US Community Oncology Setting Research Articles

Abstract PO2-17-06: Real world treatment patterns and clinical outcomes by germline BRCA (gBRCA) mutation status in patients with HER2-negative early breast cancer in the US community oncology setting: a retrospective observational chart-review study

Abstract Background: Women with early-stage breast cancer (eBC) who have inherited BRCA1 or BRCA2 mutations (gBRCAm) are typically diagnosed at a younger age and often require more intensive treatment. In the randomized, double-blind OlympiA trial of HER2-negative (HER2–) gBRCAm patients, olaparib, a targeted poly (ADP-ribose) polymerase inhibitor (PARPi), significantly improved invasive disease free survival (IDFS), distant disease free survival (DDFS) and overall survival (OS) and was subsequently approved for adjuvant treatment of gBRCAm HER2– high-risk eBC patients. This study examined the real-world patient characteristics, treatment patterns and clinical outcomes by gBRCA status among patients with HER2– eBC in a US community oncology setting prior to olaparib US approval for treatment of eBC. Methods: This retrospective observational study used chart review data from The US Oncology Network's iKnowMed database to examine adult patients diagnosed with HER2– eBC (stage I-III) initiating systemic neoadjuvant or adjuvant therapy with chemotherapy and/or endocrine therapy between January 1, 2012 and December 31, 2018. Patients with valid gBRCAm test results (all gBRCAm and randomly selected BRCAwt patients) were included and followed through December 31, 2021. Patients were excluded if they had HER2+ tumors and progressed to stage IV within 6 months after initiation of neoadjuvant therapy or were diagnosed with another primary cancer. Descriptive analyses assessed patient characteristics. Kaplan Meier methods and multivariate Cox proportional hazard models (CPHM) were used to evaluate IDFS, DDFS and OS by gBRCA status and by HR+/HER2– or TNBC eBC subsets. Results: Among 298 BC patients meeting initial criteria, 42% had gBRCAm (n=124, 43% hormone receptor positive [HR+], 56% triple-negative BC [TNBC], 1% unknown), and 58% had gBRCAwt (n=174, 74% HR+, 22% TNBC). Median (interquartile) age at surgery was numerically lower in gBRCAm (45 [36,55] years) than gBRCAwt (48 [41,55] years) patients. A numerically higher proportion of gBRCAm patients received neoadjuvant therapy compared with gBRCAwt (Neoadj: gBRCAm 37.1% vs gBRCAwt 12.6%) but the reverse was true for adjuvant (Adj: gBRCAm 42.7% vs gBRCAwt 65.5%) and neoadjuvant + adjuvant use was numerically similar (Neoadj+Adj: gBRCAm 20.1% vs gBRCAwt 21.8%). The majority of TNBC patients received neoadjuvant therapy while the majority of HR+ patients received adjuvant therapy (Neoadj: TNBC 51.4% vs HR+ 6.6%, Adj: TNBC 29.0% vs HR+ 71.4%, Neoadj+Adj: TNBC 19.6% vs HR+ 22.0%). Median IDFS, DDFS, and OS in both study cohorts were not reached. Median follow-up from surgery was < 5 years (overall 59.0 months; gBRCAm 50.6 months; gBRCAwt 61.3 months). At 60 months, in gBRCAm and gBRCAwt respectively, estimated IDFS were 85.5% and 90.9%, estimated DDFS 88.1% and 92.2%, and estimated survival 91.9% and 95.2%. At 60 months, in HR+/HER2– and TNBC respectively, estimated IDFS were 92.4% and 81.2%, estimated DDFS 93.9% and 85.7%, and estimated survival 96.3% and 90.9%. CPHM results showed that risks of invasive disease (HR 1.74; 95% CI 0.83-3.64; p=0.15), distant disease (HR 1.24; 95% CI 0.50-3.07; p=0.65) and death (HR 1.79; 95% CI 0.52-6.13; p=0.353) were similar between gBRCAm and gBRCAwt patients. Between HR+/HER2– and TNBC patients, risks of invasive disease (HR=0.63; 95% CI 0.21-1.89; p=0.41), distant disease (HR=0.42; 95% CI 0.11-1.67; p=0.22) and death (HR 0.48; 95% CI 0.09-2.70; p=0.41) were similar. Conclusions: This real-world chart review study of data through 2021 (before PARPi approval for eBC) with limited follow up of 5 years found that gBRCAm patients had a numerically shorter survival (IDFS, DDFS and OS) than gBRCAwt, but this difference was not statistically significantly different. Given that the follow-up period was too short to draw conclusions, further studies examining clinical outcomes over a longer follow-up period after approval of PARPi may be of interest. Citation Format: Jay Andersen, Jagadeswara Earla, Nicole Fulcher, Juliet Ndukum, Nicholas J Robert, Mark Robson, Weiyan Li, Jaime Mejia. Real world treatment patterns and clinical outcomes by germline BRCA (gBRCA) mutation status in patients with HER2-negative early breast cancer in the US community oncology setting: a retrospective observational chart-review study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-17-06.

Abstract PO3-03-10: Race and neoadjuvant treatment of triple negative breast cancer (TNBC) in the US community oncology setting

