Association of patient characteristics with real-world ROS1 NSCLC testing patterns among community practices in the United States.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e18321-e18321
Author(s):  
William Bruce Wong ◽  
Ning Wu ◽  
Ravindra Gupta ◽  
Aaron Scott Mansfield

e18321 Background: Despite the availability of targeted therapy for ROS1 NSCLC since 2016, there is limited information on real-world ROS1 testing practices to identify patients potentially eligible for targeted treatment among community practices. The objective of this study was to characterize ROS1 testing rates and identify potential barriers to ROS1 testing. Methods: The Flatiron Health EHR-derived database was used to identify patients diagnosed with advanced NSCLC between 7/1/2016 - 7/30/2018 and received systemic treatment in a community practice setting. Descriptive statistics were used to summarize the population, biomarker testing rates and timing of testing. Logistic and multinomial regressions including patient demographics and clinical characteristics were used to identify factors associated with the following outcomes: ROS1 testing, testing for biomarkers other than ROS1 (PDL1, ALK, EGFR) , longer times from advanced diagnosis (adv. dx) to ROS1 test results and initiation of therapy prior to ROS1 testing. Results: Of 9,275 eligible patients, ROS1 testing rates in squamous (SQ) and non-squamous histologies increased over the study period (30% to 52%, 62% to 75% respectively). Older age, males, poorer performance status, SQ histology, history of smoking and recurrent disease (RD) patients were significantly less likely to be tested. Among patients not tested for ROS1, 62% were tested for other biomarkers including > 50% of non-squamous patients tested for PDL1, EGFR or ALK and 51% of squamous patients tested for PDL1. The median time from adv. dx to test result was 24 days, with patient characteristics (i.e. Hispanic ethnicity, history of smoking) as well as test type predicting longer times to test results ( > 41 days vs. < 24 days after adv. dx). Patients who had a delay in test results were more likely to receive other therapy prior to availability of their ROS1 test results (25+ days vs. < 24 days OR [95% CI]: 9.18 [7.87, 10.70]). Conclusions: In real-world practice, patient characteristics were associated with ROS1 testing and testing delays which may result in some patient subgroups being less likely to be identified for potential targeted therapy.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16740-e16740
Author(s):  
George P. Kim ◽  
Paul Cockrum ◽  
Andy Surinach ◽  
Jim M. Koeller

e16740 Background: The goals of randomized control trials (RCTs) are to make causal inferences and precise treatment comparisons, not to describe large heterogeneous pt populations. RWE allows population-based healthcare decision makers to assess and manage therapeutic and economic options for their pts, including those who would and would not have met inclusion/exclusion criteria of a given RCT and are instead managed under usual care, irrespective of clinical trial protocols. In the pivotal phase 3 trial, NAPOLI-1, 117 pts were treated with liposomal irinotecan + 5-fluorouracil/folinic acid, median age 63 years; 66% were treated first- (1L) or second line (2L), and 91% had performance score ECOG 0 or 1. Pts in the trial had overall survival (OS) of 6.2 months (mos), time to treatment failure (TTF) 2.3 mos, and 27% experienced grades 3-4 neutropenia. The present study describes the patient characteristics and outcomes of pts with mPDAC treated with liposomal irinotecan in the US. Methods: This retrospective observational study used data from Flatiron Health EHR-derived de-identified database from over 280 cancer clinics. Patient characteristics, OS, TTF, and rates of neutropenia during treatment (tx) were assessed in adult pts diagnosed with mPDAC who received liposomal irinotecan based tx between November 1, 2015 and October 31, 2019. Results: 600 pts with mPDAC treated with a liposomal irinotecan based regimen were identified. Of these, 56% were initially diagnosed with stage IV disease, 53% were male, 21% had undergone a previous Whipple procedure, and 61% initiated liposomal irinotecan in the 1L or 2L metastatic setting. Median age at tx initiation was 68 (IQR: 62 – 75) years. 92% of pts were treated in the community setting. Among pts with available ECOG (n = 440), 77.5% were score 0-1. Grade 3/4 neutropenia was observed in 11% (n = 66). Overall, median OS was 5.0 mos [95%CI: 4.2–5.6]. mOS among pts treated in 1L (n = 88), 2L (n = 280), and third line plus (3L+, n = 232) were 6.9 mos [5.3–9.2], 5.4 mos [4.6–6.4], and 4.0 mos [3.4–4.5], respectively. Overall, median TTF was 1.9 mos [1.6–2.1]. TTF by line was 3.5 mos [2.3–4.8] in 1L, 2.1 mos [1.7–2.8] in 2L, and 1.4 mos [1.2–1.6] in 3L. Conclusions: This real-world cohort of pts with mPDAC were older, had worse performance status, and had more prior lines compared to the pivotal trial for liposomal irinotecan. Median OS, TTF, and neutropenia were similar to those previously reported. As expected, pts receiving liposomal irinotecan in earlier lines had higher median OS and TTF.


