Genomic/genetic testing patterns for patients with metastatic castrate-resistant prostate cancer: Results from a real-world study in the United States.

2021 ◽  
Vol 39 (6_suppl) ◽  
pp. 49-49
Author(s):  
Andrea Leith ◽  
Amanda Ribbands ◽  
Matthew Last ◽  
Alicia Gayle ◽  
Sarah Payne ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Genetic Testing ◽  
Real World ◽  
Patient Characteristics ◽  
The United States ◽  
Molecular Testing ◽  
Cancer Disease ◽  
The Us ◽  
Castrate Resistant

49 Background: In May 2020, Olaparib was approved for HRRm mCRPC post progression on abiraterone and enzalutamide, and rucaparib was approved for BRCAm mCPRC following progression on androgen receptor targeted inhibitors and prior taxane therapy for mCRPC. HRRm are associated with approximately 25% of mCRPC and may be derived from germline or somatic origin. Somatic and germline alterations can be detected by tumour testing, but to differentiate between these, independent germline testing is needed. This study examined real-world genomic/genetic testing (GT) patterns in patients (pts) diagnosed with mCRPC in the United States (US). Methods: Data were drawn from the Adelphi Prostate Cancer Disease Specific Programme; a point-in-time survey administered to oncologists (onc), urologists (uro) and surgeons (sur) between January and August 2020 in the US. Physicians (phys) completed an attitudinal survey and a patient record form for the next four to nine mCRPC pts seen. Study variables included patient demographics, clinical factors and GT patterns. HRRm testers were defined as phys who tested for HRRm. Pts were identified as positive, negative or unknown depending on the outcome of the HRRm test. Results: A total of 72 phys (69% onc/ 29% uro/ 1% sur; 40% academic vs. 60% community) reported on 346 mCRPC pts. 41% of phys were based in the Northeast, 24% Midwest, 23% South and 13% in the West region of the US. 65 phys (90%) reported having access to overall GT; of these 5% identified as having access to germline tests only, while 94% were able to test for germline and somatic mutations. Challenges to conducting GT overall were ‘cost per test’ (50%), ‘having to send out for the tests (within country)’ (25%), ‘inadequate sample available’ (25%) and ‘patient refusal’ (25%). GT was typically conducted at identification of castrate-resistance (52%), metastases (51%) and at initial diagnosis (49%). 72% of total phys were HRRm testers; for these, patient characteristics primarily driving HRRm testing included Ashkenazi Jewish heritage (63%) and ECOG of 2-4 (58%). Other common drivers were family history, young diagnosis age and hormone therapy failure (all 46%). 132 (38% of 326) mCRPC pts were tested for HRRm; 39% of tested pts were identified with a HRRm. Most common HRRm tested were BRCA1 (90%), BRCA2 (89%) and ATM (55%). Conclusions: In this study majority of US phys had access to GT, but testing was only performed in 38% of pts with mCRPC. The higher than expected % of pts identified with an HRRm suggest that molecular testing was prioritised in high risk populations, as identified by the phys. With the recent approval of olaparib and rucaparib, GT may become more routine in clinical practice to identify eligible pts. Broader testing may also depend on addressing other barriers to testing including cost and testing logistics/practicalities.

Enrollment disparities in cancer clinical trials leading to FDA approvals between 2008 and 2020.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18501-e18501
Author(s):  
Ryan Huu-Tuan Nguyen ◽  
Yomaira Silva ◽  
Vijayakrishna K. Gadi
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Clinical Trials ◽  
Drug Approval ◽  
The United States ◽  
Cancer Clinical Trials ◽  
Cancer Prevalence ◽  
Fda Approval ◽  
The Us ◽  
Enrollment Data

