Multi-pilot implementation experiences of patient-centered pathology reports: lessons learned for the advancement of patient-centered tools for cancer decision-making.

PURPOSE: New federal legislation in the United States grants patients expanded access to their medical records, making it critical that medical records information is understandable to patients. Provision of informational summaries significantly increase patient perceptions of patient-centered care and reduce feelings of uncertainty, yet their use for cancer pathology is limited. METHODS: Our team developed and piloted patient-centered versions of pathology reports (PCPRs) for four cancer organ sites: prostate, bladder, breast, and colorectal polyp. The objective of this analysis was to identify common barriers and facilitators to support dissemination of PCPRs in care delivery settings. We analyzed quantitative and qualitative data from pilot PCPR implementations, guided by the RE-AIM framework to explore constructs of reach, effectiveness, adoption, implementation, and maintenance. RESULTS: We present two case studies of PCPR implementation - breast cancer and colorectal polyps-that showcase diverse workflows for pathology reporting. Cross-pilot learnings emphasize the potential for PCPRs to improve patient satisfaction, knowledge, quality of shared decision-making activities, yet several barriers to dissemination exist. CONCLUSION: While there is promise in expanding patient-centered cancer communication tools, more work is needed to expand the technological capacity for PCPRs and connect PCPRs to opportunities to reduce costs, improve quality, and reduce waste in care delivery systems.

The Impact of Breast-Conserving Surgery Re-excision on Patient-Reported Outcomes Using the BREAST-Q.

BACKGROUND: Approximately 14% of women undergoing breast-conserving surgery (BCS) require re-excision to achieve negative margins following the Society of Surgical Oncology (SSO) and American Society for Radiation Oncology (ASTRO) margin guidelines, which may influence patient-reported outcomes (PROs). Few studies have assessed the impact of re-excision on PROs following BCS. PATIENTS AND METHODS: Women with stage 0-III breast cancer undergoing BCS who completed a BREAST-Q PRO measure from 2010 to 2016 were identified from a prospective database. Baseline characteristics were compared between women who underwent one BCS and those who underwent ≥ 1 re-excision surgery for positive margins (R-BCS). Linear mixed models were used to analyze associations between number of excisions and BREAST-Q scores over time. RESULTS: Of 2543 eligible women, 1979 (78%) had one BCS and 564 (22%) had R-BCS. Younger age, lower BMI, surgery pre-SSO Invasive Guidelines issuance, ductal carcinoma in situ (DCIS), multifocal disease, radiation therapy receipt, and endocrine therapy omission were more common in the R-BCS group. Breast satisfaction and sexual well-being were lower in the R-BCS group 2 years postoperatively. There were no differences in psychosocial well-being between groups over 5 years. On multivariable analysis, re-excision was associated with lower breast satisfaction and sexual well-being (p= 0.007 and p= 0.049, respectively), but there was no difference in psychosocial well-being (p= 0.250). CONCLUSIONS: Women with R-BCS had lower breast satisfaction and sexual well-being 2 years postoperatively, but this difference did not remain long term. Psychosocial well-being in women who underwent one BCS were largely comparable over time to the R-BCS group. These findings may help in counseling women who are concerned about satisfaction and quality-of-life outcomes with BCS if re-excision is necessary.

Genetic Testing Among Patients with High-Risk Breast, Ovarian, Pancreatic, and Prostate Cancers.

BACKGROUND: The National Comprehensive Cancer Network recommends genetic testing in patients with potentially hereditary breast, ovarian, pancreatic, and prostate cancers (HBOPP). Knowledge of genetic mutations impacts decisions about screening and treatment. METHODS: A retrospective cohort study of 28,586 HBOPP patients diagnosed from 2013 to 2019 was conducted using a linked administrative-cancer database in the Seattle-Puget Sound SEER area. Guideline-concordant testing (GCT) was assessed annually according to guideline updates. Frequency of testing according to patient/cancer characteristics was evaluated using chi-squared tests, and factors associated with receipt of genetic testing were identified using multivariable logistic regression. RESULTS: Testing occurred in 17% of HBOPP patients, increasing from 9% in 2013 to 21% in 2019 (p < 0.001). Ovarian cancer had the highest testing (40%) and prostate cancer the lowest (4%). Age < 50, female sex, non-Hispanic White race, commercial insurance, urban location, family history of HBOPP, and triple negative breast cancer (TNBC) were associated with increased testing (all p < 0.05). GCT increased from 38% in 2013 to 44% in 2019, and was highest for early age at breast cancer diagnosis, TNBC, male breast cancer, and breast cancer with family history of HBOPP (all > 70% in 2019), and lowest for metastatic prostate cancer (6%). CONCLUSIONS: The frequency of genetic testing for HBOPP cancer has increased over time. Though GCT is high for breast cancer, there are gaps in concordance among patients with other cancers. Increasing provider and patient education, genetic counseling, and insurance coverage for testing among HBOPP patients may improve guideline adherence.

