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Lay abstract This study included 308 patients with early-stage triple-negative breast cancer treated in the USA at community oncology practices. Patients were female, 18 years or older and diagnosed with stage II, IIIA or IIIB breast cancer between March 2008 and March 2016, and the breast cancer was determined to be triple negative (i.e., negative for estrogen receptors, progesterone receptors and excess HER2 protein). There were 236 patients who received neoadjuvant treatment without subsequent adjuvant treatment (the Neo group) and 72 patients who received neoadjuvant treatment followed by adjuvant treatment (the Neo + adj group). The study looked at healthcare resource use and costs of care during two time periods: from neoadjuvant treatment start date to surgery (Time 1) and after surgery to recurrence or death (Time 2). Average monthly healthcare resource use and average monthly costs of care per patient were higher in Time 1 compared with Time 2 for both groups. These results demonstrate the economic and resource burden of early-stage triple-negative breast cancer especially in the time from neoadjuvant treatment initiation until surgery.

Background: Recurrence is common among patients with early-stage triple-negative breast cancer (ESTNBC). There is minimal real-world evidence describing the patient characteristics and clinical outcomes following recurrence among patients receiving neoadjuvant chemotherapy for ESTNBC. Methods: This retrospective, observational study aimed to describe the demographic and clinical characteristics and clinical outcomes in ESTNBC patients experiencing locoregional recurrence in the US community oncology setting in the Concerto HealthAI Definitive Oncology Dataset. Eligibility criteria included female sex, age 18+ years, diagnosis of stage II, IIIA or IIIB ESTNBC between 3/2008 and 3/2016, and receipt of definitive surgical resection following neoadjuvant systemic therapy. Descriptive methods were used to evaluate patient characteristics and treatment patterns in this population. Locoregional recurrence was defined as recurrence in the same breast and/or regional nodal recurrence as documented by the provider in the medical record. Results: Of 308 patients who received neoadjuvant treatment for ESTNBC, 27.3% patients (n=84) observed recurrence, within which 25.0% (n=21) were locoregional and 75.0% (n=63) were metastatic. All 21 patients with locoregional recurrence were 65 or younger, with mean age of 50.6 (SD 8.7) at initial diagnosis. They were primarily White (47.6%, n=10) or African American (42.9%, n=9). Over half of patients were stage II at initial diagnosis (61.9%, n=13), while 38.1% (n=8) were stage III. The majority had ductal histology (90.5%, n=19) and had Grade 3 tumors (90.5%, n=19). Of the 21 patients with locoregional recurrence, less than one-tenth (9.5%, n=2) had achieved pathologic complete response (pCR) prior to their recurrence, compared to 41.2% (n=127) of the 308 patients receiving neoadjuvant treatment. In terms of treatment following locoregional recurrence, two-thirds of patients received radiation therapy (66.6%, n=14) with median duration of 47.5 days. Over half of patients (57.1%, n=12) had mastectomy following recurrence, while 14.3% (n=3) had partial mastectomy (breast conserving surgery). Most patients (85.7%, n=18) received systemic chemotherapy after recurrence. Median duration of systemic therapy following locoregional recurrence was 108 days. Nearly one-half (47.6%, n=10) had a subsequent metastatic diagnosis and nearly one-third (28.6%, n=6) had a record of death. Median time from locoregional recurrence to metastatic diagnosis was 36.6 months, but median time from locoregional recurrence to death was not reached. Conclusions: Among patients who received neoadjuvant therapy for ESTNBC in the real-world setting, nearly 7% (n=21) experienced locoregional recurrence. Nearly one-fourth of those patients had a prior pCR which potentially suggests a higher risk of recurrence associated with ESTNBC patients. Chemotherapy was the mainstay of treatment following recurrence. Most patients also received radiation therapy and surgery, but despite those nearly one-half of the patients went on to have a subsequent metastatic diagnosis. This probably reflects the limitations of existing treatment modalities for ESTNBC patients. Future studies with a bigger sample size could confirm our findings. Our study provides some benchmark perspective to such future studies. Citation Format: Amin Haiderali, Whitney C. Rhodes, Santosh Gautam, Min Huang, Jan Sieluk, Karen E. Skinner, Lee S. Schwartzberg. Locoregional recurrence in patients with early-stage triple-negative breast cancer receiving neoadjuvant systemic therapy: Patient characteristics and clinical outcomes [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 PS13-42.

