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Publications
Publications (88)
Background:
The availability of safe and effective COVID-19 vaccines has enabled protections against serious COVID-19 outcomes, which are particularly important for patients with cancer. The American Society of Clinical Oncology Registry enabled the study of COVID-19 vaccine uptake in patients with cancer who were positive for severe acute respira...
Clinical trial participants do not reflect the racial and ethnic diversity of people with cancer. ASCO and the Association of Community Cancer Centers collaborated on a quality improvement study to enhance racial and ethnic equity, diversity, and inclusion (EDI) in cancer clinical trials. The groups conducted a pilot study to examine the feasibilit...
Purpose:
Cancer trial participants do not reflect the racial and ethnic diversity in the population of people with cancer in the United States. As a result of multiple system-, patient-, and provider-level factors, including implicit bias, cancer clinical trials are not consistently offered to all potentially eligible patients.
Materials and meth...
Purpose:
Treatment goals for patients with metastatic cancer include prolongation and maintenance of quality of life. Patients and oncologists have questioned the current paradigm of initial dose selection for systemic therapy; however, data on oncologists' dose selection strategies and beliefs are lacking.
Methods:
We conducted an electronic in...
Pediatric pan-cancer genome analyses do not capture the full range of diagnoses encountered in clinical practice. To inform basket trial design and real-world precision oncology practice, we classified diagnoses and assessed the landscape of mutations, including trial-matching, in an unselected cohort of pediatric solid tumors.
Since 2013 all Dana-...
Background
An ASCO taskforce comprised of representatives of oncology clinicians, the American Cancer Society National Lung Cancer Roundtable (NLCRT), LUNGevity, the GO2 Foundation for Lung Cancer, and the ROS1ders sought to: characterize U.S. oncologists’ biomarker ordering and treatment practices for advanced non-small-cell lung cancer (NSCLC); a...
PURPOSE
People with cancer are at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. ASCO's COVID-19 registry promotes systematic data collection across US oncology practices.
METHODS
Participating practices enter data on patients with SARS-CoV-2 infection in cancer treatment. In this analysis, we focus on a...
The purpose of this study was to evaluate the potential collective opportunities and challenges of transforming real‐world data (RWD) to real‐world evidence (RWE) for clinical effectiveness by focusing on aligning analytic definitions of oncology endpoints. Patients treated with a qualifying therapy for advanced non‐small cell lung cancer (aNSCLC)...
PURPOSE
Advances in genomic techniques have led to increased use of next-generation sequencing (NGS). We evaluated the extent to which these tests guide treatment decisions.
METHODS
We developed and distributed a survey assessing NGS use and outcomes to a survey pool of ASCO members. Comparisons between groups were performed with Wilcoxon two-samp...
PURPOSE
The TAPUR Study is a phase II basket trial that aims to identify signals of antitumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known to be drug targets. Results in a cohort of patients with metastatic breast cancer (mBC) with high tumor mutational burden (HTMB) treate...
Purpose:
Cancer prevalence and outcomes data, necessary to understand disparities in transgender populations, are significantly hampered because gender identity data are not routinely collected. A database of clinical data on people with cancer, CancerLinQ, is operated by the ASCO and collected from practices across the United States and multiple...
Purpose: Restrictive clinical trial eligibility criteria (EC) limit the number of patients who can enroll and potentially benefit from protocol-driven, investigational treatment plans and reduce the generalizability of trial results to the broader population. Following publication of expert stakeholder recommendations for broadening EC in 2017, the...
Purpose: Cancer clinical trials often accrue slowly or miss enrollment targets. Strict eligibility criteria are a major reason. Restrictive criteria also limit opportunities for patient participation while compromising external validity of trial results. We examined the impact of broadening select eligibility criteria on characteristics and number...
Purpose:
Performance status (PS) is one of the most common eligibility criteria. Many trials are limited to patients with high-functioning PS, resulting in important differences between trial participants and patient populations with the disease. In addition, existing PS measures are subjective and susceptible to investigator bias.
Experimental d...
PURPOSE
Feasibility assessments (FAs) are important to establish site capabilities to conduct clinical trials and their suitability for specific trials. However, current FA methods used by biotechnology and pharmaceutical (biotech-pharma) trial sponsors and contract research organizations (CROs) are costly, inefficient, unnecessarily burdensome, an...
This report presents the American Society of Clinical Oncology’s (ASCO’s) evaluation of the adaptations in care delivery, research operations, and regulatory oversight made in response to the coronavirus pandemic and presents recommendations for moving forward as the pandemic recedes. ASCO organized its recommendations for clinical research around...
