Mediators of racial and ethnic inequities in clinical trial participation among patients with cancer, 2011-2023.

Background: Although racially and ethnically minoritized populations are less likely to participate in cancer trials, it is unknown whether social determinants of health (SDOH) explain these inequities. Here we identify SDOH factors that contribute to racial and ethnic inequities in clinical trial participation among patients with 22 common cancers.

Methods: This retrospective cohort study used electronic health record data (2011-2023) linked to neighborhood (US Census tract) data from multiple sources.

Are community oncology practices with or without clinical research programs different? A comparison of patient and practice characteristics.

Background: Expanding access to clinical trials in community settings is a potential approach to addressing disparities in accrual of historically underrepresented populations. However, little is known about the characteristics of practices that do not participate in research. We investigated differences in patient and practice characteristics of US community oncology practices with high vs low engagement in clinical research.

Evaluation of US oncology electronic health record real-world data to reduce uncertainty in health technology appraisals: a retrospective cohort study.

Objectives: Examine whether data from early access to medicines in the USA can be used to inform National Institute for Health and Care Excellence (NICE) health technology assessments (HTA) in oncology.

Design: Retrospective cohort study.

Setting: Oncology-based community and academic treatment centres in the USA.

Racial and Ethnic Inequities in US Oncology Clinical Trial Participation From 2017 to 2022.

Importance: There is increasing recognition from regulatory agencies that racial and ethnic representation in clinical trials is inadequate and linked to health inequities. The extent of racial inequities in clinical trial participation is unclear because prior studies have synthesized enrollment data from published trials, which often do not report participant race and ethnicity.

Objective: To evaluate racial and ethnic inequities in oncology clinical trial participation in a contemporary cohort of patients with cancer before and during the COVID-19 pandemic.

Lessons Learned Using Real-World Data to Emulate Randomized Trials: A Case Study of Treatment Effectiveness for Newly Diagnosed Immune Thrombocytopenia.

Regulatory agencies are increasingly considering real-world evidence (RWE) to support label expansions of approved medicines. We conducted a comparative effectiveness study to emulate a proposed randomized trial of romiplostim vs. standard-of-care (SOC) therapy among patients with recently diagnosed (≤12 months) immune thrombocytopenia (ITP), that could support expansion of the romiplostim label.

Real-World Dosing Patterns of Ruxolitinib in Patients With Polycythemia Vera Who Are Resistant to or Intolerant of Hydroxyurea.

Introduction: Approximately one-quarter of patients with polycythemia vera become resistant to and/or intolerant of hydroxyurea. This analysis characterizes reasons patients were switched from hydroxyurea to ruxolitinib and describes ruxolitinib dosing patterns and outcomes in real-world clinical practice.

Patients And Methods: This medical chart review of United States community hematology/oncology practices in the Cardinal Health Oncology Provider Extended Network included patients with polycythemia vera who were ≥18 years old, received hydroxyurea for ≥3 months, started ruxolitinib between January 1, 2015 and December 31, 2016, and had ≥2 visits during the subsequent 6 months.

Assessment of thrombotic risk during long-term treatment of immune thrombocytopenia with fostamatinib.

Background: Patients with immune thrombocytopenia (ITP) are at risk of bleeding and, paradoxically, thromboembolic events (TEEs), irrespective of thrombocytopenia. The risk of thrombosis is increased by advanced age, obesity, and prothrombotic comorbidities: cancer, hyperlipidemia, diabetes, hypertension, coronary artery disease, and chronic kidney disease, among others. Certain ITP treatments further increase the risk of TEE, especially splenectomy and thrombopoietin receptor agonists.

Cabozantinib and Panitumumab for RAS Wild-Type Metastatic Colorectal Cancer.

Lessons Learned: Antitumor activity was observed in the study population. Dose modifications of cabozantinib improve long-term tolerability. Biomarkers are needed to identify patient populations most likely to benefit.

