Adjuvant radiotherapy use in a population-based sample of breast cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 617-617
Author(s):  
R. Jagsi ◽  
P. Abrahamse ◽  
J. J. Griggs ◽  
S. J. Katz

617 Background: Previous studies have suggested underutilization and socioeconomic disparities in use of adjuvant radiotherapy (RT) among patients with breast cancer. However, these studies used registry data which may be incomplete. Methods: We evaluated data from 2260 survey respondents with nonmetastatic breast cancer, aged 20–79 years, diagnosed from June 2005-February 2007 in Detroit and Los Angeles and reported to SEER registries (72% response rate). Survey responses regarding treatment and sociodemographic factors were merged to SEER data. Rates of RT receipt were based on patient report. Patients were divided into 3 populations: DCIS pts undergoing breast conservation (BCS), invasive pts undergoing BCS, and invasive pts undergoing mastectomy. These were then stratified based on recurrence risk in the absence of RT (3 groups based on tumor size and grade for DCIS pts, 2 groups separating pts over 70 with Stage I, ER+ tumors from others undergoing BCS for invasive disease, and 3 groups based on tumor size and nodal status for those undergoing mastectomy for invasive disease). Results: Among 306 pts undergoing BCS for DCIS, 85.6% received RT (77.9% of pts at low recurrence risk, 84.8% at intermediate risk, and 95.8% at high risk). Among 1018 pts undergoing BCS for invasive disease, 93.6% received RT (83.6% of low-risk patients and 94.9% of others). Among 661 pts undergoing mastectomy for invasive disease, 39.3% received RT (81.5% of pts at high-risk, 44.5% at intermediate-risk, and 12.1% at low risk). In separate multivariate logistic regression models including risk grouping and sociodemographic variables for each population, there were no significant associations between RT receipt and race, education, or income. Among pts receiving RT, delay was reported by 15.9% of the DCIS group, 19.5% of those treated for invasive disease after BCS, and 27.4% of those treated for invasive disease after mastectomy. Conclusions: RT use is high after BCS with little evidence of socioeconomic disparities. But lower than optimal rates after mastectomy even among patients with high expected benefit suggest lingering barriers to effective treatment in these patients. Less RT use in patients with lower expected benefit suggests that legitimate clinical uncertainty influences decision-making. No significant financial relationships to disclose.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 555-555
Author(s):  
Dennis Sgroi ◽  
Yi Zhang ◽  
Catherine A. Schnabel

555 Background: Identification of N+ breast cancer patients with a limited risk of recurrence improves selection of those for which chemotherapy and/or extended endocrine therapy (EET) may be most appropriate to reduce overtreatment. BCIN+ integrates gene expression with tumor size and grade, and is highly prognostic for overall (0-10yr) and late (5-10yr) distant recurrence (DR) in N1 patients. Clinical Treatment Score post-5-years (CTS5) is a prognostic model based on clinicopathological factors (nodes, age, tumor size and grade) and significantly prognostic for late DR. The current analysis compares BCIN+ and CTS5 for risk of late DR in N1 patients. Methods: 349 women with HR+, N1 disease and recurrence-free for ≥5 years were included. BCIN+ results were determined blinded to clinical outcome. CTS5 was calculated as previously described (Dowsett et al, JCO 2018; 36:1941). Kaplan-Meier analysis and Cox proportional hazards regression for late DR (5-15y) were evaluated. Results: 64% of patients were > 50 years old, 34% with tumors > 2cm, 79% received adjuvant chemotherapy and 64% received up to 5 years of ET. BCIN+ stratified 23% of patients as low-risk with 1.3% risk for late DR vs those classified as high-risk with 16.1% [HR 12.4 (1.7-90.4), p = 0.0014]. CTS5 classified patients into 3 risk groups: 29% of patients as low-risk (4.2% DR), 37% as intermediate-risk (10.6% DR), and 34% as high-risk (22.1% DR) [HR intermediate vs. low: 2.3 (0.7-7.0), p = 0.16; high vs. low: 5.3 (1.8-15.5), p = 0.002]. In a subset of patients who completed 5 years of ET (N = 223), BCIN+ identified 22% of patients as low-risk with a late DR rate of 2.1%, while CTS5 identified 29% and 37% of patients as low- and intermediate-risk with late DR rates of 5.2% and 10.3%, respectively. Conclusions: BCIN+ classified N1 patients into binary risk groups and identified 20% patients with limited risk of late DR ( < 2%) that may be advised to forego EET and its attendant toxicities/side effects. In comparison, CTS5 classified patients into 3 risk groups, with low- and intermediate-risk of late DR of 4-5% and 10%, wherein the risk-benefit profile for extension of endocrine therapy is less clear.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 529-529
Author(s):  
Tanmayi Pai ◽  
Angelica Gil ◽  
Yaohua Ma ◽  
Zhuo Li ◽  
Pooja Advani ◽  
...  

