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.

scholarly journals Treatment Patterns, Adverse Events, and Economic Burden in a Privately Insured Population of Newly Diagnosed Patients with Chronic Lymphocytic Leukemia in the United States

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3557-3557 ◽  
Author(s):  
Shaum Kabadi ◽  
Ravi K Goyal ◽  
Saurabh P Nagar ◽  
James A Kaye ◽  
Keith L Davis ◽  
...  
Keyword(s):  
Health Care ◽  
Adverse Events ◽  
Systemic Therapy ◽  
Research Funding ◽  
The United States ◽  
Treatment Patterns ◽  
Newly Diagnosed ◽  
The Us ◽  
Privately Insured

Abstract Introduction: Contemporary data describing treatment patterns, adverse events (AEs) and outcomes in CLL patients in clinical practice is lacking. We conducted a retrospective cohort study and assessed treatment patterns, AEs, health care resource use (HCRU), and costs in patients with newly diagnosed CLL. Methods: Using a nationally representative population of privately insured patients in the US, adult patients with CLL were selected if they had continuous health plan enrollment for ≥12 months before the first CLL diagnosis without any evidence of any CLL-directed treatment. Treatment patterns up to 4 lines of therapy (LOT) and occurrence of AEs during CLL therapies were assessed. Mean per-patient monthly HCRU and costs were assessed overall and by number of unique AEs. Results: Of all patients meeting the selection criteria (n=7,639; median age, 66 years), 18% (n=1,379) received a systemic therapy during study follow-up. The most common systemic therapy regimens, regardless of therapy line, were bendamustine/rituximab (BR) (32%), rituximab monotherapy (24% [including maintenance]), ibrutinib monotherapy (15%), and fludarabine/cyclophosphamide/ rituximab (FCR) (14%). Of these, BR was the most common LOT-1 regimen (28.1%), while ibrutinib was the most common regimen in LOT-2 (20.8%) and in LOT-3 (25.5%). Use of idelalisib was limited to 1.6% of all patients receiving systemic therapy; however, an increasing trend was observed as patients moved from first to fourth LOT (<1% in LOT-1, 3.1% in LOT-2, 4.7% in LOT-3, and 8.6% in LOT-4). AEs identified during the most common treatments for CLL are presented by treatment regimen in Table 1. The mean monthly all-cause and CLL-related costs, among patients treated with a systemic therapy, were $7,943 (SD=$15,757) and $5,185 (SD=$9,935), respectively. Figure 1 depicts mean monthly costs by care setting and number of AEs, among all patients. Mean (SD) monthly all-cause costs during the post-index date follow-up were $905 ($1,865) among those with no AEs, $1,655 ($5,364) among those with 1-2 AEs, $2,883 ($8,483) among those with 3-5 AEs, and $6,032 ($13,290) among those with ≥6 AEs. Conclusions: This population-based study yielded recent real-world evidence on treatment patterns, AEs, HCRU, and costs in patients enrolled in health plans in the US. Immunochemotherapy, particularly BR, remained the preferred frontline therapy for CLL, whereas ibrutinib was the preferred therapy in LOT-2 and LOT-3, during the study period. This study demonstrates that the AE burden associated with current treatment alternatives for CLL is substantial, and the management of AEs occurring during treatments may have a significant impact on the overall health care costs. Disclosures Kabadi: AstraZeneca: Employment. Goyal:RTI Health Solutions: Employment, Research Funding. Nagar:RTI Health Solutions: Employment, Research Funding. Kaye:RTI Health Solutions: Employment, Research Funding. Davis:RTI Health Solutions: Employment, Research Funding. Mato:Celgene: Consultancy; AstraZeneca: Consultancy; Pharmacyclics: Consultancy, Honoraria, Research Funding; Abbvie: Consultancy; Sunesis: Honoraria, Research Funding; TG Therapeutics: Research Funding; Janssen: Consultancy, Honoraria; Acerta: Research Funding; Prime Oncology: Speakers Bureau; Regeneron: Research Funding.

