Economic and clinical impact of a novel, light-based, at-home antiviral treatment on mild-to-moderate COVID-19.

Objectives: Antiviral treatments for early intervention in patients with mild-to-moderate COVID-19 are needed as a complement to vaccination. We sought to estimate the impact on COVID-19 cases, deaths, and direct healthcare costs over 12 months following introduction of a novel, antiviral treatment, RD-X19, a light-based, at-home intervention designed for the treatment of mild-to-moderate COVID-19 infection.

Methods: A time-dependent, state transition (semi-Markov) cohort model was developed to simulate infection progression in individuals with COVID-19 in 3 US states with varying levels of vaccine uptake (Alabama, North Carolina, and Massachusetts) and at the national level between 1 June 2020 and 31 May 2021.

Ruxolitinib Re-Treatment in Patients with Myelofibrosis: Real-World Evidence on Patient Characteristics and Outcomes.

Ruxolitinib is an FDA-approved treatment of intermediate- and high-risk myelofibrosis. In the phase 3 COMFORT studies, ruxolitinib reduced spleen volume in patients with myelofibrosis, with a median time to response of 3 months. However, nearly 20% of patients discontinued by month 4 with few treatment options available following discontinuation of ruxolitinib treatment.

Impact of Augmented Intelligence on Utilization of Palliative Care Services in a Real-World Oncology Setting.

Purpose: For patients with advanced cancer, timely referral to palliative care (PC) services can ensure that end-of-life care aligns with their preferences and goals. Overestimation of life expectancy may result in underutilization of PC services, counterproductive treatment measures, and reduced quality of life for patients. We assessed the impact of a commercially available augmented intelligence (AI) tool to predict 30-day mortality risk on PC service utilization in a real-world setting.

Second-line Afatinib or Chemotherapy Following Immunochemotherapy for the Treatment of Metastatic, Squamous Cell Carcinoma of the Lung: Real-world Effectiveness and Safety From a Multisite Retrospective Chart Review in the USA.

Background: The ErbB family blocker, afatinib, is approved for patients with squamous cell carcinoma (SqCC) of the lung following platinum-doublet chemotherapy but has not been explored following immunochemotherapy. Here, we assessed the characteristics and outcomes of patients with SqCC of the lung who received second-line afatinib or chemotherapy after first-line pembrolizumab plus chemotherapy in a "real-world" setting.

Methods: In this retrospective, multisite cohort study, community oncologists identified eligible patients and extracted data from electronic health records.

Comparison of Solid Tumor Treatment Response Observed in Clinical Practice With Response Reported in Clinical Trials.

Importance: In clinical trials supporting the regulatory approval of oncology drugs, solid tumor response is assessed using Response Evaluation Criteria in Solid Tumors (RECIST). Calculation of RECIST-based responses requires sequential, timed imaging data, which presents challenges to the method's application in real-world evidence research.

Objective: To evaluate the feasibility and validity of a novel real-world RECIST method in assessing tumor burden associated with therapy for a large heterogeneous patient population undergoing treatment in routine clinical practice.

Effectiveness of Eribulin in Metastatic Breast Cancer: 10 Years of Real-World Clinical Experience in the United States.

Introduction: Eribulin was approved in the United States (US) in 2010 for patients with metastatic breast cancer (MBC) who previously received at least two chemotherapeutic regimens, including anthracycline and taxane in the adjuvant or metastatic setting. With significant changes to the treatment landscape over the past decade, assessment of the real-world effectiveness of eribulin in clinical practice when used according to the approved US indication is valuable.

Methods: Patients with MBC were identified by community oncologists through a retrospective, multi-site patient chart review; de-identified data were abstracted into electronic case report forms.

Use of Real-World Evidence to Support FDA Approval of Oncology Drugs.

Objectives: Real-world evidence (RWE) has gained increased attention in recent years as a complement to traditional clinical trials. The use of RWE to establish the efficacy of oncology drugs for Food and Drug Administration (FDA) approval has not been described. In this paper, we review 5 recent examples where RWE was submitted in support of the FDA approvals of original or supplementary indications for oncology drugs.

Neurological adverse events following CAR T-cell therapy: a real-world analysis.

