scholarly journals Characteristics of Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL) Patients Treated with Acalabrutinib in a Real World Setting in the United States

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 3488-3488
Author(s):  
Kellie Ryan ◽  
Chakkarin Burudpakdee ◽  
Xiaohui Zhao ◽  
Hannah Le ◽  
Aimee Near
Keyword(s):  
High Risk ◽  
Real World ◽  
Hematologic Malignancies ◽  
Lymphocytic Leukemia ◽  
Phase Iii ◽  
First Line ◽  
The Real ◽  
Prior Therapy ◽  
Real World Setting ◽  
Phase Iii Trials

Introduction Acalabrutinib was approved by the US Food and Drug Administration on October 31, 2017 for patients with MCL who have progressed on at least one prior therapy and is currently being evaluated in phase III trials for first-line MCL, first-line CLL, and relapsed/refractory (r/r) CLL. Additionally, acalabrutinib received guideline and compendia listing for use in MCL and CLL patients. There is a lack of information on the current treatment patterns with acalabrutinib in real world clinical practice. To that end, we conducted a descriptive analysis of the use of acalabrutinib in the real-world setting for MCL and CLL patients. Methods A retrospective cohort study was conducted using IQVIA's longitudinal prescription (LRx) database linked to the medical claims (Dx) database. Patients ≥18 years old with ≥1 claim for acalabrutinib in LRx between November 1, 2017 and April 30, 2019 were identified; the first claim was index date. Patients were also required to have ≥ 1 Dx claim between November 1, 2016 and April 30, 2019, and ≥ 12 months baseline (defined as ≥ 1 LRx claim and ≥ 1 Dx claim within 12 months pre-index and > 12 months pre-index). Patients were required to have ≥2 diagnoses of either MCL or CLL before index (without diagnosis of the other cancer) to create two mutually exclusive cohorts. Patients were excluded if they had data quality issues or evidence of clinical trial enrollment during the study period. Descriptive statistics were used to summarize baseline demographic and clinical characteristics overall and stratified by prior ibrutinib use. Results were described for MCL and CLL cohorts separately. Results A total of 264 MCL and 204 CLL patients treated with acalabrutinib were identified in the study. For both cohorts, the majority (57.2% MCL / 59.3% CLL) were 70 years or older, with a median (interquartile range [IQR]) age of 71.0 (15.0), mean (standard deviation [SD]) of 70.5 (9.7) for MCL and median age of 71.5 (15.0), mean 69.9 (11.1) for CLL patients (Table 1). 76.9% of MCL and 59.8% of CLL patients were male, and over half were commercially insured (50.4% MCL / 52.5% CLL). In the 12-month pre-index period, MCL and CLL patients had a mean (SD) Charlson Comorbidity Index (CCI, excluding hematologic malignancies) of 1.6 (2.2) and 1.4 (1.8), respectively; hypertension (67.8% MCL / 67.7% CLL), other hematologic malignancies (48.9% MCL / 52.0% CLL), and infection (28.0% MCL / 31.4% CLL) were the most common comorbidities. Other common (i.e., ≥ 20%) conditions included anemia and neutropenia for the MCL cohort, and arrhythmia, fatigue/asthenia, atrial fibrillation (A-fib), anemia and thrombocytopenia for the CLL cohort. Over 60% of MCL and CLL acalabrutinib-treated patients were defined as high risk of A-Fib (Chyou, Hunter et al. 2015). In terms of prior Bruton's Tyrosine Kinase-inhibitor (BTKi) treatment, 37.9% of MCL and 64.7% of CLL patients had prior ibrutinib use. More prior ibrutinib users were defined as high risk A-Fib status at time of acalabrutinib start than patients without prior ibrutinib use, and prior ibrutinib users had a higher frequency of several comorbidities (e.g., hypertension, fatigue/asthenia; Table 1). Conclusions With the relatively recent approval, this is the first analysis of acalabrutinib use in clinical practice and description of characteristics of MCL and CLL patients being treated with this medication in the real world. Before initiating acalabrutinib, approximately one-third of MCL patients and two-thirds of CLL patients received ibrutinib (reasons for discontinuing ibrutinib were not explored). Although the overall comorbidity score was similar between patients with and without prior BTKi exposure, BTKi-naïve patients had a slightly lower frequency of high-risk A-Fib status at acalabrutinib initiation. Future studies are warranted to evaluate the treatment patterns of acalabrutinib and outcomes in the real-world setting. Disclosures Ryan: AstraZeneca: Employment, Equity Ownership. Burudpakdee:IQVIA: Consultancy. Zhao:IQVIA: Consultancy. Le:AstraZeneca: Employment, Other: Stocks. Near:IQVIA: Consultancy. OffLabel Disclosure: Acalabrutinib is an oral inhibitor of Bruton's Tyrosine Kinase. It was approved by the US Food and Drug Administration on October 31, 2017 for patients with mantle cell lymphoma (MCL) who have progressed on at least one prior therapy and is currently being evaluated in phase III trials for first-line MCL, first-line chronic lymphocytic leukemia (CLL), and relapsed/refractory CLL.

