Patient demographics and clinical status at baseline
Patient demographics . | . | |||
---|---|---|---|---|
Age, range, y (M ± SD) | 17-86 (57.2 ± 14.5) | |||
Sex, % | ||||
Male | 55.0 | |||
Female | 45.0 | |||
Race, % | ||||
White | 96.4 | |||
Non-white | 3.6 | |||
Secondary school or higher education, % | 55.5 | |||
Living at home alone, % | 19.5 | |||
History of CML and treatment | ||||
Years since CML diagnosis, range, y (M ± SD) | 0-29 (4.7 ± 4.4) | |||
Symptomatic at diagnosis, % | 45.1 | |||
Prior CML treatments and outcome, % | ||||
Interferon | 64.2 | |||
Failure | 28.0 | |||
Not tolerated | 59.0 | |||
Success but relapse* | 13.0 | |||
Hydroxycarbamide | 77.1 | |||
Failure | 40.3 | |||
Not tolerated | 32.3 | |||
Success but relapse | 27.4 | |||
Transplantation | 1.8 | |||
Failure | 0.0 | |||
Not tolerated | 0.0 | |||
Success but relapse | 100.0 | |||
Current CML status | ||||
Disease status, % | ||||
Primary | 93.3 | |||
Relapse | 6.7 | |||
Disease phase | ||||
Chronic phase | 98.2 | |||
Accelerated phase | 1.8 | |||
Blast crisis | 0.0 | |||
Current disease parameters | ||||
Too early to judge | 11.1 | |||
Available (see Parameters, below) | 88.9 | |||
Parameters (if available) | ||||
Hematologic response | ||||
Complete | 87.0 | |||
No evidence of leukemia | 4.1 | |||
Return to chronic phase | 0.0 | |||
Not documented | 8.9 | |||
Cytogenetic response | 65.1 | |||
Complete | ||||
Major | 5.3 | |||
Partial | 5.9 | |||
Not documented | 23.7 | |||
Molecular response | ||||
≥ 3 log | 47.9 | |||
≥ 2 log | 13.6 | |||
Not documented | 38.5 | |||
Imatinib treatment, range, mo (M ± SD) | 1.0-72.8 (32.9 ± 19.8) | |||
Months on imatinib therapy at baseline | 100-800 (395.2 ± 77.9) | |||
Starting dose, mg/day | 100-800 (429.0 ± 106.2) | |||
Baseline dose, mg/day | 100-800 (420.1 ± 120.0) | |||
Follow-up dose, mg/day | 100-800 (420.1 ± 120.0) | |||
Number of patients in whom imatinib treatment changed between baseline and follow-up | ||||
Imatinib dose change | 7 | |||
100 mg/day | 1 | |||
300 mg/day | 2 | |||
400 mg/day | 3 | |||
600 mg/day | 1 | |||
Change because of intolerance | 6 | |||
Change because of suboptimal response | 1 | |||
Imatinib discontinued | 3 | |||
Intolerance | 1 | |||
Progressive disease | 2 | |||
Patient-reported variables, range (M ± SD) | ||||
Functional status / quality of life (scale of 8-42) | 14-42 (31.5 ± 6.5) | |||
Quality of chronic care (scale of 1-5) | 1-5 (2.8 ± 0.9) | |||
Long-term medication behavior self-efficacy (scale of 1-5) | 1-5 (4.7 ± 0.5) | |||
Knowledge of disease and treatment (scale of 0-100) | 0-100 (71.9 ± 20.3) | |||
Comorbidities, % | Past | Current | ||
Cardiac | 11.8 | 12.4 | ||
Vascular | 7.1 | 4.1 | ||
Pulmonary | 8.3 | 4.1 | ||
Renal | 3.0 | 1.2 | ||
Hepatic | 1.8 | 1.2 | ||
Neurologic | 6.5 | 3.0 | ||
Endocrine/metabolic | 7.7 | 10.7 | ||
Muscular | 2.4 | 0.6 | ||
Skeletal | 18.9 | 8.9 | ||
Skin/connective tissue | 6.5 | 1.2 | ||
Gastrointestinal | 26.0 | 4.7 | ||
Genitourinary | 10.1 | 1.8 | ||
Hematologic (except CML) | 3.0 | 0.0 | ||
Concomitant medications, % | ||||
Paracetamol | 9.5 | |||
Medication burden on typical day | Range | Q1 | Median | Q3 |
No. drugs taken per day | 1-11 | 1 | 2 | 4 |
No. times per day drugs are taken | 1-5 | 1 | 2 | 3 |
No. medication units taken per day | 1-18 | 3 | 4 | 6 |
Patient demographics . | . | |||
