Real-world treatment patterns and outcomes in patients with follicular lymphoma in the United States.

e19534 Background: Despite the availability of new therapies for follicular lymphoma (FL), there are limited data on the real-world treatment (tx) of FL in a contemporary cohort of patients (pts). We examined tx patterns and outcomes in pts who received FL therapy in the US. Methods: This retrospective cohort study used the nationwide Flatiron Health electronic health record-derived de-identified database. During the study, the de-identified data originated from ̃280 cancer clinics (̃800 sites of care) in the US. We selected pts aged ≥18 years, with an initial FL diagnosis (ICD-9-CM: 202.0x; ICD-10-CM: C82.0x) between January 2011 and July 2020, who had received ≥1 line of therapy (LOT) for FL (follow-up ended September 2020). The initiation date of a LOT was considered the index date for analyses by LOT. Pts with evidence of clinical trial participation during the study period, high-grade (3b) FL at diagnosis, transformed aggressive lymphoma at any time before first-line (1L) FL tx, or chemotherapy/immunotherapy or stem cell transplant 12 months before 1L FL tx, were excluded. Pt characteristics at diagnosis were assessed using descriptive statistics. Tx patterns and clinical outcomes (time to next tx [TTNT] and overall survival [OS]) were reported by LOT. Median TTNT and OS were estimated using Kaplan–Meier methods. Results: Overall, 2383 pts met all eligibility criteria. Median age at FL diagnosis was 66 years; 49.2% were male, 77.5% had low-grade (1–2) FL, and 75.2% had advanced stage (III/IV) FL at diagnosis. Median follow-up was 43.1 months, and median time from diagnosis to 1L FL tx was 38 days. Most pts received up to 2 LOTs (n=2258 [94.8%]). The most common regimens across all LOTs were rituximab-bendamustine (R-benda; n=1256 [52.7%]), R monotherapy (n=812 [34.1%]), R-CHOP (n=483 [20.3%]), R-CVP (n=172 [7.2%]), and obinutuzumab (G)-benda (n=77 [3.2%]). The use of newer FL therapies was limited across all LOTs, but more common in the third-line onwards (3L+): chemotherapy-free combinations (R-/G-lenalidomide): 2.3% (all LOTs) and 19.2% (3L+); and phosphoinositide 3-kinase inhibitors: 1.6% (all LOTs) and 21.6% (3L+). In total, 111 (4.7%) pts received G-based regimens. Median TTNT after 1L and second-line onwards (2L+) was 79.4 months and 38.3 months, respectively. Median OS was not reached (NR) and 82.9 months after 1L and 2L+, respectively (Table). Conclusions: We provide a comprehensive update on real-world tx patterns and clinical outcomes in pts with FL in the US. Chemoimmunotherapy remains the standard of care across all LOTs, though the shorter durations of TTNT and OS in 2L+ may support the role of novel therapies in this setting. Tx outcomes by LOT.[Table: see text]

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Real-World Use of Maintenance Therapy and Associated Outcomes Following Autologous Stem Cell Transplant in US Patients with Newly Diagnosed Multiple Myeloma

Blood ◽

10.1182/blood-2020-139882 ◽

2020 ◽

Vol 136 (Supplement 1) ◽

pp. 25-26

Author(s):

Eric M. Ammann ◽

Annette Lam ◽

Wenze Tang ◽

Tobias Kampfenkel ◽

Mohit Sharma ◽

...

Keyword(s):

