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Annals of Oncology Advance Access published online on July 10, 2006
Annals of Oncology, doi:10.1093/annonc/mdl150
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© 2006 European Society for Medical Oncology
Received March 17, 2006
Revised May 9, 2006
Accepted May 22, 2006

original article

Real-time PCR analysis of PML-RAR{alpha} in newly diagnosed acute promyelocytic leukaemia patients treated with arsenic trioxide as a front-line therapy

S. H. Ghaffari 1 *, S. Rostami 1, D. Bashash 1, K. Alimoghaddam 1, and A. Ghavamzadeh 1

1 Hematology, Oncology and BMT Research Center, Tehran University Medical Sciences, Tehran, Iran

* To whom correspondence should be addressed.
S. H. Ghaffari, E-mail: shghaffari2000{at}yahoo.com


  Abstract

Background: Recently, patients with acute promyelocytic leukaemia (APL) have experienced significant clinical gains after treatment with arsenic trioxide. However, the use of this agent as a front-line therapy for newly diagnosed patients is unclear.

Patients and methods: Of 95 newly diagnosed APL patients, 85 patients who achieved complete remission (CR) were sequentially evaluated during a 4-60 month period by conventional RT-PCR. A total of 30 patients (six relapsed and 24 in continued CR) were selected and monitored by quantitative real-time PCR (RQ-PCR) assay. The PML-RAR{alpha} fusion transcripts values were normalised to every 106 copies of G6PDH transcripts (NQ).

Results: RQ-PCR analyses showed a rapid rate of clearance of NQ levels during the courses of arsenic therapy. In the majority of patients in CR, the NQ levels were below 5 x 102 in peripheral blood (PB) samples. In all the relapsed cases with follow-up intervals of 1-6 months (median 3 months) clinical relapse was predictable by increasing NQ level above this threshold.

Conclusions: Our study highlights the usefulness of PB and the definition of threshold level for early prediction of relapse. The threshold level correlates well with risk of relapse; therefore, transcript ratio below the level should be regarded as a goal in the clinical management of this disease.

Keywords: arsenic trioxide; RQ-PCR; MRD; PML-RAR{alpha}; APL.
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