NCCN Guidelines® Insights: Breast Cancer Screening and Diagnosis, Version 1.2023.

The NCCN Guidelines for Breast Cancer Screening and Diagnosis provide health care providers with a practical, consistent framework for screening and evaluating a spectrum of clinical presentations and breast lesions. The NCCN Breast Cancer Screening and Diagnosis Panel is composed of a multidisciplinary team of experts in the field, including representation from medical oncology, gynecologic oncology, surgical oncology, internal medicine, family practice, preventive medicine, pathology, diagnostic and interventional radiology, as well as patient advocacy. The NCCN Breast Cancer Screening and Diagnosis Panel meets at least annually to review emerging data and comments from reviewers within their institutions to guide updates to existing recommendations. These NCCN Guidelines Insights summarize the panel's decision-making and discussion surrounding the most recent updates to the guideline's screening recommendations.

Alcohol consumption, smoking, and invasive breast cancer risk after ductal carcinoma in situ.

PURPOSE: Alcohol is an established risk factor for invasive breast cancer, and women with a prior ductal carcinoma in situ diagnosis are at higher risk of invasive breast cancer than the general population. However, for women with a prior ductal carcinoma in situ diagnosis, few studies have evaluated the association between alcohol and smoking and risk of subsequent invasive breast cancer. METHODS: Utilizing a population-based case-control design nested among women diagnosed with a ductal carcinoma in situ between 1995 and 2013, we compared 243 cases diagnosed with a subsequent invasive breast cancer and 423 individually matched controls never diagnosed with a subsequent breast cancer. RESULTS: Compared with never to occasional drinkers, drinkers consuming at least 7 alcoholic drinks per week on average at ductal carcinoma in situ diagnosis had a higher risk of invasive breast cancer that was borderline significant (OR 1.79, 95% CI 1.01-3.17, P value = 0.04). Smoking was not significantly associated with risk of developing an invasive breast cancer after adjustment for alcohol consumption. CONCLUSIONS: These findings suggest that consuming at least one alcoholic drink per day on average is positively associated with invasive breast cancer for women with a prior ductal carcinoma in situ diagnosis. If confirmed, modulating alcohol consumption could be one strategy for women with a history of ductal carcinoma in situ to impact their risk of invasive breast cancer.

Association of HSD3B1 Genotype and Clinical Outcomes in Postmenopausal Estrogen-Receptor-Positive Breast Cancer.

BACKGROUND: Homozygous inheritance of a single-nucleotide polymorphism (1245A > C) in HSD3B1 results in an adrenal permissive phenotype of increased adrenal steroid precursor conversion to potent androgens. This is associated with poor outcomes in prostate cancer. We hypothesized that inheritance of the HSD3B1 adrenal permissive genotype would similarly negatively impact breast cancer outcomes. PATIENTS AND METHODS: Germline HSD3B1 was sequenced in 644 postmenopausal women diagnosed between 2004 and 2015 with stage I-III estrogen receptor-positive (ER+), HER2/neu-negative (HER2-) breast cancer enrolled in a population-based study in western Washington. Primary endpoint was distant metastatic recurrence according to genotype. Secondary endpoint was breast cancer-specific survival. Hazard ratios (HR) were calculated using cause-specific Cox regression accounting for competing risks. RESULTS: Adrenal restrictive genotype (homozygous wild type) was most prevalent (47%), followed by heterozygous (44%) and adrenal permissive (9%). There were no significant differences comparing demographic, tumor, or treatment characteristics apart from higher frequency of adrenal permissive genotype among non-Hispanic white participants (p = 0.04). After accounting for competing risks, the cumulative incidence of distant metastatic recurrence (15 events) was significantly higher among participants with adrenal permissive compared with the adrenal restrictive genotype (HR 4.9, 95% CI 1.32-18.4, p = 0.02). The adrenal permissive genotype was also predictive of breast cancer-specific mortality (HR 3.5, 95% CI 1.27-9.59, p = 0.02). CONCLUSIONS: Inheritance of the HSD3B1 adrenal permissive genotype is associated with increased incidence of distant metastasis and higher cause-specific mortality in postmenopausal ER+/HER2- breast cancer. Further research is necessary to understand the effect of excess adrenal androgen metabolism in promoting breast cancer growth and progression.

