scholarly journals Utilizing Multiple Linked Populations Registers to Estimate Incidence and Prevalence of Multiple Myeloma in Sweden and Denmark from the Real-World HUMANS Study

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 5037-5037
Author(s):  
Markus Hansson ◽  
Niels Abildgaard ◽  
Anders Waage ◽  
Pekka Anttila ◽  
Anders Green ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Cancer Diagnosis ◽  
Real World ◽  
Research Funding ◽  
Inclusion Criteria ◽  
Real World Data ◽  
World Data ◽  
Best Estimate ◽  
Icd 10 ◽  
Incidence Prevalence

Introduction Multiple myeloma (MM) is an incurable but treatment sensitive plasma cell cancer with an average survival of 2-5 years following diagnosis, depending on age and stage. Few studies report real-world data in MM, with limited estimations of incidence and prevalence. The Health Outcome and Understanding of Myeloma - a multi-national real-world evidence (HUMANS) study utilized real-world data from nationwide registers in Sweden and Denmark, with almost complete population coverage, to estimate the incidence and prevalence of MM. Methods This population-based, retrospective, observational, cohort study used linked, secondary data from national healthcare registers in Sweden (National Patient Register [NPR], Cancer Register [CR], Cause of Death [COD], and Prescription Drug Register [PDR]) and Denmark (NPR and CR) from 2005-2018. Patients with MM diagnosis recorded in the NPR and/or CR treated and untreated with MM specific drugs were included. The NPR in both countries is a hospital discharge register, in which patients receive an ICD-10 diagnosis each time they visit outpatient or inpatient care as the main reason for the hospital visit. The CR is manually reported by physicians when a cancer diagnosis is confirmed. In Denmark, the CR is automatically connected to the NPR, thereby obliging physicians to register whether a diagnosis is confirmed upon first NPR ICD-10 code registration of a cancer diagnosis. The Swedish CR requires active registration of a pathologist or treating hematologist to confirm the diagnosis. To determine the completeness of registration in each respective CR, treatments from the Swedish PDR and Danish NPR from 2010-2018 were used to assess incident NPR cases. Treated patients registered in the NPR, but not in the CR (NPR+/CR-) were compared with treated patients registered in both (NPR+/CR+) to assess any systematic reasons for lack of CR registration. Final inclusion criteria were determined for best estimate of incidence/prevalence of MM. Prevalence was defined as the number of non-deceased patients with MM recorded during each calendar year, as assessed from the COD register. Incidence and prevalence rates were calculated as the crude incident and prevalent cases, divided by the patients at risk (total population minus prevalent population) for each year and multiplied by 100,000. Results In Sweden, data for 13,523 unique patients with registered MM was collected. Of these, 4,563 and 874 fulfilled the inclusion criteria of NPR+/CR+ and NPR+/CR-, respectively. In the comparative analysis, NPR+/CR+ and NPR+/CR- patients had a similar frequency of treatment at a hematology department (57% of NPR+/CR+ and 53% of NPR+/CR- patients had ≥1 visit ), and had a similar share of patients with autologous stem cell transplant (22% for NPR+/CR+ and 18% for NPR+/CR-), and of MM pharmacological treatment type (53% for NPR+/CR+ and 47% for NPR+/CR- had ≥1 prescription of lenalidomide). Both university hospitals and general hospitals had a high share of NPR+/CR- patients. As no systematic difference was found for patients registered in the CR or not, we considered the estimate of incidence to be a sum of NPR+/CR+ treated AND untreated + NPR+/CR- treated. In Denmark, data for 6331 unique patients with registered MM were collected. Of these, 3,680 met inclusion criteria for NPR+/CR+ and 233 for NPR+/CR-. Patients registered as NPR+/CR- were 33% more commonly not visiting a hematology department versus NPR+/CR+. Thus, a systematic skew in CR misregistration could not be excluded. We propose the best estimate of incidence and prevalence of MM in Denmark to be patients registered in the NPR and CR (treated or untreated). In Sweden and Denmark, incidence and prevalence were higher in patients aged ≥70 versus <70 years, and in males versus females. Between the two countries, incidence and prevalence of MM were generally similar, with slightly higher prevalence in Sweden (vs Denmark) and incidence in Denmark (vs Sweden) in patients aged ≥ 70 years (Tables 1 and 2). Best estimates for validated incidences of MM were largely similar to those reported in the Swedish and Danish myeloma registries (Table 3). Conclusion The use of several nationwide registries with independent case registration, rigorous inclusion criteria, and careful consideration of criteria used to estimate incidence/prevalence, arguably provides improved estimates of incidence/prevalence compared with previous studies. Disclosures Abildgaard: Takeda: Research Funding; Celgene: Research Funding; Amgen: Research Funding; Janssen: 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.

