Journal of Clinical Oncology, Vol 7, 1533-1538, Copyright © 1989 by American Society of Clinical Oncology
Response to pentostatin in hairy-cell leukemia refractory to interferon- alpha. The European Organization for Research and Treatment of Cancer Leukemia Cooperative Group
AD Ho, J Thaler, F Mandelli, F Lauria, R Zittoun, R Willemze, G McVie, AM Marmont, O Prummer and P Stryckmans
Department of Internal Medicine V. University of Heidelberg, Federal Republic of Germany.
Interferon-alpha (IFN-a) or 2'-deoxycoformycin (pentostatin; DCF) have each
been shown to be highly active in hairy-cell leukemia (HCL). In this phase
II study of the Leukemia Cooperative Group of the European Organization for
Research and Treatment of Cancer (EORTC), the efficacy and toxicity of DCF
were investigated in patients who were resistant to IFN-a treatment.
Resistance was defined as: (1) progressive disease (PD) under IFN-a therapy
for more than 2 months; (2) stable disease (SD) after more than 6 months of
IFN-a treatment; (3) relapse within 3 months of discontinuing IFN-a; and
(4) intolerance to IFN-a because of World Health Organization (WHO) grade 3
or 4 toxicity. DCF was applied at a dosage of 4 mg/m2 weekly x 3, then 4
mg/m2 every other week x 3. Responders were given a maintenance therapy
once per month for a maximum of 6 months. At the time of report, 33
patients with resistant disease were evaluable for response and toxicity.
Median duration of IFN-a therapy before DCF administration was 14.7 months
(range, 1 to 41 months). Complete remissions (CRs) were achieved in 11
patients and partial remissions (PRs) in 15, resulting in a total response
rate of 78.8%. Median interval between beginning of DCF therapy to best
response was 3.9 months with a range from 2.0 to 7.0 months. Two patients
who achieved PR have relapsed 7 and 14 months after cessation of DCF
therapy. The median duration of response was over 11.5 months (range, over
3.0 to over 24.0 months). Three patients died within the first 6 weeks of
DCF treatment: one of drug-unrelated cardiomyopathy and two of fungal
pneumonia. The patients with early death (n = 3) and nonresponsive disease
(n = 4) received IFN-a treatment for a longer period (median, 18.0 months)
than did the 26 responsive patients (median, 10.0 months). Major side
effects included nausea, skin rash, and infections and were otherwise mild.
Thus, DCF is highly active in patients with HCL resistant to IFN-a.
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