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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.

Background: Treatment (Tx) options for METex14 NSCLC have been limited to chemotherapy (Ctx), immunotherapy (IO), and multikinase inhibitors (MKi) until FDA approvals of selective MET inhibitors (METi) from 2020. BM are a further challenge to treat. We previously reported NGS timing in relation to start of first-line Tx (1L) for pts with METex14 NSCLC in the RW. Here we provide overall survival (OS) data, including subgroup analyses for pts with known BM prior to 1L initiation. Methods: Data originating from ~280 US cancer clinics (~800 sites of care) from the US electronic health record-derived de-identified Flatiron Health Foundation Medicine clinico-genomic database (FH-FMI CGDB) were evaluated. Pts were ≥18 yrs, diagnosed with advanced/metastatic NSCLC from Jan 1, 2011, with NGS-confirmed METex14, ≥1 line of Tx, and ≥90 days follow-up from 1L initiation to cutoff date (Dec 2020). Pts treated with capmatinib or tepotinib were excluded. We examined Tx patterns and OS for pts with and without known BM before starting 1L, and OS for pts with an NGS report before or on/after 1L initiation (time from 1L initiation to death or censoring, analyzed using Kaplan-Meier method with left truncation adjustment to mitigate bias due to the prerequisite for NGS testing). HRs were estimated using Cox regression models with covariates adjustment to estimate risk of death. Results: The analysis included 156 METex14 NSCLC pts: median age 75 yrs, 59% females, 85.3% non-squamous (NSQ), 9% squamous cell carcinoma (SQ), and 64% had history of smoking. A total of 31 pts (20%) had BM before 1L initiation: median age 73 yrs, 61% females, 94% NSQ, 0% SQ, and 71% had history of smoking. Overall, treatment patterns were similar for pts with and without known BM before 1L initiation (Ctx with or without IO, IO monotherapy, and MKi were all used in 1L). Median OS for pts with BM was 8.11 mo (95% CI, 6.0-19.8) and 14.39 mo (11.1-22.1) for pts without BM, corresponding to a 73% increase in risk of death for pts with BM vs pts without BM by univariate analysis (HR 1.73 [95% CI, 1.06-2.82]; P=0.03). Median OS for pts with an NGS report before and on/after 1L initiation was 13.3 mo (8.8-26.2) and 6.8 mo (0.03-19.8), respectively (P=0.45); HR by multivariate analysis was 0.78 (0.45-1.35) when comparing pts with NGS report before vs on/after 1L initiation. Conclusions: Tx patterns in 1L were similar for pts with or without BM at time of 1L initiation; presence of BM prior to 1L was associated with inferior outcomes. Numerically longer OS was observed in pts with NGS report prior to 1L initiation vs pts with NGS report on/after 1L, supporting further investigation of underlying causes. These data underline the ongoing unmet clinical need of METex14 NSCLC BM and the importance of investigating upfront comprehensive genomic testing in NSCLC. Citation Format: Xiuning Le, Stephen Robb, Nydia Caro, Simona Doria, Whitney C. Rhodes, Wen-Hsing Wu, Julia Kim, Vincent Prêtre, Fen Ye. Brain metastases (BM) and next-generation sequencing (NGS) timing: Real-world (RW) outcomes for patients (pts) with advanced non-small cell lung cancer (aNSCLC) and MET exon 14 skipping mutations (METex14) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 4118.