Abstract Background: TNBC is an aggressive subtype of breast cancer with limited targeted therapies. Black women have twice the incidence of TNBC compared to White women and within TNBC, Black women have worse outcomes than White women. Differences in both tumor biology of TNBC and social determinants of health (SDOH) play a role in observed disparities. The focus of this study is to evaluate SDOH factors associated to differences in the use of neoadjuvant chemotherapy (NC) in Black and White women in the US community oncology setting. Methods: This study was a retrospective, observational, cross-sectional design and used iKnowMed SM EHR data from the The US Oncology Network. Patients diagnosed with TNBC between 03/31/2017 and 09/30/2021 with stages II-III disease of tumor size ≥ 2cm (T2 or higher) were included. The index date was date of TNBC diagnosis and records were assessed from 6 months pre- to 6 months post-diagnosis for NC initiation. Univariable and multivariable logistic regression was conducted to evaluate impact of self-reported race on NC. Age, stage, BMI, insurance, area deprivation index (ADI), size of practice represented by physician count and geographical region, were studied in their mediating and moderating effects1 on the relationship between race and NC treatment. Results: Of the 3321 patients with TNBC identified in this study, 1969 self-reported white and 494 self-reported black (80% and 20% respectively). In multivariable regression accounting for all variables, Black race (OR = 1.57, 95% CI [ 1.02, 2.44], p=0.04), younger age, more advanced stage, obesity, non-Medicaid insurance, and West region, were all found to be positively associated with use of NC. Higher physician count was nominally associated, (p = 0.07). ADI was not found to be associated to NC. Mediator and moderator analysis for the relationship between race and NC showed that only stage and ADI variable inclusion in the model are required for the positive association between black race and NC. This is driven by a significant interaction between ADI and stage (p = 0.027) which differed for Black and White women. Mainly, for Black women ADI is positively associated to NC treatment in stage IIA, but negatively associated in all other stages (interaction term, p = 0.033). For White women, ADI is negatively associated to NC treatment in all stages. Only Black women with stage IIA tend to be treated more instead of less with NC in areas of greater deprivation (greater ADI). BMI presents nominal interactions with both race and stage, where obesity was more strongly associated with NC treatment in Black women (p = 0.088) and in stage IIA (p = 0.086). All other variables presented association to NC treatment without mediation or moderation of the race effect and without detectable differences across stages. Conclusions: Black women with stage IIA appear to be a special subgroup of TNBC patients for whom treatment with NC increases with ADI. Increased ADI generally results in less standard of care treatment; this is observed in this study for White women overall and for Black women in stages > IIA. Black women in areas of greater deprivation with stage IIA disease, may be perceived to be presenting with more aggressive disease and thus offered NC preferentially. This result lends support to the hypothesis that young black women present with a distinct, more aggressive subtype of TNBC in the early stages. Mediator and moderator analyses are important tools in elucidating the relationships between factors underlying racial disparities in both care and outcomes. 1. Hayes AF, Rockwood NJ. Regression-based statistical mediation and moderation analysis in clinical research: Observations, recommendations, and implementation. Behav Res Ther. 2017 Nov;98:39-57. Odds ratios for multivariable analysis –insert figure image– Race, stage and ADI –insert figure image– Race and BMI in stage IIA –insert figure image– Citation Format: Paola Raska, Joseph Dye, Nicholas J Robert, Angel Kidd, Michael Danso. Race and neoadjuvant treatment of triple negative breast cancer (TNBC) in the US community oncology setting [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-03-10.

Frontline pembrolizumab monotherapy for metastatic non-small cell lung cancer with PD-L1 expression ≥50%: real-world outcomes in a US community oncology setting.

This study investigated real-world time on treatment (rwToT) and overall survival (OS) for patients with metastatic non-small cell lung cancer (mNSCLC) who initiated first-line (1L) pembrolizumab monotherapy. We also explored discontinuation reasons and subsequent treatments, stratified by number of cycles among those who completed ≥17 cycles of 1L pembrolizumab. Patients with mNSCLC without actionable genetic aberrations, Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2 and unknown, and PD-L1 TPS ≥ 50% starting 1L pembrolizumab monotherapy between 24-Oct-2016 and 31-Dec-2018 within The US Oncology Network were identified retrospectively and evaluated using structured data, with a data cutoff of 30-Sep-2021. Patient characteristics and disposition were summarized using descriptive statistics. OS and rwToT were evaluated using Kaplan-Meier method for all ECOG PS and PS 0-1. A subgroup of patients who completed ≥17 cycles were evaluated using supplemental chart review data to discern reasons for discontinuation. Of the 505 patients with mNSCLC with PD-L1 TPS ≥50%, 61% had ECOG PS 0-1, 23% had ECOG PS 2, and 65% had nonsquamous histology. Median rwToT and OS of pembrolizumab were 7.0 (95% CI, 6.0-8.4) months and 24.5 (95% CI, 20.1-29.3) months, respectively. In the subgroup with ECOG PS 0-1, they were 7.6 months (95% CI, 6.2-9.2) and 28.8 months (95% CI, 22.4-37.5), respectively. Of the 103 patients who completed ≥17 cycles, 57 (55.3%) patients received 17 - 34 cycles and 46 (44.7%) patients received ≥35 cycles. Approximately 7.7% of the study population received pembrolizumab beyond 35 cycles. Most common reasons for discontinuation were disease progression (38.6%) and toxicity (19.3%) among patients who received 17-34 cycles of pembrolizumab, and disease progression (13.0%) and completion of therapy (10.9%) among patients who received ≥35 cycles. Consistent with findings from KEYNOTE-024 and other real-world studies, this study demonstrates the long-term effectiveness of pembrolizumab monotherapy as 1L treatment for mNSCLC with PD-L1 TPS ≥50%. Among patients who completed ≥17 cycles, nearly half completed ≥35 cycles. Disease progression and toxicity were the most common reasons for discontinuation among patients who received 17-34 cycles of pembrolizumab. Reasons for discontinuation beyond 35 cycles need further exploration.

95P Understanding the real-world (RW) impact of time between treatment regimens on clinical outcomes in patients with metastatic NSCLC previously treated with immunotherapy (IO) in the US community oncology setting

95P Understanding the real-world (RW) impact of time between treatment regimens on clinical outcomes in patients with metastatic NSCLC previously treated with immunotherapy (IO) in the US community oncology setting

Health care services utilization in patients with ovarian cancer receiving PARP inhibitor maintenance treatment in a US community oncology setting

ObjectivesThe objective of this study was to describe healthcare resource use (HCRU) in addition to treatment patterns and discontinuations, in patients with ovarian cancer (OC) initiating PARP inhibitor (PARPi) maintenance treatment in a US community oncology setting. MethodsThis was a retrospective study of patients with OC initiating PARPi monotherapy maintenance during 01/01/2017 to 06/30/2019 (followed until 12/31/2019). Patients aged ≥18 years at first diagnosis of OC with ≥2 visits within The US Oncology Network were included. Structured and chart review data as well as claims data were used to describe treatment patterns and HCRU. ResultsOf the 162 charts reviewed, the median age of patients was 66 years and 80% had stage III or IV disease at diagnosis. In the niraparib, rucaparib and olaparib groups, proportions of patients experiencing dose interruptions were 51%, 50%, and 28%, and discontinuations due to toxicity were 37%, 17% and 15%, respectively. Within the first 6 months, mean numbers of total claims were 43.5, 56.4, and 36.0 in the niraparib, rucaparib, and olaparib groups, and laboratory claims were 13.9, 19.4, and 15.6, respectively. Proportions of patients with hospitalizations (niraparib 40%, rucaparib 32%, olaparib 19%; p = 0.03), also differed as did emergency department visits (niraparib 37%, rucaparib 23%, olaparib 16%; p = 0.02). ConclusionDespite patients initiating niraparib having higher rates of dose management events and toxicity-related discontinuations, outpatient and laboratory utilization were similar across all three PARPi. Adequate monitoring of these medications, with differing toxicities, should be emphasized to potentially decrease dose reductions and toxicities.

