Background The clinical landscape in non-small-cell lung cancer (NSCLC) treatment has rapidly evolved in recent years. Real-world data (RWD) can provide insights into current clinical practice. Objective This study examined the patient characteristics and treatment patterns of patients with metastatic NSCLC using RWD sources. Methods This was a retrospective cohort study using health insurance claims and electronic health records (EHRs). Adult patients treated for metastatic NSCLC during the period 2017 to September 2020 were followed from the earliest treatment date until a censoring event. Results The claims cohort included 7917 patients with a mean age of 70 years and a mean follow-up period of 373 days. The EHR cohort included 7087 patients with a mean age of 67 years and a mean follow-up period of 362 days. The five most common first-line therapies (LoT1) were the same for both cohorts: carboplatin + paclitaxel, pembrolizumab, carboplatin + pemetrexed + pembrolizumab, cisplatin + pemetrexed, and nivolumab. Mean LoT1 durations were 146 and 147 days in the claims and EHR cohorts, respectively. For patients who received a second LoT (LoT2), the five most common LoT2 were also the same in both cohorts: durvalumab, nivolumab, pembrolizumab, carboplatin + pembrolizumab + pemetrexed, and carboplatin + pemetrexed. Mean LoT2 durations were 157 and 158 days in the claims and EHR cohorts, respectively. Conclusions LoTs between the claims and EHR cohorts were comparable and showed similar treatment patterns. Traditional platinum-containing chemotherapy was most common in LoT1, whereas programmed cell death protein-1 inhibitors became the most common choices in LoT2. Our findings suggest that RWD can reliably provide up-to-date insight into current treatment modalities and indicate that new clinical evidence is rapidly adopted in patients with NSCLC.

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e18754 Background: Factors that affect overall survival (OS) for women with metastatic or recurrent breast cancer (BC) and BRCA1 or BRCA2 mutations (BRCA+) are a matter of debate. We analyzed electronic health records (EHR) from centers across the US to examine the effect of bilateral salpingo oophorectomy (BSO) and other factors on OS across treatment and molecular subtypes with emphasis on hormone-positive (HR+) and triple-negative BC (TNBC). Methods: A cohort of women diagnosed with stage 3 or 4 HR+ or TNBC from 1-Jan-2015 to 31-Dec-2019 was identified from EHR (Tempus Labs, Chicago, IL). BRCA+ was confirmed from medical notes and laboratory reports. A comparator group included HR+ and TNBC with no record of BRCA testing (Non-BRCA). Kaplan-Meier and Cox proportional hazards were used to evaluate predictors of OS from earliest diagnosis in multivariate models by BRCA status and molecular phenotype; treatment exposure (any time), mastectomy and BSO were treated as time-dependent variables. Results: We identified 1227 women with median age of 53 years (range 18-89) at BC diagnosis and median follow up of 26.1 months (max > 26 years) and 358 deaths. Two-thirds had distant visceral or bone metastases, almost 60% were recurrent after original stage 1-3 BC; 302 women were stage 3 and 296 stage 4 at BC. The BRCA+ cohort included 439 women (195 BRCA1, 220 BRCA2, 24 “BRCA” mutation; 265 HR+, 142 TNBC) and median age at BC was 46 years (44 BRCA1, 47 BRCA2). Non-BRCA cohort consisted of 788 women with a median age of 57 at BC (378 HR+, 341 TNBC). BRCA+ had longer OS than non-BRCA ( P= 0.0001); HR+ had longer OS than TNBC ( P= 0.0001). For 331 TNBC, chemotherapeutic regimens were most common first line treatment; few (17%) received third line and 31% had no evidence of receiving systemic therapy. Age ≤50, BRCA+, and mastectomy were associated with increased OS in HR+; BRCA+ status and mastectomy were predictors of increased OS whereas platinum-based chemotherapy was associated with decreased OS in TNBC (Table). Across molecular subtypes, BSO was not an independent predictor of OS and most women (92%) had BSO after BC diagnosis. Conclusions: Regardless of BRCA status, women with advanced TNBC were almost exclusively treated with chemotherapy, which highlights the remaining unmet need for effective treatment options. Taking timing of BSO and other interventions into account is critical to understanding their effects of BC mortality.[Table: see text]