scholarly journals Analyses of Real World Data on Overall Survival in Multiple Myeloma Patients with at Least 3 Prior Lines of Therapy Including a PI and an IMiD, or Double Refractory to a PI and an IMiD

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 4498-4498 ◽  
Author(s):  
Saad Usmani ◽  
Tahamtan Ahmadi ◽  
Yvette Ng ◽  
Annette Lam ◽  
Ravi Potluri ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Overall Survival ◽  
Real World ◽  
Research Funding ◽  
Target Population ◽  
Novel Agents ◽  
Real World Data ◽  
World Data ◽  
Eligible Population ◽  
Heavily Pretreated

Abstract Background: To fully evaluate the potential benefit of novel agents for the treatment of patients with multiple myeloma (MM) who are heavily pretreated and refractory, it is important to understand the outcomes of this patient population based on current real-world experience. An International Myeloma Working Group study determined that the median overall survival (OS) of patients refractory to bortezomib (proteasome inhibitor, PI) and at least 1 immunomodulatory drug (IMiD) was 9 months (Kumar S et al. Leukemia 2012; 26: 149). Since then, other therapies have been approved for relapsed and refractory MM in the United States (US), including pomalidomide (IMiD) and carfilzomib (PI). In this analysis, real-world data were used to define the treatment landscape and outcomes of patients with MM refractory to PIs and IMiDs or who had received ³3 prior lines of therapy (LOT; including a PI and an IMiD) and provide context to results from the single-agent daratumumab phase 2 study MMY2002 (Sirius) recently presented at ASCO 2015 (Lonial S. J Clin Oncol 33, 2015 suppl; abstr LBA8512). Methods: Two independent databases were analyzed.TheIMS LifeLink: IMS Oncology Electronic Medical Records (EMR) Database (IMS Health Incorporated, Danbury, CT) and the OPTUM Database (OPTUM, Inc., Eden Prairie, MN) both comprised US patients only. For the IMS LifeLink database, patient records from the index period of 2000-2011 were screened. For the OPTUM database, the indexing period was 2007-2014. Median OS was assessed for cohorts that met the criteria of disease that was double refractory to a PI and IMiD (Criteria 1) or had been treated with ³3 LOT including a PI and IMiD and showed disease progression within 60 days on completion of last regimen (Criteria 2). Patients who met Criteria 1 could have received ³3 prior LOT, however those who met Criteria 2 only did not meet the double refractory criteria. Subgroup analyses of the eligible population were conducted on those who were only double refractory and triple/quadruple refractory. Results: For the IMS LifeLink database, 4,030 patients with MM were screened, approximately 90% of patients were diagnosed with MM in 2006 or later, and 500 met the criteria for the target population. Of the 500 patients, 323 patients met Criteria 1 and 177 patients only met Criteria 2. For the OPTUM database, 3,837 patients with MM were screened, approximately 90% of patients were diagnosed after 2009, and 162 met the criteria for the target population, 120 of whom met Criteria 1 and 42 of whom only met Criteria 2. In the total eligible populations, median OS was 239 days in the IMS LifeLink dataset compared with 240 days in the OPTUM dataset (P = 0.5358). Among patients that were only double refractory (triple/quadruple refractory patients excluded), median OS was 228 days (n = 253) in the IMS LifeLink dataset compared with 259 days (n = 97) in the OPTUM dataset (P = 0.8052). In triple/quadruple refractory patients, median OS was 154 days (n = 70) in the IMS LifeLink dataset and 95 days (n = 23) in the OPTUM dataset (P = 0.6675). The results from both databases were consistent, hence the data were pooled for further analyses; the pooled analyses indicated that the median OS was 240 days for the eligible population (n = 662), 237 days for patients who were only double refractory (n = 350), and 154 days for patients who were triple/quadruple refractory (n = 93). A naïve comparison of the OS curves from the MMY2002 study and the pooled analysis suggests a survival benefit with daratumumab versus the real-world historical control (Figure). Conclusions: Analyses of real-world data from two independent US patient databases indicated that outcomes remain poor among patients with MM who are heavily pretreated and/or highly refractory despite the availability and use of newer PIs and IMiDs, such as carfilzomib and pomalidomide. Median OS of approximately 8 months was observed in patients with ≥3 LOT (including a PI and IMiD) or refractory to a PI and IMiD. These data not only highlight the critical need for new MM treatments for patients with advanced MM, but also provide a point of reference against which novel agents such as daratumumab could be evaluated. Disclosures Usmani: Onyx: Consultancy, Honoraria, Research Funding; Janssen: Research Funding; Celgene Corporation: Consultancy, Honoraria. Ahmadi:Janssen: Employment. Ng:Janssen: Employment. Lam:Janssen: Employment. Potluri:Smart Analyst: Employment. Mehra:Janssen: Employment.

