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Report on the Relative Efficacy of Oral Cancer Therapy for Medicare Beneficiaries Versus Currently Covered Therapy

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Figure 4: Definition of Tumor Response Criteria Relevant to CML

Tumor Response Definition
Complete hematologic remission Normal complete blood count and normal physical examination
Reported as Complete Hematologic Response (CHR) Complete HR Normal complete blood count and exam
Partial HR Improved but not normal complete blood count and exam
Hematologic improvement Complete plus partial hematologic response
Complete cytogenetic remission Normal chromosome examination with no Ph-positive cells detectable on metaphase cytogenetic of bone marrow with 20-25 cells analyzed
Reported as Complete Cytogenetic Response (CCR)2 Complete CR 0% Ph positive cells detectable
Partial CR 1-34% Ph positive cells detectable
Major CR (= Complete CR plus Partial CR) <35% Ph positive cells detectable
Minor CR 35-65% Ph positive cells detected*
Minimal CR 66-95% Ph positive cells detected
No CR >95% Ph positive cells detected
Molecular remission Negative RT-PCR evidence of the BCR-ABL mRNA
Variably reported as Complete Molecular Response (CMR) Complete MR No detectable BCR-ABL mRNA
Major MR > 3 log reduction in detectable BCR-ABL mRNA33
Overall survival (OS) The percentage of CML subjects in a study who have survived for a defined period of time. Usually reported as time since diagnosis or treatment.
Time to progression (TTP) A measure of time after CML is diagnosed (or treated) until it starts to get worse.
Progression-free survival (PFS) The probability that a CML patient will remain alive, without the disease getting worse.
Disease-free survival (DFS) Length of time after treatment during which no CML is found. Can be reported for an individual patient or for a study population.
Event-free survival (EFS) Length of time after treatment that a CML participant in a clinical study remains free of pre-defined events. Events are defined by the study and can include adverse treatment effects, CML relapse/progression, or survival.
Survival rate The percentage of people in a study or treatment group who are alive for a given period of time after diagnosis. Commonly expressed as 1-year, 2-year, 5-year, and 10-year survival.

Note: *Some authors define Minor CR as 35-95% Ph positive cells.38

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