Survival impact on regorafenib (REG) and trifluridine/tipiracil hydrochloride (FTD/TPI) for patients with metastatic colorectal cancer: Single institutional experience.

2020 ◽  
Vol 38 (4_suppl) ◽  
pp. 43-43
Author(s):  
Keigo Chida ◽  
Daisuke Kotani ◽  
Kentaro Sawada ◽  
Yoshiaki Nakamura ◽  
Akihito Kawazoe ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Metastatic Colorectal Cancer ◽  
Real World ◽  
Phase Iii ◽  
First Line ◽  
Standard Chemotherapy ◽  
Exon 2 ◽  
The Real ◽  
Real World Setting ◽  
Tipiracil Hydrochloride

43 Background: Regorafenib (REG) and trifluridine/tipiracil hydrochloride (FTD/TPI) demonstrated overall survival (OS) benefit in patients (pts) with metastatic colorectal cancer (mCRC) in the CORRECT and RECOURSE phase III trials. In Japan, REG and FTD/TPI have been approved in 2013 and 2014, respectively. However, little is known about survival impact on these agents in the real-world setting. Therefore, the aim of this retrospective study was to evaluate the effects of REG and FTD/TPI in pts with mCRC. Methods: We collected medical records from consecutive 1142 pts who had been initiated with first-line chemotherapy for mCRC from 2008 to 2016 at National Cancer Center Hospital East. The survival outcomes were compared between pts from 2008 to 2011 (cohort A) and those from 2012 to 2016 (cohort B). This study excluded pts who have not been refractory or intolerant to standard chemotherapy including fluoropyrimidine, oxaliplatin, irinotecan, and anti-EGFR antibody if KRAS exon 2/ RAS wild-type tumors. Results: A total of 590 pts were analyzed (cohort A; N = 236 and cohort B; N = 354). More patients received at least one of REG or FTD/TPI in cohort B (16.1% vs. 59.9%, p < 0.001). The time from initiation to end of standard chemotherapy was comparable between the two cohort (20.0 vs. 17.5 months, p = 0.266). With a median follow-up period of 34.9 months, salvage-line OS (sOS) after standard chemotherapy was significantly longer in cohort B (4.8 vs. 6.6 months, p = 0.001), while there was only a favorable trend in cohort B in terms of OS from start of first-line treatment (27.3 vs. 28.5 months, p = 0.516). In cohort B, pts who sequentially received both of REG and FTD/TPI showed longest sOS (median, both of REG and FTD/TPI; 11.3 months, either REG or FTD/TPI; 7.0 months, neither REG nor FTD/TPI; 3.1 months). Conclusions: Our study showed that REG and FTD/TPI led to prolongation of sOS in the real-world setting, indicating the importance of strategies which make all active agents available to pts with mCRC.

Atezolizumab in first-line treatment of metastatic nonsquamous non-small cell lung cancer in the real-world setting.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21112-e21112
Author(s):  
Javier De Castro ◽  
Begoña Campos Balea ◽  
Diego Perez Parente ◽  
Letizia Polito ◽  
Marcus Lawrance ◽  
...  
Keyword(s):  
Real World ◽  
Real Life ◽  
Phase Iii ◽  
Egfr Mutations ◽  
First Line ◽  
Early Adopters ◽  
The Real ◽  
Real World Setting ◽  
Health Database