BackgroundTAPUR is a pragmatic, phase II basket study evaluating the antitumor activity of commercially available targeted agents in patients with advanced cancers harboring genomic alterations known to be drug targets. Sunitinib is an oral multikinase inhibitor of FMS-like tyrosine kinase-3 (FLT-3), among other targets. Results from a cohort of pa...
Background: In April 2020, ASCO initiated a registry to capture and analyze status and outcomes of patients with cancer and COVID-19, and to describe effects of the pandemic on U.S. cancer practices. Initial findings of changes to care delivery are included.
Methods: Practices provide data on changes to care delivery due to COVID-19 and longitudina...
PURPOSE
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a phase II pragmatic basket trial evaluating antitumor activity of commercially available targeted agents in patients with advanced cancer with genomic alterations known to be drug targets. Results in a cohort of patients with non–small-cell lung cancer (NSCLC) with CDKN...
e19311
Background: Leveraging data from a collaboration with 9 data partners, Friends of Cancer Research convened the Real-world Evidence Pilot 2.0, to examine trends and real world (rw) data endpoints in immunotherapy (IO) use for the front line treatment of aNSCLC. Methods: This study leveraged parallel analyses of rw data elements across heterog...
e19145
Background: Scientific advances in genomics have ushered in new cancer tests and therapies. Many researchers, clinicians and advocates wonder how breakthroughs are implemented in practice. Methods: We examined Next Generation Sequencing (NGS) use, results, actions and outcomes among US oncologists (oncs) in treatment of their patients (pts)...
2076
Background: Despite opioid misuse and abuse, opioids remain a mainstay for management of cancer pain. Government, payers, and institutions have implemented policies to reduce opioid use. The impact of these restrictions on oncologist prescriptions (Rx) of opioids and management of cancer pain in pts with cancer is not well known. Methods: A re...
e19046
Background: Data regarding people who are gender minorities are not well-captured in oncology practices or large cohorts. Given this, collection of cancer prevalence and outcomes data, which are necessary to understand disparities in this population, are significantly hampered. Real-world data may be the most readily available source to expl...
The coronavirus disease 2019 (COVID-19) pandemic has disrupted all aspects of clinical care, including cancer clinical trials. In March 2020, ASCO launched a survey of clinical programs represented on its Cancer Research Committee and Research Community Forum Steering Group and taskforces to learn about the types of changes and challenges that clin...
PURPOSE
Company-reported payments from the Open Payments database (OP) have been compared with self-disclosed financial relationships made by physician authors. Discrepancies have been viewed as under-reporting of financial relationships. Our goal was to perform a systematic comparison to determine sources of discordance between company-reported an...
Purpose:
Investigators often send reports to sponsors that incorrectly categorize adverse event (AE)s as serious or attribute AEs to investigational drugs. Such errors can contribute to high volumes of uninformative investigational new drug safety reports that sponsors submit to the US Food and Drug Administration and participating investigators,...
Targeted cancer therapies are drugs and biologics designed to affect cancer cell growth by blocking or interfering with specific molecular pathways in the cancer cell. Use of targeted agents usually requires verification through molecular testing that the patient's tumor harbors the molecular biomarker that is the target of the drug or is predictiv...
PURPOSE
The Targeted Agent and Profiling Utilization Registry (TAPUR) Study identifies signals of antitumor activity of commercially available targeted agents in patients with advanced cancers that harbor genomic alterations known as drug targets. In this article, data from two cohorts of patients with pancreatic and biliary cancers with CDKN2A los...
Background: TAPUR is a phase II multi-basket study evaluating the anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations known to be drug targets. S is an oral multi-kinase inhibitor that inhibits Fms-like tyrosine kinase-3 () in biochemical and cellular assays. Results from mCRC pts each...
Background: The TAPUR Study is a phase II multi-basket study that evaluates the anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations known to be drug targets. Results in two cohorts of BC and NSCLC pts each without reported mutationstreated with C are reported.
Methods: Simon’s optimal...
Background: TAPUR is a phase II multi-basket study evaluating the anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations known to be drug targets. S is an oral multi-kinase inhibitor that inhibits Fms-like tyrosine kinase-3 () in biochemical and cellular assays. Results from mCRC pts each...
