Relationship between Oncotype DX testing and the use of chemotherapy in high-risk patients (pts).

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 6098-6098
Author(s):  
Winston Wong ◽  
Joseph Cooper ◽  
Steve Richardson ◽  
Bruce A. Feinberg
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Risk Groups ◽  
Oncotype Dx ◽  
Molecular Diagnostic ◽  
Risk Category ◽  
High Risk Population ◽  
Unexpected Finding ◽  
High Risk Category

6098 Background: CareFirst BlueCross BlueShield (CFBCBS) insurance network partnered with Cardinal Health Specialty Solutions (CHSS) to develop a cancer care pathway for network physicians in 2008. The program included a recommendation for molecular diagnostic testing with the Oncotype DX assay for pts with early-stage estrogen receptor-positive breast cancer. Based on NCCN guidelines, the pathway suggested adjuvant chemotherapy for all pts with Oncotype DX Recurrence Scores (RS) in the high-risk category. We aimed to determine the RS risk distribution among pts who received Oncotype DX testing and assess the patterns of care that followed. Methods: Using data from CFBCBS, CHSS proprietary claims software, and Genomic Health, we retrospectively identified a cohort of women with breast cancer who were treated on the CFBCBS clinical care pathways program from 8/2008 to 6/2011 and received Oncotype DX testing. We determined the number of pts with a RS value in the low- (RS <18), intermediate- (RS 18-30), and high-risk (RS ≥31) groups along with the number of pts who subsequently received chemotherapy in each category. Results: Of 1174 women who received Oncotype DX testing, 53% of pts were in the low-, 35% in intermediate-, and 12% in the high-risk groups. Five percent of low-, 41% of intermediate-, and 74% percent of pts in the high-risk category were treated with chemotherapy. Twenty-six percent of pts in the high-risk group did not receive chemotherapy. Conclusions: The proportionate use of chemotherapy in the low and intermediate risk groups was as expected based on adjuvant chemotherapy guidelines; however, the underuse of chemotherapy in 26% of high-risk pts was an unexpected finding. Further study is needed to determine: (1) why physicians avoided chemotherapy in 26% of high-risk pts; (2) the overall number of appropriate pts who underwent Oncotype DX testing; and, (3) the tumor characteristics that may have driven the underutilization of chemotherapy in the high-risk population.

scholarly journals Omission of Chemotherapy in HR+/HER2- Early Invasive Breast Cancer Based on Combined 6-IHC Score?

2020 ◽  
Author(s):  
Jiaman Lin ◽  
Zihe Guo ◽  
Shuo Wang ◽  
Xinyu Zheng
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Risk Group ◽  
Disease Free Survival ◽  
Risk Groups ◽  
High Risk Group ◽  
Low Risk ◽  
Oncotype Dx ◽  
Axillary Lymph ◽  
Training Cohort

