Insurance status as a strong predictor of outcome in triple-negative breast cancer (TNBC): A multi-institutional retrospective study.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 1069-1069
Author(s):  
Tithi Biswas ◽  
Shreya Prasad ◽  
Timothy Zagar ◽  
Jimmy Efird ◽  
Sarah E. James ◽  
...  

1069 Background: TNBC accounts for about 15-20% of all breast cancer. TNBC has particularly aggressive clinical course and accounts for a disproportionate number of breast cancer relapses and deaths in early stage disease. TNBC also have worse prognosis especially in African American (AA) women compared with white women. This retrospective study aims to investigate various clinical and demographic prognostic factors in TNBC. Methods: 476 TNBC patients who were treated at Eastern Carolina University and University of North Carolina, CH between 4/96 and 9/11 were included in this analysis. We collected data on age, race, grade, lymphovascular invasion (LVI), stage, treatments including surgery, chemotherapy, radiation, chemotherapy drugs, insurance type and year of treatment. Overall Survival (OS) was computed from the date of diagnosis to the date of death or last FU. For disease free survival (DFS), patients were scored if they failed either locally or distally. The Cox proportional-hazards regression model was used to compute hazard ratios. Results: The median age was 52 years (21-88 years) with median FU of 3.7 years. 49% women were white race followed by AA 223 (47%) and Hispanic or other race (5%). Stage (p<0.001), grade (p=0.02), surgery (p<0.0001), adjuvant chemotherapy (p=0.025), LVI (p=0.05) and type of insurance were significant predictor of OS. Similarly, stage (p<0.0001), surgery (p<0.0001), LVI (p=0.03) and insurance were significant predictors for DFS. On multivariate analysis, stage, surgery and adjuvant chemotherapy remained statistically significant predictors. Medicaid vs. Private Insurance also remained a significant detriment of survival (OS: HR=3.6, p<0.0001; DFS: HR=2.8, p<0.0001) as did having No Insurance for OS (HR=2.0, p=0.0074). Conclusions: To our knowledge, this is a largest retrospective study showing type of insurance to be a strong predictor of outcome in this very specific breast cancer subtype which remained significant after adjusting all other variables. Further insight is needed to determine the cause of this finding.

2014 ◽  
Vol 32 (26_suppl) ◽  
pp. 93-93
Author(s):  
Rebekah Young ◽  
Kimberly Gergelis ◽  
Shalom Kalnicki ◽  
Jana Lauren Fox

93 Background: Women with early-stage TN breast cancers are at increased risk for recurrence (RR) compared to other molecular subtypes, and are often treated with mastectomy without local adjuvant therapy. We wish to evaluate the RR for these women. Methods: In this single institution retrospective study, women with T1-2N0 TN breast cancer who underwent mastectomy between 2008-12 were identified from tumor registry. Adjuvant chemotherapy was allowed, but adjuvant radiotherapy (RT) was excluded. Of 3,000 cases reviewed, 52 women were identified. Median age was 58.5 (30–90). Lesions were high-grade (83%), and T1-2 (47%, 53%). 21 women (42%) had at least 1 risk factor. 5 women were BRCA+. Women underwent total mastectomy or modified radical mastectomy, and the majority (84%) had adjuvant chemotherapy. Results: At a median follow-up of 3.5 years (6-71 months), there were 8 recurrences (15.4%). 3 (5.8% of cohort) were locoregional (LR) only (2 chest wall (CW) and 1 ipsilateral axilla), 6 (11.5%) involved a concurrent LR and distant recurrence, and 2 (3.8%) were distant only. Median time to recurrence was 17.3 months. The isolated LR recurrences (LRR) were at 14, 15.6 and 15.1 months. Most women (41, 78.8%) were alive with NED. 3 were alive with disease, underdoing treatment, and 1 woman was disease free after treatment for CW recurrence. 8 patients (15.4%) are deceased, half from their cancer. On univariate analysis, there was no significant correlation (p>0.05) between age or high-risk features and RR (STATA v 11). Conclusions: T1-2N0 breast cancer patients are believed to have a low RR following mastectomy. TN disease, however, is more aggressive, and the question of irradiating early stage disease after mastectomy has arisen. A single institution, retrospective study found women with T1-2N0 TN disease fare better with BCT that includes RT, compared to mastectomy alone. Other studies have shown no statistical difference in RR between these 2 groups. We found an isolated LRR rate at 3.5 years of 5.8%. Follow-up and ultimately prospective data is needed to determine whether the isolated LRR warrants a change in treatment recommendations for this pt subset.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 10524-10524
Author(s):  
Alexandra Wehbe ◽  
Mark A. Manning ◽  
Hadeel Assad ◽  
Kristen Purrington ◽  
Michael S. Simon