e21112 Background: The phase III IMpower150 study showed efficacy benefits with atezolizumab in combination with bevacizumab, carboplatin and paclitaxel (ABCP; arm B) as first-line (1L) treatment for patients (pts) with metastatic non-squamous (nsq) NSCLC. The FDA approved this regimen for these pts (with no EGFR or ALK mutations [WT]) on December 2018. However, to date there is limited evidence on its use in real life. This study aimed to explore the use of ABCP in the real-world setting and to describe the characteristics of early adopters (those who received ABCP in 1L). Methods: Data were extracted from the Flatiron Health database (US population). Pts with advanced stage IIIB/IV nsq NSCLC at diagnosis receiving ABCP regimen in any line were eligible for the study. Finally, early adopters were selected. Results: A total of 67 pts received the ABCP regimen in 1L. Baseline characteristics for these pts and comparisons with the IMpower150 population are summarized in Table. Real-world (rw) response in the WT group ( n = 49; 6 pts were excluded due to EGFR mutations and 12 because minimum follow-up was not reached) was similar to that of the IMpower150 series (rwRR: 55.1% [40.2-69.3] vs. 63.5% [58.2-68.5]), despite the WT population being older with a higher proportion of ECOG PS = 1. In patients who would have met the IMpower150 inclusion criteria ( n = 24), rwRR was 70.8% (48.9-87.4). Conclusions: The ABCP regimen has been adopted in the real-world setting. In terms of efficacy, response rates and current PFS data were in line with trial results, despite the population being unselected and having a worse clinical profile. Longer follow-up is required for rwOS data. vs. arm B IMpower150 results.[Table: see text]

scholarly journals Characteristics and Outcomes of Non-Transplanted Patients with Newly Diagnosed Multiple Myeloma (NDMM) Initiating Treatment with Bortezomib, Lenalidomide, and Dexamethasone (VRd) As First-Line of Therapy

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 3782-3782
Author(s):  
Rohan Medhekar ◽  
Tao Ran ◽  
Alex Z. Fu ◽  
Sharmila Patel ◽  
Shuchita Kaila
Keyword(s):  
Multiple Myeloma ◽  
High Risk ◽  
Real World ◽  
Index Date ◽  
Newly Diagnosed ◽  
First Line ◽  
The Real ◽  
Real World Setting ◽  
Line Of Therapy ◽  
Ecog Ps