scholarly journals Evaluation and Comparison of Characteristics and Outcomes Among Frontline Multiple Myeloma (FLMM) Patients with and without Stem Cell Transplant Treatment

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4738-4738 ◽  
Author(s):  
Ajai Chari ◽  
Maneesha Mehra ◽  
Mary Slavcev ◽  
Annette Lam ◽  
Ravi Potluri ◽  
...  
Keyword(s):  
Stem Cell ◽  
Board Of Directors ◽  
Real World ◽  
Research Funding ◽  
Patient Characteristics ◽  
The United States ◽  
Cell Transplant ◽  
Real World Data ◽  
Advisory Committees ◽  
World Data

Abstract Background: High-dose therapy with autologous stem cell transplantation (SCT) is a standard treatment option in FLMM patients who are ≤65 years of age. Few studies have examined the real-world patient characteristics and outcomes associated with those who receive an SCT compared with non-SCT patients. Aims: To use real-world data to characterize patients with FLMM who received SCT compared with those who did not receive SCT, and determine their overall survival (OS). Methods: Data were extracted from 3 real-world data sources from the United States: Surveillance, Epidemiology, and End Results (SEER)-Medicare Linked (January 2007 to December 2014), OPTUM™ Commercial Claims (January 2000 to March 2017), and OPTUM™ Electronic Medical Records (EMR; January 2007 to March 2016) databases. Patients with 1) an index MM diagnosis on or after 1 January 2007 who 2) had known gender and medical prescription coverage at the time of diagnosis, 3) had a 1-year look-back period prior to index diagnosis, 4) had no prior cancers in the 1-year period prior to index diagnosis, and 5) had at least 1 line of treatment were included. SCT patients were defined as those who received an SCT at any time during their follow-up. Patient characteristics such as age (at index diagnosis), gender, and comorbidities (180 days before start of first line of therapy [LOT1]) were descriptively compared. OS was evaluated from the start of LOT1 using the Kaplan-Meier method and multivariable Cox regression analyses. Results: A total of 9,323 patients were analyzed, comprising 1,599 SCT (17.2%) and 7,724 (82.8%) non-SCT patients. Patient characteristics and OS are summarized in the Table. Descriptive differences in patient characteristics were observed between SCT and non-SCT patients, including median age at start of frontline treatment, gender, and incidences of baseline comorbidities. In terms of survival outcomes, median OS was not reached (NR; 95% confidence interval [CI], 91.8-not estimable [NE]) for SCT patients compared with 45.1 (95% CI, 43.1-46.8) months for non-SCT patients. Age at index diagnosis, gender, time to and year of treatment initiation, and presence of baseline comorbidities were significantly associated with OS. Accounting for differences in these patient characteristics, the adjusted hazard ratio (HR) for OS in non-SCT versus SCT patients was 2.29 (95% CI, 2.01-2.61; P <0.0001). Among the different age subgroups (<65, 65-74, and ≥75 years of age), the OS benefit for SCT versus non-SCT was maintained across these subgroups (Figure). Conclusions: In a real-world setting, FLMM patients who received SCT were younger and had lower rates of several comorbidities at baseline compared with non-SCT patients. A significant OS benefit was observed among patients who had received SCT, underlying the need for more effective treatment options in patients who do not receive SCT. Disclosures Chari: Takeda: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Array Biopharma: Research Funding; Celgene: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; Pharmacyclics: Research Funding; Seattle Genetics: Membership on an entity's Board of Directors or advisory committees; Bristol Myers Squibb: Consultancy; Adaptive Biotechnology: Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Membership on an entity's Board of Directors or advisory committees, Research Funding; The Binding Site: Consultancy. Mehra:Janssen Global Services, LLC: Employment. Slavcev:Janssen Global Services, LLC: Employment. Lam:Janssen Global Services, LLC: Employment. Potluri:SmartAnalyst Inc.: Employment. Kaufman:Abbvie: Consultancy; Roche: Consultancy; BMS: Consultancy; Janssen: Consultancy; Karyopharm: Other: data monitoring committee.

