Lack of concordance between Ki67 labeling index and 21-gene Breast Recurrence Score® test results in patients with ER+, HER2−, clinically node-negative breast cancer: a secondary analysis of TransNEOS neoadjuvant study

Abstract Purpose A subset of patients with intermediate 21-gene signature assay recurrence score may benefit from adjuvant chemoendocrine therapy, but a predictive strategy is needed to identify such patients. The 95-gene signature assay was tested to stratify patients with intermediate RS into high (95GC-H) and low (95GC-L) groups that were associated with invasive recurrence risk.Methods Patients with ER-positive, HER2-negative, node-negative breast cancer and RS 11-25 who underwent definitive surgery and adjuvant endocrine therapy without any cytotoxic agents were included. RNA was extracted from archived formalin-fixed, paraffin-embedded samples, and 95-gene signature was calculated. Results Two hundred six patients had RS of 11-25 (95GC-L, N = 163; 95GC-H, N = 43). In Cox proportional hazards model, 95GC-H was significantly associated with shorter time to recurrence than was 95GC-L (HR 5.94; 95%CI 1.81-19.53; P = 0.005). The correlation between 95-gene signature and 21-gene signature assay scores was not strong (correlation coefficient r = 0.27), which might suggest that 95-gene signature reflects biological characteristics differing from what 21-gene signature shows.Conclusions The 95-gene signature stratifies patients with ER-positive, HER2-negative, node-negative invasive breast cancer and intermediate RS of 11-25 into high and low groups that are associated with recurrence risk of invasive disease. Further retrospective analysis in the prospectively-accrued TAILORx population is warranted to confirm that 95-gene signature can identify patients who would benefit from adjuvant chemoendocrine therapy.

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Prognostic implication of labeling index versus estrogen receptors and tumor size in node-negative breast cancer

Breast Cancer Research and Treatment ◽

10.1007/bf01806246 ◽

1986 ◽

Vol 7 (3) ◽

pp. 161-169 ◽

Cited By ~ 102

Author(s):

Rosella Silvestrini ◽

Maria Grazia Daidone ◽

Giovanni Di Fronzo ◽

Alberto Morabito ◽

Pinuccia Valagussa ◽

...

Keyword(s):

Breast Cancer ◽

Estrogen Receptors ◽

Tumor Size ◽

Labeling Index ◽

Prognostic Implication ◽

Node Negative ◽

Node Negative Breast Cancer

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Adjuvant treatment decision in patients with node-negative, ER+/Her2-, early stage breast cancer with Oncotype DX (ODX) recurrence score (RS) of 11-30: Impact of clinicopathologic features.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e12022 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e12022-e12022

Author(s):

Gwenalyn Garcia ◽

Shiksha Kedia ◽

Nishitha Thumallapally ◽

Elias Moussaly ◽

Saqib Abbasi ◽

...

Keyword(s):

Breast Cancer ◽

Endocrine Therapy ◽

Early Stage ◽

Univariate Analysis ◽

Prospective Trial ◽

Recurrence Score ◽

Clinicopathologic Features ◽

Node Negative ◽

Her2 Breast Cancer ◽

Node Negative Breast Cancer

e12022 Background: The ODX RS predicts the risk of distant recurrence and the benefit of adjuvant chemotherapy (CT) in patients with ER+/Her2- breast cancer. High RS predicts a large benefit whereas low RS predicts minimal benefit from CT. A prospective trial showed that patients with low RS of 0-10 may be safely spared adjuvant CT. Recommendations in patients with intermediate RS are less clear. We performed a retrospective study of adjuvant therapy decision in patients with RS 11-30. Methods: We identified patients with ER+/Her2-, node-negative breast cancer with ODX RS 11-30 treated at our center from 2010-2016. Data on patient age, type of surgery, tumor size, grade, lymphovascular invasion (LVI), RS and treatment were collected. Statistical associations were tested using Chi square/Fisher's exact test and t test. Logistic regression analysis was used to determine odds ratios (OR). Results: 76 patients were identified. 86% (65/76) of them received adjuvant endocrine therapy alone and 14% (11/76) received adjuvant CT plus endocrine therapy. Patient characteristics are shown in the table. Using univariate analysis, significant predictors of receiving CT included RS, LVI, and ER positivity. In the patients who received CT, RSs were all ≥ 18 whereas in the group who did not receive CT, 42% (27/65) patients had RS 11-17. Increase in RS was associated with increase in the likelihood of receiving CT (OR 1.40, 95% CI 1.14-1.74, p=0.00017). Decrease in ER positivity was correlated with increased likelihood of receiving CT (OR 0.922, 95% CI 0.856-0.992, p=0.03). The presence of LVI increased the likelihood of receiving CT (OR 26.24, 95% CI 4.16-165.43, p=0.0005). Conclusions: In patients with ER+/Her2-, node-negative breast cancer with RS 11-30, the majority received endocrine therapy alone. RS and some clinicopathologic features (LVI, ER) impacted the decision to receive CT. [Table: see text]

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Abstract P5-06-05: Discordant classification and outcomes between Prosigna and Oncotype Dx Recurrence Score for ER-positive, HER2-negative, node-negative breast cancer

10.1158/1538-7445.sabcs19-p5-06-05 ◽

2020 ◽

Author(s):

Ivana Sestak ◽

Sean Ferree ◽

Itay Shemesh ◽

Wesley Buckingham ◽

Jack Cuzick ◽

...

Keyword(s):

Breast Cancer ◽

Recurrence Score ◽

Oncotype Dx ◽

Node Negative ◽

Node Negative Breast Cancer ◽

Er Positive ◽

Oncotype Dx Recurrence Score

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A novel approach for 21-genes testing associated with prognosis in Chinese patients with ER-positive/HER2-negative breast cancer: A real-world study.

