Primary anti-infective prophylaxis during routine treatment of lymphoma in the United States: A large real-world cohort analysis.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 268-268
Author(s):  
Mengyang Di ◽  
Pamela R. Soulos ◽  
Scott F. Huntington

268 Background: While infectious complications contribute to considerable morbidity and mortality in patients with cancer, most scenarios lack evidence to guide optimal anti-infective prophylaxis (AIP). We evaluated a large real-world dataset to identify baseline utilization and factors associated with AIP in patients with non-Hodgkin lymphoma (NHL) treated in the US-community setting. Methods: Using the nationwide Flatiron Health de-identified electronic health record-derived database (from ≈ 280 US cancer clinics), we selected patients treated prior to 7/1/2020 with 1) R-CHOP for DLBCL, 2) bendamustine and rituximab (BR) for CLL/SLL, or 3) ibrutinib for CLL/SLL. We limited our analysis to patients treated by providers with documented prescribing of guideline recommended anti-viral prophylaxis (ppx) during proteasome inhibitor administration to ≥1 multiple myeloma patient. Our main outcome was the documented use of primary AIP defined as anti-viral and/or pneumocystis jiroveci (PJP) ppx within +/- 14 days of treatment initiation. We also report the delayed documented AIP use from day 15 to 60. We applied separate multivariable logistic regression models to each setting to examine the associations of patient-level characteristics with primary AIP (including age, sex, race, region, insurance, ECOG, year of treatment initiation). Results: A total of 3,142 (R-CHOP for DLBCL), 2,180 (BR for CLL/SLL), and 3,590 (ibrutinib for CLL/SLL) patients were included, with median age of 69, 69, and 72 years, respectively. Primary AIP was most common during BR for CLL/SLL, with 16.8% receiving any AIP (antiviral 15.6%, PJP 7.3%). Primary AIP was used in 10.5% of DLBCL patients initiating R-CHOP (antiviral 7.6%, PJP 5.6%), with the lowest utilization of AIP during ibrutinib for CLL/SLL (any 6.4%, antiviral 5.6%, PJP 2.6%). In the delayed setting, an additional 4-6% and 2-5% received viral and PJP ppx, respectively. Across all three of our multivariable analyses, higher provider rate of anti-viral ppx during proteosome inhibitor administration in MM, residing in the Midwest (vs. Northeast), and more recent treatment initiation were associated with greater odds of AIP. Other patient characteristics (age, race, ECOG) were less consistently associated with AIP across models. Furthermore, C-statistics were <0.7 in all three models (0.660-0.685), suggesting suboptimal discrimination for AIP based on patient-level characteristics alone. Conclusions: We observed low utilization of primary AIP during treatment in three common NHL settings that lack clear consensus on AIP. Variation was not well explained by measured patient characteristics, and future studies should consider provider and system attributes. Ultimately, robust evidence generation (e.g. pragmatic clinical trials) and quality improvement measures are needed to optimize ppx during routine lymphoma management.

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.


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.


Author(s):  
Raffi Tachdjian ◽  
Karin Johnson ◽  
Deborah Casso ◽  
Susan Oliveria ◽  
Giovanna Devercelli ◽  
...  