Author(s):  
Celine Deschaseaux ◽  
Puza Sharma ◽  
Anders Gabrielsen ◽  
Athanasio Siadimas ◽  
Melissa Bauer ◽  
...  

Background: C-reactive protein can be measured by a high-sensitivity assay (hsCRP) to detect persistent low grade vascular inflammation predictive of cardiovascular (CV) risk in patients with history of myocardial infarction (MI). However, the real-world use of hsCRP testing among patient with history of MI, and hence the contemporary usage to address residual inflammatory risk, is unknown Methods: Patients with ≥1 claim with an inpatient, primary diagnosis for MI (ICD-9-CM code: 410.xx) between 01 October 2011 to 30 September 2014 (the most recent set as an index) in MarketScan and 1 year continuous enrolment pre- and post-hospital admission were included Results: A total of 71,071 patients (mean age 63.6 years, 67.6% males) were included. The hsCRP measurement was performed in 3.3% patients (CCAE: 4.7%; Medicare: 1.3%) with a mean time of 4.3 months after the index MI; 81.7% of patients were tested ≥30 days after the index MI. Patient characteristics and resource uses were similar among hsCRP tested and non-tested patients (Table 1) Conclusion: hsCRP testing with a potential to evaluate residual inflammatory CV risk is not used widely in routine clinical practice in US patients with history of MI. No systematic effect of hsCRP testing was observed with respect to patient characteristics and resource use. Further research is warranted to understand and describe the real-world usage of hsCRP testing to evaluate residual inflammatory risk and the associated patient characteristics, outcomes and burden of disease


Author(s):  
Ara H Rostomian ◽  
Daniel Sanchez ◽  
Jonathan Soverow

Background: Several studies have examined the risk of cardiovascular disease (CVD) among larger racial and ethnic groups such as Hispanics and African-Americans in the United States, but limited information is available on smaller subgroups such as Armenians. According to the World Health Organization, Armenia ranks eighth in CVD rates among all countries however it is unclear if Armenian immigrants living in the US have the same high rates of disease. This study examined whether being of Armenian descent increased the risk of having a positive exercise treadmill test (ETT) among patients treated at a safety net hospital in Los Angeles County. Methods: Data on patients who received an ETT from 2008-2011 were used to conduct a retrospective analysis of the relationship between Armenian ethnicity and ETT result as a surrogate measure for CVD. A multivariate logistic regression analysis was used to estimate the odds ratios (OR) for having a positive ETT among Armenians relative to non-Armenians, adjusting for the following pre-specified covariates: gender, age, diabetes, hypertension, hyperlipidemia, smoking, family history of coronary artery disease (CAD), and patient history of CAD. Results: A total of 5,297 patients, ages 18 to 89, were included. Of these, 13% were Armenian and 46% were male, with an average age of 53 years. Armenians had higher odds of having a positive ETT than non-Armenians (Crude OR=1.30, p=0.037, CI:1.02,1.66). After adjusting for CV risk factors, Armenians were still significantly more likely to have a positive ETT than non-Armenians (OR=1.33, p=0.029, CI:1.03,1.71). CAD (OR 2.02, p<0.001, CI:1.38,2.96), and hyperlipidemia (OR=1.31, p=0.008, CI:1.07,1.60) were also significantly associated with a positive ETT. Conclusion: Armenians have a higher likelihood of having a positive ETT than non-Armenians. This relationship appears to be independent of traditional CV risk factors and suggests a role for cultural and/or genetic influences.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 8561-8561
Author(s):  
Eric S. Nadler ◽  
Anupama Vasudevan ◽  
Kalatu Davies ◽  
Yunfei Wang ◽  
Ann Johnson ◽  
...  

