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Cladribine Therapy for Hairy Cell Leukemia: Does Schedule Matter?

Daily or weekly cladribine provided equivalently high response and survival rates, with similar toxicity profiles.

Cladribine monotherapy yields a high response rate and durable remission for most patients with hairy cell leukemia (HCL), usually with only one treatment cycle. Varying treatment schedules have been employed, including 7-day continuous infusion, daily 2-hour infusions for 5 days, and weekly 2-hour infusions for 6 weeks; some reports have suggested that fewer treatment-related complications occur with the once-weekly schedule. The Polish Adult Leukemia Group conducted a randomized prospective comparison of two cladribine regimens in 116 previously untreated HCL patients: 0.12 mg/kg during 2 hours daily for 5 consecutive days, or the same dose and infusion time once weekly for 6 weeks. Patients with complete responses (CRs) received no further therapy, whereas those with partial responses continued with additional treatment. No antibiotic or cytokine prophylaxis was used.

Most patients (74%) required only a single treatment cycle to achieve CR. Five patients had no response, and three early deaths occurred due to infection within 4 months of therapy initiation. For daily versus weekly schedules, no differences in CR (76% and 72%), 6.5-year overall survival (91% and 88%), or median progression-free survival rates (4.3 and 5.1 years) were seen. Toxicity did not differ for the two treatment schedules. Severe (grade 3/4) infections occurred in 18% of the daily- and 26% of the weekly-treated patients, and no differences were noted in treatment-related cytopenia or transfusion requirements. Second neoplasms, primarily solid tumors, were diagnosed in seven patients, with a median time to diagnosis of 2.3 years.

Comment: For patients with previously untreated HCL, this study demonstrated similarly high response and survival rates, with no difference in toxicity rates, for weekly versus daily cladribine dosing schedules. Serious infectious complications, including early deaths due to sepsis, were not uncommon, however, and suggest a role for prophylactic antibiotics and cytokine support.

— Michael E. Williams, MD

Published in Journal Watch Oncology and Hematology May 25, 2007

Citation(s):

Robak T et al. 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; 109:3672-5.

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