STATinMED (United States)

Abstract Early Adoption of Molecular Residual Disease Testing in Breast Cancer Patients using Real World Data Authors: Ning Yan Gu1, Kohli M2, Stephen J Noga1, Quang A. Le1, Rodriguez-Silva J2, Barhoush Y2, Batchu L2, Gebra Cuyun Carter11Exact Sciences, Madison, WI, USA; 2STATinMED LLC., Dallas, TXWord count: 2765/3400 characters OBJECTIVE: Testing for molecular residual disease (MRD) via circulating tumor DNA (ctDNA) biomarker is an emerging practice in cancer treatment and disease recurrence detection. This study aims to assess the early adoption of MRD for patients diagnosed with breast cancer (BC) using real-world data. METHODS: A national multi-payer medical and pharmacy claims data (STATinMED RWD Insights) with nearly 80% of the US healthcare system was used. Data were extracted for female patients aged ≥18 years between January 1, 2015, and November 30, 2023. Index date was defined as the first date of BC diagnosis. Included patients were required to have continuous enrollment for a minimum of 12 months pre-index, 30 days post-index, and had ≥1 inpatient or ≥2 outpatient BC claims (ICD-9-CM: 174x, 175x; ICD-10-CM: C50x). Patients were excluded if they had metastasized disease, other cancers (not including non-melanoma skin cancers), any BC treatment, or had evidence of pregnancy during the 12-month baseline period. Proxies were used to determine BC subtype and cancer stage. MRD utilization was identified from the index date to study end time and/or patients’ death. Multivariate logistic regression was used to identify predictors of the MRD test adoption. RESULTS: Among 652,463 eligible patients (mean age: 65.4 years), 815 (0.12%) had evidence of MRD testing, the first one was in 2021, increased in 2022, and continued to the study end date of November 30th, 2023, with most of the MRD testing occurred in 2023 (n=748, 91.8%). The mean follow-up time per patient was 38.76 months (SD: 26.57) with a median follow-up per patient of 29.70 months. The mean age of MRD tested patients was 62.7 years; 67.7% were White; 60.1% were non-Hispanic; 36.0% had a college education; 51.4% had Medicare; 27.3% had an income below $25,000 and 55.5% resided in the Southern United States. Categorizing the subtype, 65.2% had HR+/HER2- BC, 23.3% had triple-negative BC (TNBC), and 9.5% had HR+/HER2+ BC. During the study time frame, 60.9% of patients received only one MRD test, 23.1% received two, 8.3% received three and the remaining 7.7% of patients received four or more MRD tests, for up to 10 MRD tests. The mean number of MRD tests per patient was 1.72 (SD: 1.27). Among the 815 MRD-tested patients, 392 (48%) had evidence of breast-conserving surgery (BCS). Of those 392 patients, 5 (1.3%) received MRD testing before the BCS and 387 (98.7%) received MRD test after the BCS. For every BC subtype, the average time between tests was > 80 days between the 1st and 2nd tests, > 70 days between the 2nd and 3rd tests, with shorter intervening times for additional MRD tests conducted during study period. Based on the multivariate logistic regression, key factors associated with the receipt or adoption of MRD test included younger age, advanced BC stage, BC subtype, and patients’ residence region. CONCLUSION: This descriptive analysis using real-world data offers insights into the early adoption of the MRD testing among BC patients in the United States. The real-world evidence showcased an upward adoption trajectory during the study period and there were variations in early utilization patterns. Findings herein provide hypothesis generating opportunities for future investigations. Key Words: 1. Molecular residual disease 2. MRD testing 3. ctDNA 4. Breast cancer 5. Real world data Citation Format: N. Gu, M. Kohli, S. J. Noga, Q. A. Le, J. Rodriguez-Silva, Y. Barhoush, L. Batchu, G. C. Carter. Early Adoption of Molecular Residual Disease Testing in Breast Cancer Patients using Real World Data [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS2-04-01.