Abstract Background: Previous randomized studies have assessed the possibility of omission of chemotherapy in some hormone receptor (HR)-positive and HER2-negative (HR+/HER2-) breast cancers (BC) based on gene profiling test, e.g., Oncotype DX. The goal of this study was to evaluate if combination of six proliferation related biomarkers by immunohistochemistry (6-IHC) could be a cost-effective option in determining the necessity of adjuvant chemotherapy in HR+/HER2- BC.Methods: A retrospective analysis of HR+/HER2- BC patients was conducted in the First Affiliated Hospital of China Medical University from 2010 to 2016. The expression of 6 BC-related proliferation and invasion genes (Cathepsin L2, MMP11, CyclinB1, Aurora A, Survivin and Ki67) from Oncotype DX were analyzed through IHC (designated as 6-IHC). All the included patients were divided randomly at a 7:3 ratio into training and testing cohorts. The cutoff prognosis index (PI) of 6-IHC was determined by multivariate Cox risk regression analysis after calculating the PI of each patient in training cohort and confirmed in testing cohort. The patients were classified into “Low” and “High” risk groups based on the PI value. Kaplan-Meier (KM) method was used to analyze Disease-free survival (DFS) and overall survival (OS). 6-IHC score and other factors associated with survival benefit of adjuvant chemotherapy were compared with Ki67 index.Results: A total of 330 patients were included and divided into training cohort (n = 231) and validation cohort (n = 99). The receiver operating characteristic (ROC) curve analysis showed that the patients can be divided into 6-IHC score “High” and “Low” risk groups using the cut-off PI of 2.16. The 8-year DFS and OS were 54.6% and 69.2%, respectively in the 6-IHC score “High” risk group; 85.5% and 92.5%, respectively in the 6-IHC score “Low” risk group. The 8-year DFS and OS were 70.8% and 80.9%, respectively in the Ki67 “High” risk group, 77.7% and 87.6%, respectively in the Ki67 “Low” risk group. The KM curves showed that chemotherapy did not significantly improve the DFS in the 6-IHC score “Low” risk group (p = 0.830), but significantly improved the DFS in the 6-IHC score “High” risk group (P = 0.012).Conclusions: Combined 6-IHC score could be a reliable tool in predicting cancer-specific recurrences and survival in HR+/HER2- BC patients and identifying patients who could benefit from adjuvant chemotherapy regardless of the involvement of axillary lymph node (ALN).

scholarly journals Risk Stratification of Patients with Gastrointestinal Stromal Tumours by Histopathological and Immunuhistochemical Analysis

2020 ◽  
Author(s):  
Prathima Shivaji Rao ◽  
Manikya Manjunath
Keyword(s):  
High Risk ◽  
Risk Stratification ◽  
Statistical Significance ◽  
Tumour Size ◽  
Demographic Data ◽  
Risk Groups ◽  
P Value ◽  
Risk Category ◽  
Gastrointestinal Stromal Tumours ◽  
High Risk Category

Introduction: Gastrointestinal Stromal Tumours (GISTs) are the most common mesenchymal tumours of the alimentary canal. Interstitial cells of Cajal are believed to be the cell of origin of GIST which regulates gastrointestinal peristalsis. GISTs encompass a clinicopathologically distinctive, but heterogenous group of neoplasms with reference to their origin, cellular differentiation and prognosis. Aim: The aim of this study was to analyse the histopathological and immunohistochemical characteristics of GIST. Materials and Methods: A hospital-based cross-sectional study of 108 cases of GIST were studied over a period of three years from January, 2017 to December, 2019 in Department of Pathology, Vydehi Institute of Medical Sciences and Research Institute (VIMS&RC), Bangalore. Patient’s demographic data like age and gender were collected. Tumour characteristics like site, size and number of lesions were analysed. Histopathological and immunohistochemistry for Desmin, CD117 and DOG-1 were analysed for significant association with risk groups. Risk stratification according to the Fletcher's risk classification, the cases were divided was divided into very low, low, intermediate and high risk groups. The master chart of collected data was prepared in Excel sheet. Chi-square test with Yates correction was used to calculate p-value to ascertain statistical significance. The master chart of collected data was prepared in Excel sheet. Descriptive statistical analysis was presented in the form of tables, figures and diagrams wherever necessary using Epi info 07 statistical software package. Results: The mean age of the patients was 55.6±14.4 years. Males (55.6%/60 cases) were commonly affected than females (44.4%/48 cases). Small intestine was the commonest location (44.4%/48 cases). Tumour size ranged from 1.5 cm to 25 cm with a mean of 9.1 cm. Microscopic findings revealed that spindle cell type was the most common (86.1%/93 cases). Majority of the cases belonged to high risk category. Multifocality, necrosis, tumour size and >5 mitosis/50 High Power Field (HPF) showed significant association with high risk category tumours (p-value 0.033, 0.016, 0.004 and <0.001, respectively). Immunohistochemical staining showed positivity for CD 117 (83.3%/90 cases), DOG-1 (88.9%/96 cases) and 108 cases/100% negativity for desmin. Conclusion: This study found significant association of high risk groups with tumour size, multifocality, necrosis and mitosis >5/50 HPF. Risk categorisation of GIST remains important. A combination of CD117 and DOG-1 will be more useful in diagnosing GIST rather than using them alone.

