scholarly journals Patient Characteristics and Temporal Changes in Anticoagulation Treatment Patterns in Patients Diagnosed with Cancer-Associated Thrombosis: An Oscar-US Analysis

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2132-2132
Author(s):  
Craig I. Coleman ◽  
Kimberly Snow Caroti ◽  
Khaled Abdelgawwad ◽  
George Psaroudakis ◽  
Samuel Fatoba ◽  
...  
Keyword(s):  
Emergency Department ◽  
Metastatic Disease ◽  
Research Funding ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Diagnosis Code ◽  
Observation Unit ◽  
Cancer Subtypes ◽  
Cancer Associated Thrombosis ◽  
Active Cancer

Abstract Background: Although guidelines include direct-acting oral anticoagulants (DOACs) as an alternative to low molecular weight heparins (LMWHs) for treatment of cancer associated venous thrombosis (CAT), specific recommendations for selection of patients for DOAC treatment vary. Recommendations for use of DOACs are driven predominantly by perceptions of risk: benefit ratio (often associated with different cancer subtypes). We sought to assess patient characteristics and temporal changes in DOAC (vs. LMWH) utilization in patients being treated in routine practice for CAT. Methods: This analysis is part of the Observational Studies in Cancer Associated Thrombosis for Rivaroxaban - United States (OSCAR-US) program. OSCAR-US is an ongoing study utilizing longitudinal patient-level medical record data from Optum for 91+ million patients seen at 700+ hospitals and 7,000+ clinics across the US. To be included in the present study, adult patients had to be diagnosed with active (primary or metastatic) cancer, undergone hospitalization, emergency department or observation unit admission associated with a primary International Classification of Diseases (ICD)-9th or -10 th revision diagnosis code for venous thromboembolism (VTE) between January 2013 and September 2020, received a DOAC or LMWH on day 7 of CAT treatment, and been active in the data set for at least 12 months prior to the CAT. Cohort assignment was based upon anticoagulant received on day 7 to increase the study's likelihood of appropriately classifying patients into their intended long-term treatment group. We defined active cancer as any cancer associated with ongoing treatment with chemotherapy, immunotherapy, radiation, or recent surgery; the presence of metastatic disease (regardless of time from initial cancer diagnosis); or provider encounter with a primary diagnosis code for cancer within the 6 months prior to the CAT. We excluded patients with an alternative indication for anticoagulation use or evidence of anticoagulation during the 12 months prior (per written prescription or patient self-report). For this analysis, year of CAT diagnosis was grouped into three mutually exclusive categories (2013-2015, 2016-2018, and 2019-2020) to represent early DOAC availability for VTE, peri-DOAC CAT trials and post-CAT guideline recommendation periods. Categorical data were reported as percentages, while continuous data were reported as means ± standard deviations (SDs). Chi-square and independent sample t-tests were used to test for differences in characteristics and treatment patterns between cohorts. Results: In total, 95,072 adult patients experiencing a VTE-related hospitalization, emergency department or observation unit visit were identified. Of these, 14,377 (15.1%) met our pre-specified criteria for active cancer; including 84.7% who received a cancer treatment modality within 6-months and/or had metastatic disease (Table). Though a majority (76.0%) of patients received parenteral therapy as their first anticoagulant upon CAT diagnosis; on day 7 of CAT management, 5325 (52.0%) were receiving a DOAC and 4925 (48.0%) a LMWH. Mean age of patients was 65.2±13.7 years, body mass index (BMI) was 29.9±7.7 kg/m2 and 55.9% were women. Pulmonary embolism (PE)±deep vein thrombosis (DVT) was present in 47.2% of patients and more frequent in patients treated with LMWH than a DOAC on day 7 (p<0.001). The most common cancer types were lung (18.3%) genitourinary (13.5%), breast (12.7%) and colorectal (10.5%) (Figure). The proportion of patients treated with a DOAC increased substantially for all cancers over the three time periods evaluated (27.5% to 55.9% to 73.2%, p<0.001). This temporal relationship of increasing DOAC use (vs. LMWH) remained consistent across individual cancer subtypes (p<0.001 for all). Mean anticoagulant treatment duration was 193±143 days for the entire cohort and was longer in patients treated with DOACs vs. LMWHs (226±138 vs. 147±138 days, p<0.001). Conclusions: In this US population, DOACs were increasingly being utilized for the management of CAT patients and for longer treatment durations than LMWHs. The finding of increasing frequency in use of DOACs vs. LMWHs appeared consistent across all major cancer subtypes. Given their common use, future analyses should evaluate the real-world effectiveness and safety of DOACs compared to LMWHs within individual cancer subtypes. Figure 1 Figure 1. Disclosures Coleman: Bayer AG: Consultancy, Honoraria, Research Funding; Janssen Scientific Affairs LLC: Consultancy, Honoraria, Research Funding; Alexion Pharmaceuticals: Research Funding. Abdelgawwad: Bayer AG: Current Employment. Psaroudakis: Bayer AG: Current Employment. Fatoba: Bayer AG: Current Employment. Rivera: Bayer AG: Current Employment. Brobert: Bayer AG: Current Employment.