e23259 Background : Oral-AZA was approved in the US in Sep 2020 for maintenance treatment of transplant-ineligible pts with AML in remission following intensive chemotherapy. Approval was based on the QUAZAR trial (NCT01757535), which showed that Oral-AZA was associated with longer survival outcomes than placebo in this pt population. Both the prescribing information and clinical guidelines recommend antiemetic prophylaxis with Oral-AZA for at least the first 2 cycles to prevent the most common adverse events, nausea and vomiting. However, the extent to which antiemetics are being used with Oral-AZA in the real world is not yet well understood. This study aimed to examine the use of antiemetics among pts with AML receiving Oral-AZA in RW clinical practice and to determine whether this has any association with duration of therapy (DoT). Methods : This was a retrospective, observational study using Flatiron Health electronic health record data from Jan 2014 to Apr 2023. Eligible pts were ≥18 years and had a diagnosis of AML and ≥1 order for Oral-AZA on or after Sep 1, 2020. The index date was date of Oral-AZA initiation. Pts were followed until death, loss to follow-up, or the end of the study. Pt characteristics were assessed on the index date; antiemetic use was assessed at index and over the follow-up period. For each pt, each 28-day cycle of Oral-AZA was denoted as “covered” or “not covered” by antiemetics according to whether the pt had ≥14 days of antiemetics available during the cycle. Total DoT was measured for Oral-AZA using cumulative incidence curves and compared between pts with their first 2 cycles covered and those without. Results: 189 pts with AML were included. Mean age was 66 years, 52% were female, 56% had evidence of prior cytarabine use, and 10% had a prior stem cell transplant. 152 pts had ≥2 cycles of Oral-AZA. Overall, less than half of pts (48%) had a claim for an antiemetic on the index date. 16% never initiated an antiemetic between index and the end of follow-up; in the remaining 84%, the mean time from the index date to antiemetic initiation was 57 days and 29% had a time to antiemetic initiation of > 56 days. Only 9% (14/152) of pts had both their first 2 Oral-AZA cycles covered by antiemetics. Overall, pts had a median of 5 Oral-AZA cycles. Pts with antiemetic coverage of their first 2 cycles had a median of 8.5 Oral-AZA cycles versus 6 in those without. The median DoT was longer for pts with antiemetic coverage of cycles 1 and 2 than those without (258 days vs 154 days). Conclusions: These findings suggest that antiemetics are not currently widely utilized with Oral-AZA in RW US clinical practice. This may reduce DoT and could potentially impact the likelihood of observing RW efficacy outcomes like those in the QUAZAR trial. Further studies are required to examine the association between guideline-recommended antiemetic use and clinical outcomes.

ABSTRACT Background This study retrospectively compared annualized billed bleed rates (ABRb) in people with hemophilia A (PwHA) without inhibitors who switched from factor VIII (FVIII) prophylaxis to emicizumab. Research design and methods A real-world comparison study was performed on the effect of switching from FVIII to emicizumab prophylaxis in male, non-inhibitor patients on ABRb using an all-payer claims database (APCD) dataset from 1 January 2014, to 31 March 2021. The identification period was from 1 November 2017, to 30 September 2020. Results One hundred and thirty-one patients were included with a total of 82 and 45 bleeds in the pre- and post-switch periods, respectively. The average follow-up period pre-switch was 978.37 days (SD 555.03), whereas the average follow-up period post-switch was 522.26 days (SD 191.36). No significant differences in mean ABRb were observed pre-/post-switch (0.25 and 0.20, respectively; P = 0.4456). Conclusions The results of this study demonstrate no significant reduction in ABRb, suggesting that switching from FVIII to emicizumab may not deliver incremental benefits to PwHA receiving prophylactic care.

ObjectiveAssess healthcare costs associated with systemic lupus erythematosus (SLE) flares among patients with and without lupus nephritis (LN).MethodsThis retrospective cohort study used medical and pharmacy claims data from the United States-based Optum Clinformatics database to identify adults with SLE between 1 January 2016, and 31 December 2018. Index was the date of a patient’s earliest SLE diagnosis claim during the identification period. Patients were categorized based on ICD-9/-10 diagnosis codes into one of two cohorts: SLE with LN (LN) and SLE without LN (non-LN). Baseline characteristics were assessed in the 12 months preceding index (baseline period). The presence, severity, and healthcare costs (in 2019 US dollars) of flares were determined in the 12 months following index (follow-up period).ResultsOverall, 11,663 patients with SLE were included (LN, n = 2916; non-LN, n = 8747). During the baseline period, a greater proportion of patients in the LN cohort versus non-LN cohort had a Charlson Comorbidity Index score ≥4 (72.5% vs 13.7%) and inpatient stays (41.0% vs 17.0%). A total of 12,190 flares were identified during the follow-up period (LN, 3494; non-LN, 8696). A greater proportion of flares experienced by patients with LN versus those without LN were moderate (61.2% vs 53.6%) and severe (10.6% vs 5.4%). The mean (standard deviation [SD]) number of moderate and severe flares per patient was greater among the LN cohort than the non-LN cohort (moderate: LN, 1.8 [1.2] and non-LN, 1.4 [1.2]; severe: LN, 0.2 [0.6] and non-LN, 0.1 [0.3]). The mean (SD) total healthcare costs associated with SLE flares of any severity were greater for patients with LN (LN, $5842 [9604]; non-LN, $2600 [4249]). The mean (SD) cost per flare increased with severity (mild: LN, $2753 [4640] and non-LN, $1606 [2710]; moderate: LN, $4561 [7156] and non-LN, $2587 [3720]; severe: LN, $29,148 [27,273] and non-LN, $14,829 [19,533]).ConclusionsPatients with SLE with LN have greater healthcare costs than those without LN. Flares among patients with LN were more frequent, severe, and costly than among patients without LN. This highlights the need for treatments that prevent or reduce flares among patients with SLE, both with and without LN.

In the sentence beginning 'After adjusting for age...' in this article, the value of upper CI limit '0.84' should have read '0.94'.