Multiple Myeloma ◽

Stem Cell ◽

Maintenance Therapy ◽

Clinical Outcomes ◽

Real World ◽

Treatment Patterns ◽

Cell Transplant ◽

Newly Diagnosed ◽

The Us

Background: In patients with newly-diagnosed multiple myeloma (NDMM) who receive frontline autologous stem cell transplantation (ASCT), maintenance therapy (MT) following ASCT has been shown to delay disease progression and death. Current National Comprehensive Cancer Network (NCCN) guidelines also recommend MT for patients with MM, including the use of lenalidomide, bortezomib-based regimens, or ixazomib. However, there is limited evidence on the use and outcomes associated with MT in contemporary real-world patients. The present study assessed MT treatment patterns and clinical outcomes in a real-world US cohort of patients with NDMM following ASCT. Methods: This retrospective, observational cohort study included NDMM patients initially diagnosed from 2011-2018 who received frontline ASCT. Patients were selected from the US Flatiron Health (FH) deidentified electronic health record (EHR)-derived database, which includes longitudinal patient-level data from over 265 community-based and academic cancer clinics across the US. To ensure capture of post-ASCT consolidation and MT, the study sample was restricted to patients who resumed contact within the FH network within 60 days following ASCT. Patients were excluded if they received treatment within the context of a clinical trial or had a second transplant within 180 days of their initial ASCT. Patients were classified as receiving MT if (during the 180-day post-transplant period) they initiated treatment with an NCCN-recommended MT regimen or continued to receive a subset of the antimyeloma agents used as induction regimen following ASCT and consolidation (if any). Key measures included baseline demographic and clinical characteristics, antimyeloma treatments (frontline induction, consolidation, and MT, if any), and clinical outcomes (time to next myeloma treatment [TTNT] and overall survival [OS]). Treatment duration and clinical outcomes were analyzed using Kaplan-Meier estimators and Cox regression to account for right-censoring. For TTNT and OS, follow-up began on the earlier of the ASCT date + 90 days or start of MT and continued through the dataset cut-off date (May 30, 2020) or loss to follow-up; TTNT and OS were estimated for patients receiving lenalidomide maintenance [R-MT], bortezomib maintenance [V-MT], or no MT, but was not estimated for other MT regimens due to sample size considerations. Results: 528 NDMM patients (median age 61 years, interquartile range [IQR]: 55, 68; 45.3% female) underwent ASCT and met study inclusion criteria. The most common induction regimens were bortezomib-lenalidomide-dexamethasone (VRd; 60.0%), lenalidomide-dexamethasone (Rd; 16.3%), and cyclophosphamide-bortezomib-dexamethasone (CyBorD; 10.2%). Following ASCT, 7.2% of patients received consolidation therapy and 74.2% received MT (lenalidomide monotherapy [R-MT]: 58.7%; bortezomib monotherapy [V-MT]: 7.6%; other MT: 7.8%). Median duration of MT was 18.0 months (IQR: 8.7, 29.1), and was similar for R-MT and V-MT (median 18.9 and 18.6 months, respectively). MT use increased from 69.3% to 79.0% from 2011-2013 to 2017-2018 (P=0.04); in addition, patients were more likely to have received VRd as induction across different MT (Table 1). R-MT and V-MT were both associated with longer TTNT relative to no MT (unadjusted hazard ratios [HRs]: 0.29 [95% CI: 0.22, 0.38] and 0.39 [95% CI: 0.25, 0.61], respectively) (Figure 1A). Improvements in OS were marginally significant with R-MT (HR: 0.58 [95% CI: 0.33, 1.00]) and nonsignificant with V-MT (HR: 0.86 [95% CI: 0.35, 2.11]) relative to no MT (Figure 1B); however, the OS estimates are characterized by low precision due to the relatively small number of events observed. Limitations included lack of documentation of reasons for treatment in the FH database, and use of consolidation and MT were inferred from observed treatment patterns; therefore, misclassification of MT was possible. Conclusions: This analysis demonstrates that MT use following ASCT has increased in routine clinical practice in the US since 2011-2013, with R-MT being the most common regimen followed by V-MT. However, a substantial proportion of patients did not receive MT. MT use in real-world settings was associated with longer TTNT and a trend toward longer OS. Exploration of additional maintenance regimens to improve clinical outcomes is warranted in this patient population. Disclosures Ammann: Janssen Scientific Affairs: Current Employment, Current equity holder in publicly-traded company. Lam:Janssen: Current Employment. Tang:Janssen: Current Employment. Kampfenkel:Janssen: Current Employment. Sharma:Mu Sigma: Current Employment; Janssen: Other: Contractor. Lee:Janssen: Current Employment. Kaila:Janssen Scientific Affairs: Current Employment. Fu:Janssen: Current Employment. Gray:Janssen: Current Employment. He:Janssen: Current Employment.

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Healthcare utilization and costs associated with first-line treatment with obinutuzumab- and rituximab-based regimens for follicular lymphoma.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.e19536 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. e19536-e19536

Author(s):

Jamie T. Ta ◽

Tu My To ◽

Cheryl Sud ◽

Sheila Shapouri ◽

Arpamas Seetasith

Keyword(s):

