Chronic myeloid leukemia: a prospective comparison of interphase fluorescence in situ hybridization and chromosome banding analysis for the definition of complete cytogenetic response: a study of the GIMEMA CML WP
Nicoletta Testoni, Giulia Marzocchi, Simona Luatti, Marilina Amabile, Carmen Baldazzi, Monica Stacchini, Mauro Nanni, Giovanna Rege-Cambrin, Emilia Giugliano, Ursula Giussani, Elisabetta Abruzzese, Simonetta Kerim, Maria Grazia Grimoldi, Alessandro Gozzetti, Barbara Crescenzi, Carlo Carcassi, Paolo Bernasconi, Antonio Cuneo, Francesco Albano, Giuseppina Fugazza, Alfonso Zaccaria, Giovanni Martinelli, Fabrizio Pane, Gianantonio Rosti, Michele Baccarani, Nicoletta Testoni, Giulia Marzocchi, Simona Luatti, Marilina Amabile, Carmen Baldazzi, Monica Stacchini, Mauro Nanni, Giovanna Rege-Cambrin, Emilia Giugliano, Ursula Giussani, Elisabetta Abruzzese, Simonetta Kerim, Maria Grazia Grimoldi, Alessandro Gozzetti, Barbara Crescenzi, Carlo Carcassi, Paolo Bernasconi, Antonio Cuneo, Francesco Albano, Giuseppina Fugazza, Alfonso Zaccaria, Giovanni Martinelli, Fabrizio Pane, Gianantonio Rosti, Michele Baccarani
Abstract
In chronic myeloid leukemia, different methods are available to monitor the response to therapy: chromosome banding analysis (CBA), interphase fluorescence in situ hybridization (I-FISH), and real-time quantitative polymerase chain reaction (RT-Q-PCR). The GIMEMA CML WP (Gruppo Italiano Malattie Ematologiche Adulto Chronic Myeloid Leukemia Working Party) has performed a prospective study to compare CBA and I-FISH for the definition of complete cytogenetic response (CCgR). Samples (n = 664) were evaluated simultaneously by CBA and I-FISH. Of 537 cases in CCgR, the number of positive nuclei by I-FISH was less than 1% in 444 cases (82.7%). Of 451 cases with less than 1% positive nuclei by I-FISH, 444 (98.4%) were classified as CCgR by CBA. The major molecular response rate was significantly greater in cases with I-FISH less than 1% than in those with I-FISH 1% to 5% (66.8% vs 51.6%, P < .001) and in cases with CCgR and I-FISH less than 1% than in cases with CCgR and I-FISH 1% to 5% (66.1% vs 49.4%, P = .004). I-FISH is more sensitive than CBA and can be used to monitor CCgR. With appropriate probes, the cutoff value of I-FISH may be established at 1%. These trials are registered at http://www.clinicaltrials.gov as NCT00514488 and NCT00510926.
Source: PubMed