Abstract P2-08-07: Prognostic impact of the 21-gene recurrence score assay among young women with node-negative and node-positive ER+/HER2- breast cancer

2019 ◽  
Author(s):  
PD Poorvu ◽  
SI Gelber ◽  
SM Rosenberg ◽  
KJ Ruddy ◽  
RM Tamimi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Young Women ◽  
Recurrence Score ◽  
Prognostic Impact ◽  
Node Negative ◽  
Node Positive ◽  
Her2 Breast Cancer

scholarly journals Prognostic Impact of the 21-Gene Recurrence Score Assay Among Young Women With Node-Negative and Node-Positive ER-Positive/HER2-Negative Breast Cancer

2020 ◽  
Vol 38 (7) ◽  
pp. 725-733 ◽  
Author(s):  
Philip D. Poorvu ◽  
Shari I. Gelber ◽  
Shoshana M. Rosenberg ◽  
Kathryn J. Ruddy ◽  
Rulla M. Tamimi ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Young Women ◽  
Expression Profiles ◽  
Recurrence Score ◽  
Distant Recurrence ◽  
Prognostic Impact ◽  
Node Negative ◽  
Node Positive ◽  
Her2 Breast Cancer

PURPOSE The 21-gene recurrence score (RS) assay is prognostic among women with early-stage estrogen receptor–positive (ER+) and human epidermal growth factor receptor 2–negative (HER2−) breast cancer and is used to inform recommendations for chemotherapy. Women ≤ 40 years of age represent a minority of patients studied using gene expression profiles. METHODS The Young Women's Breast Cancer Study is a prospective cohort of women diagnosed with breast cancer at age ≤ 40 years and enrolled patients between 2006 and 2016 (N = 1,302). We identified patients with stage I-III ER+/HER2− breast cancer. The RS assay was performed on banked specimens for patients who had not been tested clinically. Distant recurrence-free survival (DRFS) was assessed by TAILORx and traditional RS risk groups among patients with axillary node–negative (N0) and limited node–positive (N1) breast cancer. RESULTS Among eligible women (N = 577), 189 (33%) had undergone RS testing, and 320 (56%) had banked specimens sufficient for testing. Median follow-up was 6.0 years. Median age at diagnosis was 37.2 years; 300 of 509 patients (59%) had N0 breast cancer, of whom 195 (65%) had an RS of 11-25 and fewer than half (86 of 195; 44%) received chemotherapy. Six-year DRFS rates were 94.4% and 92.3% (RS < 11), 96.9% and 85.2% (RS 11-25), and 85.1% and 71.3% (RS ≥ 26) among women with N0 and N1 disease, respectively. CONCLUSION The RS assay is prognostic among young women with node-negative and limited node-positive breast cancer, representing a valuable tool for risk stratification. Disease outcomes with a median follow-up of 6 years among young women with N0 disease and an RS of 0-25, a minority of whom received chemotherapy, and node-positive disease with an RS < 11 were very good, whereas those with N0 disease and an RS ≥ 26 or N1 disease with an RS ≥ 11 experienced substantial risk of early distant recurrence.

NSABP B-47: A phase III trial of adjuvant therapy comparing chemotherapy alone (six cycles of docetaxel plus cyclophosphamide or four cycles of doxorubicin plus cyclophosphamide followed by weekly paclitaxel) to chemotherapy plus trastuzumab in women with node-positive or high-risk, node-negative, HER2-low invasive breast cancer.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. TPS1142-TPS1142
Author(s):  
Louis Fehrenbacher ◽  
Jong-Hyeon Jeong ◽  
Priya Rastogi ◽  
Charles E. Geyer ◽  
Soonmyung Paik ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Chemotherapy Regimen ◽  
Phase Iii ◽  
Weekly Paclitaxel ◽  
Loading Dose ◽  
Node Negative ◽  
Node Positive ◽  
Trastuzumab Therapy ◽  
Her2 Breast Cancer

