Abstract Various histopathological, clinical and imaging parameters have been evaluated to identify a subset of women diagnosed with lesions with uncertain malignant potential (B3 or BIRADS 3/4A ...lesions) who could safely be observed rather than being treated with surgical excision, with little impact on clinical practice. The primary reason for surgery is to rule out an upgrade to either ductal carcinoma in situ or invasive breast cancer, which occurs in up to 30% of patients. We hypothesised that the stromal immune microenvironment could indicate the presence of carcinoma associated with a ductal B3 lesion and that this could be detected in biopsies by counting lymphocytes as a predictive biomarker for upgrade. A higher number of lymphocytes in the surrounding specialised stroma was observed in upgraded ductal and papillary B3 lesions than non-upgraded ( p < 0.01, negative binomial model, n = 307). We developed a model using lymphocytes combined with age and the type of lesion, which was predictive of upgrade with an area under the curve of 0.82 95% confidence interval 0.77–0.87. The model can identify some patients at risk of upgrade with high sensitivity, but with limited specificity. Assessing the tumour microenvironment including stromal lymphocytes may contribute to reducing unnecessary surgeries in the clinic, but additional predictive features are needed.
Post-mastectomy pain syndrome (PMPS) is a common and often debilitating condition. The syndrome is defined by chest wall pain unresponsive to standard pain medications and the presence of exquisite ...point tenderness along the inframammary fold at the site of the T4 and T5 cutaneous intercostal nerve branches as they exit from the chest wall. Pressure at the site triggers and reproduces the patient's spontaneous or motion-evoked pain. The likely pathogenesis is neuroma formation after injury to the T4 and T5 intercostal nerves during breast surgery. We assessed the rate of long-term resolution of post-mastectomy pain after trigger point injections (2 mL of 1:1 mixture of 0.5% bupivacaine and 4 mg/mL dexamethasone) to relieve neuropathic pain in a prospective single-arm cohort study. Fifty-two women (aged 31-92) who underwent partial mastectomy with reduction mammoplasty or mastectomy with or without reconstruction, and who presented with PMPS were enrolled at the University of California San Francisco Breast Care Center from August 2010 through April 2018. The primary outcome was a long-term resolution of pain, defined as significant or complete relief of pain for greater than 3 months. A total of 91 trigger points were treated with mean follow-up 43.9 months with a 91.2% (83/91) success rate. Among those with a long-term resolution of pain, 60 trigger points (72.3%) required a single injection to achieve long-lasting relief. Perineural infiltration with bupivacaine and dexamethasone is a safe, simple, and effective treatment for PMPS presenting as trigger point pain along the inframammary fold.
Breast cancer risk reduction has been validated by large-scale clinical trials, but uptake remains low. A risk communication tool could provide personalized risk-reduction information for high-risk ...women. A low-literacy-friendly, visual, and personalized tool was designed as part of the Women Informed to Screen Depending On Measures of risk (WISDOM) study. The tool integrates genetic, polygenic, and lifestyle factors, and quantifies the risk-reduction from undertaking medication and lifestyle interventions. The development and design process utilized feedback from clinicians, decision-making scientists, software engineers, and patient advocates. We piloted the tool with 17 study participants, collecting quantitative and qualitative feedback. Overall, participants felt they better understood their personalized breast cancer risk, were motivated to reduce their risk, and considered lifestyle interventions. The tool will be used to evaluate whether risk-based screening leads to more informed decisions and higher uptake of risk-reduction interventions among those most likely to benefit.
