Table 2.
IRIS Protocol Criteria (n539)* | ELN Recommendations (n548)* | ||
---|---|---|---|
Reason | No. (%) | Reason | No. (%) |
No CHR at 3 mo | 7 (18) | 3 mo: Failure or suboptimal response (no HR or CHR) | 7 (15) |
No MinCyR at 12mo | 8 (21) | 6 mo: Failure (no CHR, no CyR) | 1 (2) |
Loss of MCyR | 18 (46) | 12 mo: Suboptimal response (no CCyR) | 4 (8) |
Progression† | 6 (15) | 12 mo: Failure (no MCyR) | 11 (23) |
18 mo: Failure (no CCyR) | 10 (21) | ||
Failure at anytime (confirmed loss of CHR or loss of CCyR) | 15 (31) |
IRIS indicates the International Randomized Study of Interferon and STI571 trial; ELN, European LeukemiaNet; CHR, complete hematologic response; HR, hematologic response; MinCyR, minimal cytogenetic response; CyR, cytogenetic response; MCyR, major cytogenetic response; CCyR, complete cytogenetic response.
Includes 34 patients who met both ELN and IRIS protocol criteria for dose escalation,
A subset of patients with disease progression was included in the “per IRIS Protocol Criteria” analysis, because the prescribing information for imatinib allows for dose escalation for this reason.