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Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials

Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials
Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials
An international basis for comparison of BCR-ABL mRNA levels is required for the common interpretation of data derived from individual laboratories. This will aid clinical decisions for individual patients with chronic myeloid leukemia (CML) and assist interpretation of results from clinical studies. We aligned BCR-ABL values generated by 38 laboratories to an international scale (IS) where a major molecular response (MMR) is 0.1% or less. Alignment was achieved by application of laboratory-specific conversion factors calculated by comparisons performed with patient samples against a reference method. A validation procedure was completed for 19 methods. We determined performance characteristics (bias and precision) for consistent interpretation of MMR after IS conversion. When methods achieved an average BCR-ABL difference of plus or minus 1.2-fold from the reference method and 95% limits of agreement within plus or minus 5-fold, the MMR concordance was 91%. These criteria were met by 58% of methods. When not met, the MMR concordance was 74% or less. However, irrespective of precision, when the bias was plus or minus 1.2-fold as achieved by 89% of methods, there was good agreement between the overall MMR rates. This indicates that the IS can deliver accurate comparison of molecular response rates between clinical trials when measured by different laboratories.
0006-4971
3330-3338
Branford, Susan
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Fletcher, Linda
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Cross, Nicholas C.P.
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Müller, Martin C.
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Hochhaus, Andreas
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Kim, Dong-Wook
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Radich, Jerald P.
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Saglio, Giuseppe
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Pane, Fabrizio
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Kamel-Reid, Suzanne
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Wang, Y. Lynn
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Press, Richard D.
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Lynch, Kevin
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Rudzki, Zbigniew
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Goldman, John M.
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Hughes, Timothy
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Branford, Susan
fc8a5cf1-4c36-48b5-92f1-835ee701260f
Fletcher, Linda
4fcc1409-37ba-42f7-87e6-5f5bb2de2292
Cross, Nicholas C.P.
f87650da-b908-4a34-b31b-d62c5f186fe4
Müller, Martin C.
ea37982c-00bb-44b5-bc73-f4b5bd0825e9
Hochhaus, Andreas
b37b9b7d-85ff-455e-994d-fcc2adf94088
Kim, Dong-Wook
252df2be-3037-413e-865e-03bffdcfacea
Radich, Jerald P.
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Saglio, Giuseppe
46ec4e74-92c7-4459-ac47-0b10cbcd887e
Pane, Fabrizio
82663d99-c04b-4564-85b7-9a9e1574d541
Kamel-Reid, Suzanne
0455fd94-2c7c-4317-ad75-da5cbcffc933
Wang, Y. Lynn
281a4bfb-c4f7-4bb1-b883-902d17f0e04c
Press, Richard D.
522c06c4-4aa7-44d8-85d7-484c9c81463c
Lynch, Kevin
efd2561b-4c37-437a-83c9-f44712f968f5
Rudzki, Zbigniew
1b8a3e4c-e976-4fb1-9cb6-b84fc791c147
Goldman, John M.
2632cc83-5866-46bd-914d-8450157fe689
Hughes, Timothy
3ae3f369-388b-4c4c-819a-5224a1a34179

Branford, Susan, Fletcher, Linda, Cross, Nicholas C.P., Müller, Martin C., Hochhaus, Andreas, Kim, Dong-Wook, Radich, Jerald P., Saglio, Giuseppe, Pane, Fabrizio, Kamel-Reid, Suzanne, Wang, Y. Lynn, Press, Richard D., Lynch, Kevin, Rudzki, Zbigniew, Goldman, John M. and Hughes, Timothy (2008) Desirable performance characteristics for BCR-ABL measurement on an international reporting scale to allow consistent interpretation of individual patient response and comparison of response rates between clinical trials. Blood, 112 (8), 3330-3338. (doi:10.1182/blood-2008-04-150680).

Record type: Article

Abstract

An international basis for comparison of BCR-ABL mRNA levels is required for the common interpretation of data derived from individual laboratories. This will aid clinical decisions for individual patients with chronic myeloid leukemia (CML) and assist interpretation of results from clinical studies. We aligned BCR-ABL values generated by 38 laboratories to an international scale (IS) where a major molecular response (MMR) is 0.1% or less. Alignment was achieved by application of laboratory-specific conversion factors calculated by comparisons performed with patient samples against a reference method. A validation procedure was completed for 19 methods. We determined performance characteristics (bias and precision) for consistent interpretation of MMR after IS conversion. When methods achieved an average BCR-ABL difference of plus or minus 1.2-fold from the reference method and 95% limits of agreement within plus or minus 5-fold, the MMR concordance was 91%. These criteria were met by 58% of methods. When not met, the MMR concordance was 74% or less. However, irrespective of precision, when the bias was plus or minus 1.2-fold as achieved by 89% of methods, there was good agreement between the overall MMR rates. This indicates that the IS can deliver accurate comparison of molecular response rates between clinical trials when measured by different laboratories.

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Published date: 15 October 2008

Identifiers

Local EPrints ID: 69746
URI: https://eprints.soton.ac.uk/id/eprint/69746
ISSN: 0006-4971
PURE UUID: 0e67d175-bdb9-4c32-8fdf-4d2e73b027da
ORCID for Nicholas C.P. Cross: ORCID iD orcid.org/0000-0001-5481-2555

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Date deposited: 02 Dec 2009
Last modified: 12 Nov 2019 01:51

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Contributors

Author: Susan Branford
Author: Linda Fletcher
Author: Martin C. Müller
Author: Andreas Hochhaus
Author: Dong-Wook Kim
Author: Jerald P. Radich
Author: Giuseppe Saglio
Author: Fabrizio Pane
Author: Suzanne Kamel-Reid
Author: Y. Lynn Wang
Author: Richard D. Press
Author: Kevin Lynch
Author: Zbigniew Rudzki
Author: John M. Goldman
Author: Timothy Hughes

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