Risk-reducing endocrine therapy use, though the benefit is validated, is extremely low. The FDA has approved tamoxifen and raloxifene for a 5-year Breast Cancer Risk Assessment Tool (BCRAT) risk ≥ ...1.67%. We examined the threshold at which high-risk women are likely to be using endocrine risk-reducing therapies among Athena Breast Health Network participants from 2011-2018. We identified high-risk women by a 5-year BCRAT risk ≥ 1.67% and those in the top 10% and 2.5% risk thresholds by age. We estimated the odds ratio (OR) of current medication use based on these thresholds using logistic regression. One thousand two hundred and one (1.2%) of 104,223 total participants used medication. Of the 33,082 participants with 5-year BCRAT risk ≥ 1.67%, 772 (2.3%) used medication. Of 2445 in the top 2.5% threshold, 209 (8.6%) used medication. Participants whose 5-year risk exceeded 1.67% were more likely to use medication than those whose risk was below this threshold, OR 3.94 (95% CI = 3.50-4.43). The top 2.5% was most strongly associated with medication usage, OR 9.50 (8.13-11.09) compared to the bottom 97.5%. Women exceeding a 5-year BCRAT ≥ 1.67% had modest medication use. We demonstrate that women in the top 2.5% have higher odds of medication use than those in the bottom 97.5% and compared to a risk of 1.67%. The top 2.5% threshold would more effectively target medication use and is being tested prospectively in a randomized control clinical trial.
Abstract
BackgroundOptions for breast cancer risk reduction include endocrine medications (tamoxifen, raloxifene, aromatase inhibitors) and lifestyle modifications (increasing exercise, reducing BMI, ...or alcohol intake). At present, there are limited patient-facing resources that provide information on personalized risk and prevention strategies. To address this unmet need, the Breast Health Decisions (BHD) Tool was designed to educate and empower women in the WISDOM (Women Informed to Screen Depending on Measures of risk) Study, a preference-tolerant randomized control trial comparing personalized risk-based screening to traditional annual screening. The tool supports Aim 4 of the WISDOM Study: test whether risk-based screening, including individualized risk assessment and targeted risk reduction education for those in the top 2.5% risk, enables higher uptake of preventive interventions. We conducted a study of the first 100 participants counseled using the BHD Tool to assess its impact on risk-reduction strategies.
MethodsThe BHD Tool, built on the Salesforce platform, integrates WISDOM Study risk assessments to generate personalized education about risk and risk reduction, using concise wording, 8th-grade reading level or lower, and visual representations to support shared decision making for high-risk women. Changes to improve usability were incorporated from an initial pilot study. The study population was WISDOM Study participants in the top 2.5% 5-year risk by age, excluding mutation carriers. 5-year risk was calculated using the Breast Cancer Surveillance Consortium risk modified by a polygenic risk score. The tool was available through the participants’ online study portals. Study staff contacted these participants to schedule consultations via Zoom with a WISDOM Breast Health Specialist, who navigated the participant through the tool during an interactive 45-minute consultation. Participants could decline the consultation and use the tool independently. A survey was conducted afterward to assess the tool’s utility in motivating women to pursue risk-reducing options.
ResultsWe surveyed 100 high-risk participants who used the BHD Tool. 65% found it very helpful in understanding their breast cancer risk. 27 participants listed additional lifestyle improvements that they were practicing or hoping to begin, including yoga, walking, breast exams, self-exams, yard work, dietary improvements, meditation, and stress reduction. 37% of participants agreed that the tool eased their breast cancer worries and anxiety, while 44% were neutral and 17% disagreed. At the time of presentation, we will present 3-month follow up data and report which preventive actions were actually taken and barriers encountered.
ConclusionsThe BHD Tool synthesizes up-to-date chemoprevention literature in a patient-friendly interface to help educate women about their prevention options and to facilitate future discussions with a provider to empower informed decisions. Data from the first 100 high-risk women who used this tool suggest that the majority of women presented with information about their risk are interested in reducing it. More are considering lifestyle measures than medications. The BHD tool will be made available to all women in the personalized arm of the WISDOM Study. Future improvements include making the tool accessible to clinicians who counsel high-risk women.
Survey questionNumber of participants (N=100)Interested in reducing chance of developing breast cancer97Currently participating in a breast cancer risk reducing activity*77Reducing alcohol intake35Losing weight60Increasing exercise27Risk reducing medications5Considering participating in a breast cancer risk reducing activity*72Reducing alcohol intake12Losing weight26Increasing exercise24Risk reducing medications22*Participants can choose more than one risk-reducing activity
Citation Format: Tianyi Wang, Mandy Che, Yash Huilgol, Deborah Goodman, Holly Keane, Vivian Lee, Jeff Belkora, Allison Fiscalini, Laura Esserman. Validation study results for a personalized prevention education aid in breast cancer risk reduction abstract. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS7-43.
