Journal of Clinical Oncology, Vol 7, 433-438, Copyright © 1989 by American Society of Clinical Oncology
Pentostatin in chronic lymphocytic leukemia: a phase II trial of Cancer and Leukemia group B
RO Dillman, R Mick and OR McIntyre
University of California San Diego School of Medicine, La Jolla.
We conducted a phase II trial of deoxycoformycin (pentostatin [DCF]) in
chronic lymphocytic leukemia (CLL). Eligibility criteria included age
greater than 18 years, Cancer and Leukemia Group B (CALGB) performance
status 0 to 2, lymphocyte count greater than or equal to 15,000
cells/microL, international stage B or C disease (multiple lymph nodes
involved and/or hemoglobin [Hgb] less than 11 g and/or platelets less than
100,000/microL) and no more than one prior treatment regimen. DCF dose was
4 mg/m2 intravenously (IV) weekly for 3 weeks and then every 2 weeks. There
were 39 eligible patients (35 men and four women; median age, 63 years;
median time from diagnosis to study entry, 3 years). Of these 39 patients,
31% were stage B and 33% had no prior treatment. Median laboratory values
at entry were Hgb 10.5 g, WBC 96,100/microL, and platelets 93,500/microL.
Nodal involvement was present in 90%, splenomegaly in 81%, and hepatomegaly
in 47%. Patients received a median of nine DCF injections, with a range of
four to 26. Three patients were not evaluable for response. Overall, 3%
achieved a complete response (CR), 23% a partial response (PR), 28% showed
clinical improvement (CI), and 38% had stable disease (SD). Associated
toxicities (grade 2 or worse) observed were infections (52%), worsening of
thrombocytopenia (26%) or anemia (33%), nausea and vomiting (31%), rash or
pruritis (20%), and stomatitis (8%). We conclude that DCF is an active
agent in CLL with acceptable toxicity.

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