scholarly journals Demographic and Comorbidity Characteristics of Newly Diagnosed Multiple Myeloma Patients in the United States: A Real World Data Analysis

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1301-1301 ◽  
Author(s):  
Yaozhu J Chen ◽  
Ajita P De ◽  
Ze Cong ◽  
Sanjay K Aggarwal ◽  
Rolin L Wade
Keyword(s):  
Real World ◽  
Research Funding ◽  
Index Date ◽  
The United States ◽  
Newly Diagnosed ◽  
Real World Evidence ◽  
The Us ◽  
Skeletal Related Events ◽  
Baseline Characteristics ◽  
Baseline Demographic

Abstract Background Multiple myeloma (MM) remains an incurable plasma cell neoplasm with >20,000 new cases diagnosed annually in the United States (US). The presentation of MM is diverse and the management is guided by disease- and patient- related factors. Real world evidence regarding disease presentation is sparse for newly diagnosed MM (NDMM) patients. The goal of this study was to describe the baseline demographic and clinical characteristics of NDMM patients by linking multiple large claims databases in the US. Methods A retrospective cohort study was conducted by linking the records between 01/01/2006-12/31/2013 from three longitudinal IMS databases (Medical Claims, Pharmacy Prescriptions, and Hospital Charge Master), to reflect a complete treatment continuum for patients in all ages and by all payer types across healthcare settings. Included patients met the following criteria: ≥2 claims with a diagnosis of MM (ICD-9-CM 203.0x) at least 30 days apart between 01/01/2007-12/31/2012 (first MM diagnosis date = index date); provider stability for at least 6 months before and 3 months after index date; aged 18+ as of index date. NDMM patients were identified as those with no MM diagnosis in the 6 months pre-index. Patient baseline characteristics were assessed using data at index for age, gender, geographic region and payer type; 6-month pre-index plus index day data for Charlson Comorbidity Index (CCI); 6-month pre-index data for 32 comorbidities (e.g., cardiac arrhythmia, cerebrovascular disease, chronic kidney disease, diabetes, hypertension, among others); and 5 comorbidity categories (cardiovascular, renal, metabolic, skeletal-related events, and other). Autologous stem cell transplant (ASCT) status was also assessed based on the available follow-up data after initial diagnosis. Patient baseline characteristics were compared between the patients with versus without ASCT after MM diagnosis. Chi-square tests for categorical variables and t-tests for continuous variables (alpha=0.05) were conducted. Results The study cohort of 8,239 NDMM patients had a mean (SD) age of 66.2 (11.3) years at diagnosis, with 56.7% aged 65+; 51.8% were female; and the majority were with commercial (43.3%) or Medicare (42.8%) as payer. Patients with post-index ASCT (n=1,429; 17.3%) were distinctly different from those without (n=6,810; 82.7%): they were younger with a mean (SD) age of 58.1 (8.7) vs. 67.9 (11.1) years, fewer aged 65+, 24.1% vs. 63.5%; fewer female, 47.6% vs. 52.6% (all p<0.001); and the majority (67.5%) of patients who later had ASCT were covered by commercial plans, compared to Medicare as the biggest payer (48.2%) for those who did not have post-index ASCT. NDMM patients had an overall mean (SD) CCI score of 3.1 (1.6). Patients who later received ASCT were healthier than those who did not, with mean (SD) CCI scores of 2.7 (1.4) vs. 3.2 (1.6) (p<0.001). Close to half (47.9%) of all NDMM patients had >1 type of comorbidities at baseline. Figure 1 depicts the baseline comorbidity categories among all NDMM patients as well as the two subsets (with versus without post-index ASCT). Comorbidities were prevalent even before MM diagnosis: 43.9% of patients presented with metabolic comorbidities, 21.4% with cardiovascular diseases, 11.5% with renal conditions, 5.9% with skeletal-related events, and 45.0% with other comorbidities. The patient subset with post-index ASCT had lower comorbidity occurrences compared to those without: 10.5% vs. 23.6% in cardiovascular diseases, 5.9% vs. 12.7% in renal conditions, 32.7% vs. 46.3% in metabolic diseases (all p<0.001), consistent with literature showing that ASCT candidates tend to be younger and have less severe comorbidities. Conclusions This study provided baseline demographic and comorbidity profiles of NDMM patients and showed that the NDMM patient population presented with various comorbidities prior to the first MM diagnosis, suggesting the needs for efficacious, tolerable and safe treatment options for a heterogeneous patient population with complex disease profiles. As expected, patients who had ASCT after initial diagnosis were younger and healthier than those who did not have ASCT. The study findings portray a clearer picture of NDMM patients in the US, and provide clinicians with valuable real world evidence to identify appropriate treatment strategies for these patients. Figure 1 Figure 1. Disclosures Chen: Onyx Pharmaceuticals: Research Funding. De:Onyx Pharmaceuticals: Research Funding. Cong:Onyz Pharmaceuticals: Employment. Aggarwal:Onyx Pharmaceuticals: Employment. Wade:Onyx Pharmaceuticals: Research Funding.