529 Background: Multiple prognostic models exist to predict late relapse risk in early stage hormone receptor-positive (HR+) breast cancer (BC). The CTS5 is one such model that has been validated in HR+ HER2-negative BC. The value of this model in HR+ HER2+ has not been established. Here, we assessed CTS5 in patients (pts) with early stage HER2+ BC treated in the NCCTG N9831 (Alliance) trial. Methods: Pts with stage I-III HER2+ HR+ BC who survived ≥ 5 years were included. The online CTS5 calculator was used to determine CTS5 score and risk group (low, intermediate, and high) based on age, tumor size, grade, and number of involved nodes. Kaplan-Meier (KM) estimates, Cox regression models, and C index were used for analysis. Results: From 3,130 pts, 1,204 pts met the criteria and were included. Median age was 49 (22-79) years and median tumor size was 2.4 (0.1-12) cm. 63.6% had grade 3 tumors, 33.6% grade 2, and 2.8% grade 1. Median follow up was 10.89 (5.01-15.32) years. Based on CTS5, 821 (68.2%) pts were classified as high risk, 289 (24%) as intermediate risk, and 94 (7.8%) as low risk. Overall, using univariate Cox regression analysis, there was no statistically significant difference in recurrence free survival (RFS) among pts with intermediate vs. low (HR 0.47 95%CI 0.18-1.22, p = 0.12) and high vs. low (HR1.23 95%CI0.57-2.67, p = 0.6) with the C index of 0.58. Among pts who received concurrent trastuzumab (H) with HR+ BC, there was also no statistical difference in RFS between high vs. low (HR 0.68 95%CI0.24-1.97, p = 0.48) with the C index of 0.55. Paradoxically, pts with intermediate risk had better RFS than low risk (HR 0.18 95%CI0.03-0.97, p = 0.05). As a continuous variable, there is also no significant improvement in RFS per 1 unit increase in CTS5 score (HR 1.19 95%CI 0.73-1.96, p = 0.49) with the C index of 0.54. After 5 years, 7.06% (n = 30/425) of HR+ pts treated with concurrent H recurred. Conclusions: The CTS5 model is not prognostic in pts with early stage HR+ HER2+ BC receiving adjuvant H. While most HR+ HER2+ pts are classified as high risk by CTS5, the recurrence between years 5-10 was low in pts who received adjuvant H. This study highlights the need to develop a new predictive model for risk of late relapse in this specific group of pts to enable clinicians to determine which pts would benefit from extended adjuvant endocrine therapy. Support: BCRF-19-161, U10CA180821, Genentech. https://acknowledgments.alliancefound.org Clinical trial information: NCT00005970 .