Systematic Coronary Risk Evaluation (SCORE) Chart Identify Chronic Myeloid Leukemia Patients at Risk of Cardiovascular Diseases during Nilotinib Treatment

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 4545-4545
Author(s):  
Massimo Breccia ◽  
Matteo Molica ◽  
Irene Zacheo ◽  
Giuliana Alimena
Keyword(s):  
Risk Factors ◽  
High Risk ◽  
Chronic Myeloid Leukemia ◽  
Myeloid Leukemia ◽  
Systolic Pressure ◽  
Low Risk ◽  
Risk Category ◽  
High Risk Population ◽  
Moderate Risk ◽  
High Risk Category

Abstract Nilotinib is currently approved for the treatment of chronic myeloid leukemia (CML) in chronic (CP) and accelerated phase (AP) after failure of imatinib and in newly diagnosed patients. Atherosclerotic events were retrospectively reported in patients with baseline cardiovascular risk factors during nilotinib treatment. We estimated the risk of developing atherosclerotic events in patients treated with second or first line nilotinib, with a median follow-up of 48 months, by retrospectively applying the SCORE chart proposed by the European Society of Cardiology (ESC) and evaluating risk factors at baseline (diabetes, obesity, smoking and hypertension). Overall, we enrolled in the study 82 CP patients treated frontline (42 patients, at the dose of 300 mg BID) or after failure of other tyrosine kinase inhibitors (40 patients, treated with 400 mg BID). The SCORE chart is based on the stratification of sex (male vs female), age (from 40 to 65 years), smoker vs non-smoker, systolic pressure (from 120 to 180 mm Hg) and cholesterol (measured in mmol/l, from 150 to 300 mg/dl). For statistical purposes we considered patients subdivided in low, moderate, high and very high risk. There were 48 males and 34 females, median age 51 years (range 22-84). According to WHO classification, 42 patients were classified as normal weight (BMI < 25), 26 patients were overweight (BMI 26- <30) and 14 were obese (BMI > 30). Retrospective classification according to the SCORE chart revealed that 27 patients (33%) were in the low risk category, 30 patients (36%) in the moderate risk category and 24 patients (29%) in the high risk category. As regards risk factors, we revealed that 17 patients (20.7%) had a concomitant type II controlled diabetes (without organ damage), 23 patients (28%) were smokers, 29 patients (35%) were receiving concomitant drugs for hypertension, 15 patients (18%) had concomitant dyslipidaemia. Overall, the cumulative incidence of atherosclerotic events at 48 months was 8.5% (95% CI: 4.55-14.07): none of the low-risk patients according to the SCORE chart experienced atherosclerotic events compared to 10% in the moderate risk and 29% in the high risk category (p=0.002). Atherosclerotic-free survival was 100%, 89% and 69% in the low, moderate and high-risk population, respectively (p=0.001). SCORE chart evaluation at disease baseline could be a valid tool to identify patients at high risk of atherosclerotic events during nilotinib treatment. Disclosures Breccia: novartis: Consultancy; BMS: Consultancy; Celgene: Consultancy.