To characterize real-world neurological adverse events (AEs) associated with chimeric antigen receptor T-cell therapies in patients with refractory/relapsed large B-cell lymphomas. Postmarketing case reports from the US FDA AEs reporting system involving axicabtagene ciloleucel (axi-cel) and tisagenlecleucel (tisa-cel) for large B-cell lymphomas were analyzed. Of 804 AE cases identified (637 axi-cel, 167 tisa-cel), 428 (67%) of axi-cel cases and 43 (26%) of tisa-cel cases reported neurological AEs.

Lenvatinib and Subsequent Therapy for Radioactive Iodine-Refractory Differentiated Thyroid Cancer: A Real-World Study of Clinical Effectiveness in the United States.

Introduction: Lenvatinib has become the most commonly prescribed first-line (1L) agent for the treatment of radioactive iodine-refractory differentiated thyroid cancer (RAI-r DTC) since its approval in 2015. With no real-world studies describing clinical outcomes of 1L lenvatinib and subsequent therapy, the current study aimed to assess treatment sequencing and related clinical outcomes in patients treated with 1L lenvatinib in the USA METHODS: We conducted a multisite, retrospective chart review of US patients with a diagnosis of RAI-r DTC who had initiated 1L therapy with lenvatinib from January 1, 2016 through May 31, 2017 with follow-up through October 17, 2018. Physicians completed electronic case report forms for two patient cohorts: patients still receiving 1L lenvatinib (cohort 1) and those who had initiated second-line (2L) therapy prior to data cutoff (cohort 2).

Real-world risk assessment and treatment initiation among patients with myelofibrosis at community oncology practices in the United States.

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm with a prevalence of 4 to 6 per 100,000 people in the USA. Treatment recommendations are risk-adapted. This study was conducted to evaluate how physicians risk-stratify patients at the time of MF diagnosis, the accuracy of the risk stratification, and its effect on treatment selection.

Real-world incidence and cost of pneumonitis post-chemoradiotherapy for Stage III non-small-cell lung cancer.

To estimate the real-world incidence and timing of radiation pneumonitis following chemoradiotherapy for Stage III non-small-cell lung cancer and compare costs between patients with and without radiation pneumonitis. Retrospective analysis using the Symphony Health Integrated Dataverse. Pneumonitis incidence was 12.

Observational study of clinical outcomes of eribulin mesylate in metastatic breast cancer after cyclin-dependent kinase 4/6 inhibitor therapy.

To examine the effectiveness of eribulin mesylate for metastatic breast cancer post cyclin-dependent kinase inhibitor (CDKi) 4/6 therapy. US community oncologists reviewed charts of patients who had received eribulin from 3 February 2015 to 31 December 2017 after prior CDKi 4/6 therapy and detailed their clinical/treatment history, clinical outcomes (lesion measurements, progression, death) and toxicity. Four patient cohorts were created according to eribulin line of therapy: second line, third line, per US label and fourth line with objective response rates/clinical benefit rates of 42.

Real-world treatment patterns, cost of care and effectiveness of therapies for patients with squamous cell carcinoma of head and neck pre and post approval of immuno-oncology agents.

In 2016, nivolumab and pembrolizumab were approved for the treatment of squamous cell carcinoma of the head and neck (SCCHN) following progression after initial platinum-based therapy. We sought to explore the uptake, effectiveness, and impact on healthcare resource utilization (HRU) and total costs of care pre and post introduction of immuno-oncology (IO) agents. Recurrent/metastatic SCCHN patients were identified from a healthcare claims clearinghouse by selecting patients with a claim for distant metastases or who initiated systemic therapy at least 120 days following discontinuation of platinum-based therapy.

Understanding total cost of care in advanced non-small cell lung cancer pre- and postapproval of immuno-oncology therapies.

This study assesses resource utilization and total direct medical cost among patients in the United States starting systemic antineoplastic therapy (ST) pre- and postapproval of immuno-oncology (IO) agents for advanced non-small cell lung cancer. Adults diagnosed with lung cancer initiating first-line ST within 6 months of diagnosis during either the pre- (March 2013-March 2014) or post-IO (March 2015-December 2016) approval period were identified in a US-based multipayer administrative claims database. Excluded were patients with small cell lung cancer, secondary malignancies, less than 1 month follow-up, and those in clinical trials.

Clinical benefit of treatment with eribulin mesylate for metastatic triple-negative breast cancer: Long-term outcomes of patients treated in the US community oncology setting.

