© 1990 by Oxford University Press
Journal of the National Cancer Institute, Vol. 82, No. 17, 1416-1420,
September 5, 1990
© 1990 Oxford University Press
Pentostatin in Refractory Chronic Lymphocytic Leukemia: A Phase II Trial of the European Organization for Research and Treatment of Cancer
Hunstein, Department of Internal Medicine V, University of Heidelberg, Federal Republic of Germany
Medizinische Universitätsklinik Innsbruck, Austria
Institut Jules Bordet, Clinique et Laboratoire d'Hematologie Brussels, Belgium
Centre Hospitalier Lyon-Sud, Service d'Hematologie Clinique Pierre-Benite, France
Cattedra di Ematologia Rome, Italy
Dijkzigt Ziekenhuis Rotterdam, The Netherlands
Allgemeines Krankenhaus Wien, Austria
The Netherlands Cancer Institute Amsterdam, The Netherlands
Univ. Zieknhuis Antwerpen Edegem, Belgium
Ospedale di Niguarda Ca'granda, Comune di Milano Milan, Italy
Acad. Ziekenhuis Nijmegen Nijmegen, The Netherlands
EORTC Data Centre Brussels. Belgium
Institute of Pathology, University of Kiel Federal Republic of Germany
Hotel-Dieu de Paris Paris, France
Pentostatin was used to treat 26 patients with advanced B-cell chronic lymphocytic leukemia resistant to conventional treatment. Twenty patients had progressive disease on previous regimens and six had had partial remission and then relapsed 334 months after previous chemotherapy. Eleven patients had previously been treated with three different regimens, 10 had been treated with two regimens, and five had been treated with one regimen. Pentostatin was administered at a dosage of 4 mg/m2 weekly for 3 weeks, then 4 mg/m2 every other week for 6 weeks and once a month for 6 months. Seven of 26 assessable patients (27%) achieved partial remission and five (19%) achieved clinical improvement. The median duration of partial remission until relapse or death was 210 days. Myelosuppression was minor and transient in responsive patients, indicating some degree of selective effect on lymphocytes. Except for one patient who died of cerebral hemorrhage during the first 6 weeks of treatment, no drug-related deaths were registered. Major toxic effects included nausea in 17 patients (mainly grade 1), infections in 15, and liver enzyme elevations in five. Thus, pentostatin is active, even in patients with advanced B-cell chronic lymphocytic leukemia that is refractory to multiple chemotherapy regimens. Response can be achieved with mild myelosuppression. [J Natl Cancer Inst 82: 14161420, 1990]
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