Risk of Lobular Neoplasia Upgrade with Synchronous Carcinoma.

BACKGROUND: Atypical lobular hyperplasia (ALH) and classic lobular carcinoma in situ encompass a spectrum of proliferative lesions known as lobular neoplasia (LN). When imaging-concordant and found in isolation on core needle biopsy (CNB), LN infrequently upgrades to carcinoma on surgical excision, and routine excision is not indicated. Upgrade rates in the setting of synchronous carcinoma are not well studied. PATIENTS AND METHODS: Patients with radiology-pathology concordant synchronous LN and separately biopsied ipsilateral (n = 35) or contralateral (n = 15) carcinoma who underwent excision between 2010 and 2021 were retrospectively identified. Frequency of upgrade, to either invasive or in situ carcinoma, was quantified, and factors associated with upgrade were assessed using Fisher's exact test. RESULTS: The median age was 55 (range 33-74) years. The upgrade rate of LN was 6% and not significantly different between ipsilateral (2.9%) and contralateral (13.3%) carcinoma (p = 0.15). All upgraded LN lesions were ALH on CNB and detected as non-mass enhancement on magnetic resonance imaging (MRI). No additional disease was demonstrated after excision at the site of the original LN CNB in 22.9% (8 out of 35) of ipsilateral and 13.3% (2 out of 15) of contralateral patients. Upgrade was not associated with family history, menopausal status, imaging modality used to detect LN, or extent of LN on CNB (p > 0.05). CONCLUSIONS: Our results demonstrate a low upgrade rate (6%) in our study cohort of LN with synchronous ipsilateral or contralateral carcinoma, which suggests that not all LN mandates excision with synchronous carcinoma. Larger, multi-institution studies are needed to validate these findings.

Is Sentinel Lymph Node Biopsy Required for a Core Biopsy Diagnosis of Ductal Carcinoma In Situ with Microinvasion?

BACKGROUND: Among patients with a core biopsy diagnosis of ductal carcinoma in situ (DCIS), approximately 10% have microinvasion (DCISM), which, like DCIS, is subject to upstaging by surgical excision, but for which the rates of T and N upstaging are unknown, as is the role of sentinel lymph node biopsy (SLNB), since current studies of SLNB for DCISM are based on the final pathologic report, not the core needle biopsy. In this study, we identified the rates of T and N upstaging following surgical excision in patients with a suspected versus definite core needle biopsy diagnosis of DCISM. METHODS: Overall, 369 consecutive patients (2007-2017) with a core biopsy diagnosis of suspected versus definite DCISM and surgical excision were stratified by extent of DCISM on core biopsy: suspicious focus, single focus, multiple foci/single biopsy, and multiple foci/multiple biopsies. Within strata, we identified clinicopathologic features associated with T and N upstaging. RESULTS: Across core biopsy strata, there were no clear differences in imaging characteristics or median invasive tumor size (0.2 cm). Among 105 patients with a core biopsy suspicious for DCISM versus 264 with definite DCISM, 28% and 37%, respectively, were upstaged to at least pT1a, but only 1% and 6%, respectively, to pN1. CONCLUSIONS: Although 28% of patients with suspected DCISM on core biopsy were surgically upstaged to invasive cancer, the frequency of pN1 SLN metastasis (1%) was comparable with that of DCIS, and was insufficient to recommend SLNB at initial surgery. SLNB remains reasonable for patients with definite DCISM on core biopsy.

Chemoprevention Uptake for Breast Cancer Risk Reduction Varies by Risk Factor.

