scholarly journals Treatment Regimens and Clinical Outcomes Among Follicular Lymphoma Patients Treated with Third-Line Therapy in the United States: A Real-World EHR Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1360-1360
Author(s):  
Dong Dai ◽  
Ji Haeng Heo ◽  
Andrew Rava ◽  
Etienne Jousseaume ◽  
Roberto Ramos ◽  
...  
Keyword(s):  
United States ◽  
Follicular Lymphoma ◽  
Median Time ◽  
Index Date ◽  
Treatment Options ◽  
The United States ◽  
Time To Progression ◽  
Publicly Traded ◽  
Treatment Regimens ◽  
Third Line

Abstract Objective: To determine treatment regimens used in clinical practice and the associated clinical outcomes among third line (3L) follicular lymphoma (FL) patients in the United States (US). Methods: This non-interventional, retrospective study used Optum electronic health records (EHR) database for FL patients in the US between 1 Jan 2007 and 31 Dec 2020. The start of this period was selected to align with the Morrison et al. 2019, with 5 years of additional data. The identification period was 1 Jan 2008 to 31 Dec 2019, to ensure at least 1 year of baseline before and 60 days of follow-up (unless death happens before) after the index date, defined as start date of 3L treatment. Adult patients (≥18 years) treated in integrated delivery networks with at least one of the 3L treatments of interest (rituximab, bendamustine and rituximab, phosphatidylinositol 3-kinase [PI3K] inhibitors [copanlisib, duvelisib, idelalisib], lenalidomide and rituximab [R2], tazemetostat, and stem cell transplant) were included. Patients with Diffuse Large B-cell Lymphoma (DLBCL) diagnosis or clinical trial enrollment on or before the index date or any other cancer diagnosis before the first FL diagnosis were excluded. All agents initiated within 90 days after the index diagnosis constituted the 1L treatment. A subsequent line of therapy (LOT) was defined as treatment initiated after ≥180 days following the runout date of all agents, or addition or substitution of a new agent in the prior LOT after 90 days. The primary endpoints were time to progression (DLBCL transformation, new LOT initiation, or supportive care), overall survival (OS) and progression-free survival (PFS), while time to next treatment (TTNT) and treatment patterns were the key secondary endpoints. The analyses were conducted for the overall cohort, patients with early progression within 24 months (POD24) after 1L treatment, patients with index date after and including year 2014, as well as for different 3L treatment regimens. The sub-group with 2014 as index date was selected based on idelalisib approval in 2014. Results: The final cohort of patients (used one of the 3L treatments of interest and met inclusion/exclusion criteria) consisted of 687 patients: mean age 62.9 years (range 18 - 86), female (46.9%), Caucasians (87.3%), non-Hispanics (92.1%), and median Charlson Comorbidity Index (CCI) 3 (range 1 - 18). Rituximab-based regimens (73.7%) were the most common 3L treatments (mono 38.4%, combo 35.2%). Obinutuzumab was used as combination 3L therapy by 6 (0.87%) patients. Bendamustine, PI3K and lenalidomide monotherapies were administered to 3.1%, 2.2% and 1.9% patients, respectively (Figure 1). Rituximab-based regimens were also the most frequently used 1L, 2L, and 4L treatment options (50.8% moved to 4L and 33.6% had rituximab-based regimens). The median time to progression, PFS, and TTNT for 3L in the overall cohort were 16.6 (95% CI 14.4, 18.1), 12.5 (95% CI 11.3, 14.4), and 18 (95% CI 15.8, 19.9) months, respectively. The 1-, 2-and 5-year OS were 83.1%, 74.8% and 61.4%, respectively. The outcomes of 3L among POD24 , non-POD24, as well as patients with index date after and including year 2014 were similar to that of the overall cohort. The median time to progression, PFS, and TTNT with rituximab treatment were 19.1 (95% CI 16.7, 21.7), 15.7 (95% CI 14.2, 17.5), and 18.8 (95% CI 17, 21.7) months respectively. The median OS with rituximab therapy was not reached while the 5-year OS was 67% (Table 1). Moreover, we did not observe statistically significant differences in time to progression, OS, PFS, and TTNT for the 3L treatment between POD24 and non-POD24 patients using a Cox regression model with adjustment for baseline characteristics (age, gender, region, and CCI). The median time to progression, PFS, and TTNT among POD24 vs. non-POD24 were 15.7 vs. 17.9, 11.6 vs. 15.2, and 18 vs. 17.9 months, respectively. Conclusion: Rituximab-based regimens were the most common 3L treatment options for FL patients. Bendamustine, PI3K, and lenalidomide monotherapies were used by a smaller proportion of patients. R2 was used by a small number of patients for 3L treatment, but it is becoming an important option for FL treatment since its approval in 2019. The majority of outcomes observed could be considered poor, newer agents undergoing clinical trials could provide additional treatment choices to physicians to balance treatment effectiveness with safety and patients' quality of life. Figure 1 Figure 1. Disclosures Dai: Novartis: Current Employment, Current equity holder in publicly-traded company. Heo: Genesis Research: Current Employment, Current equity holder in publicly-traded company. Rava: Genesis Research: Current Employment, Current equity holder in publicly-traded company. Jousseaume: Novartis: Current Employment, Current equity holder in publicly-traded company. Ramos: Novartis: Current Employment, Current equity holder in publicly-traded company. Bollu: Novartis: Current Employment, Current equity holder in publicly-traded company.

