Gary H Lyman

• MD, MPH, FRCP(Edin)
• Professor (Full) at Duke University Medical Center

11042 Background: Sex-based differences in outcomes with contemporary oncology treatments remain underexplored, creating a gap in the evidence required for personalised care. To address this, our objective was to systematically evaluate whether sex differences exist in survival and adverse event outcomes with modern anticancer therapies. Methods: I...

The leading cause of death in patients with giant cell arteritis (GCA) and polymyalgia rheumatica (PMR) is cardiovascular disease. The objective of this study was to determine whether the use of selective serotonin reuptake inhibitors (SSRI) and serotonin norepinephrine reuptake inhibitors (SNRI) in veterans with GCA and PMR could have a cardio-mod...

Background Patients with cancer frequently visit the emergency department (ED) and are at high risk for hospitalization due to severe illness from cancer progression or treatment side effects. With an aging population and rising cancer incidence rates worldwide, it is crucial to understand how EDs and other acute care venues manage oncologic emerge...

Introduction: Venous thromboembolism (VTE) in patients with cancer is associated with considerable morbidity, mortality and costs. The first validated VTE score, Khorana Score (KS) (Khorana, Kuderer et al. Blood 2008) was derived from a logistic regression (LR) model based on a large, prospective cohort study of ambulatory patients initiating cance...

Background: Approximately 20% of breast cancer (BC) cases are human epidermal growth factor receptor 2-positive (HER2+; immunohistochemistry [IHC] 3+, IHC 2+/in-situ hybridization [ISH]+), and up to ~50% of patients with primary or metastatic BC (mBC) have HER2-low tumors (IHC 1+, IHC 2+/ISH−), a new therapeutically targetable subset of BC. Trastuz...

The move toward early detection and treatment of cancer presents challenges for value assessment using traditional endpoints. Current cancer management rarely considers the full economic and societal benefits of therapies. Our study used a modified Delphi process to develop principles for defining and assessing value of cancer therapies that aligns...

Background Patients with cancer visit the emergency department often and have a high rate of admission compared to other patients. Admission rates by institution may vary widely, even after accounting for patient and hospital-specific characteristics. Objectives To review the variables that affect admission rates among patients with cancer in the...

Background: Transparent and objective reporting of treatment toxicities in cancer clinical trials is critical to inform patient-centred, shared decision-making. Previous studies have shown that toxicity reporting is inconsistent and incomplete in randomized controlled trials (RCTs) presented at major conferences in both hematologic (Chin-Yee et al....

Background: Limited information is available for patients with breast cancer (BC) and coronavirus disease 2019 (COVID-19), especially among underrepresented racial/ethnic populations. Methods: This is a COVID-19 and Cancer Consortium (CCC19) registry-based retrospective cohort study of females with active or history of BC and laboratory-confirmed s...

Importance The pharmaceutical industry has made substantial investments in developing processes for sharing individual-participant data (IPD) from clinical trials. However, the utility and completeness of shared IPD and supporting documents must be evaluated to ensure the potential for scientific advancements from the data sharing ecosystem can be...

Purpose: We conducted a pragmatic, cluster-randomized trial to test whether a guideline-based standing order entry (SOE) improves use of primary prophylactic CSF (PP-CSF) prescribing for patients receiving myelosuppressive chemotherapy. We investigated variability in adherence to the intervention. Methods: We conducted a cluster-randomized trial...

Purpose Primary prophylactic granulocyte colony-stimulating factors (PP-CSFs) are prescribed alongside chemotherapy regimens that carry a significant risk of febrile neutropenia (FN). As part of S1415CD, a prospective, pragmatic trial evaluating the impact of automated orders to improve PP-CSF prescribing, we evaluated patients’ baseline knowledge...

Background: Prophylactic growth-factor therapy with granulocyte colony-stimulating factor (G-CSF) reduces the risk of febrile neutropenia (FN) in patients with breast cancer initiating myelosuppressive chemotherapy. However, little is known about the protective benefit early in the chemotherapy cycle. Methods: To assess the relationship between...

1567 Background: Objective and complete toxicity reporting in clinical trials is critical for patient-centered shared decision-making. Conference abstracts inform initial impressions of practice-changing treatments. Methods: We performed a systematic review of all abstracts of CRC and PaC phase 3 RCTs presented at ASCO annual meetings between 2012...

e13647 Background: Oncology-relevant measures of disease and treatment support earlier detection, accelerated drug development, and inform treatment pathways. To advance access to transformative treatments for people with cancer, especially those for early-stage cancers where medical intervention has the greatest opportunity to impact the course of...