Background
Magseed technology is a recently introduced localisation technique for impalpable breast lesions with possible advantages over traditional techniques. These include improved theatre ...logistics, flexibility in incision placement and improved patient experience. This multicentre study evaluates the experience of introducing Magseed technology into routine surgical practice.
Methods
A prospective multicentre study of Magseed localised procedures was performed. Insertion data were recorded by the radiologist including lesion characteristics and Magseed insertion accuracy. The surgical team recorded time from insertion to operation, operating time and surgical satisfaction. Pathology results were reviewed for specimen weight and margins.
Results
Between February 2019 and June 2020, 100 patients were enrolled. Magseed localised procedures included 18 excisional biopsies, 23 wide local excisions (WLE), 50 WLE with axillary surgery and four cases of Magseed localised breast WLE with Magseed localised axillary surgery. There were three therapeutic mammoplasties and two cases of Magseed localised targeted axillary node dissection alone. A total of 90% of Magseeds were radiologically placed within 5 mm of the target lesion/node. Time between incision and specimen removal was 17 min (range 6–40 min). All breast and axillary Magseeds were successfully identified and retrieved during surgery. The target lesion was identified in the specimen in all cases. A total of 10% of cases required further surgery for pathologically positive margins. Overall, surgeons reported that Magseed localisation was “easy” or “very easy” in 77% of cases.
Conclusion
Magseed is a reliable, safe and accurate surgical technique that provides logistical advantages and flexibility of surgical approach. The method was well‐accepted by all users.
Magseed localisation of non‐palpable breast lesion.
Magseed localisation of non‐palpable breast lesion.
Abstract
Problem statement: Breast cancer risk reduction has been validated by Level I evidence generated in large-scale clinical trials, however uptake of chemoprevention among women at high risk ...remains very low.
Methods: A patient-facing shared decision-making aid was designed to inform women enrolled in the PCORI-funded WISDOM Study of their individualized breast cancer risk and ways to reduce their risk. It built upon a breast health decision tool used for the prior ten years. The tool displays the key factors that are used to calculate a participant’s risk (Breast Cancer Surveillance Consortium BCSC and Polygenic Risk Score). The aid also estimates the anticipated change in a participant’s risk due to particular risk-reduction interventions (medication, lifestyle). After Institutional Review Board approval, we used a mixed-methods analysis to evaluate the decision aid. Expert opinion was sought from decision scientists, low literacy experts, breast health specialists, epidemiologists, and breast cancer specialists, in order to generate a tool with suitable language and adequate communication of content. We piloted the decision-making aid with 15 elevated risk WISDOM Study participants without a common mutation associated with breast cancer.
Results: To date, the pilot has enrolled 10 elevated-risk participants with an average age of 63. Six have completed the quantitative survey. 3 (50%) indicated that they would consider chemoprevention. 6 (100%) indicated that they would consider lifestyle changes, such as exercise or reducing their body mass index (BMI). 3 (50%) indicated the aid has been “extremely helpful” and 6 (100%) indicated that they had a better understanding of their breast cancer risk. Participants also indicated the benefit of visuals and greater engagement with high-risk counselors when using the aid. The full pilot data plus the ongoing experience will be presented.
Conclusion: The WISDOM Study shared decision-making aid represents a novel, participant-centered approach to integrate breast cancer prevention and personal breast cancer risk. This decision aid will be used in the WISDOM Study to evaluate whether risk-based screening will improve uptake of chemoprevention in the WISDOM Study population.
Citation Format: Holly Keane, Yash Huilgol, W. Patrick Shibley, Yiwey Shieh, Deborah Goodman, Jeff Tice, Jeff Belkora, Karen Sepucha, Elissa Ozzane, Allison Fiscalini, Laura Esserman. Personalized, prevention decision aid developed for breast cancer risk-reducing discussions and interventions in the WISDOM study abstract. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-08-23.
Abstract
Background: Large-scale chemoprevention trials validated endocrine risk reduction strategies to lower breast cancer risk. We sought to understand the risk at which women are likely to adopt ...chemoprevention. A 5-year Gail risk of 1.67% or above is considered elevated risk, and the FDA indication for prescribing chemoprevention. We examined chemoprevention use in the Athena Breast Health Network (Athena), which includes approximately 100,000 women who are screened by mammography at Sanford Health, UC Davis, UC Irvine, UC Los Angeles, UC San Diego, and UC San Francisco.
