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.