Predictors of adjuvant chemotherapy for breast cancer patients with an intermediate Oncotype-DX score: A SEER-based population study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e12014-e12014
Author(s):  
Sowmya Goranta ◽  
Tarek Haykal ◽  
Areeg Bala ◽  
Ragheed Al-Dulaimi ◽  
Ghassan Bachuwa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Breast Cancer Patients ◽  
T Stage ◽  
Grade Iii

e12014 Background: Oncotype-DX Assay is a 21-gene based recurrence score (RS) that helps stratify breast cancer patients based on their risk of recurrence. It is often used to help identify patients that may benefit from adjuvant chemotherapy (AC). Prior to the TAILORx Trial results, there were no guidelines for AC in patients with an intermediate score (18-30). Management of these patients was often at the clinical judgement of the provider. We sought to determine predictors of AC among these patients, and measure treatment effect on survival. Methods: We queried the Surveillance, Epidemiology, and End-Results database for breast cancer patients newly diagnosed between 2010-2015. We included patients with T1-T3, hormone receptor positive, HER2-negative, and lymph node-negative breast cancer with an intermediate RS. Male patients, those younger than 40 years, tumors 5 mm or less, and incomplete records were excluded. Univariate and multivariate analysis was performed to derive independent predictors of AC. Cox Proportional-Hazards Model was done to examine the effect of AC on survival. Results: We included 14,710 patients of whom 4,508 (30.6%) received AC. Patients that received AC were younger (55.4 years [8.8] vs 60.0 [9.7], p < 0.001), grade III or higher (29.8% vs 16.4%, p < 0.001), and had a higher RS (23.9 [3.6] vs 21.5 [3.1], p < 0.001). Higher T stage was associated with a higher rate of patients receiving AC (p < 0.001). Marital status was also associated with AC; a higher proportion of patients who received AC were married (67.9% vs 64.4%, p < 0.001). There was no significant association between race/ethnicity or insurance type with AC. Multivariate analysis showed that RS (OR: 1.24 [1.23-1.26], p < 0.001), T stage (OR: 1.67 [1.21-2.30], p < 0.001), and a grade III tumor (OR: 1.85 [1.64-2.09], p < 0.001) were the strongest predictors of AC. The age decile 80-89 years (OR: 0.05 [0.02-0.10], p < 0.001) was the most negative predictor of AC. AC did not have an effect on 5 year overall survival (97.6% vs 96.0%, p = 0.28). Conclusions: Between 2010-2015, our study shows 30.6% of breast cancers patients with an intermediate Oncotype-DX score were given AC. The decision to treat was largely based on tumor size, grade and age. AC had no effect on overall survival.

scholarly journals Treatment Choices Based on OncotypeDx in the Breast Oncology Care Setting

2012 ◽  
Vol 2012 ◽  
pp. 1-6 ◽  
Author(s):  
Teri L. Malo ◽  
Isaac Lipkus ◽  
Tobi Wilson ◽  
Hyo S. Han ◽  
Geza Acs ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Multivariable Analysis ◽  
Recurrence Score ◽  
Treatment Decision ◽  
Breast Cancer Patients ◽  
Multivariable Logistic Regression Model ◽  
Treatment Decision Making ◽  
Inform Treatment Decision

Introduction. This study aimed to evaluate whether OncotypeDx test results predict receipt of adjuvant chemotherapy in breast cancer patients who received an OncotypeDx recurrence score (RS).Materials and Methods. Pathology records were used to identify breast cancer patients who had OncotypeDx testing between December 2004 and January 2009 (n=118). Patient sociodemographic information, tumor characteristics, RS, and treatment-specific data were collected via chart review. RS was classified as follows: low (RS≤17), intermediate (RS = 18–30), or high (RS≥31). Bivariate analyses were conducted to investigate the relationship between adjuvant chemotherapy receipt and each sociodemographic and clinical characteristic; significant sociodemographic and clinical variables were included in a multivariable logistic regression model.Results. In multivariable analysis controlling for tumor size, histologic grade, and nuclear grade, only RS remained significantly associated with chemotherapy uptake. Relative to low RS, an intermediate (adjusted odds ratio [AOR], 21.24; 95% confidence interval [CI], 3.62–237.52) or high (AOR, 15.07; 95% CI, 1.28–288.21) RS was associated with a greater odds of chemotherapy uptake.Discussion. Results indicate that RS was significantly associated with adjuvant chemotherapy uptake, suggesting that OncotypeDx results were used to inform treatment decision making, although it is unclear if and how the information was conveyed to patients.