Real‐world data on survival improvement in patients with multiple myeloma treated at a single institution over a 45‐year period

2021 ◽  
Author(s):  
Luis Gerardo Rodríguez‐Lobato ◽  
Arturo Pereira ◽  
Carlos Fernández de Larrea ◽  
Maria Teresa Cibeira ◽  
Natalia Tovar ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Single Institution ◽  
Real World Data ◽  
World Data

P0816CLINICAL CHARACTERISTICS AND EGFR AND UACR DISTRIBUTION ACCORDING TO THE 2012 KDIGO CKD CLASSIFICATION: A REPORT FROM THE US DISCOVER CKD COHORT

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Juan Jose Garcia Sanchez ◽  
Juan Jesus Carrero ◽  
Supriya Kumar ◽  
Roberto Pecoits-Filho ◽  
Glen James ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Real World ◽  
Patient Characteristics ◽  
Study Cohort ◽  
Diagnostic Code ◽  
Inclusion Criteria ◽  
Real World Data ◽  
Electronic Health Record Data ◽  
World Data ◽  
Co Morbidity

Abstract Background and Aims In 2012, the Kidney Disease Improving Global Outcomes (KDIGO) guidelines recommended categorising and prognosticating chronic kidney disease (CKD) based on estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). Contemporary studies describing the prevalence and characteristics of patients with CKD categorised according KDIGO 2012 and how studies of new pharmacotherapies relate to these categories are scarce. One such new therapy class of key interest are the sodium glucose co-transporter 2 inhibitors (SGLT-2i), shown to delay the progression to renal failure and prevent cardiovascular/renal death in patients with CKD. We aimed to describe patient characteristics and the prevalence of CKD according to the 2012 KDIGO categories in a large real-world US cohort of patients with CKD (part A). We also describe a subset of the population according to the DAPA-CKD trial inclusion criteria (eGFR [25-75ml/min/1.73m2] and UACR [200-5000mg/g]) (part B). Method DISCOVER-CKD is an international observational study in patients with CKD. The DISCOVER-CKD retrospective US cohort of patients was extracted using real-world data from the integrated Limited Claims and Electronic Health Record data (IBM Health, Armonk, NY) and HealthVerity. Patients were aged ≥18 years, with ≥1 UACR measure. For part A, required first diagnostic code of CKD (Stages 3A, 3B, 4, 5, or ESRD) or two eGFR of &lt;75 mL/min/1.73 m2 recorded at least 90 days apart and for part B, two measures of eGFR 25-75 mL/min/1.73 m2 recorded at least 90 days apart between 1st January 2008 and September 2018. Index date was diagnostic code or 2nd eGFR. The first UACR, recorded +/-12 months of index, was used to categorise patients. Descriptive analyses were used to summarise prevalence and patient characteristics. Results Of the overall study cohort (N=4330, 49.1% women, mean age 65.3±10.64 years), by KDIGO categories (part A): 85.7% (n=3601) had normal to mildly increased albuminuria, 11.0% (n=463) had moderately increased albuminuria and 3.3% (n=137) had severely increased albuminuria (Figure 1). 4.6% (n=193) fulfilled DAPA-CKD trial inclusion criteria (part B). In both populations, the most common comorbidities were hypertension (HTN, 73.0% for both) and type 2 diabetes (T2D, 57.6% and 56.2%, respectively). Anti-hypertensive drugs were frequently used (76.4% and 76.9%, respectively). Conclusion This study, utilising real-world data, adds to the scarcity of knowledge reporting the characteristics of patients with CKD in different eGFR and UACR strata according to the KDIGO 2012 definitions. We observed a trend in higher UACR in the group of patients with lower eGFR and report a high prevalence of T2D and HTN in the study population, demonstrating the high co-morbidity burden in patients, for whom new therapies may be beneficial.

