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Articles by Gary Lyman
Heterogeneity and Utility of Pharmaceutical Company Sharing of Individual-Participant Data Packages
Key Points Question What is the utility and completeness of individual-participant data (IPD) and supporting documents provided from industry-sponsored clinical trials through data transparency processes? Findings In this quality improvement study, IPD packages were received from 70 of 91 eligible clinical oncology trials (77%) for a planned meta-analysis.
Use of Biosimilar Medications in Oncology
Advances in cancer care have been accompanied by rising health care costs. Strategies to lower the overall cost of expensive oncology pharmaceuticals and cost-containment approaches have been prioritized in the United States and around the world, leading to the development of biosimilars.
Medications in Single-Dose Vials and Implications of Discarded Injectable Drugs: A National Academies Report
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 generally prohibited or severely restricted; accordingly, the unused drug amount will typically be discarded.
Aligning Cancer Clinical Trials With Cancer Burden
Despite tremendous progress in cancer treatment and prevention made over the past few decades, the global cancer burden is estimated to exceed 29 million new diagnoses annually by 2040, along with more than 16 million cancer-related deaths.1 The worldwide rise of cancer burden will continue to disproportionately affect low- and middle-income countries (LMICs), where the proportion of global deaths is projected to increase from 65% in 2012 to 75% by 2030.2 Alignment between clinical trial...
Association of Generic Imatinib Availability and Pricing With Trends in Tyrosine Kinase Inhibitor Use
The increasing price of new cancer therapies over the past 3 decades has contributed considerably to increasing health care expenditures.
Health Care Cost Associated With Contemporary Chronic Myelogenous Leukemia Therapy Compared With That of Other Hematologic Malignancies
Article Tools ORIGINAL CONTRIBUTIONS Care Delivery Jennifer J. Wilkes, MD, MSCE1,2,3; Gary H. Lyman, MD, MPH4,5; David R. Doody, MS4; Shasank Chennupati, PharmD, MPH4; Laura K. Becker, MS3; Pamela E. Morin, MBA3; Lena E. Winestone, MD, MSHP6; Henry J. Henk, PhD3; and Eric J.
Health Care Cost Associated With Contemporary Chronic Myelogenous Leukemia Therapy Compared With That of Other Hematologic Malignancies
PURPOSE: Given the widespread introduction of tyrosine kinase inhibitors (TKIs), we evaluated the cost associated with chronic myelogenous leukemia (CML) care compared with the cost of care for patients with hematologic malignancies (HEM) and for patients without cancer (GEN), to aid with resource allocation and clinical decision making.
Health Care Cost Associated With Contemporary Chronic Myelogenous Leukemia Therapy Compared With That of Other Hematologic Malignancies
PURPOSE: Given the widespread introduction of tyrosine kinase inhibitors (TKIs), we evaluated the cost associated with chronic myelogenous leukemia (CML) care compared with the cost of care for patients with hematologic malignancies (HEM) and for patients without cancer (GEN), to aid with resource allocation and clinical decision making.
Crowdsourcing in Crisis: Rising to the Occasion
Amid the global, ongoing COVID-19 pandemic, among the tireless work of health care workers, policy makers, and government officials across various nations, there is another player with “skin in the game” if you will—crowdsourcing projects.
Crowdsourcing in Crisis: Rising to the Occasion
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Importance of comparative effectiveness research to the future of healthcare evaluation and delivery
Q Could you tell our readers a little about your career to date & how you came to your current role? My current position is that of a Co-Director of the Hutchinson Institute for Cancer Outcomes Research (HICOR) in the Division of Public Health Sciences at the Fred Hutchinson Cancer Research Center in Seattle where I also hold faculty appointments in Medicine, Public Health and Pharmacy at the University of Washington.
Economic Evaluation of Chimeric Antigen Receptor T-Cell Therapy by Site of Care Among Patients With Relapsed or Refractory Large B-Cell Lymphoma
Key Points español 中文 (chinese) Question Is the cost of chimeric antigen receptor T-cell therapy administration associated with the site of care and the safety profile of the therapy? Findings In this economic evaluation, a decision-tree model was used to document the clinical outcomes and costs of chimeric antigen receptor T-cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.
The Evolving Biosimilars Revolution in Oncology: Why Interest in Biosimilars, Requirements for Biosimilarity & Concept of Extrapolation
The Evolving Biosimilars Revolution in Oncology: Why Interest in Biosimilars, Requirements for Biosimilarity & Concept of Extrapolation
Concept of Product Variability and Drift in Biologics and Biosimilars, Interchangeability and Substitution & FDA-Approved Biosimilars
Concept of Product Variability and Drift in Biologics and Biosimilars, Interchangeability and Substitution & FDA-Approved Biosimilars
Letter in reply | Journal of Comparative Effectiveness Research
We appreciate the comments from Hannouf et al. that allow for elaboration on the analyses and implications. Several queries concern the incidence of distant recurrence among women not prescribed chemotherapy, clinically referred to as prognosis. Across multiple large-cohort studies and control arms of clinical trials of chemotherapy, the average 10-year incidence of distant recurrence in node-negative tumors for all women receiving endocrine therapy varies between 6.4 and 14.8% [].