e18501 Background: Cancer clinical trials based in the United States (US) have lacked adequate representation of racial and ethnic minorities, the elderly, and women. Pivotal clinical trials leading to United States Food and Drug Administration (FDA) approval are often multi-national trials and may also lack generalizability to underrepresented populations in the United States. We determined the racial, ethnic, age, and sex enrollment in pivotal trials relative to the US cancer population. Methods: We reviewed the FDA’s Drug Approvals and Databases for novel and new use drug approvals for breast, colorectal, lung, and prostate cancer indications from 2008 through 2020. Drugs@FDA was searched for drug approval summaries and FDA labels to identify clinical trials used to justify clinical efficacy that led to FDA approval. For eligible trials, enrollment data were obtained from FDA approval summaries, FDA labels, ClinicalTrials.gov, and corresponding journal manuscripts. Enrollment Fraction (EF) was calculated as enrollment in identified clinical trials divided by 2017 SEER cancer prevalence. All data sources were publicly available. Results: From 2008 through 2020, 60 drugs received novel or new use drug approval for breast, colorectal, lung, or prostate cancer indications based on 66 clinical trials with a total enrollment of 36,830. North America accounted for 9,259 (31%) enrollees of the 73% of trials reporting location of enrollment. Racial demographics were reported in 78% of manuscripts, 66% of ClinicalTrials.gov pages, and 98% of FDA labels or approval summaries. Compared with a 0.4% enrollment fraction among White patients, lower enrollment fractions were noted in Hispanic (0.2%, odds ratio [OR] vs White, 0.46; 95% confidence interval [CI], 0.43 to 0.49, P< 0.001) and Black (0.1%, OR 0.29; 95% CI 0.28 to 0.31, P< 0.001) patients. Elderly patients (age ≥ 65 years) were less likely than younger patients to be enrollees (EF 0.3% vs 0.9%, OR 0.27; 95% CI 0.26 to 0.27, P< 0.001) despite accounting for 61.3% of cancer prevalence. For colorectal and lung cancer trials, females were less likely than males (EF 0.7% vs 1.1%, OR 0.66; 95% CI 0.63 to 0.68, P< 0.001) to be enrolled. Conclusions: Black, Hispanic, elderly, and female patients were less likely to enroll in cancer clinical trials leading to FDA approvals from 2008 to 2020. Race and geographic enrollment data were inconsistently reported in journal manuscripts and ClinicalTrials.gov. The lack of appropriate representation of specific patient populations in these key clinical trials limits their generalizability. Future efforts must be made to ensure equitable access, representation, and reporting of enrollees that adequately represent the US population of patients with cancer.

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.

Current landscape of prostate cancer quality measures in the United States.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 273-273
Author(s):  
Scott C Flanders ◽  
Eleanor Fitall ◽  
Dayo Jagun ◽  
Kristi Mitchell ◽  
Peter St. John Francis ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Risk Stratification ◽  
Late Stage ◽  
Symptom Assessment ◽  
Quality Measures ◽  
The United States ◽  
Additional Treatment ◽  
Urological Surgery ◽  
The Us

273 Background: Prostate cancer (PCa) is the leading cancer for men in the United States (US) and identified by the Centers for Medicare & Medicaid Services (CMS) as one of the top 20 high-impact Medicare conditions experienced by beneficiaries. Thus, there is increasing focus by stakeholders to measure and achieve high-value, quality care in PCa. However, quality measurement is particularly difficult in oncology. Our aim was to assess the current landscape of PCa quality measures (QMs) in the US. Methods: Published literature and online resources from the past 5 years were reviewed to identify PCa QMs and general oncology QMs relevant to PCa. PCa QMs were categorized using a “continuum of care” framework across 5 stages: 1) symptom assessment and screening; 2) diagnosis and risk stratification; 3) initial treatment; 4) monitoring and additional treatment; and 5) advanced- or late-stage care. Finally, PCa QMs were evaluated for their type (eg. process, outcomes), and use by CMS. Results: We identified 16 PCa-specific QMs and 20 general oncology QMs relevant to PCa. The majority of PCa QMs were developed by the American Medical Association–Physician Consortium for Performance Improvements (6 measures) and the Michigan Urological Surgery Improvement Collaborative (6 measures). There are 3 QMs for symptom assessment and screening, 5 QMs for diagnosis and risk stratification, 6 QMs for initial treatment, 2 QMs for monitoring and additional treatment, and 0 QMs for advanced- or late-stage care. Fourteen PCa QMs focus on process of care, but only 2 PCa QMs address outcomes. Nine PCa QMs are part of CMS quality improvement programs, 6 of which are reportable through the Michigan Urological Surgery Improvement Collaborative. Three new PCa QMs are under consideration by CMS. Conclusions: We found few PCa QMs that capture outcomes of patient experience or care, and no PCa-specific QMs available for advanced disease and late-stage care, demonstrating a need to better define quality in this setting. Opportunities to increase the focus on innovative, real-world data-generation strategies, such as PCa disease registries that collect clinical outcomes, patient preferences, and comorbidities, may inform stakeholder development and adoption of new QMs in the US.