Racial and Socioeconomic Disparities Among Patients with Chronic Lymphocytic Leukemia (CLL) Treated in the US Community Oncology Setting

Background: Since the first targeted therapy for CLL was approved by the Food and Drug Administration in 2014, new therapies and clinical practices have improved the care for patients with CLL. There is increased attention to racial disparities in healthcare. Objectives: To describe characteristics and outcomes of patients with CLL and assess whether there is equitable benefit from contemporary CLL therapies across racial and socioeconomic groups by analyzing real-world data collected in a large community oncology setting in the US. Methods: Patients with CLL treated in the US Oncology Network (The Network) from January 2015 through June 2023 were included. Data were sourced from structured data fields in iKnowMed™ (iKM), an oncology-specific electronic health record (EHR) system that captures outpatient practice encounters, including data on demographic and relevant clinical information for nearly 40% of US community oncology practices. iKM records are updated daily, and deterministically linked to supplementary Datavant mortality data and social determinants of health (SDoH) EHR data. Kaplan-Meier methods, univariate and multivariable cox regression were used to analyze overall survival (OS) and to determine the adjusted hazard ratio (HR) of OS. Considering that estimating the OS from initial diagnosis date is subject to immortal time bias, we performed the following two analyses: (1) time from the first visit date at a Network practice on or after the diagnosis date to OS, and (2) time from the initial diagnosis date among those newly diagnosed patients. In the primary analysis of OS, patients without a death date were censored at their last visit at The Network. In a sensitivity analysis, all follow-up data were censored at July 1, 2023. Results: The study included 12,253 CLL patients across all 4 census regions in the US, 60% were male. Of the 10,521 (86%) patients with race reported, 91.0% were white, 5.1% Black, and 3.9% were Other race. The median (Q1, Q3) age was 69 (61, 76) with Black patients 1.2 years younger than White patients (median: 69.0 versus 67.8, P=0.004). The initial CLL diagnosis was available for 11,576 (94%) patients and the majority (6,874; 59%) either had their initial diagnosis in The Network or had their first visit in The Network within 30 days after their initial diagnosis elsewhere. The median time from initial diagnosis to the first visit in The Network was slightly shorter for Black patients (2.4 weeks) as compared to White (3.9 weeks, p=0.001). At the initial diagnosis, more Black patients had Rai Stage III or IV than White patients (54% versus 46%, P=0.002). Death dates were available for 2,231 (18%) of patients. The analysis of time from first visit to death showed that the 8-year death rate was significantly higher for Black patients (61%) than White patients (43%, P=0.002) with statistically significant HR (95% confidence interval [CI]) of 1.34 (1.11, 1.61), P=0.002 in the univariate analysis. The median (95% CI) OS was 7.5 (6.4, not estimable) years for Black patients. The median OS was not estimable for White patients for this study because the study was designed to use data in the last 8 years and the median survival for White patients was longer than 8 years. After adjusting for education level and income, the race effect was no longer significant 1.25 (0.76, 2.05), P=0.37. The wider CI was due to SDoH data being only available for 2,928 (24%) of patients. Even with reduced statistical power, income of <$30k was significantly associated with higher risk of a shorter time to death with HR (95% CI) of 1.78 (1.32, 2.41), P<0.001 as compared to >$75k in the adjusted model. The analysis of time from the initial diagnosis date to OS among those newly diagnosed patients and the sensitivity analyses showed similar trends. Conclusion: This study identifies racial disparities in this modern era of CLL therapy using real-world data from a large community setting in the US. Black race and low income are prognostic of less favorable OS in CLL. Further research is needed to determine whether racial and income disparities in CLL are due to differences in access to therapy, quality of care, disease biology, comorbidities or other factors. This research may contribute to developing interventions to ensure that progress in CLL therapy benefits all patients.

A Patient-Centered Programmatic Approach for Higher-Risk Myelodysplastic Syndromes (HR-MDS) in the US Community Oncology Setting

Introduction: Prompt diagnosis and treatment are critical for patients with higher-risk myelodysplastic syndromes (HR-MDS) given the high likelihood of progression to leukemia and adverse clinical outcomes. However, pre-diagnosis dynamics can contribute to delays in diagnosis, genetic testing, and treatment initiation, especially among patients receiving care in the community oncology setting. A patient-centered program has been designed and is proposed to be executed in 4 phases: understanding adherence to guideline-concordant care for HR-MDS patients; gaining perspectives to contextualize the patient experience; and implementing a program that can monitor the process for improving patient outcomes (Figure 1). The objectives of this study are to evaluate and address the gaps and disparities of care in the diagnostic and treatment journey of patients with HR-MDS treated in a community oncology setting in order to provide an evidence-based understanding of the patient characteristics and journey to testing, diagnosis, and treatment (Phase 1 of the program). Methods: This is a retrospective chart review including patients treated in the community oncology network and identified in the Integra PrecisionQ deidentified database. Patients were identified as diagnosed with HR-MDS between January 1, 2014 and June 30, 2022, using a combination of ICD codes and receipt of hypomethylating agents in line with National Comprehensive Cancer Network guidelines as their first treatment. Eligible patients had at least 3 months of follow-up and at least 6 months of look-back prior to HR-MDS diagnosis. Signs and symptoms such as fatigue, weight loss, bruise, chills, night sweats, anemia, thrombocytopenia, and neutropenia that initiated the HR-MDS diagnosis journey were collected by manual curation. Results: A total of 350 patients aged 18 years or older diagnosed with HR-MDS over the study period were selected. The majority of patients included in this sample were White (82.6%) and male (59.4%) (Table 1). More than 50% of the 350 patients were ≥75 years old at diagnosis and most of them (91%) were diagnosed by a hematologist/oncologist in an outpatient setting. The median time from first sign/symptom to bone marrow biopsy and treatment initiation were 19.3 months (interquartile range [IQR] 8.9, 44.3) and 22 months (IQR 11.4, 45.8), respectively. Of the 350 patients included in the study, 342 (97.7%) had at least 1 sign or symptom leading to HR-MDS diagnosis, with the majority of patients presenting with anemia (77.2%), followed by thrombocytopenia (66.4%), fatigue (64.3%), and neutropenia (43.3%). International Prognostic Scoring System (IPSS) scores were not documented for nearly half (43.7%) of the patients included in this chart review. Conclusions: This initial analysis highlights several challenges in the HR-MDS patient care journey, including long time intervals elapsed between first sign/symptom and bone marrow biopsy, leading to further treatment, accompanied by a relatively high absence of IPSS score documentation. These findings suggest several potential opportunities to optimize patient care, such as shortening the time from symptoms to diagnosis and time from diagnosis to treatment, utilization and documentation of IPSS score, and prompt treatment initiation. Ultimately, this program aims to utilize this Phase 1 data to identify the gaps in care and to formulate quality measures to optimize care and facilitate timely diagnosis and appropriate treatment initiation among HR-MDS patients.

