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.
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.
Robak
Tadeusz
T
Department of Hematology, Medical University of Lodz, 93-513 Lodz, Poland. robaktad@csk.umed.lodz.pl
Jamroziak
Krzysztof
K
Gora-Tybor
Joanna
J
Blonski
Jerzy Z
JZ
Kasznicki
Marek
M
Dwilewicz-Trojaczek
Jadwiga
J
Wiater
Elzbieta
E
Zdunczyk
Andrzej
A
Dybowicz
Jacek
J
Dmoszynska
Anna
A
Wojtaszko
Maria
M
Zdziarska
Barbara
B
Calbecka
Malgorzata
M
Kostyra
Aleksandra
A
Hellmann
Andrzej
A
Lewandowski
Krzysztof
K
Stella-Holowiecka
Beata
B
Sulek
Kazimierz
K
Gawronski
Krzysztof
K
Skotnicki
Aleksander B
AB
Nowak
Wieslaw
W
Zawilska
Krystyna
K
Molendowicz-Portala
Lucyna
L
Kloczko
Janusz
J
Sokolowski
Jaroslaw
J
Warzocha
Krzysztof
K
Seferynska
Ilona
I
Ceglarek
Bernardeta
B
Konopka
Lech
L
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
D017338:Cladribine