BACKGROUND/OBJECTIVE: The efficacy of chemoprevention for breast cancer risk reduction has been demonstrated in randomized controlled trials; however, use remains low. We sought to determine whether uptake differed by risk factors, and to identify reasons for refusal and termination. METHODS: Women seen in a high-risk clinic from October 2014 to June 2017 considered eligible for chemoprevention (history of lobular carcinoma in situ, atypia, family history of breast/ovarian cancer, genetic mutation, or history of chest wall radiation) were retrospectively identified. Breast cancer risk factors were compared among those with and without chemoprevention use, and compliance was noted. RESULTS: Overall, 1506 women were identified, 24% with prior/current chemoprevention use. Women ≥ 50 years of age were more likely to use chemoprevention than women < 50 years of age (28% vs. 11%, p < 0.001). Chemoprevention use by risk factor ranged from 7 to 40%. Having multiple risk factors did not increase use. Significant variation by risk factor was present among women ≥ 50 years of age (p < 0.001), but not among women < 50 years of age (p = 0.1). Among women with a documented discussion regarding chemoprevention (575/1141), fear of adverse effects was the most common refusal reason (57/156; 36%). The majority of women (61%) who initiated chemoprevention completed 5 years. CONCLUSION: Chemoprevention use among women at increased risk for breast cancer remains low, with more frequent use among women ≥ 50 years of age. These data highlight the need for ongoing educational efforts and counseling, as the majority who begin therapy complete 5 years of use. Given the fear of adverse effects as well as low uptake, particularly among women < 50 years of age, alternative risk-reducing strategies are needed.

A Comparison of Patient-Reported Outcomes After Breast-Conserving Surgery and Mastectomy with Implant Breast Reconstruction.

BACKGROUND: Many factors influence decisions regarding choice of breast-conserving surgery (BCS) versus mastectomy with reconstruction for early invasive breast cancer. The purpose of this study was to compare patient satisfaction following BCS and mastectomy with implant reconstruction (M-iR) utilizing the BREAST-Q patient-reported outcome measure. METHODS: Women with stage I or II breast cancer undergoing BCS or M-iR who completed a BREAST-Q from 2010 to 2016 were identified by retrospective review of a prospective database. Baseline characteristics were compared, and linear mixed models were used to analyze associations with BREAST-Q scores over time. RESULTS: Our study group was composed of 3233 women; 2026 (63%) had BCS, 123 (3.8%) had nipple-sparing mastectomy, and 1084 (34%) had skin-sparing or total mastectomy. Median time from surgery to BREAST-Q was 205 days for BCS and 639 days for M-iR (p < 0.001). Regardless of type of surgery, breast satisfaction scores decreased significantly over time (p < 0.001), whereas psychosocial (p = 0.001) and sexual (p = 0.004) well-being scores increased significantly over time. BCS was associated with significantly higher scores over time compared with M-iR across all subscales (all p < 0.001). Radiation was significantly associated with decreased scores over time across all subscales (all p < 0.05). CONCLUSIONS: Breast satisfaction and quality-of-life scores were higher for BCS compared with M-iR in early-stage invasive breast cancer. These findings may help in counseling women who have a choice for surgical treatment. Breast satisfaction scores decreased over time in all women, highlighting the need for further evaluation with longer follow-up.

Adjuvant Endocrine Therapy in Patients with Ductal Carcinoma In Situ: A Population-Based Retrospective Analysis from 2005 to 2012 in the National Cancer Data Base.

BACKGROUND: Adjuvant endocrine therapy (AET) has been shown to reduce the risk of second breast cancer events in women with ductal carcinoma in situ (DCIS). There is no population-level evaluation of AET use in DCIS patients after standardized reporting of estrogen receptor (ER) status in cancer registries in 2004. METHODS: We conducted a retrospective cohort study of women with DCIS in the National Cancer Data Base between 2005 and 2012. Patient, tumor, and treatment characteristics as well as temporal trends associated with receipt of AET were evaluated by generalized linear regression. RESULTS: Among 206,255 DCIS patients, 36.5% received AET. Fewer than half of ER-positive patients (n = 62,146, 46.4%) received AET, with a modest but significant increase over time (43.6% in 2005 to 47.5% in 2012; unadjusted p trend <0.001). AET decreased among ER-negative patients (8.9-6.5%, p trend <0.001) over the same time period. On multivariate analysis, younger (<40 years) and older (≥70 years) women were less likely to receive AET than 50- to 59-year-old women (<40 years: relative risk 0.86, 95% confidence interval 0.82-0.89; ≥70 years: relative risk 0.79, 95% confidence interval 0.77-0.81). ER-positive status conferred a 6.15-fold higher likelihood of receiving AET compared to ER-negative status (95% confidence interval 5.81-6.50). Women who underwent breast-conserving surgery (BCS) with adjuvant radiotherapy were most likely to receive AET. CONCLUSIONS: Receipt of AET is relatively low in the group of women most likely to benefit from its use, namely ER-positive patients who underwent BCS. Significant variation exists with respect to patient, tumor, site, and treatment factors. More tolerable drugs or clearer guideline recommendations may increase use.