Table 3.
CTC Prevalence Rates from WG-Stained Cytology Slides by Various Demographics and Clinical Characteristics. The Fisher’s exact test p-values shown (when applicable) are for the comparison of the proportions of either HV subjects or MBC patients with and without one or more CTCs or five or more CTCs between the various clinical and demographical groupings
| Parameter and Categories | Eligible Subjects with Evaluable WG-Stained Slides | |||||
|---|---|---|---|---|---|---|
| All HV Subjects | All MBC Patients | |||||
| N | > = 1 CTC | > = 5 CTC | N | > = 1 CTC | > = 5 CTC | |
| All Patients | 69 | 3 (4.3%) | 2 (2.9%) | 70 | 30 (42.9%) | 15 (21.4%) |
| Age at the time of the blood collection | ||||||
| < 30 | 14 | 1 (7.1%) | 1 ( 7.1%) | 0 | 0 ( 0.0%) | 0 (0.0%) |
| 30—39 | 30 | 1 (3.3%) | 1 (3.3%) | 2 | 1 (50.0%) | 1 (50.0%) |
| 40—49 | 13 | 0 (0.0%) | 0 ( 0.0%) | 7 | 6 (85.7%) | 3 (42.9%) |
| 50—59 | 8 | 1 (12.5%) | 0 (0.0%) | 12 | 2 (16.7%) | 0 (0.0%) |
| 60—69 | 4 | 0 (0.0%) | 0 ( 0.0%) | 23 | 13 (56.5%) | 6 (26.1%) |
| > = 70 | 0 | 0 (0.0%) | 0 ( 0.0%) | 26 | 8 (30.8%) | 5 (19.2%) |
| Fisher’s Exact Test p-value | 0.528 | 0.815 | 0.011 | 0.097 | ||
| Blood Collection Method | ||||||
| Venipuncture | 69 | 3 (4.3%) | 2 ( 2.9%) | 31 | 4 (12.9%) | 0 ( 0.0%) |
| Port | 0 | 0 (0.0%) | 0 ( 0.0%) | 39 | 26 (66.7%) | 15 (38.5%) |
| Fisher’s Exact Test p-value | –- | –- | 0.000 | 0.000 | ||
| Volume of Blood Processed | ||||||
| ≤ 8.0 mL | 19 | 1 (5.3%) | 0 ( 0.0%) | 16 | 4 (25.0%) | 1 ( 6.3%) |
| 8.5—9.0 mL | 30 | 2 (6.7%) | 2 ( 6.7%) | 21 | 9 (42.9%) | 2 ( 9.5%) |
| 9.5 mL | 14 | 0 (0.0%) | 0 ( 0.0%) | 21 | 13 (61.9%) | 9 (42.9%) |
| ≥ 10.0 mL | 6 | 0 (0.0%) | 0 ( 0.0%) | 12 | 4 (33.3%) | 3 (25.0%) |
| Fisher’s Exact Test p-value | 1.000 | 0.757 | 0.134 | 0.023 | ||
| Menopausal Status | ||||||
| Pre-Menopausal | 54 | 2 (3.7%) | 1 ( 1.9%) | 7 | 4 (57.1%) | 3 (42.9%) |
| Post-Menopausal | 12 | 0 (0.0%) | 0 ( 0.0%) | 60 | 26 (43.3%) | 12 (20.0%) |
| Unknown | 3 | 1 (33.3%) | 1 (33.3%) | 3 | 0 ( 0.0%) | 0 ( 0.0%) |
| Fisher’s Exact Test p-value | 0.199 | 0.114 | 0.367 | 0.263 | ||
| Race | ||||||
| White | 62 | 3 (4.8%) | 2 ( 3.2%) | 64 | 26 (40.6%) | 12 (18.8%) |
| Black | 1 | 0 (0.0%) | 0 ( 0.0%) | 6 | 4 (66.7%) | 3 (50.0%) |
| Other | 6 | 0 (0.0%) | 0 ( 0.0%) | 0 | 0 ( 0.0%) | 0 ( 0.0%) |
| Fisher’s Exact Test p-value | 1.000 | 1.000 | 0.391 | 0.108 | ||
| Smoking Status | ||||||
| Never Smoked | 45 | 2 (4.4%) | 2 ( 4.4%) | 34 | 14 (41.2%) | 6 (17.6%) |
| Previous Smoker | 21 | 1 (4.8%) | 0 ( 0.0%) | 31 | 13 (41.9%) | 9 (29.0%) |
| Current Smoker | 2 | 0 (0.0%) | 0 ( 0.0%) | 5 | 3 (60.0%) | 0 ( 0.0%) |
| Unknown | 1 | 0 (0.0%) | 0 ( 0.0%) | 0 | 0 ( 0.0%) | 0 ( 0.0%) |
| Fisher’s Exact Test p-value | 1.000 | 1.000 | 0.808 | 0.310 | ||
| Previous History of Cancer? | ||||||
| Yes | 1 | 0 (0.0%) | 0 ( 0.0%) | 4 | 1 (25.0%) | 0 ( 0.0%) |
| No | 68 | 3 (4.4%) | 2 ( 2.9%) | 66 | 29 (43.9%) | 15 (22.7%) |