Socioeconomic Status Is an Independent Prognostic Factor for Overall Survival in Patients With Multiple Myeloma: Real-World Data From a Cohort of 223 Patients

2020 ◽  
Vol 20 (10) ◽  
pp. 704-711
Author(s):  
Stergios Intzes ◽  
Marianthi Symeonidou ◽  
Konstantinos Zagoridis ◽  
Zoe Bezirgiannidou ◽  
Aikaterini Pentidou ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Socioeconomic Status ◽  
Overall Survival ◽  
Prognostic Factor ◽  
Real World ◽  
Independent Prognostic Factor ◽  
Real World Data ◽  
World Data

scholarly journals Ideal Vial Size for Bortezomib: Real-World Data on Waste and Cost Reduction in Treatment of Multiple Myeloma in Brazil

2011 ◽  
Vol 14 (5) ◽  
pp. S82-S84 ◽  
Author(s):  
Luciana Clark ◽  
Ana Paula Castro ◽  
Anna Flávia Fortes ◽  
Fábio Santos ◽  
Otávio Clark ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Cost Reduction ◽  
Real World Data ◽  
World Data

scholarly journals Real-World Outcomes for Standard-of-Care Treatments in Patients with Relapsed/Refractory Multiple Myeloma

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4075-4075
Author(s):  
Michel Delforge ◽  
Marie-Christiane Vekemans ◽  
Sébastien Anguille ◽  
Julien Depaus ◽  
Nathalie Meuleman ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Board Of Directors ◽  
Real World ◽  
Research Funding ◽  
Retrospective Chart Review ◽  
Standard Of Care ◽  
Real World Data ◽  
Advisory Committees ◽  
Treatment Regimens

