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Introduction:Payers are implementing reimbursement restrictions for non-guideline based care. Limited information exists regarding real-world concordance with guidelines for metastatic breast cancer (MBC) treatment. Further, the impact of non-concordance on mortality is unknown. We address these gaps by using the Surveillance, Epidemiology, and End Results (SEER) Program-linked Medicare database to evaluate national concordance with NCCN guidelines and the association between concordance and mortality. Methods: From 2007 to 2013, women with de novo (n=988) or recurrent metastatic breast cancer (n=5651) were evaluated for concordance of first-line systemic therapy (hormonal therapy, chemotherapy, and Her2-targeted therapy) with NCCN guidelines. Concordance was defined as receipt of single agent or combination treatments listed on NCCN guidelines. Non-concordant treatments were grouped into 5 categories: single-agent HER2-targeted therapy (33%), adjuvant regimens used in the metastatic setting (12%), therapy mismatched with ER/HER2 status (12%), non-approved bevacizumab regimens (10%), and other miscellaneous reasons (33%). Multivariable logistic regression was used to identify predictors of non-concordance. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated using Cox regression to compare all-cause mortality associated with non-concordant vs. concordant treatment adjusted for receptor status, comorbidities, age, race, poverty level, entitlement reason, and treatment year. Results: Mean age at MBC diagnosis was 69y; 77% were white. Median follow-up was 1.2 years. The prevalence of non-concordant first-line systemic therapy was 19% for de novo MBC and 18% for recurrent MBC. Younger age, hormone-receptor negative status, and Her2-positive status were associated with non-concordant treatments for Stage IV and recurrent MBC patients (p<0.001). Higher poverty by census tract was associated with non-concordance in recurrent MBC (p<0.05). The most frequent category of non-concordant treatment in de novo MBC was use of adjuvant regimens in Stage IV MBC (43%) and use of single-agent HER2-targeted therapy (31%) in recurrent MBCs. Adjusted overall survival was similar for patients with de novo MBC receiving concordant and non-concordant treatments (HR 0.88, CI 0.72-1.65). Mortality was modestly increased for patients with recurrent MBC receiving non-concordant care (HR 1.12, CI 1.02-1.22); however, substantial differences were noted by category of non-concordance. Compared to concordant treatment, single-agent HER2-targeted therapy was associated with decreased risk of mortality (HR 0.78, CI 0.68-0.91). Increased mortality was observed for non-approved bevacizumab use (HR 1.79, CI 1.44-2.22) and other miscellaneous regimens (HR 1.42, CI 1.26-1.60). Mortality for therapy mismatched with ER/HER2 status was similar to concordant treatment (HR 1.13, CI 0.88-1.44). Conclusions: In the first-line setting, treatment inconsistent with NCCN guidelines remains common (18%). Overall mortality was not substantially higher among non-concordant patients. However, mortality risk varied (in both directions) by category of non-concordance. These findings may provide an opportunity for considering refinement of NCCN guidelines. Citation Format: Rocque GB, Williams CP, Jackson BE, Halilova KI, Pisu M, Andres F, Smita B. Concordance with National comprehensive cancer network (NCCN) metastatic breast cancer guidelines and impact on overall survival [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-07-02.