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18581-e18581
Author(s):  
Kristin M. Sheffield ◽  
Jessica R. Peachey ◽  
Michael W. Method ◽  
Brenda R. Grimes ◽  
Jacqueline Brown ◽  
...  

e18581 Background: While most patients (pts) with HR+, HER2- early breast cancer (EBC) do not experience disease recurrence, those with high risk clinicopathologic features may have recurrence within the first few years on adjuvant endocrine therapy (AET). This study estimates risk of recurrence in pts with EBC based on clinicopathologic features and evaluates the medical need for more efficacious treatments using US oncology practice data. Methods: This retrospective study used the nationwide Flatiron Health electronic health record derived deidentified database. The cohort included pts with HR+, HER2- stage I-III breast cancer, diagnosed Jan 2011-Mar 2020, who received surgery and AET. Clinicopathologic features were used to identify a ‘high risk (HiR) group’ (≥ 4 positive axillary lymph nodes (LN), or 1-3 positive axillary LN and ≥ 1 of the following: Grade 3, tumor size ≥ 5 cm, or Ki-67 ≥ 20%) and ‘low risk (LoR) group’ (pts who do not meet above criteria, including a subset with node negative (N0) disease). Cox proportional hazards regression models compared invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) from AET initiation between groups according to a sequential gatekeeping strategy and stepwise analysis: first compare HiR group to N0 pts; if significant then compare HiR to LoR group. Results: 557 (13.8%) pts were in the HiR group and 3,471 (86.2%) in the LoR group (including 2,867 N0 pts). The study population (median age 64 yrs) was predominantly female (99.2%), white (69.4%) and postmenopausal (75.6%) with median follow-up of 39.6 months. Pts in the HiR group were younger and more likely premenopausal, have a BRCA mutation, invasive lobular carcinoma and less likely to have received an Oncotype DX test compared to LoR pts. Of the 557 HiR pts, 231 (41.5%) had ≥ 4 positive LN and 326 (58.5%) had 1-3 positive axillary LN with additional risk factor(s): tumor size ≥ 5 cm (11.7%), histologic grade 3 (32.0%), and/or Ki-67 ≥ 20% (31.6%). Most HiR pts received radiotherapy (82.4%) and chemotherapy (68.1%). Significant differences in IDFS and DRFS were observed between HiR group and N0 and LoR groups (logrank test p < .0001 for all). The 2-year IDFS rate was 88.1% in the HiR group, compared to 97.4% in N0 pts and 97.1% in the LoR group; 2-year DRFS rates were 89.0% compared to 97.9% and 97.7%, respectively. Pts in the HiR group had significantly higher hazard of invasive disease recurrence or death compared to N0 (HR = 3.42, 95% CI: 2.69-4.34, p < .0001) and LoR group (HR = 3.07, 95% CI: 2.46-3.84, p < .0001). Similar results observed for DRFS (HiR vs N0: HR = 3.46, 95% CI: 2.70-4.44, p < .0001; HiR vs LoR HR = 3.16, 95% CI: 2.50-3.98, p < .0001). Conclusions: Approximately 12% of pts with EBC and high risk clinicopathologic features experienced invasive disease recurrence or death within 2 years of initiating AET. Optimal use of standard therapies and novel treatment options are needed to prevent early recurrence and metastases in these pts.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 551-551
Author(s):  
Reshma L. Mahtani ◽  
Vijayakrishna K. Gadi ◽  
Theresa N. Operana ◽  
Harris S Soifer ◽  
Brock Schroeder ◽  
...  