The Characteristics, Treatment Patterns, and Outcomes of Older Adults with Multiple Myeloma

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4463-4463
Author(s):  
Mark A. Fiala ◽  
Tanya M. Wildes ◽  
Mark A. Schroeder ◽  
Armin Ghobadi ◽  
Keith E. Stockerl-Goldstein ◽  
...  
Keyword(s):  
Older Adults ◽  
Multiple Myeloma ◽  
Board Of Directors ◽  
Research Funding ◽  
Performance Status ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Advisory Committees ◽  
Improved Outcomes ◽  
Immunomodulatory Drug

Abstract Background: Advances in the treatment for multiple myeloma (MM) have dramatically improved outcomes for younger patients. Older adults, particularly those 80 years of age or older at diagnosis, have seen more modest gains. MM incidence increases with age, and as more of the population is living later into life, the segment of the MM population over 80 will continue to grow. In this study, we sought to better understand the characteristics, treatment, and outcomes of older patients with MM. Methods: We identified all patients diagnosed with MM at age 80 or older in the Surveillance, Epidemiology, and End Results Program (SEER) database from 2007-2013 to determine incidence and outcomes. Subset analysis was then performed on patients included in the SEER-Medicare linked database who were enrolled in Medicare Parts A, B, and D to further explore patient characteristics and treatment patterns. Results: The incidence of MM increases over age, peaking after age 80. The annual incidence for those aged 65-69, 70-74, 75-79, 80-84 and 85+ was 24.4, 32.7, 39.5, 42.8 and 36.4 per 100,000, respectively. Based on 2010 US population estimates, approximately 4,500 new cases of MM were diagnosed annually 2007-2013 in patients age 80 or older. In that period, 8,093 cases, approximately 1,150 per year, were reported to SEER. The estimated median overall survival (OS) of these patients was 14 months (95% CI 13.2-14.8). The estimated relative 12 month survival was 58.9% (95% CI 57.4-60.4) compared to their peers without cancer. Of the 8,093 cases of MM reported to SEER during the study period, 2,385 were present in the SEER-Medicare linked dataset. Of these, 225 were identified as smoldering MM using a previously established algorithm (Fiala, et al, JCOCCI, 2018) and excluded leaving 2,160 for the analyses. The median age was 84 (range 80-100) and 55% were female. 81% were white, 13% black or African-American, and 6% another race. At disease presentation, 22% had claims indicating hypercalcemia, 61% renal failure or chronic kidney disease, 59% anemia, and 34% MM bone involvement. The estimated median OS was 13.4 months (95% CI 12.2-15.1). Only 52% of patients had claims indicating they received systemic MM treatment within 6 months post-diagnosis. Nearly all that did received novel agents; 38% received bortezomib-based treatment, 41% immunomodulatory drug (IMID)-based, and 14% both. The others received antineoplastic chemotherapies such as melphalan or cyclophosphamide. Interestingly, bortezomib utilization increased incrementally from 25% of patients treated in 2007 to 62% in 2013 while IMID utilization declined from 67% to 49%. The median OS of those receiving treatment was 21 months (95% CI 18.5-23.1) compared to 6.3 months (95% CI 5.3-7.3) for those who did not (p <0.0001). MM treatment was associated with a 26% decrease in hazard for death (aHR 0.74; 95% CI 0.67-0.82; p < 0.0001) independent of age, race, gender, poverty, comorbidities, and proxy measures of performance status. Outcomes improved for patients in more recent years; the hazard for death decreased by 3% (HR 0.97; 95% CI 0.94-0.99; p = 0.0096) each year 2007-2013. This can be attributed to increasing treatment rates. In 2007, only 41% of patients received treatment compared to 61% in 2013. After controlling for MM treatment, the year of diagnosis was no longer a significant predictor of survival. Conclusions: The outcomes of patients with MM over 80 years old are still relatively poor; nearly half of the patients do not receive systemic treatment and for those who do the median OS is just 21 months. The population over 80, when MM incidence peaks, is projected to triple over the next few decades. It is imperative that we improve our understanding of the needs of this vulnerable subgroup of patients of MM. Disclosures Schroeder: Amgen Inc.: Consultancy, Membership on an entity's Board of Directors or advisory committees. Vij:Bristol-Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharma: Honoraria, Membership on an entity's Board of Directors or advisory committees; Amgen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Jazz Pharmaceuticals: Honoraria, Membership on an entity's Board of Directors or advisory committees; Jansson: Honoraria, Membership on an entity's Board of Directors or advisory committees; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Celgene: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding.

scholarly journals Treatment Patterns and Outcomes of Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Treated with Hypomethylating Agents (HMA) in the United States (US)

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 14-16
Author(s):  
Timothy S. Pardee ◽  
Jessica Oschwald ◽  
Esprit Ma ◽  
Tao Xu ◽  
Melissa Montez ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Research Funding ◽  
Community Setting ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Survival Outcomes ◽  
Newly Diagnosed ◽  
Publicly Traded ◽  
The Past ◽  
The Us