| Fisher’s Exact Test p-value | 1.000 | 1.000 | 0.630 | 0.571 | ||
| Current Diagnosis of Hypertension? | ||||||
| Yes | 4 | 0 ( 0.0%) | 0 ( 0.0%) | 38 | 20 (52.6%) | 8 (21.1%) |
| No | 65 | 3 ( 4.6%) | 2 ( 3.1%) | 32 | 10 (31.3%) | 7 (21.9%) |
| Fisher’s Exact Test p-value | 1.000 | 1.000 | 0.092 | 1.000 | ||
| Current Diagnosis of High Cholesterol? | ||||||
| Yes | 2 | 0 ( 0.0%) | 0 ( 0.0%) | 15 | 7 (46.7%) | 3 (20.0%) |
| No | 67 | 3 ( 4.5%) | 2 ( 3%) | 55 | 23 (41.8%) | 12 (21.8%) |
| Fisher’s Exact Test p-value | 1.000 | 1.000 | 0.775 | 1.000 | ||
| Current Taking Growth Factors? | ||||||
| Yes | 0 | 0 ( 0.0%) | 0 ( 0.0%) | 2 | 2 (100.0%) | 1 (50.0%) |
| No | 69 | 3 ( 4.3%) | 2 ( 2.9%) | 68 | 28 (41.2%) | 14 (20.6%) |
| Fisher’s Exact Test p-value | –- | –- | 0.180 | 0.385 | ||
| Current Taking Anti-Coagulants? | ||||||
| Yes | 0 | 0 ( 0.0%) | 0 ( 0.0%) | 11 | 5 (45.5%) | 4 (36.4%) |
| No | 69 | 3 ( 4.3%) | 2 ( 2.9%) | 59 | 25 (42.4%) | 11 (18.6%) |
| Fisher’s Exact Test p-value | –- | –- | 1.000 | 0.233 | ||
| Current Taking Anti-Inflammatories? | ||||||
| Yes | 3 | 0 ( 0.0%) | 0 ( 0.0%) | 32 | 11 (34.4%) | 6 (18.8%) |
| No | 66 | 3 ( 4.5%) | 2 ( 3.0%) | 38 | 19 (50.0%) | 9 (23.7%) |
| Fisher’s Exact Test p-value | 1.000 | 1.000 | 0.230 | 0.772 | ||
| Current Taking Pain Medications? | ||||||
| Yes | 3 | 0 ( 0.0%) | 0 ( 0.0%) | 46 | 20 (43.5%) | 10 (21.7%) |
| No | 66 | 3 ( 4.5%) | 2 ( 3.0%) | 24 | 10 (41.7%) | 5 (20.8%) |
| Fisher’s Exact Test p-value | 1.000 | 1.000 | 1.000 | 1.000 | ||
| Current Taking Cytotoxic Therapies? | ||||||
| Yes | 0 | 0 ( 0.0%) | 0 ( 0.0%) | 30 | 19 (63.3%) | 12 (40.0%) |
| No | 69 | 3 ( 4.3%) | 2 ( 2.9%) | 40 | 11 (27.5%) | 3 ( 7.5%) |
| Fisher’s Exact Test p-value | –- | –- | 0.004 | 0.002 | ||
| Breast Cancer ER Status | ||||||
| Positive | 0 | 0 ( 0.0%) | 0 ( 0.0%) | 62 | 24 (38.7%) | 12 (19.4%) |
| Negative | 0 | 0 ( 0.0%) | 0 ( 0.0%) | 8 | 6 (75.0%) | 3 (37.5%) |
| Fisher’s Exact Test p-value | –- | –- | 0.066 | 0.355 | ||
| Breast Cancer PR Status | ||||||
| Positive | 0 | 0 (0.0%) | 0 (0.0%) | 52 | 20 (38.5%) | 10 (19.2%) |
| Negative | 0 | 0 (0.0%) | 0 (0.0%) | 18 | 10 (55.6%) | 5 (27.8%) |
| Fisher’s Exact Test p-value | –- | –- | 0.272 | 0.510 | ||
| Breast Cancer HER2-neu Status | ||||||
| Positive | 0 | 0 (0.0%) | 0 (0.0%) | 16 | 10 (62.5%) | 7 (43.8%) |
| Equivocal | 0 | 0 (0.0%) | 0 (0.0%) | 6 | 1 (16.7%) | 0 (0.0%) |
| Negative | 0 | 0 (0.0%) | 0 (0.0%) | 41 | 15 (36.6%) | 7 (17.1%) |
| Unknown | 0 | 0 (0.0%) | 0 (0.0%) | 7 | 4 (57.1%) | 1 (14.3%) |
| Fisher’s Exact Test p-value | –- | –- | 0.158 | 0.092 | ||
| MBC Patient Disease Status | ||||||
| Newly Diagnosed | 0 | 0 (0.0%) | 0 (0.0%) | 5 | 2 (40.0%) | 0 (0.0%) |
| Stable / Responding | 0 | 0 (0.0%) | 0 (0.0%) | 42 | 21 (50.0%) | 12 (28.6%) |
| Progressive / Recurrent | 0 | 0 (0.0%) | 0 (0.0%) | 23 | 7 (30.4%) | 3 (13.0%) |
| Fisher’s Exact Test p-value | –- | –- | 0.345 | 0.217 | ||