Table 1.
Estimated clinical sensitivity, specificity, and odds ratios for Oncotype DX recurrence scores in women with lymph node-negative, estrogen receptor-positive breast cancer treated with tamoxifen, and subsequent breast cancer outcome
| Publication | Study design | Total N (outcome)a | Primary outcome | Positive test defined asb | Sensitivity (%) (95% CI) | Specificity (%) (95% CI) | Odds ratio (95% CI) |
|---|---|---|---|---|---|---|---|
| Habel, et al.24 | Case-control | 205 (55) | Death by 10 yrs | High+ IM | 71 (57–82) | 63 (55–71) | 4.2 (2.1–8.7) |
| High only | 31 (19–45) | 87 (80–92) | 2.9 (1.3–6.5) | ||||
| Paik, et al.25 | Cohort | 668 (99) | Distant recurrence by 10 yrs | High+ IM | 77 (67–85) | 55 (51–59) | 4.1 (2.4–6.9) |
| High only | 56 (45–66) | 78 (74–81) | 4.4 (2.8–7.0) | ||||
| Paik, et al.34 | Cohort | 227 (27) | Recurrence by 10 yrs | High+ IM | 85 (66–96) | 66 (58–72) | 11 (3.4–39) |
| High only | 70 (50–86) | 86 (80–90) | 15 (5.4–41) |
a
Total number in the study (number with primary outcome).
b
All studies categorized Oncotype DX recurrence scores into high (>31), intermediate-IM (18–30) and low- (<18) risk groups. For these calculations, “Positive” was defined twice for each study, with the intermediate risk group first combined with the high-risk group, and then with the low-risk group.