Introduction: AML is an aggressive disease with poor prognosis that predominantly affects older adults. Due to advanced age and associated comorbidities, many patients are not fit for intensive induction chemotherapy. Monotherapy with HMAs such as azacitidine (AZA) or decitabine (DEC) is often still considered as standard of care for these patients, despite mixed evidence from studies regarding the benefit of HMAs alone (Duchmann & Itzykson. Int J Hematol 2019). The aim of the current study is to evaluate patient characteristics, treatment patterns and outcomes of patients with AML treated with HMA monotherapy as first line (1L) in clinical practice in the US. Methods: This is a retrospective observational study of the Flatiron Health database; a nationwide, longitudinal, demographically and geographically diverse database representing more than 2.4 million patients with cancer in the US. The database contains de-identified data derived from electronic health records from over 280 cancer clinics, which are predominantly community oncology practices. Patients ≥18 years, diagnosed with AML between 1/1/2014 and 3/30/2020 (excluding acute promyelocytic leukemia and clinical trial enrollment), and who received HMAs as 1L treatment ≤30 days from AML diagnosis were evaluated. Descriptive analyses were conducted on patient characteristics and treatment patterns. Kaplan-Meier analyses were used to estimate time to last administration (TTLA; from initiation to last observed administration before death, end of follow-up or a gap of 60 days) and median overall survival (OS). Results: A total of 2589 patients with an AML diagnosis were included for analysis, where 574 (22%) were treated with 1L HMAs (AZA: n=341 [59%]; DEC: n=233 [41%]). The median age of 1L HMA patients was 79 years with 63% male. Most patients were treated in the community setting (n=511 [89%]; median age: 79 years); those treated in academic centers were slightly younger (n=63 [11%]; median age: 77 years). Characteristics for non-antecedent hematological disorder (AHD)-AML (n=327) and AHD-AML (n=247) patients are presented in Table 1. Median TTLA with 1L HMA was 77 days with a median of 3 cycles of both AZA and DEC. Of the 168 patients who received second-line (2L) therapy, 82% (n=138) received another low-intensity therapy or combination (of which only 14 received targeted therapies) (Figure 1). Overall, 44% of 1L HMA patients (n=254) had evidence of molecular testing before 1L treatment initiation (this was more common in later years). Of the 228 patients tested for FLT3, 30 (13%) were FLT3 positive; 7 (23%) FLT3-positive patients were treated with 2L or third-line (3L) FLT3-targeted therapies (gilteritinib, midostaurin or sorafenib). Of the 152 patients tested for IDH1/2, 35 (23%) were IDH1/2 positive; 5 (14%) IDH1/2-positive patients were treated with 2L or 3L targeted agents (enasidenib or ivosidenib). A median OS of 6.3 months (95% CI: 5.5-7.5) was observed in the overall 1L HMA cohort. Median OS in 1L HMA patients did not differ with respect to different types of AML (non-AHD-AML: 6.6 [95% CI: 5.5-7.9] months; AHD-AML: 6.0 [95% CI: 4.8-7.5] months, p=0.34) or practice setting (community: 6.0 [95% CI: 5.3-7.0] months; academic: 8.3 [95% CI: 6.9-13.3] months, p=0.14). One-year OS was 31.4% and 30.1% for non-AHD-AML and AHD-AML patients, respectively. Patients treated in the community setting had numerically lower 1-year OS (29.7% [95% CI: 25.8-34.3]) than those treated in the academic setting (39.5% [95% CI: 28.6-54.6]), which reflects the higher rates of 2L treatment in academic practice, though this analysis is unadjusted. Conclusions: This new database enabled a detailed analysis of 1L HMA-treated patients with newly diagnosed AML in routine clinical practice predominantly in the community setting. 1L HMA patients have poor survival outcomes (median OS 6.3 months) which are comparable to other real-world data from SEER-Medicare (Zeidan et al. Blood Adv 2020; median OS 7-8 months; median age: 77 years); but shorter than the median OS of 9-10 months observed in 1L HMA-treated AML patients in clinical trials (DiNardo et al. EHA 2020). Limitations of the study included limited conduct of bone marrow biopsies for response and lack of transfusion data. The observed survival outcomes highlight the importance of further treatment advances to address the unmet need in older patients with AML ineligible for intensive induction chemotherapy. Disclosures Pardee: Rafael: Research Funding; Celgene: Consultancy, Honoraria, Speakers Bureau; Amgen: Honoraria, Speakers Bureau; Pharmacyclics: Speakers Bureau; Rafael Pharmaceuticals: Consultancy; BMS: Consultancy, Honoraria, Speakers Bureau; AbbVie: Consultancy; Genentech, Inc.: Consultancy; Karyopharm: Research Funding. Oschwald:Roche Products Limited: Current Employment. Ma:Genentech, Inc.: Current Employment, Current equity holder in publicly-traded company. Xu:F. Hoffmann-La Roche Ltd: Current Employment, Other: All authors received support for third party writing assistance, furnished by Scott Battle, PhD, provided by F. Hoffmann-La Roche, Basel, Switzerland.. Montez:F. Hoffmann-La Roche: Current equity holder in publicly-traded company; Genentech, Inc.: Current Employment. Ramsingh:Genentech, Inc.: Current Employment; NEKTAR: Current equity holder in publicly-traded company; Exelixis: 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; F. Hoffmann-La Roche: Current equity holder in publicly-traded company. Hong:Genentech, Inc.: Current Employment; F. Hoffmann-La Roche: Current equity holder in publicly-traded company. Choi:AbbVie: Current Employment, Current equity holder in publicly-traded company. Flahavan:Roche Products Ltd.: Current Employment; F. Hoffmann-La Roche: Current equity holder in publicly-traded company. OffLabel Disclosure: Discussion will include the use of decitabine for the treatment of AML.