---|---|---|---|---|
Age, range, y (M ± SD) | 17-86 (57.2 ± 14.5) | |||
Sex, % | ||||
Male | 55.0 | |||
Female | 45.0 | |||
Race, % | ||||
White | 96.4 | |||
Non-white | 3.6 | |||
Secondary school or higher education, % | 55.5 | |||
Living at home alone, % | 19.5 | |||
History of CML and treatment | ||||
Years since CML diagnosis, range, y (M ± SD) | 0-29 (4.7 ± 4.4) | |||
Symptomatic at diagnosis, % | 45.1 | |||
Prior CML treatments and outcome, % | ||||
Interferon | 64.2 | |||
Failure | 28.0 | |||
Not tolerated | 59.0 | |||
Success but relapse* | 13.0 | |||
Hydroxycarbamide | 77.1 | |||
Failure | 40.3 | |||
Not tolerated | 32.3 | |||
Success but relapse | 27.4 | |||
Transplantation | 1.8 | |||
Failure | 0.0 | |||
Not tolerated | 0.0 | |||
Success but relapse | 100.0 | |||
Current CML status | ||||
Disease status, % | ||||
Primary | 93.3 | |||
Relapse | 6.7 | |||
Disease phase | ||||
Chronic phase | 98.2 | |||
Accelerated phase | 1.8 | |||
Blast crisis | 0.0 | |||
Current disease parameters | ||||
Too early to judge | 11.1 | |||
Available (see Parameters, below) | 88.9 | |||
Parameters (if available) | ||||
Hematologic response | ||||
Complete | 87.0 | |||
No evidence of leukemia | 4.1 | |||
Return to chronic phase | 0.0 | |||
Not documented | 8.9 | |||
Cytogenetic response | 65.1 | |||
Complete | ||||
Major | 5.3 | |||
Partial | 5.9 | |||
Not documented | 23.7 | |||
Molecular response | ||||
≥ 3 log | 47.9 | |||
≥ 2 log | 13.6 | |||
Not documented | 38.5 | |||
Imatinib treatment, range, mo (M ± SD) | 1.0-72.8 (32.9 ± 19.8) | |||
Months on imatinib therapy at baseline | 100-800 (395.2 ± 77.9) | |||
Starting dose, mg/day | 100-800 (429.0 ± 106.2) | |||
Baseline dose, mg/day | 100-800 (420.1 ± 120.0) | |||
Follow-up dose, mg/day | 100-800 (420.1 ± 120.0) | |||
Number of patients in whom imatinib treatment changed between baseline and follow-up | ||||
Imatinib dose change | 7 | |||
100 mg/day | 1 | |||
300 mg/day | 2 | |||
400 mg/day | 3 | |||
600 mg/day | 1 | |||
Change because of intolerance | 6 | |||
Change because of suboptimal response | 1 | |||
Imatinib discontinued | 3 | |||
Intolerance | 1 | |||
Progressive disease | 2 | |||
Patient-reported variables, range (M ± SD) | ||||
Functional status / quality of life (scale of 8-42) | 14-42 (31.5 ± 6.5) | |||
Quality of chronic care (scale of 1-5) | 1-5 (2.8 ± 0.9) | |||
Long-term medication behavior self-efficacy (scale of 1-5) | 1-5 (4.7 ± 0.5) | |||
Knowledge of disease and treatment (scale of 0-100) | 0-100 (71.9 ± 20.3) | |||
Comorbidities, % | Past | Current | ||
Cardiac | 11.8 | 12.4 | ||
Vascular | 7.1 | 4.1 | ||
Pulmonary | 8.3 | 4.1 | ||
Renal | 3.0 | 1.2 | ||
Hepatic | 1.8 | 1.2 | ||
Neurologic | 6.5 | 3.0 | ||
Endocrine/metabolic | 7.7 | 10.7 | ||
Muscular | 2.4 | 0.6 | ||
Skeletal | 18.9 | 8.9 | ||
Skin/connective tissue | 6.5 | 1.2 | ||
Gastrointestinal | 26.0 | 4.7 | ||
Genitourinary | 10.1 | 1.8 | ||
Hematologic (except CML) | 3.0 | 0.0 | ||
Concomitant medications, % | ||||
Paracetamol | 9.5 | |||
Medication burden on typical day | Range | Q1 | Median | Q3 |
No. drugs taken per day | 1-11 | 1 | 2 | 4 |
No. times per day drugs are taken | 1-5 | 1 | 2 | 3 |
No. medication units taken per day | 1-18 | 3 | 4 | 6 |
M indicates mean; SD, standard deviation; Q1, 25th percentile; Median, 50th percentile; and Q3, 75th percentile.
Relapse = loss of response.