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. Author manuscript; available in PMC: 2015 May 27.
Published in final edited form as: Cancer. 2009 Feb 1;115(3):551–560. doi: 10.1002/cncr.24066

Table 2.

Reasons for Dose Escalation of Imatinib Among Patients Randomized to Receive Imatinib in the International Randomized Study of Interferon and STI571 Study

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.