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Table 2 Summary of studies assessing the relationship of the RS and LR in breast cancer

From: The 21-gene recurrence score complements IBTR! Estimates in early-stage, hormone receptor-positive, HER2-normal, lymph node-negative breast cancer

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

  1. Abbreviations: NSABP National Surgical Adjuvant Breast and Bowel Project, AC doxorubicin plus cyclophosphamide, AT doxorubicin plus docetaxel, ECOG Eastern Cooperative Oncology Group, AC-T AC followed by paclitaxel, MVA multivariate analyis, IBE ipsilateral breast event (defined as local recurrence of DCIS or invasive carcinoma), LR locoregional recurrence.