Follicular Lymphoma ◽

Healthcare Utilization ◽

Real World ◽

Healthcare Costs ◽

Trial Participation ◽

Administrative Claims ◽

Cell Transplant ◽

First Line ◽

Real World Data ◽

Eligibility Criteria

e19536 Background: Current real-world data on healthcare utilization (HCU) and costs of common first-line (1L) follicular lymphoma (FL) regimens, including obinutuzumab (G), remain limited. The aim of this study was to examine real-world HCU and costs for the most common National Comprehensive Cancer Network (NCCN)-recommended 1L FL treatments. Methods: This was a retrospective cohort study using administrative claims data from the IQVIA PharMetrics Plus and IBM MarketScan Commercial and Medicare Supplemental databases. We identified patients (pts) ≥18 years, who had ≥1 inpatient claim or ≥2 outpatient claims, with a diagnosis of FL from February 1, 2015 to March 31, 2020, and had received 1L FL treatment (per NCCN guidelines) between February 1, 2016 and September 30, 2019. The first claim for FL treatment was the index date. All pts had ≥12 months of pre- and ≥6 months of post-index continuous enrollment in medical and pharmacy benefits. Pts with other primary cancers, FL treatment, or stem cell transplant during the pre-index period, and clinical trial participation or end-stage renal disease during the study period were excluded. All-cause HCU and costs (2020 USD) per pt during the 6-month post-index period were reported for the five most common 1L FL regimens (only complete NCCN regimens were considered). Results: Overall, 1991 pts met the eligibility criteria, and 53% were male. The mean (standard deviation [SD]) age and Charlson Comorbidity Index at index were 58 (10.4) years, and 1.7 (1.0), respectively. The most common 1L regimens were rituximab-bendamustine (R-benda; n=818 [41.1%]), R-monotherapy (R-mono; n=592 [29.7%]), R-CHOP (n=461 [23.2%]), G-benda (n=86 [4.3%]), and R-CVP (n=34 [1.7%]). The proportion of pts who had ≥1 hospitalization or an emergency room visit was highest with R-CHOP (26.7% and 33.6%, respectively) and lowest with R-mono (11.3% and 18.1%, respectively). Mean (SD) all-cause total healthcare costs were highest with R-benda and G-benda, followed by R-CHOP, R-CVP, and R-mono (Table). Mean (SD) all-cause medical and FL treatment costs (drug and administration) were highest for R-benda ($174,407 [$110,520]; $135,520 [$96,492]) and lowest for R-mono ($87,368 [$83,910]; $54,271 [$40,433]). Conclusions: This real-world study provides an update on HCU and costs among pts initiating current NCCN-recommended 1L treatment for FL. Unadjusted 6-month total healthcare costs were highest with R-benda, followed by G-benda, while the lowest costs were seen with R-CVP and R-mono. Future studies with adjustment for pt characteristics are needed to compare HCU and costs between FL regimens.[Table: see text]

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Real-world outcomes in patients (pts) with metastatic urothelial carcinoma (mUC) who received first- or second-line immunotherapies (IO) in the United States (US).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.6_suppl.457 ◽

2020 ◽

Vol 38 (6_suppl) ◽

pp. 457-457

Author(s):

Marley Boyd ◽

Srinivas Annavarapu ◽

Gurjyot K. Doshi ◽

Kentaro Imai ◽

Eric Sbar ◽

...

Keyword(s):

Clinical Outcomes ◽

Real World ◽

Performance Status ◽

The United States ◽

Future Research ◽

Second Line ◽

Ecog Performance Status ◽

Using Data ◽

Line Of Therapy

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.

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1358. A Real-World Study of the Burden of Illness and Treatment Patterns Among Patients with Uncomplicated Urogenital Gonorrhea in the United States

Open Forum Infectious Diseases ◽

10.1093/ofid/ofab466.1550 ◽

2021 ◽

Vol 8 (Supplement_1) ◽

pp. S765-S766

Author(s):

Madison T Preib ◽

Fanny S Mitrani-Gold ◽

Ziyu Lan ◽

Xiaoxi Sun ◽

Ashish V Joshi

Keyword(s):

Real World ◽

Healthcare Costs ◽

Linear Models ◽

Burden Of Illness ◽

Unmet Need ◽

The United States ◽

Prescribing Practices ◽

Real World Data ◽

The Us

Abstract Background Gonorrhea (GC) is a major public health threat in the US. The Centers for Disease Control and Prevention (CDC) estimated direct healthcare costs of &271 million in 2018. CDC 2015 guidelines (applicable up to December 18, 2020) recommended cephalosporin plus azithromycin for GC. We used real-world data to assess patterns of inappropriate or suboptimal (IA/SO) or appropriate and optimal (AP&OP) antibiotic (AB) prescription (by CDC 2015 guidelines), and related healthcare costs, in US patients with uncomplicated urogenital GC (uUGG) diagnosed from July 1, 2013–June 30, 2018. Methods A retrospective cohort study of IBM MarketScan data (commercial/Medicare claims) in patients ≥ 12 years old with uUGG. Eligible patients had an AB prescription ±5 days of uUGG diagnosis (index date) and continuous health-plan enrollment with ≥ 6 months’ baseline/≥ 12 months’ follow-up data. Patients with complicated urogenital GC were excluded. Patients were stratified by AB prescription (IA/SO or AP&OP; defined in Table 1) during the first uUGG episode (ie, within 30 days of index). Generalized linear models were used for multivariate analysis. Table 1. Definitions of appropriateness of AB prescriptions Results Of 2847 patients with uUGG (58.5% male), 77.1% had an IA/SO prescription (mostly due to IA AB class [~82.0%] and duration [24.0%]), while only 22.9% had an AP&OP prescription; uUGG episodes were more frequent with IA/SO (n=2386) than AP&OP (n=714) prescriptions during follow-up. Patients with IA/SO prescriptions had higher GC-related total adjusted costs per patient (PP) per index episode (&196) vs those with AP&OP prescriptions (&124, p < 0.0001; Figure). Patients with IA/SO prescriptions also had higher GCrelated total adjusted costs PP during follow-up (&220) vs those with AP&OP prescriptions (&148, p < 0.0001), mostly driven by higher outpatient ambulatory and emergency room (ER) adjusted costs with IA/SO (&148 and &71, respectively) vs AP&OP prescriptions (&129 and &12, respectively, p ≤ 0.0152; Figure). ER visits PP at index and during follow-up were higher with IA/SO vs AP&OP prescriptions (p < 0.0001; Table 2). Figure. GC-related costs per patient with uUGG, stratified by appropriateness of AB prescription* Table 2. GC-related HRU per patient with uUGG, stratified by AB prescription Conclusion Most patients with uUGG were not prescribed treatments in accordance with CDC 2015 guidelines. High IA/SO AB prescriptions and associated healthcare costs suggest an unmet need for improved prescribing practices for uUGG in the US. Disclosures Madison T. Preib, MPH, STATinMED Research (Employee, Former employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Fanny S. Mitrani-Gold, MPH, GlaxoSmithKline plc. (Employee, Shareholder) Ziyu Lan, MSc, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Xiaoxi Sun, MA, STATinMED Research (Employee, Employee of STATinMED Research, which received funding from GlaxoSmithKline plc. to conduct this study) Ashish V. Joshi, PhD, GlaxoSmithKline plc. (Employee, Shareholder)