Background: There is limited real-world evidence on hereditary angioedema (HAE) patient characteristics and health-careresource utilization (HCRU); in addition, pediatric patients have been described in small cohorts.Objective: To describe patient characteristics, treatment patterns, and HCRU among adult and pediatric patients treatedfor HAE in a large U.S. cohort.Methods: This retrospective cohort study used an administrative claims data base (January 2006 to September 2015).Eligible patients with either greater than or equal to one pharmacy claim for HAE-indicated therapies (C1 inhibitors, ecallantide, icatibant) or gtaer than or equal to two medical claims with codes associated with HAE (per medical billing codes), and greater than or equal to one claim for androgens, fresh frozen plasma, tranexamic acid, or « -aminocaproic acid formed a “treated cohort.” Three nonexclusive treated cohorts were assessed: overall, pediatric, and HCRU (greater than or equal to 2 years of continuous enrollment during 2010–2015).Results: Overall, 1429 patients received treatment (mean =/- 6 standard deviation [SD] age, 38.8 +/- 15.7 years; 62.4% femalepatients; mean +/- SD Charlson Comorbidity Index of 1.4 +/- 2.4). Common comorbidities were allergy or anaphylaxis (51.4%)and anxiety or depression (35.8%). Diagnoses indicative of HAE attacks included swelling and/or angioedema (78.5%), abdominalpain (55.6%), and asphyxiation (27.2%). Use of HAE-indicated medication rose between 2006 and 2015 to 81.8%, whereas androgen use declined (from 91.5% to 24.9%). Similar trends were observed in the pediatric treated cohort (n = 143). In the HCRU treated cohort (n = 538), HAE-related claims for emergency department and inpatient admissions were observed for 36.6% and 22.3% of patients, respectively.Conclusion: In a large U.S. cohort of adult and pediatric patients who received treatments indicated or used for HAE,common comorbidities and trends in resource use denoted the substantial burden of attacks, which reflected a continued needthat recently approved long-term prophylactic treatments may help to address


2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 550-550 ◽  
Author(s):  
Arthur C. Houts ◽  
Sarika Ogale ◽  
Nicolas Sommer ◽  
Mark Stephen Walker

550 Background: Patients with KRAS WT mCRC treated with B or C plus standard chemotherapy backbones had comparable outcomes in the Phase III CALGB 80405 trial; comparative effectiveness in a real-world community setting remains unknown. Methods: This retrospective study examined PFS and OS in a US community sample of adult, KRAS WT, mCRC patients treated 1st line with B or C containing regimens. Medical records from the Vector Oncology and Affiliate Data Warehouse were used. Disease progression was determined from patient charts. OS was measured from start of 1st line treatment until death; patients were censored at the last observed office visit. Results: B and C samples were comparable on patient characteristics (Table). Oxaliplatin-based and Irinotecan-based backbones were used more frequently with B and C, respectively. Median PFS and OS did not differ significantly between B and C, and were of similar magnitude as in CALGB 80405. In Cox models, number of metastatic sites was a significant predictor of PFS and OS, p < 0.01. Outcomes did not differ significantly with different chemotherapy backbones. Conclusions: Consistent with CALGB 80405, 1st line PFS and OS for KRAS WT mCRC patients treated with B or C were comparable in this real-world analysis. Further analyses will focus on treatment sequences. [Table: see text]


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e17020-e17020
Author(s):  
Shelby Corman ◽  
Chizoba Nwankwo ◽  
Youngmin Kwon ◽  
Ruchit Shah

e17020 Background: Treatment options for cervical cancer include surgery, radiation therapy, chemotherapy, and immunotherapy depending upon the disease stage. There is limited real-world evidence providing us with a clinical profile for a treated cervical cancer patient. The objective of this study was to compare cervical cancer patients who were currently receiving treatment versus those not receiving treatment. Methods: This was a retrospective, cross-sectional analysis of Medical Expenditure Panel Survey (MEPS) data (2006-2015). Cervical cancer cases were identified using ICD-9 CM code 180 or clinical classification software code 26. Patients receiving only chemotherapy, radiation therapy, undergoing surgery, or a combination of these treatments in a given year were regarded as “currently receiving treatment”. The comparator cohort included patients “not currently receiving treatment”. The two cohorts were compared in terms of patient clinical characteristics using bivariate analyses. Results: The analytic cohort consisted of 275,246 cervical cancer cases (mean age: 42 years, Caucasian: 88.0%, having private insurance: 55.3%) of which 115,639 (42.01%) were “currently receiving treatment”. The most common treatment option was undergoing surgery only (88.21%), followed by combination therapy (6.82%), chemotherapy only (3.84%), and radiation therapy only (1.12%). The “currently receiving treatment” cohort had a significantly higher proportion of patients having a history of myocardial infarction (4.21% vs 3.50%), congestive heart failure (2.73% vs 1.42%), chronic obstructive pulmonary disorder (29.5% vs 23.2%), connective tissue disease (20.5% vs 11.6%), renal disease (2.49% vs 0.48%), and diabetes (17.7% vs 11.7%) compared to those “not currently receiving treatment”. The latter cohort had a higher proportion of patients with moderate/severe liver disease (0.46% vs 5.32%). Conclusions: The observed real-world patient characteristics and treatment patterns were indicative of a cohort of largely early stage cervical cancer patients. Patients receiving treatment appeared to have a higher comorbidity burden which may subsequently result in poorer quality of life and activity limitations.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e16751-e16751
Author(s):  
Jim M. Koeller ◽  
Paul Cockrum ◽  
Bruce Belanger ◽  
Frank A. Corvino ◽  
Andy Surinach ◽  
...  