Real-world clinical outcomes of patients with metastatic renal cell carcinoma receiving pembrolizumab + axitinib vs. ipilimumab + nivolumab

BackgroundImmune-Oncology (IO) therapies have changed first-line (1L) treatment paradigm for metastatic renal cell carcinoma (mRCC) in last few years with robust clinical trial data. We examined clinical outcomes among clear cell mRCC (mccRCC) patients who received pembrolizumab + axitinib (pembro-axi) or ipilimumab + nivolumab (ipi-nivo) in the US community oncology setting. MethodsThis retrospective cohort study utilized data from electronic health records and chart review within The US Oncology Network to identify adult patients with mccRCC initiating 1L pembro-axi or ipi-nivo from January 01, 2019 to December 31, 2020 and followed through March 31, 2021. Physician-recorded response (real-world overall response rate [rwORR] and real-world disease control rate [rwDCR]) was assessed descriptively. Real-world progression-free survival (rwPFS), real-world time to next treatment (rwTTNT) and time on treatment (rwToT) were estimated using Kaplan-Meier analysis. Association of 1L systemic treatment with time-to-event outcomes was examined using multivariable cox proportional hazards models. ResultsStudy included 331 mccRCC patients (pembro-axi:44%, ipi-nivo:56%). Median age was 65 years, 75.5% were male, and 82.5% had intermediate/poor (I/P) IMDC risk score. RwORR and rwDCR were 71.0% and 80.0% for pembro-axi and 45.2% and 58.6% for ipi-nivo. In multivariable analysis, pembro-axi was associated with longer rwToT (aHR, 0.53 [95% CI, 0.40, 0.71]), rwTTNT (aHR, 0.60 [95% CI, 0.42, 0.87]), and rwPFS (aHR, 0.70 [95% CI, 0.49, 0.99]) compared to ipi-nivo (P < 0.01). ConclusionsOur study provides insight into newer mccRCC treatment tolerability and effectiveness in the real-world US community setting. Our real-world results were comparable to data from clinical trials, which is encouraging for mccRCC patients.

Comparison of real-world mortality data among patients with glioblastoma (GBM) and metastatic pancreatic cancer (mPC) treated in the community oncology setting.

e18805 Background: Evaluation of endpoints in oncology research requires accurate assessment of patients’ vital status. For real-world investigations of cancer populations, comprehensive capture of patients’ death dates may require several data sources. The intent of this evaluation was to assess capture of documented death dates across multiple datasets in the US community oncology setting. Methods: This was a retrospective observational study of adult patients with GBM or mPC who initiated treatment between 1 January 2019 and 31 December 2019 within The US Oncology Network. Patient demographic, clinical and treatment characteristics were sourced from an electronic health record (EHR) database, iKnowMed (iKM). Patients were followed until January 2023 with death dates captured from the iKM EHR (structured and unstructured fields), the iKM claims database, the Social Security Administration’s Death Master File, as well as a commercially available mortality dataset from Datavant comprised of obituary, claims and government records. Chart review was used to confirm if patients were alive on 15 January 2023. The overall capture rate of death information from each source was evaluated descriptively. Agreement was assessed using two approaches: 1) as death dates that were an exact match between sources and 2) as death dates that occurred within 30 days of each other and/or within the same month. Results: A total of 173 patients with GBM (median age 65 years, median follow-up time 12.0 months) and 990 patients with mPC (median age 68 years, median follow-up time 7.1 months) were included. Across all sources, 91.1% of the pooled population had at least one documented death date or were confirmed to be alive (85.5% and 92.1% of patients with GBM and mPC, respectively). Among patients with full day-month-year death dates from at least 2 sources (n = 835), 95.4% of death records were matched on the exact death dates. Among patients with any death record from at least 2 sources (n = 852), 99.3% of death records were matched within 30 days of each other or within the same month. Conclusions: The findings of this study describe the capture rate of mortality and vitality status in the US community oncology setting. Future analyses are planned to augment these assessments of concordance, sensitivity, specificity, positive predictive value and negative predictive value across the sources with comparison to death dates captured by the National Death Index. These insights are important for development of composite mortality databases, comprised of death information from multiple sources using appropriate tokenization and overlap methodologies.