Background: For patients with stage II-III early-stage triple-negative breast cancer (ESTNBC), either neoadjuvant or adjuvant administration of chemotherapy is recommended. There is limited evidence describing the real-world patient characteristics and treatment patterns among patients receiving neoadjuvant +/- adjuvant chemotherapy for ESTNBC. Methods: We conducted a retrospective observational study to describe the demographic and clinical characteristics and treatment patterns in ESTNBC patients in the US community oncology setting. Eligibility criteria included female sex, age 18+, diagnosis of stage II, IIIA or IIIB ESTNBC between 3/2008 and 3/2016, receipt of definitive surgical resection, and neoadjuvant systemic therapy with or without adjuvant systemic therapy. Descriptive methods were used to compare demographic and clinical characteristics and treatment patterns among patients who received neoadjuvant systemic therapy only (Neo) versus patients who received neoadjuvant plus adjuvant systemic therapy (Neo+Adj). Results: 308 patients were eligible for the study. There were 236 patients (76.6%) who received Neo, while 72 (23.4%) received Neo+Adj. Mean age was 52.1 (SD 11.3), with 86.4% (n=266) of patients 65 or younger. Patients were predominantly White (56.8%, n=175) followed by African American (35.7%, n=110). Demographic characteristics did not differ by treatment group. The majority of patients were stage II at initial diagnosis (66.6%, n=205) and had ductal histology (93.5%, n=288). Over half of all patients (55.8%, n=172) had mastectomy; 44.2% (n=136) had breast conservation surgery. The majority of patients (79.5%, n=245) had no comorbid conditions and most (82.8%, n=255) had grade 3 tumors. Overall, 42.2% were peri/postmenopausal (n=130) at diagnosis. Distribution of stage at diagnosis was significantly different between groups (p=0.013). The pattern of findings suggests that the Neo group had earlier stage disease. Over one-third of patients with Neo were stage IIA at diagnosis (36.0%, n=85). Nearly one-fifth of patients with Neo+Adj were stage IIIB at diagnosis (19.4%, n=14), compared to 8.5% of patients receiving Neo (n=20). A significant difference in surgery type by treatment group was observed (p=0.035). Patients with Neo had a lower rate of mastectomy (52.5%, n=124) compared to Neo+Adj (66.7%, n=48), likely as a result of earlier stage disease at presentation. Among the Neo group, the most common neoadjuvant regimen was cyclophosphamide, doxorubicin and paclitaxel (59.3%, n=140), followed by cyclophosphamide, doxorubicin and docetaxel (14.4%, n=34). Most (85.2%, n=201) patients receiving Neo received one regimen in the neoadjuvant setting, while 13.1% (n=31) received two regimens. Among the Neo+Adj group, the most common neoadjuvant regimens were cyclophosphamide, doxorubicin and paclitaxel (38.9%, n=28) and cyclophosphamide with doxorubicin (23.6%, n=17), while the most common adjuvant regimens were paclitaxel (22.2%, n=16) and capecitabine (12.5%, n=9). Most (70.8%) patients receiving Neo+Adj received one neoadjuvant regimen followed by a different adjuvant regimen. Conclusions: In this sample of real-world patients with ESTNBC, the majority of patients were diagnosed with stage II disease, with limited or no comorbidities. This evaluation of treatment patterns confirmed that real-world treatment is limited to chemotherapy, which is consistent with the NCCN guidelines. Citation Format: Whitney C Rhodes, Santosh Gautam, Amin Haiderali, Min Huang, Jan Sieluk, Karen E Skinner, Lee S Schwartzberg. Patient characteristics and real-world treatment patterns in patients with early-stage triple-negative breast cancer receiving neoadjuvant chemotherapy [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 P2-16-33.