scholarly journals The Present Status of Immuno-Oncolytic Viruses in the Treatment of Pancreatic Cancer

Viruses ◽  
2020 ◽  
Vol 12 (11) ◽  
pp. 1318
Author(s):  
Scott D. Haller ◽  
Michael L. Monaco ◽  
Karim Essani
Keyword(s):  
United States ◽  
Pancreatic Cancer ◽  
Surgical Resection ◽  
Clinical Investigation ◽  
Treatment Options ◽  
Late Phase ◽  
The United States ◽  
Oncolytic Viruses ◽  
Ductal Adenocarcinoma ◽  
Treatment Regimens

Pancreatic ductal adenocarcinoma (PDAC) is the fifth leading cause of cancer-related death in Western countries. The incidence of PDAC has increased over the last 40 years and is projected to be the second leading cause of cancer death by 2030. Despite aggressive treatment regimens, prognosis for patients diagnosed with PDAC is very poor; PDAC has the lowest 5-year survival rate for any form of cancer in the United States (US). PDAC is very rarely detected in early stages when surgical resection can be performed. Only 20% of cases are suitable for surgical resection; this remains the only curative treatment when combined with adjuvant chemotherapy. Treatment regimens excluding surgical intervention such as chemotherapeutic treatments are associated with adverse effects and genetherapy strategies also struggle with lack of specificity and/or efficacy. The lack of effective treatments for this disease highlights the necessity for innovation in treatment options for patients diagnosed with early- to late-phase PDAC and immuno-oncolytic viruses (OVs) have been of particular interest since 2006 when the first oncolytic virus was approved as a therapy for nasopharyngeal cancers in China. Interest resurged in 2015 when T-Vec, an oncolytic herpes simplex virus, was approved in the United States for treatment of advanced melanoma. While many vectors have been explored, few show promise as treatment for pancreatic cancer, and fewer still have progressed to clinical trial evaluation. This review outlines recent strategies in the development of OVs targeting treatment of PDAC, current state of preclinical and clinical investigation and application.

scholarly journals Veno-Occlusive Disease/Sinusoidal Obstruction Syndrome without Hematopoietic Cell Transplantation in a Real-World Population in the United States: Patient Characteristics, Prior Treatment Patterns, and Time to Diagnosis