e16751 Background: The NAPOLI-1 study, a randomized phase 3 study in pts with mPDAC previously treated with gemcitabine-based therapy, demonstrated an improvement in overall survival (OS) with liposomal irinotecan + 5-fluorouracil/ leucovorin (5-FU/LV) vs. 5-FU/LV. In this analysis we describe the trends in pt characteristics, real-world OS (rwOS), and real-world time to-treatment failure (rwTTF) among pts with mPDAC treated with liposomal Irinotecan based regimens overall and stratified by tx initiation prior to 2018 (pre-2018) or after 2018 (post-2018). Methods: This retrospective observational study used de-identified data from Flatiron Health EHR database from over 280 cancer clinics in the US. Pt characteristics, rwOS, and rwTTF were assessed in adult pts diagnosed with mPDAC who received liposomal irinotecan treatment (tx) between January 1, 2016 and October 31, 2019. Results: Of the 590 pts treated with liposomal irinotecan based regimens, 53% were male, 56% were initially diagnosed with Stage IV disease, 92% were treated in the community setting, and median age at tx initiation was 69 (IQR: 62 – 75) years. Among pts with available ECOG scores (N = 435), 77% had a score of 0 or 1. 43% (n = 254) initiated tx pre-2018 and 57% (n = 336) post-2018. Pre-2018, 106 (42%) pts initiated liposomal irinotecan in the third line metastatic setting or later (3rd line+), 125 (49%) had ECOG score of 0-1, and median age was 68 (62–74) years. Post-2018, 36% of pts initiated tx in 3rd line+, 211 (63%) had ECOG score of 0-1, and median age was 70 (63 – 75) years. Median rwOS was 4.4 months [95% CI: 4.3–6.2] pre-2018 and 5.2 mos [4.3–6.2] post-2018. rwTTF was 1.6 mos [1.4–1.9] pre-2018 and 2.1 mos [1.6–2.5] among pts post-2018. Among pts treated in first- or second-line, pre-2018 rwOS was 5.3 mos [3.9–6.4] and post-2018 rwOS was 6.3 mos [5.0– 7.6]. Conclusions: In this descriptive real-world study of pts with mPDAC receiving liposomal irinotecan based regimens, pts initiating treatment post-2018 appear to be less pre-treated, older, and have better performance status than pts pre-2018. Pts treated post-2018 experienced numerically longer rwTTF and rwOS than pts treated pre-2018.


2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 49-49
Author(s):  
Andrea Leith ◽  
Amanda Ribbands ◽  
Matthew Last ◽  
Alicia Gayle ◽  
Sarah Payne ◽  
...  