Background: Standard of care treatment for early-stage triple-negative breast cancer (ESTNBC) is chemotherapy. Minimal research has examined real-world effectiveness outcomes in patients with ESTNBC. Methods: This retrospective observational study evaluated event-free survival (EFS) and overall survival (OS) in patients with ESTNBC from US community oncology practices. Eligible patients were female and age 18+ at the time of stage II, IIIA or IIIB ESTNBC diagnosis that occurred between 3/2008 and 3/2016. All eligible patients received definitive surgery following neoadjuvant systemic therapy, with or without adjuvant systemic therapy. Kaplan-Meier analysis and Cox regression models were used to evaluate EFS and OS from the start of neoadjuvant therapy. EFS events are recurrence, second primary malignancy or death, whichever occurred first. Results: Of 308 patients included in the study, 236 (76.6%) received neoadjuvant only (Neo); 72 (23.4%) received neoadjuvant plus adjuvant systemic therapy (Neo+Adj). Overall, mean age was 52.1 years (SD 11.3), 56.8% were White (n=175), 35.7% African-American (n=110), 7.4% other/undocumented (n=23). Demographic characteristics did not differ between treatment groups. Two-thirds of patients (66.6%, n=205) were stage II at diagnosis, 33.4% (n=103) were stage IIIA or IIIB at diagnosis (22.4% and 11.0%, respectively). Most (82.8%, n=255) had grade 3 tumors and 42.2% were peri/postmenopausal (n=130) at diagnosis. Evidence of pathologic complete response (pCR) was observed in 41.2% of patients (n=127), while 57.5% of patients (n=177) had residual disease, and 1.3% (n=4) had undocumented/other response status. pCR was observed in 47.5% of Neo and 20.8% of Neo+Adj patients. Median EFS for all patients was not reached while mean EFS was 55.6 months (SD 1.6). Stage at diagnosis, surgery type and BMI were significant predictors of an EFS event, with stage II patients having less risk than stage III patients (Hazard ratio [HR]: 0.496 p Median OS for all patients was not reached while mean OS was 70.3 months (SD 1.5). Stage at diagnosis, surgery type and BMI were significant predictors of OS; patients with stage II had a reduced risk of death compared to stage III patients (HR: 0.299, p Conclusions: This real-world study found that stage at diagnosis, surgery type and BMI were significant predictors of EFS and OS events from the start of neoadjuvant treatment. This study highlights the need for improved therapies to extend EFS and OS for patients with ESTNBC. Given the association between pCR and EFS and OS, further analyses will evaluate EFS and OS by pCR status for each group. Time to recurrence analyses are also planned. Citation Format: Whitney C Rhodes, Santosh Gautam, Amin Haiderali, Min Huang, Jan Sieluk, Karen E Skinner, Lee S Schwartzberg. Real-world outcomes in patients receiving neoadjuvant chemotherapy for early-stage triple-negative breast cancer [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 P2-16-12.

Lay abstract This study included 450 patients with early-stage triple-negative breast cancer treated in the USA at community oncology practices. Patients were female, 18 years or older, diagnosed with stage II, IIIA or IIIB breast cancer between March 2008 and March 2016, and the breast cancer was determined to be triple negative (i.e., negative for estrogen receptors, progesterone receptors and excess HER2 protein). The study looked at the treatments received, whether those treatments worked and the response to treatment at the time of surgery. The study findings align with findings from other studies that complete response in tissue samples is associated with improved clinical outcomes. Triple-negative breast cancer remains challenging to treat, and there is a clear need for innovation in treatment options. Intervening in the early stages of triple-negative breast cancer is critical to improving outcomes.