An estimation model for Oncotype Dx score using routine clinical and pathological parameters.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 548-548
Author(s):  
Rossana Esther Ruiz Mendoza ◽  
Fernando Namuche ◽  
Claudio J. Flores ◽  
Alfredo Aguilar ◽  
Henry Leonidas Gomez
Keyword(s):  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Health Care Systems ◽  
Multiple Linear Regression Model ◽  
Oncotype Dx ◽  
Cancer Center ◽  
Risk Category ◽  
Estimation Model ◽  
Classification Rate ◽  
Linear Predictor

548 Background: Oncotype Dx(ODX) prognosticates the risk of recurrence and predicts the benefit of adjuvant chemotherapy in estrogen-receptor-positive breast cancer (BC). However, its cost makes it prohibitive for many health care systems. Our objective is to develop a model using routine clinical and pathological parameters to estimate ODX high risk category to guide adjuvant chemotherapy decisions. Methods: We retrospectively reviewed ODX and pathology reports from 190 early BC patients (2014 to 2016) in a specialized cancer center. Variables were selected through a multiple linear regression model. Coefficients of statistically significant variables were used to build an equation. Its results were divided into 2 estimated risk categories. ODX RS was also divided into 2 categories; above or below 25 (cut-off in TAILORx and RxPONDER). The final locked model was independently validated in 57 patients. Results: Among the tested variables, tumor size (pT), progesterone receptor (PR), Ki67 and Elston-Ellis grade were significantly associated with ODX RS (Table 1). The linear predictor is: (0.2544 x pT) – (0.0739 x PR) + (0.0861 x Ki67) + (5.4232 x Elston grade). The threshold score for this equation was set on 13 (median value) to discriminate low and high estimated risks. The correct classification rate (CCR) for the training and validation sets was 60% and 56%, respectively. CCR for high risk was 72% and 87% in the training and validation sets, respectively. Conclusions: An equation based on readily available variables correctly classified more than half of cases. Although the overall CCR is modest, our equation is remarkably useful for high risk cases requiring chemotherapy. With further validation, our model could provide a clinically useful estimation of high risk at lower cost. [Table: see text]

Recurrence risk stratification by Dutch clinical risk criteria for early-stage luminal breast cancer patients in Taiwan: A population-based analysis.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e12509-e12509
Author(s):  
Lei Lei ◽  
Han-Ching Chan ◽  
Wang Xiao Jia ◽  
Tzu-Pin Lu ◽  
Skye Hung-Chun Cheng
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Early Stage ◽  
Risk Groups ◽  
Low Risk ◽  
Luminal Breast Cancer ◽  
Breast Cancer Patients ◽  
Risk Patients

e12509 Background: Dutch clinical risk criteria (low-risk definition: age > 35 years and (grade 1 with tumor ≤3cm, grade 2 with tumor ≤2cm, or grade 3 with tumor ≤1cm) have been used to stratify the benefit of MammaPrint and Oncotype DX for the decision-making regarding adjuvant chemotherapy for early-stage luminal breast cancer. We propose that the criteria could help to identify low-risk patients who could barely benefit from multi-gene testing. Methods: Breast cancer patients from Taiwan Cancer Database initially treated with primary surgeries between 2008 and 2012 who met the following criteria: (1) pathologic node-negative, (2) hormone receptor-positive, (3) HER2-negative, (4) undergone hormonal therapy, and (5) a minimum follow-up time of 5-year if free from any event, were enrolled in this study. Out of the total 2679 eligible patients, 1074 (40.1%) patients received adjuvant chemotherapy in addition to endocrine therapy. The study endpoints included breast cancer-specific survival (BCSS) and overall survival (OS). Kaplan-Meier statistics estimated the difference between clinical outcomes in low- and high-risk groups. Results: The median follow-up time of BSCC and OS was 5.9 years (range, 0-7 years) and 5.8 years (range, 0-7 years), respectively. There were statistical significances of 5-year BCSS (n = 2679) and 5-year OS (n = 2636) between low-risk and high-risk groups (in both endpoints, P < 0.0001). According to the Dutch criteria, low-risk patients with and without adjuvant chemotherapy had a 5-year BCSS of 99.0% vs. 99.2% and a 5-year OS of 98.4% vs. 97.4%, respectively. High-risk patients with and without adjuvant chemotherapy had a 5-year BCSS of 97.7% vs. 98.1% and a 5-year OS of 96.4% vs. 95.3%, respectively. Conclusions: The benefit of chemotherapy in low-risk patients classified by Dutch criteria might be very small since the breast cancer mortality was less than 1% with a minimum of 5-year follow-up. Dutch criteria cannot identify high-risk patients who would benefit from chemotherapy. We assumed that multi-gene testing in low-risk patients would not be cost-effective.