49 Background: In May 2020, Olaparib was approved for HRRm mCRPC post progression on abiraterone and enzalutamide, and rucaparib was approved for BRCAm mCPRC following progression on androgen receptor targeted inhibitors and prior taxane therapy for mCRPC. HRRm are associated with approximately 25% of mCRPC and may be derived from germline or somatic origin. Somatic and germline alterations can be detected by tumour testing, but to differentiate between these, independent germline testing is needed. This study examined real-world genomic/genetic testing (GT) patterns in patients (pts) diagnosed with mCRPC in the United States (US). Methods: Data were drawn from the Adelphi Prostate Cancer Disease Specific Programme; a point-in-time survey administered to oncologists (onc), urologists (uro) and surgeons (sur) between January and August 2020 in the US. Physicians (phys) completed an attitudinal survey and a patient record form for the next four to nine mCRPC pts seen. Study variables included patient demographics, clinical factors and GT patterns. HRRm testers were defined as phys who tested for HRRm. Pts were identified as positive, negative or unknown depending on the outcome of the HRRm test. Results: A total of 72 phys (69% onc/ 29% uro/ 1% sur; 40% academic vs. 60% community) reported on 346 mCRPC pts. 41% of phys were based in the Northeast, 24% Midwest, 23% South and 13% in the West region of the US. 65 phys (90%) reported having access to overall GT; of these 5% identified as having access to germline tests only, while 94% were able to test for germline and somatic mutations. Challenges to conducting GT overall were ‘cost per test’ (50%), ‘having to send out for the tests (within country)’ (25%), ‘inadequate sample available’ (25%) and ‘patient refusal’ (25%). GT was typically conducted at identification of castrate-resistance (52%), metastases (51%) and at initial diagnosis (49%). 72% of total phys were HRRm testers; for these, patient characteristics primarily driving HRRm testing included Ashkenazi Jewish heritage (63%) and ECOG of 2-4 (58%). Other common drivers were family history, young diagnosis age and hormone therapy failure (all 46%). 132 (38% of 326) mCRPC pts were tested for HRRm; 39% of tested pts were identified with a HRRm. Most common HRRm tested were BRCA1 (90%), BRCA2 (89%) and ATM (55%). Conclusions: In this study majority of US phys had access to GT, but testing was only performed in 38% of pts with mCRPC. The higher than expected % of pts identified with an HRRm suggest that molecular testing was prioritised in high risk populations, as identified by the phys. With the recent approval of olaparib and rucaparib, GT may become more routine in clinical practice to identify eligible pts. Broader testing may also depend on addressing other barriers to testing including cost and testing logistics/practicalities.


2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 90-90
Author(s):  
Richard DeClue ◽  
Whitney Rhodes ◽  
Neil A Accortt ◽  
Ran Jin ◽  
Darcie Sandschafer ◽  
...  

90 Background: Bevacizumab-awwb is a biosimilar to bevacizumab approved by the FDA based on evidence obtained in a phase 3 study in non-squamous non-small cell lung cancer. The present real-world evidence study evaluated experience with bevacizumab-awwb (launched 07/19/2019) in patients with metastatic colorectal cancer (mCRC) in a real-world oncology setting to gain insight into biosimilar use for a bevacizumab-awwb approved indication lacking clinical trial data. Methods: This retrospective analysis identified patients, age ≥ 18 years (y), within existing medical records diagnosed with mCRC who initiated bevacizumab-awwb as first- or later-line treatment. Patients were identified from the ConcertAI Definitive Oncology Dataset, a consolidated EMR database of CancerLinQ and Vector Oncology, representing geographically diverse practice locations, including rural and urban centers, within the United States. Results: A total of 304 patients were eligible for this analysis. First use of bevacizumab-awwb in mCRC occurred within 20 days of product launch. Most patients (n = 262, 86%) were treated in a community setting and more than half of all eligible patients received prior bevacizumab (n = 162, 53%). Among 42 patients treated in academic settings 29 (69%) had not received bevacizumab prior to receiving bevacizumab-awwb. In the 162 patients with prior bevacizumab use, 134 (83%) had no recorded disease progression between the last bevacizumab infusion and start of bevacizumab-awwb. Among these 134 patients, 111 (83%) received bevacizumab-awwb within 28 days of last bevacizumab dose. Demographic and clinical characteristics of patients stratified by prior bevacizumab use were comparable (Table). In both subgroups most patients had an adenocarcinoma histological diagnosis with primary tumors in the rectum or sigmoid colon. Overall, most frequent comorbidities of mCRC patients were diabetes (24%), chronic obstructive pulmonary disease (10%), and renal disease (8%). Conclusions: Patients with mCRC who received bevacizumab-awwb in this real-world oncology setting in the first year post product launch were similar regardless of prior bevacizumab use. Among patients with prior bevacizumab use, 83% continued with bevacizumab-awwb in the same line. In the subset of patients without progression post bevacizumab, most received bevacizumab-awwb within 28 days of last bevacizumab dose demonstrating use of bevacizumab-awwb in new and continuing patients. [Table: see text]