551 Background: Randomized trials demonstrated a modest (3-5%) absolute benefit from EET in patients (pts) with early stage HR+ breast cancer (BC), but also a risk of toxicities. BCI is a validated gene expression-based assay that provides 2 results: BCI Prognostic, based on the algorithmic combination of HoxB13/IL17BR (H/I ratio) and a set of proliferation-based genes, reports individualized risk of late distant recurrence (DR); BCI Predictive, based on H/I alone, reports a prediction of high vs low likelihood of benefit from EET. The objective of this study was to assess clinical and pathologic patient characteristics, prognostic and predictive assay results, and physician testing patterns in >14,000 clinical cases. Methods: The BCI Clinical Database for Correlative Studies is a de-identified database developed under an IRB approved protocol that contains >50 clinicopathologic and molecular variables from cases submitted for BCI in clinical practice. Clinicopathologic variables were abstracted from pathology reports, and were available for a subset of cases. Results: Across all pts (N=14,463), median age was 58.2y (range: 23-92y; 73.9% ≥50y). The majority were Stage I (47.3% IA, 3.5% IB, 29.1% IIA, 14.1% IIB, 6% III). Cases were 29%, 51%, and 20% Grade 1, 2, and 3, respectively. Most pts were ER+/PR+ (87.7%) or ER+/PR- (11.3%); 11.3% were HER2+. The majority of cases (55.7%) were ordered 4-6y postdiagnosis, with 23.1% >6y, 14.4% between 1-4y, and 6.8% <1y postdiagnosis. In LN- pts (n=3395), BCI Prognostic identified 50.6% as low risk for late DR vs 49.4% as high risk, while BCI Predictive (H/I) classified 41.0% as high vs 59.0% as low likelihood of benefit. In LN+ pts tested with the BCIN+ Prognostic algorithm (BCI + size/grade, n=818), 77.3% were classified as high risk vs 22.7% as low risk, while BCI Predictive (H/I) classified 44.6% and 55.4% as high vs low likelihood of benefit. Conclusions: Findings from this large cohort characterize utilization of BCI in clinical practice for pts with early-stage, HR+ BC. BCI stratification of pts with high risk and high likelihood of benefit from EET may facilitate selection of pts for prolonged regimens.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 537-537
Author(s):  
Wade T. Swenson ◽  
Shantanu Mallick

537 Background: The 21-gene recurrence assay predicts cancer recurrence rates and benefit from adjuvant chemotherapy among patients with hormone-receptor-positive breast cancer. The National Cancer Institute and Genomic Health collaborated to provide Recurrence Score (RS) results to complement data from 17 population-based cancer registries in the Surveillance, Epidemiology, and End Results (SEER) Program. Methods: Using the SEER database with linked RS results, a cohort of female breast cancer patients, age greater than 20 years, was identified by RS (low: < 18, intermediate: 18-30, high: > 30) diagnosed between the years 2004 and 2007. A retrospective analysis was conducted to determine eight-year breast cancer-specific survival rates based on RS and other variables. Results: 10,318 patients were identified in the cohort. 5,194 had a low risk RS; 4,282 had an intermediate risk RS; 872 had a high risk RS. Histologic subtypes were: 7,459 infiltrating ductal carcinoma, 941 mixed infiltrating and lobular carcinoma, 933 lobular carcinoma, 327 mixed infiltrating ductal and other histology, 244 mucinous adenocarcinoma, 101 tubular adenocarcinoma, 45 mixed lobular and other histology, 268 other histologies. 644 low risk RS patients received chemotherapy (12.4%); 1,608 intermediate risk RS patients received chemotherapy (37.8%); 593 high risk patients received chemotherapy (68.0%). The eight-year breast cancer-specific survival rates (with 95% confidence intervals) among low risk RS patients without known chemotherapy administration was 98.9% (98.5, 99.2), and 98.4% (97.0, 99.1) with chemotherapy; intermediate risk RS patients without known chemotherapy was 97.0% (96.2, 97.6), and 96.9% (95.9, 97.7) with chemotherapy; high risk RS patients without known chemotherapy was 89.7% (85.4, 92.8), and 92.9% (90.4, 94.7) with chemotherapy. Conclusions: Among a large cohort of patients identified in a population-based cancer registry between 2004 and 2007, there was no statistically significant difference in eight-year breast cancer-specific survival rates among those who received chemotherapy and those who did not, regardless of RS risk group.


Cancers ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2772
Author(s):  
Michael A. Jacobs ◽  
Christopher B. Umbricht ◽  
Vishwa S. Parekh ◽  
Riham H. El Khouli ◽  
Leslie Cope ◽  
...  