LBA108
Background: Restrictive trial eligibility criteria limit data generalizability and patient opportunity to participate. We compared numbers and characteristics of patients (pts) eligible using traditional vs expanded criteria recommended by ASCO and Friends of Cancer Research. Methods: A retrospective, observational analysis used deidentified...
e18279
Background: CancerLinQ Discovery (CLQD) is a real-world dataset (RWD) derived from electronic health records across the US. This analysis builds on the prior observation of cautioned use of bevacizumab (Bev) among older adults using Medicare claims data. The goals of this study are to estimate the prevalence and incidence of hypertension (HT...
1014
Background: TAPUR is a phase II basket study evaluating the anti-tumor activity of commercially available targeted agents in pts with advanced cancers with specific genomic alterations. P is an immune checkpoint inhibitor and HTMB is an emerging predictive biomarker for checkpoint inhibitor therapy. Results in a cohort of MBC pts with HTMB tre...
6531
Background: This survey of Targeted Agent and Profiling Utilization Registry (TAPUR) Study physicians examined use, attitudes, and perception of tumor genomic testing (TGT), defined as any DNA test performed on tumor specimen/plasma. TAPUR is a multibasket study of marketed agents targeting tumor genomics. Methods: 333 physicians at 54 TAPUR s...
9041
Background: TAPUR is a phase II basket study evaluating anti-tumor activity of commercially available targeted agents in pts with advanced cancers with genomic alterations. Results in a cohort of NSCLC pts with CDKN2A loss or mutation treated with P are reported. Methods: Eligible pts had advanced NSCLC, no standard treatment options, measurab...
Purpose:
Advanced practice providers (APPs, which include NPs and physician assistants [PAs]) are integral members of oncology teams. This study aims first to identify all APPs in oncology and, second, to understand personal and practice characteristics (including compensation) of those APPs.
Methods:
We identified APPs who practice oncology fro...
Purpose:
Advanced practice providers (APPs, which include nurse practitioners [NPs] and physician assistants [PAs]) are integral members of oncology teams. This study aims to identify all oncology APPs and to understand personal and practice characteristics (including compensation) of those APPs.
Methods:
We identified APPs who practice oncology...
Purpose
Case reports and small prospective trials suggest that administering targeted therapies to patients with advanced cancer and an identified genomic target may be associated with clinical benefit. The Targeted Agent and Profiling Utilization Registry (TAPUR) study, a phase II prospective, nonrandomized, multibasket pragmatic clinical trial, a...
Purpose: Advanced practice providers (APPs, which include nurse practitioners [NPs] and physician assistants [PAs]) are integral members of oncology teams. This study aims first to identify all oncology APPs and, second, to understand personal and practice characteristics (including compensation) of those APPs. Methods: We identified APPs who pract...
Purpose:
Advanced practice providers (APPs, which include nurse practitioners [NPs] and physician assistants [PAs]) are integral members of oncology teams. This study aims first to identify all oncology APPs and, second, to understand personal and practice characteristics (including compensation) of those APPs.
Methods:
We identified APPs who pr...
Purpose:
To describe the US hematology and medical oncology practice landscape and to report findings of the sixth annual ASCO Oncology Practice Census survey.
Participants and methods:
ASCO used Medicare Physician Compare data to characterize oncology practices in the United States. Practice size, number of care sites, and geographic distributi...
Introduction:
This analysis evaluates the impact of bundling drug costs into a hypothetic bundled payment.
Methods:
An economic model was created for patient vignettes from: advanced-stage III colon cancer and metastatic non-small-cell lung cancer. First quarter 2016 Medicare reimbursement rates were used to calculate the average fee-for-service...
Purpose:
- Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from the American Society of Clinical Oncology and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research.
Methods:
- An Exp...
Purpose
Clinical use of analytical tests to assess genomic variants in circulating tumor DNA (ctDNA) is increasing. This joint review from ASCO and the College of American Pathologists summarizes current information about clinical ctDNA assays and provides a framework for future research.
Methods
An Expert Panel conducted a literature review on th...
Purpose
Patients with organ dysfunction, prior or concurrent malignancies, and comorbidities are often excluded from clinical trials. Excluding patients on the basis of these factors results in clinical trial participants who are healthier and younger than the overall population of patients with cancer.
Methods
ASCO and Friends of Cancer Research...
Purpose
The primary purposes of eligibility criteria are to protect the safety of trial participants and define the trial population. Excessive or overly restrictive eligibility criteria can slow trial accrual, jeopardize the generalizability of results, and limit understanding of the intervention’s benefit-risk profile.
Methods
ASCO, Friends of C...
Purpose
Children have historically been excluded from first-in-human studies of promising new cancer drugs and later phase adult clinical trials. Delays in evaluation may result in off-label use without dosing information as the only access to new drugs. A multistakeholder workshop was convened in May 2016 by ASCO and Friends of Cancer Research to...