8561 Background: Atezolizumab plus chemotherapy was the first CIT combination regimen approved for 1L treatment of ES-SCLC in 2019. This study investigated patient characteristics and treatment patterns for patients with ES-SCLC receiving this regimen in the real-world community oncology setting. Methods: This was a retrospective study including adult patients diagnosed with ES-SCLC between 01-Oct-2018 (after IMpower 133 publication in NEJM Sep-2018) and 31-Dec-2019, with follow-up through 31-March-2020 using The US Oncology Network electronic health records data. Descriptive analyses of patient characteristics and treatment patterns were conducted, with Kaplan-Meier (K-M) methods used to assess time to treatment discontinuation (TTD) and time to next treatment/death (TTNT). Results: Of the 408 patients included in this study, 267 (71.4%) received atezo+carboplatin+etoposide (Atezo+Chemo), 80 (21.4%) received carboplatin+etoposide (Chemo only) and the rest received other regimens. The Atezo+Chemo patients in the real-world cohort compared with the IMpower 133 trial (n = 201) were older (median age 68 vs. 64 years) and included fewer males (45% vs. 64%), fewer white race (73% vs. 81%), more patients with brain metastases at baseline (23% vs. 9%), and more patients with worse ECOG (2/3) performance-status score (24% vs. 0%). The median follow-up, TTD, and TTNT in months (mo) for the real-world cohort are presented in the table alongside the best comparable measures reported for the trial. Conclusions: Most patients in this real-world ES-SCLC cohort received the Atezo+Chemo regimen in the 1L setting. While the follow-up was much shorter and patients had worse baseline characteristics (age, brain metastases, ECOG) in the real-world setting compared to the IMpower 133 trial, the real-world median TTD in this descriptive analysis was found to be in line with the median duration of treatment in the trial. Further research with longer follow-up comparing the real-world effectiveness of the CIT and chemo regimens is needed.[Table: see text]


Author(s):  
Janey Phelps

Congenital heart disease is the most common type of birth defect and is estimated to affect nearly 1% of all births per year in the United States. Echocardiograms are necessary to fully evaluate these defects, and depending on the age of the child, sedation may be required to ensure optimal imaging. This chapter discusses the sedation/anesthesia options for transthoracic echocardiography, transesophageal echocardiography, and cardioversion. For all of these procedures high-risk patients should be triaged to a pediatric anesthesia provider and in some cases, a pediatric cardiac anesthesiologist. Transthoracic echocardiograms can be completed with distraction and/or minimal sedation with oral or intranasal midazolam. If moderate sedation is required due to patient characteristics or previous history of failure with minimal sedation, intranasal dexmedetomidine is a good option. Transesophageal echocardiography is an invasive procedure; patients <2 years of age should be intubated and those >2 years of age can maintain a native airway with deep sedation with propofol. The need for cardioversion is infrequent in pediatrics but when needed, propofol is a good choice.


2019 ◽  
Vol 6 (Supplement_2) ◽  
pp. S656-S656
Author(s):  
James Karichu ◽  
Mindy Cheng ◽  
Pedro Rodriguez ◽  
Nicole Robinson ◽  
Chakkarin Burudpakdee ◽  
...  

