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Blood, 1 May 2007, Vol. 109, No. 9, pp. 3676-3678.
Prepublished online as a Blood First Edition Paper on January 9, 2007; DOI 10.1182/blood-2006-10-052746.


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CLINICAL TRIALS AND OBSERVATIONS

Brief Report

Imatinib plus steroids induces complete remissions and prolonged survival in elderly Philadelphia chromosome–positive patients with acute lymphoblastic leukemia without additional chemotherapy: results of the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) LAL0201-B protocol

Marco Vignetti1, Paola Fazi2, Giuseppe Cimino1, Giovanni Martinelli3, Francesco Di Raimondo4, Felicetto Ferrara5, Giovanna Meloni1, Achille Ambrosetti6, Giovanni Quarta7, Livio Pagano8, Giovanna Rege-Cambrin9, Loredana Elia1, Raffaello Bertieri10, Luciana Annino11, Robin Foà1, Michele Baccarani3, and Franco Mandelli1

1 Department of Cellular Biotechnologies and Hematology, "La Sapienza" University, Rome, Italy; 2 GIMEMA Data Center, GIMEMA Foundation, Rome, Italy; 3 Hematology and Medical Oncology Institute "L. e A. Seragnoli," University of Bologna, Italy; 4 Department of Hematology, "Ferrarotto" Hospital, University of Catania, Italy; 5 Department of Hematology, "A. Cardarelli" Hospital, Naples, Italy; 6 Department of Hematology, University of Verona, Italy; 7 Department of Hematology, "A. Di Summa" Hospital, Brindisi, Italy; 8 Department of Hematology, "Sacro Cuore" Catholic University, Rome, Italy; 9 Department of Clinical and Biological Sciences, University of Turin, Italy; 10 Novartis Pharma S.p.A., Origgio, Milan, Italy; 11 Department of Hematology, "S. Giovanni" Hospital, Rome, Italy

Thirty elderly (> 60 years) Philadelphia chromosome–positive (Ph+) patients with acute lymphoblastic leukemia (ALL) received imatinib, 800 mg daily, associated to steroids without further chemotherapy as frontline treatment. Median age was 69 years (range, 61-83 years). Twenty-nine patients were evaluable for response and all of them obtained a hematologic complete remission, with a median BCR-ABL reduction of 2.9 and 2.0 logs in p190+ and p210+ cases, respectively. Most of the induction treatment did not require admission of the patients. No major toxicities occurred and the treatment was well tolerated. Median survival from diagnosis was 20 months. This study shows that elderly Ph+ patients with ALL—often considered eligible only for palliative treatment strategies—may benefit from an imatinib-steroids protocol, which does not require chemotherapy nor a long hospitalization, is feasible, highly active, and associated with a good quality of life.


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