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

Blood ◽  
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.

Hospitalizations and emergency department use in cancer clinical trial patients.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 160-160
Author(s):  
Ryan David Nipp ◽  
Elizabeth Powell ◽  
Beverly Moy
Keyword(s):  
Health Care ◽  
Emergency Department ◽  
Health Care Utilization ◽  
Metastatic Disease ◽  
Massachusetts General Hospital ◽  
Patient Characteristics ◽  
Care Utilization ◽  
Care Needs ◽  
Hematologic Cancer ◽  
Ed Visits

160 Background: Cancer clinical trials (CTs) often represent the best available treatment for many patients, but little is known about the health care utilization of these patients. We examined correlates of hospitalizations and emergency department (ED) use in cancer CT patients to determine those at greatest risk for these outcomes. Methods: We prospectively collected data on patient characteristics, hospitalizations and ED use among all patients enrolled in cancer CTs at Massachusetts General Hospital in 2014. We calculated the number of hospitalizations and ED visits in the 6-month interval following patients’ CT enrollment. We used linear regression with purposeful selection of covariates to identify factors associated with hospitalizations and ED use. Results: Of 1,218 CT patients (mean age = 58 years; 575 (47%) male), 781 (64%) were married and 851 (70%) had metastatic disease. All cancer types were represented, but hematologic cancers (21%) were most common. Within 6 months following CT enrollment, 519 (43%) and 327 (27%) had at least one hospitalization and ED visit, respectively. At any time during their cancer course, 177 (15%) received a palliative care (PC) consult. Controlling for presence of metastatic disease, PC consults correlated with both hospitalizations and ED visits. Having a hematologic cancer and being unmarried correlated with more hospitalizations and ED visits, respectively. Conclusions: Hospitalizations and ED visits occur in a substantial proportion of cancer CT patients. We need to better understand reasons for these high rates of health care utilization, but the correlations with PC consults suggest that CT patients have unique supportive care needs and that PC services are being targeted to a population particularly in need. [Table: see text]

scholarly journals Physical Therapist Practice in the Emergency Department Observation Unit: Descriptive Study

2015 ◽  
Vol 95 (2) ◽  
pp. 249-256 ◽  
Author(s):  
Laura Plummer ◽  
Sowmya Sridhar ◽  
Marianne Beninato ◽  
Kristin Parlman
Keyword(s):  
Emergency Department ◽  
Physical Therapy ◽  
Physical Therapist ◽  
Massachusetts General Hospital ◽  
Patient Characteristics ◽  
Descriptive Study ◽  
Observation Unit ◽  
Billing Data ◽  
Medical Diagnoses ◽  
Discharge Disposition

Background An upward trend in the number of hospital emergency department (ED) visits frequently results in ED overcrowding. The concept of the emergency department observation unit (EDOU) was introduced to allow patients to transfer out of the ED and remain under observation for up to 24 hours before making a decision regarding the appropriate disposition. No study has yet been completed to describe physical therapist practice in the EDOU. Objective The objectives of this study were: (1) to describe patient demographics, physical therapist management and utilization, and discharge dispositions of patients receiving physical therapy in the EDOU and (2) to describe these variables according to the most frequently occurring diagnostic groups. Design This was a descriptive study of patients who received physical therapist services in the EDOU of Massachusetts General Hospital during the months of March, May, and August 2010. Methods Data from 151 medical records of patients who received physical therapist services in the EDOU were extracted. Variables consisted of patient characteristics, medical and physical therapist diagnoses, and physical therapist management and utilization derived from billing data. Descriptive statistics were used to analyze data. Results The leading EDOU medical diagnoses of individuals receiving physical therapist services included people with falls without fracture (n=30), back pain (n=27), falls with fracture (n=22), and dizziness (n=22). There were significant differences in discharge disposition, age, and total physical therapy time among groups. Limitations This was a retrospective study, so there was no ability to control how data were recorded. Conclusions This study provides information on common patient groups seen in the EDOU, physical therapist service utilization, and discharge disposition that may guide facilities in anticipated staffing needs associated with providing physical therapist services in the EDOU.

scholarly journals Patient Characteristics, Treatment Patterns and Outcomes Among Black and White Patients with Multiple Myeloma Initiating Daratumumab: A Real-World Chart Review Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1965-1965
Author(s):  
Shebli Atrash ◽  
Philippe Thompson-Leduc ◽  
Ming-Hui Tai ◽  
Shuchita Kaila ◽  
Kathleen Gray ◽  
...  
Keyword(s):  
Board Of Directors ◽  
Research Funding ◽  
Index Date ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Advisory Committees ◽  
New Therapies ◽  
Black Patients ◽  
Line Of Therapy ◽  
White Patients