10524 Background: Carriers of pathogenic variants in cancer susceptibility genes have an elevated risk of developing breast, ovarian, and other cancers.We conducted a medical record review to determine the uptake of genetic counseling and testing in a clinic-based population of women with breast cancer. Methods: Medical records of 150 women with breast cancer seen at the Karmanos Cancer Institute between January-December 2018 were reviewed to determine the proportion eligible for genetic testing according to National Comprehensive Cancer Network guidelines. We also assessed genetics referral rates, appointment completion and results of genetic testing. Using chi-square and ANOVA tests, we analyzed the association of demographic and clinical factors with eligibility and referral to genetic counseling. Results: The average age of diagnosis was 57.1 years old, with 68.7% of women diagnosed with stage I-III disease, and 31.3% diagnosed with stage IV disease. There were 91 (60.7%) women who met NCCN criteria for genetic testing, of which 46.2% ultimately underwent genetic testing. Eligible women were more likely to be younger (52.6 vs. 64.0 years old), White (75.0% vs. 54.5%), and have Medicaid (75.0%) or private insurance (72.9%) vs. Medicare (44.8%). Women who met NCCN criteria were 3.5 times more likely to be referred for genetic counseling than those that did not meet eligibility criteria. Women were also more likely to be referred if they had early-stage disease compared to stage IV (67.8% vs. 48.3%), and Medicaid or private insurance compared to Medicare (71.4%, 72.0% and 40.0%, respectively). Of eligible women, 59.3% had a genetic counseling appointment scheduled, and of those, 78.0% attended their appointment. There were no apparent differences in appointment completion based on race with similar percentages of Black and White women completing their appointments (74.0% and 77.0% respectively). Women with stage IV disease were more likely to complete their appointments (83.0%) compared to women with stages I-III (74.0%) and fewer women with Medicare completed their genetic counseling appointment (56.0%) compared to women with Medicaid (83.0%) and women with private insurance (83.0%). Among women who attended their appointment, 95.9% underwent genetic testing. Of women who had genetic testing, 8.5% had a pathogenic variant and 30.4% had a variant of unknown significance. Conclusions: The results of this study indicate that lack of genetic counseling referrals contribute to a gap between the need for and completion of genetic testing. By understanding barriers to genetic counseling and testing, future clinical initiatives could effectively improve accessibility to genetic counseling services.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. TPS598-TPS598
Author(s):  
Heather L. McArthur ◽  
Michail Ignatiadis ◽  
Sebastian Guillaume ◽  
Andrew Bailey ◽  
Jorge Luis Martinez ◽  
...  