scholarly journals Real-World Multiple Myeloma Treatment Patterns By Patient Characteristics and Outcomes in the United States

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4114-4114
Author(s):  
Joshua Richter ◽  
Erin Singh ◽  
Megan S. Rice
Keyword(s):  
Real World ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
First Line ◽  
Treatment Regimens ◽  
First Line Therapy ◽  
Line Therapy ◽  
Line Of Therapy ◽  
To Receive

Abstract Introduction: Despite numerous therapies approved for multiple myeloma (MM) in the past decade, the disease remains largely incurable. As a result, patients (pts) typically require successive lines of therapy, comprised of various combinations of drugs, to treat relapsed disease. As the treatment landscape evolves, continued real-world (RW) studies provide additional understanding of the treatment patterns of MM pts outside of clinical trials, particularly for those with unmet medical need and/or high-risk disease. In this retrospective, observational cohort study, we examined RW treatment patterns among MM pts overall and within patient subgroups classified by age, race/ethnicity, renal impairment (RI), cytogenetic risk, and 1q21 amplification, as well as patient outcomes. Methods: This study used the nationwide Flatiron Health electronic health record-derived de-identified database of MM pts treated in the United States. During the study period, January 1, 2016 to April 30, 2021, pts who had ≥1 line of therapy or whose first-line treatment was initiated after the study start were included. Treatment class regimens (lines 1-4) were classified as: proteasome inhibitor (PI)-based, immunomodulatory drug (IMiD)-based, PI + IMiD-based, chemotherapy-based, antibody-based, or other treatments. We examined patient characteristics as well as treatment patterns overall and in patient subgroups. We also assessed real-world progression-free survival (rwPFS), defined as the time from start of line therapy to the date of progression or death, by treatment regimen received. Results: At the time of data cutoff, 5465 pts received ≥1 line of therapy; 45.3% of pts were female, 57.4% were white, median age at the start of first-line therapy was 70 years (interquartile range 62-77), and 88.7% received care at community practices. A total of 14.6% had high-risk cytogenetic abnormalities, 21.0% had 1q21 amplification, 20.7% had International Staging System stage III at diagnosis and 33.2% had RI (eGFR &lt;60 mL/min/1.73 m 2) at the start of first-line therapy. The most common first-line regimens were PI + IMiD-based (53.4%), whereas 12.8% received PI-based, 11.5% IMiD-based, 13.4% chemotherapy-based, 2.8% antibody-based, and 6.1% had other treatments (Figure 1). Although uncommon in first-line therapy, antibody-based treatments were more commonly used in later lines of therapy (second-line: 21.0%; third-line: 33.7%; fourth-line: 40.0%). In first-line, pts aged ≥75 years were less likely to receive PI + IMiD-based regimens than those aged &lt;75 years (40.4% vs 60.1%) (Figure 2). Similarly, RI pts received PI + IMiD-based regimens less frequently in first-line than those without impairment (47.8% vs 65.0%). In first-line, 18.9% of pts had evidence of undergoing a transplant. Both older pts and those with RI were also less likely to receive a transplant as part of their first-line treatment (1.7% vs 27.7% and 13.9% vs 24.2% respectively). Treatment differences were less pronounced in later lines as well as by race/ethnicity, cytogenetic risk, and 1q21 amplification. In first-line therapy, rwPFS was longer for pts treated with PI + IMiD-based regimens (median [95% confidence interval], 29.5 months [27.3-31.9]). In later lines of therapy, pts treated with IMiD-based regimens had longer median rwPFS (second-line: 22.7 months [18.5-30.4]; third-line: 19.7 months [14.2-37.0]; fourth-line: 16.1 months [6.4-26.7]). Additional analyses examining newer treatment regimens will be presented. Conclusions: PI + IMiD combination therapy was the most common first-line therapy. Although not commonly used in first-line therapy, antibody-based regimens are increasingly used in later lines of therapy. Older pts as well as pts with RI were less likely to receive PI + IMiD regimens or transplant in first-line therapy. Pts receiving PI + IMiD regimens in first-line therapy had longer rwPFS. Pts receiving IMiD-based regimens had longer rwPFS in later lines. Analyses of newer treatment regimens to be presented within this dataset will provide additional insight into changes in RW treatment patterns in the era of novel agents. Figure 1 Figure 1. Disclosures Richter: BMS, Karyopharm, Antengene: Membership on an entity's Board of Directors or advisory committees; Adaptive biotechnologies: Speakers Bureau; Janssen, Celgene: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Tisch Cancer Institute: Icahn School of Medicine at Mount Sinai: Current Employment. Singh: Sanofi: Current Employment. Rice: Sanofi: Current Employment, Current holder of individual stocks in a privately-held company.