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 1946-1946
Author(s):  
Xue Wang ◽  
Bouchra Benettaib ◽  
Weiyi Ni ◽  
Harry Jin ◽  
Seth Kuranz ◽  
...  
Keyword(s):  
United States ◽  
Cell Transplantation ◽  
Median Time ◽  
Real World ◽  
Hematopoietic Cell Transplantation ◽  
The United States ◽  
Prior Treatment ◽  
Sinusoidal Obstruction Syndrome ◽  
Publicly Traded ◽  
Index Treatment

Abstract Introduction: Sinusoidal obstruction syndrome (SOS), also known as hepatic veno-occlusive disease (VOD), is a rare form of hepatic injury where liver veins are blocked by damaged endothelial cells (Hildebrandt GC, et al. Br J Haematol. 2020;190:508-19). It is often associated with chemotherapy and radiation therapy given before a hematopoietic cell transplantation (HCT) but may occur outside of the HCT setting (Richardson PG, et al. Expert Rev Clin Pharm. 2018;11:113-24). The most severe form of VOD/SOS is associated with multiorgan dysfunction/multiorgan failure (MOD/MOF) and has a mortality rate of >80% if untreated (Coppell JA, et al. Biol Blood Marrow Transplant. 2018:53:138-45). This study describes the characteristics of VOD/SOS that occurs outside of the HCT setting (non-HCT VOD/SOS) in patients in the United States (US). Methods: This retrospective real-world evidence (RWE) study identified patient records within the TriNetX Dataworks US Network Electronic Medical Records (EMR) database, which covers 67 million patients from 44 healthcare organizations. Inclusion criteria required that patients had ≥1 record of a VOD/SOS diagnosis (ICD-10 code: K76.5) between January 1, 2016 and December 31, 2020, had received ≥1 instance of chemotherapy, antibody drug conjugates (ADC), or radiotherapy within 100 days prior to their first recorded VOD/SOS diagnosis, and had no record of HCT during the study period. Patient demographics and clinical characteristics, prior treatment regimen, and time to VOD/SOS diagnosis were characterized using descriptive statistics. Index treatment was defined as the treatment taken in the 100 days prior to VOD/SOS diagnosis, determined by the following hierarchy list of therapies: radiotherapy, gemtuzumab ozogamicin (GO)/inotuzumab ozogamicin (INO), vincristine, cytarabine, oxaliplatin-based, thioguanine, cyclophosphamide, 5-fluorouracil-based, etoposide, daunorubicin, doxorubicin, PEG-L-asparaginase, fludarabine, actinomycin-D, and other chemotherapies. Results: Of the 67 million patients available in the TriNetX database, 614 patients had documented VOD/SOS during the study period. Of those, 542 had ≥1 record in the EMR prior to the first VOD/SOS diagnosis. Among these 542 cases, 419 (77%) were non-HCT-related (did not have a record of HCT in the entire study period); the other 123 (23%) had a record of HCT (Figure 1). Of the 419 non-HCT VOD/SOS patients, 183 (44%) had ≥1 record of chemotherapy, ADC, or radiotherapy within the 100 days prior to first VOD/SOS diagnosis and comprised the study population. Among those 183 patients, 73 (40%) had a diagnosis of MOD/MOF at the same time VOD/SOS was documented; 61 (33%) were pediatric patients (≤16 years of age). Hematologic malignancies were the most common underlying condition (Table 1). A few patients had prior treatment with GO or INO (1% and 3%, respectively). The top 5 most common chemotherapies administered included cytarabine (25%), cyclophosphamide (20%), vincristine (17%), fludarabine (12%), and doxorubicin (11%). Overall, 103 (56%) non-HCT patients had a VOD/SOS diagnosis ≤21 days from index treatment. The median time from index treatment to VOD/SOS diagnosis was 13 days (interquartile range [IQR]: 1, 43 days) among all 183 patients. Among patients without MOD/MOF, median time was 18 days (IQR: 2, 44 days) and among patients with MOD/MOF, median time was 9 days (IQR: 0, 34 days). Conclusions: In this retrospective RWE study, the number of patients diagnosed with VOD/SOS outside of the HCT setting was approximately 3 times higher than those diagnosed in the HCT setting. Less than half of the patients diagnosed with non-HCT VOD/SOS had prior chemotherapy, ADC, or radiotherapy. Many of the non-HCT VOD/SOS patients were diagnosed with MOD/MOF. Among patients with non-HCT VOD/SOS, approximately half received their last dose of chemotherapy/ADC/radiotherapy >21 days before VOD/SOS diagnosis. Study limitations included those inherent to a retrospective study, the absence of availability of chemotherapy dosing in the database, and inability to detect misdiagnosis or under-diagnosis of VOD/SOS (which may result in under-estimation of the true number of VOD/SOS cases). The unexpected, relatively high number of VOD/SOS cases in the non-HCT setting, compared to the post-HCT setting, demonstrates a substantial unmet need, as there is no VOD/SOS treatment currently indicated for these patients. Figure 1 Figure 1. Disclosures Wang: Jazz Pharmaceuticals: Current Employment, Current equity holder in publicly-traded company. Benettaib: Jazz Pharmaceuticals: Current Employment, Current equity holder in publicly-traded company. Ni: Jazz Pharmaceuticals: Current Employment, Current equity holder in publicly-traded company. Jin: TriNetX: Current Employment. Kuranz: Apellis Pharmaceuticals, Inc.: Other: Payments from Apellis Pharmaceuticals to my institution TriNetX; TriNetX: Current Employment. Amber: Jazz Pharmaceuticals: Current Employment, Current equity holder in publicly-traded company. Ben-Joseph: Jazz Pharmaceuticals: Current Employment, Current equity holder in publicly-traded company.

