Table 1.
Patient Demographics, Health History, and Historical Receipt of Inpatient Chemotherapy
| Variables | Total, N (%) | Major Shortageo, N (%) | Moderate Shortageo, N (%) | Non Shortageo, N (%) | p‐value |
|---|---|---|---|---|---|
| Sample size (N) | 1,568 | 105 | 316 | 1,147 | n/a |
| Demographics | |||||
| Age at AML diagnosisa | 0.198 | ||||
| Mean (SD) | 70.13 (2.57) | 69.79 (2.58) | 70.19 (2.65) | 70.15 (2/55) | 0.970 |
| Median (min/max) | 70 (65,74) | 70 (65,74) | 70 (65,74) | 70 (65,74) | 1.000 |
| Age 65–69 | 654 (41.7) | 52 (49.5) | 135 (42.7) | 467 (40.7) | |
| Age 70–74 | 914 (58.3) | 53 (50.5) | 181 (57.3) | 680 (59.3) | |
| Sexa | |||||
| Male | 899 (57.3) | 66 (62.9) | 185 (58.5) | 648 (56.5) | 0.401 |
| Female | 669 (42.7) | 39 (37.1) | 131 (41.5) | 499 (43.5) | |
| Marital statusa | |||||
| Single/never married | 139 (8.9) | (IS) | (IS) | 101 (8.8) | 0.420 |
| Married/domestic partner | 987 (62.9) | 65 (61.9) | 194 (61.4) | 728 (63.5) | |
| Sep/widowed/divorced | 360 (23) | 25 (23.8) | 68 (21.5) | 267 (23.3) | |
| Unknown | 82 (5.2) | (IS) | (IS) | 51 (4.4) | |
| Racea | |||||
| Non‐Hispanic white | 1348 (86.1) | 94 (89.5) | 263 (84) | 991 (86.4) | 0.657 |
| Black | 109 (7) | (IS) | (IS) | 79 (6.9) | |
| Other | 108 (6.9) | (IS) | (IS) | 77 (6.7) | |
| U.S. Census Regionb , c | |||||
| Region 1 (Northeast) | 264 (16.8) | (IS) | (IS) | 197 (17.2) | 0.816 |
| Region 2 (Midwest) | 207 (13.2) | (IS) | (IS) | 157 (13.7) | |
| Region 3 (South) | 435 (27.7) | 32 (30.5) | 85 (26.9) | 318 (27.7) | |
| Region 4 (West) | 662 (42.2) | 48 (45.7) | 139 (44) | 475 (41.4) | |
| Urban or Rural countyc | |||||
| <2,500 urban population | 44 (2.8) | (IS) | (IS) | (IS) | 0.616 |
| Sociodemographic | |||||
| Medicare entitlement “old age”d | 1,299 (82.8) | 86 (81.9) | 269 (85.1) | 944 (82.3) | 0.482 |
| Medicaid dual eligiblee | 217 (13.8) | 15 (14.3) | 38 (12) | 164 (14.3) | 0.579 |
| Health history | |||||
| AML is first primary cancere | 964 (61.5) | 56 (53.3) | 160 (50.6) | 748 (65.2) | 0.000 |
| Charlson Scoref | |||||
| Mean (SD) | 1.157 (1.482) | 1.200 (1.534) | 1.272 (1.570) | 1.122 (1.451) | 0.116 |
| Median (min, max) | 1 (0, 9) | 1 (0, 7) | 1 (0, 8) | 1 (0, 9) | 1.000 |
| HX Myelodysplastic Syndrome (238)g | 392 (25) | 34 (32.4) | 98 (31) | 260 (22.7) | 0.002 |
| HX of multiple myeloma (203)h | 28 (1.8) | (IS) | (IS) | (IS) | 0.799 |
| HX of ALL (204)i | 26 (1.7) | (IS) | (IS) | (IS) | 0.805 |
| HX other leukemias (206–209)j | 50 (3.2) | (IS) | (IS) | 35 (3.1) | 0.471 |
| HX receipt of a hypo‐methylating agentk | 84 (5.4) | (IS) | (IS) | 44 (3.8) | 0.000 |
| History of prior therapeutic radiation | |||||
| Any dose/any type per registry | 35 (2.3) | (IS) | (IS) | (IS) | 0.416 |
| History of radiation as noted in claimsl | 34 (2.17) | (IS) | (IS) | 22 (1.92) | 0.393 |
| ICD‐O‐3 histologic typem , n | |||||
| Less favorable | 1,534 (98.2) | 101 (97.1) | 313 (99.1) | 1,120 (98.1) | 0.350 |
As recorded within PEDSF Registry files.
Northeast = Connecticut, New Jersey; Midwest = Iowa, Michigan; South = Georgia, Kentucky, Louisiana; West = California, New Mexico, Utah, Washington.
Geographic program data points reported by SEER are from the record of the first diagnosis of cancer at age 65 or older. Zip codes reported by SEER as a component of the PEDSF file are sourced from Medicare enrollment file in the year of first diagnosis at age 65 or older or the last diagnosis if never 65 (Adamo, Dickie, and Ruhl 2016).
Subjects with initial entitlement reason of end stage renal failure excluded from sample. Patients aged 65 at time of diagnosis may have originally qualified for Medicare coverage secondary to a documented disability.