scholarly journals Chromatin conformation changes in peripheral blood can detect prostate cancer and stratify disease risk groups

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Heba Alshaker ◽  
Robert Mills ◽  
Ewan Hunter ◽  
Matthew Salter ◽  
Aroul Ramadass ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
High Risk ◽  
Peripheral Blood ◽  
Risk Groups ◽  
Low Risk ◽  
Risk Category ◽  
Specific Chromosome ◽  
Early Stage Disease ◽  
Conformation Changes ◽  
High Risk Category

Abstract Background Current diagnostic blood tests for prostate cancer (PCa) are unreliable for the early stage disease, resulting in numerous unnecessary prostate biopsies in men with benign disease and false reassurance of negative biopsies in men with PCa. Predicting the risk of PCa is pivotal for making an informed decision on treatment options as the 5-year survival rate in the low-risk group is more than 95% and most men would benefit from surveillance rather than active treatment. Three-dimensional genome architecture and chromosome structures undergo early changes during tumourigenesis both in tumour and in circulating cells and can serve as a disease biomarker. Methods In this prospective study we screened whole blood of newly diagnosed, treatment naïve PCa patients (n = 140) and cancer-free controls (n = 96) for the presence of 14,241 chromosomal loops in the loci of 425 genes. Results We have detected specific chromosome conformation changes in the loci of ETS1, MAP3K14, SLC22A3 and CASP2 genes in peripheral blood from PCa patients yielding PCa detection with 80% sensitivity and 80% specificity. Further analysis between PCa risk groups yielded prognostic validation sets consisting of HSD3B2, VEGFC, APAF1, BMP6, ERG, MSR1, MUC1, ACAT1 and DAPK1 genes that achieved 80% sensitivity and 93% specificity stratifying high-risk category 3 vs low risk category 1 and 84% sensitivity and 89% specificity stratifying high risk category 3 vs intermediate risk category 2 disease. Conclusions Our results demonstrate specific chromosome conformations in the blood of PCa patients that allow PCa diagnosis and risk stratification with high sensitivity and specificity.

scholarly journals Deep learning from HE slides to predict the clinical benefit from adjuvant chemotherapy in hormone receptor-positive breast cancer

2020 ◽  
Author(s):  
Soo Youn Cho ◽  
Jeong Hoon Lee ◽  
Jai Min Ryu ◽  
Jeong Eon Lee ◽  
Eun Yoon Cho ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Deep Learning ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Hormone Receptor ◽  
Early Stage ◽  
Oncotype Dx ◽  
Hormone Receptor Positive ◽  
Gene Assay ◽  
Positive Breast Cancer