Abstract Introduction: In the US, bortezomib, lenalidomide, and dexamethasone (VRd) is one of the preferred treatment regimens in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM) based on the results from the phase 3 Southwest Oncology Group (SWOG) S0777 study. Although the efficacy of VRd in transplant-ineligible or -deferred NDMM patients was demonstrated in SWOG S0777, clinical trials have strict eligibility criteria that may not translate to the real-world. There is limited real-world data on the characteristics and outcomes of non-transplanted patients with NDMM treated with VRd, especially in older, frail patients with comorbidities. This study aimed to address these knowledge gaps by evaluating the characteristics and outcomes of patients with NDMM who received VRd as first-line of therapy (LOT) in US oncology practice. Methods: This retrospective observational study included patients from the Flatiron Multiple Myeloma Core Registry who received VRd as first LOT between November 1, 2015 and February 28, 2021. The index date was defined as the first observed record of the VRd regimen. Non-transplanted patients were defined as those who did not receive a stem cell transplant (SCT) from the diagnosis date to the index date. Patients were excluded if they were &lt;18 years of age on index date; were enrolled in a clinical trial; had other malignancies prior to the index date; had a diagnosis of amyloid light-chain amyloidosis prior to the index date; or had a SCT prior to index date. Demographics, clinical characteristics, and outcomes were assessed in the overall study cohort and among specific subgroups: older adults (≥75 years of age on index date); frail patients (frailty score ≥2, calculated using age on index date, Charlson Comorbidity Index during the pre-index period, and Eastern Cooperative Oncology Group performance status [ECOG PS] score on the closest date to the index date ≤90 days prior to and ≤7 days after the index date, patients with missing ECOG were not excluded); patients with high-risk cytogenetics, and patients with acute renal impairment ([RI], serum creatinine &gt;2 mg/dL on the closest date to the index date or having diagnosis codes of ICD-9-CM 584.5-584.9, ICD-9-CM 586, ICD-10-CM N17.0-2, N17.8-9, and N19, measured ≤90 days prior to and ≤7 days after the index date). Duration of therapy was measured as the time between the index date and end of the LOT. Progression-free survival (PFS) was measured as time between the index date and disease progression or death, whichever occurred first. PFS did not account for treatment discontinuation for reasons other than progression or death. Disease progression was defined as a clinically meaningful increase in serum M-protein, urine M-protein, or the free light chain ratio according to the International Myeloma Working Group criteria. PFS was analyzed using the Kaplan-Meier method. Results: A total of 2342 eligible NDMM patients treated with VRd as first LOT were identified, with a median follow-up of 21.0 months. A majority of patients were ≥65 years (64.3%), with the mean (SD) age at index date being 67 (±10) years. Most patients were male (53.3%), had International Staging System [ISS] stage I/II (48.4%; 33% missing) and the ECOG PS score 0/1 (63.5%; 22% missing). Of the 2342 patients, 597 (25.5%) patients were categorized as older adults (≥75 years of age); 1122 (47.9%) as frail; 374 (16.0%) as patients with high-risk cytogenetics; and 250 (10.7%) as patients with RI. About 28% of the patients received a SCT within 1-year of the index date. The median duration of therapy was 5.6 months. The median PFS for the overall study group was 33.2 months. Median PFS was substantially shorter for patients who were ≥75 years of age (22.8 months), were frail (28.7 months), had high-risk cytogenetics (25.1 months), or had RI (25.1 months) (Figure). Conclusions: The majority of patients with NDMM treated with VRd in the real-world setting were aged ≥65 years, were ISS stage I or II, had an ECOG PS score of 0 or 1, and had standard-risk cytogenetics. Median PFS observed in the real-world setting was shorter than that observed in the SWOG S0777 clinical trial. Patients who were ≥75 years of age, were frail, had high-risk cytogenetics, or had RI demonstrated shorter median PFS than patients in the overall study population. Alternate treatment options with demonstrated efficacy in the older, frail, and transplant ineligible patients are available. Figure 1 Figure 1. Disclosures Medhekar: Janssen: Current Employment. Ran: Janssen Scientific Affairs, LLC: Current Employment. Fu: Janssen: Current Employment. Patel: Janssen: Current Employment. Kaila: Janssen Scientific Affairs, LLC: Current Employment. OffLabel Disclosure: Bortezomib, and lenalidomide are both FDA approved agents for treating multiple myeloma. The combination of bortezomib, lenalidomide, and dexamethasone is commonly used in clinical practice and is listed as a preferred regimen in NCCN guidelines.

scholarly journals Front-Line Treatment with Obinutuzumab ± Chlorambucil for Chronic Lymphocytic Leukemia in Real-World Clinical Practice: Results of a Multinational, Multicenter Study By Eric and Icllsg

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1766-1766
Author(s):  
Yair Herishanu ◽  
Adir Shaulov ◽  
Riva Fineman ◽  
Sandra Bašić-Kinda ◽  
Ariel Aviv ◽  
...  
Keyword(s):  
High Risk ◽  
Board Of Directors ◽  
Real World ◽  
Research Funding ◽  
Lymphocytic Leukemia ◽  
Advisory Committees ◽  
Entire Cohort ◽  
Real World Setting ◽  
High Risk Disease ◽  
Frontline Treatment

