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| 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. |
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