Real-world prescribing patterns in acute myeloid leukemia in the United States.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e18524-e18524 ◽  
Author(s):  
Bruno C. Medeiros ◽  
Bhavik J. Pandya ◽  
Anna Hadfield ◽  
Samuel Wilson ◽  
Cynthia Mueller ◽  
...  
Keyword(s):  
United States ◽  
Acute Myeloid Leukemia ◽  
Real World ◽  
High Intensity ◽  
Myeloid Leukemia ◽  
Patient Characteristics ◽  
The United States ◽  
First Line ◽  
Low Intensity ◽  
Acute Myeloid

e18524 Background: The effective treatment of patients with acute myeloid leukemia (AML) remains a challenge in clinical practice. This analysis describes the patient characteristics and real-world use of AML treatments in the United States for patients on high- and low-intensity treatment. Methods: Data from the Adelphi AML Disease-Specific Programme, a real-world, cross-sectional survey conducted between February–May 2015, were analysed. A total of 61 hematologist/hem-oncologists, across academic, non-academic and office-based practice locations, provided data on 457 AML patients. Patient characteristics were derived from physician-completed patient record forms where each physician was asked to provide treatment details, including the treatment intensity, for each line of therapy. Results: A total of 91% (n = 415) of patients included in this analysis were previously untreated for AML. Patients had a mean age of 60 years and been diagnosed with AML for a median of 5.0 months. At first-line induction therapy, over half (53%; n = 241) of the patients were initiated on a high-intensity treatment, the most common regimen being cytarabine plus anthracycline (61%; n = 147). The remaining 47% (n = 216) of patients received a low-intensity induction therapy such as low dose cytarabine monotherapy (28%, n = 61), azacitidine monotherapy (25%, n = 54), or decitabine monotherapy (21%, n = 45). Over half (55%, n = 62) of patients suited to high intensity treatment went on to receive cytarabine monotherapy during the consolidation phase of their first-line treatment. Conclusions: According to treating physicians, the large majority of patients receive traditional, well-established therapies at first-line induction for AML. Whilst cytarabine combinations dominate the high-intensity treatment setting, the hypomethylating agents, azacitidine and decitabine, are frequently used for those more suited to low-intensity treatment.

scholarly journals Design and Simulation of Robotic Needle Guide for Transperineal Prostate Biopsy

2018 ◽  
Author(s):  
Hossein Dehghani ◽  
Shihao Zhang ◽  
Pankaj Kulkarni ◽  
Pradipta Biswas ◽  
Leslie Simms ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Prostate Biopsy ◽  
The United States ◽  
The Third ◽  
Transperineal Prostate Biopsy ◽  
The Us ◽  
Reproductive Gland

Prostate cancer is the third leading cause of cancer-related death for males in the United States [1]. Over three million Americans with prostate cancer were reported in 2016 [2] marking the prostate cancer as the most prevalent cancer among males in the US. In 2016, 180,890 new cases and 26,120 deaths were reported [1]. The prostate is a male reproductive gland located in the pelvis and surrounded by the rectum posteriorly and the bladder superiorly.

scholarly journals Understanding Implementation Challenges to Genetic Testing for Familial Hypercholesterolemia in the United States

