.lastname: Wojtaszko
authors.forename: Barbara
authors.initials: B
authors.lastname: Zdziarska
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Calbecka
authors.forename: Aleksandra
authors.initials: A
authors.lastname: Kostyra
authors.forename: Andrzej
authors.initials: A
authors.lastname: Hellmann
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Lewandowski
authors.forename: Beata
authors.initials: B
authors.lastname: Stella-Holowiecka
authors.forename: Kazimierz
authors.initials: K
authors.lastname: Sulek
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Gawronski
authors.forename: Aleksander B
authors.initials: AB
authors.lastname: Skotnicki
authors.forename: Wieslaw
authors.initials: W
authors.lastname: Nowak
authors.forename: Krystyna
authors.initials: K
authors.lastname: Zawilska
authors.forename: Lucyna
authors.initials: L
authors.lastname: Molendowicz-Portala
authors.forename: Janusz
authors.initials: J
authors.lastname: Kloczko
authors.forename: Jaroslaw
authors.initials: J
authors.lastname: Sokolowski
authors.forename: Krzysztof
authors.initials: K
authors.lastname: Warzocha
authors.forename: Ilona
authors.initials: I
authors.lastname: Seferynska
authors.forename: Bernardeta
authors.initials: B
authors.lastname: Ceglarek
authors.forename: Lech
authors.initials: L
authors.lastname: Konopka
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D017338:Cladribine / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007943:Leukemia, Hairy Cell / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011044:Poland; D011446:Prospective Studies; D012074:Remission Induction; D018805:Sepsis / Q000209:etiology / Q000401:mortality; D015996:Survival Rate
chemical_list: D017338:Cladribine