Real-world treatment patterns and outcomes of triple-exposed multiple myeloma patients treated in community oncology practices in the United States.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18727-e18727
Author(s):  
Robert Smith ◽  
Mei Xue ◽  
Natalie Dorrow ◽  
Prateesh Varughese ◽  
Cosima Hogea ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Real World ◽  
Proteasome Inhibitors ◽  
Office Visit ◽  
The United States ◽  
Subsequent Treatment ◽  
Treatment Patterns ◽  
Duration Of Therapy ◽  
The Us

e18727 Background: Treatment for multiple myeloma (MM) over the past decade has significantly improved survival. In particular, 3 drug classes have altered the treatment paradigm for MM patients: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and CD38 monoclonal antibodies (anti-CD38s). Despite these advances, the majority of patients with MM will become refractory to PIs, IMiDs, and anti-CD38s, and limited evidence indicates these patients have poor outcomes. A retrospective study in the US showed that 275 patients treated at 14 academic institutions with prior exposure to a PI, IMiD, and anti-CD38 had median overall survival of 9.2 months. The aim of this study was to evaluate real-world treatment patterns and outcomes (duration of therapy and overall survival) of patients who had been treated with a PI, IMiD, and anti-CD38 in community practices in the US. Methods: This retrospective observational study was conducted using the Integra Connect (IC) database. The IC database includes electronic health data from structured and unstructured fields from 12 community practices on the East and West Coast of the US. Adult patients with ≥2 ICD-9/ICD-10 codes for MM on at least 2 separate dates, who received MM treatment between Jan 1, 2016, and Dec 31, 2019, with treatment history that included at least one PI, one IMiD, and one anti-CD38 (triple exposed), and initiated a subsequent line of therapy (s-LOT) after becoming triple exposed, were included. Duration of length of s-LOT was defined as number of days from start of s-LOT to last-day supply of s-LOT. Overall survival was defined as the length of time from start of s-LOT through death or the date of the last office visit. Results: A total of 501 patients were included in this analysis. The median age of patients was 64.9 years; 50% were male; 50% had commercial insurance. 82.8% of patients had ECOG 0 or 1 at diagnosis and had received a median of 3 prior lines of therapy (LOTs) before initiating s-LOT. Prior to initiating s-LOT, 91% had been exposed to bortezomib, 81% to carfilzomib, 94% to lenalidomide, 82% to pomalidomide, and 100% to daratumumab. In s-LOT, 95% received treatment that included same drug or same drug class (30% received bortezomib, 48% carfilzomib, 31% lenalidomide, 47% pomalidomide, and 31% daratumumab). The median duration of s-LOT was 78 days and median survival was 10.3 months (308 days) from initiation of s-LOT. Conclusions: For triple-class exposed patients, there is a lack of consensus on the most efficacious approach to subsequent treatment. The present study shows a significant amount of retreatment with previously used agents or classes among these patients with short duration of therapy and poor survival. As has been previously noted, new strategies and agents targeting novel aspects of MM are needed to improve outcomes for these patients. Disclosures: This study (213286) was sponsored by GlaxoSmithKline.