Introduction: Real-world data are critical to demonstrate the consistency of evidence and external generalizability of randomized controlled trials (RCTs). This study examined characteristics and outcomes of metastatic triple-negative breast cancer (mTNBC) patients treated with eribulin mesylate at community oncology practices in the United States.

Methods: Physicians identified mTNBC patients initiating eribulin between 1 January 2011 and 1 January 2014 and abstracted data into an electronic case report form (eCRF).

Prioritizing US Cervical Cancer Prevention With Results From a Geospatial Model.

Purpose: To determine if differences in screening and vaccination patterns across the population may accentuate ethnic and geographic variation in future burden of disease.

Methods: Using Cancer in North America data provided by the North American Association of Central Cancer Registries, county cervical cancer incidence trends from 1995 to 2009 were modeled for the entire United States using ecologic covariates. Rates for health service areas were also modeled by ethnicity.

Estimating the Economic Impact of Adding Panobinostat to a U.S. Formulary for Relapsed and/or Refractory Multiple Myeloma: A Budget Impact and Cost-Benefit Model.

Background: Multiple myeloma is an incurable B-cell malignancy with a natural history that involves alternating periods of remission and subsequent relapse. For relapsed and/or refractory multiple myeloma (RRMM), the typical patient currently receives more lines of therapy than has been feasible in the past, translating into longer progression-free survival (PFS). Consequently, cost issues have become more prominent because patients may be offered newer and more expensive therapies during a more prolonged overall treatment course.

Estimating the Costs of Therapy in Patients with Relapsed and/or Refractory Multiple Myeloma: A Model Framework.

Background: Multiple myeloma is a progressive cancer for which there is no cure. Despite treatment, almost all patients eventually experience periods of disease relapse and remission. With the increasing use of novel therapies, including bortezomib, lenalidomide, carfilzomib, pomalidomide, and panobinostat, benchmarks for assessing the value of these therapies in treating patients with relapsed or refractory multiple myeloma (RRMM) are needed for physicians and payers alike.

Racial and ethnic disparities in cancer survival by neighborhood socioeconomic status in Surveillance, Epidemiology, and End Results (SEER) Registries.

Introduction: Reducing cancer disparities is a major public health objective. Disparities often are discussed in terms of either race and ethnicity or socioeconomic status (SES), without examining interactions between these variables.

Methods: Surveillance, Epidemiology, and End Results (SEER)-18 data, excluding Alaska Native and Louisiana registries, from 2002 to 2008, were used to estimate five-year, cause-specific survival by race/ethnicity and census tract SES.

Earlier presentation and application of curative treatments in hepatocellular carcinoma.

Unlabelled: The purpose of the study was to assess the use of curative therapies for hepatocellular carcinoma (HCC) in the population. HCC treatment patterns were examined in Surveillance, Epidemiology, and End Results (SEER) 18 registries (28% of U.S.

Ethnicity predicts metabolic syndrome after liver transplant.

Purpose: Post-transplant metabolic syndrome (PTMS) is associated with important causes of morbidity and mortality in solid organ transplant recipients. Our aim was to investigate predictors of PTMS in liver transplant (LT) recipients.

Methods: We randomly selected 343 adults (>18 years of age) from a large cohort of 1,262 ethnically diverse patients who received LTs during 2000-2010.

Burden of Human Papillomavirus among Haitian Immigrants in Miami, Florida: Community-Based Participatory Research in Action.

Background. Haitian immigrant women residing in Little Haiti, a large ethnic enclave in Miami-Dade County, experience the highest cervical cancer incidence rates in South Florida. While this disparity primarily reflects lack of access to screening with cervical cytology, the burden of human papillomavirus (HPV) which causes virtually all cases of cervical cancer worldwide, varies by population and may contribute to excess rate of disease.

The BEACHES Study: health effects and exposures from non-point source microbial contaminants in subtropical recreational marine waters.

Background: Microbial water-quality indicators, in high concentrations in sewage, are used to determine whether water is safe for recreational purposes. Recently, the use of these indicators to regulate recreational water bodies, particularly in sub/tropical recreational marine waters without known sources of sewage, has been questioned. The objectives of this study were to evaluate the risk to humans from exposure to subtropical recreational marine waters with no known point source, and the possible relationship between microbe densities and reported symptoms in human subjects with random-exposure assignment and intensive individual microbial monitoring in this environment.