Does Cancer Treatment-Related Financial Distress Worsen Over Time?

Patients with cancer are at risk for both objective and subjective financial distress. Financial distress during treatment is adversely associated with physical and mental well-being. Little is known about whether patients' subjective financial distress changes during the course of their treatment.

Rapid rise in the cost of targeted cancer therapies for Medicare patients with solid tumors from 2006 to 2015.

Background: Inflation-adjusted cancer costs in the United States have increased 40% in the last decade, leading to increasing financial burden on both payers and patients. Patients under 65 show substantial increases in utilization of expensive targeted therapy anticancer agents; however, patients aged 65+ account for the majority of new malignancies. Utilization and cost trends for these emerging agents have not been examined in detail in the Medicare population.

Treatment Patterns Among Adults with Primary Immune Thrombocytopenia Diagnosed in Hematology Clinics in the United States.

Purpose: Patients with immune thrombocytopenia (ITP) have low platelet counts and an increased risk of bleeding. We described treatment patterns and clinical outcomes in routine practice in the United States (US).

Patients And Methods: Using electronic health record data from hematology/oncology clinics linked to administrative claims in the US, we studied 447 adults newly diagnosed with primary ITP from 2011 to 2016.

Treatment Patterns and Blood Counts in Patients With Polycythemia Vera Treated With Hydroxyurea in the United States: An Analysis From the REVEAL Study.

Background: Polycythemia vera (PV) is associated with increased blood cell counts, risk of thrombosis, and symptoms including fatigue and pruritus. National guidelines support the use of hydroxyurea (HU) in high-risk patients or those with some other clinical indication for cytoreduction.

Patients And Methods: REVEAL is a prospective, observational study designed to collect data pertaining to demographics, disease burden, clinical management, patient-reported outcomes, and health care resource utilization of patients with PV in the United States.

A phase Ib study of capecitabine and ziv-aflibercept followed by a phase II single-arm expansion cohort in chemotherapy refractory metastatic colorectal cancer.

Background: Patients with chemotherapy refractory metastatic colorectal cancer (CRC) have a poor prognosis and limited therapeutic options. In this phase Ib/II clinical trial, we established the maximum tolerated dose (MTD) and recommended phase II dose (RPTD) for the combination of capecitabine and ziv-aflibercept, and then we evaluated the efficacy of the combination in patients with chemotherapy refractory metastatic CRC.

Methods: All patients were required to have a Karnofsky Performance Status > 70% and adequate organ function.

Going for Broke: A Longitudinal Study of Patient-Reported Financial Sacrifice in Cancer Care.

Purpose: Patients with cancer are at risk for substantial treatment-related costs; however, little is known about patients' willingness to sacrifice to receive cancer care and how their attitudes and burden may change with time.

Patients And Methods: We conducted a longitudinal survey of insured patients with solid tumor cancers receiving chemotherapy or hormonal therapy. Patients were surveyed at two time points about their willingness to make financial sacrifices and their actual sacrifices, including out-of-pocket costs.

Using a geriatric oncology assessment to link with services (GOAL).

Objective: Geriatric screening tools assess functional limitations and inform clinical decision-making for older adults with cancer. Our objective was to evaluate the feasibility and effectiveness of a screener in community-based oncology clinics.

Materials And Methods: Eligible patients were from two rural, underserved community-based cancer clinics; within 12 months of a cancer diagnosis (breast, lung, colorectal, pancreas, esophageal); aged ≥60 years; and not exclusively pursuing palliative care.

Out-of-Pocket Costs, Financial Distress, and Underinsurance in Cancer Care.

This cross-sectional survey study examines financial distress and cost expectations among patients with cancer presenting for anticancer therapy.

Rate of bleeding-related episodes in elderly patients with primary immune thrombocytopenia: a retrospective cohort study.

Objective: Immune thrombocytopenia (ITP) is characterized by low platelet counts and a tendency toward increased bleeding and bruising. We aimed to describe bleeding frequency and use of rescue ITP therapy to treat or prevent bleeding in elderly ITP patients in a real-world setting.

