Published online 14 January 2009
Haematologica, Vol 94, Issue 2, 205-212 doi:10.3324/haematol.13529
Copyright © 2009 by Ferrata Storti Foundation

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Chronic Myeloid Leukemia

The long-term durability of cytogenetic responses in patients with accelerated phase chronic myeloid leukemia treated with imatinib 600 mg: the GIMEMA CML Working Party experience after a 7-year follow-up

Francesca Palandri¹, Fausto Castagnetti¹, Giuliana Alimena², Nicoletta Testoni¹, Massimo Breccia², Simona Luatti¹, Giovanna Rege-Cambrin³, Fabio Stagno⁴, Giorgina Specchia⁵, Bruno Martino⁶, Luciano Levato⁷, Serena Merante⁸, Anna Maria Liberati⁹, Fabrizio Pane¹⁰, Giuseppe Saglio³, Daniele Alberti¹¹, Giovanni Martinelli¹, Michele Baccarani¹, Gianantonio Rosti¹

¹ Department of Hematology/Oncology "L. and A. Seràgnoli" S.Orsola Malpighi Hospital, University of Bologna, Bologna
² Department of Cellular Biotechnology and Hematology, University "La Sapienza", Rome
³ Department of Clinical and Biological Science, University of Turin at Orbassano, Turin
⁴ Department of Hematology, Catania
⁵ Department of Hematology, University of Bari
⁶ Department of Hematology, Ospedali Riuniti, Reggio Calabria
⁷ Department of Hematology, Catanzaro
⁸ Department of Hematology, San Matteo Hospital, University of Pavia, Pavia
⁹ Istituto di Medicina Interna e Scienze Oncologiche, Policlinico Monteluce Perugia
¹⁰ CEINGE Biotecnologie Avanzate and Department of Biochemistry and Medical Biotechnology, University of Naples Federico II, Napoli and
¹¹ Novartis Pharma, Origgio, Italy

Correspondence: Gianantonio Rosti, Institute of Hematology and Medical Oncology "L. and A. Seràgnoli", St. Orsola-Malpighi University Hospital, Via Massarenti, 9 -40138 Bologna, Italy. E-mail:gianantonio.rosti{at}unibo.it

Background: Imatinib mesylate is the first line treatment for chronic myeloid leukemia. The advent of imatinib increased survival significantly in patients in an advanced phase of the disease. However, few long-term data on the outcome of these patients based on large, prospective and controlled trials are available.

Design and Methods: A phase 2 multicenter trial of the use of imatinib 600 mg/daily in patients with accelerated phase chronic myeloid leukemia was sponsored and promoted by the Italian Cooperative Study Group on Chronic Myeloid Leukemia in 2001.

Results: One hundred and eleven patients were enrolled; the median follow-up of the 41 living patients is 82 months (range, 73–87). One hundred and seven patients (96%) returned to chronic phase and 79 patients (71%) achieved a complete hematologic response. Cumulative best rates of major cytogenetic response and complete cytogenetic response were 30% and 21%, respectively. All responses were maintained for a minimum of 4 weeks. At last follow-up, four patients were alive in complete remission after allogeneic transplant, 16 patients (14%) had switched to a second generation tyrosine kinase inhibitor and 21 patients (19%) were alive on imatinib therapy. No late toxicities were observed. Progression-free survival and event-free survival rates were 36.5% and 15%, respectively, at 7 years. The median survival time was 37 months, and was significantly associated with the achievement of a complete hematologic response or a complete cytogenetic response.

Conclusions: Imatinib may induce durable responses, associated with prolonged survival, in patients with accelerated phase chronic myeloid leukemia

Key words: chronic myeloid leukemia, accelerated phase, long-term results, imatinib.