scholarly journals Therapeutic strategies and potential implications of silver nanoparticles in the management of skin cancer

2020 ◽  
Vol 9 (1) ◽  
pp. 1500-1521
Author(s):  
Shaloam Dasari ◽  
Clement G. Yedjou ◽  
Robert T. Brodell ◽  
Allison R. Cruse ◽  
Paul B. Tchounwou
Keyword(s):  
United States ◽  
Silver Nanoparticles ◽  
Skin Cancer ◽  
Cell Carcinoma ◽  
Treatment Options ◽  
The United States ◽  
Major Health Problem ◽  
Major Health ◽  
Treatment Regimens ◽  
Excisional Surgery

Abstract Skin cancer (SC) is the most common carcinoma affecting 3 million people annually in the United States and millions of people worldwide. It is classified as melanoma SC (MSC) and non-melanoma SC (NMSC). NMSC represents approximately 80% of SC and includes squamous cell carcinoma and basal cell carcinoma. MSC, however, has a higher mortality rate than SC because of its ability to metastasize. SC is a major health problem in the United States with significant morbidity and mortality in the Caucasian population. Treatment options for SC include cryotherapy, excisional surgery, Mohs surgery, curettage and electrodessication, radiation therapy, photodynamic therapy, immunotherapy, and chemotherapy. Treatment is chosen based on the type of SC and the potential for side effects. Novel targeted therapies are being used with increased frequency for large tumors and for metastatic disease. A scoping literature search on PubMed, Google Scholar, and Cancer Registry websites revealed that traditional chemotherapeutic drugs have little effect against SC after the cancer has metastasized. Following an overview of SC biology, epidemiology, and treatment options, this review focuses on the mechanisms of advanced technologies that use silver nanoparticles in SC treatment regimens.

scholarly journals 1665. Using Electronic Health Records to Describe TB in Community Health Settings: a Cohort Analysis in a Large Safety-Net Population

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S819-S820
Author(s):  
Jonathan Todd ◽  
Jon Puro ◽  
Matthew Jones ◽  
Jee Oakley ◽  
Laura A Vonnahme ◽  
...  
Keyword(s):  
United States ◽  
Risk Factors ◽  
Electronic Health Records ◽  
Safety Net ◽  
The United States ◽  
Research Network ◽  
Health Records ◽  
Treatment Regimens ◽  
Data Source ◽  
Electronic Health