TPS1142 Background: Adjuvant studies utilizing trastuzumab in early HER2+ breast cancer demonstrated a large reduction in recurrence and death. Post-enrollment central testing showed HER2 non-amplified participants derived similar benefit. Methods: Selection of one of the two chemotherapy regimens is by physician choice: The non-anthracycline regimen is TC (docetaxel 75 mg/m2, cyclophosphamide 600 mg/m2) administered IV every 3 weeks for 6 cycles; the anthracycline regimen is AC followed by WP (doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered IV either every 3 weeks or every 2 weeks [per investigator discretion] for 4 cycles followed by paclitaxel 80 mg/m2 IV weekly for 12 doses). Patients are randomly assigned to receive chemotherapy with or without trastuzumab therapy. For patients receiving the TC chemotherapy regimen, trastuzumab is given every 3 weeks during and following chemotherapy until 1 year after the first trastuzumab dose (8 mg/kg loading dose; 6 mg/kg for the remaining doses). For patients receiving the AC followed by WP chemotherapy regimen, trastuzumab begins with the first dose of weekly paclitaxel and will be given weekly for 12 doses (4 mg/kg loading dose; 2 mg/kg for the remaining weekly doses). Following completion of WP, trastuzumab therapy continues with 6 mg/kg doses given every 3 weeks for a total of 1 year. Eligibility: Eligibility includes: node positive or high risk node negative female breast cancer patients; HER2 IHC 1+ or 2+ scores, but non amplified by FISH Statistical Design: The primary aim is to determine whether the addition of trastuzumab to chemotherapy improves invasive disease-free survival (IDFS). 3260 patients will be enrolled to provide statistical power of 0.9 to detect a 33% reduction in the hazard rate of IDFS using a one-sided alpha level of 0.025. Progress: Protocol was activated in January 2011. As of January 27, 2012, 486 of 3260 patients have been enrolled. Supported by NCI U10-12027, -37377, 69651, 69974, and Genentech, Inc.

NSABP B-47: A randomized phase III trial of adjuvant therapy comparing chemotherapy alone to chemotherapy plus trastuzumab in women with node-positive or high-risk node-negative HER2-low invasive breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. TPS1139-TPS1139 ◽  
Author(s):  
Louis Fehrenbacher ◽  
Jong-Hyeon Jeong ◽  
Priya Rastogi ◽  
Charles E. Geyer ◽  
Soonmyung Paik ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Statistical Power ◽  
Disease Free Survival ◽  
Phase Iii ◽  
Adjuvant Radiation ◽  
Weight Changes ◽  
Node Negative ◽  
Node Positive ◽  
Her2 Breast Cancer

TPS1139 Background: Adjuvant trastuzumab trials in HER2+ breast cancer (BC) demonstrated a large reduction in recurrence and death. Central testing showed HER2 non-amplified participants derived similar benefit. Among HER2-amplified patients (pts), multiple studies showed no effect on benefit by degree of amplification. Blinded internal and external review confirmed the non-amplified nature of the HER2 normal group. Based on these findings, NSABP B-47, sponsored by the NCI, was activated January 2011 and is actively accruing. The study is NCI central IRB approved, open via the CTSU, and endorsed by SWOG, ECOG, and RTOG. Methods: Study: Chemotherapy treatment is by physician choice: The non-anthracycline regimen is TC (docetaxel 75 mg/m2, cyclophosphamide (C) 600 mg/m2) IV q 3 wks for 6 cycles; the anthracycline regimen is AC → WP (doxorubicin 60 mg/m2 and C 600 mg/m2 IV either q 3 wks or q 2 wks [investigator discretion] for 4 cycles → paclitaxel 80 mg/m2 IV wkly for 12 doses). Pts are randomly assigned to chemotherapy with or without trastuzumab for 1 year. Pts receive adjuvant radiation therapy and endocrine therapy, as clinically indicated. Detailed menstrual history, concurrent medications, weight changes, and biomarkers (estrogen, stress, inflammation), are being collected. Eligibility: Eligibility includes: node positive or high risk node negative BC pts; HER2 IHC 1+ or 2+ scores, but non amplified by FISH; normal cardiac, renal, and liver function. Detailed eligibility will be provided. Statistical Design: The primary aim is to determine whether the addition of trastuzumab to chemotherapy improves invasive disease-free survival (IDFS). 3,260 pts will be enrolled to provide statistical power of 0.9 to detect a 33% reduction in the hazard rate of IDFS using a one-sided alpha level of 0.025. Progress: Protocol was activated in January 2011. First pt was entered in February 2011. As of January 23, 2013, 1,416 of 3,260 (43.4 %) pts have been enrolled. Updated information on enrollment and study background will be provided. Support: NCI U10-12027, -37377, 69651, 69974, and Genentech, Inc. Clinical trial information: NCT01275677.

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.

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]

Oncotype DX testing in early-stage node-positive breast cancer and impact on chemotherapy use at a comprehensive cancer center.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 549-549
Author(s):  
Katya Losk ◽  
Rachel A. Freedman ◽  
Elizabeth A. Mittendorf ◽  
Zhenying Tan-Wasielewski ◽  
Lorenzo Trippa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Lymph Node ◽  
Multinomial Logistic Regression ◽  
Recurrence Score ◽  
Low Risk ◽  
Oncotype Dx ◽  
Comprehensive Cancer Center ◽  
Factors Associated ◽  
Node Positive ◽  
Her2 Breast Cancer