TPS598 Background: Early stage triple negative breast cancer (TNBC) is associated with a high risk of distant relapse. Because TNBC does not currently have specific targeted agents approved for use in the early setting it is treated primarily with chemotherapy. TNBC may be more immunogenic than other subtypes of breast cancer and promising clinical activity has been reported with the anti–PD-L1 antibody, atezolizumab, in Phase 1/1b metastatic TNBC trials. Furthermore, the randomized phase 3 IMpassion130 study demonstrated enhanced anti-tumor activity when atezolizumab was co-administered with chemotherapy in the first line metastatic setting, with benefit mainly observed in PD-L1+ cohort. ALEXANDRA/IMpassion030 will evaluate the efficacy and safety of atezolizumab in combination with standard anthracycline/taxane adjuvant chemotherapy in early TNBC patients. Methods: ALEXANDRA/IMpassion030 is a global, prospective, randomized, open-label, phase 3 trial investigating the efficacy, safety and pharmacokinetic profile of adjuvant atezolizumab plus standard chemotherapy versus chemotherapy alone in early TNBC. In total, 2300 patients with operable stage II or III TNBC, confirmed by central pathology review, will be randomized. Patients are stratified by type of surgery, nodal status, and centrally assessed PD-L1 status. Adjuvant treatment will consist of weekly paclitaxel 80 mg/m2 for 12 weeks followed by dose dense anthracycline (epirubicin 90 mg/m2 or doxorubicin 60 mg/m2) and cyclophosphamide 600 mg/m2 for 4 doses every 2 weeks or the same chemotherapy regimen (T-EC/AC) given concomitantly with atezolizumab 840 mg every 2 weeks followed by maintenance atezolizumab 1200 mg every 3 weeks until completion of 1 year of atezolizumab. The primary end-point is invasive disease-free survival (iDFS) and secondary end-points include iDFS by PD-L1 and lymph node status, overall survival, safety, patient functioning and health related quality of life (HRQoL). Tumor tissue and blood samples will be collected for biomarker research. The first patient was enrolled on August 2nd 2018, and approximately 430 sites are expected to be opened globally in 30 countries. Clinical trial information: NCT03498716.


Mastology ◽  
2020 ◽  
Vol 30 (Suppl 1) ◽  
Author(s):  
Bianca Pamela Soares ◽  
Grasiela Benini dos Santos Cardoso ◽  
Marcia Fernanda Roque da Silva ◽  
Roberto Odebrecht Rocha

Introduction: Breast cancer remains the second most common type of cancer in the world and the first among women, with breast cancer incidence rates doubling in the last thirty years. In 2013, the St Gallen Consensus recommended the use of a study of the multigene profile and phenotyping to indicate adjuvance by use of the MammaPrint and Oncotype4 applications; however, as they are not available in the Unified Health System (Sistema Único de Saúde–SUS), clinical predictive criteria and laboratory tests are used for indication of adjuvant therapy. Objective: Evaluation of clinical and laboratory criteria in the selection of patients with breast cancer after surgery for adjuvant chemotherapy and quantification of the factors used in the selected patients and their results. Method: This is a retrospective, cross-sectional observational study with patients over 18 years of age, without gender and race restriction, diagnosed with breast cancer at a public hospital in São Paulo, from 09/10/18 to 10/12/18, who underwent surgical treatment and discussed adjuvant therapy. Patients with metastatic neoplasia and/or undergoing neoadjuvant treatment were excluded. Data collected were: TNM staging, histological type and hormone receptors, age and comorbidities in all medical records collected. Results: 1,390 consultations were carried out, with 42 patients selected, according to the study criteria. Since 40% of the patients were outside the recommended range for breast cancer screening, regarding TNM, late diagnoses were evidenced, with 69% presenting ≥T2 and 36% with lymph node involvement. Of the 42 patients, 98% received adjuvant therapy. Conclusion: It was evidenced by Paik et al., that 92.1% of the 668 patients enrolled in the NSABP B-14 study were considered of intermediate or high risk according to the NCCN and St. Gallen criteria, and by Oncotype DX, 50.6% of the patients were classified as at low risk of recurrence. However, as these are not available in SUS, the present study shows the need to use clinical and laboratory factors to indicate adjuvant therapy, and with these, of the 42 patients, 98% had indication, showing that they are not such effective means in the use of genetic tests, and patients treated by SUS initiate their treatments late, which impacts disease-free survival, since less than 10% of patients received care with early stage neoplasia.


2020 ◽  
Author(s):  
Katsutoshi Sato ◽  
Amol Padgaonkar ◽  
Stacey Baker ◽  
Stephen Cosenza ◽  
Olga Rechkoblit ◽  
...  