2019 ◽  
Vol 9 (1) ◽  
pp. 9 ◽  
Author(s):  
Rachele Hendricks-Sturrup ◽  
Christine Lu
Keyword(s):  
United States ◽  
Genetic Testing ◽  
Familial Hypercholesterolemia ◽  
Ethnic Diversity ◽  
Heart Association ◽  
The United States ◽  
Cvd Risk ◽  
Implementation Challenges ◽  
The Us ◽  
Control And Prevention

Cardiovascular disease (CVD) is the leading cause of death in the United States (US), with familial hypercholesterolemia (FH) being a major inherited and genetic risk factor for premature CVD and atherosclerosis. Genetic testing has helped patients and providers confirm the presence of known pathogenic and likely pathogenic variations in FH-associated genes. Key organizations, such as the Centers for Disease Control and Prevention (CDC), American Heart Association (AHA), FH Foundation, and National Lipid Association (NLA), have recognized the clinical utility of FH genetic testing. However, FH genetic testing is underutilized in clinical practice in the US for reasons that are underexplored through the lens of implementation science. In this commentary, we discuss seven key implementation challenges that must be overcome to strengthen the clinical adoption of FH genetic testing in the US. These implementation challenges center on evidence of cost-effectiveness, navigating patient and provider preferences and concerns, gender and ethnic diversity and representation in genetic testing, and establishing clinical consensus around FH genetic testing based on the latest and most relevant research findings. Overcoming these implementation challenges is imperative to the mission of reducing CVD risk in the US.

A Blighted History

ORBIT ◽  
2020 ◽  
pp. 1-27
Author(s):  
Laurence J. Alison ◽  
Neil D. Shortland ◽  
Frances Surmon-Böhr ◽  
Emily K. Alison
Keyword(s):  
United States ◽  
Real World ◽  
The United States ◽  
Reliable Information ◽  
Terrorist Attacks ◽  
Underlying Theory ◽  
The Us ◽  
History Of ◽  
Enhanced Interrogation

This chapter outlines the history of “harsh” interrogation methods based on coercion and torture. This includes discussion of the US “Enhanced Interrogation” Program and the British military’s development and use of the “Five Techniques,” along with real-world examples, including the interrogation of two detainees thought to be associated with the 2001 9/11 terrorist attacks on the United States. The chapter discusses the underlying theory behind the use of torture and coercion and explains why these interrogation methods are ineffective at obtaining reliable information from detainees. It also describes the reasons why torture continues to be used. Such reasons relate to revenge, dehumanization, and hatred.

scholarly journals Treatment Pattern and Outcomes with Systemic Therapy in Men with Metastatic Prostate Cancer in the Real-World Patients in the United States

Cancers ◽  
2021 ◽  
Vol 13 (19) ◽  
pp. 4951
Author(s):  
Umang Swami ◽  
Jennifer Anne Sinnott ◽  
Benjamin Haaland ◽  
Nicolas Sayegh ◽  
Taylor Ryan McFarland ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
United States ◽  
Real World ◽  
Comparative Effectiveness ◽  
Metastatic Prostate Cancer ◽  
Proportional Hazards Model ◽  
The United States ◽  
Cox Proportional Hazards Model ◽  
Real World Data ◽  
Hormonal Therapies

Background: Both novel hormonal therapies and docetaxel are approved for treatment of metastatic prostate cancer (mPC; in castration sensitive or refractory settings). Present knowledge gaps include lack of real-world data on treatment patterns in patients with newly diagnosed mPC, and comparative effectiveness of novel hormonal therapies (NHT) versus docetaxel after treatment with a prior NHT. Methods: Herein we extracted patient-level data from a large real-world database of patients with mPC in United States. Utilization of NHT or docetaxel for mPC and comparative effectiveness of an alternate NHT versus docetaxel after one prior NHT was evaluated. Comparative effectiveness was examined via Cox proportional hazards model with propensity score matching weights. Each patient’s propensity for treatment was modeled via random forest based on 22 factors potentially driving treatment selection. Results: The majority of patients (54%) received only androgen deprivation therapy for mPC. In patients treated with an NHT, alternate NHT was the most common next therapy and was associated with improved median overall survival over docetaxel (abiraterone followed by docetaxel vs. enzalutamide (8.7 vs. 15.6 months; adjusted hazards ratio; aHR 1.32; p = 0.009; and enzalutamide followed by docetaxel vs. abiraterone (9.7 vs. 13.2 months aHR 1.40; p = 0.009). Limitations of the study include retrospective design.