Abstract Background and Objective: Daratumumab, a CD38 monoclonal antibody, was approved for the treatment of multiple myeloma (MM) among previously treated patients in 2015, and among newly diagnosed patients in 2018. While the safety and efficacy of daratumumab has been well documented in clinical trials, there is limited real world information on the use and outcomes of daratumumab in patients of different races. This is of particular relevance for potential health care disparities, as evidence suggests that African American patients with MM receive new therapies later in their disease and may experience different outcomes than White patients (Blood Adv. 2019;3:2986-94, Cancer Med. 2017;6: 2876-85). Therefore, we sought to describe patient characteristics, treatment patterns and outcomes of patients with MM who received daratumumab. Results were stratified by race (i.e., Black vs. White). Methods: We conducted a retrospective chart review of patients with MM initiating daratumumab between 1/2018 and 5/2020. De-identified data were retrieved from two U.S. clinical sites, Levine Cancer Institute (Atrium Health) and Weill Cornell Medicine. Patients were included if they had a confirmed diagnosis of MM and were at least 18 years old at the time of daratumumab initiation (index date). Patients who accessed daratumumab through interventional clinical trials were excluded. Patients were followed from the index date until death, loss to follow-up, or date of chart abstraction, whichever occurred first. Patient characteristics included age, sex, body mass index, MM stage at diagnosis, cytogenetic profile as of the index date, and number of prior regimens. Treatment patterns included type and duration of daratumumab-based regimen. Treatment outcomes included treatment response (as per physician notes and guided by the International Myeloma Working Group consensus criteria) and time to next line of therapy (TTNT; the time between the index date and the initiation of the following line of therapy, censoring at the end of follow-up). All analyses were descriptive and stratified by race. Results: A total of 252 patient charts were extracted: 89 Black (35.3%) and 163 White (64.7%). Black patients were, on average, younger at diagnosis (61.7 years old vs. 67.0) and at the index date (Table 1). The proportion of females was similar across both races (Black: 44.9%, White: 46.6%), and mean body mass index was slightly higher in Black patients (28.7 vs. 26.8). Black patients had longer time between initial MM diagnosis and initiation of daratumumab (43.2 vs. 34.1 months). MM stage at diagnosis, cytogenetic profile at index, and prior regimens were similar between White and Black patients (Table 1). While unknown cytogenetics were most common for both White (45.4%) and Black (59.6%) patients, White patients (20.2%) were twice as likely as Blacks (9.0%) to have high-risk cytogenetics. Black patients received more lines of treatment prior to the initiation of daratumumab (mean 2.9 vs. 2.3), with 55.1% of Black patients receiving 3 or more prior lines. The most common regimen was daratumumab with pomalidomide and dexamethasone (DPd) for both races (Table 1), with use of DPd being particularly common (51.7%) in Black patients. Duration of treatment with daratumumab was similar across races (Table 1). Treatment response was similar across races: among patients initiating daratumumab in first, second and third line or after, respectively, overall response rate was 100.0%, 90.9% and 67.6% for Black patients and 100.0%, 82.9% and 65.4% for White patients. Among patients initiating daratumumab in third line or after, median TTNT was 12.3 months among Black patients and 10.4 months among White patients. Conclusions: Black and White patients had similar overall response rate and comparable TTNT. However, Black patients initiated daratumumab later in their treatment, with more than half of Black patients initiating daratumumab in fourth or later line of therapy, and a lower percentage of Black patients had high-risk cytogenetics, suggesting a potential discrepancy in access to new therapies for MM. These findings were observed in a relatively modest sample size, and therefore interpretation warrants caution. Future studies should investigate whether such a discrepancy in treatment access exists, potential reasons for this discrepancy, and strategies to mitigate the effect of race on access to new therapies in MM. Figure 1 Figure 1. Disclosures Atrash: GSK: Research Funding; AMGEN: Research Funding; Jansen: Research Funding, Speakers Bureau. Thompson-Leduc: Biogen: Consultancy; Novartis: Consultancy; Shire/Takeda: Consultancy; Regeneron: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; BioMerieux: Consultancy; Merck: Consultancy; GlaxoSmithKline: Consultancy; BioFire Diagnostics: Consultancy. Tai: Janssen Scientific Affairs, LLC: Current Employment. Kaila: Janssen Scientific Affairs, LLC: Current Employment. Gray: Janssen Scientific Affairs, LLC: Current Employment, Current holder of individual stocks in a privately-held company. Ghelerter: Janssen Scientific Affairs, LLC: Consultancy; GlaxoSmithKline: Consultancy; Regeneron: Consultancy; Novartis: Consultancy. Lafeuille: Pharmacyclics: Consultancy; Pfizer: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; GlaxoSmithKline: Consultancy. Lefebvre: Regeneron: Consultancy; Novartis: Consultancy; Otsuka: Consultancy; Pfizer: Consultancy; Pharmacyclics: Consultancy; Janssen Scientific Affairs, LLC: Consultancy; GlaxoSmithKline: Consultancy. Rossi: Janssen Scientific Affairs, LLC: Consultancy, Membership on an entity's Board of Directors or advisory committees; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees; Sanofi: Consultancy, Membership on an entity's Board of Directors or advisory committees; Bristol-Myers Squibb: Consultancy, Membership on an entity's Board of Directors or advisory committees.

scholarly journals Lower-Risk Myelodysplastic Syndromes: Erythropoiesis-Stimulating Agent Treatment Approaches and Outcomes in the United States

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4657-4657
Author(s):  
Kristin M. Zimmerman Savill ◽  
Ajeet Gajra ◽  
Kwanza Price ◽  
Jonathan K. Kish ◽  
Cherrishe Brown-Bickerstaff ◽  
...  
Keyword(s):  
Data Collection ◽  
Board Of Directors ◽  
Systemic Therapy ◽  
Research Funding ◽  
Patient Characteristics ◽  
Treatment Patterns ◽  
Publicly Traded ◽  
Independent Contractor ◽  
Advisory Committees

