title: Feasibility and clinical significance of real-time quantitative RT-PCR assay of PML-RARalpha fusion transcript in patients with acute promyelocytic leukemia.
abstract: BACKGROUND
  To study the relationship between the expression level of the PML-RARalpha fusion transcripts and the clinical status and efficiency of the therapy in acute promyelocytic leukemia (APL) patients, we applied a very sensitive and specific real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR) system to quantify the dose of PML-RARalpha fusion transcripts in a series of APL patients at distinct disease stages.
  
  
  METHODS
  A total of 31 APL patients (19 males and 12 females; aged from 8 to 74 years) from eight hospitals in Shanghai were analysed. Real-time Quantitative RT-PCR was used to measure the normalized dose (DoseN) of PML-RARalpha fusion transcripts.
  
  
  RESULTS
  A wide range of PML-RARalpha DoseN above 1 x 10(3) was noted in 25 newly diagnosed patients. PML-RARalpha DoseN was significantly decreased after remission induction with ATRA, ATRA/chemotherapy or As2O3 and further reduced after consolidation. The fact that all patients with long disease free survival had a constantly low PML-RARalpha DoseN below 2 x 10(2) and a higher level predicted impending relapse suggests that this value could serve as a 'threshold' for molecular remission. PML-RARalpha DoseN was also of prognostic value in a group of relapsed patients, since good response to As2O3 reinduction was accompanied by a remarkable reduction of fusion transcript level, whereas patients with high PML-RARalpha Dose(N) after the second CR tended to relapse again rapidly.
  
  
  CONCLUSIONS
  These results confirm that real-time RT-PCR assay for PML-RARalpha transcripts in APL patients is useful in reflecting leukemic burden, assessing response to treatment and indicating the ultimate clinical outcome or curability of disease.
authors.affiliation: Shanghai Institute of Hematology, Key Laboratory of Human Genome Research, Ministry of Public Health and Shanghai Municipality, Rui-Jin Hospital, Shanghai Second Medical University, 197 Rui Jin Road II, Shanghai 200025, P.R. China.
authors.forename: B W
authors.initials: BW
authors.lastname: Gu
authors.forename: J
authors.initials: J
authors.lastname: Hu
authors.forename: L
authors.initials: L
authors.lastname: Xu
authors.forename: H
authors.initials: H
authors.lastname: Yan
authors.forename: W R
authors.initials: WR
authors.lastname: Jin
authors.forename: Y M
authors.initials: YM
authors.lastname: Zhu
authors.forename: W L
authors.initials: WL
authors.lastname: Zhao
authors.forename: C
authors.initials: C
authors.lastname: Niu
authors.forename: Q
authors.initials: Q
authors.lastname: Cao
authors.forename: X Y
authors.initials: XY
authors.lastname: Su
authors.forename: J
authors.initials: J
authors.lastname: Gu
authors.forename: H Y
authors.initials: HY
authors.lastname: Ying
authors.forename: Y
authors.initials: Y
authors.lastname: Chen
authors.forename: S M
authors.initials: SM
authors.lastname: Xiong
authors.forename: Z X
authors.initials: ZX
authors.lastname: Shen
authors.forename: Z
authors.initials: Z
authors.lastname: Chen
authors.forename: S J
authors.initials: SJ
authors.lastname: Chen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage; D001853:Bone Marrow / Q000473:pathology; D002648:Child; D018450:Disease Progression; D018572:Disease-Free Survival; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D015473:Leukemia, Promyelocytic, Acute / Q000175:diagnosis* / Q000188:drug therapy / Q000235:genetics; D008297:Male; D008875:Middle Aged; D009363:Neoplasm Proteins / Q000032:analysis* / Q000235:genetics; D018365:Neoplasm, Residual / Q000175:diagnosis / Q000235:genetics; D015514:Oncogene Proteins, Fusion / Q000032:analysis* / Q000235:genetics; D011379:Prognosis; D012333:RNA, Messenger / Q000032:analysis; D015203:Reproducibility of Results; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000592:standards*; D012680:Sensitivity and Specificity
chemical_list: D000970:Antineoplastic Agents; D009363:Neoplasm Proteins; D015514:Oncogene Proteins, Fusion; D012333:RNA, Messenger; C093476:promyelocytic leukemia-retinoic acid receptor alpha fusion oncoprotein