A validated model to predict low recurrence risk distinguished by 21-gene recurrence score in hormone receptor-positive invasive breast cancer patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 532-532
Author(s):  
Yasue Tsuchida ◽  
Sachiko Ohde ◽  
Ryota Nakamura ◽  
Yoko Kanada ◽  
Sakiko Miura ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Multivariate Analysis ◽  
Prediction Model ◽  
Cancer Patients ◽  
Endocrine Therapy ◽  
Hormone Receptor ◽  
Recurrence Score ◽  
Premenopausal Women ◽  
Breast Cancer Patients ◽  
Derivation Cohort

532 Background: In the prospective TAILORx and RxPONDER trials, the 21-gene Recurrence Score (RS) showed endocrine therapy alone was non-inferior to chemo-endocrine therapy in the analysis of invasive disease-free survival in postmenopausal hormone-receptor (HR)-positive breast cancer patients with RS < = 25. They also indicated chemotherapy was associated with benefit for women 50 years or younger with RS 11 to 25. However, in Japan, the test is not conventionally available because of non-coverage by national insurance. We aimed to develop and validate a model to predict RS using clinicopathological factors that identify patients who would have low risk shown by testing the 21-gene RS and can avoid chemotherapy. Methods: Four hundred patients, including 187 N0/1 postmenopausal, and 213 N0 premenopausal women who underwent surgery and had the RS from St. Luke’s International Hospital, Tokyo, Japan, were included in derivation cohort. Derivation cohort was divided into 2 groups by RS 25; patients with RS of 0 to 25 (n = 321) and with RS over 26 (n = 79). Multivariate logistic regression analysis was performed using candidate factors for all patients and pre- or postmenopausal patients. The prediction model was validated using an external cohort of 70 patients from Showa University School of Medicine, Tokyo, Japan. Results: Nuclear grade (NG) (adjusted OR, 5.28, 95% CI, 2.47–11.30), high Progesterone receptor (PgR) expression (Allred score 7-8) (adjusted OR, 10.62, 95% CI, 5.34–21.13) and low Ki67 level ( < = 20%) (adjusted OR, 5.29, 95% CI, 2.33-12.01) were significant independent predictors of RS of 0 to 25. With these factors could predict RS of 0 to 25 (AUC of 0.848, 95% CI, 0.803-0.893) with the highest probability of low-RS for 100%. The prediction model of the validation cohort had same discriminatory ability having an AUC of 0.812 (95% CI, 0.701-0.923). In postmenopausal patients, NG (adjusted OR, 4.81, 95% CI, 1.72–13.42), high PgR expression (adjusted OR, 10.62, 95% CI, 4.52–37.72), and low Ki67 level (adjusted OR, 4.94, 95%CI, 1.87-13.04) were significantly associated with RS of 0 to 25 in multivariate analysis. A regression model with these 4 factors could predict RS of 0 to 25 (AUC of 0.842, 95%CI, 0.782-0.902). In premenopausal patients, NG (adjusted OR, 8.76, 95% CI, 1.14–67.40), high PgR expression (adjusted OR, 3.22, 95% CI, 1.61–6.43), and low Ki67 level (adjusted OR, 2.87, 95% CI, 1.20–6.87) were significantly associated with RS of 0 to 10 in multivariate analysis. These factors could predict RS of 0 to 10 (AUC of 0.811, 95% CI, 0.731-0.891). However, the highest probability of low-RS provided this model for premenopausal women was 46.8%. Conclusions: Our validated model could provide useful information to distinguish low-RS especially for postmenopausal patients with high reproducibility. However, for premenopausal women, the 21-gene RS is warranted.