Real world treatment patterns and survival by germline BRCA (gBRCA) mutation status in patients with HER2-negative early breast cancer (eBC) in the US community oncology setting: A retrospective observational study.

e12535 Background: Germline BRCA mutations (gBRCAm) are associated with a higher risk of breast cancer at a younger age. Generally, gBRCA gene testing is performed in patients perceived as high risk for gBRCAm. Olaparib, a targeted poly (ADP-ribose) polymerase inhibitor (PARPi), has significantly improved overall survival (OS) in the randomized, double-blind OlympiA trial of patients with HER2-negative gBRCAm and was subsequently approved for the adjuvant treatment of patients with gBRCAm HER2-negative high-risk early breast cancer (eBC) treated with neoadjuvant or adjuvant chemotherapy. This study examines the real-world patient characteristics, treatment patterns and OS by gBRCA status among patients with HER2-negative eBC in a US community oncology setting prior to olaparib US approval for treatment of eBC. Methods: This retrospective observational study used structured data from The US Oncology Network's iKnowMed database. Adult patients were included if diagnosed with HER2-negative eBC (stage I-III) and if they initiated systemic neoadjuvant or adjuvant therapy between January 1, 2012-December 31, 2018 (followed through December 31, 2021). Patients were excluded if they progressed to stage IV within 6 months after neoadjuvant treatment or were diagnosed with another primary cancer. Descriptive analyses assessed patient characteristics, early-stage systemic treatments and OS among patients by gBRCA status. Results: Among 19,258 patients with BC meeting initial criteria, 1436 (7.5%) had a documented gBRCA test result. Among them, 10% had gBRCAm (n = 141, 43% hormone receptor positive [HR+], 57% triple-negative BC [TNBC]), 90% BRCAwt (n = 1294, 70% HR+, 30% TNBC), and 1 had a variant of uncertain significance. Median age at surgery was numerically lower in gBRCAm (43 years) than gBRCAwt (48 years) patients. Treatments included neoadjuvant-only therapy (gBRCAm 58%; gBRCAwt 34%), adjuvant-only therapy (gBRCAm 42%; gBRCAwt 66%) and both neoadjuvant and adjuvant therapy (gBRCAwt 0.1%). Median OS in both study cohorts was not reached. Median follow-up from surgery was less than 4 years (gBRCAm 47 months; gBRCAwt 46 months). At 48 months, estimated survival was 95% in gBRCAm and 94% in gBRCAwt patients. Conclusions: In this cohort of patients with HER2-negative eBC, among the 7.5% with a documented gBRCA result, 10% were identified with gBRCAm, reinforcing the need for gBRCA testing. Using structured real-world data through 2021 (prior to PARPi approval for eBC) with limited follow-up of &lt; 4 years, our study found that OS by gBRCA status was similar among patients with HER2-negative eBC. Our further research with chart review data containing granular clinical information looking at intermediate endpoints such as recurrence in eBC is under way.

Factors associated with platinum sensitivity (PST) and related outcomes in patients with ovarian cancer (OC) in a US community oncology setting: Looking beyond.

e17590 Background: Along with residual disease after surgery, response to platinum therapy is a key prognostic indicator in patients with advanced OC. It is a prerequisite for receiving PARP inhibitor maintenance therapy and directs future treatment choices. Our objective was to describe differences in characteristics and outcomes between patients with platinum resistance (PR) or PST in a community oncology setting. Methods: This was a retrospective study of adult female patients with advanced OC (Stage III/IV) who received 4+ cycles of a 1L platinum-based regimen during 01/01/2017 to 06/30/2021 (followed until 12/31/2021) and had ≥ 2 visits within The US Oncology Network. Patients who were platinum resistant (PR, relapse 30 days to &lt; 6 months after platinum discontinuation) or PST (relapse at 6+ months after platinum discontinuation) were included; refractory patients (relapse during or within 30 days of platinum discontinuation) were excluded. Structured and chart review data were used. Multivariable logistic regression assessed the association of factors with PST vs. PR. Results: In total 142 patient charts (108 PST, 34 PR) were reviewed. In addition to platinum-based chemotherapy, 19% of patients also initiated bevacizumab. Most patients were White (63%), diagnosed at Stage IIIC (55%) or IV (33%), and had epithelial OC (82%). Overall, 52%, 23% and 25% of patients had ECOG performance status scores of 0/1, 2+ and not documented, respectively. BRCA status was positive for 7.7% but not documented for 38%, and Charlson comorbidity score (CCS) was 0 for 63% of patients. PST vs. PR patients were younger, 69 (27-90+) years vs. 71 (51-89) [median (range), p = 0.045]. More PST vs. PR patients were normal weight (40% vs. 29%) or overweight (30% vs. 15%) and fewer were obese (24% vs. 41%) (p = 0.011). In multivariable adjusted analysis (excluding underweight and unreported BMI categories for low counts), Stage IV vs. III (p = 0.003) was associated with significantly higher odds of PR after 1L, while obesity vs. healthy weight (p = 0.067) and ECOG 2+ vs. 0/1 (p = 0.057) were associated with numerically higher odds of PR after 1L; age, CCS and 1L bevacizumab use were not associated with PST. Kaplan-Meier median (95% confidence interval [CI]) overall survival in PST vs. PR was not reached [NR] (44.6, NR) vs. 16.7 (13.9, 23.6) months while median (95% CI) progression-free survival was 19.6 (17.6,24.9) months vs.7.9 (7.1,8.5) months, respectively. Conclusions: When exploring factors associated with response to 1L platinum-based treatment of OC adjusting for other factors, higher stage was significantly associated with PR, while patients with obesity and poor ECOG status had nonsignificantly greater odds of PR. PR patients have poorer survival and fewer treatment options, and standard of care treatment of 1L OC in these subgroups should be further explored to address this unmet need.

Biomarker testing and treatment patterns in US patients (pts) with advanced/metastatic non-small cell lung cancer (NSCLC) harboring MET amplification.