Methods: We calculated the Gail risk score for women who had completed an Athena online intake survey distributed before being seen at screening centers; this survey included questions about chemoprevention usage. First, we analyzed 16,518 surveys of 9,318 unique women without breast cancer or DCIS who received breast cancer screening at UCSF from 2011- 2018 and who consented to research. These women also self-reported use of chemoprevention. We stratified Gail risk scores by a threshold of 1.67%, and by percentiles to identify those women in the top 2.5% by age. We compared current chemoprevention use in these different breast cancer risk strata, and factors associated with its use. An analysis including all 100,000 women in the Athena Network will be presented at SABCS.
Results: Overall, at UCSF, 48 of 9,318 women (0.51%) reported current chemoprevention use. The 5-year Gail risk was greater than 1.66% in 3,675 of 9,318 women (39%), of whom 205 (2.2%) were in the top 2.5% of risk by age. Chemoprevention use was reported by 13 of 205 (6.3%) women in the top 2.5% of risk by age (mean Gail risk 5.6%), as compared to 41 of 3,675 (1.1%) who were at Gail above 1.66% (mean Gail = 3.9%). Women in the top 2.5% and those with Gail risk >1.66% were significantly more likely to be using chemoprevention p< 0.01 for each respectively). Chemoprevention uptake was correlated with the joint effect of the top 2.5% of risk by age and increasing Gail score (OR = 10.25; P = 0.009). Preliminary results were consistent among the 100,000 women in the Athena registry (analysis ongoing). In addition, chemoprevention use was more likely in older women (OR = 1.10; P < 0.01, for every year of age) and in those women with Ashkenazi ancestry on both sides of the family compared to none (OR = 2.32; P = 0.02). Race and education were not associated with use of chemoprevention.
Discussion: Women with higher Gail scores in the top 2.5% of risk by age are positively associated with current chemoprevention use (6.34%). Importantly, this analysis presents a risk-stratified, population-level risk reduction strategy, using the top 2.5% risk threshold by age. It provides an opportunity to specifically target chemoprevention to women at highest need to reduce their breast cancer risk. In the WISDOM Study (NCT02620852), we are prospectively testing active outreach based on breast cancer risk in the top 2.5% of risk by age, and have developed a breast health decisions aid to standardize communication of risk-reducing options.
Citation Format: Yash S Huilgol, Holly Keane, Yiwey Shieh, Jeffrey Tice, Elad Ziv, Lisa Madlensky, Leah Sabacan, Irene Acerbi, Mandy Che, Allison Stover Fiscalini, Hoda Anton-Culver, Alexander D Borowsky, Sharon Hunt, Arash Naeim, Barbara Parker, Laura J van 't Veer, Athena Breast Health Network Investigators and Advocate Partners and Laura J Esserman. Breast cancer risk thresholds as a predictor of chemoprevention uptake in the Athena Breast Health Network abstract. In: Proceedings of the 2019 San Antonio Breast Cancer Symposium; 2019 Dec 10-14; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2020;80(4 Suppl):Abstract nr P5-08-01.
To examine practice patterns for breast cancer patients with limited sentinel node (SN) disease in light of the ACOSOG Z0011 results. Retrospective analysis of patients with T1‐2 breast cancer and ...positive sentinel lymph node biopsy (SLNB) admitted between January 2009 and December 2012. Patient demographics, tumor characteristics, and treatments were recorded. Eight hundred positive SLNBs were identified. A total of 452 (56.5%) proceeded to completion axillary lymph node dissection (cALND). cALND rate decreased from 65.1% to 49.7% from 2009–2010 to 2011–2012. cALND was performed for micrometastasis or isolated tumor cells in 39.3% in 2009–2010 and 22.2% in 2011–2012, whereas for macrometastases the rates were 83.1% and 68.6%, respectively. cALND rates diminished for both Z0011‐eligible and ‐ineligible patients. The ACOSOG Z0011 trial presentation and publication coincided with a reduction in cALND for breast cancer with limited nodal disease. There appears equipoise regarding management of macrometastatic SN disease.
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