Abstract Triple negative breast cancer (TNBC) remains clinically challenging as patients have heterogeneous responses to current standard of care therapies. Chemotherapy sensitivity is a strong predictor of long-term outcomes for patients, and incomplete response of early stage disease to chemotherapy treatment is associated with a much higher risk of disease relapse and metastatic progression, often occurring within a short time from initial diagnosis. Therefore, treatment strategies that target chemotherapy-resistant TNBC and/or enhance chemosensitivity would improve outcomes for these high-risk patients. Breast cancer stem cell-like cells (BCSC) have been proposed to represent a chemotherapy-resistant subpopulation within the tumor which are also responsible for tumor initiation, progression and metastases. Targeting this population could lead to improved TNBC disease control. We have identified a novel multi-kinase inhibitor 108600 from a screen for inhibitors of this TNBC BCSC population. 108600 treatment suppresses growth, colony and mammosphere forming capacity of the BCSC population. Treatment with 108600 induces G2M arrest and eventual apoptosis of TNBC cells in vitro and of TNBC xenografts in vivo, and overcomes chemotherapy (paclitaxel) resistance of triple negative patient-derived xenografts (PDX). Finally, treatment with 108600 and chemotherapy suppressed the growth of already established TNBC metastases, providing additional support for the clinical translation of this agent to clinical trials.


2009 ◽  
Vol 27 (24) ◽  
pp. 3881-3886 ◽  
Author(s):  
Raymond Tubbs ◽  
William E. Barlow ◽  
G. Thomas Budd ◽  
Eric Swain ◽  
Peggy Porter ◽  
...  

PurposeAmplification and deletion of the TOP2A gene have been reported as positive predictive markers of response to anthracycline-based therapy. We determined the status of the HER2 and TOP2A genes in a large cohort of breast cancer patients treated with adjuvant doxorubicin (A) and cyclophosphamide (C).Patients and MethodsTOP2A/CEP17 and HER2/CEP17 fluorescent in situ hybridization (FISH) were performed on tissue microarrays (TMAs) constructed from 2,123 of the 3,125 women with moderate-risk primary breast cancer who received equivalent doses of either concurrent adjuvant chemotherapy with A plus C (n = 1,592) or sequential A followed by C (n = 1,533).ResultsAn abnormal TOP2A genotype was identified for 153 (9.4%) of 1,626 patients (4.0% amplified; 5.4% deleted). An abnormal HER2 genotype was identified for 303 (20.4%) of 1,483 patients (18.8% amplified; 1.6% deleted). No significant differences in either overall survival (OS) or disease-free survival (DFS) were identified for TOP2A. In univariate analysis, OS and DFS rates were strongly and adversely associated only with higher levels of HER2 amplification (ratio ≥ 4.0). Survival was not associated with low-level HER2 amplification (ratio ≥ 2; OS hazard ratio [HR], 1.14; P = .39; DFS HR, 1.07; P = .62), but it was associated for a ratio ≥ 4 (OS HR, 1.45; P = .03; DFS HR, 1.38; P = .033), in which analysis was adjusted for menopausal status, hormone receptor status, treatment, number of positive nodes, and tumor size.ConclusionIn this population of patients with early-stage breast cancer who were treated with adjuvant AC chemotherapy, TOP2A abnormalities were not associated with outcome. HER2 high-level amplification was a prognostic marker in anthracycline-treated patients.


Author(s):  
Jennifer Erdrich ◽  
Felina Cordova-Marks ◽  
Angela R. Monetathchi ◽  
Manxia Wu ◽  
Arica White ◽  
...  