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Abstract 307: Real-world Clinical Characteristics and Recurrence Burden of Patients Diagnosed With Recurrent Pericarditis in The United States

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/hcq.13.suppl_1.307 ◽

2020 ◽

Vol 13 (Suppl_1) ◽

Author(s):

David Lin ◽

Christine Majeski ◽

Maral DerSarkissian ◽

Matt Magestro ◽

Cristi Cavanaugh ◽

...

Keyword(s):

Real World ◽

The United States ◽

Recurrent Pericarditis ◽

Real World Data ◽

Acute Pericarditis ◽

The Us ◽

History Of ◽

Artery Disease ◽

First Recurrence

Introduction: Real-world data describing acute pericarditis (AP) etiology in the US are limited. Data on the characteristics of recurrent pericarditis (RP) patients (pts) are also sparse. To fill this gap, our study assesses longitudinal data from a nationwide privately-insured population. Methods: OptumHealth Reporting and Insights employer claims data (1/2007-3/2017) were used. AP pts were identified and categorized as idiopathic or non-idiopathic etiology based on presence or absence of attributable conditions. Among idiopathic AP pts, a subgroup of RP pts was identified. Recurrence was defined as ≥2 AP events separated by >4 weeks. First recurrence date marked the index date. Pts aged ≥18 years with ≥12 months of continuous enrollment pre-index (baseline) were included. Results: Of 17,168 AP pts, 4,175 (24.3%) had non-idiopathic and 12,993 (75.7%) had idiopathic etiology (Table 1). Application of inclusion criteria left 8,822 idiopathic AP pts, of whom 1,604 (18.2%) had ≥1 recurrence during a mean observation period of 29 months. On average, idiopathic RP pts were aged 50.7 years, 51.6% female, and 42.3% had baseline history of hypertension, 23.8% of coronary artery disease, 11.7% of hypercholesterolemia, and 7.3% of myocardial infarction. Mean (±SD) time from initial AP diagnosis to first recurrence was 8.7 (±12.1) months and mean (±SD) number of recurrences was 1.7 (±1.3) per pt. In idiopathic RP pts with ≥4 years of follow-up after the initial AP diagnosis (N=512), 35.9% had ≥2, 18.2% had ≥3, and 9.8% had ≥4 recurrences within 4 years. Conclusions: The etiologic distribution and proportion of pts with RP are consistent with previous reports. About 36% of RP pts experience ≥2 recurrences after AP diagnosis over 4 years. RP represents a significant clinical burden for affected pts.

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Real World Evidence in Relapsed/Refractory Classical Hodgkin Lymphoma Patients Who Are Ineligible for Stem Cell Transplant in the United States (US)

Blood ◽

10.1182/blood-2018-99-113682 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 2268-2268

Author(s):

Joseph Feliciano ◽

Nate Way ◽

Gerald Engley ◽

Nilanjan Ghosh

Keyword(s):

