TABLE 1.
Sample Characteristics by TKI Initiation Time from First CML Diagnosis
| Patients Who Initiated TKI Therapy | P Valuea | ||||
|---|---|---|---|---|---|
| ≤ 1 Month from First CML Diagnosis (n = 397) | Within >1-12 Months from First CML Diagnosis (n = 80) | ||||
| Demographic characteristics | |||||
| Age at index date, years, mean ± SD [median] | 49.10 ± 10.49 [51] | 47.59 ± 11.35 [49.5] | 0.32 | ||
| Age group, years, n (%) | 0.35 | ||||
| 18-39 | 71 (17.9) | 21 (26.3) | |||
| 40-49 | 101 (25.4) | 19 (23.8) | |||
| 50-59 | 166 (41.8) | 28 (35.0) | |||
| 60-64 | 59 (14.9) | 12 (15.0) | |||
| Male, n (%) | 223 (56.2) | 35 (43.8) | 0.04b | ||
| Patient relationship to subscriber, n (%) | 0.80 | ||||
| Subscriber | 264 (66.5) | 52 (65.0) | |||
| Spouse or dependent | 133 (33.5) | 28 (35.0) | |||
| Health plan type, n (%) | 0.64 | ||||
| Group: comprehensive/PPO/POS/EPO | 292 (73.6) | 56 (70.0) | |||
| CDHP/high deductible health plan | 40 (10.1) | 11 (13.8) | |||
| HMO | 37 (9.3) | 9 (11.3) | |||
| Missing/unknown | 28 (7.1) | 4 (5.0) | |||
| Region of residence, n (%) | 0.29 | ||||
| Northeast | 88 (22.2) | 11 (13.8) | |||
| North Central | 83 (20.9) | 14 (17.5) | |||
| South | 152 (38.3) | 40 (50.0) | |||
| West | 64 (16.1) | 13 (16.3) | |||
| Unknown | 10 (2.5) | 2 (2.5) | |||
| Index year, n (%) | 0.29 | ||||
| 2011 | 101 (25.4) | 26 (32.5) | |||
| 2012 | 111 (28.0) | 26 (32.5) | |||
| 2013 | 95 (23.9) | 14 (17.5) | |||
| 2014 | 90 (22.7) | 14 (17.5) | |||
| Time to drug index date from diagnosis date, days, mean ± SD [median] | 12.05 ± 7.75 [11] | 85.68 ± 63.08 [68.5] | < 0.001b | ||
| Index treatment, n (%) | 0.01b | ||||
| Imatinib | |||||
| Started on ≤ 400 mg/day | 138 (34.8) | 35 (43.8) | |||
| Started on ≥ 600 mg/day | 9 (2.3) | 0 | |||
| Dasatinib | |||||
| Started on ≤ 100 mg/day | 157 (39.5) | 21 (26.3) | |||
| Started on ≥ 140 mg/day | 2 (0.5) | 0 | |||
| Index treatment, n (%) | 0.01b | ||||
| Nilotinib | |||||
| Started on ≤ 600 mg/day | 80 (20.2) | 17 (21.3) | |||
| Started on ≥ 800 mg/day | 11 (2.8) | 5 (6.3) | |||
| Bosutinib | |||||
| Started on ≤ 500 mg/day | 0 | 1 (1.2) | |||
| Ponatinib | |||||
| Started on ≤ 45 mg/day | 0 | 1 (1.2) | |||
| CML chronic phase, n (%) | 375 (94.5) | 73 (91.3) | 0.27 | ||
| Darkow CML Complexity Index, n (%) | 0.55 | ||||
| Usual | 245 (61.7) | 54 (67.5) | |||
| Moderate | 96 (24.2) | 15 (18.8) | |||
| High | 56 (14.1) | 11 (13.8) | |||
| Deyo-Charlson Comorbidity Index, mean±SD [median] | 2.38 ± 0.96 [2] | 2.59 ± 1.47 [2] | 0.75 | ||
| 10 most prevalent comorbidities, n (%) | -c | ||||
| Diabetes | 42 (10.6) | 8 (10.0) | |||
| Chronic obstructive pulmonary disease | 23 (5.8) | 4 (5.0) | |||
| Cerebrovascular | 6 (1.5) | 1 (1.3) | |||
| Rheumatoid disease | 6 (1.5) | 1 (1.3) | |||
| Acute myocardial | 6 (1.5) | 0 | |||
| Metastatic cancer | 5 (1.3) | 4 (5.0) | |||
| Renal | 5 (1.3) | 1 (1.3) | |||
| Congestive heart | 4 (1.0) | 2 (2.5) | |||
| Peripheral vascular | 4 (1.0) | 1 (1.3) | |||
| Hemiplegia/paraplegia | 2 (0.5) | 0 | |||
| Concomitant medications/number of unique drug classes, mean ± SD [median] | 3.79 ± 3.19 [3] | 3.41 ± 3.31 [3] | 0.19 | ||
| Out-of-pocket costs for first 30 days supply of TKI medication, $, mean ± SD [median] | 189.37 ± 683.14 [36.79] | 230.24 ± 645.48 [56.06] | < 0.01b | ||
| Out-of-pocket costs group, n (%) | 0.04b | ||||
| $0 | 60 (15.1) | 9 (11.2) | |||
| > $0-$50 | 172 (43.3) | 25 (31.2) | |||
| > $50-$100 | 84 (21.2) | 19 (23.8) | |||
| > $100 | 81 (20.4) | 27 (33.8) | |||
aComparing the differences between patients who initiated TKI therapy ≤ month and > 1-12 months. Continuous variables were compared using the Wilcoxon-Mann-Whitney test. Categorical variables were compared using Pearson’s chi-square test or the Fisher’s exact test if 1 or more cells had an expected frequency of 5 or less.
bSignificant at the 5% level.
cP values not presented because data were too sparse.
CDHP = consumer-driven health plan; CML = chronic myeloid leukemia; EPO = exclusive provider organization; HMO = health maintenance organization; POS = point of service; PPO = preferred provider organization; SD = standard deviation; TKI = tyrosine kinase inhibitor.