scholarly journals Treatment characteristics for nonmetastatic castration-resistant prostate cancer in the United States, Europe and Japan

2019 ◽  
Vol 15 (35) ◽  
pp. 4069-4081 ◽  
Author(s):  
Ruchitbhai Shah ◽  
Marc Botteman ◽  
Reginald Waldeck
Keyword(s):  
Prostate Cancer ◽  
Eastern Cooperative Oncology Group ◽  
Patient Characteristics ◽  
The United States ◽  
Treatment Patterns ◽  
Castration Resistant Prostate Cancer ◽  
Androgen Synthesis ◽  
Castration Resistant ◽  
The Us ◽  
Androgen Synthesis Inhibitors

Aim: We conducted this study to describe nonmetastatic castration-resistant prostate cancer (nmCRPC) patient characteristics and treatment patterns in the US, Europe and Japan. Materials & methods: Descriptive analyses were conducted using the 2015–2017 Ipsos Global Oncology Monitor Database. Results: A total of 2065 (442 in the US, 509 in Europe and 1114 in Japan) patients (median age: 74–80 years; stage III at diagnosis : 38.5%; Eastern Cooperative Oncology Group [ECOG] score ≤1: 79.4%; treated by urologist : 88.4%) were included in the analytic cohort. Luteinizing hormone-releasing hormone agonists and antiandrogens were the most commonly used first regimen treatments. With subsequent nmCRPC regimens their use decreased, while the use of chemotherapy, corticosteroids, androgen synthesis inhibitors and second-generation androgen receptor inhibitors increased. Conclusion: These data represent real-world treatment patterns in nmCRPC.

scholarly journals Patient Characteristics and Treatment Patterns in the First-Line and Second-Line Treatment of Diffuse Large B-Cell Lymphoma and Follicular Lymphoma in the United Kingdom, France, and Germany

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4234-4234 ◽  
Author(s):  
Aaron Galaznik ◽  
Nate Way
Keyword(s):  
Systemic Therapy ◽  
B Cell Lymphoma ◽  
Patient Characteristics ◽  
Current Treatment ◽  
Treatment Patterns ◽  
Initial Diagnosis ◽  
The United Kingdom ◽  
Real World Evidence ◽  
The Uk ◽  
Combination Regimens

