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Chronic Myeloid Leukemia |
1 Department of Hematology/Oncology "L. and A. Seràgnoli" S.Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy
2 Division of Hematology, AIEOP, Milano, Italy
3 Department of Cellular Biotechnology and Hematology, University "La Sapienza", Rome, Italy
4 Division of Hematology, Ospedale Niguarda, Milano, Italy
5 Department of Clinical and Biological Science, University of Turin at Orbassano, Torino, Italy
6 Division of Hematology, San Martino Hospital, Genova, Italy
7 Division of Hematology, Bari, Italy
8 Division of Hematology, Ravenna, Italy
9 Division of Hematology, Napoli, Italy
10 Hematology Section, University of Perugia, Italy
11 CEINGE Biotecnologie Avanzate and Department of Biochemistry and Medical Biotechnology, University of Naples Federico II, Napoli, Italy
12 Novartis Pharmaceutical, East Hanover, NJ, USA
Correspondence: Gianantonio Rosti, Institute of Hematology and Medical Oncology "L. and A. Seràgnoli", S. 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. In patients with advanced phase of the disease, the advent of imatinib significantly increased survival. However, few long-term data, based on large, prospective and controlled trials are available on the outcome of these patients.
Design and Methods: We conducted a phase II trial of imatinib 600 mg daily in patients with chronic myeloid leukemia in blast crisis. The return to chronic phase was defined as <15% blasts and <30% blasts plus promyelocytes in blood or bone marrow and <20% peripheral basophils. A complete hematologic response required the normalization of platelet and white cell differential counts and absence of extramedullary involvement. Cytogenetic response was assessed by the standard banding technique and rated as usual.
Results: Ninety-two patients were enrolled (20 with lymphoid blast crisis and 72 with myeloid blast crisis). Forty-six patients (50%) returned to chronic phase, and 24 patients (26%) achieved also a complete hematologic response. Sixteen patients (17%) had a cytogenetic response (9 complete, 1 partial, and 6 minor or minimal). The complete cytogenetic response was subsequently lost by all but two patients between 2 and 12 months after first having achieved it: the median duration of complete cytogenetic response was 7 months. All responses were sustained for a minimum of 4 weeks. The median survival of all the patients was 7 months. After a median observation time of 66 months, seven (8%) patients are alive. Three of these patients are on imatinib treatment (1 in complete hematologic remission, 1 in partial cytogenetic response and 1 in complete cytogenetic remission). Three patients are in complete remission after allogeneic stem cell transplantation. One patient is alive in blast crisis, on therapy with a second-generation tyrosine kinase inhibitor.
Conclusions: Imatinib was effective and safe in the short-term treatment of chronic myeloid leukemia in blast crisis, but longer-term outcome was not significantly influenced (ClinicalTrials.gov identifier: NCT00514969).
Key words: chronic myeloid leukemia, blast crisis, imatinib, outcome, long-term.
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