• Ilaria Iacobucci, Giuseppe Saglio, Gianantonio Rosti, Nicoletta Testoni, Fabrizio Pane, Marilina Amabile, Angela Poerio, Simona Soverini, Simona Bassi, Daniela Cilloni, Renato Bassan, Massimo Breccia, Francesco Lauria, Barbara Izzo, Serena Merante, Francesco Frassoni, Stefania Paolini, Enrico Montefusco, Michele Baccarani, Giovanni Martinelli, and GIMEMA Working Party on Chronic Myeloid Leukemia.
• Institute of Hematology and Medical Oncology Seràgnoli, University of Bologna, Bologna, Italy.
• Clin Cancer Res. 2006 May 15; 12 (10): 3037-42.

PurposeMost patients with chronic-phase chronic myeloid leukemia (CML) who receive imatinib achieve a complete cytogenetic remission (CCgR) and low levels of BCR-ABL transcripts. CCgR is durable in the majority of patients but relapse occurs in a subset.Experimental DesignTo determine the potential of quantitative reverse transcription-PCR of BCR-ABL to predict cytogenetic relapse, we serially monitored residual disease in 97 CML patients with an imatinib-induced CCgR. Patients with late chronic phase CML after IFN-alpha failure were treated with imatinib (400 mg daily).ResultsDuring the imatinib median follow-up time of 36 months (range, 12-54 months), disease monitoring occurred by cytogenetics and quantitative PCR. Twenty percent of patients experienced cytogenetic relapse at a median of 18 months after CCgR and a median of 24 months after starting imatinib. None of the possible prognostic factors studied in univariate and multivariate analyses seemed to predict for loss of cytogenetic response but the reduction of BCR-ABL transcript levels at the time of CCgR is an important prognostic factor.ConclusionsIn our study, we showed not only that achieving a major molecular remission at 12 months is predictive of a durable cytogenetic remission but also that patients who achieved a major molecular remission (expressed both as the BCR-ABL/beta2 microglobulin ratio % <0.0005 and as a 3-log reduction from median baseline value) already at the time of first achieving a CCgR have significantly longer cytogenetic remission durations than those without this magnitude of molecular response (P < 0.05).

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