Abstract Introduction: Diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) are hematologic malignancies with poor prognosis for patients who do not respond well to therapy. As current treatment options may be suboptimal for many patients, it is important to better understand the current treatment landscape for DLBCL and FL. Here we provide recent real-world evidence on patient characteristics and treatment patterns in relapsed/refractory (R/R) DLBCL and R/R FL across the United Kingdom (UK), France (FRA), and Germany (DE). Methods: Hematologists and oncologists (N=140) from the UK, FRA, or DE retrospectively identified patients diagnosed with R/R DLBCL or R/R FL who received at least two lines of therapy and had radiographically or clinically measurable disease with at least one target lesion per International Working Group criteria for malignant lymphoma. Descriptive statistics examined patient characteristics and treatment patterns in first-line (1L) and second-line (2L) therapy. Results: Mean (SD) age at initial diagnosis was 59.9 (10.9) years for the aggregate DLBCL patient sample (N=272). DLBCL patients were primarily male (69.1%), distributed across the UK (29.0%), FRA (36.8%), and DE (34.2%), and had various Eastern Cooperative Oncology Group (ECOG) performance statuses at initial diagnosis (0 ECOG 28.7%, 1 ECOG 48.9%, 2 ECOG 14.3%, ≥3 ECOG 5.9%, unknown ECOG 2.2%). Mean (SD) age at initial diagnosis was 61.0 (10.2) years for the aggregate FL patient sample (N=282). FL patients were primarily male (53.9%), distributed across the UK (29.4%), FRA (36.9%), and DE (33.7%), and had various ECOG performance statuses at initial diagnosis (0 ECOG 30.5%, 1 ECOG 50.7%, 2 ECOG 13.5%, ≥3 ECOG 4.2%, unknown ECOG 1.1%). DLCBL and FL patient characteristics by country are presented in Table 1. DLCBL patients in 1L and 2L received combination regimens (93.8% and 82.7%, respectively) or monotherapy regimens (6.2% and 17.3%, respectively). DLCBL patients in 1L received treatment largely consistent with current guidelines, consisting mainly of systemic therapy only (86.8%) and treatment with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone (R-CHOP, 68.0%). DLCBL patients in 2L completed multiple therapy cycles (median 3 cycles) and were treated with systemic therapy only (79.4%), systemic therapy and radiation (4.0%), systemic therapy and stem cell transplantation (SCT, 16.2%), or systemic therapy, radiation, and SCT (0.4%). The most common 2L DLCBL regimens were: rituximab, dexamethasone, high-dose cytosine arabinoside, and cisplatin (R-DHAP, 19.5%); bendamustine plus rituximab (12.9%); rituximab, dexamethasone, cytarabine, and oxaliplatin (R-DHAX, 12.5%). FL patients in 1L and 2L received combination regimens (86.5% and 78.4%, respectively) or monotherapy regimens (13.5% and 21.6%, respectively). FL patients in 1L received treatment largely consistent with current guidelines, consisting mainly of systemic therapy only (90.8%) and treatment with R-CHOP (35.1%). FL patients in 2L completed multiple therapy cycles (median 4 cycles) and were treated with systemic therapy only (90.1%), systemic therapy and radiation (2.1%), systemic therapy and SCT (6.0%), or systemic therapy, radiation, and SCT (1.8%). The most common 2L FL regimens were: bendamustine plus rituximab (33.3%); R-CHOP (9.6%); R-DHAP (8.5%). DLCBL and FL 2L treatment patterns by country are presented in Table 2. Conclusion/Summary: Given the rapid evolution of therapies used to treat FL and DLBCL, these findings fill a crucial data gap in real-world evidence on patient characteristics and treatment patterns in R/R DLCBL and R/R FL in the UK, FRA, and DE. There is an unmet need in DLBCL and FL. As novel treatments for patients with DLBCL and FL are currently in development, it is important to better understand the patients being treated for these conditions and the current treatment landscape. Disclosures Galaznik: Takeda Pharmaceuticals International Co.: Employment. Way:Seattle Genetics: Research Funding; Kantar Health: Employment.

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 Treatment Patterns from the HUMANS Study in Multiple Myeloma in Denmark

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5030-5030
Author(s):  
Niels Abildgaard ◽  
Anders Waage ◽  
Markus Hansson ◽  
Pekka Anttila ◽  
Mate Szilcz ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Treatment Duration ◽  
Research Funding ◽  
Population Based ◽  
Treatment Patterns ◽  
Line Treatment ◽  
First Line ◽  
Real World Evidence ◽  
First Line Treatment