Chronic lymphocytic leukemia (CLL) occurs in older individuals with a median age at diagnosis of 72 years. In recent years, there has been considerable progress in the frontline therapy of elderly/physically unfit patients with CLL. The German CLL11 trial showed that addition of obinutuzumab to chlorambucil (G-Clb) prolongs progression free survival (PFS) and overall survival (OS) compared to chlorambucil alone or in combination with rituximab. More recently, obinutuzumab together with ibrutinib or venetoclax were shown to be superior to G-Clb with regard to PFS, but there was no advantage in terms of OS. In this retrospective, multinational and multicenter co-operative study the European Research Initiative on CLL (ERIC) and the Israeli CLL Study Group (ICLLSG) evaluated the efficacy of frontline treatment with G-Clb in patients with CLL, in a "real-world" setting. Our analysis excluded CLL patients with documented del(17p) or TP53 mutations since they are no longer treated with chemotherapy. Results: A total of 437 treatment-naïve patients with CLL from 51 medical centers located in 13 countries were included. The median age of this patient population was 75.9 years; 59.7% were men, median CIRS total score was 8 and estimated creatinine clearance 61.1 mL/min. Seventy four patients had Binet stage A (17.2%), 167 (38.8%) stage B and 190 (44.1%) stage C. Results of FISH and IGHV mutational status were available for 332 and 115 patients, respectively. High-risk cytogenetics, del(11q) was documented in 18.7% patients and IGHV-unmutated gene in 64.4%. The vast majority of patients were treated with G-Clb (N=408) and the rest with obinutuzumab monotherapy (G-monotherapy, N=29). The clinical overall response was 86.5%, including clinical complete and partial responses in 41.6% and 45.8% of cases, respectively. The median observation time was 14.1 months (m) and the median PFS of the entire cohort was 27.6m (95% CI, 24.2-31.0). The PFS for G-Clb was significantly better than G-monotherapy (P=0.001; HR=0.38, 95% CI: 0.22-0.67), being the 2-year PFS estimates 61.8% and 52.8%, respectively. The median PFS was significantly shorter for patients with del(11q) (19.2m) compared to those with normal FISH (not reached, P<0.001), del(13q) (29.9m, P<0.001) and trisomy12 (not reached, P=0.027). Patients with IGHV-unmutated had a trend for shorter PFS compared to those with IGHV-mutated gene (median PFS 25.3m vs. not reached, respectively. p=0.06). In a multivariate analysis, older age, high risk-disease, lymph nodes >5cm, G-monotherapy, reduced cumulative dose of obinutuzumab and status less than CR, were independently associated with shorter PFS. Seventy patients (16%) received a second-line treatment. The median OS for the entire cohort has not been reached yet and 2-year OS estimate is 88%. In conclusion, in a "real-world" setting, frontline treatment with G-Clb achieves PFS comparable to that reported in clinical trials. Inferior outcomes were observed in patients with high-risk disease [del(11q) and/or IGHV-unmutated] and those treated with G-monotherapy. Thus, even today in the era of novel drugs, G-Clb can be considered a legitimate frontline treatment in unfit CLL patients with low-risk disease [non-del(11q) and IGHV-mutated]. Disclosures Herishanu: Roche: Honoraria; AbbVie: Honoraria; Janssen: Honoraria. Simkovic:Roche: Honoraria; University Hospital Hradec Kralove: Employment; AbbVie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Gilead: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; Acerta: Consultancy, Honoraria. Mauro:Gilead: Consultancy, Research Funding; Shire: Consultancy, Research Funding; Abbvie: Consultancy, Research Funding; Jannsen: Consultancy, Research Funding; Roche: Consultancy, Research Funding. Coscia:Abbvie: Membership on an entity's Board of Directors or advisory committees; Gilead: Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Karyopharm Therapeutics: Research Funding. Scarfo:AstraZeneca: Honoraria; Janssen: Honoraria; AbbVie: Honoraria. Tedeschi:AbbVie: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen spa: Consultancy, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Gilead: Consultancy; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; SUNESIS: Consultancy, Membership on an entity's Board of Directors or advisory committees; Janssen: Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; BeiGene: Honoraria. Gimeno Vázquez:JANSSEN: Consultancy, Speakers Bureau; Abbvie: Speakers Bureau. Assouline:F. Hoffmann-La Roche Ltd: Consultancy, Honoraria; Abbvie: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Speakers Bureau; Pfizer: Consultancy, Honoraria, Speakers Bureau. Levato:Novartis: Honoraria; Pfizer: Honoraria; Incyte: Honoraria; BMS: Honoraria. Rigolin:Gilead: Speakers Bureau; Gilead: Research Funding; AbbVie: Speakers Bureau. Loscertales:Janssen: Honoraria; Roche: Honoraria; AstraZeneca: Honoraria; AbbVie: Honoraria; Gilead: Honoraria. Ghia:Dynamo: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria, Research Funding; Acerta/AstraZeneca: Consultancy, Honoraria; ArQule: Consultancy, Honoraria; BeiGene: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Research Funding; Juno/Celgene: Consultancy, Honoraria; Sunesis: Consultancy, Honoraria, Research Funding; Novartis: Research Funding; Pharmacyclics LLC, an AbbVie Company: Consultancy; Gilead: Consultancy, Honoraria, Research Funding.

scholarly journals Real-World Efficacy and Safety of Bevacizumab in the First-Line Treatment of Metastatic Cervical Cancer: A Cohort Study in the Total Population of Croatian Patients

