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

Blood. 2007 May 1;109(9):3672-5. doi: 10.1182/blood-2006-08-042929. Epub 2007 Jan 5.

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.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Cladribine / administration & dosage*
  • Cladribine / adverse effects
  • Disease-Free Survival
  • Drug Administration Schedule
  • Female
  • Humans
  • Infusions, Intravenous
  • Leukemia, Hairy Cell / complications
  • Leukemia, Hairy Cell / drug therapy*
  • Leukemia, Hairy Cell / mortality
  • Male
  • Middle Aged
  • Poland
  • Prospective Studies
  • Remission Induction
  • Sepsis / etiology
  • Sepsis / mortality
  • Survival Rate

Substances

  • Cladribine