Molecular response in acute promyelocytic leukemia: a direct comparison of regular and real-time RT-PCR.

Evaluation of molecular response is important for the diagnosis and monitoring of minimal residual disease in patients with acute promyelocytic leukemia (APL). In this study, we analyzed the molecular response by regular reverse transcription-polymerase chain reaction (RT-PCR) and quantitative real-time RT-PCR in 31 newly diagnosed patients. The real-time RT-PCR results are reported as normalized DoseN and log-reduction (3.0-4.9 log-reduction as minor and > or =5.0 log-reduction as major molecular response). After induction therapy and completion of consolidation, minor molecular response was documented in 35.5 and 96.8% patients, respectively, which was equivalent to the regular RT-PCR (22.6 and 96.8%), whereas the major molecular response rate was significantly lower (12.9 and 90.3%, respectively). All patients achieved major molecular response during and after maintenance therapy. During the follow-up study, loss of major molecular response was observed in two patients, which was associated with subsequent loss of minor molecular response, positive RT-PCR and then documentation of central nervous system leukemia or clinical relapse in 3-6 months. For summary, we demonstrated that the real-time RT-PCR is potentially superior to regular RT-PCR in evaluation of molecular response in APL patients and that reporting real-time RT-PCR data by log-reduction is feasible and clinically relevant.