Medicare‐Medicaid dual eligibility determination based upon Medicaid eligibility indicator sourced from Medicare Part D enrollment file.
AML represent first malignant patient cancer. This measure takes into account all reportable malignant, in situ, benign, and borderline primary tumors over the lifetime of a patient, regardless of geographical location at time diagnosed.
Charlson Comorbidity Index calculated using formula published by the National Cancer Institute (NCI) which excludes a cancer morbidity component score. The syntax utilized includes the Deyo adaptation to the Charlson comorbidity index) inclusive of several procedure codes reflecting the Romano adaptation. The calculated score is a summation of prior plus index values calculated based upon a 12‐month lead in period continuing through month of diagnosis (13 months in total) using method amended by Klabunde et al. which factors in reported diagnosis from carrier claims (http://https://healthcaredelivery.cancer.gov/SEERmedicare/program/comorbidity.html [accessed October 7, 2016]).
ICD‐9‐CM (Center for Disease Control and Prevention and National Center for Health Statistics) diagnosis code of 238.x, where “x” represents any digit.
ICD‐9‐CM (Center for Disease Control and Prevention & National Center for Health Statistics) diagnosis code of 203.x, where “x” represents any digit.
ICD‐9‐CM (Center for Disease Control and Prevention & National Center for Health Statistics) diagnosis code of 204,x, where “x” represents any digit.
ICD‐9‐CM (Center for Disease Control and Prevention & National Center for Health Statistics) diagnosis code of 206.x 209.x, where “x” represents any digit.
As detected by presence of HCPCS (Centers for Medicare and Medicaid Services [CMS] 2018) codes J9025 (azacitidine) or J0894 (decitabine) in Medicare Part B outpatient claims.
As detected by ICD‐9‐CM (Center for Disease Control and Prevention and National Center for Health Statistics) procedure code 92.2x or HCPCS (Centers for Medicare and Medicaid Services [CMS] 2018) codes 61793, 77261, 77262, 77263, 77280, 77285, 77290,77295, 77299, 77300, 77331, 77332, 77333, 77334, 7399, 77401, 77402, 77403, 77404, 77406, 77407, 77408, 77409, 77411, 77412, 77413, 77414, 77416, 77418, 77419, 77420, 77425, 77427, 77430, 77431, 77432, 77470, 77499, 77761, 77762, 77763, 77776, 77777, 77778, 77789, 0190T, 0520F, A4650, D5983, G0231, G0232, G0233.
ICD‐0‐3 histological grouping category. All patients included within sample have an AYAWHO classification of 02 which equates to acute myeloid leukemia, as based upon ICD‐0‐3 (World Health Organization 2008) hematopoietic codes and WHO classification of tumors of haematopoietic and lymphoid tissues. Persons with an ICD‐0‐3 subtype consistent with acute promyelocytic leukemia have been excluded as this disease group is typically NOT treated with cytarabine (standard protocol is 5‐azacytidine + arsenic).
More favorable subtypes include 9896 Acute myeloid leukemia t(8;21)(q22;q22) RUNX1‐RUNX1T1 and 9871 AML with inv(16)(p13.1q22) or t(16;16)(p13.1;q22)) CBFB‐MYH11. Less favorable subtypes include 9840 Acute erythroid leukemia (M6 type); 9861 Acute myeloid leukemia; 9865 AML w/t(6;9)(p23;q34) DEK‐NUP2145; 9867 Acute myelomonocytic leukemia; 9869 Acute myeloid leuk. inv(3)(q21;q26.2) or t(3;3)(q21;q26.2); RPN1‐EVI1; 9871 Ac. myelomonocytic leuk. w abn. mar. eosinophils; 9872 AMLwith minimal differentiation; 9873 AML without maturation; 9874 AML with maturation; 9891 Acute monoblastic and monocytic leukemia; 9895 AML with myelodysplasia‐related changes (multilineage dysplasia); 9896 Acute myeloid leukemia, t(8;21)(q22;q22); 9897 Acute myeloid leukemia with t(9;11)(p22;q23);MLLT3‐MLL; 9910 Acute megakaryoblastic leukemia; 9920 Therapy‐related (acute) myeloid neoplasm (Khwaja et al. 2016; Ruhl et al.2018).
Shortage periods: Major Shortage = first quarter 2011; Moderate Shortage = quarters 2–4, 2011; N‐Nonshortage = calendar years 2008–2010.
Descriptive statistics were compared using two‐sided Student‐T tests or Anova for continuous variables, Pearson Chi‐Square (Pearson 1900) or Fishers’ Exact (Fisher 1922) for categorical variables and the Wilcoxon Rank‐Sum test (Wilcoxon 1945) for comparison of medians.
ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; AYA, adolescents and young adults; CCI, Charlson Comorbidity Index; DGN, diagnosis; HX, history; NOS, not otherwise described; SD, standard deviation; SEER, surveillance, epidemiology and end results; WHO, World Health Organization.
(IS) Insufficient Sample Size: counts suppressed to protect patient confidentiality. [Correction added on 24 September 2018, after first online publication: in Table 1, some data in columns “Major Shortage”, “Moderate Shortage” and “Non Shortage” have been changed to “(IS)” and a corresponding footnote has been added.]