Evaluation of Multiplex Polymerase Chain Reaction (PCR) as Prognostic Tools for Chronic Myeloid Leukemia (CML) Patients in Resource-Limited Setting at Tikur Anbessa Specialized Hospital, Addis Ababa, Ethiopia.
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Date
2021-09
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Addis Abeba University
Abstract
Background:-The hallmark diagnostic tool for Chronic myeloid leukemia (CML) is Philadelphia
chromosome t (9; 22) (q34; q11)) which gives rise to bcr-abl1 fusion oncogenic protein. QrtPCR
of bcr-abl1has been established as a prognostic tool since the introduction of TKI drugs.
But, in a resource-limited setting, like Ethiopia, multiplex reverse transcriptase PCR, which is
used to be as a screening tool, could be adopted into the clinic as a relative prognostic tool than
relying on hematological response.
Objective: - to evaluate multiplex polymerase chain reaction (PCR) as prognostic tools for
chronic myeloid leukemia (CML) patients in resource-limited settings at Tikur Anbessa
Specialized Hospital (TASH).
Method: - Hospital-based Cross-sectional study design was used for a total of 114 confirmed
CML patients who were enrolled at the Hematology Clinic of TASH. Multiplex reverse
transcriptase-polymerase chain reaction (RT-PCR) and quantitative reverse transcriptase PCR
were performed at AHRI molecular lab, and Leipzig hematology clinic, respectively. The
descriptive statistic and ROC curve using excel were used to assess the demographic feature of
the patients and to evaluate the prognostic value, respectively, and thereby the most valuable cutoff
multiplex
PCR
was
calculated
in comparison
with QRT-
PCR.
Result:
- of the total enrolled study subjects (114), most of the transcripts were major fusion
gene (M-bcr-abl1), b2a2 (28.1%), b3a2 (49.1%), and co-expressed were b2a2/b3a2 (0.9%). All
new cases and follow-up patients who were positive with the multiplex RT-PCR method for bcrabl
transcript were more than 95% agreement with quantitative PCR compared to the limit of
detection sated for multiplex PCR. Multiplex RT- PCR at a cut-off 0.31% IS and above, in
comparison to the standard prognostic tools (Qrt PCR) has a comparable result; sensitivity 96.6%
and specificity 88% at the area under the curve 0.977(97.7 %) and CI 95% (0.952 to 1, P-value
0.0001).
Conclusion: - Follow-up of patients on the hematological parameter is rather crude and not
sensitive enough to modify the treatment regimen. But, the use of multiplex PCR, besides as
screening tools, can provide an early sign of relapse as low as 0.31% IS bcr-abl transcript. As
compared to Qrt-PCR, it is relatively cheap and accessible to be adopted into the routine clinic.
Description
Keywords
BCR-ABL- RT-PCR, chronic myeloid leukemia, molecular response, Ethiopia.