Abstract Introduction: Myelodysplastic syndromes (MDS) comprise a group of clonal hematopoietic disorders characterized by ineffective hematopoiesis, cytopenias, dysplasia in ≥ 1 cell line, cytogenetic and molecular abnormalities, and variable risk of progression to acute myeloid leukemia. Treatment goals for MDS classified as lower-risk (LR-MDS) include transfusion independence, improvement in hemoglobin (Hb) levels, and maintenance of or improvement in quality of life. Erythropoiesis-stimulating agents (ESAs) are the first-line (1L) treatment for anemia in most patients with LR-MDS lacking del(5q), but a proportion of patients do not respond to ESA treatment, or experience progression of anemia despite ESA treatment. The objective of this real-world analysis was to describe patient characteristics, treatment patterns (including ESA use), and outcomes in patients with LR-MDS. Methods: A retrospective, observational, US multisite, cohort study was conducted among adult patients initially diagnosed with LR-MDS between January 1, 2017 and June 25, 2020. Eligible patients had ≥ 1 year of follow-up after diagnosis (unless the patient died during this time) and did not receive luspatercept or any MDS treatment as part of a randomized, controlled trial. Community oncologists abstracted data from medical records, and descriptive statistics were used to summarize patient characteristics, treatment patterns, and outcomes. Data presented are from an interim analysis of an ongoing study; the last date of data collection for this analysis was July 6, 2021. Results: Among 125 eligible patients with LR-MDS, median follow-up time was 16 months, and 83% of patients were still alive at the time of data collection. In the 8 weeks prior to diagnosis, 54% of patients did not receive any red blood cell (RBC) or platelet transfusions, while 42% and 4% had low or moderate transfusion burden, respectively. Overall, 75% of patients were negative for del(5q), and 80% of patients were negative for ring sideroblasts (RS). At diagnosis of LR-MDS, serum erythropoietin levels were &lt; 200 U/L in 49% of patients, ≥ 200 U/L in 25%, and unknown in 26%. In terms of disease management, 35% of patients did not receive any systemic therapy or transfusions, 14% received RBC and/or platelet transfusions, but no systemic therapy for MDS, and 50% were reported to have received ≤ 2 lines of systemic therapy following LR-MDS diagnosis (Table). Of the 42% of patients who received an ESA, 70% received an ESA for MDS as a single agent (SA) only, 15% as combination therapy only, and 8% as both SA and combination therapy. A further 8% received SA ESA followed by a non-ESA-based regimen. Among 45 patients who received SA ESA as 1L treatment, 18% went on to receive a hypomethylating agent (HMA) or immunomodulatory imide drug as an SA, or ESA combined with HMA or a granulocyte or granulocyte-macrophage colony-stimulating factor (G-CSF/GM-CSF) in a subsequent line. Among patients who received an ESA, 72% were still on ESA-based therapy at the time of data collection. Abstracting physicians reported that 17% of patients who received an ESA failed ESA treatment. Among these patients, physicians' determination of ESA failure was based on the National Comprehensive Cancer Network guidelines/International Working Group 2006 response criteria for 78% of patients, and on physicians' own clinical judgement for 22%. At data collection, ESA was still being administered to 22% of patients considered to have failed ESA treatment. Finally, 34% of those who received an ESA also received RBC transfusion(s) during ESA-based treatment and therefore were not transfusion independent for the entire duration of ESA-based treatment (Table). Conclusions: Results from this real-world cohort study indicate that over a third of patients with LR-MDS have been managed using watchful waiting only, with no systemic treatment or transfusions received; among those patients who received treatment, most received an ESA. Nearly one-fifth of patients in this study treated with an ESA were considered to have failed ESA treatment by abstracting physicians, though this proportion is likely to be higher with extended follow-up; 2 of 9 patients who failed ESA treatment were still receiving an ESA. Further research including longer follow-up is warranted to understand how patients with LR-MDS respond to different treatment regimens. Figure 1 Figure 1. Disclosures Zimmerman Savill: Cardinal Health: Current Employment; Roche/Genentech: Ended employment in the past 24 months. Gajra: Cardinal Health: Current Employment, Current equity holder in publicly-traded company. Price: Bristol Myers Squibb: Current Employment, Current equity holder in publicly-traded company. Kish: Cardinal Health: Current Employment, Current equity holder in publicly-traded company, Research Funding. Brown-Bickerstaff: Cardinal Health: Current Employment. Falkenstein: Cardinal Health: Current Employment. Miller: Cardinal Health: Current Employment. Laney: Cardinal Health: Current Employment. Mukherjee: Acceleron: Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Research/Independent Contractor, Research Funding; McGraw Hill: Honoraria, Other: Editor of Hematology Oncology Board Review (ongoing); Celgene Corporation: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Research/Independent Contractor, Research Funding; AbbVie: Membership on an entity's Board of Directors or advisory committees; Genentech: Membership on an entity's Board of Directors or advisory committees; AAMDS in Joint Partnership with Cleveland Clinic Taussig Cancer Institute: Honoraria; Eusa Pharma: Consultancy, Membership on an entity's Board of Directors or advisory committees, Other: Teaching and Speaking; Jazz Pharmaceuticals: Research Funding; Bristol-Myers Squibb Co.: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; BioPharm: Consultancy; Partnership for Health Analytic Research: Honoraria; Blueprint Medicines: Membership on an entity's Board of Directors or advisory committees.