Real World ◽

Systemic Therapy ◽

Research Funding ◽

Patient Characteristics ◽

The United States ◽

Treatment Patterns ◽

Cell Transplant ◽

Real World Evidence ◽

The Us ◽

Line Of Therapy

Abstract Introduction: Treatment of relapsed or refractory classical Hodgkin lymphoma (R/R cHL) in patients considered ineligible for stem cell transplant (SCT) in the United States (US) has evolved since 2011. It is important to understand the current treatment landscape and the outcomes associated with current standards of care as new treatment options have been introduced. This analysis provides recent real-world evidence on patient characteristics, treatment patterns, and outcomes in R/R cHL patients in the US who are initially considered ineligible for SCT and are treated with or without brentuximab vedotin (BV). Methods: Hematologists and oncologists (N=205) from the US retrospectively identified patients diagnosed with R/R cHL who received at least two lines of therapy and received their most recent line of therapy between January 2014 and May 2018. The physicians were responsible for abstracting data and completing response forms for variables of interest. The current analysis focused on patients who were considered ineligible for SCT by their physician: descriptive statistics on patient demographics/clinical characteristics, treatment patterns, and outcomes by line of therapy; bivariate analyses (chi-square) comparing treatment modalities by line of therapy. Results: Physicians retrospectively identified 297 patients that they considered ineligible for SCT. Mean (SD) age at initial cHL diagnosis was 53.0 (18.5), most patients were male (69.4%) and Caucasian (61.3%). The most common cHL subtype at diagnosis was nodular sclerosis HL (40.4%), and patients had either Stage I/II (45.8%) or Stage III/IV (54.2%) cHL at initial diagnosis. Median follow-up time for the cohort included here was 15.96 months from initiation of 1L treatment. The majority of the cohort (N = 297) received systemic therapy alone (84.5%) compared to those who received systemic therapy in combination with radiation therapy (RT) (15.5%) in 1L. 1L systemic regimens included regimens that contained ABVD alone or ABVD in combination with other regimens (69.4%). Of those who used ABVD alone or in combination with another regimen (N = 206), 24.8% used a PET adapted approach and deescalated to AVD (N = 51) and 11% escalated to be BEACOPP (N = 18). Other systemic regimens included AVD (10.1%), BEACOPP (7.4%) and ICE (5.7 %). The majority of patients achieved a complete response (CR) or partial remission (PR) after 1L therapy (41.4%, 38% respectively) while 34.1% (N = 61) failed to achieve remission or progressed while on therapy. The most common systemic regimens in 2L (N = 293) were BV monotherapy or in combination with bendamustine (34.6%), salvage regimens [including ICE, DHAP, ESHAP or gemcitabine based combinations] (33%), re-challenge with a previous 1L regimen (19.5%), and PD-1 inhibitors (10.8%). Very few patients received systemic therapy in combination with RT (6.7%) in 2L.The most common systemic regimens used in 3L (N = 21) for the selected cohort of patients not eligible for SCT were BV monotherapy (28.6%) and PD-1 inhibitors (33.3%). Median (range) number of cycles in 2L and 3L was four (1-18) and two (1-14), respectively. Treatment outcomes were variable for patients in 2L and 3L. In 2L, 27.6% achieved a CR, 25.6% achieved a PR, while 24.2% and 15.8% were refractory or progressed on treatment. There were no CRs reported in 3L (N = 21). 26 patients died in 2L and 3L combined. Conclusion/Summary: Given the rapid evolution of therapies used to treat R/R cHL, these findings fill a crucial data gap in real-world evidence on patient characteristics, treatment patterns, and outcomes of patients deemed SCT ineligible in the US. Disclosures Feliciano: Seattle Genetics: Employment. Way:Kantar Health: Employment; Seattle Genetics: Research Funding. Engley:Seattle Genetics: Employment. Ghosh:Juno: Consultancy, Research Funding; SGN: Consultancy, Research Funding, Speakers Bureau; PCYC: Consultancy, Research Funding, Speakers Bureau; Celgene: Consultancy; Spectrum: Consultancy; Gilead: Consultancy, Speakers Bureau; Pharmacyclics, an Abbvie Company: Consultancy, Research Funding, Speakers Bureau; Genentech: Research Funding; F. Hoffman-La Roche Ltd: Research Funding; Abbvie: Consultancy, Speakers Bureau; Forty seven Inc: Research Funding; TG Therapeutics: Honoraria, Research Funding.

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Bone Targeting Agent Treatment Patterns Among Patients with Multiple Myeloma Treated at Oncology Clinics Across the United States: Observations from Real-World Data

Blood ◽

10.1182/blood.v128.22.2364.2364 ◽

2016 ◽

Vol 128 (22) ◽

pp. 2364-2364

Author(s):

Christopher Kim ◽

Rohini K. Hernandez ◽

Paul C Cheng ◽

Jeremy Smith ◽

Lori Cyprien ◽

...