Abstract Background Little is known about the surgical patterns of American Indian/Alaska Native (AI/AN) breast cancer patients. The purpose of this study is to determine whether there are disparities in breast cancer surgery and radiation therapy between non-Hispanic AI/AN (NH-AI/AN) women and non-Hispanic White (NHW) women. Methods Data from the National Program of Cancer Registries of the Centers for Disease Control and Surveillance, Epidemiology, and End Results were used for this cross-sectional study. Female patients with invasive breast cancer diagnosed 2010–2015 were stratified by race/ethnicity, surgical procedure, radiation, and region. Percentage distributions of mastectomy and lumpectomy were compared overall and by region and stage. Results From 2010 to 2015 there were 3292 NH-AI/AN women and 165,225 NHW women diagnosed with breast cancer. For early stage (AJCC stage 1 and 2), NH-AI/AN women had overall significantly higher percentage of mastectomy (41% vs 34.4%, p < 0.001) and significantly lower percentage of lumpectomy (59% vs 65.6%) compared with NHW women, without significant differences in post-lumpectomy radiation (71% vs 70%). There were regional variations, notably in the Northern Plains, where the percentage of mastectomy for early-stage disease was 48.9% for NH-AI/AN women versus 35.9% for NHW women, and in Alaska with 47% for NH-AI/AN women versus 33.3% for NHW women (p < 0.001). There were no overall significant differences in type of surgery or radiation for late-stage disease between groups. Conclusion This is the first study to show disparities in surgical management of NH-AI/AN women with breast cancer. For early-stage disease, NH-AI/AN women undergo a higher percentage of mastectomy. Future clinical directions could focus on the factors that drive awareness, decision-making, and access to breast conservation.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. TPS597-TPS597
Author(s):  
Shigehira Saji ◽  
Heather L. McArthur ◽  
Michail Ignatiadis ◽  
Andrew Bailey ◽  
Sarra El-Abed ◽  
...  

TPS597 Background: Early stage triple negative breast cancer (TNBC) is associated with a high risk of distant relapse. Because TNBC does not currently have specific targeted agents approved for use in the early setting, it is treated primarily with chemotherapy. TNBC may be more immunogenic than other subtypes of breast cancer. Atezolizumab (an anti–PD-L1 antibody), in combination with nab-paclitaxel has been approved in >70 countries for the treatment of PD-L1-positive unresectable locally advanced or metastatic TNBC based on the results of the randomized phase 3 IMpassion130 trial. The phase 3 IMpassion031 study, evaluating atezolizumab in combination with chemotherapy (nab-paclitaxel followed by doxorubicin and cyclophosphamide) in comparison to placebo plus chemotherapy as neoadjuvant treatment demonstrated a statistically significant and clinically meaningful improvement in pCR in both PD-L1 positive and PD-L1 negative tumors. ALEXANDRA/IMpassion030 is a global, prospective, randomized, open-label, phase 3 trial currently investigating the efficacy, safety and pharmacokinetic profile of adjuvant atezolizumab plus standard anthracycline/taxane adjuvant chemotherapy versus chemotherapy alone in early stage TNBC. Methods: ALEXANDRA/IMpassion030 will randomize 2300 patients with operable stage II-III TNBC, confirmed by central pathology review. Patients are stratified by type of surgery, nodal status, and centrally assessed PD-L1 status. Adjuvant chemotherapy consist of weekly paclitaxel 80 mg/m2 for 12 weeks followed by dose dense anthracycline (epirubicin 90 mg/m2 or doxorubicin 60 mg/m2) and cyclophosphamide 600 mg/m2 for 4 doses every 2 weeks or the same chemotherapy regimen (T-EC/AC) given concomitantly with atezolizumab 840 mg every 2 weeks followed by maintenance atezolizumab 1200 mg every 3 weeks until completion of 1 year of atezolizumab. The primary endpoint is invasive disease-free survival (iDFS) and secondary endpoints include, iDFS in the PD-L1 selected tumour status (IC1/2/3) and node-positive subpopulations, overall survival, safety, patient functioning and health related quality of life (HRQoL). Tumor tissue and blood samples will be collected for biomarker research. The first site was activated on May 4 2018, and approximately 373 sites in 30 countries are currently participating in this trial. This trial is sponsored by F. Hoffmann-La Roche Ltd and conducted in partnership with the Breast International Group, Frontier Science and Technology Research Foundation, Institute Jules Bordet and Alliance Foundation Trials. Clinical trial information: NCT03498716.


