Table 2: Association of RS with specified outcome in women with early breast cancer receiving adjuvant tamoxifen plus chemotherapy.
Author | Design | Population | Treatment | N (Event) | Primary Outcome | Risk of Outcome (95% CI) | Positive Test | Sensitivity % (95% CI) |
Specificity % (95% CI) |
Multivariate Cox Proportional HR (95% CI) | |
---|---|---|---|---|---|---|---|---|---|---|---|
Paik 2006 (15) |
Retro. subgroup analysis of an RCT | ER+ LN- HER2+/- <5 cm 18+ yrs No prior chemo |
Tamoxifen plus CMF or MF chemo | 227 (27) |
Distant recurrence at 10 years | High | 11.9 (5.8–18.0) |
High | 41 (25–59) | 74 (69–78) | NR |
IM | 10.9 (4.1–17.6) |
High + IM | 71 (52–84) | 53 (48–58) | |||||||
Low | 4.4 (1.4–7.3) |
||||||||||
Mamounas 2010 (32) |
Retro. analysis of pts from single arms of multiple RCTs | ER+ LN- HER2+/- <5 cm 18+ yrs No prior chemo |
Tamoxifen +CMF or MFchemo | 424 (14) |
Locoregional recurrence at 10 years | High | 7.8 (2.6–13.0) |
High | 64 (36–86) | 74 (69–78) | NR |
IM | 2.7 (0–6.4) |
High + IM | 79 (49–94) | 52 (47–57) | |||||||
Low | 1.6 (0–3.5) |
||||||||||
Goldstein 2008 (25) |
Nested case-control | ER+ and/or PR+ LN+/- HER2+/- Any age ≥1.1 cm |
Tamoxifen + docetaxel | 465 (99) |
Any recurrence at 5 years | NR | N/A | Unable to estimate | Unable to estimate | Multivariate Cox proportional HR (95% CI): Central grade 2.12 (0.97–4.65) P-value 0.06 Local grade 3.13 (1.60–6.14) P-value 0.0009 RS not predictive in HER-2/neu-negative women (P-value NR but not significant) |
Abbreviations: CI, confidence interval; ER, estrogen receptor; HR, hormone receptor; IM, intermediate; LN, lymph node; PR, progesterone receptor; RS, recurrence score.