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Table 1 Characteristics of the study sample versus registry sub-sample at the initiation of trastuzumab treatment

From: Survival in patients with non-metastatic breast cancer treated with adjuvant trastuzumab in clinical practice

 

Study sample

Registry sub-sample

N = 3188

N = 624

Demographic characteristicsa

  

 Ageb [years; mean ± SD (median)]

62.1 ± 12.7 [63.0]

54.3 ± 11.6 [54.0]

 Geographic region [N (%)]

  

  West

771 (24.2)

165 (26.4)

  Northeast

607 (19.0)

151 (24.2)

  Southeast

791 (24.8)

117 (18.8)

  Central

688 (21.6)

103 (16.5)

  Other

85 (2.7)

51 (8.2)

  Unknown

246 (7.7)

37 (5.9)

 Trastuzumab initiation [N (%)]

  

  Trastuzumab initiated as neoadjuvant therapyc

277 (8.7)

50 (8.0)

  Trastuzumab initiated as adjuvant therapyd

2911 (91.3)

574 (92.0)

 Type of surgery prior to adjuvant trastuzumab [N (%)]

  

  Breast-removing

1746 (54.8)

367 (58.8)

  Breast-conserving

1442 (45.2)

257 (41.2)

  Radiation therapy prior to the first adjuvant trastuzumab [N (%)]

1849 (58.0)

427 (68.4)

Comorbiditiese (>5 % prevalence)

  

 Charlson comorbidity index (Quan et al. 2005)f (mean ± SD [median])

4.2 ± 2.3 [3.0]

3.7 ± 2.0 [3.0]

 Physical comorbidities (Elixhauser et al. 2004)g [N (%)]

  

  Valvular disease

616 (19.3)

65 (10.4)

  Peripheral vascular disorder

203 (6.4)

11 (1.8)

  Hypertension, uncomplicated

1681 (52.7)

233 (37.3)

  Hypertension, complicated

218 (6.8)

21 (3.4)

  Other neurological disorders

184 (5.8)

15 (2.4)

  Chronic pulmonary disease

563 (17.7)

65 (10.4)

  Diabetes without chronic complications

595 (18.7)

74 (11.9)

  Diabetes with chronic complications

176 (5.5)

17 (2.7)

  Hypothyroidism

542 (17.0)

75 (12.0)

  Rheumatoid arthritis/collagen vascular diseases

166 (5.2)

23 (3.7)

  Obesity

371 (11.6)

64 (10.3)

  Fluid and electrolyte disorders

400 (12.5)

74 (11.9)

  Deficiency anemia

755 (23.7)

147 (23.6)

  Psychoses

163 (5.1)

20 (3.2)

 Mental comorbidities (American Psychiatric Association 2013)h [N (%)]

  

  Depressive disorders

502 (15.7)

85 (13.6)

  Anxiety disorder

437 (13.7)

85 (13.6)

  Trauma- and stressor-related disorders

135 (4.2)

49 (7.9)

  Sleep-wake disorders

390 (12.2)

68 (10.9)

  Substance-related and addictive disorders

348 (10.9)

60 (9.6)

Cancer characteristics (recorded in cancer registry)

  

 Breast cancer stagei [N (%)]

  

  Stage 0

1 (0.2)

  Stage I

260 (41.7)

  Stage II

268 (42.9)

  Stage III

85 (13.6)

  Stage IV

3 (0.5)

  Missing

7 (1.1)

 Tumor size

  

  Mean size ± SD [median] (mm)

28.5 ± 49.6 [20.0]

  Missing [N (%)]

33 (5.3)

 Tumor type [N (%)]

 

  Infiltrating duct carcinoma NOS—invasive

454 (72.8)

  Infiltrating ductal carcinoma—invasive

40 (6.4)

  Infiltrating duct carcinoma NOS

18 (2.9)

  Infiltrating duct and lobular carcinoma—invasive

30 (4.8)

  Inflammatory carcinoma—invasive

11 (1.8)

  Lobular carcinoma NOS—invasive

12 (1.9)

  Infiltrating duct mixed with other types—invasive

10 (1.6)

  Carcinoma NOS—invasive

8 (1.3)

  Other (<1 % each)

 

41 (6.6)

 Tumor histologic grade [N (%)]

 

  Grade 1

30 (4.8)

  Grade 2

205 (32.9)

  Grade 3

330 (52.9)

  Grade 4

4 (0.6)

  Missing

55 (8.8)

 Lymph node status [N (%)]

 

  No regional lymph node involvement or isolated tumor cells

324 (51.9)

  Some lymph node involvement

272 (43.6)

  No regional lymph node involvement, but isolated tumor cells

11 (1.8)

  Missing

17 (2.7)

  1. aAll demographic characteristics were measured as of the index date, defined as the date of the first trastuzumab
  2. bAge groups were based on year of birth
  3. cNeoadjuvant therapy was defined as the initiation of trastuzumab alone or in combination with other drugs prior to the breast surgery. By design, patients treated with neo-adjuvant trastuzumab re-initiated trastuzumab following breast surgery
  4. dAdjuvant trastuzumab therapy was defined as treatment with trastuzumab alone or in combination with other drugs within 1 year of the breast cancer surgery
  5. eComorbidities and risk factors were measured during the 365 days prior to index trastuzumab
  6. fThe Charlson comorbidity index (CCI) score includes two points for the cancer diagnosis. Please see corresponding reference
  7. gOnly comorbidities with >1 % prevalence in both the study sample and registry sub-sample are presented. Please see corresponding reference
  8. hOnly comorbidities with >1 % prevalence in both the study sample and registry sub-sample are presented. Please see corresponding reference
  9. iThe charts of 120 patients with missing cancer stage in the Automated Central Tumor Registry (ACTUR) were pulled from the US Department of Defense (DOD) military facilities that followed the patients and were individually reviewed by EB to assign a stage; for 3 patients in this group the pathological report was not available in the patient chart, so the stage was determined clinically; for 7 patients there was not enough information in the patient chart, so the cancer stage remains missing (for patients who receive care in both military and civilian facilities, only the patient charts from the military facilities were available for review)