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Blood, 15 March 2004, Vol. 103, No. 6, pp. 2284-2290.
Prepublished online as a Blood First Edition Paper on November 26, 2003; DOI 10.1182/blood-2003-07-2575.
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NEOPLASIA
Molecular response to imatinib in late chronic-phase chronic myeloid leukemia
Gianantonio Rosti,
Giovanni Martinelli,
Simona Bassi,
Marilina Amabile,
Elena Trabacchi,
Barbara Giannini,
Daniela Cilloni,
Barbara Izzo,
Antonio De Vivo,
Nicoletta Testoni,
Giovanna Rege Cambrin,
Francesca Bonifazi,
Simona Soverini,
Simona Luatti,
Enrico Gottardi,
Daniele Alberti,
Fabrizio Pane,
Francesco Salvatore,
Giuseppe Saglio, and
Michele Baccarani, the Study and Writing Committee of the Italian Cooperative Study Group [ICSG] on Chronic Myeloid Leukemia
From the Institute of Hematology and Medical Oncology "L. and A. Seràgnoli," University of Bologna, Bologna, Italy; Division of Hematology and Internal Medicine, Department of Clinical and Biological Science, University of Turin, Turin, Italy; CEINGE Biotecnologie Avanzate and Department of Biochemistry and Medical Biotechnology, University of Naples Federico II, Naples, Italy; Novartis Pharma, Origgio, Italy.
Imatinib is a tyrosine-kinase inhibitor that binds to ABL proteins and induces cytogenetic remissions in patients with chronic myeloid leukemia (CML). In these patients measuring response by molecular techniques is clearly required. We determined the cytogenetic and molecular response (CgR, MR) to imatinib in 191 patients with late chronic-phase Philadelphia-positive (Ph+) CML, previously treated with interferon  . MR was assessed with real-time quantitative (TaqMan) reverse transcription–polymerase chain reaction and was expressed as the ratio between BCR/ABL and  2-microglobulin x 100, the lowest level of detectability of the method being 0.00001. A complete CgR (CCgR) was achieved in 85 (44%) of 191 patients and was maintained for 2 years in 67 (79%) of 85 patients. A reduction of the transcript level of more than 2 logs was achieved in all but 9 patients with CCgR versus none of 23 with partial CgR. In the CCgRs the median value of the MR was 0.0008 after 12 months and 0.0001 after 24 months, with the transcript level undetectable in 22 cases. We conclude that in CCgRs the degree of MR may vary from 2 to more than 4 logs, and that there is a progressive decrease of transcript level by time. Only 1 of 22 negative cases has had a relapse as yet.
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