Table 2.

The cumulative results of an imatinib-treated de-novo patient in chronic phase. In this patient detection of BCR-ABL was dependent on the sensitivity achieved with each RNA sample as indicated by the control gene transcript level.

Collection DateSource of MaterialBCR-ABLCopy NumberBCRControl Gene Copy NumberRatio (%)International Scale Conversion (%)CodeComment
Codes: 
B: BCR-ABL at a level <1% on international scale suggests patient has achieved CCR 
C: Major molecular response achieved 
F. BCR-ABL undetectable at a sensitivity of at least 0.01% on international scale, which is equivalent to > 4 logs below the standardized baseline as defined in the IRIS trial 
G. BCR-ABL undetectable at a sensitivity of at least 0.003% on international scale, which is equivalent to > 4.5 logs below the standardized baseline as defined in the IRIS trial 
Sensitivity indicator: 
BCR level 100,000–400,000 sensitivity at least 0.01% on international scale. 
BCR level > 400,000 sensitivity at least 0.003% on international scale. 
Measurement reliability: 
BCR-ABL values < 0.1% CV = 27.7% 
BCR-ABL values 0.11–1% CV = 19.8% 
BCR-ABL values > 1% CV = 15.3% 
02/11/2003 Blood 79,860 50,950 156 195  Pre-imatinib 
05/20/2003 Blood 415 144,760 0.29 0.36 B 3 months on imatinib 
08/11/2003 Blood 115 252,755 0.05 0.06 C 6 months on imatinib 
10/27/2003 Blood 10 215,715 0.006 0.008  9 months on imatinib 
01/19/2004 Blood 20 236,310 0.008 0.010  12 months on imatinib 
04/19/2004 Blood 20 241,555 0.009 0.011  15 months on imatinib 
07/08/2004 Blood 0 330,100 0 0 F 18 months on imatinib 
10/11/2004 Blood 0 320,450 0 0 F 21 months on imatinib 
01/04/05 Blood 15 914,160 0.002 0.003  24 months on imatinib 
03/08/05 Blood 0 567,340 0 0 G 27 months on imatinib 
Collection DateSource of MaterialBCR-ABLCopy NumberBCRControl Gene Copy NumberRatio (%)International Scale Conversion (%)CodeComment
Codes: 
B: BCR-ABL at a level <1% on international scale suggests patient has achieved CCR 
C: Major molecular response achieved 
F. BCR-ABL undetectable at a sensitivity of at least 0.01% on international scale, which is equivalent to > 4 logs below the standardized baseline as defined in the IRIS trial 
G. BCR-ABL undetectable at a sensitivity of at least 0.003% on international scale, which is equivalent to > 4.5 logs below the standardized baseline as defined in the IRIS trial 
Sensitivity indicator: 
BCR level 100,000–400,000 sensitivity at least 0.01% on international scale. 
BCR level > 400,000 sensitivity at least 0.003% on international scale. 
Measurement reliability: 
BCR-ABL values < 0.1% CV = 27.7% 
BCR-ABL values 0.11–1% CV = 19.8% 
BCR-ABL values > 1% CV = 15.3% 
02/11/2003 Blood 79,860 50,950 156 195  Pre-imatinib 
05/20/2003 Blood 415 144,760 0.29 0.36 B 3 months on imatinib 
08/11/2003 Blood 115 252,755 0.05 0.06 C 6 months on imatinib 
10/27/2003 Blood 10 215,715 0.006 0.008  9 months on imatinib 
01/19/2004 Blood 20 236,310 0.008 0.010  12 months on imatinib 
04/19/2004 Blood 20 241,555 0.009 0.011  15 months on imatinib 
07/08/2004 Blood 0 330,100 0 0 F 18 months on imatinib 
10/11/2004 Blood 0 320,450 0 0 F 21 months on imatinib 
01/04/05 Blood 15 914,160 0.002 0.003  24 months on imatinib 
03/08/05 Blood 0 567,340 0 0 G 27 months on imatinib 
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