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Dora Čerina ◽  
Višnja Matković ◽  
Kristina Katić ◽  
Ingrid Belac Lovasić ◽  
Robert Šeparović ◽  
...  
Keyword(s):  
Cervical Cancer ◽  
Cohort Study ◽  
Real World ◽  
Total Population ◽  
Line Treatment ◽  
Efficacy And Safety ◽  
First Line ◽  
The Real ◽  
Real World Setting ◽  
First Line Treatment

Background. Although today it is almost preventable, cervical cancer still represents a significant cancer burden, especially in some developing parts of the world. Since the introduction of bevacizumab in the first-line treatment of metastatic disease, improvements of the outcomes were noted. However, results from randomized controlled trials are often hard to recreate in the real-world setting. Objective. To assess the real-world efficacy and safety of bevacizumab as a first-line treatment of advanced cervical cancer. Methods. We conducted a retrospective cohort study on the total population of Croatian patients diagnosed with metastatic cervical cancer from 2016 to 2019 who were treated with bevacizumab in combination with cisplatin and paclitaxel (TCB) in the first line. The comparison group was the consecutive sample of patients treated with chemotherapy alone. The primary endpoint was overall survival (OS). Secondary endpoints were progression-free survival (PFS), objective response rate, incidence of adverse events, and the proportion of treatment discontinuation. Results. We enrolled 67 patients treated with TCB and a control group of 62 patients treated with chemotherapy alone. The TCB cohort had significantly longer unadjusted OS with a median of 27.0 (95% CI 18.5; not calculable) months, compared to 15.5 (10.7; 30.1) months in the chemotherapy-alone cohort. Adjusted OS was not significantly different. PFS was significantly longer for the TCB cohort, with a median of 10.6 (95% CI 8.5; 15.4) months, than for the chemotherapy-alone cohort, with a median of 5.4 (95% CI 3.9; 9.1) months, even after adjustment for baseline covariates (HRadjusted = 0.60; 95% CI 0.39; 0.94; p = 0.027 ; false discovery rate <5%). Conclusions. In a real-world setting, TCB as a first-line treatment of metastatic cervical cancer was associated with longer PFS, better objective disease control rate, and acceptable toxicity profile in comparison to chemotherapy alone. These results may indicate its utility and potential applicability in other parts of the developing world.

scholarly journals Clinical Practice Utilization and Outcomes with Rasburicase Vs Allopurinol for Patients at High Risk of Tumor Lysis Syndrome

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2203-2203
Author(s):  
Janna Radtchenko ◽  
Daniel Lyons ◽  
Yvonne Barnes ◽  
Scott Milligan ◽  
Edward Drea
Keyword(s):  
Uric Acid ◽  
Clinical Practice ◽  
High Risk ◽  
Renal Impairment ◽  
Real World ◽  
Research Funding ◽  
Tumor Lysis Syndrome ◽  
Lymphocytic Leukemia ◽  
Tumor Lysis ◽  
The Real