Despite the importance of chemotherapy-associated adverse events in oncology practice and the broad range of interventions available to mitigate them, limited systematic efforts have been made to identify, critically appraise and summarize the totality of evidence on the effectiveness of these interventions. Herein, we review the most common long-t...

Purpose: Biosimilars offer increased patient choice and potential cost-savings, compared with originator biologics. We studied 3 years of prescribed biologics among US physician practices to determine the relationship of practice type and payment source to oncology biosimilar use. Methods: We acquired biologic utilization data from 38 practices...

Purpose: To conduct an update of the ASCO venous thromboembolism (VTE) guideline. Methods: After publication of potentially practice-changing clinical trials, identified through ASCO's signals approach to updating, an updated systematic review was performed for two guideline questions: perioperative thromboprophylaxis and treatment of VTE. PubMe...

As the voice of cancer care clinicians and the patients they serve, ASCO has taken steps to elevate awareness about biosimilar products and their use in oncology. In 2018, ASCO released its Statement on Biosimilars in Oncology which was subsequently published in the Journal of Clinical Oncology to serve as an educational tool which highlighted and...

Importance: Trastuzumab has been the standard of care for the treatment of patients with ERBB2-positive breast cancer; however, cardiac events have been reported. This long-term follow-up study provides clinical evidence supporting the similarity of a trastuzumab biosimilar (SB3) to reference trastuzumab (TRZ). Objective: To compare cardiac safe...

Introduction: COVID-19 particularly impacted patients with co-morbid conditions, including cancer. Patients with melanoma have not been specifically studied in large numbers. Here, we sought to identify factors that associated with COVID-19 severity among patients with melanoma, particularly assessing outcomes of patients on active targeted or imm...

Background Limited information is available for patients with breast cancer (BC) and coronavirus disease 2019 (COVID-19), especially among underrepresented racial/ethnic populations. Methods This is a COVID-19 and Cancer Consortium (CCC19) registry-based retrospective cohort study of females with active or history of BC and laboratory-confirmed se...

Neutropenia is the major toxicity of myelosuppressive cancer chemotherapy. Grade 4 neutropenia (Gr4N) is a measure of chemotherapy-induced neutropenia (CIN) severity. We conducted a meta-analysis of CIN data. Gr4N incidence was significantly correlated with febrile neutropenia (FN), days of severe neutropenia (DSN), and nadir absolute neutrophil co...

BACKGROUND: Chemotherapy-induced neutropenia increases the risk of febrile neutropenia (FN) and infection with resultant hospitalizations, with substantial health care resource utilization (HCRU) and costs. Granulocyte-colony stimulating factor (GCSF) is recommended as primary prophylaxis for chemotherapy regimens having more than a 20% risk of FN....

Purpose: Although representing the majority of newly diagnosed cancers, patients with breast cancer appear less vulnerable to COVID-19 mortality compared with other malignancies. In the absence of patients on active cancer therapy included in vaccination trials, a contemporary real-world evaluation of outcomes during the various pandemic phases, a...

Over the past decade, multiple trials, including the precision medicine trial NCI-MATCH (National Cancer Institute-Molecular Analysis for Therapy Choice, EAY131, NCT02465060) have sought to determine if treating cancer based on specific genomic alterations is effective, irrespective of the cancer histology. Although many therapies are now approved...

PURPOSE Older women with high-risk early breast cancer (EBC) benefit from adjuvant chemotherapy, but their treatment is frequently complicated by toxic side effects, resulting in dose reductions and delays. This makes it challenging for oncologists to maintain a relative dose intensity (RDI) ≥ 85%, as recommended for optimal curative-intent treatme...

Plain language summary What is this article about? This article is about the evaluation of how effective the stakeholder engagement was in a comparative effectiveness research (CER) study funded by the Patient Centered Outcomes Research Institute (PCORI). The research team found a framework (developed by Lavalle et al.) that defined six different c...

Giant cell arteritis (GCA) that affects older patients is an independent risk factor for thromboembolic events. The objective of this study was to identify predictive factors for thromboembolic events in patients with GCA and develop quantitative predictive tools (prognostic nomograms) for pulmonary embolism (PE) and deep venous thrombosis (DVT). A...

Background Immune-related Adverse Events (irAEs) are rare but serious sequelae of treatment with immuno-oncology (IO) therapeutics. These therapeutics, including monoclonal antibodies targeting programmed cell death protein 1 (PD-1), programmed death-ligand 1 (PD-L1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), have had transformative...

