Table 4.
Chemotherapy administration and vital status of the patients with invasive breast carcinoma tested with a 21-gene recurrence score assay for breast cancer (Oncotype DX): National Cancer Data Base analysis from 2010 to 2012 comparing commercial Oncotype Dx cut-off values [2] to the new TAILORx trial-defined cut-off values [8] for low-, intermediate-, and high-risk recurrence scores
| Commercial Oncotype DX cut-off values | New TAILORx trial-defined cut-off values | |||||
|---|---|---|---|---|---|---|
| Low-risk score 0–17 | Intermediate-risk score 18–30 | High- risk score 31–100 | Low- risk score 0–10 | Intermediate-risk score 11–25 | High- risk score 26–100 | |
| # and % of analyzed patients per score; total = 74,334* | 41,682 (56.1 %) | 24,965 (33.6 %) | 7687 (10.3 %) | 15,887 (21.4 %) | 45,549 (61.3 %) | 12,898 (17.4 %) |
| Chemotherapy (# and % of analyzed patients per score; total = 74,334) | ||||||
| Chemotherapy not received | 38,057 (91.3 %) | 14,827 (59.4 %) | 1430 (18.6 %) | 14,888 (93.7 %) | 36,073 (79.2 %) | 3353 (26 %) |
| Chemotherapy received | 3218 (7.7 %) | 9942 (39.8 %) | 6214 (80.8 %) | 844 (5.3 %) | 9069 (19.9 %) | 9461 (73.4 %) |
| Chemotherapy unknown | 407 (1 %) | 196 (0.8 %) | 43 (0.6 %) | 155 (1 %) | 407 (0.9 %) | 84 (0.7 %) |
| Vital status—# and % per score; total = 46,245 | ||||||
| Dead | 280 (1.1 %) | 246 (1.5 %) | 151 (3 %) | 113 (1.2 %) | 349 (1.2 %) | 215 (2.6 %) |
| Alive | 24,813 (98.9 %) | 15,912 (98.5 %) | 4843 (97 %) | 9056 (98.8 %) | 28,298 (98.8 %) | 8214 (97.4 %) |
* From 91,651 patients that had Oncotype DX test performed from 2010 to 2012, 74,334 patients (81.1 %) had known Oncotype DX test score recorded as a numerical value (0–100) and were analyzed here. 677/46,245 patients died in this study period (1.5 % overall mortality)
Patients with intermediate- and high-risk recurrence score were 1.37–2.76 times more likely to die, respectively, than patients with low-risk recurrence score (95 % CI 1.15–1.62 and 2.26–3.37, respectively) for commercial test cut-off values. With TAILORx cut-off values, patients with high-risk recurrence score were 2.1 times more likely to die than patients with low-risk recurrence score (95 % CI 1.66–2.63), but there was no significant difference between low-risk recurrence score and intermediate-risk recurrence score