Purpose
People with HIV are living longer as a result of effective antiretroviral therapy. Cancer has become a leading cause of morbidity and mortality in this patient population. However, studies of novel cancer therapeutics have historically excluded patients with HIV. Critical review of eligibility criteria related to HIV is required to accelera...
BACKGROUND
The Affordable Care Act (ACA) includes a mandate requiring most private health insurers to cover routine patient care costs for cancer clinical trial participation; however, the impact of this provision on cancer centers’ efforts to accrue patients to clinical trials has not been well described.
METHODS
First, members of cancer research...
Purpose:
Trimodality therapy (chemoradiation and surgery) is the standard of care for stage II/III rectal cancer but nearly one third of patients do not receive radiation therapy (RT). We examined the relationship between the density of radiation oncologists and the travel distance to receipt of RT.
Methods and materials:
A retrospective study b...
Observational evidence has established a relationship between obesity and cancer risk and outcomes. Interventional studies have demonstrated the feasibility and benefits of lifestyle change after cancer diagnosis, and guidelines recommend weight management and regular physical activity in cancer survivors; however, lifestyle interventions are not a...
As more clinical trials of molecularly targeted agents evolve, the number of eligibility criteria seems to be increasing. The importance and utility of eligibility criteria must be considered in the context of the fundamental goal of a clinical trial: to understand the risks and benefits of a treatment in the intended-use patient population. Althou...
The American Society of Clinical Oncology (ASCO) convened a subcommittee to develop recommendations on improving the evidence base for treating older adults with cancer in response to a critical need identified by the Institute of Medicine. Older adults experience the majority of cancer diagnoses and deaths and make up the majority of cancer surviv...
The management of cancer varies across its type, stage, and natural history. This necessitates involvement of a variety of individuals and groups across a number of provider types. Evidence from other fields suggests that a team-based approach helps organize and optimize tasks that involve individuals and groups, but team effectiveness has not been...
This article discusses the care process among three groups (primary care, radiology, and surgery) aiding a 57-year-old woman during her screening mammography and diagnosis of breast cancer. This is the first in a series of articles exploring principles and topics relevant to teams guiding clinicians involved in cancer care. The challenges demonstra...
The American Society of Clinical Oncology (ASCO) represents more than 35,000 oncologists and other health care professionals who care for people with cancer and conduct research to improve cancer treatment. ASCO approved a policy statement on the importance of phase I trials in cancer treatment in 1996 and published it in 1997.1 ASCO and its member...
This article is one in a series of articles published in the 2014 Journal of Oncology Practice celebrating the 50th anniversary of ASCO and reflecting on cancer care and research over that time period. Key events enabled research to be integrated into many community oncology practices. We recount milestones affecting community-based research, focus...
Multiple studies have shown survival benefits in patients with cancer treated with radiation therapy, but access to treatment facilities has been found to limit its use. This study was undertaken to examine access issues in Iowa and determine a methodology for conducting a similar national analysis.
All Iowa residents who received radiation therapy...
Geographic disparities have raised important questions about factors related to treatment choice and travel time, which can affect access to cancer care.
Iowa residents who received chemotherapy regardless of where they were diagnosed or treated were identified through the Iowa Cancer Registry (ICR), a member of the SEER program. Oncologists and th...
The American Society of Clinical Oncology (ASCO) 2007 workforce report projected US oncologist shortages by 2020. Intervening years have witnessed shifting trends in both supply and demand, demonstrating the need to capture data in a dynamic manner. The ASCO Workforce Information System (WIS) provides an infrastructure to update annually emerging c...
The American Society of Clinical Oncology (ASCO) published a study in 2007 that anticipated a shortage of oncologists by 2020. This study aims to update and better assess the market for chemotherapy and radiation therapy and the impact of health reform on capacity of and demand for oncologists and radiation oncologists.
The supply of oncologists an...
Many challenges to clinical trial accrual exist, resulting in studies with inadequate enrollment and potentially delaying answers to important scientific and clinical questions.
The National Cancer Institute (NCI) and the ASCO (ASCO) cosponsored the Cancer Trial Accrual Symposium: Science and Solutions on April 29-30, 2010 to examine the state of a...
To address oncology community stakeholder concerns regarding implementation of the Risk Evaluation and Mitigation Strategies (REMS) program, ASCO sponsored a workshop to gather REMS experiences from representatives of professional societies, patient organizations, pharmaceutical companies, and the US Food and Drug Administration (FDA). Stakeholder...