Abstract Background: The predictive value of adjuvant chemotherapy for early-stage hormone receptor-positive breast cancer has been only validated by a 21-gene expression assay. We hypothesized that deep-learning prediction from HE images, called Lunit-SCOPE, is a potential prognostic and predictive biomarker of adjuvant chemotherapy.Methods: We retrospectively collected HE slides from 1153 de-identified breast cancer patients at the Samsung Medical Center (SMC) in order to develop a deep-learning algorithm called Lunit-SCOPE. The histological parameters from 255 patients, deciphered by Lunit-SCOPE, were trained to predict the recurrence score (RS) using the 21-gene assay from Oncotype DX. We validated the model’s performance using the recurrence survival of 898 patients and The Cancer Genome Atlas (TCGA) cohort, and examined related biological functions through RNA sequence data.Results: The histologic parameter-based RS prediction model predicted the oncotype DX score (R2=0.96) and the recurrence survival analysis on the validation (p<0.01) and TCGA cohort (p<0.01), where the most important variables were the nuclear grade and the mitotic cells in the cancer epithelium. Of the 85 patients classified as the high-risk group, 72 patients who received adjuvant therapy had a significantly better survival (p<0.01). The functions of the top 300 highly correlated genes with a predicted RS were enriched for cell cycle, nuclear division and cell division. Of the 21-genes from the Oncotype DX, the predicted RS had positive correlations with the proliferation category genes and was negatively correlated with the prognostic genes in the estrogen category.Conclusion: An integrative analysis using Lunit-SCOPE predicts a high risk of recurrence and those who would benefit from adjuvant chemotherapy for early-stage hormone-positive breast cancer.

Chemotherapy costs associated with receipt of the adoption of oncotype DX in early-stage breast cancer within the SEER-Medicare population.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 32-32
Author(s):  
Michaela Ann Dinan ◽  
Xiaojuan Mi ◽  
Shelby D. Reed ◽  
Gary H. Lyman ◽  
Lesley H Curtis
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Adjuvant Chemotherapy ◽  
Patient Outcomes ◽  
Early Stage ◽  
Oncotype Dx ◽  
Primary Analysis ◽  
Pathologic Features ◽  
Er Positive ◽  
Positive Breast Cancer

32 Background: The Oncotype DX (ODX) multigene assay has been previously suggested to result in an overall reduction in the use of adjuvant chemotherapy and associated costs for women with early stage, estrogen receptor (ER)-positive breast cancer. However, the association between adoption of ODX and chemotherapy costs has only previously been considered in theoretical models and has not been examined using actual patient outcomes in real world clinical practice. Methods: Retrospective analysis of Surveillance, Epidemiology, and End Results (SEER) -Medicare data of the association between overall and chemotherapy-specific costs associated with adoption of ODX testing in patients diagnosed with invasive, non-metastatic, ER-positive breast cancer between 2005 and 2009. We limited our primary analysis to women ages 66 to75 to include women in which adjuvant chemotherapy would be most likely to be considered. Total Medicare payments were used to calculate direct costs in the year following diagnosis. NCCN guidelines were used to stratify patients on the basis of clinical and pathologic features into low ( < 1.0 cm), intermediate, and high risk (node positive) disease. Results: A total of 21,272 women met study criteria. Average costs in the year following diagnosis were $31,532 in the overall cohort, and was highest for women with NCCN high risk ($45,192) vs. intermediate ($28,642) or low ($23,662) risk disease. Chemotherapy costs followed similar trends ($4,819, $1,157, and $226 respectively). In multivariable analyses, ODX was associated with a relative decrease in chemotherapy costs among high risk women (RR 0.54, 0.37-0.77), but increased costs among low and intermediate risk women (RR1.36, 1.13-1.26 and RR 3.73, 2.13-56.54). Women with high risk disease had significantly lower absolute chemotherapy costs associated with receipt of ODX (-$2,298, -$3,049 to -$1,547; All P < 0.001). Conclusions: Receipt of ODX testing was associated with relative and absolute decreases in chemotherapy costs, but only in women with high NCCN risk disease. Further research is needed to disentangle correlative vs. causative association of ODX testing with patient outcomes and costs.

scholarly journals Application of St Gallen Categories in Predicting Survival for Patients With Breast Cancer in Vietnam

2019 ◽  
Vol 26 (1) ◽  
pp. 107327481986279 ◽  
Author(s):  
Van Chu Nguyen ◽  
Tien Quang Nguyen ◽  
Thi Ngoc Ha Vu ◽  
Thi Huyen Phung ◽  
Thi Phuong Hoa Nguyen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Survival Rates ◽  
Disease Free Survival ◽  
Risk Groups ◽  
Clinicopathological Characteristics ◽  
Risk Category ◽  
Intermediate Risk ◽  
Risk Patients ◽  
Risk Categories

