Study | Molecular profiling tool | Population | Objective | Number of patients in the study | Outcomes and conclusions |
---|---|---|---|---|---|
Thaker et al. (present study) | 21-gene RS assay | Early-stage, HR-positive, lymph node-negative | Correlation between 21-gene RS and IBTR! nomogram | 308 | No correlation between 21-gene RS and IBTR! estimates; RS may complement traditional CP factors when assessing risk of IBTR in intermediate-risk patients |
Mamounas et al. | 21-gene RS assay | Tamoxifen-treated, node-negative, ER-positive disease treated with placebo, tamoxifen, or chemotherapy plus tamoxifen from two NSABP trials (B-14 and B-20) | Association between RS and risk of LR | 895 tamoxifen-treated, 355 placebo-treated, 424 chemotherapy plus tamoxifen-treated | Significant association between RS and risk for LR; LR was significantly associated with RS risk group in tamoxifen-treated, placebo-treated, and chemotherapy- plus tamoxifen-treated patients; RS was an independent significant predictor of LR along with age and type of initial treatment |
Solin et al. | 21-gene RS assay | Operable breast adenocarcinoma with either 1–3 axillary lymph nodes involved or negative axillary lymph nodes with a primary tumor size >1 cm; patients with HR-positive tumors received adjuvant hormonal therapy; patients received AC versus AT chemotherapy as per ECOG E2197 | Evaluation of the significance of the 21-gene RS and biological subtype relative to LR after BCT | 388 | Neither biological subtype nor 21-gene RS was associated with LR; for HR-positive tumors, the 21-gene RS evaluated as a continuous variable was significant for LR; neither biological subtype nor 21-gene RS should preclude BCT with RT |
Mamounas et al. | 21-gene RS assay | ER-positive, tamoxifen-treated, node-positive disease treated with adjuvant chemotherapy with AC versus AC-T in the NSABP B-28 trial | Association between RS and risk of LR | 1065 | RS was significantly associated with LR after lumpectomy and breast RT and after mastectomy (no RT) as well as in patients with ≥4 positive nodes (with a nonsignificant trend in patients with 1–3 positive nodes); in MVA, RS, nodal status, and tumor size were all independent predictors of LR |
Solin et al. | DCIS RS assay | DCIS treated with surgical excision without RT in the ECOG E5194 study | Association of DCIS score (modified RS assay with 7 cancer-related genes and 5 reference genes) with risk of IBE | 327 | Continuous DCIS score was significantly associated with the risk of an IBE and invasive IBE; this score complements traditional CP factors |