Proposal for Value-Based, Tiered Reimbursement for Tumor Biomarker Tests to Promote Innovation and Evidence Generation
Cancer precision medicine depends on high-quality tumor biomarker tests (TBTs) for treatment selection. TBT reimbursement within the United States in the current regulatory environment is not tied to premarket evidence of clinical utility, resulting in a vicious cycle wherein low-level evidence of utility leads to poor reimbursement, thereby impeding investment in developing new, clinically valuable TBTs supported by high-level evidence.
Incidence and Predictors of Low Dose-Intensity in Adjuvant Breast Cancer Chemotherapy: A Nationwide Study of Community Practices
Purpose: This retrospective study was undertaken to assess practice patterns in adjuvant chemotherapy for early-stage breast cancer (ESBC) and to define the incidence and predictive factors of reduced relative dose-intensity (RDI). Patients and Methods: A nationwide survey of 1,243 community oncology practices was conducted, with data extracted from records of 20,799 ESBC patients treated with adjuvant chemotherapy.
Availability of Experimental Therapy Outside Oncology Randomized Clinical Trials in the United States
DOI: 10.1200/JCO.2010.28.6567 Journal of Clinical Oncology 28, no. 34 (December 1 2010) 5067-5073. Published online October 25, 2010. PMID: 20975070
Acute Myeloid Leukemia or Myelodysplastic Syndrome in Randomized Controlled Clinical Trials of Cancer Chemotherapy With Granulocyte Colony-Stimulating Factor: A Systematic Review
Randomized controlled trials (RCTs) of recombinant granulocyte colony-stimulating factors (G-CSF) in patients receiving cancer chemotherapy have demonstrated efficacy in reducing the severity and duration of neutropenia, the risk of febrile neutropenia, and infection-related mortality while enabling an increase in delivered chemotherapy dose-intensity.1,2 There have been several meta-analyses of the myeloid growth factors in both adults and children.3–5 These studies have consistently...
Evaluation and Regulation of Oncology Drug Approval
In 2015, the US Food and Drug Administration (FDA) approved 18 new drugs and biologic agents in the treatment of cancer and added nearly as many new indications or formulations to existing drug labels. Recent surveys1,2 have demonstrated that oncology drugs are more likely and rapidly approved in the United States than in either Europe or Canada.
American Society of Clinical Oncology Statement: Biosimilars in Oncology
Despite considerable advances in cancer care, rising health care costs have prompted the need for cost-containment strategies.1 This is especially true with regard to new oncology pharmaceuticals—eight of the 10 most expensive drugs on the market are cancer drugs. Since the enactment of the Biologics Price Competition and Innovation Act (BPCIA) in 2010, biosimilars have been developed and marketed as competitive, lower-cost alternatives to newer biologic treatments.
Aiming to reduce the risk for venous thromboembolism
From the Lyman Group, Divisions of Public Health Sciences and Clinical Research April 15, 2019 Venous thromboembolism (VTE) is a major cause of morbidity and mortality worldwide. In the United States alone, it is estimated to be responsible for up to 100,000 deaths each year. While there are several known risk factors for VTE, cancer and related treatments may confer the greatest risk. Indeed, thrombosis is a leading cause of death in cancer patients.
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Association of Leukemia With Radium Groundwater Contamination
Abstract Radiation exposure, including the ingestion of radium, has been causally associated with leukemia in man. Groundwater samples from 27 counties on or near Florida phosphate lands were found to exceed 5 pCi/L total radium in 12.4% of measurements. The incidence of leukemia was greater in those counties with high levels of radium contamination (>10% of the samples contaminated) than in those with low levels of contamination.
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Multi-gene assays: effect on chemotherapy use, toxicity and cost in estrogen receptor-positive early stage breast cancer
The conventional approach to selecting adjuvant chemotherapy for women with estrogen receptor-positive (ER+) early stage breast cancer is to consider tumor size (pT1-pT3, >0.5 cm), nodal status (pN0 or pN1mi) and results of a multi-gene assay (MGA) [1,2].
FDA breakthrough therapy designation not associated with improved novelty, safety, efficacy
Receive an email when new articles are posted on this topic . Please provide your email address to receive an email when new articles are posted on this topic . A “breakthrough” designation led to faster FDA approval for new medications, although these agents did not show improved safety, novelty or efficacy compared with nonbreakthrough agents, study data showed. “In July 2012, Congress established the breakthrough therapy program to expedite the development and review of new medicines,” Aaron S.
