Figure 4
Figure 4. Treatment assignments and molecular outcomes for patients who failed to achieve TIDEL-II treatment targets. The proportion of patients with an imatinib trough level of <1000 ng/mL at day 22 is denoted by numbers in parentheses. Outcomes for the 25 patients who failed to achieve their 3-month molecular target of BCR-ABL1 ≤10% have been described in the article. Excluding the 25 patients who failed to achieve their 3-month target, 23 of the remaining 185 patients (11%) failed to achieve BCR-ABL1 <1% at 6 months. Fifteen switched to nilotinib by 12 months either directly or after a trial of imatinib 800 mg/day; another 3 remained on imatinib 800 mg/day, and 5 withdrew. At 24 months, 9 of the 23 had withdrawn (3 each as a result of toxicity, nonadherence to treatment protocol, or treatment failure). Of the remaining 14 patients, 2 remained on imatinib 800 mg/day and 12 remained on nilotinib; all had BCR-ABL1 <1%. Overall, 6 (26%) of the 23 patients had MMR at 24 months, only one doing so on escalated-dose imatinib. The 24-month MMR rate in this group is similar to that of patients with BCR-ABL1 >10% at 3 months. Of the 159 patients who achieved their 3- and 6-month TIDEL-II targets and had not withdrawn from the study before 12 months, 30 had BCR-ABL1 ≥0.1% at 12 months. At 24 months, 20 (67%) of these 30 patients had achieved and maintained MMR (10 on nilotinib, 9 on imatinib 800 mg/day, and 1 on imatinib 600 mg/day). Of the remainder, 6 had achieved and maintained BCR-ABL1 ≤1%; the other 4 of 30 withdrew from the study (2 with nilotinib-resistant mutations). Forty patients had trough imatinib levels <1000 ng/mL at day 22, 20 of whom subsequently failed to achieve 1 of the TIDEL-II molecular targets and are included in this diagram. This group of patients makes up 40%, 13%, and 23% of patients who failed to achieve their 3-, 6-, and 12-month targets, respectively. The other 20 patients all achieved MMR at 12 months, 15 of them having done so on imatinib 800 mg/day, 2 on imatinib 600 mg/day, and 3 on nilotinib (supplemental Figure 4). C1, cohort 1; C2, cohort 2; IM 400, imatinib 400 mg/day; IM 600, imatinib 600 mg/day; IM 800, imatinib 800 mg/day; NIL, nilotinib; T, total; W, withdrawn from TIDEL-II (MRs not recorded).

Treatment assignments and molecular outcomes for patients who failed to achieve TIDEL-II treatment targets. The proportion of patients with an imatinib trough level of <1000 ng/mL at day 22 is denoted by numbers in parentheses. Outcomes for the 25 patients who failed to achieve their 3-month molecular target of BCR-ABL1 ≤10% have been described in the article. Excluding the 25 patients who failed to achieve their 3-month target, 23 of the remaining 185 patients (11%) failed to achieve BCR-ABL1 <1% at 6 months. Fifteen switched to nilotinib by 12 months either directly or after a trial of imatinib 800 mg/day; another 3 remained on imatinib 800 mg/day, and 5 withdrew. At 24 months, 9 of the 23 had withdrawn (3 each as a result of toxicity, nonadherence to treatment protocol, or treatment failure). Of the remaining 14 patients, 2 remained on imatinib 800 mg/day and 12 remained on nilotinib; all had BCR-ABL1 <1%. Overall, 6 (26%) of the 23 patients had MMR at 24 months, only one doing so on escalated-dose imatinib. The 24-month MMR rate in this group is similar to that of patients with BCR-ABL1 >10% at 3 months. Of the 159 patients who achieved their 3- and 6-month TIDEL-II targets and had not withdrawn from the study before 12 months, 30 had BCR-ABL1 ≥0.1% at 12 months. At 24 months, 20 (67%) of these 30 patients had achieved and maintained MMR (10 on nilotinib, 9 on imatinib 800 mg/day, and 1 on imatinib 600 mg/day). Of the remainder, 6 had achieved and maintained BCR-ABL1 ≤1%; the other 4 of 30 withdrew from the study (2 with nilotinib-resistant mutations). Forty patients had trough imatinib levels <1000 ng/mL at day 22, 20 of whom subsequently failed to achieve 1 of the TIDEL-II molecular targets and are included in this diagram. This group of patients makes up 40%, 13%, and 23% of patients who failed to achieve their 3-, 6-, and 12-month targets, respectively. The other 20 patients all achieved MMR at 12 months, 15 of them having done so on imatinib 800 mg/day, 2 on imatinib 600 mg/day, and 3 on nilotinib (supplemental Figure 4). C1, cohort 1; C2, cohort 2; IM 400, imatinib 400 mg/day; IM 600, imatinib 600 mg/day; IM 800, imatinib 800 mg/day; NIL, nilotinib; T, total; W, withdrawn from TIDEL-II (MRs not recorded).

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