scholarly journals 855. Persistence on F/TAF versus F/TDF for HIV Pre-Exposure Prophylaxis: A Real-World Evidence Analysis in the United States

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S518-S519
Author(s):  
Li Tao ◽  
Valentina Shvachko ◽  
Moupali Das ◽  
Christoph C Carter ◽  
Jared Baeten ◽  
...  
Keyword(s):  
United States ◽  
Real World ◽  
The United States ◽  
Odds Ratios ◽  
Preexposure Prophylaxis ◽  
Hazard Ratios ◽  
Real World Evidence ◽  
The Us ◽  
Evidence Analysis ◽  
Exposure Prophylaxis

Abstract Background Persistence to preexposure prophylaxis (PrEP) is an important determinant of its efficacy, but evidence on real-world persistence is lacking. This study assesses adherence to F/TDF and F/TAF for PrEP both in terms of discontinuation and re-initiation patterns. Methods We identified HIV-negative individuals in the United States who initiated F/TDF or F/TAF for PrEP between October 2019 and December 2020 from a de-identified prescription claims database; users taking generic F/TDF were excluded. Non-persistence was defined as a prescription fill gap of &gt;30 days; discontinuation included switch from F/TDF to F/TAF or F/TAF to F/TDF. We used survival analyses to estimate persistence, Cox regressions to compare the hazard ratios (HR) of discontinuation, and logistic regression to compare the odds ratios of re-initiation after discontinuation. Results Among F/TAF users (N=82,402) median age at PrEP initiation was 35 years (interquartile range [IQR] 28−47) and median PrEP persistence was 4 months (IQR 1.8-8.9), compared to 31 years (IQR 25−40) and 2 months (IQR 1.0-3.8) for F/TDF users (N=48,501). PrEP persistence at 60 and 90 days was higher among F/TAF users than F/TDF users (Figure). F/TDF users were 2.5 times more likely to discontinue than F/TAF users, with more marked differences in older users than that in younger users (p for interaction between discontinuation and age group &lt; 0.01, Table). We also observed a higher rate of discontinuation of F/TDF versus F/TAF if PrEP was prescribed by internal medicine or infectious disease physicians than by family medicine physicians (data not shown). After discontinuation, F/TAF users were 1.7 times more likely than F/TDF users to re-initiate PrEP; the association was not different by age. Persistence rates of F/TAF and F/TDF for PrEP by time of PrEP initiation Hazard ratios (HR) and corresponding 95% confidence intervals (CI) of non-persistence and odds ratios (OR) of re-initiation after discontinuation for users of F/TAF and F/TDF for PrEP in the US, Oct 2019 – Dec 2020 Conclusion In this real-world analysis, the F/TAF for PrEP regimen was associated with higher persistence and re-initiation than F/TDF for PrEP. These findings underscore the dynamic nature of PrEP utilization in the real-world and the importance of interventions aimed at improving PrEP persistence and re-initiation in people who would benefit from PrEP. Disclosures Li Tao, MD, PhD, Gilead Sciences Inc (Employee, Shareholder) Valentina Shvachko, MS, Gilead Sciences Inc (Employee, Shareholder) Moupali Das, MD, Gilead Sciences Inc. (Employee, Shareholder) Christoph C. Carter, MD, Gilead Sciences Inc. (Employee, Shareholder) Jared Baeten, MD, PHD, Gilead Sciences Inc. (Employee, Shareholder) David Magnuson, PharmD, Gilead Sciences Inc (Employee, Shareholder)

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