Abstract Background Over 80% of tuberculosis (TB) cases in the United States are attributed to reactivation of latent TB infection (LTBI). Eliminating TB in the United States requires expanding identification and treatment of LTBI. Centralized electronic health records (EHRs) are an unexplored data source to identify persons with LTBI. We explored EHR data to evaluate TB and LTBI screening and diagnoses within OCHIN, Inc., a U.S. practice-based research network with a high proportion of Federally Qualified Health Centers. Methods From the EHRs of patients who had an encounter at an OCHIN member clinic between January 1, 2012 and December 31, 2016, we extracted demographic variables, TB risk factors, TB screening tests, International Classification of Diseases (ICD) 9 and 10 codes, and treatment regimens. Based on test results, ICD codes, and treatment regimens, we developed a novel algorithm to classify patient records into LTBI categories: definite, probable or possible. We used multivariable logistic regression, with a referent group of all cohort patients not classified as having LTBI or TB, to identify associations between TB risk factors and LTBI. Results Among 2,190,686 patients, 6.9% (n=151,195) had a TB screening test; among those, 8% tested positive. Non-U.S. –born or non-English–speaking persons comprised 24% of our cohort; 11% were tested for TB infection, and 14% had a positive test. Risk factors in the multivariable model significantly associated with being classified as having LTBI included preferring non-English language (adjusted odds ratio [aOR] 4.20, 95% confidence interval [CI] 4.09–4.32); non-Hispanic Asian (aOR 5.17, 95% CI 4.94–5.40), non-Hispanic black (aOR 3.02, 95% CI 2.91–3.13), or Native Hawaiian/other Pacific Islander (aOR 3.35, 95% CI 2.92–3.84) race; and HIV infection (aOR 3.09, 95% CI 2.84–3.35). Conclusion This study demonstrates the utility of EHR data for understanding TB screening practices and as an important data source that can be used to enhance public health surveillance of LTBI prevalence. Increasing screening among high-risk populations remains an important step toward eliminating TB in the United States. These results underscore the importance of offering TB screening in non-U.S.–born populations. Disclosures All Authors: No reported disclosures

Hypothyroidism in Otherwise Healthy Hypercholesterolemic Children

PEDIATRICS ◽  
1991 ◽  
Vol 88 (2) ◽  
pp. 332-334
Author(s):  
ARTHUR LAVIN ◽  
ALAN H. NAUSS
Keyword(s):  
United States ◽  
Coronary Artery Disease ◽  
The United States ◽  
Plaque Formation ◽  
Preventive Cardiology ◽  
Treatment Regimens ◽  
Atherosclerotic Plaque Formation ◽  
Symptomatic Coronary Artery Disease ◽  
Artery Disease ◽  
High Risk Screening

Atherosclerosis is the leading cause of death in the United States. Studies in adults have shown that intervention with combined diet and medication can reduce atherosclerotic plaque formation and, as a result, the incidence of symptomatic coronary artery disease.1-4 With a strong tradition of preventive medicine, the pediatric community has begun exploring the prevention of adult atherosclerosis through intervention in childhood. Although issues such as universal vs selective high-risk screening, ideal age for screening and intervention, and treatment regimens remain unresolved and controversial, many preventive cardiology clinics, as well as individual pediatricians, have been screening and treating children.5,6 As part of an initial evaluation of hypercholesterolemic children and prior to any intervention, it is important to determine whether other disease processes are contributing to the child's dyslipoproteinemia.

