Annals of Oncology Advance Access published online on January 10, 2006
Annals of Oncology, doi:10.1093/annonc/mdj106
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1 Institute of Hematology and Medical Oncology L. and A. Seràgnoli, University of Bologna
* To whom correspondence should be addressed. Imatinib mesylate (STI571), a specific Bcr-Abl inhibitor, has shown a potent antileukemic activity in clinical studies of chronic myeloid leukemia (CML) patients. Early prediction of response to imatinib cannot be anticipated. We used a standardized quantitative reverse-transcriptase polymerase chain reaction (QRT-PCR) for BCR-ABL transcripts on 191 out of 200 late-chronic phase CML patients enrolled in a phase II clinical trial with imatinib 400 mg/day. Bone marrow samples were collected before treatment, after 12, 20 and at the end of study treatment (52 weeks) while peripheral blood samples were obtained after 2, 3, 6, 10, 14, 20 and 52 weeks of therapy. The amount of BCR-ABL transcript was expressed as the ratio of BCR-ABL to
Received August 22, 2005
Revised November 3, 2005
Accepted November 7, 2005
original article
Prediction of response to imatinib by prospective quantitation of BCR-ABL transcript in late chronic phase chronic myeloid leukemia patients
G. Martinelli 1 *,
I. Iacobucci 1,
G. Rosti 1,
F. Pane 2,
M. Amabile 1,
F. Castagnetti 1,
D. Cilloni 3,
S. Soverini 1,
N. Testoni 1,
G. Specchia 4,
S. Merante 5,
A. Zaccaria 6,
F. Frassoni 7,
G. Saglio 3,
M. Baccarani 1,
and
(study writing committee for the GIMEMA Working Party on Chronic Myeloid Leukemia)
2 CEINGE Biotecnologie Avanzate and Department of Biochemistry and Medical Biotechnology, University of Naples Federico II
3 Division of Hematology and Internal Medicine, Department of Clinical and Biological Science, University of Turin
4 Hematology Section, DIMIMP Department, University of Bari
5 Division of Hematology, IRCCS Policlinico San Matteo, University of Pavia
6 Hematology Unit, Santa Maria delle Croci Hospital, Ravenna
7 Department of Internal Medicine and Department of Haematology and Oncology, University of Genova
G. Martinelli, E-mail: gmartino{at}kaiser.alma.unibo.it
Abstract 
2-microglobulin (2M). We show that, following initiation of imatinib, the early BCR-ABL level trends in both bone marrow and peripheral blood samples made it possible to predict the subsequent cytogenetic outcome and response. We propose this method as the method of choice for monitoring patients on imatinib therapy. QRT-PCR studies may be able to identify degrees of molecular response that predict both complete cytogenetic response and long term stability, as well as patterns of response that provide an early indication of relapse and imatinib resistance.
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