Breast cancer is a heterogeneous disease with different tumor subtypes. Identifying risk categories will help make better treatment decisions. Hence, this study aimed to predict the survival outcomes of invasive breast cancer in Vietnam, using St Gallen 2007 classification. This study was conducted on 501 patients with breast cancer who had surgical operations, but had not received neoadjuvant chemotherapy, from 2011 to 2013. The clinicopathological characteristics were recorded. Immunohistochemistry staining was performed on ER, PR, HER2/neu, and Ki67 markers. For HER2/neu(2+), fluorescence in situ hybridization was used as the test. All patients with breast cancer were stratified according to 2007 St Gallen categories. Kaplan-Meier and log-rank models were used to analyze survival rates. There were 3.8% cases classified as low risk (LR), 72.1% as intermediate risk (IR1: 60.1% and IR2: 12.0%), and 24.1% as high risk (HR1: 11.8% and HR2: 12.3%). Patients who were LR had the best prognosis, with a 5-year overall survival (OS) rate of 100%. Intermediate-risk patients were at 92.3%. High-risk patients had the worst prognosis, with a 5-year OS proportion of 69.3% ( P < .05). For disease-free survival (DFS), risk categories were categorized as LR: 100%, IR: 90.3%, and HR: 69.3% ( P < .05). Three main risk categories of breast cancer had a distinct OS and DFS. These findings suggest that the 2007 St Gallen risk category could be used to stratify patients with breast cancer into different risk groups in Vietnam.

scholarly journals Cisplatin +/− rucaparib after preoperative chemotherapy in patients with triple-negative or BRCA mutated breast cancer

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Maitri Kalra ◽  
Yan Tong ◽  
David R. Jones ◽  
Tom Walsh ◽  
Michael A. Danso ◽  
...  
Keyword(s):  
Breast Cancer ◽  
High Risk ◽  
Neoadjuvant Therapy ◽  
Triple Negative ◽  
Residual Disease ◽  
Disease Free Survival ◽  
Parp Inhibition ◽  
High Risk Population ◽  
Risk Population ◽  
The Impact

AbstractPatients with triple-negative breast cancer (TNBC) who have residual disease after neoadjuvant therapy have a high risk of recurrence. We tested the impact of DNA-damaging chemotherapy alone or with PARP inhibition in this high-risk population. Patients with TNBC or deleterious BRCA mutation (TNBC/BRCAmut) who had >2 cm of invasive disease in the breast or persistent lymph node (LN) involvement after neoadjuvant therapy were assigned 1:1 to cisplatin alone or with rucaparib. Germline mutations were identified with BROCA analysis. The primary endpoint was 2-year disease-free survival (DFS) with 80% power to detect an HR 0.5. From Feb 2010 to May 2013, 128 patients were enrolled. Median tumor size at surgery was 1.9 cm (0–11.5 cm) with 1 (0–38) involved LN; median Residual Cancer Burden (RCB) score was 2.6. Six patients had known deleterious BRCA1 or BRCA2 mutations at study entry, but BROCA identified deleterious mutations in 22% of patients with available samples. Toxicity was similar in both arms. Despite frequent dose reductions (21% of patients) and delays (43.8% of patients), 73% of patients completed planned cisplatin. Rucaparib exposure was limited with median concentration 275 (82–4694) ng/mL post-infusion on day 3. The addition of rucaparib to cisplatin did not increase 2-year DFS (54.2% cisplatin vs. 64.1% cisplatin + rucaparib; P = 0.29). In the high-risk post preoperative TNBC/BRCAmut setting, the addition of low-dose rucaparib did not improve 2-year DFS or increase the toxicity of cisplatin. Genetic testing was underutilized in this high-risk population.

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