e21057 Background: Limited published evidence exists on pts with advanced stage NSCLC harboring MET amplification ( METamp), a rare oncogenic driver. We report here real-world biomarker testing and treatment patterns for these patients. Methods: This was a non-interventional, descriptive cohort study using ConcertAI electronic medical record data derived from US community oncology centers and linked with ASCO/CancerLinQ data. Eligible pts had stage IIIB–IV NSCLC and METamp. Study period: Jan 1, 2004 – Oct 31, 2021. Results: Of 8,454 lung cancer pts with minimum 1 molecular test including MET, 164 had METamp (1.9%). Pts were mainly identified from 2015 onwards and primarily in oncology in the Southern and Midwest regions (86.6%). Majority of pts were tested by tissue biopsy (67.1%), 20.7% by liquid biopsy and 12.2% not specified. At least 64.5% of pts were highly MET amplified (either gene copy number ≥8 or by liquid biopsy ++, +++). Other mutations screened for were ALK, ROS1 and EGFR (99.4%, 98.2% and 97.6%), with oncogenic ALK, ROS1 fusions and activating EGFR mutations in 0.6% and 13.1%, respectively. BRAF and KRAS were less frequently screened for (90.2% and 87.2%), with potential oncogenic alterations in 2.0% and 12.6%. Of 127 pts tested for PD-L1 (by immunohistochemistry), 63.0% were positive, and 72.5% had tumor proportion score ≥50. Eighteen pts had METamp detected after receiving an EGFR tyrosine kinase inhibitor (TKI), indicating METamp as a secondary oncogenic driver. RB1 loss and MYC amplification, as potential mechanisms of MET inhibition resistance, were not frequently screened for (30.5% and 46.3%). RB1 loss was identified in 2.0% and MYC amplification in 15.8%. Next generation sequencing was the most frequent diagnostic used overall. A total of 144 pts (87.8% of 164 pts) received first-line (1L) anticancer therapy; platinum-based chemotherapy 57/144 (39.6%), immune-checkpoint inhibitors 50/144 (34.7%) or EGFR TKI monotherapy 24/144 (16.7%), other 2/144 (1.4%) and MET TKIs (mainly crizotinib) were used in 11/144 pts (7.6%) in 1L, 14/78 (17.9) in second line and 7/42 (16.7%) in third line. Conclusions: In this cohort of pts identified in a US community oncology setting, biomarker screening even for rarer genetic alterations occurred. Concomitant genetic alterations to METamp were infrequent except for alterations of EGFR and KRAS. The frequency of pts with high level of METamp in the cohort may explain the lower frequency of other biomarkers, as high level of amplification indicates a cleaner MET profile. Overall MET inhibitor treatment was not common. Screening for novel and rare biomarkers such as METamp as a primary or secondary oncogenic driver is becoming increasingly important to enable efficacious targeted treatment.

Abstract 6752: Patient (pt) characteristics, diagnostic journey, and cancer enrichment among pts with nonspecific signs and/or symptoms (s/sx) in the US community oncology setting: a real-world retrospective study

Abstract Of the &amp;gt;1.6 million people diagnosed with cancer in the US each year, &amp;gt;60% are diagnosed after symptomatic presentation, including nonspecific s/sx. These nonspecific s/sx may cause pts to undergo unnecessary diagnostic evaluation while the possibility of cancer and search for its origin is explored, causing delayed treatment and poor outcomes. Additionally, pts who do not have cancer are often subjected to various undirected/misdirected procedures due to initial cancer suspicion. Our objective was to examine pt characteristics, diagnostic journey, and cancer incidence of pts with nonspecific s/sx within The US Oncology Network. This retrospective observational cohort study included pts aged ≥40 with ≥1 of the following nonspecific s/sx in their problem list at their first visit within The US Oncology Network (index date) during the identification period from 1/1/2016 to 12/31/2020: anemia, venous thromboembolism, general malaise, weight loss, nonspecific abdominal symptoms, new and unexplained breathlessness, unexplained worsening pain, and abnormal lab test results. Pts were excluded if diagnosed with any cancer (except basal cell carcinoma and squamous cell carcinoma skin cancer) within 3 years prior to or on index date. Pts were followed longitudinally with data from electronic health records for initial cancer diagnosis (dx), death, end of study observation period, or 12 months, whichever occurred first. Demographic and clinical characteristics were assessed descriptively. 103,984 pts were identified. The median age was 65.7, 64% were female, 65% were White, 41% were obese, 47% were never smokers, and 48% were from a southern practice region. 6,774/103,984 pts (7%) were diagnosed with cancer and 6,537/6,774 (97%) with 1 primary cancer: 3,825/6,537 (59%) were diagnosed with a hematologic malignancy and 2,712/6,537 (41%) with a solid tumor cancer. Among pts diagnosed with primary solid tumors, 31% had gastrointestinal, 15% genitourinary, 15% respiratory, 13% breast, and 11% gynecologic cancer. Among pts diagnosed with cancer, median time to cancer dx after being referred to secondary care within The US Oncology Network with nonspecific s/sx was &amp;gt;5 wks (solid: &amp;gt;7 wks; hematologic: &amp;gt;4 wks); by 17 and 34 wks, 75% and 90% of pts received a cancer dx, respectively. Within this population of pts most frequently presenting with nonspecific hematologic s/sx and subsequent cancer dx, 40% were diagnosed with solid tumor cancers within 1 year. This speaks to the unmet need for more tools such as a multi-cancer detection test that could aid in detection of multiple cancers and faster diagnostic resolution of nonspecific s/sx. Given the impact of delayed cancer dx and timely treatment on outcomes, such a test could potentially substantially improve cancer care and diagnostic evaluations. Citation Format: Christopher Benton, Ding He, Karen Todoroff, Marie V. Coignet, Ying Luan, Kathryn N. Kurtzman, Ira Zackon. Patient (pt) characteristics, diagnostic journey, and cancer enrichment among pts with nonspecific signs and/or symptoms (s/sx) in the US community oncology setting: a real-world retrospective study. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 6752.

Comparative effectiveness of abiraterone and enzalutamide in the first-line treatment of metastatic castration-resistant prostate cancer (mCRPC): A retrospective cohort study in a large database of deeply curated EHR real-world data (RWD) from community oncology practices in the US.