scholarly journals Anticoagulant Treatment Patterns and Outcomes in Patients with Venous Thromboembolism and Active Cancer - a Nationwide Cohort Study in France

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 670-670
Author(s):  
Laurent Bertoletti ◽  
Gaelle Gusto ◽  
Artak Khachatryan ◽  
Nadia Quignot ◽  
Jose Chaves ◽  
...  
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Venous Thromboembolism ◽  
Metastatic Disease ◽  
Cancer Diagnosis ◽  
Treatment Patterns ◽  
All Cause Mortality ◽  
Treatment Naïve ◽  
Event Rates ◽  
Active Cancer

Abstract BACKGROUND: Cancer is a major risk factor for venous thromboembolism (VTE) and for all-cause mortality following a VTE event. Higher risk can be attributed to certain cancer types and to metastatic disease. Until recently the gold standard for VTE and active cancer was low molecular weight heparin (LMWH), shown to be superior to warfarin in preventing thrombosis (Lee et al. 2003). Previously only minimal data from the direct oral anticoagulant (DOAC) pivotal RCTs were available in this population. However recent RCTs have been conducted that provide rationale for the use of DOACs as an alternative to LMWH in this patient group (Agnelli et al. 2020; Raskob et al. 2018; Young et al. 2018). This evidence is reflected in international guidelines (ASH 2021; ESC 2019; ITAC 2019, NCCN 2021) where DOACs are now proposed in VTE and active cancer patients without gastrointestinal cancer. PURPOSE: To describe patient characteristics, anticoagulant (AC) treatment patterns and outcomes among patients with VTE and active cancer in France. The analysis included all relevant ACs that were available for the treatment of VTE to understand how treatment recommendations were being reflected in clinical practice. METHODS: A nationwide retrospective cohort study of all adult patients (identified via the French national health data system: SNDS) with VTE and active cancer prescribed LMWH, a vitamin K antagonist (VKA), or a DOAC (apixaban or rivaroxaban) from 2013 to 2018. AC treatment-naïve (defined as patients without an AC prescription 24 months prior to index VTE) and AC treatment-experienced patients were included. Active cancer was defined by the presence of medical claims for cancer diagnosis or cancer-specific treatment in the 6 months prior or 30 days after index VTE event. A modified Khorana VTE risk scale (based on ICD codes and not blood tests) was used to evaluate the distribution of baseline VTE risk associated with different cancers. Rates of bleeding (defined as principal diagnoses of hospital stays), recurrent VTE, and all-cause mortality were assessed at 6 months for the standard of care (LMWH) cohort. RESULTS: 39,023 patients with VTE and active cancer were included. Most patients were prescribed LMWH 31,771 (81.42%), followed by rivaroxaban 2,259 (5.79%), VKAs 1,591 (4.08%), and apixaban 678 (1.74%). 2,724 (6.98%) were prescribed other parenteral anticoagulants (PAC) or PAC combinations. A slightly lower proportion of patients prescribed LMWH or VKAs were AC treatment naïve (44.4% and 45% respectively) compared to those prescribed rivaroxaban (51.2%) or apixaban (51.6%). Median duration of treatment (months; IQR) was shortest for LMWH patients (3.84; 1.35-8.48) and similar amongst the other ACs: VKAs (5.26; 1.05-14.16), rivaroxaban (5.85; 1.91-10.74), and apixaban (5.73; 1.74-9.07). Patients initiating VKAs and apixaban were older than those initiating rivaroxaban or LMWH (mean age in years: VKAs, 74; apixaban, 73; rivaroxaban, 67; LMWH, 66) however, LMWH patients had a higher comorbidity burden (mean CCI score: LMWH 6.4, VKAs, 4.95; rivaroxaban, 4.20; apixaban, 4.31). The proportion of patients with pulmonary embolism (PE), with or without DVT, was lower for LMWH and VKA cohorts (58.74% and 61.85% respectively) compared to rivaroxaban (71.76%) and apixaban (69.32%). Amongst patients with a medical claim for cancer diagnosis, the majority receiving LMWH (19,300 (61.8%)) had cancers with very high risk (brain, pancreatic, stomach) or high risk (gynaecological, lung, lymphoma, testicular, renal cell) for VTE. This proportion was lower in patients receiving VKAs, 484 (40.27%); rivaroxaban, 719 (43.52%); or apixaban, 194 (40%). Metastatic disease was present in most LMWH patients 21,994 (72.14%) but only in about a third of those receiving other ACs: VKAs, 406 (34.18%); rivaroxaban, 591 (36.37%); and apixaban, 152 (31.73%). Event rates for LMWH are reported in the table. CONCLUSIONS: AC therapy for a significant majority of patients with VTE and active cancer was LMWH. Most LMWH patients had metastatic disease. Median LMWH treatment was less than 4 months and VTE-related clinical event rates remained high in this population, suggesting a key unmet medical need. Future studies reflecting potential changes in clinical practice, because of guideline updates and the emergence of new RCT evidence, are required to understand clinical outcomes with different AC treatments. Figure 1 Figure 1. Disclosures Bertoletti: Pfizer: Honoraria, Other: Personal fees; BMS: Honoraria, Other: Personal Fees; Aspen: Other: Personal Fees; Bayer: Other: Personal Fees; Leo Pharma: Other: Personal Fee. Gusto: Pfizer: Consultancy. Khachatryan: Pfizer: Consultancy. Quignot: Pfizer: Consultancy. Chaves: Pfizer: Current Employment. Moniot: Pfizer: Current Employment. Mokgokong: Pfizer: Current Employment.