scholarly journals Adjuvant chemotherapy in elderly breast cancer patients: Pattern of use and impact on overall survival

2019 ◽  
Vol 30 ◽  
pp. v64
Author(s):  
A. Berthelot ◽  
A. De Nonneville ◽  
J.-M. Classe ◽  
M. Cohen ◽  
F. Reyal ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Breast Cancer Patients

Assessment of Hematologic and Non-Hematologic Toxicity in Older Cancer Patients Receiving Systemic Chemotherapy: Results from a Prospective Nationwide Registry.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 3131-3131
Author(s):  
Naeem Tahir ◽  
Jerome H. Goldschmidt ◽  
Eva Culakova ◽  
Marek S. Poniewierski ◽  
Debra A. Wolff ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Multivariate Analysis ◽  
Cancer Patients ◽  
Performance Status ◽  
Univariate Analysis ◽  
Hematologic Toxicity ◽  
Breast Cancer Patients ◽  
Nationwide Registry ◽  
Older Cancer Patients ◽  
Grade Iii

Abstract Introduction: Although 60% of all malignancies occur in patients ≥65, this population is poorly represented in cancer clinical trials. While fit elderly patients appear to tolerate chemotherapy as well as younger individuals, less is known about chemotherapy tolerance in older cancer patients with poor performance status or co-morbidities. The purpose of this study was to examine the impact of patient and disease characteristics on the reported toxicities of cancer chemotherapy. Methods: This study represents part of a prospective, nationwide registry based at 137 randomly selected practice sites throughout the US. The major malignancies considered were cancers of the breast (33%), colon (10%), lung (19%) and ovary (7%) along with malignant lymphoma (8%). To date, 3422 patients have been registered of which 2719 are available for analysis including 1083 patients age ≥65 (40%). Primary outcome measures were: relative dose intensity (RDI) compared to standard doses, anemia (Hgb &lt;10), neutropenia (neutrophils &lt;1000) and non-hematologic toxicities pertinent to older adults including stomatitis, diarrhea, anorexia, dehydration and weight loss. Univariate and multivariate logistic regression analysis was performed to compare the difference between the 65–74 and ≥75 age groups. Results: Complete data were available on 927 patients ≥65 years of age. Among breast cancer patients, increasing age (&lt;65, 65–74, ≥75) was associated with progressively less Grade III/IV neutropenia (62%, 51% and 41%), respectively (p=0.006). This corresponds to patients receiving progressively less RDI (93.4%, 91.3%, 89.8%; P=.025) with 17%, 19% and 25% receiving RDI &lt;85%, respectively. Most of the reduced RDI was planned in patients ≥75 years compared with less than half in younger patients (P=.035). Non-breast cancer patients experienced no significant difference in rates of Grade III/IV neutropenia by age. Increasing age was associated with progressively more anemia (27%, 34%, and 44%) respectively (p&lt;0.0001) among non-breast cancer patients but not among those with breast cancer. Despite a trend, no significant increase in non-hematologic toxicities was observed with increasing age in breast cancer or non-breast cancer patients. Factors significantly associated with Grade III/IV neutropenia in univariate analysis included baseline ANC &lt;3000, BSA&lt;2.0, female gender and anthracycline containing regimens. In multivariate analysis, after adjusting for tumor type and performance status the following were significant predictors of Grade III/IV neutropenia: BSA&lt;2.0 (OR=1.5 p=0.04), Baseline ANC&lt;3000 (OR=2.0 p=0.001) and anthracycline containing regimen (OR=3.5 p&lt;0.0001). Factors associated with non-hematologic toxicity in univariate analysis included colon cancer (p&lt;0.0001), Charlson Co-morbidity Index (CCI) ≥ 3 (p=0.068), ECOG performance status ≥2 (p=0.05), and 5-Fluorouracil containing regimens (p&lt;0.0001) while in multivariate analysis, only the CCI maintained a trend towards increased non-hematologic toxicity (p=0.069). Conclusions: While anemia increases with age in non-breast cancer patients, neutropenia decreases with increasing age in breast cancer patients, most likely as a result of age-related reductions in RDI.