2021 ◽  
Vol 42 (1) ◽  
pp. 55-64 ◽  
Author(s):  
Brian Stone ◽  
Karen Rance ◽  
Douglas Waddell ◽  
Mark Aagren ◽  
Eva Hammerby ◽  
...  

Background: There is a dearth of real-world evidence studies focused on allergy immunotherapy (AIT) use among patients with allergic rhinitis (AR). Objective: This study examined claims data of AR patients residing in the United States to assess patient characteristics and health outcomes. Methods: AR patients were identified in the IBM MarketScan database between January 1, 2014, and March 31, 2017. Patients receiving AIT were identified with relevant billing codes (earliest AIT claim for vaccine as the index date); patients without AIT were identified with claims that contained a diagnosis code for AR (earliest AR claim as the index date). All the patients were required to have continuous enrollment 12 months prior to and following their index date. AIT patients reaching 25+ injection claims were analyzed as a separate maintenance cohort. Patients were assessed for demographic characteristics, comorbid conditions, and health care utilization. Results: A total of 2,334,530 AR patients were included; 103,207 had at least one AIT claim, with 45,279 (43.9%) of these patients reaching maintenance. Patients who reached AIT maintenance presented higher rates of baseline comorbidities than both the full AIT cohort and the patients with no AIT claims, including asthma (34.6% versus 30.1% versus 7.5%) and upper respiratory tract infections (63.1% versus 60.3% versus 34.2%). From baseline to follow-up, maintenance AIT patients demonstrated reductions in all AR-related comorbidities assessed, along with reductions in all-cause and AR-related service utilization. Conclusion: Patients initiating AIT presented the greatest need for therapeutic intervention, as evidenced by higher allergy-related comorbidities; those who reached maintenance demonstrated improved outcomes following the initiation of therapy. Continued efforts to increase patient awareness and adherence to AIT are needed.


2020 ◽  
Author(s):  
Hua Zhao ◽  
Bernard Fuemmeler ◽  
Tilahun Adera ◽  
EVAN Leung ◽  
Silviu-Alin Bacanu ◽  
...  

BACKGROUND Significant variations in experience of the COVID-19 pandemic have been observed in the United States. However, there is currently no published study which comprehensively examines the relationship between patient characteristics and COVID-19 related health outcomes. OBJECTIVE In this study, using aggregated real-world data extracted from TriNetx electronic medical record data from 34 hospitals around United States, we intended to fill the gap. METHODS A total of 12,555 patients aged 18-80 years old who contracted COVID-19 were identified from January 20th to April 20th, 2020. RESULTS First, in the univariate analysis, we found that patients who were older (age 51-80), Black, male, and had pre-existing chronic diseases (e.g. obesity, diabetes, hypertension, and chronic kidney diseases (CKD)) had increased risk ratio (RR) of exhibiting severe outcomes, including increased C-reactive protein (CRP), decreased oxygen saturation, hospitalization, use of ventilator, and ultimately death. Next, we applied propensity score matching to match the patients based on their characteristics. We found that patients who were older, Black, male, and diagnosed with CKD had 3.69, 1.77, 1.75, and 1,61-fold increased RR of death. On the other hand, while obesity, diabetes, and hypertension had no direct relationship with death, they were associated with other severe outcomes. In further analysis by including CRP as a matching variable, death disparity by age group, race, gender, and CKD was reduced, particularly for race and CKD where a significant disparity was no longer observed. CONCLUSIONS In summary, our data show significant disparities in COVID-19 related outcomes by patient characteristics and further suggest that acute inflammation plays an important role in the disparity in COVID-19 death.


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