Abstract Background Current HIV diagnostic laboratory testing guidelines from the US Centers for Disease Control and Prevention (CDC) recommend a sequence of tests for detection, differentiation, and confirmation of HIV-1 and HIV-2 diagnosis. There is a gap in knowledge about real-world implementation of the testing algorithm. The aim of this study was to characterize the population that underwent HIV antibody differentiation and confirmatory testing and to describe subsequent testing patterns from a large US clinical laboratory database. Methods Patients who received one or more HIV-1/2 antibody differentiation test (BioRad Geenius™ HIV 1/2 Supplemental Assay [Geenius]) in the Quest Diagnostics laboratory database between January 1, 2017 and December 31, 2017 were selected into the study; earliest test date was index date. Geenius tests, HIV-1 qualitative RNA (Aptima HIV-1 RNA Qualitative Assay [Aptima]), and HIV-2 DNA/RNA confirmatory tests subsequent to index date were captured. Study measures included pt demographic characteristics, testing frequency and sequencing, and test results. For patients with >1 Geenius test in 2017, concordance between index and subsequent test results was assessed. Results There were 26,319 unique patients identified who received ≥1 HIV antibody differentiation result from the Geenius assay. Mean age was 40.7 ± 14.3 years, 66.4% were male, and 42.5% were from southern states. Among the study population, there were 28,954 Geenius, 7,234 Aptima, and 298 HIV-2 DNA/RNA confirmatory tests. 26.4% of Geenius test results were discordant with the initial positive fourth-generation HIV screening results and required subsequent confirmatory testing. In terms of sequencing, the CDC-recommended HIV diagnostic algorithm was followed 74% of the time after screening. 8.5% of patients had >1 Geenius test in 2017; 11.2% of the retests returned different results compared with the first test. Conclusion The CDC recommended algorithm for HIV diagnosis is complex for laboratories to implement and currently available assays do not support testing efficiency. To mitigate observed inefficiencies and reduce the laboratory burden of HIV testing, a more accurate and reliable approach for HIV differentiation and confirmatory testing is needed. Disclosures All authors: No reported disclosures.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18524-e18524 ◽  
Author(s):  
Bruno C. Medeiros ◽  
Bhavik J. Pandya ◽  
Anna Hadfield ◽  
Samuel Wilson ◽  
Cynthia Mueller ◽  
...  

e18524 Background: The effective treatment of patients with acute myeloid leukemia (AML) remains a challenge in clinical practice. This analysis describes the patient characteristics and real-world use of AML treatments in the United States for patients on high- and low-intensity treatment. Methods: Data from the Adelphi AML Disease-Specific Programme, a real-world, cross-sectional survey conducted between February–May 2015, were analysed. A total of 61 hematologist/hem-oncologists, across academic, non-academic and office-based practice locations, provided data on 457 AML patients. Patient characteristics were derived from physician-completed patient record forms where each physician was asked to provide treatment details, including the treatment intensity, for each line of therapy. Results: A total of 91% (n = 415) of patients included in this analysis were previously untreated for AML. Patients had a mean age of 60 years and been diagnosed with AML for a median of 5.0 months. At first-line induction therapy, over half (53%; n = 241) of the patients were initiated on a high-intensity treatment, the most common regimen being cytarabine plus anthracycline (61%; n = 147). The remaining 47% (n = 216) of patients received a low-intensity induction therapy such as low dose cytarabine monotherapy (28%, n = 61), azacitidine monotherapy (25%, n = 54), or decitabine monotherapy (21%, n = 45). Over half (55%, n = 62) of patients suited to high intensity treatment went on to receive cytarabine monotherapy during the consolidation phase of their first-line treatment. Conclusions: According to treating physicians, the large majority of patients receive traditional, well-established therapies at first-line induction for AML. Whilst cytarabine combinations dominate the high-intensity treatment setting, the hypomethylating agents, azacitidine and decitabine, are frequently used for those more suited to low-intensity treatment.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13076-e13076
Author(s):  
Elias Obeid ◽  
Rohan Parikh ◽  
Elizabeth Esterberg ◽  
Bhakti Arondekar ◽  
Abigail Hitchens ◽  
...  