175 Background: Abiraterone(A) and enzalutamide(E), both oral androgen receptor targeted agents, are available as first-line treatment options for mCRPC patients. Direct comparisons of efficacy have not been performed for mCRPC patients primarily receiving their cancer care outside of academic centers or integrated health care systems. The study aims to evaluate the real-world effectiveness between first-line A and E-containing regimens in mCRPC patients primarily receiving care in the US community oncology setting. Methods: Patients were selected from ConcertAI Patient 360 Prostate data product, a large de-identified database of deeply curated EHR RWD, sourced from data sharing agreements with community oncology practices. mCRPC patients treated with a first-line A or E-cont. regimen between 1/2011 and 6/2022 were included. OS, TTNT, TTD outcomes were described using KM estimates and evaluated with Cox proportional hazard (HR) model. Confounding was addressed with inverse probability treatment weighting (IPTW) propensity scores based on age, BMI, ECOG, prior anti-androgen exposure, smoking status, comorbidities, and nadir PSA. Sensitivity analysis evaluated KM and HR for each covariate strata. Hazard ratios were also evaluated with multiple imputation by chained equations for missing covariates. Results: From 3,578 mCRPC patients, 1,210 (33.8%) received E-cont. regimen and 1,357 (37.9%) received A-cont. regimen(ref) with a median of 8 months duration for both drugs. Adjusted HR (aHR) for all three outcomes showed a slight increase in effectiveness for E albeit not significant (OS (aHR 0.99, CI 0.87-1.12), TTNT (aHR 0.98, CI 0.89-1.08). Adjusted model including imputation (iHR) supported unimputed results (OS (iHR 0.97, CI 0.88-1.07), TTNT (aHR 0.94, CI 0.9-1.10). The HRs for OS, TTNT and TTD in sicker patients were consistent (2+ ECOG TTNT (aHR 0.95, 0.81-1.12)), (BMI &gt;30, TTNT (aHR 0.84, 0.61-1.18)), and reached significance for some models (2+ ECOG TTD (aHR 0.66, 0.48-0.91)). Conclusions: First-line E-cont. regimens consistently showed increased effectiveness in outcomes compared to A-cont. regimens in mCRPC patients treated in community oncology setting. The effects sizes are modest and did not reach significance, however analysis of the sickest patients showed a trend of consistently larger effect sizes which reached significance for some outcomes. More work needs to be done to evaluate if these results support findings from other RWD sources.

Treatment Patterns and Overall Survival (OS) Among Patients with Myelodysplastic Syndromes (MDS) Treated in the US Community Oncology Setting: A Real-World Retrospective Observational Study

Treatment Patterns and Overall Survival (OS) Among Patients with Myelodysplastic Syndromes (MDS) Treated in the US Community Oncology Setting: A Real-World Retrospective Observational Study

Lanreotide Depot to Treat Gastroenteropancreatic Neuroendocrine Tumors in a US Community Oncology Setting: A Prospective, Observational Study.

Gastroenteropancreatic neuroendocrine tumors (GEP-NETs) can result in symptoms such as diarrhea, flushing, abdominal pain, and fatigue and are often associated with a significant disease burden and poor prognosis. This non-interventional, prospective, observational study evaluated the real-world safety and effectiveness of lanreotide depot, a somatostatin analog (SSA) used to treat GEP-NETs, in a community setting. In this prospective, non-interventional study (NCT02730104), adult patients with locally advanced (inoperable), metastatic GEP-NETs treated with lanreotide depot were evaluated by their physician every 6 months from enrollment for 24months. Clinically defined time to disease progression (TTDP) and overall survival (OS) were estimated for the total population and by primary tumor type (gastrointestinal [GI], pancreatic, unknown origin), and an exploratory analysis determined the rate of progression-free survival (PFS) at 12 and 24months. Patient satisfaction was evaluated via the Treatment Satisfaction Questionnaire for Medication (TSQM-9), and safety information was recorded. Of 99 patients, the 24-month PFS rate was 73.7% (95% confidence interval [CI] 63.1-81.7) and 24-month OS rate was 84.2% (95% CI 74.0-90.7). Median TTDP was not reached because few patients experienced disease progression during the study period. The majority of responding patients expressed satisfaction with treatment on each domain of the TSQM-9. Treatment-related adverse events (AEs) occurred in 19.2% of patients, while no serious AEs (SAEs) were related to the study drug. Lanreotide depot is an effective and well-tolerated treatment for GEP-NETs in the real-world community setting. ClinicalTrials.gov identifier, NCT02730104.

EPH95 Frequency of and Testing Patterns for Microsatellite Instability High (MSI-H) and Deficient Mismatch Repair (DMMR) Among Solid Tumors in a US Community Oncology Setting

MSI-H/ dMMR is an actionable biomarker in the treatment of several tumors. Given data paucity, the study assessed the frequency of and testing patterns for MSI-H/dMMR across various solid tumors in a real-world community oncology setting in the US.

Abstract 5876: Treatment patterns among metastatic SS patients in The US Oncology Network

Abstract Objective: Synovial sarcoma (SS) is a rare sub-type of soft tissue sarcoma with limited natural history documented. The study objective was to describe characteristics and treatment patterns of metastatic SS (mSS) patients receiving systemic treatments. Methods: This was a retrospective observational cohort study in mSS patients treated in The US Oncology Network practices. Both EHR and chart review data from 2012-2019 were used. All mSS adult patients initiating systemic treatment as first-line (1L) therapy, with &amp;gt;2 visits were included. Patients diagnosed with or treated for other primary tumors were excluded. Demographic and clinical characteristics were reported based on index date (date of first systemic treatment initiation in the metastatic setting). Time to treatment discontinuation (TTD) and time to next treatment (TTNT) were assessed using the Kaplan-Meier method. Results: 39 adult mSS patients were identified receiving 1L systemic treatment. Of these, 25 went on to receive a 2L treatment (64%), and 16 went on to receive 3L+ treatment (41%) during the study observation period. Median age was 41.0 years, 74% male, 70% Caucasian. 25% had metastatic disease at original diagnosis of SS (vs. localized disease). 87% had metastases to lung, 25% had &amp;gt;1 site of metastasis. See Table 1 for treatment distributions by line and for TTD and TTNT. Conclusions: This study provides information on treatment patterns for mSS patients treated across multiple institutions within a US community oncology setting. About 2/3 of mSS patients received 2L systemic treatments. While doxorubicin and ifosfamide regimens were most common in 1L, variability exists in the 2L and onward settings, with ifosfamide and pazopanib being more frequently used than in earlier lines. Additionally, shorter TTD and TTNT with each subsequent line of therapy documents the need for effective treatment options in the 2L+ setting that can further delay progression. Funding: GSK [208280] Distribution of treatments by line Median time to discontinuation in months(95% CI) Median time to next treatment in months(95% CI) 1L systemic treatment (n=39) Doxorubicin + Ifosfamide containing regimen 14 (35.90%) 3.9 (2.2, 5.1) 9.3 (6.2, 11.1) Pazopanib alone or in combination 7 (17.95%) Docetaxel + gemcitabine 6 (15.38%) Ifosfamide monotherapy 6 (15.38%) Doxorubicin + olaratumab combination &amp;lt;5 Other treatment regimens including gemcitabine, trabectedin, and investigational drugs (not related to SS) &amp;lt;5 2L systemic treatment (n=25) Ifosfamide alone or in combination 7 (28.00%) 3.6 (1.5, 6.0) 6.7 (4.4, 11.1) Pazopanib alone or in combination 7 (28.00%) Doxorubicin containing regimen &amp;lt;5 Gemcitabine alone or in combination &amp;lt;5 Others including cisplatin containing regimen, trabectedin &amp;lt;5 3L+ systemic treatment (n=31 among 16 patients) Chemotherapy monotherapy* 13 (41.94%) 2.7 (1.0, 3.7) 4.6 (1.5, 9.8) Pazopanib alone or in combination 9 (29.03%) Ifosfamide alone or in combination 5 (16.13%) Chemotherapy combination (other than with pazopanib or ifosfamide) &amp;lt;5 *Includes dacarbazine, doxorubicin, pembrolizumab, nivolumab, IL-2, temozolomide, vinorelbine.1L, first-line therapy; 2L, second-line therapy; 3L, third-line therapy; IL-2, interleukin-2.Time to treatment discontinuation (TTD; in months) was calculated as the time interval between the initiation of each line of therapy and the last administration of that line, if there was a record of discontinuation, death or movement to the next treatment, or last administration date of the treatment if ≥120 days before the last visit date. Otherwise, patients were censored on the last administration date.Time to next treatment (TTNT; in months) was calculated as the interval between systemic treatment initiation for a given line and initiation of the next systemic treatment. Patients who did not initiate a next treatment or did not die during the study observation period were censored on the study end date, or the last visit date available in the dataset, whichever occurred first. Citation Format: Shibani Pokras, Wan-Yu Tseng, Janet Espirito, April Beeks, Charlotte Carroll, Ken Culver, Eric Nadler. Treatment patterns among metastatic SS patients in The US Oncology Network [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 5876.