2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 62-62
Author(s):  
Andrew L. Salner ◽  
Shelby Smith ◽  
Peter Paul Yu

62 Background: Adjuvant chemotherapy treatment has contributed to the reduction in cause-specific mortality from early stage breast cancer by reducing the risk of recurrence and metastasis. The initiation of adjuvant chemotherapy is typically started within 4-8 weeks following surgery. Although earlier treatment does not necessarily render a better prognosis, treatment delayed beyond 12 weeks may result in an unfavorable decrease in disease-free survival. In order to explore quality data for each of our 5 cancer centers and their breast surgeons, we conducted a quality outcomes project to examine our data and factors which could result in delay. Methods: We conducted a retrospective review evaluating all cases of patients diagnosed with stage 1 and 2 breast cancer at all of our cancer centers during the 2015 and 2016 calendar years, utilizing patient lists obtained from our cancer registries. Patients who received neoadjuvant chemotherapy or who had inadequate data were excluded. Variables included stage at diagnosis, percent of nodal positivity, age at diagnosis, race and ethnicity, attending surgeon, type of surgery (breast conservation vs. mastectomy +/- reconstruction), and number of days from final breast surgery to initiation of adjuvant chemotherapy treatment. Results: 757 and 319 patients with Stage I and II breast cancer respectively were identified in our 5 cancer centers. 16% had nodal positivity, and 25.6% received adjuvant chemotherapy. Average age at diagnosis was 62.5, and average age for node positive and adjuvant chemotherapy were 58.5 and 56.8. Days to chemotherapy ranged from 3-208, with 94% of patients treated in less than 12 weeks and ranges of mean days to begin chemotherapy 35.6 to 55.4 in our cancer centers. No significant differences were noted by age, race, ethnicity, stage, surgery type, surgeon, or hospital. Conclusions: This study reveals outcomes suggesting that our breast cancer teams at our cancer centers are meeting the current standard of care for initiation of adjuvant chemotherapy, and points to the value of quality studies in assuring standards of care.


BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Xingfa Huo ◽  
Jinming Li ◽  
Fuxing Zhao ◽  
Dengfeng Ren ◽  
Raees Ahmad ◽  
...  

Abstract Background The role of capecitabine in neoadjuvant and adjuvant chemotherapy for early-stage triple-negative breast cancer (TNBC) is highly controversial. Our meta-analysis was designed to further elucidate the effects of capecitabine on survival in early-stage TNBC patients and its safety. Methods PubMed, Embase, and papers presented at several main conferences were searched up to December 19, 2019, to investigate capecitabine-based versus capecitabine-free neoadjuvant and adjuvant chemotherapy in TNBC patients. Heterogeneity was assessed using I2 test, combined with hazard ratios (HRs) and odds ratios (ORs) with 95% confidence intervals (CI) computed for disease-free survival (DFS), overall survival (OS), and over grade 3 adverse events (AEs). Results A total of 9 randomized clinical trials and 3842 TNBC patients were included. Overall, the combined capecitabine regimens in neoadjuvant and adjuvant chemotherapy showed significantly improved DFS (HR = 0.75; 95% CI, 0.65–0.86; P < 0.001) and OS (HR = 0.63; 95% CI, 0.53–0.77; P < 0.001). In subgroup analysis, there were improvements in DFS in the groups with addition of capecitabine (HR = 0.64; 95% CI, 0.53–0.78; P < 0.001), adjuvant chemotherapy (HR = 0.73; 95% CI, 0.63–0.85; P < 0.001), and lymph node positivity (HR = 0.62; 95% CI, 0.44–0.86; P = 0.005). Capecitabine regimens were related to higher risks of diarrhea (OR = 2.88, 95% CI 2.23–3.74, P < 0.001), stomatitis (OR = 2.01, 95% CI 1.53–2.64, P < 0.001) and hand–foot syndrome (OR = 8.67, 95% CI 6.70–11.22, P < 0.001). Conclusion This meta-analysis showed that neoadjuvant and adjuvant chemotherapy combined with capecitabine significantly improved both DFS and OS in early-stage TNBC patients with tolerable AEs. There were benefits to DFS in the groups with the addition of capecitabine, adjuvant chemotherapy, and lymph node positivity.


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