e13076 Background: g BRCA1/2mut ABC represents ~5% of all breast cancer (BC) including pts with HER2+ BC. While HER2-targeted therapy remains an effective tx for those pts, limited information is available on the use and effectiveness of PARP inhibitors (PARPi) for pts with HER2+ g BRCA1/2mut ABC. Recently, NCCN updated its guidelines (v1.2020) to support the use of PARPi in pts with g BRCA1/2mut metastatic BC regardless of subtype. In order to establish a baseline reference point, we assessed real-world tx patterns and clinical outcomes among pts with g BRCA1/2mut HER2+. Methods: Oncologists retrospectively reviewed charts (July-Oct 2019) of randomly selected pts ≥18 y, with g BRCA1/2mut HER2+ABC who received ≥1 cytotoxic chemotherapy (CT) regimen(s) for ABC between Jan 2013-April 2018. Descriptive analysis was performed for 1st line ABC tx patterns. Clinical outcomes (1st line ABC PFS rates) were estimated using the Kaplan-Meier method. PARPi clinical outcomes data was immature given its recent launch. Additional analyses evaluating outcomes in pts receiving PARPi are planned. Results: Of the 225 pts with g BRCA1/2mut ABC included in the study, 48 (21%) female pts had HER2+ disease. Of the g BRCA1/2mut HER2+ pts, 77% were white with a median age of 58 y. Clinical characteristics: 42% HR+/HER2+, 56% HR-/HER2+, 2% had unknown HR/HER2+ ABC. Txs in the 1st line setting for HR+/HER2+ ABC pts (n = 20) included: CT (75%), CT + HER2-targeted therapy (25%) (Table). First-line txs used for HR-/HER2+ ABC pts (n = 27) included: CT + HER2-targeted therapy (78%), CT (15%), other (7%) (Table). 12-month PFS for 1st line HR+/HER2+ pts was 73% and for HR-/HER2+ pts was 69% (Table). Later line tx patterns will be presented. Conclusions: In this analysis of pts with g BRCA1/2mut HR+/HER2+, unexpectedly low rates of HER2-targeted therapy were observed. As expected, high rates of HER2-targeted therapy with CT were observed among g BRCA1/2mut HR-/HER2+ pts. Clinical outcome findings demonstrate the need for more efficacious tx options. Studies assessing clinical outcomes among g BRCA1/2mut HER2+ ABC pts receiving PARPi +/- HER2-targeted tx are warranted. This is a limited sample size; additional data collection including median PFS is ongoing. [Table: see text]


2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 457-457
Author(s):  
Marley Boyd ◽  
Srinivas Annavarapu ◽  
Gurjyot K. Doshi ◽  
Kentaro Imai ◽  
Eric Sbar ◽  
...  