Optimal use of multiparametric magnetic resonance imaging (mpMRI) can identify key MRI parameters and provide unique tissue signatures defining phenotypes of breast cancer. We have developed and implemented a new machine-learning informatic system, termed Informatics Radiomics Integration System (IRIS) that integrates clinical variables, derived from imaging and electronic medical health records (EHR) with multiparametric radiomics (mpRad) for identifying potential risk of local or systemic recurrence in breast cancer patients. We tested the model in patients (n = 80) who had Estrogen Receptor positive disease and underwent OncotypeDX gene testing, radiomic analysis, and breast mpMRI. The IRIS method was trained using the mpMRI, clinical, pathologic, and radiomic descriptors for prediction of the OncotypeDX risk score. The trained mpRad IRIS model had a 95% and specificity was 83% with an Area Under the Curve (AUC) of 0.89 for classifying low risk patients from the intermediate and high-risk groups. The lesion size was larger for the high-risk group (2.9 ± 1.7 mm) and lower for both low risk (1.9 ± 1.3 mm) and intermediate risk (1.7 ± 1.4 mm) groups. The lesion apparent diffusion coefficient (ADC) map values for high- and intermediate-risk groups were significantly (p < 0.05) lower than the low-risk group (1.14 vs. 1.49 × 10−3 mm2/s). These initial studies provide deeper insight into the clinical, pathological, quantitative imaging, and radiomic features, and provide the foundation to relate these features to the assessment of treatment response for improved personalized medicine.


2008 ◽  
Vol 74 (10) ◽  
pp. 887-890 ◽  
Author(s):  
Jessica A. Rayhanabad ◽  
L. Andrew Difronzo ◽  
Phillip I. Haigh ◽  
Lina Romero

Advances in molecular genetics aimed at individualizing breast cancer treatment have been validated. We examined the use of gene assays predictive of distant recurrence in breast cancer and their impact on adjuvant treatment. A retrospective chart review of 58 T1/T2, node-negative, estrogen-receptor positive breast cancer patients that underwent Oncotype DX gene assay testing between January and December 2006 was performed. We compared treatment received after gene assay evaluation to treatment based on National Comprehensive Cancer Network guidelines. Patients were grouped using these recommendations: Low-risk group (T1a/T1b), no chemotherapy; High-risk group (T1c/T2), chemotherapy. Oncotype DX recommendations are as follows: Low recurrence risk, no chemotherapy; high recurrence risk, chemotherapy. A change in management was defined as chemotherapy for T1a/T1b disease and no chemotherapy for T1c/T2 disease. Two T1a/T1b patients had high risk of recurrence per gene assay scores and were treated with chemotherapy (P < 0.05). Eighteen T1c/T2 patients had low recurrence risk scores; 13 (72%) were spared chemotherapy. The recurrence score increased the number of patients classified as low risk of recurrence by 12 per cent and downstaged 63 per cent of high-risk patients (P < 0.003). Gene assay results changed management in 15 of 58 (26%) patients (P < 0.05). The use of gene assays allowed us to better tailor treatment in a significant number of our patients.


2021 ◽  
Vol 11 ◽  
Author(s):  
Liye Wang ◽  
Rongzhen Luo ◽  
Qianyi Lu ◽  
Kuikui Jiang ◽  
Ruoxi Hong ◽  
...  