The approval and adoption of biosimilar products are essential to contain increasing healthcare costs and provide more affordable choices for patients. Despite steady progress in the number of the US Food and Drug Administration (FDA) biosimilar approvals over the years, biosimilar adoption in the United States has been slow and gradual, largely dr...

Importance Cytokine storm due to COVID-19 can cause high morbidity and mortality and may be more common in patients with cancer treated with immunotherapy (IO) due to immune system activation. Objective To determine the association of baseline immunosuppression and/or IO-based therapies with COVID-19 severity and cytokine storm in patients with ca...

Importance Colony-stimulating factors are prescribed to patients undergoing chemotherapy to reduce the risk of febrile neutropenia. Research suggests that 55% to 95% of colony-stimulating factor prescribing is inconsistent with national guidelines. Objective To examine whether a guideline-based standing order for primary prophylactic colony-stimul...

Reliable risk models can greatly facilitate patient-centered inferences and decisions. Herein we summarize key considerations related to risk modeling in clinical oncology. Often overlooked challenges include data quality, missing data, effective sample size estimation, and selecting the variables to be included in the risk model. The stability and...

Despite the enthusiasm surrounding novel targeted agents and immunotherapies, chemotherapy remains the mainstay treatment for most human malignancies, either alone or in combination. Yet, the burden of chemotherapy-associated adverse events (CAAEs) remains high and, importantly, is associated with considerable morbidity, mortality and costs that af...

339 Background: Primary prophylactic colony stimulating factors (PP-CSF) are prescribed to patients undergoing chemotherapy to reduce the risk of febrile neutropenia (FN). Prior research suggested poor adherence to PP-CSF prescribing relative to national guidelines. Accordingly, the objective of the TrACER study was to examine whether a guideline-b...

374 Background: Pragmatic trials evaluate the effectiveness of interventions in routine practice conditions. Pragmatic trials have high generalizability, but the treatment effect can be influenced by nonadherence to the intervention of interest. We conducted a pragmatic, cluster-randomized trial to test whether a guideline-based standing order entr...

Purpose: The aim of this joint guideline is to provide evidence-based recommendations to practicing physicians and other health care providers on integrative approaches to managing pain in patients with cancer. Methods: The Society for Integrative Oncology and ASCO convened an expert panel of integrative oncology, medical oncology, radiation onc...

Despite the incorporation of trastuzumab biosimilars (to treat HER2-positive breast cancer) in clinical practice guidelines, gaps remain such as patient and clinician education. We hosted a webinar comprised of a panel of biosimilars experts, oncologists, pharmacist, infusion nurse, patient advocate. The outcomes of the webinar include: audience re...

1518 Background: Primary prophylactic colony stimulating factors (PP-CSF) are prescribed to patients undergoing chemotherapy to reduce the risk of febrile neutropenia (FN) but their benefit for regimens with intermediate FN risk is uncertain. Within a pragmatic, randomized trial of a standing order entry (SOE) intervention for prescribing PP-CSF, w...

Introduction Disparities in care of older adults in cancer treatment trials and emergency department (ED) use exist. This report provides a baseline description of older adults ≥65 years old who present to the ED with active cancer. Materials and methods Planned secondary analysis of the Comprehensive Oncologic Emergencies Research Network observa...

1525 Background: Primary prophylactic colony stimulating factors (PP-CSF) are prescribed to patients undergoing chemotherapy to reduce the risk of febrile neutropenia (FN). Prior studies have shown that 55-95% of CSF prescribing is inconsistent with practice guidelines. We conducted a cluster randomized trial to determine if guideline-informed stan...

Background: Older adults with cancer use the emergency department (ED) for acute concerns. Objectives: Characterize the palliative care needs and clinical outcomes of advanced cancer patients in the ED. Design: A planned secondary data analysis of the Comprehensive Oncologic Emergencies Research Network (CONCERN) data. Settings/Subjects: Cancer pat...

The NCCN Guidelines for Hematopoietic Growth Factors provide recommendations for the appropriate use of growth factors in the clinical management of febrile neutropenia (FN), chemotherapy-induced thrombocytopenia (CIT), and chemotherapy-induced anemia (CIA). Management and prevention of these sequelae are an integral part of supportive care for man...

Introduction: Patients diagnosed with cancer have an increased risk both for myelodysplastic syndromes (MDS) and for acute myeloid leukemia (AML) following treatment. Methods: Using SEER-Medicare data, we selected patients aged 66 years and older who completed systemic therapy between 2002 and 2014 for breast (stage I-III), lung (stage I-III), o...

