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Annals of Oncology 10:1493-1498, 1999
© 1999 European Society for Medical Oncology


research-article

Pentostatin in T-cell malignancies – a phase II trial of the EORTC

A. D. Ho1,, S. Suciu2, P. Stryckmans3, F. De Cataldo4, R. Willemze5, J. Thaler6, M. Peetermans7, H. Döhner1, G. Solbu2, M. Dardenne2, R. Zittoun8 and Leukemia Cooperative Group

1Department of Medicine V, University of Heidelberg Heidelberg, Germany
2European Organization for Research and Treatment of Cancer Data Center
3Institut Jules Bordet, Clinique et Laboratoire d'Hematologie Brussels, Belgium
4Servizio d'Ematologia, Ospedale Maggiore Ca'Grande Milano, Italy
5Department of Hematology, University Medical Center Leiden, The Netherlands
6Medizinische Universitätsklinik Innsbruck, Austria
7University of Antwerpen, Haematology and Bloodtransfusion Edegem, Belgium
8Service d'hé;matologie de l'Hôtel-Dieu Paris, France

Correspondence to: A. D. Ho, MD, Department of Medicine V, University of Heidelberg, Hospitalstr. 3, 69115 Heidelberg, Germany, E-mail. anthony.ho{at}med.uni-heidelberg.de

Purpose: Within this phase II EORTC trial, we have investigated the safety and efficacy of pentostatin in lymphoid malignancies. We have previously reported the results in T-and B-cell prolymphocytic leukemia, B-cell chronic lymphocytic leukemia (B-CLL) and hairy cell leukemia. This report focuses on the outcome in T-cell malignancies: T-CLL, Sézary syndrome (Sézary), mycosis fungoides (MF) and T-zone lymphoma (TZL).

Patients and methods: Of the 92 patients with these diagnoses enrolled, 76 were evaluable for response and toxicity, i.e., 25 of 28 with T-CLL, 21 of 26 with Sézary, 22 of 26 with MF, and 8 of 12 with TZL. All patients had progressive and advanced disease. Pentostatin was administered at a dosage of 4 mg/m2 every week for the first 3 weeks, then 4 mg/m2 every 14 days for another 6 weeks, followed by maintenance therapy of 4 mg/m2 monthly for a maximum of 6 months.

Results: Response rates (complete and partial responses) in patients with Sézary (n = 22) or MF (n = 21) were 33% and 23%, respectively, and in patients with T-CLL (n = 21) or TZL (n = 8) 8% and 25%, respectively. Sixteen (21%) patients died during the first ten weeks of treatment: twelve of progressive disease, two of infectious complications with progressive disease, one of myocard infarction and one of renal failure related to administration of i.v. contrast. Major toxicity (grade 3–4) included infection in 11% of patients, nausea/vomiting in 4%, diarrhea in 3%. Hematologic toxicity was mild to non-existent.

Conclusions: We conclude that pentostatin is active in Sézary and MF but showed marginal activity in T-CLL or TZL. Toxicities are mild to moderate at the dose schedule administered. Due to its relatively specific lympholytic effect and its favorable toxicity spectrum, pentostatin might be especially useful for the palliative treatment of T-cell malignancies.

cutaneous T-cell lymphoma, mycosis fungoides, pentostatin, Sézary syndrome, T-CLL, T-zone lymphoma


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