Integrative Therapies During and After Breast Cancer Treatment: ASCO Endorsement of the SIO Clinical Practice Guideline
Integrative oncology coordinates the delivery of evidence-based complementary therapies with conventional cancer care.1 Complementary therapies encompass a broad range of mind and body practices, natural products, and lifestyle modifications, and are commonly used by patients with breast cancer and survivors of breast cancer.2-4 Although evidence remains limited for many of these therapies, a growing number of well-conducted randomized controlled trials suggests that selected therapies may...
Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety
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Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety | Journal of Clinical Oncology
Since 1992, the US Food and Drug Administration (FDA) has implemented several programs for streamlined review and approval of agents that treat serious or life-threatening conditions, including the Accelerated Approval Pathway as well as designations for Priority-Review, Fast-Track, and Breakthrough Therapies.1-3 Accelerated approval is based on surrogate end points considered to have a reasonable likelihood of leading to overall clinical benefit, and it is conditional on confirmatory...
Evolving Landscape of US Food and Drug Administration Drug Approval in the Era of Precision Oncology: Finding the Right Balance Between Access and Safety: Journal of Clinical Oncology: Vol 0, No 0
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American Society of Clinical Oncology Statement: Biosimilars in Oncology
As many biosimilars come to market in the next several years, their use in oncology will play an important role in the future care of patients with cancer.
A stakeholder-informed randomized, controlled comparative effectiveness study of an order prescribing intervention to improve colony stimulating factor use for cancer patients receiving myelosuppressive chemotherapy: the TrACER study | Journal of Comparat
Research reported in this manuscript was partially funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (PCS-1402-09988) and through the National Cancer Institute (5U10 CA180819-03 and 5UG1CA189974). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Biosimilars in the Changing Cancer Care Landscape
The rapid increase in health care costs—most notably in cancer care and the price of cancer drugs in the United States—has prompted increasing consideration of strategies for containing the cost of cancer care.
Comparison of 2 Commercially Available Next-Generation Sequencing Platforms in Oncology
Research Letter July 2017 JAMA Oncol. 2017;3(7):996-998. doi:10.1001/jamaoncol.2016.4983 The growing use of next generation-sequencing to identify cancer-associated alterations as well as the increasing number of targeted drugs holds promise for better matching patients with cancer with effective therapies. The FoundationOne (F1; Foundation Medicine) test sequences clinical tumor samples to characterize the exons of 315 cancer-associated genes and introns from 28 genes involved in rearrangements.
Selection of Optimal Adjuvant Chemotherapy Regimens for Human Epidermal Growth Factor Receptor 2 (HER2) -Negative and Adjuvant Targeted Therapy for HER2-Positive Breast Cancers: An American Society of Clinical Oncology Guideline Adaptation of the Cancer C
Purpose A Cancer Care Ontario (CCO) guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer including adjuvant targeted therapy for human epidermal growth factor receptor 2 (HER2)–positive breast cancers was identified for adaptation. Methods The American Society of Clinical Oncology (ASCO) has a policy and set of procedures for adapting clinical practice guidelines developed by other organizations.
Biomarker Tests for Molecularly Targeted Therapies: Laying the Foundation and Fulfilling the Dream
Precision medicine focuses on the management of individual patients on the basis of biomarkers and other distinguishing characteristics, with the overarching objective of improving clinical outcomes. The rapid proliferation of biomarker tests and targeted therapies has revolutionized patient care in a variety of serious disorders. Targeted cancer therapies interrupt oncogenic molecular pathways driven by mutations, overexpression, or translocation of specific genes.
Biomarker Tests for Molecularly Targeted Therapies - The Key to Unlocking Precision Medicine
As the promise and the pitfalls of precision medicine gain increasing attention,1,2 enthusiasm about the field has been heightened by a rapid reduction in the cost of high-throughput genomic sequencing and a dramatic increase in the identification of potential molecular targets for therapy. Biomarker tests for molecularly targeted therapies can help physicians to select the most effective therapy for a patient’s condition and avoid treatments that could be ineffective or harmful.
Evaluation and Regulation of Oncology Drug Approval: Finding the Right Balance
The American Medical Association is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. The AMA designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 CreditTM per course. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Oncologist speaks out on human toll of high health care costs
Dr. Gary Lyman is co-director of the Hutchinson Institute for Cancer Outcomes Research, which is working to reduce the economic and human burden of cancer for patients, families and society. A breast cancer oncologist, Lyman has had patients end treatment – and die – because of the devastatingly high cost of cancer care. "That tears at you," he said. Photo by Robert Hood / Fred Hutch News Service COMMENTARY When I was 12, my father died of a cancer-like condition called aplastic anemia.
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