Background Cancer Care Delivery (CCD) research studies often require practice-level interventions that pose challenges in the clinical trial setting. The SWOG Cancer Research Network (SWOG) conducted S1415CD, one of the first pragmatic cluster-randomized CCD trials to be implemented through the National Cancer Institute (NCI) Community Oncology Pro...

Importance: Non-Hispanic Black individuals experience a higher burden of COVID-19 than the general population; hence, there is an urgent need to characterize the unique clinical course and outcomes of COVID-19 in Black patients with cancer. Objective: To investigate racial disparities in severity of COVID-19 presentation, clinical complications,...

Patients with B-lymphoid malignancies have been consistently identified as a population at high risk of severe COVID-19. Whether this is exclusively due to cancer-related deficits in humoral and cellular immunity, or whether risk of severe COVID-19 is increased by anticancer therapy, is uncertain. Using data derived from the COVID-19 and Cancer Con...

Background: SB3 (trastuzumab-dttb) is a biosimilar approved globally based on its similarity with reference trastuzumab (TRZ) demonstrated by thorough comparability exercises in analytical, biological, and clinical studies. In a randomized, double-blind, multicenter Phase 3 study of 875 patients with HER2-positive early or locally advanced breast c...

Background The frequency of coinfections and their association with outcomes have not been adequately studied among patients with cancer and COVID-19, a high-risk group for coinfection. Methods We included adult (≥18 years) patients with active or prior hematologic or invasive solid malignancies and laboratory-confirmed SARS-CoV-2 infection, using...

PURPOSE The increased number and expanded utilization of biosimilars raise important considerations for their safe and appropriate use in oncology practice. This report provides an update on currently approved oncology biosimilars and identifies current knowledge gaps in the management of patients with cancer. METHODS An Expert Panel was convened...

Importance The COVID-19 pandemic has had a distinct spatiotemporal pattern in the United States. Patients with cancer are at higher risk of severe complications from COVID-19, but it is not well known whether COVID-19 outcomes in this patient population were associated with geography. Objective To quantify spatiotemporal variation in COVID-19 outc...

Purpose Emergency department (ED) visits by patients with cancer frequently end in hospitalization. As concerns about ED and hospital crowding increase, observation unit care may be an important strategy to deliver safe and efficient treatment for eligible patients. In this investigation, we compared the prevalence and clinical characteristics of c...

Background Outcomes among Hodgkin lymphoma (HL) patients diagnosed between 22 and 39 years are worse than among those diagnosed <21 years, and have not seen the same improvement over time. Treatment at an NCI-designated Comprehensive Cancer Center (CCC) mitigates outcome disparities, but may be associated with higher expenditures. Methods We exami...

Purpose Our goal was to identify discrete clinical characteristics associated with safe discharge from an emergency department/urgent care for patients with a history of cancer and concurrent COVID-19 infection during the SARS-CoV-2 pandemic and prior to widespread vaccination. Patients and Methods We retrospectively analyzed 255 adult patients wi...

Patients with cancer are at significantly greater risk of COVID-19 and its complications than the general population. Since IgG antibodies remain detectable well after infection with the SARS-CoV-2 virus, seroprevalence can be used to estimate the proportion of the cancer population previously infected and potentially immune to SARS-CoV-2. The curr...

Pain is common in patients with cancer seeking emergency department (ED) care. Fifty percent of ED patients with cancer present with pain and 39% report pain at final ED pain assessment. Thus, ED practitioners seemingly remain challenged to manage pain in this population. Such findings support calls encouraging safe, effective, and timely pain mana...

58 Background: The introduction of biosimilar colony-stimulating factors has led to the reduction in prices for these historically expensive therapies. To understand the impact of recent pricing trends on delivering efficient care, the cost-effectiveness of primary prophylaxis (PP) versus secondary prophylaxis (SP) using pegfilgrastim was assessed...

Trustworthy health guidelines should provide recommendations, document the development process, and highlight implementation information. Our objective was to develop a guideline manuscript template to help authors write a complete and useful report. The McMaster Grading of Recommendations Assessment, Development and Evaluation (GRADE) centre colla...

Importance: The COVID-19 pandemic has had consequences for patients with cancer worldwide and has been associated with delays in diagnosis, interruption of treatment and follow-up care, and increases in overall infection rates and premature mortality. Observations: Despite the challenges experienced during the pandemic, the global oncology commu...

Background Sargramostim [recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF)] was approved by US FDA in 1991 to accelerate bone marrow recovery in diverse settings of bone marrow failure and is designated on the list of FDA Essential Medicines, Medical Countermeasures, and Critical Inputs. Other important biological acti...