549 Background: The 21-gene Oncotype DX Recurrence Score (RS) is widely used to guide adjuvant chemotherapy decisions in hormone receptor positive (HR+), HER2-negtive (HER2-), lymph node negative (LN-) breast cancer. It’s adoption in lymph node positive (LN+) disease remains controversial. In 2016, we implemented ‘reflex’ RS testing for patients ≤65 years with HR+/HER2- breast cancer including T1/T2 N1 (grade 1 or 2) tumors. Providers can also order Oncotype DX outside of reflex criteria. We sought to assess RS distribution and factors associated with chemotherapy use in HR+/HER2-/LN+ breast cancer patients at our center. Methods: Patients with non-metastatic HR+/HER2-/LN+ breast cancer who underwent primary surgery at our center were identified from our prospective database. We examined the distribution of low (RS < 18), intermediate (RS 18-30) and high (RS > 30) RS and identified characteristics for those who did not meet reflex criteria. A multinomial logistic regression model was performed to identify factors associated with chemotherapy receipt among all LN+ patients. Results: From 1/2016-3/2018, we identified 296 consecutive patients with HR+/HER2-/LN+ breast cancer. 200 (68%) patients had RS testing and 128 (64%) met reflex criteria. Reasons for not meeting RS reflex criteria included age > 65 (n = 35), grade III disease (n = 35) and N2/N3 tumors (n = 10). Among the 200 patients with RS, 122 (61%) had RS < 18, 67 (34%) had RS 18-30, and 11 (6%) had RS > 30. Only 68/200 (34%) patients with RS received chemotherapy as compared to 54/96 (56%) patients without RS (p = 0.0004). Compared to patients without RS testing, the odds of receiving chemotherapy were less with RS < 18 (OR = 0.46). The odds of receiving chemotherapy were greater with ≥3 positive LNs versus 1 positive LN (OR = 3.40). Conclusions: The majority of HR+/HER2-/LN+ patients undergoing upfront surgery at our center receive RS testing (200/296), with 122 (61%) resulting in low risk RS. Patients with low risk scores (RS < 18) were less likely to receive chemotherapy. While nodal involvement remains a common driver of chemotherapy use, our study demonstrates that RS testing provides clinically useful information in this population.

Use of adjuvant chemotherapy in young women with node-negative ER+ breast cancer: Refining the use of recurrence score—A decision analysis

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 11547-11547
Author(s):  
C. E. Woodall ◽  
N. P. Reuter ◽  
C. R. Scoggins ◽  
R. C. Martin ◽  
K. M. McMasters ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Decision Analysis ◽  
Young Women ◽  
Recurrence Score ◽  
Node Negative

Prediction of Risk of Distant Recurrence Using the 21-Gene Recurrence Score in Node-Negative and Node-Positive Postmenopausal Patients With Breast Cancer Treated With Anastrozole or Tamoxifen: A TransATAC Study

2010 ◽  
Vol 28 (11) ◽  
pp. 1829-1834 ◽  
Author(s):  
Mitch Dowsett ◽  
Jack Cuzick ◽  
Christopher Wale ◽  
John Forbes ◽  
Elizabeth A. Mallon ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Hormone Receptor ◽  
Prognostic Value ◽  
Recurrence Score ◽  
Distant Recurrence ◽  
Cox Proportional Hazards ◽  
Node Negative ◽  
Node Positive ◽  
Hormone Receptor Positive ◽  
Node Status

Purpose To determine whether the Recurrence Score (RS) provided independent information on risk of distant recurrence (DR) in the tamoxifen and anastrozole arms of the Arimidex, Tamoxifen, Alone or in Combination (ATAC) Trial. Patients and Methods RNA was extracted from 1,372 tumor blocks from postmenopausal patients with hormone receptor–positive primary breast cancer in the monotherapy arms of ATAC. Twenty-one genes were assessed by quantitative reverse transcriptase polymerase chain reaction, and the RS was calculated. Cox proportional hazards models assessed the value of adding RS to a model with clinical variables (age, tumor size, grade, and treatment) in node-negative (N0) and node-positive (N+) women. Results Reportable scores were available from 1,231 evaluable patients (N0, n = 872; N+, n = 306; and node status unknown, n = 53); 72, 74, and six DRs occurred in N0, N+, and node status unknown patients, respectively. For both N0 and N+ patients, RS was significantly associated with time to DR in multivariate analyses (P < .001 for N0 and P = .002 for N+). RS also showed significant prognostic value beyond that provided by Adjuvant! Online (P < .001). Nine-year DR rates in low (RS < 18), intermediate (RS = 18 to 30), and high RS (RS ≥ 31) groups were 4%, 12%, and 25%, respectively, in N0 patients and 17%, 28%, and 49%, respectively, in N+ patients. The prognostic value of RS was similar in anastrozole- and tamoxifen-treated patients. Conclusion This study confirmed the performance of RS in postmenopausal HR+ patients treated with tamoxifen in a large contemporary population and demonstrated that RS is an independent predictor of DR in N0 and N+ hormone receptor–positive patients treated with anastrozole, adding value to estimates with standard clinicopathologic features.

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