Use of pretreatment serum CA9 (carbonic anhydrase 9) to predict PFS and survival in trastuzumab-treated metastatic breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 11092-11092
Author(s):  
K. Leitzel ◽  
H. Y. Hou ◽  
V. Shrivastava ◽  
U. Anyanwu ◽  
S. M. Ali ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Metastatic Breast ◽  
Breast Cancer Patients ◽  
First Line ◽  
Her2 Positive ◽  
Pretreatment Serum

11092 Background: Approximately half of HER2-positive breast cancer patients will respond to first-line trastuzumab-containing therapy. However, in those patients with an initial trastuzumab response, most will progress within a year with acquired resistance. Since trastuzumab treatment is also now used in the HER2-positive adjuvant breast cancer setting, trastuzumab resistance will continue to be a vexing clinical problem, and better predictive and prognostic biomarkers are urgently needed. Methods: Serum HER2, tissue inhibitor of metalloproteinase-1 (TIMP-1), urokinase-type plasminogen activator (uPA), CA9, VEGF-165, and endoglin were measured using ELISA assays in 66 metastatic breast cancer patients before starting first-line trastuzumab-containing therapy. The HER2, TIMP-1, uPA, CA9, and VEGF-165 ELISAs were from Oncogene Science/Siemens Healthcare Diagnostics, Cambridge, MA; and the endoglin ELISA was from R&D Systems, Minneapolis, MN. Progression-free (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method and Cox modeling with continuous pretreatment serum biomarker variables. Results: Pretreatment serum HER2 (p= 0.005), TIMP-1 (p< 0.0001), uPA (p= 0.006), endoglin (p= 0.008), and CA9 (p <0.0001) were all significant as univariate continuous biomarkers for predicting PFS to first-line trastuzumab-containing therapy, but VEGF was not. In multivariate analysis for PFS with all six biomarkers, only serum CA9 (p= 0.002) was a significant independent covariate. For OS, pretreatment serum HER2 (p= 0.018), TIMP-1 (p< 0.0001), uPA (p< 0.0001), endoglin (p= 0.002), and CA9 (p< 0.0001) were all significant as univariate continuous biomarkers for prognosis, but serum VEGF was not. In multivariate analysis for OS with all six biomarkers, only serum CA9 was a significant independent prognostic covariate (p= 0.001). Conclusions: Elevated pretreatment serum CA9 (a marker of hypoxia) predicts reduced progression-free survival and overall survival in metastatic breast cancer patients treated with first-line trastuzumab-containing therapy. These serum biomarkers deserve further study in larger trials of HER2-targeted breast cancer treatment. Supported by a grant from Komen for the Cure. [Table: see text]

Proliferation-based prediction for overall survival in locally advanced HER2(+) breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12007-e12007
Author(s):  
Manuel Pedregal ◽  
Federico Rojo ◽  
Cristina Carames Sanchez ◽  
Francisco Lobo ◽  
Yann Izarzugaza ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Tumor Cells ◽  
Locally Advanced ◽  
Luminal Breast Cancer ◽  
Breast Cancer Patients ◽  
Ki67 Expression ◽  
Her2 Breast Cancer