Retrospective Study of Real-World Treatment Patterns and Outcomes in Advanced/Metastatic Renal Cell Carcinoma Patients Receiving Lenvatinib/Everolimus after Heavy Pretreatment1

BACKGROUND: Lenvatinib with everolimus (“Len/Eve”) is approved for advanced/metastatic RCC following one antiangiogenic therapy. OBJECTIVE: This study evaluated patient characteristics, treatment patterns and overall survival (OS) with second-line or later (2L+) Len/Eve for advanced/metastatic RCC. METHODS: A retrospective observational study was conducted using electronic health records. Adult patients who initiated 2L+ Len/Eve for advanced/metastatic RCC from May 13, 2016 to July 31, 2019 were included. Patient characteristics and treatment patterns were assessed across the overall population and by post-immuno-oncology (IO) and post-tyrosine kinase inhibitors (TKI) groups. OS was estimated from Len/Eve initiation (i.e., index date) using Kaplan-Meier. RESULTS: Among the study population (n = 152), 44.1%received 2L/3L Len/Eve and median number of prior therapies was 3 (range:1–8). Median age was 63.2 years, 78.9%were Caucasian, 73.7%were male, and 56.6%had ECOG performance status 0/1. At initial diagnosis, 65.8%had stage IV disease. At index, 53.3%had an International Metastatic RCC Database Consortium risk score of intermediate/poor, 15.1%favorable, and 31.6%missing score. Sixty-five (42.8%) received IO-based regimens and 49.3%received TKIs directly before index. Median OS from index was 13.9 (95%CI: 9.5–16.5) months and 2L/3L and 4L+ were 12.1 (95%CI: 8.4–17.0) and 14.8 (95%CI: 8.9–22.5) months, respectively. Median OS for Len/Eve post-IO and post-TKI were 13.9 (95%CI: 8.4–21.3) and 14.8 (95%CI: 7.8–16.5) months, respectively. Conclusion: This study suggested that 2L+ Len/Eve has clinical effectiveness for advanced/metastatic RCC in a US community oncology setting. Future studies are needed to confirm the association of improved survival with 2L+ Len/Eve.

Real-world Clinical Effectiveness of Lenvatinib/Everolimus in a Heavily Pretreated Advanced/Metastatic Renal Cell Carcinoma Population in the US Community Oncology Setting

Few studies have evaluated real-world effectiveness of lenvatinib (Len)/everolimus (Eve) for advanced/metastatic renal cell carcinoma (a/mRCC). This study evaluated patient profiles and clinical outcomes of second- and subsequent-line (≥ 2L) Len/Eve for a/mRCC. A longitudinal retrospective study examined adult patients initiating ≥ 2L Len/Eve for a/mRCC from May 13, 2016, to July 31, 2019. Len/Eve clinical trial participants or those treated for other primary tumors were excluded. Outcomes included objective response rate, duration of response, progression-free survival (PFS), time to treatment discontinuation, and overall survival. Time-to-event outcomes were estimated using Kaplan-Meier methods. Seventy-nine patients were assessed: the median age was 64.8 years, 78.5% were Caucasian, 73.4% were male, 78.5% had an Eastern Cooperative Oncology Group performance status score of 0/1, 29.1% received 2L/3L Len/Eve, and the median number of prior lines of therapy was 3 (range, 1-8). At initial diagnosis, 55.7% had stage IV disease, 65.8% had International Metastatic risk scores of intermediate/poor, 19.0% favorable, and 15.2% with missing score. Thirty-one (39.2%) patients received immuno-oncology-based regimens, and 50.6% received tyrosine kinase inhibitors directly before Len/Eve initiation. The median time to treatment discontinuation was 5.7 months (95% CI, 3.3-6.9). The physician-assessed objective response rate was 55.7% (1.6% complete response and 54.1% with some degree of tumor shrinkage). The median duration of response was 9.7 months (95% CI, 5.8-17.1). The median PFS was 6.1 months (95% CI, 4.4-9.0). The median PFS for patients receiving Len/Eve post-immuno-oncology was 6.4 months (95% CI, 4.1-10.8) and for post-tyrosine kinase inhibitor 5.7 months (95% CI, 4.1-10.5). Median overall survival was 14.8 months (95% CI, 10.2-23.9). In this longitudinal retrospective study, Len/Eve showed real-world effectiveness in clinical practice in a heavily pretreated a/mRCC patient population.