Keyword(s):

Zoledronic Acid ◽

Real World ◽

The United States ◽

Treatment Patterns ◽

First Year ◽

Real World Data ◽

Employment Equity ◽

The Us ◽

Equity Ownership

Abstract Introduction: Multiple myeloma (MM) is a hematologic malignancy with 30,330 estimated new cases in the US in 2016. The International Myeloma Working Group recommended that intravenous (IV) bisphosphonates be initiated in all patients with active MM administered at 3 to 4-week intervals. However, there are limited data to date on the real-world use of bone target agents (BTA; zoledronic acid and pamidronate disodium) in MM. The primary goal of this study is to describe current real-world BTA treatment patterns. Methods: A database of electronic medical records from >1 million patients treated at approximately 220 cancer centers across the United States, OSCER (Oncology Services Comprehensive Electronic Records, generated by Flatiron Health), was used to identify individuals 18 years or older diagnosed with MM (ICD-9 203.00; ICD-10 C90.00) with at least 1 clinic visit within 1 month of diagnosis date between January 1, 2009 and March 31, 2016. Timing of BTA administrations, frequency, schedule, and changes/discontinuation were calculated, renal function, and BTA treatment relative to anti-MM therapy regimens was also determined. Results: During the study period, 11,099 patients were diagnosed with MM; most were male (55%), white (59%), and 65 and older at diagnosis (66%). Through the end of the follow-up period (median follow-up: 687 days), 64% of patients received ≥1 administration of a BTA (% consistent across study period) and zoledronic acid was the predominant BTA (93% of patients received ≥1 administration). The mean time from MM diagnosis until first BTA was 105.7 days (median: 29, IQR: 11-78). In more recent years, the time to BTA initiation decreased. Initial BTA treatment occurred in first year after MM diagnosis in 58.7% of patients. By calendar year of diagnosis, the percentage of patients that ever received BTA treatment had decreased over time (2009-2010: 72.3%; 2011-2012: 68.0%; 2013-2014: 63.6%). Most BTA administrations were dosed on a Q4W schedule (77%), particularly in the first year of MM diagnosis (84%). A total of 2,350 patients (33.2%) either discontinued or changed BTA dosing scheduling through the end of follow-up. Approximately 54% of patients that received a first line anti-MM therapy received BTA concomitantly; in second line, concomitant BTA was 59%, and in third line, 55%. Conclusions: Real-world data from oncology practices across the US indicate that approximately two-thirds of MM patients received BTA treatment, and the treatment rate did not increase in more recent years. Additionally, few patients continued BTA beyond 2 years. Among BTA treated patients, BTA initiation occurred at approximately 3.5 months after diagnosis, and the majority of administrations followed a Q4W schedule with zoledronic acid. Further work will explore reasons for non-treatment and treatment discontinuation with particular attention given to potential contraindications such as renal impairment, and the added burden of IV therapy in MM. Disclosures Kim: Amgen Inc.: Employment, Equity Ownership. Hernandez:Amgen: Employment, Equity Ownership. Cheng:Amgen: Employment, Equity Ownership. Smith:Amgen: Consultancy. Cyprien:Amgen: Consultancy. Liede:Amgen: Employment, Equity Ownership.

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Treatment Patterns and Outcomes Among Patients with Relapsed/Refractory Follicular Lymphoma Treated in Routine Clinical Practice in the US with Three or More Lines of Therapy

Blood ◽

10.1182/blood-2021-145412 ◽

2021 ◽

Vol 138 (Supplement 1) ◽

pp. 4080-4080

Author(s):

Jamie T. Ta ◽

Stella Arndorfer ◽

Cristina Julian ◽

Mei Wu ◽

Dominic Lai ◽

...

Keyword(s):