INTRODUCTION: The risk of tumor lysis syndrome (TLS) varies depending upon the underlying malignancy, tumor burden, and anti-tumor activity of the treatment administered. With the recent approval of several anti-cancer treatments across hematologic malignancies, mitigation of TLS has been a priority. Understanding the background rates of TLS and factors associated with the risk of TLS will likely aid in TLS mitigation. Current literature documenting background rates of TLS in hematologic malignancies is primarily based on studies involving small sample sizes and/or includes older data. This study aims to address the literature gap by assessing differences in frequency of TLS across hematologic malignancies and evaluating factors associated with the risk of TLS in large real-world populations. METHODS: Retrospective cohort study conducted using MarketScan Commercial, and Supplemental Medicare databases (2012-2016). Data include details on medical and pharmacy utilization for employees and their dependents in employer sponsored health plans in the US. Study includes adults (≥18 years) with ≥2 medical claims with diagnosis for one of the following hematologic malignancies: CLL, CML, MCL, AML, FL, DLBCL, and MM. Patients were classified into 7 sub-cohorts based on the index (initial) malignancy diagnosis. Study cohort was restricted to newly diagnosed patients who initiated malignancy-specific treatments post-diagnosis. The date of treatment initiation defined the index date. Patients were required to have continuous health plan enrollment ≥12 months before index date. TLS event was assessed based on medical claim with following diagnosis codes: ICD-9-CM: 277.88; ICD-10: E88.3x. Patients were followed from index date until TLS event, end of health plan enrollment or end of database, whichever occurred earlier. Time to TLS was calculated from date of treatment initiation until date of TLS event. Demographic characteristics, comorbidities and treatments were assessed for the study cohort. Univariate analysis was conducted to assess differences in patient and treatment characteristics across hematologic malignancies among patients with TLS. RESULTS: Cohort sample size (total n = 10,255), demographic characteristics and baseline comorbidity details are provided in Table 1. Variations in post-diagnosis initial treatments were observed across the 7 sub-cohorts (Table 2). Following treatment initiation the proportion of patients with a medical claim with a diagnosis of TLS was as follows: CLL (2.1%), CML (1.7%), AML (2.1%), MCL (1.4%), FL (0.5%), DLBCL (1.9%), and MM (0.9%). In most patients, the initial medical claim for TLS was observed in an inpatient setting (Figure 1). Median time to development of TLS from treatment initiation across the 7 sub-cohorts was as follows: CLL (12 days), CML (21 days), AML (101 days), MCL (222 days), FL (42 days), DLBCL (17 days), and MM (104 days). The treatments observed during the 60-day period prior to the TLS event are presented in Table 3. Among patients with TLS, age (p-value: 0.015) and treatments received 60 days prior to the TLS event (p-value: 0.001) differed significantly across hematologic malignancies. However, no differences were observed for covariates gender, region and Charlson co-morbidities index score (all p-values >0.05). CONCLUSIONS: This study based on a large-population database provides recent data on differences in the frequency of TLS across hematologic malignancies. Frequency of TLS varied across the 7 sub-cohorts, with higher frequency observed in CLL, CML, AML and DLBCL (range 1.7-2.1%) compared with MCL, FL, MM (range 0.5-1.4%). Majority (89%) of patients were on treatments prior to the TLS event; however, 11% had a TLS diagnosis and received no treatment 60 days prior to the event, indicating that TLS mitigation also needs to be considered in untreated patients. With emerging mono- and combination treatments, this study provides background data along with most common factors associated with risk of TLS, a useful tool to plan for mitigation strategies. Due to the limitations of claims data, the study could not distinguish between laboratory and clinical TLS; also, patients included were from an employer-sponsored plan and therefore likely younger and potentially with fewer comorbidities. Finally, data lacked detailed clinical characteristics these factors should be considered in interpreting the study results. Disclosures Karve: AbbVie: Employment, Equity Ownership. Diegidio:AbbVie: Other: Contractor. Zhang:AbbVie: Employment, Equity Ownership; Merck: Equity Ownership. Sebby:AbbVie: Employment, Equity Ownership. Cerri:AbbVie: Employment, Equity Ownership. Rosenberg:AbbVie: Employment, Equity Ownership.

e13004 Background: BRCA is a hereditary genetic mutation associated with a higher risk of breast cancer at younger age. Generally, BRCA gene testing is done in perceived high-risk individuals, and different management approaches might be considered given the high risk of breast cancer. This study examines treatment outcomes among BRCA-positive, metastatic breast cancer patients with consideration of prophylactic management by using US nationwide EHR data. Methods: This was a retrospective cohort study using Optum EHRs. The study cohort includes female adults who underwent their first systemic chemotherapy for metastatic breast cancer between 2013-2018 with a BRCA positive test result prior to the systemic chemotherapy, with ≥ 6 months baseline period from the chemotherapy. Physicians’ notes captured in Natural Language Processing (NLP) were further used to construct the cohort. Patients were followed from the earliest breast cancer diagnosis date until a censoring event (death or end of observation period). Death information was provided with national death certificate data. Descriptive statistics were used for patient characteristics and a stepwise Cox Proportional Hazard (CPH) regression model was fit to compare survival time. Results: Of 3624 patients included in the cohort, median age at the earliest breast cancer diagnosis is 50 years old (IQR 43-59), and a total of 540 (14.9%) deaths was observed. Prior to systemic chemotherapy, 1430 (39.5%) received mastectomy/lumpsectomy. 571 (15.8%) received hormone therapy prior to systemic chemotherapy. 646 (17.8%) had a clinical record indicating a triple negative breast cancer (TNBC). 2196 (60.6%) received more than 1 line of chemotherapy. Overall median survival days in the study cohort was 3778 days from the earliest breast cancer diagnosis. Median survival days in those with ER/PR positive and with TNBC status were 4150 days and 3124 days, respectively. From the CPH model, age, tumor mutation status, and prior mastectomy/lumpectomy were identified as significant factors; Hazard Ratio (HR) with each 1 year older in age at diagnosis was 1.02 (95% CL 1.01-1.03), that of TNBC vs ER/PR positive status was 2.27 (95% CL 1.87-2.77) and that of those with prior surgery vs without was 0.567 (95% CL 0.457-0.703). Conclusions: This study demonstrated the utility of EHR database for survival analysis. In metastatic breast cancer patients with a known BRCA-positive status, age at the initial diagnosis, tumor mutation status, and prior mastectomy/lumpectomy were significant factors in survival time.