IntroductionHR+/HER2− breast cancer (BC) has a much lower pathological complete response (pCR) rate to neoadjuvant chemotherapy (NAC). Therefore, to better stratify the relapse risk for HR+/HER2− non-pCR populations, it is essential to accurate identification new prognostic markers.Materials and MethodsThe study retrospectively analyzed 105 stage II–III patients who were diagnosed with HR+/HER2− BC and received NAC followed by breast and axilla surgery between 2013 and 2019 in Sun Yat-Sen University Cancer Center. The Miller–Payne (MP) grading system was used to evaluate pathological responses to NAC. The 70-gene signature was used to classify the prognosis signatures.ResultsAmong the 105 patients, the study demonstrated that larger tumor size and lower progesterone receptor level at baseline and larger tumor size postoperative were statistically significantly associated with worse disease-free survival (DFS) (p = 0.004, p = 0.021, and p = 0.001, respectively). Among 54 patients who underwent the 70-gene assays, 26 (48.1%) had a low-risk signature; 28 (51.9%) patients had a high-risk signature. Patients with poor response (MP grades 1–2) were more likely to with a high-risk 70-gene signature than those with good response (MP grades 4–5). The final analysis showed that DFS was longer in the low-risk group than in the high-risk group [52.4 vs. 36.1 months of the median DFS, hazard ratio (HR) for recurrence, 0.29; 95% confidence interval (CI), 0.10–0.80; p = 0.018]. DFS was longer in the good response (MP grades 3–4) group than in the poor response (MP grades 1–2) group (94.7% vs. 60% of the patients free from recurrence; HR, 0.16; 95% CI, 0.05–0.47; p = 0.037). When stratified by MP grades combined with the 70-gene signature, subgroup analyses showed the good-response low-risk group with the best DFS, whereas the poor-response high-risk group showed the worst DFS (p = 0.048). Due to the short median follow-up time of 34.5 months (5.9–75.1 months), MP grades and the 70-gene signature did not show significant prognostic value for overall survival.ConclusionThe study showed that analysis of MP grades combined with the 70-gene signature with residual NAC-resistant breast samples has a significant correlation with DFS.


2015 ◽  
Vol 33 (28_suppl) ◽  
pp. 131-131
Author(s):  
John Mullinax ◽  
Danielle Carr ◽  
Nora Vera ◽  
Weihong Sun ◽  
M. Catherine Lee ◽  
...  

131 Background: Distant recurrence (DR) is the cause of most breast cancer deaths. The 21-gene assay (ODX) Recurrence Score (RS) result predicts both 5 and 10-yr DR risk and can guide adjuvant chemotherapy (CT) recommendations to mitigate this risk. This study analyzed the use of the RS result to guide adjuvant treatment decisions in a large single-institution, prospective cohort of patients (pts). Methods: This is an IRB-approved review of a prospective database of pts receiving ODX on an initial primary breast cancer. Data collected included demographics, primary operation, margin status, receptor status, RS, adjuvant treatment, recurrence, and survival. Pts were stratified as low risk (RS < 18), intermediate risk, or high risk (RS > 30). The primary analysis computed Kaplan-Meier estimates for rate of DR at 5 yrs when pts were stratified by RS. Results: From 2003 to 2009, a RS result was obtained on 606 pts. Median follow up was 2.9 yrs (0.1-9.7) and median age was 58 yrs (27-84). Median RS result was 16 (0-63); 344(57%) pts were low, 212(35%) intermediate, 50(8%) high. Endocrine therapy was given to 92.4%, 94.3%, and 87.5% low, intermediate, and high risk pts, respectively. Adjuvant CT was given to 8.6%, 47.6%, and 70.8% low, intermediate, and high risk pts, respectively. There were 8 DR events with 1.8% 5-yr estimated risk of DR. The 5-yr estimated risk of DR was 0.7% for low risk (344) pts, 3.4% for intermediate risk (211) pts, and 2.6% for high risk (50) pts. Among node negative [N(-)] pts (502), the 5-yr estimated risk of DR was 0.8% for low risk (287) pts, 3.7% for intermediate risk (174) pts, and 3.3% for high risk (41) pts. Among node positive [(N+)] pts (54) there was only 1 DR, which was in a high risk pt. Of pts with unknown nodal status (50), there were no DRs. Conclusions: The RS result is predictive of DR at 5 yrs as shown in historical datasets (Table). The use of ODX to guide adjuvant treatment recommendations in our contemporary, prospective cohort resulted in a much lower 5-year DR rate and thus supports its use to guide adjuvant treatment decisions. [Table: see text]


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