Aim: To examine real-world treatment patterns and outcomes in neoadjuvant and adjuvant settings for early-stage triple-negative breast cancer (TNBC). Patients & methods: Using the Surveillance, Epidemiology, and End Results-Medicare database, we identified patients (≥65 years) with newly diagnosed stage II/III TNBC in 2010–2015 who had surgery plus neoadjuvant and/or adjuvant (systemic and/or radiation) therapy. Treatment, survival, healthcare resource use and costs were assessed through 2016. Results: Of 1569 patients (>99% women), 6%/74%/20% received neoadjuvant-only/adjuvant-only/both (neo + adj) therapies, respectively. Median overall survival was 23 months/not reached (NR)/78 months, with longer survival at stage II (NR/NR/78 months) than stage III (22/43/38 months). Mean per patient per month costs were $10,620 and $17,872 in neoadjuvant and adjuvant periods. Conclusion: These findings provide insights into clinical and economic outcomes for early-stage TNBC in 2010–2016.

Purpose Regulators approve written medical information for healthcare professionals and consumers, but the consistency of these sources has not been studied. We investigated the consistency of information regarding four cardiovascular risks of attention-deficit/hyperactivity disorder (ADHD) medications approved in four countries. Methods Professional and consumer product labeling for five ADHD medications approved in Australia, Canada, the UK, and the USA were obtained in March/April 2016. Language describing the relationship between medication and elevated blood pressure and/or heart rate, myocardial infarction, stroke, and sudden death was extracted verbatim and classified into one of four categories based on the described relationship between medication and adverse event: “confirmed,” “unconfirmed,” “mixed,” and “not mentioned.” We judged the consistency of messages delivered to healthcare professionals and consumers as either “consistent” or “inconsistent.” Results We obtained 20 healthcare professional labels and 20 corresponding consumer labels for the five ADHD medications registered in all four countries. Not all professional and consumer labeling contained language regarding all four adverse events. Of the 80 theoretically evaluable drug-risk pairs, 38 (48%) were not evaluable because of absence of mention of the adverse event in the consumer label. For the remaining 42, the potential causal relationship was expressed consistently in professional and consumer labeling in 25 (60%) cases. The cardiovascular risk profile was not described consistently across all four countries for any of the five drugs. Conclusions Product labeling provides healthcare professionals and consumers with inconsistent messages regarding the potential causal relationship between stimulant use and specific cardiovascular risks in children and adolescents. Copyright © 2017 John Wiley & Sons, Ltd.

Introduction Management of high-risk non-muscle invasive bladder cancer (NMIBC) represents a clinical challenge due to high failure rates despite prior bacillus Calmette-Guerin (BCG) therapy. We describe real-world patient characteristics, long-term outcomes, as well as the economic burden in a high-risk NMIBC population. Methods We retrospectively identified a random sample of 412 high-risk NMIBC patients who received ≥ 1 dose of BCG within Veterans Affairs (VA) centers from Jan 1, 2000, to Dec 31, 2016. HR NMIBC was defined as high-grade Ta (TaHG), T1, and/or carcinoma-in-situ (CIS). Adequate BCG induction included at least 5 of 6 instillations, and adequate BCG therapy was at least 7 instillations. We used the Kaplan-Meier method to estimate outcomes including event-free survival. All-cause expenditures were summarized as medians with corresponding interquartile ranges (IQR) and adjusted to 2019 USD. Results The total follow-up was 2,694 person-years. At high-risk NMIBC diagnosis, 69 (17%) patients had CIS +/- T1 or TaHG, and 341 (83%) had TaHG or T1, no CIS. A total of 392 (95%) patients received adequate BCG induction and 152 (37%) patients received adequate BCG therapy. Recurrence and progression were observed in 61 (32%) and 71 (17%) patients, respectively. There were 166 deaths during follow-up, of which 27 (7%) patients died from bladder cancer. Total median costs at 1, 2 and 5-year were $29,459 ($14,991-$52,060), $55,267 ($28,667-$99,846), and $117,361 ($59,680-$211,298), respectively. Patients which progressed had significantly higher costs (5-yr, $232,729 vs. $94,879, p Conclusions In an equal access setting, the vast majority of BCG-treated patients with high-risk NMIBC received adequate BCG induction; however, less than 50% of patients received adequate maintenance therapy. Patients with CIS had increased risk of progression which was associated with significantly increased costs up to 5-yrs after diagnosis. These findings associated with $366,857 per patient that underwent subsequent radical cystectomy further highlight the considerable economic burden of managing BCG treated high-risk NMIBC.