Methods: Using Medicare 20% sample data, 2007-2012, we identified elderly (ages ≥67 years) Medicare fee-for-service enrollees diagnosed with primary ITP between 1 January 2009 and 30 September 2012.

Cost of Bleeding-related Episodes in Adult Patients With Primary Immune Thrombocytopenia: A Population-based Retrospective Cohort Study of Administrative Claims Data for Commercial Payers in the United States.

Purpose: We estimated the real-world costs of bleeding-related episodes (BREs) in adults with primary immune thrombocytopenia (ITP).

Methods: This retrospective cohort study used the MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases. We identified adult patients diagnosed with primary ITP between 2007 and 2012, defined by at least 2 outpatient claims separated by ≥30 days or 1 inpatient claim (International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis code for primary ITP [287.

Rate of bleeding-related episodes in adult patients with primary immune thrombocytopenia: a retrospective cohort study using a large administrative medical claims database in the US.

Background: Immune thrombocytopenia (ITP) is a rare disorder characterized by low platelet counts and an increased tendency to bleed. The goal of ITP therapy is to treat or prevent bleeding. Actual rates of bleeding are unknown.

Physician Experience and Attitudes Toward Addressing the Cost of Cancer Care.

Purpose: We surveyed US cancer doctors to examine current attitudes toward cost discussions and how they influence decision making and practice management.

Methods: We conducted a self-administered, anonymous, electronic survey of randomly selected physician ASCO members to evaluate the frequency and nature of cost discussions reported by physicians, attitudes toward discussions of cost in clinics, and potential barriers.

Results: A total of 333 of 2,290 physicians responded (response rate [RR], 15%; adjusted RR after omitting nonpracticing physician ASCO members, 25%), Respondent practice settings were 45% academic and 55% community/private practice.

The utility of cost discussions between patients with cancer and oncologists.

Objectives: Patients with cancer can experience substantial financial burden. Little is known about patients' preferences for incorporating cost discussions into treatment decision making or about the ramifications of those discussions. The objective of this study was to determine patient preferences for and benefits of discussing costs with doctors.

Integrated analysis of long-term safety in patients with chronic immune thrombocytopaenia (ITP) treated with the thrombopoietin (TPO) receptor agonist romiplostim.

A safety analysis of pooled data from clinical studies of romiplostim, a thrombopoietin (TPO) receptor agonist, in which patients with immune thrombocytopaenia (ITP) received romiplostim, placebo, or medical standard of care (SOC) Rodeghiero et al. (Eur J Haematol 91:423-436, 2013), has been updated. Included are data from 14 trials spanning 2002-2011; placebo- and SOC-arm data are pooled.

Biomarker signatures correlate with clinical outcome in refractory metastatic colorectal cancer patients receiving bevacizumab and everolimus.

A novel combination of bevacizumab and everolimus was evaluated in refractory colorectal cancer patients in a phase II trial. In this retrospective analysis, plasma samples from 49 patients were tested for over 40 biomarkers at baseline and after one or two cycles of drug administration. Analyte levels at baseline and change on-treatment were correlated with progression-free survival (PFS) and overall survival (OS) using univariate Cox proportional hazard modeling.

The neoadjuvant treatment of rectal cancer: a review.

Rectal adenocarcinoma is an important cause of cancer-related deaths worldwide, and key anatomic differences between the rectum and the colon have significant implications for management of rectal cancer, especially in the curative setting. For stage II and III rectal cancers, combined chemoradiotherapy offers the lowest rates of local and distant relapse, and is delivered neoadjuvantly to improve tolerability and optimize surgical outcomes, particularly when sphincter-sparing surgery is an endpoint. We review both pivotal trial data that has shaped the current standard of care, fluoropyrimidine-based chemoradiotherapy, while also presenting results from more recent studies, which aim to outperform this standard.