Abstract Background: With the advent of immunomodulatory agents (IMiDs), proteasome inhibitors (PIs) and, more recently, anti-CD38 monoclonal antibodies (mAbs), prognosis of patients with multiple myeloma (MM) has improved considerably. Unfortunately, even with these 3 major MM drug classes, most patients ultimately relapse and require further therapy. There remains an incomplete understanding of how patients who have received extensive therapy and with relapsed/refractory multiple myeloma (RRMM) are treated in routine clinical practice, as no standard-of-care exists for these patients, and what the outcomes are in this real-world setting. Objective: This study aims to evaluate the outcomes of patients with triple-class (IMiD, PI and anti-CD38 mAb) and triple-line exposed RRMM using real-world data from patients in Belgium. Methods: A multicenter, observational study, involving 7 non-academic and academic Belgian centers, was conducted based on a retrospective chart review of adult RRMM patients who started subsequent treatment from March 2017 through May 2021 after having received ≥3 lines of therapy including at least an IMiD, a PI, and anti-CD38-directed therapy (tri-exposed). Data were captured in an electronic case report form (Castor EDC). Patients with an ECOG performance status of ≥2, who received prior CAR-T treatment or prior BCMA-targeted therapy, or with a known active or prior history of CNS involvement (or with clinical signs thereof), were excluded. All treatment lines initiated after becoming eligible were used in the analysis. Specifically, all treatment lines for patients meeting the eligibility criteria more than once in their entire follow-up were included as separate observations, with date of treatment initiation as specific baseline for each treatment line. Cox proportional hazards models were fitted to explore the prognostic value with Overall Survival (OS), Progression Free Survival (PFS), and Time to Next Therapy (TTNT). Results: A total of 112 patients with 237 eligible treatment lines were included in the analysis; median follow-up was 16.6 months. In 45% of the initiated treatment lines, patients were refractory to 4 or 5 therapies, 62% had received ≥5 prior lines, 22% had extramedullary disease and in 48% of observations the time to progression in prior line was shorter than 4 months. After patients became tri-exposed, more than 50 unique treatment regimens were initiated, with the following being the most common: carfilzomib + dexamethasone (14%), pomalidomide + dexamethasone + chemotherapy (8%), and ixazomib + lenalidomide + dexamethasone (6%). Additionally, 4% of included observations were exposed to anti-BCMA agents. Overall, the following treatment classes were the most frequently started: PI only (19%), PI + IMiD combinations (17%), and regimens including anti-CD38 antibodies (15%). Median OS was 9.79 months [95% CI: 7.79; 12.22], median PFS was 3.42 months [95% CI: 2.79; 4.27], median TTNT was 3.61 months [95% CI: 3.09; 4.57]. Higher refractory status (p&lt;0.001), being male (p=0.001), older age (p&lt;0.001), shorter duration of prior lines (p&lt;0.001), shorter time to progression in prior line (p=0.025), and higher LDH levels (p&lt;0.002) were prognostic for worse outcomes for both OS (Figure 1) and PFS. Conclusions: This retrospective chart review of patients with tri-exposed RRMM in Belgium shows that real-world outcomes in terms of OS, PFS and TTNT are poor for these patients, with a median OS of &lt;10 months. A wide variety of treatment regimens used in clinical practice confirm the absence of a clear standard-of-care in this patient population. The literature also confirms that these poor outcomes observed in Belgium, for this subset of MM patients, are similar in other countries. These real-world data highlight the high unmet medical need in this patient population and critical need for new and effective treatment options. MD and MCV contributed equally to this work. Figure 1 Figure 1. Disclosures Delforge: Amgen, Celgene, Janssen, Sanofi: Honoraria, Research Funding. Vekemans: Amgen: Membership on an entity's Board of Directors or advisory committees; Takeda: Membership on an entity's Board of Directors or advisory committees; BMS-Celgene: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen Pharmaceutica: Membership on an entity's Board of Directors or advisory committees, Research Funding; Sanofi: Membership on an entity's Board of Directors or advisory committees. Depaus: Takeda: Consultancy; Novartis: Consultancy; Janssen: Consultancy; Celgene: Consultancy. Meuleman: iTeos Therapeutics: Consultancy. Strens: Realidad bvba: Consultancy. Van Hoorenbeeck: Janssen: Current Employment. Moorkens: Janssen-Cilag: Current Employment. Diels: Janssen: Current Employment. Ghilotti: Janssen-Cilag SpA, Cologno Monzese, Italy: Current Employment. Dalhuisen: Janssen: Current Employment. Vandervennet: Janssen: Current Employment.

scholarly journals PS1415 SURVIVAL OF MULTIPLE MYELOMA PATIENTS DIAGNOSED 1970–2015: REAL-WORLD DATA FROM A SINGLE CENTER

HemaSphere ◽  
2019 ◽  
Vol 3 (S1) ◽  
pp. 650-651
Author(s):  
L.G. Rodríguez-Lobato ◽  
A. Pereira ◽  
C. Fernández de Larrea ◽  
N. Tovar ◽  
M.T. Cibeira ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Real World ◽  
Single Center ◽  
Real World Data ◽  
World Data
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