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Annals of Oncology Advance Access originally published online on July 10, 2006
Annals of Oncology 2006 17(10):1553-1559; doi:10.1093/annonc/mdl150
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© 2006 European Society for Medical Oncology

hematologic malignancies

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

SH Ghaffari*, S Rostami, D Bashash, K Alimoghaddam and A Ghavamzadeh

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

*Correspondence to: Dr S. H. Ghaffari, Hematology, Oncology and BMT Research Center, Tehran University Medical Sciences, Shariaty Hospital, Tehran, Iran. Tel: +98-21-84902638; Fax: +98-21-8004140; E-mail: shghaffari2000{at}yahoo.com

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.

Key words: arsenic trioxide, RQ-PCR, MRD, PML-RAR{alpha}, APL


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