Table 1. Achievement of MR4.5 according to response status at baseline and crossover.
Nilotinib arm | Imatinib arm | P-valuea | |
---|---|---|---|
All patients | n=104 | n=103 | |
Achieved MR4.5 by 48 months | |||
ITT, n (%) | 56 (53.8) | 46 (44.7) | 0.1766 |
Up to crossover, n (%) | 56 (53.8) | 33 (32.0) | 0.0011 |
After crossover, n/m (%)b | NA | 20/46 (43.5)c | NA |
Patients without MMR at baseline | n=24 | n=28 | |
Achieved MR4.5 by 48 months | |||
ITT, n (%) | 8 (33.3) | 6 (21.4) | 0.4279 |
Up to crossover, n (%) | 8 (33.3) | 1 (3.6) | 0.0055 |
After crossover, n/m (%)d | NA | 5/17 (29.4)e | NA |
Patients with MMR but without MR4.5 at baseline | n=74 | n=68 | |
Achieved MR4.5 by 48 months | |||
ITT, n (%) | 43 (58.1) | 34 (50.0) | 0.2273 |
Up to crossover, n (%) | 43 (58.1) | 26 (38.2) | 0.0084 |
After crossover, n/m (%)f | NA | 14/28 (50.0)g | NA |
Abbreviations: ITT, intention-to-treat; MMR, major molecular response; MR4.5, BCR-ABL1 ⩽0.0032% on the International Scale.
P-values are nominal. No multiplicity adjustments were made; therefore, statistical interpretation should be made with caution. P-values were obtained using the Cochran–Mantel–Haenszel test.
Denominator is the number of patients who crossed over.
A total of 20 patients achieved MR4.5 after crossover, including 13 who achieved MR4.5 for the first time on nilotinib, 4 who achieved MR4.5 on imatinib and maintained the response on nilotinib and 3 who regained MR4.5 on nilotinib after losing the response prior to crossover.
Denominator is the number of patients without MMR at baseline who crossed over.
Of the 11 patients without MMR at baseline who did not crossover, 1 achieved MR4.5 on imatinib and was not eligible to crossover; the other 10 patients were eligible to crossover but did not, and none of these achieved MR4.5.
Denominator is the number of patients with MMR but without MR4.5 at baseline who crossed over.
Of the 68 patients with MMR but without MR4.5 at baseline, 28 crossed over and 40 did not crossover. Twenty of the 40 patients who did not crossover achieved MR4.5 on imatinib by the end of the study. Fourteen of the 28 patients who crossed over achieved MR4.5 by the end of the study, including 10 patients who achieved MR4.5 for the first time after crossover and 4 patients who achieved MR4.5 before and after crossover.