e12007 Background: Breast cancer prognosis is influenced by several factors including Ki67 expression which may have a predictive role in luminal breast cancer patients. The aim of this study was to assess the value of Ki67 in breast cancers with positive hormonal receptors and HER2 overexpressed and to evaluate its impact on survival. Methods: Seventy eight consecutive patients diagnosed with locally advanced HER2 positive breast cancer who were treated with adjuvant therapy based on HER2 treatment were selected for this study (2004-2014). The adjuvant chemotherapy schemes were 44% TCH, 16% FEC, 11% AC/T and 29% other therapies. The median of followup was 68 months. Tumor proliferation was assessed immunohistochemically by Ki67 expression and calculated as percentage of stained tumor cells from this cohort previous to adjuvant chemotherapy administration and the results obtained were correlated with disease status and outcome. Results: High proliferation defined as a percentage > 15 of tumor cells was observed in 69% of the breast cancer patients cases. High proliferation significantly predicted longer overall survival (OS) (Log rank 0,012). At 10 years of follow-up, 93% of the patients with KI67 high expression were alive versus 43% of patients without overexpression. Multivariate analysis confirmed the clinical significance of Ki67 predicting OS for luminal HER2 breast cancer patients (p 0,04 y HR 9,6). Conclusions: High proliferation identifies a setting of luminal-B HER2+ subtype breast cancer patients with a significantly longer overall survival.

Oncotype-DX recurrence score distribution in breast cancer patients with BRCA1/2 mutations

2016 ◽  
Vol 157 (3) ◽  
pp. 511-516 ◽  
Author(s):  
R. Lewin ◽  
A. Sulkes ◽  
T. Shochat ◽  
D. Tsoref ◽  
S. Rizel ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Cancer Patients ◽  
Recurrence Score ◽  
Oncotype Dx ◽  
Breast Cancer Patients ◽  
Score Distribution ◽  
Oncotype Dx Recurrence Score

Elevated pretreatment serum activin A and progression-free and overall survival in trastuzumab-treated metastatic breast cancer.

2012 ◽  
Vol 30 (30_suppl) ◽  
pp. 38-38
Author(s):  
Lindsey Zubritsky ◽  
Kim Leitzel ◽  
Suhail M. Ali ◽  
Wolfgang Köstler ◽  
Eva-Maria Fuchs ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Overall Survival ◽  
Multivariate Analysis ◽  
Metastatic Breast Cancer ◽  
Cancer Patients ◽  
Metastatic Breast ◽  
Activin A ◽  
Breast Cancer Patients ◽  
First Line ◽  
Pretreatment Serum

38 Background: About half of HER2-positive metastatic breast cancer patients will respond tofirst-line trastuzumab-containing therapy, but most will progress within a year. Trastuzumab resistance remains a vexing clinical problem, and better predictive and prognostic biomarkers are needed. Activin A is a TGF-B superfamily member and regulates cell proliferation, apoptosis, differentiation, and immune response. Methods: Serum activin A was measured using ELISA (R&D Systems, Minneapolis, MN) in 60 metastatic breast cancer patients before starting first-line trastuzumab-containing therapy. Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method and Cox modeling with both continuous and dichotomous (median) serum activin A analyses. Results: Pretreatment serum activin A levels averaged 2376 pg/ml, and had a median of 629 pg/ml and 25th and 75th quartile values of 406 and 1791 pg/ml, respectively. Patients who were hormone receptor negative had significantly higher activin A levels (median 1287 vs 450 pg/ml, p=0.002). Higher serum activin A was significant on a continuous basis for predicting reduced PFS to first-line trastuzumab-containing therapy (p<0.003), and for predicting shorter OS (p<0.0001). When analyzed using a dichotomous (median) cutpoint, the elevated serum activin A cohort had a significantly reduced PFS (HR 2.79, p <0. 002) (median 6.6 mo vs. 31.1 mo) and OS (HR 5.24, p <0.0001) (median 19.6 mo vs. median not reached). In multivariate analysis for PFS with other covariates (age, line of therapy, CA 15-3, and hormone receptor status), activin A was the only significant covariate (p=0.021). In multivariate analysis for OS, activin A (p=0.002) and CA 15-3 (p=0.03) remained significant as prognostic factors. Conclusions: Elevated pretreatment serum activin A predicts reduced PFS and overall survival in metastatic breast cancer patients treated with first-line trastuzumab-containing therapy. Activin A deserves further study as an adverse biomarker, and to select patients most likely to respond to activin A-targeted therapy.

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