Osteopathic considerations in pneumonia

2021 ◽  
pp. 14-20
Author(s):  
Taner B. Celebi ◽  
Jeffrey Muller ◽  
Michael J. Terzella
Keyword(s):  
United States ◽  
Risk Factors ◽  
Treatment Options ◽  
The United States ◽  
Special Consideration ◽  
Associated Risk Factors

Pneumonia contributed to nearly 3 million deaths worldwide in 2016 and 56,000 deaths in the United States alone in 2017, and as such, it is imperative for physicians to understand the causes, subtypes, associated risk factors and treatment options. This article will address each of these, as well as special consideration for the osteopathic approach to care.

Operating Room Blood Delivery Turnaround Time

2002 ◽  
Vol 126 (8) ◽  
pp. 909-914 ◽  
Author(s):  
David A. Novis ◽  
Richard C. Friedberg ◽  
Stephen W. Renner ◽  
Frederick A. Meier ◽  
Molly K. Walsh
Keyword(s):  
United States ◽  
Operating Room ◽  
Median Time ◽  
The United States ◽  
Blood Bank ◽  
Blood Component ◽  
Blood Components ◽  
Improvement Program ◽  
Delivery Times ◽  
Blood Banks

Abstract Objectives.—To determine the normative distribution of time elapsed for blood bank personnel to fill nonscheduled operating room (OR) blood component orders in hospital communities throughout the United States, and to examine hospital blood bank practices associated with faster blood component delivery times. Design.—Participants in the College of American Pathologists Q-Probes laboratory quality improvement program collected data prospectively on the times elapsed for blood bank personnel to fill nonscheduled emergent orders from hospital ORs for red blood cell (RBC) products, fresh frozen plasma (FFP), and platelets (PLTs). Participants also completed questionnaires describing their hospitals' and blood banks' laboratory and transfusion practices. Setting and Participants.—Four hundred sixty-six public and private institutions located in 48 states in the United States (n = 444), Canada (n = 9), Australia (n = 8), the United Kingdom (n = 4), and Spain (n = 1). Main Outcome Measures.—The median time elapsed between requests for blood components by OR personnel and the retrieval of those components by blood component transport personnel, and the median time elapsed between requests for blood components by OR personnel and the arrival of those components in ORs. Results.—Participants submitted data on 12 647 units of RBCs, FFP, and PLTs. The median aggregate request-to-retrieval turnaround times (TATs) for RBCs, FFP, and PLTs ranged from 30 to 35 minutes, and the median aggregate request-to-arrival TATs for RBCs, FFP, and PLTs ranged from 33 to 39 minutes. Most of the TAT was consumed by events occurring prior to, rather than after release of components from blood banks. Shorter prerelease TATs were associated with having surgical schedules that listed patients' names and procedures available to blood bank personnel prior to surgeries, and having adequate clotted specimens in the blood bank and completed type-and-screen procedures performed before requests for blood components were submitted to blood banks. Among the fastest-performing 10% of participants (90th percentile and above), request-to-retrieval TATs ranged from 12 to 24 minutes for the 3 blood components, whereas among the slowest-performing 10% of participants (10th percentile and below), request-to-retrieval TATs ranged from 63 to 115 minutes for the 3 components. Median TATs ranged from 33 to 37 minutes for the 3 components. Institutions with TATs in the fastest-performing 25th percentile more frequently stored cross-matched RBCs in the OR daily, stocked PLTs for unexpected surgical use, stored PLTs in or near the OR, and had laboratory rather than nonlaboratory personnel deliver components to the OR than did those institutions with TATs in the slowest-performing 25th percentile. Conclusions.—Hospital blood bank personnel can deliver blood components to the OR in slightly longer than 30 minutes, measured from the time that those units are requested by OR personnel. Practices aimed at saving time before components are released from blood banks will be more efficient in reducing overall TAT than those practices aimed at saving time after components are released from blood banks. Specific practices associated with shorter blood delivery TATs included providing blood bank personnel with access to the names of surgical patients potentially requiring blood components, having pretransfusion testing completed on those patients prior to surgery, having ample blood products on hand, and having laboratory personnel control blood product delivery.

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