Purpose Many patients with cancer seek care for pain in the emergency department (ED). Prospective research on cancer pain in this setting has historically been insufficient. We conducted this study to describe the reported pain among cancer patients presenting to the ED, how pain is managed, and how pain may be associated with clinical outcomes....

Importance COVID-19 is a life-threatening illness for many patients. Prior studies have established hematologic cancers as a risk factor associated with particularly poor outcomes from COVID-19. To our knowledge, no studies have established a beneficial role for anti–COVID-19 interventions in this at-risk population. Convalescent plasma therapy may...

Chemotherapy-induced damage of hematopoietic stem and progenitor cells (HPSCs) often results in myelosuppression that adversely affects patient health and quality of life. Currently, chemotherapy-induced myelosuppression is managed with chemotherapy dose delays/reductions and lineage-specific supportive care interventions, such as hematopoietic gro...

Background: Hospitalized patients with COVID-19 have increased risks of venous (VTE) and arterial thromboembolism (ATE). Active cancer diagnosis and treatment are well-known risk factors; however, a risk assessment model (RAM) for VTE in patients with both cancer and COVID-19 is lacking. Methods: Among patients with cancer in the CCC19 cohort st...

Large randomized controlled trials (RCTs) remain the gold standard for evaluating treatment efficacy. However, observational studies including non-randomized cohort studies as well as small RCTs have gained increasing attention especially during the SARS-CoV-2 pandemic where critical evaluation of limited therapeutic options are sought to improve p...

Introduction A decrease in relative dose intensity (RDI) of chemotherapy has been shown to be associated with poor patient outcomes in solid tumors and non-Hodgkin’s lymphoma. The actual delivered chemotherapy dose received by patients can be influenced by dose reductions and treatment delays often due to toxicities, most commonly chemotherapy-indu...

e18607 Background: FN after myelosuppressive chemotherapy may result in significant morbidity/mortality and increase healthcare costs due to interventions such as hospitalization. For patients receiving chemotherapy at intermediate-risk of FN, guidelines recommend assessing patient-specific FN RFs to decide whether to provide primary prophylaxis. H...

6500 Background: Racial/ethnic minorities have disproportionately increased risk of contracting COVID-19 and experiencing severe illness; they also have worse breast cancer (BC) outcomes. COVID-19 outcomes among racial/ethnic minorities with BC are currently unknown. We sought to compare clinicopathologic characteristics and COVID-19 outcomes strat...

6561 Background: COVID-19 has been associated with immune modulation that may predispose infected patients to bacterial, viral, or fungal co-infections. Due to critical illness, > 70% of patients with severe COVID-19 receive empiric antibacterial or antifungal therapy, along with standard anti-COVID-19 treatments. However, the frequency of proven o...

PURPOSE To provide recommendations for appropriate dosing of systemic antineoplastic agents in obese adults with cancer. METHODS A systematic review of the literature collected evidence regarding dosing of chemotherapy, immunotherapy, and targeted therapies in obese adults with cancer. PubMed and the Cochrane Library were searched for randomized c...

Objectives To evaluate the use of granulocyte colony-stimulating factor (G-CSF) prophylaxis in US patients with selected metastatic cancers and chemotherapy-induced febrile neutropenia (FN) incidence and associated outcomes among the subgroup who did not receive prophylaxis. Methods This retrospective cohort study was conducted at four US health s...

PURPOSE Temporary COVID-19 guideline recommendations have recently been issued to expand the use of colony-stimulating factors in patients with cancer with intermediate to high risk for febrile neutropenia (FN). We evaluated the cost-effectiveness of primary prophylaxis (PP) with biosimilar filgrastim-sndz in patients with intermediate risk of FN c...

Outcomes for patients (pts) with sarcoma and COVID-19 are unknown. This is a single institution retrospective study of adults with sarcoma and COVID-19. Ten pts [median age 60 (range 24-69)] were identified. Five were hospitalized; two died from COVID-19 complications; another died from sarcoma. Time between last systemic treatment dose and COVID-1...

Background Patients with cancer may be at high risk of adverse outcomes from SARS-CoV-2 infection. We analyzed a cohort of patients with cancer and COVID-19 reported to the COVID-19 and Cancer Consortium (CCC19) to identify prognostic clinical factors, including laboratory measurements and anti-cancer therapies. Patients and Methods Patients with...

Every year, significant amounts of expensive injectable or infused drugs, distributed in single-dose vials, are discarded in the United States. This is due in part to the increasing number of drugs that are administered in variable doses based on a patient’s weight or body surface area. Sharing medication from single-dose vials among patients is ge...