457 Background: Benefit of IO (PD1 and PD-L1 inhibitors) for mUC was observed in clinical trials but real-world evidence for benefit and clinical outcomes is limited. Methods: This was a retrospective study of adult pts with mUC who initiated IO regardless of PD-L1 expression in the first- (1L cohort) or second-line (2L cohort) setting between 5/1/2016-1/31/2019 in the US Oncology Network (USON), a network of community oncology practices. Descriptive and Kaplan-Meier analyses to evaluate baseline characteristics, treatment patterns and clinical outcomes were conducted using data from USON’s electronic heath record. Results: Among 393 pts in the 1L cohort, median (range) age at IO initiation was 77 (42, 90+), 74% were male, 69% were White, and 19.1% and 4.1% had ECOG performance status (PS) 2 and 3/4, respectively. Among the 366 pts in the 2L cohort, median (range) age at IO initiation was 70 (29, 90+), 74% were male, 71% were White, and 19.7% and 1.4% had ECOG PS 2 and 3, respectively. Median (range) follow-up durations from IO initiation were 4.2 (0, 34.1; 1L cohort) and 4.1 (0, 31.3; 2L cohort) months (mo), during which time 43.1% (1L cohort) and 44.4% (2L cohort) of pts died. Median overall survival (OS) from IO initiation (95% confidence interval [CI]) was 10.6 (9.7, 13.2) mo for the 1L cohort and 9.4 (7.1, 11.5) mo for the 2L cohort; 1-year survival probabilities (95% CI) were 46.6% (40.1%, 52.8%; 1L cohort) and 43.4% (36.8%, 49.8%; 2L cohort). By the end of the follow-up, 48.1% of 1L pts and 47.8% of 2L pts were alive and did not advance to next line of therapy, and 13.5% of 1L and 13.4% of 2L cohort pts advanced to the next line of therapy. Median (95% CI) treatment durations were 2.6 (2.1, 2.9) and 2.8 (2.2, 3.5) mo for the 1L and 2L cohorts, respectively; 6-mo ongoing treatment probabilities (95% CI) were 26.6% (22.2%, 31.2%; 1L cohort) and 31.4% (26.4%, 36.4%; 2L cohort). Conclusions: OS of pts in the real world receiving 1L and 2L IO appears consistent with clinical trial results, although survival follow-up is limited. A minority of pts received post-IO therapy. Future research should examine influence of pt characteristics and PD-L1 expression on treatment choice and outcomes.


2021 ◽  
Author(s):  
Yuan Lu ◽  
Jing Li ◽  
Xialin Wang ◽  
Sreemanee Raaj Dorajoo ◽  
Mengling Feng ◽  
...  

ABSTRACT Background: Over one billion adults have hypertension globally, of whom approximately 70% cannot achieve blood pressure control goal with monotherapy alone. Data are lacking on patterns of dual combination therapies prescribed to patients who escalate from monotherapy in routine practice. Methods: Using eleven electronic health record databases that cover 118 million patients across eight countries/regions, we characterized the initiation of antihypertensive dual combination therapies for patients with hypertension. In each database, we first constructed twelve exposure cohorts of patients who newly initiate dual combination therapy with one of the four most commonly used antihypertensive drug classes (angiotensin-converting enzyme inhibitor [ACEi] or angiotensin receptor blocker [ARB]; calcium channel blocker [CCB]; beta-blocker; and thiazide or thiazide-like diuretic) after escalating from monotherapy with one of the three alternative classes. Using these cohorts, we then described dual combination therapy utilization, stratified by age, gender, history of cardiovascular diseases (CVD), and country. Results: Across data sources, we identified 980,648 patients with hypertension initiating dual combination therapy with antihypertensive agents after escalating from monotherapy: 12,541 from Australia, 6,980 from South Korea, 2,096 from Singapore, 7,008 from China, 16,663 from Taiwan, 103,994 from France, 76,082 from Italy, and 754,137 from the United States (US). Significant variations in treatment utilization existed across countries and patient subgroups. In Australia and Singapore, starting an ACEi/ARB monotherapy followed by a CCB was most common while in South Korea, China and Taiwan, starting a CCB monotherapy followed by an ACEi/ARB was most common. In Italy, France, and the US, sequential use of an ACEi/ARB monotherapy followed by a diuretic was most common. Younger patients were more likely to be prescribed ACEi/ARB followed by either a CCB or a diuretic compared with older patients. Women were more likely to be prescribed diuretics then an ACEi/ARB or a CCB compared with men. Among patients with history of CVD, ACEi/ARB followed by beta-blocker, and beta-blocker followed by ACEi/ARB were more commonly prescribed. Conclusion: This is the largest and most comprehensive study characterizing the real-world utilization of dual combination therapies in treating hypertension. Large variation in the transition between monotherapy and dual combination therapy for hypertension was observed across countries. These results highlight the need for future research to identify which second-line dual combination therapy is most effective in practice.


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