Follicular Lymphoma ◽

Real World ◽

Treatment Initiation ◽

Treatment Patterns ◽

Publicly Traded ◽

The Past ◽

Community Oncology ◽

The Us ◽

Early Progression

Abstract Background: Follicular lymphoma (FL) is an indolent, yet incurable disease, and patients often require several lines of therapy throughout their lifetime (Batlevi et al. Blood Cancer J 2020); however, there are limited real-world data available regarding the treatment of a contemporary cohort of patients with relapsed/refractory (R/R) FL. The objective of this study was to assess real-world treatment patterns and outcomes among patients receiving third- and later-line (3L+) therapies for FL in the US. Methods: This retrospective cohort study used the nationwide Flatiron Health electronic health record-derived de-identified database. During the study period, de-identified data originated from approximately 280 cancer clinics (~800 sites of care) in the US. We selected patients aged ≥18 years with an initial FL diagnosis between January 2011 and January 2021, who had received at least 3 lines of therapy for FL (follow-up ended March 2021). Exclusion criteria included: evidence of clinical trial participation during the study period, high-grade (3b) FL at diagnosis, transformation to an aggressive lymphoma any time before 3L FL treatment, or other anticancer therapies or stem cell transplant 12 months before first-line (1L) FL treatment. Patient demographic and clinical characteristics were assessed using descriptive statistics. Treatment patterns and time to next anti-lymphoma treatment or death (TTNTD) were reported. Median TTNTD was estimated using Kaplan-Meier methods. Results: Of 2,990 patients receiving treatment for FL during the study period, 157 patients who received at least 3 lines of therapy for FL were included. Median age at time of 3L FL treatment initiation was 70 years, and 48.4% (n=76) of patients were male. At initial FL diagnosis, 79.6% (n=125) had low-grade (1-2) FL, 78.3% (n=123) had advanced stage (III/IV) FL, and 68.6% (n=48) of the 70 patients with available Follicular Lymphoma International Prognostic Index (FLIPI) scores had high-risk FLIPI (≥3). Overall, 68.2% of patients had evidence suggestive of early progression of disease within 24 months of 1L FL treatment. The majority of patients were treated at community oncology practices (n=140 [89.2%]). Median time to 3L treatment initiation from diagnosis was 35.6 months, and median follow-up after 3L treatment was 15.4 months. Fifty-two (33.1%) patients received a subsequent fourth-line therapy. The most common 3L treatment regimens received were rituximab (R) monotherapy (n=32 [20.4%]), R plus bendamustine (n=26 [16.6%]), R plus lenalidomide (n=18 [11.5%]), obinutuzumab monotherapy (n=14 [8.9%]), and idelalisib (n=13 [8.3%]; Table). Median TTNTD after 3L treatment was 14.1 months (95% confidence interval: 10-23.6; Figure). Conclusions: Our study provides an update on the heterogeneous treatment landscape for R/R FL in the US for patients receiving 3L+ therapy in real-world clinical practice, the majority of whom were treated in community oncology practices. Many patients requiring 3L+ FL treatment had clinical characteristics predictive of poor prognosis, as evidenced by the high proportion of patients who had evidence of early progression and high-risk FLIPI at diagnosis. Treatment outcomes following 3L therapy remain poor, and approximately one-third of patients required additional treatment beyond 3L. Limitations of this analysis include those inherent to real-world observational databases and the relatively short follow-up of patients with indolent FL in the Flatiron Health database, particularly following 3L FL treatment. Future studies with additional follow-up are warranted. Nevertheless, these findings highlight the ongoing unmet need for novel, effective treatments in this setting in order to improve patient outcomes. Figure 1 Figure 1. Disclosures Ta: Genentech, Inc.: Current Employment. Arndorfer: Genesis Research: Consultancy, Current Employment. Julian: Genentech, Inc.: Current Employment, Current holder of stock options in a privately-held company. Wu: Genentech, Inc.: Current Employment; F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company. Lai: Bristol-Myers Squibb: Current equity holder in publicly-traded company; AbbVie: Current equity holder in publicly-traded company, Divested equity in a private or publicly-traded company in the past 24 months, Ended employment in the past 24 months; Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company. Shapouri: F. Hoffmann-La Roche Ltd: Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment.

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THU0389 OBESITY IS A STRONG PREDICTOR OF WORSE CLINICAL OUTCOMES AND TREATMENT RESPONSES TO BIOLOGICS IN PATIENTS WITH ANKYLOSING SPONDYLITIS

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2020-eular.4445 ◽

2020 ◽

Vol 79 (Suppl 1) ◽

pp. 429.2-429

Author(s):

L. Hu ◽

X. Ji ◽

F. Huang

Keyword(s):

Ankylosing Spondylitis ◽

Disease Activity ◽

Clinical Outcomes ◽

Normal Weight ◽

Low Grade ◽

Hla B27 ◽

Treatment Responses ◽

The Impact ◽

Overweight Or Obesity

Background:Obesity population are rising rapidly and have become a major health issue. Studies have shown that obesity is a low-grade inflammatory status characterized by increase in proinflammatory cytokines.Objectives:To examine the impact of overweight or obesity on disease activity and treatment responses to biologics in patients with ankylosing spondylitis (AS) in a real-world setting.Methods:Body mass index (BMI) is available in 1013 patients from the Chinese Ankylosing Spondylitis Imaging Cohort (CASPIC). Differences in clinical outcomes (such as BASDAI, ASDAS, BASFI, and ASAS HI) and treatment responses to biologics (ΔBASDAI and ΔASDAS) over 3, 6, 9, and 12 months are assessed between BMI categories (normal weight BMI <24 kg/m2; overweight BMI=24-28 kg/m2; obesity BMI ≥28 kg/m2) using Kruskal-Wallis test. The association between BMI and clinical characteristics and treatment responses to biologics was determined, and multivariate median regression analyses were conducted to adjust for confounders (such as age, gender, smoke, and HLA-B27).Results:Among 1013 patients with AS, overweight accounts for 33%, while obesity for 12.4%. There were significant differences between patients who were obese or overweight and those with a normal weight regarding clinical outcomes (BASDAI: 2.90/2.56 vs 2.21; ASDAS-CRP: 2.20/1.99 vs 1.81; BASFI: 2.13/1.69 vs 1.38; ASAS HI: 6.87/5.29 vs 5.12 and BASMI: 2.35/1.76 vs 1.62; all P<0.05). After adjusting for age, gender, smoke, and HLA-B27, obesity remained associated with higher disease activity (BASDAI: β=0.55, P=0.005; ASDAS-CRP: β=0.40, P<0.001), poorer functional capacity (BASFI: β=0.58, P=0.001), worse health index (ASAS HI: β=1.92, P<0.001) and metrology index (BASMI: β=0.71, P=0.013). For TNFi users, BMI was found to be negatively correlated with changes in disease activity (ΔBASDAI and ΔASDAS) in the multivariate regression model (all P<0.05), and overweight and obese patients showed an unsatisfactory reduction in disease activity during 3-month, 6-month, 9-month, and 12-month follow-up period, compared to normal weight patients (all P<0.05).Conclusion:Overweight or obesity impacts greatly on clinical outcomes and treatment responses to biologics in patients with ankylosing spondylitis, which argues strongly for obesity management to become central to prevention and treatment strategies in patients with AS.References:[1]Maachi M, Pieroni L, Bruckert E, et al. Systemic low-grade inflammation is related to both circulating and adipose tissue TNFalpha, leptin and IL-6 levels in obese women. Int J Obes Relat Metab Disord 2004;28:993–7.Figure 1.Changes of disease activity for TNFi users during 3-, 6-, 9- and 12-month follow-up according to BMI categories. a: vs. normal weight, P<0.05 in 3 months; b: vs. normal weight, P<0.05 in 6 months; c: vs. normal weight, P<0.05 in 9 months; d: vs. normal weight, P<0.05 in 12 months.Acknowledgments:We appreciate the contribution of the present or former members of the CASPIC study group.Disclosure of Interests:None declared