Introduction The efficacy of rasburicase vs allopurinol for the prevention of hyperuricemia (HU) of tumor lysis syndrome (TLS) has been demonstrated in clinical trials, yet studies evaluating these therapies in real-world clinical practice are lacking. Here, we evaluate the real-world use and clinical impact of rasburicase and allopurinol for the prevention of chemotherapy-induced HU. Methods Data were collected from a proprietary aggregated Electronic Medical Records database containing data from 21 healthcare organizations and 26 million patients in the US. Inclusion criteria included patients at high risk (HR) of TLS (Table 1) and diagnosed with acute lymphocytic leukemia, acute myeloid leukemia, Burkitt's Lymphoma, chronic lymphocytic leukemia, or diffuse large B-cell lymphoma, and receiving chemotherapy between 01/01/2017 and 06/30/2018. Baseline measures were those within 6 months but closest to and before the start of chemotherapy. Patients were followed until death or 6 months from the start of chemotherapy. Statistical analyses included Student's t-test for continuous variables and Chi-squared, Fisher's exact, or McNemar's test for categorical variables. Multivariate analyses were conducted to assess association of variables and to generate scores for propensity score matching (PSM). Results Of the patients who qualified for the study, 74% (991) received allopurinol, 7% (92 patients) rasburicase, and 19% (248) did not receive a urate-lowering therapy. Patients receiving rasburicase were more likely to be male, with pre-existing TLS at chemotherapy drug initiation, and previously treated with rasburicase or both urate-lowering therapies. The TLS risk population receiving rasburicase presented with higher mean baseline uric acid level (9.0 mg/dL) compared with patients receiving allopurinol (6.9 mg/dL), and over half had baseline uric acid levels >7.5 mg/dL (56% vs 35% for allopurinol). Multivariate analysis further indicated that a greater fraction of patients receiving rasburicase had renal impairment (glomerular filtration rate [GFR] <60 mL/min at baseline) compared with the population receiving allopurinol (Table 1). Treatment with rasburicase significantly decreased levels of uric acid and calcium and improved phosphate levels from baseline to post-treatment. These changes were significantly greater than observed in patients receiving allopurinol. In contrast, patients receiving allopurinol recorded improved GFR whereas changes in the rasburicase-treated population did not reach significance (Table 2). Follow-up varied for these treatment groups: 49% of patients at HR of TLS receiving rasburicase died within 6 months of the start of chemotherapy compared with 13% of allopurinol patients (p<0.001). PSM yielded small matched samples no longer representative of the severity of the condition of the rasburicase patients. No significant differences in rasburicase vs allopurinol efficacy were detected in these smaller samples. Conclusions Patients at HR of TLS and receiving rasburicase had higher uric acid levels at baseline, more renal impairment, and were more likely to have experienced TLS previously compared with those receiving allopurinol. Both rasburicase and allopurinol significantly decreased levels of uric acid post-treatment though the mean decrease was significantly higher in rasburicase patients. These data support previous clinical findings that rasburicase is highly effective in reducing uric acid, though observed use in the real-world setting is restricted to patients with increased sickness. These findings support the need for continued research of the outcomes associated with early recognition and prophylaxis with rasburicase for patients with moderate risk and HR features for HU of TLS. Disclosures Radtchenko: Sanofi: Research Funding. Lyons:Sanofi: Employment. Barnes:Sanofi: Employment. Milligan:Trio Health: Employment; AbbVie: Research Funding; Amgen: Research Funding; Gilead: Research Funding; Merck: Research Funding; Sanofi: Research Funding; Viiv: Research Funding. Drea:Sanofi-Genzyme: Employment.

Real-world evidence in metastatic renal cell carcinoma

2018 ◽  
Vol 104 (2) ◽  
pp. 76-82 ◽  
Author(s):  
Jeffrey Graham ◽  
Daniel YC Heng
Keyword(s):  
Renal Cell Carcinoma ◽  
Cell Carcinoma ◽  
Real World ◽  
Renal Cell ◽  
Phase Iii ◽  
Advanced Renal Cell Carcinoma ◽  
First Line ◽  
Real World Data ◽  
The Real ◽  
Real World Evidence

Real-world evidence has played an important role in expanding our knowledge on the treatment and prognostication of advanced renal cell carcinoma. This type of data has been particularly helpful in providing a better understanding of groups that are traditionally excluded from randomized controlled trials. The International mRCC Database Consortium (IMDC) represents the largest collection of real-world data on patients with advanced kidney cancer treated with targeted therapies. The IMDC prognostic model has been used to stratify patients in contemporary clinical trials and to provide risk-directed treatment selection in everyday clinical practice. More recently, it has been shown to predict response to first-line combination immunotherapy in the phase III CheckMate 214 clinical trial. In this review, we highlight the real-world evidence associated with the treatment of mRCC. We focus on first-line therapy, as well as second-line and third-line therapeutic options, including novel immuno-oncology agents. We also address the real-world evidence for the use of cytoreductive nephrectomy in advanced renal cell carcinoma in the targeted therapy era.

Trends in Insulin Therapy—A1C and Age at the Time of Insulin Initiation in the Real-World Setting

Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 2328-PUB
Author(s):  
RAJIV KOVIL ◽  
MANOJ S. CHAWLA ◽  
PURVI M. CHAWLA ◽  
MIKHIL C. KOTHARI ◽  
AMBARI F. SHAIKH
Keyword(s):  
Insulin Therapy ◽  
Real World ◽  
Insulin Initiation ◽  
The Real ◽  
Real World Setting
Sign in / Sign up

Export Citation Format

Share Document