Background: With rapid advances in research clinicians often struggle to remain current on evolving care guidelines as well as current National Quality Standards (NQS) relevant to breast cancer management. Adherence to NQS now drives much reimbursement for cancer center services but clinical workflow processes and IT solutions are often not in place to effectively document adherence. The On Q Care Planning SystemTM (CPS), an evidence-based patient assessment and care planning software, has been designed to close gaps in quality cancer care and facilitate data collection to help centers both better understand and document their adherence rates to quality care standards. Methods: This multi-site study will enroll approximately 150 non-metastatic breast cancer patients, presenting for no greater than their second medical oncology visit, across five cancer centers. Patients must be planned for but not yet receiving chemotherapy treatment. A between subject design using 150 matched historical controls will be used to assess the impact of the 2-part intervention, at both the patient and provider level, on select quality metrics. At two consecutive clinical visits, patients will engage with the On Q CPS to assess family and medical history and current symptoms and receive two separate care plans. Care plans include (when applicable) recommendations for symptom management and appropriate referrals (i.e. genetic counseling for those at increased hereditary risk, and/or reproductive endocrinology for those interested in preserving fertility). To augment the effectiveness of the On Q CPS, providers will also participate in certified continuing medical education activities designed to educate about evidence-based assessment, decision-making, and management strategies for breast cancer patients. The primary aim is to evaluate provider adherence to select quality metrics among recently diagnosed breast cancer patients following the intervention, and compare to adherence rates for historical controls from the pre-intervention period. Metrics of primary interest include distress screening and management, complete family history assessment, genetic counseling referral, discussion of infertility risk, and discussion of fertility preservation options and/or referral to a specialist. These metrics have been chosen as the primary endpoints given that they have been historically documented as being resistant to change. Outcomes will be assessed by chart abstraction using a score card method of select quality metrics for both enrolled patients and matched historical controls. Analysis/Results: Patient enrollment begins in June 2015 and thus data will be presented at time of symposium. Patient characteristics and primary outcomes will be analyzed using a multi-step approach to first describe and then compare, at the individual patient level, provider adherence to the select quality metrics evaluated in this study. Descriptive statistics will also be estimated within a mixed model approach for the rate with which each single metric was achieved across patients. Conclusions: The On Q CPS, a care planning software tool, has the potential to both improve provider adherence to NQS and allow institutions an easy and accessible way to document that adherence. Citation Format: Hathaway A, Halilova K, Gaguski ME, Thomas K, Dudley WN, Stricker CT, Hammelef KJ, Panzer SL, Rocque GB. Improving provider adherence to breast cancer care quality metrics: Use of a novel care planning tool. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P1-10-16.

Background: Survival with metastatic breast cancer (MBC) is highly variable and only ˜16% survive 10 years from the primary cancer diagnosis. In addition to treatments, proposed contributors to increased survival include cancer subtype, distribution of metastases, diet, exercise, and use of complementary and alternative medicine (CAM). We aimed to characterize long-term survivors with MBC through a self-administered survey. Methods: Patient advocates and researchers collaborated on developing and administering an ongoing web-based questionnaire (outliers.cancer.wisc.edu). Participants were recruited to this IRB-approved project through fliers, social media, MBC conferences, and Susan Love's Army of Women, with a recruiting focus on long-term survivors. Women and men are eligible if they are age ≥18 years old and have MBC by self-report. Eligible participants were invited to complete a detailed 28-part survey in English. Preliminary analysis was conducted by descriptive comparison of survivors ≥ 10 years from primary diagnosis versus those < 10 years. Results: Between March 6 and June 17, 2018, a total of 475 women and 1 man self-reported as living with MBC consented and completed the survey. Participants represented 48 U.S. states (n=414), and other countries on 4 continents (n=54). Two thirds of respondents (315) reported using medical records in preparing responses. Age of respondents ranged from 32-83 years (median 55), and participants survived from 4 months to 50 years (median 8.7), from primary breast cancer diagnosis. A total of 206 had lived ≥10 y from primary diagnosis and 270 <10 y (Table). Characteristics of long-term survivors and non-long term survivors with MBC Survival from primary diagnosis Survival from primary diagnosisFactor≥10 y<10 yFactor≥10 y<10 yAge, mean6052Bone metastasis only*36%40%Stage 411%47%BMI, mean27.428.5HR+HER2-66%65%Alcohol >2 drinks/wk26%20%HR-HER2+6%9%Smoking history36%33%HR+HER2+24%22%Sedentary23%21%Triple negative4%4%CAM use20%20%Oligometastatic (1-3)*53%50%Sleep hours/d, mean7.77.6*Number/site of tumors at time of metastatic presentation As expected, longer-term survivors were older and were less likely to have been diagnosed at stage 4. Surprisingly, there were no major differences in prevalence of breast cancer subtypes, though triple-negative breast cancer was rare in both groups. Long-term survivors reported modestly more alcohol intake and lower BMI. The two groups were well matched for oligometastatic and bone-only disease, which have been previously associated with longer survival. Additionally, there were similar rates of prior smoking, CAM use, and sedentary behavior. Conclusion: Interim analysis of this ongoing survey of MBC survivors finds that many disease and behavioral characteristics are similar between long-term versus short term survivors. Additional factors such as treatments, diet, and supplements will reported. Other possible factors, including tumor genetics, treatments and immunologic factors will be evaluated separately. Citation Format: Burkard ME, Lemmon K, Gilbert AD, Zhang X, Trentham-Dietz A, Dahl E, Rocque G. Characteristics of long-term survivors with metastatic breast cancer [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P1-08-15.