scholarly journals Patient Characteristics and Treatment Patterns in Elderly Adults with Relapsed or Refractory Acute Lymphoblastic Leukemia Using 100% Medicare ALL Data

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 5153-5153
Author(s):  
Victoria Chia ◽  
Julia T Molony ◽  
Shuling Li ◽  
Aaron Jacob Katz
Keyword(s):  
Lymphoblastic Leukemia ◽  
Patient Characteristics ◽  
Outpatient Setting ◽  
Treatment Patterns ◽  
Administrative Claims ◽  
Cell Transplant ◽  
Diagnosis Code ◽  
Diagnosis Codes ◽  
Treatment Changes ◽  
Diagnosis Date

Abstract Introduction: Acute lymphoblastic leukemia (ALL) is a very rare disease with a poor prognosis in elderly (>65 years) adult patients. Prognosis is worse in patients who have relapsed or refractory ALL (R/R ALL). Because there is limited real-world data on elderly patients with R/R ALL, we aimed to describe patient characteristics and treatment patterns among these patients in a large population-based dataset. Methods: Using 100% Medicare ALL administrative claims data from 2007-2012, we identified patients aged ≥ 66 years who were newly diagnosed with ALL in 2008-2011, continuously enrolled in Medicare fee-for-service (FFS) for 12 months prior to ALL diagnosis date, and continuously enrolled with Medicare Part D coverage for at least 30 days after diagnosis. Presence of ALL was defined as ≥1 Part A inpatient (IP)/skilled nursing facility (SNF)/home health agency (HHA)/hospice (HS) claim or ≥2 Part A outpatient (OP)/Part B (PB) claims occurring on different dates in any 2-month interval with an ICD-9 diagnosis code for ALL; date of ALL diagnosis was defined as the earlier date of the 1st IP/SNF/HHA/HS claim or the 2nd of 2 OP/PB claims carrying an ALL code. Follow-up for R/R disease began after the ALL diagnosis date, and was limited to a cohort of patients who had also received chemotherapy or a tyrosine kinase inhibitor (TKI) within 90 days of the ALL diagnosis date. Patients were identified as having R/R ALL if they had one of the following criteria: 1) a claim with an ICD-9 diagnosis code for R/R ALL (204.02) in any position after treatment was initiated; 2) use of clofarabine, nelarabine or the start of a second chemotherapy course; or 3) a change in type of TKI identified from Part D prescription drug claims. The date of R/R ALL diagnosis was defined as the earliest of date a patient met any of the R/R ALL criteria. Patient characteristics and treatment patterns were described for patients identified as having R/R ALL. Results: Of the 303 patients who were identified as having ALL from 2008-2011 and had treatment with chemotherapy or TKI within 90 days of the ALL diagnosis date, 144 patients (48%) were identified as subsequently having R/R disease. Of those, 39 (27%) were identified through diagnosis code only, 40% were identified through treatment changes only, and 47 (32%) were identified through both diagnosis codes and treatment changes. The median time from the ALL diagnosis date to date of R/R disease was 201 days, 172.5 days, and 240 days for patients identified using diagnosis codes, treatment changes, and both diagnosis codes and treatment changes, respectively. Overall, 81 (56%) patients with R/R ALL defined at the changes in treatment with or without a subsequent diagnosis. Patients who were identified with R/R ALL were slightly younger and had fewer comorbidities than the overall group of patients diagnosed with ALL (Table). Of the patients identified with R/R ALL, 126 (88%) were treated with any chemotherapy or TKIs; 120 (83%) patients were treated with chemotherapy and 26 (18%) patients were treated with TKIs. Eleven (8%) patients received a bone marrow/stem cell transplant. Of the 120 patients treated with chemotherapy, 73% had only one chemotherapy course and 51% had the first chemotherapy administration in an outpatient setting. Vincristine alone or in combination with other agents was the most commonly observed type of chemotherapy. Of the 26 patients who were treated with TKIs, 42% had only one course and 69% were treated with dasatinib. Conclusions: These data describe real-world patient characteristics and treatment patterns in elderly patients with R/R ALL. Approximately half of the elderly ALL patients who were treated for ALL within 90 days of diagnosis were identified as having R/R ALL through administrative claims data, and more than half were identified through changes in treatment and not through the use of diagnosis codes. Thus, we are likely underestimating the true proportion of elderly ALL patients who have R/R disease. Interestingly, we observed that 51% of patients treated with chemotherapy had the first chemotherapy administration in an outpatient setting, and that only 8% of patients received a bone marrow/stem cell transplant. Disclosures Chia: Amgen Inc: Employment, Equity Ownership. Katz:Amgen Inc: Employment, Equity Ownership.

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