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

• Published in: Blood 2007-05, Vol.109 (9), p.3672-3675
• Main Authors: Robak, Tadeusz, Jamroziak, Krzysztof, Gora-Tybor, Joanna, Blonski, Jerzy Z., Kasznicki, Marek, Dwilewicz-Trojaczek, Jadwiga, Wiater, Elzbieta, Zdunczyk, Andrzej, Dybowicz, Jacek, Dmoszynska, Anna, Wojtaszko, Maria, Zdziarska, Barbara, Calbecka, Malgorzata, Kostyra, Aleksandra, Hellmann, Andrzej, Lewandowski, Krzysztof, Stella-Holowiecka, Beata, Sulek, Kazimierz, Gawronski, Krzysztof, Skotnicki, Aleksander B., Nowak, Wieslaw, Zawilska, Krystyna, Molendowicz-Portala, Lucyna, Kloczko, Janusz, Sokolowski, Jarosław, Warzocha, Krzysztof, Seferyńska, Ilona, Ceglarek, Bernardeta, Konopka, Lech
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Biological and medical sciences; Cladribine - administration & dosage; Cladribine - adverse effects; Disease-Free Survival; Drug Administration Schedule; Female; Hematologic and hematopoietic diseases; Humans; Infusions, Intravenous; Leukemia, Hairy Cell - complications; Leukemia, Hairy Cell - drug therapy; Leukemia, Hairy Cell - mortality; Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis; Male; Medical sciences; Middle Aged; Poland; Prospective Studies; Remission Induction; Sepsis - etiology; Sepsis - mortality; Survival Rate
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood-2006-08-042929

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.