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.e12528 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. e12528-e12528

Author(s):

Yinduo Zeng ◽

Qian Li ◽

Jiannan Wu ◽

Heran Deng ◽

Ying Wang ◽

...

Keyword(s):

Breast Cancer ◽

High Risk ◽

Cox Regression ◽

Recurrence Score ◽

Risk Groups ◽

Chinese Version ◽

Node Negative ◽

Node Negative Breast Cancer ◽

Er Positive ◽

The Impact

e12528 Background: We previously reported a Chinese version of 21-genes Recurrence Score (RS) provides reduction chemotherapy prescription in patients with ER-Positive/HER2-Negative node negative breast cancer, while Oncotype Dx was hardly to be reached. However, the impact on clinical outcome was not mentioned. Herein, we explored whether this 21-genes recurrence score (RS) impacted on prognosis in patients with this molecular subtype of breast cancer. Methods: From Jan 2013 to Aug 2018, 378 patients with ER-Positive/HER2-Negative early stage breast cancer were enrolled. All patients received a Chinese version of 21-genes RS test, which is a new method using RNA extracted from formalin-fixed paraffin-embedded tissue performed by SurExam Campany, Guangzhou, China. . The RS score for each patient was calculated based on expression level of 21-genes used in a prosperctively defined algorithm and calculate a recurrence score range from 0 to 100 and divided three risk groups according to TAILORs study.Distant metastases-free survival (DMFS) were correlated with the 21-genes RS by Kaplan-Meier (log-rank method), and Cox regression. Multivariable logistic regression was performed to determine factors correlated with RS testing and receipt of a high-risk RS. Results: Median patient age was 46 years (18 to 77 years). The Chinese version of 21-gene RS was generated for 378 patients: 61 (16.1%) low risk ( < 11), 241 (63.8%) intermediate risk (11 to 25), and 76 (20.1%) high risk (≥ 26). At a median follow-up of 40 months, the 4-year-rate of estimated DMFS was 100%, 98.7% and 92.9% in low risk, intermediate risk and high risk groups. Meanwhile, there was no difference in RFS among three risk groups. For all patients, 21-gene RS was associated with DMFS ( P = .021). In multivariable Cox regression models, 21-gene RS was independently prognostic factor of DMFS (hazard ratio, 5.375; 95% CI, 1.00 to 28.84; P = .05). Tumor size (>2cm vs ≤2cm, OR = 2.31, P = .005), high grade ( OR = 2.15, P = .013), ki67 index ( > 14% vs ≤14%, OR = 4.24, P = .002), progesterone receptor expression ( < 20% vs ≥20%, OR = 5.07, P < .001) were predictor of high risk of RS. Conclusions: The Chinese version of 21-genes RS is independently prognostic factor for DMFS patients with ER–positive/HER2-negative node negative breast cancer. Future study was needed to explore the impact of 21 gene RS on long-term prognosis.

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Factors affecting relapse in node-negative breast cancer. A multivariate analysis including the labeling index

European Journal of Cancer and Clinical Oncology ◽

10.1016/0277-5379(89)90029-1 ◽

1989 ◽

Vol 25 (2) ◽

pp. 351-356 ◽

Cited By ~ 37

Author(s):

Adel Courdi ◽

Michel Héry ◽

Elisabeth Dahan ◽

Jeanine Gioanni ◽

Michel Abbes ◽

...

Keyword(s):

Breast Cancer ◽

Multivariate Analysis ◽

Labeling Index ◽

Node Negative ◽

Factors Affecting ◽

Node Negative Breast Cancer

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Distribution of the 21-Gene Breast Recurrence Score in Patients with Primary Breast Cancer in Germany

Geburtshilfe und Frauenheilkunde ◽

10.1055/a-1111-8734 ◽

2020 ◽

Vol 80 (06) ◽

pp. 619-627

Author(s):

Vincent P. Walter ◽

Florin-Andrei Taran ◽

Markus Wallwiener ◽

Armin Bauer ◽

Eva-Maria Grischke ◽

...

Keyword(s):

Breast Cancer ◽

Decision Making ◽

Clinical Practice ◽

Recurrence Score ◽

Routine Clinical Practice ◽

Ki 67 ◽

Node Negative ◽

Hormone Receptor Positive ◽

High Clinical Risk ◽

Breast Recurrence

Abstract Background Multigene assays are being used increasingly to aid in decision-making about chemotherapy in breast cancer. Here, we present the 21-gene recurrence score (RS) of patients tested in routine clinical practice in Germany. Patients and Methods In a retrospective analysis, 4695 patients with hormone receptor-positive and HER2-negative early breast cancer (pT1 – 3, pN0 – 1, M0) were included in whom RS testing was conducted in Germany between November 2015 and July 2018. RS groups as defined in the TAILORx trial (RS result 0 – 10; 11 – 25; 26 – 100) were used. Results Of these patients, 21% were assigned to the low RS group, 63% to the midrange RS group, and 15% to the high RS group. 1772 (81%) of 2175 node-negative patients over 50 years of age were grouped either into the low RS group or the midrange RS group. The portion of patients with a low or midrange RS was 90% among node-positive patients (1284 of 1432 patients), 79% among patients with Ki-67-high (≥ 20%) tumors (1829 of 2310 patients), 86% vs. 70% among patients with G2 and G3 tumors (3244 of 3762 patients and 368 of 522 patients), respectively, 88% among patients with a tumor size of > 5 cm (140 of 159 patients), and 82% among node-negative patients at high clinical risk (1110 of 1352). Conclusions The distribution of the 21-gene RS in German patients that were tested in routine clinical practice indicates that, according to the results of the TAILORx trial, chemotherapy may not be beneficial in most of these.

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