Introduction Current treatment for multiple myeloma (MM), an incurable but treatment sensitive plasma cell cancer, aims to extend time to disease progression, prolong survival and improve quality of life. Nevertheless, epidemiological knowledge regarding MM treatment is mostly derived from randomized controlled trials, which are limited by strict inclusion criteria, study designs that assess drug efficacy in optimal clinical settings, and short follow-up. Current treatment options for MM are associated with complex and varying treatment-related side effect profiles. However, real-world evidence is available only for a limited selection of treatment regimens. Thus, there is a need for studies to further investigate treatment patterns in clinical settings that reflect real-world practice. The Health Outcome and Understanding of Myeloma - a multi-national real-world evidence (HUMANS) study - aimed to characterize patient characteristics, treatment patterns, and outcomes for newly diagnosed patients with MM who received first-line treatment. Here we report first results from the Danish study. Methods This population-based, retrospective, longitudinal, observational study used secondary data from the Danish Cancer Register (DCR) and National Patient Register (NPR) for patients diagnosed with MM. Patients were stratified by autologous stem cell transplantation (ASCT) and pharmacological treatment (bortezomib-based, lenalidomide-based, or other first-line therapy) and characterized using descriptive statistics. To analyse recent treatment patterns and also include patients with long duration before treatment start, eligible patients had first MM diagnosis from 2005-2016 in the NPR and DCR (diagnosis date identified from the DCR), first MM-specific treatment from 2010-2018 in the NPR, no other hematologic cancer records in the NPR and DCR, and no MM treatment before diagnosis. Treatment duration (time between start and end of treatment period, with set grace period of 60 days and assumed treatment supply of 7 and 28 days per treatment event for bortezomib and lenalidomide, respectively) and overall survival (OS) were estimated by Kaplan-Meier method. Results The study population comprised 2,451 patients with MM, of which 887 patients (36%) underwent ASCT. In the non-ASCT population (n=1564), the majority (n=838, 54%) received bortezomib as first-line treatment, 102 patients (7%) received lenalidomide, and for 631 patients (40%), first-line treatment could not be identified (referred to as the other non-ASCT cohort). Mean (standard deviation) age overall at first MM diagnosis was 68 (±11) years, and was 72 (±8), 75 (±9), 77 (±7), and 59 (±8) years in the bortezomib, lenalidomide, other non-ASCT and ASCT cohorts, respectively. A higher number of men (57%) than women were diagnosed with MM. From 2015 onwards, the proportion of patients who received lenalidomide increased, whereas for patients who received other MM specific drugs, the proportion decreased (see Table 1). The median OS (95% confidence interval [CI]) from administration of first-line treatment for the bortezomib and lenalidomide cohorts was 52.9 (46.2-58.2) and 69.3 (54.7-108.4) months, respectively. For the ASCT cohort the median OS was 117.2 (104.2-133.8) months from MM diagnosis. Patients followed a once or twice weekly regimen of bortezomib treatment, i.e. 3/4 or 7 days between treatments (Figure 1). Patients in the bortezomib cohort remained treated with a median bortezomib treatment duration of 4 months (CI 4.04-4.60) and an estimated 10% remained on treatment at 10 months. In the lenalidomide cohort, patients remained treated with a median duration of 7 months (CI 4.67-10.12) and an estimated 10% remained on treatment at 23 months (Figure 2). Conclusion In this study, we present population-based treatment patterns and outcomes for MM in Danish clinical practice. The 4 month median treatment duration of bortezomib was lower than the target treatment suggested by prior clinical trials. The differences in overall survival and treatment duration should be interpreted with caution, as patients in the different cohorts have varying baseline characteristics. Linked data from the DCR and NPR may provide real-world evidence of treatment patterns in clinical practice. Research regarding time to progression in a multiple myeloma real-world setting is warranted. Disclosures Abildgaard: Amgen: Research Funding; Takeda: Research Funding; Janssen: Research Funding; Celgene: Research Funding. Szilcz:Parexel International: Employment. Ma:Parexel International: Employment. Ørstavik:Takeda Pharmaceuticals International AG: Employment. Bent-Ennakhil:Takeda Pharmaceuticals International AG: Employment. Freilich:Parexel International: Employment. Gavini:Takeda Pharmaceuticals International AG: Employment.

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