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Abstract 1122‐000142: Safety and Efficacy of Surpass Streamline for Intracranial Aneurysms: A Multicenter US Real‐World Experience (SESSIA)

Stroke: Vascular and Interventional Neurology ◽

10.1161/svin.01.suppl_1.000142 ◽

2021 ◽

Vol 1 (S1) ◽

Author(s):

Juan Vivanco‐Suarez ◽

Alan Mendez‐Ruiz ◽

Farooqui Mudassir ◽

Cynthia B Zevallos ◽

Milagros Galecio‐Castillo ◽

...

Keyword(s):

Real World ◽

Intracranial Aneurysms ◽

The United States ◽

Chromium Alloy ◽

Cobalt Chromium ◽

Anterior Circulation ◽

Safety And Efficacy ◽

Post Marketing ◽

The Mean

Introduction : Flow diversion has established itself as standard treatment of wide complex intracranial aneurysms (IA). Its recognition has been validated with positive occlusion rates and favorable clinical outcomes. The Surpass Streamline (SS) flow diverter (FD) is a braided cobalt/chromium alloy implant with 72 or 96 wires approved by the FDA in 2018. The aim of this study is to determine the safety and efficacy of the SS in a post‐marketing large US cohort. Methods : We performed a multicenter, retrospective study for consecutive patients treated with the SS FD for IA between January 2018 and June 2021 in the United States. Inclusion criteria for participants were: 1. Adults (≥ 18 years) and 2. Treatment with SS FD for IA. Primary safety end point was a major ipsilateral stroke (increase in National Institutes of Health Stroke Scale Score of ≥ 4) or neurological death within 12 months. Primary efficacy was assessed using the 3‐point Raymond‐Roy (RR) occlusion scale on digital subtraction angiography (DSA) at 6‐12‐month follow‐up. Results : A total of 276 patients with 313 aneurysms were enrolled. The median age was 59 years and 199 (72%) were females. The most common comorbidities included hypertension in 156 (57%) subjects followed by hyperlipidemia in 76 (28%) patients. One hundred and twenty‐two (44%) patients were asymptomatic while subarachnoid hemorrhage was present in only 10 (4%) patients. A total of 143 (46%) aneurysms were left‐sided. Aneurysms were located as follows: 274 (88%) were in the anterior circulation with paraophthalmic being the most common in 120 (38%) followed by petrocavernous ICA in 81 (26%); 33 (11%) aneurysms were located in the posterior circulation with basilar trunk being the most common in 14 (5%). The mean maximum aneurysm dome width was 5.77 ± 4.7 mm, neck width 4.22 ± 3.8 mm and dome to neck ratio was 1.63 ± 1.3 mm. The mean number of SS FD implanted per aneurysm was 1.06 (range 1–3) with more than one SS FD implanted in 21 (7%) aneurysms. Modified Rankin Scale (mRS) of 0–2 was present in 206/213 (97%) patients at 6–12 month follow‐up. The complete aneurysm occlusion (RR 1) rate was 145/175 (83%) among subjects who had angiographic follow‐up at 6–12 months. Major stroke and death was encountered in 7 (2%) and 5 (1.8%) of the patients respectively. Conclusions : Our data represent the largest real‐world study using SS FD. These results corroborate its post‐marketing safety and efficacy for the treatment of intracranial aneurysms showing more favorable rates to the initial experience during SCENT trial.

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