Reassessments of ESAs for Cancer Treatment in the US and Europe
Anemia is a widely prevalent complication among cancer patients. At the time of diagnosis, 30% to 40% of patients with non-Hodgkin lymphoma or Hodgkin lymphoma and up to 70% of patients with multiple myeloma are anemic; rates are higher among persons with myelodysplastic syndromes. Among patients with solid cancers or lymphomas, up to half develop anemia following chemotherapy. For almost 2 decades, erythropoiesis-stimulating agents (ESAs) were the primary treatment for cancer-related anemia. However, reassessments of benefits and risks of ESAs for cancer-associated anemia have occurred internationally. We reviewed guidelines and notifications from regulatory agencies and manufacturers, reimbursement policies, and utilization for ESAs in the cancer and chronic kidney disease settings within the United States, Europe, and Canada. In 2008 the US Food and Drug Administration (FDA) restricted ESAs from cancer patients seeking cure. Reimbursement is limited to hemoglobin levels < 10 g/dL. In the United States, ESA usage increased 340% between 2001 and 2006, and decreased 60% since 2007. The European Medicines Agency (EMEA) recommended that ESA benefits do not outweigh risks. In Europe between 2001 and 2006, ESA use increased 51%; since 2006, use decreased by 10%. In 2009, Canadian manufacturers recommended usage based on patient preferences. In Canada in 2007, approximately 20% of anemic cancer patients received ESAs, a 20% increase since 2004. In contrast to Europe, where ESA use has increased over time, reassessments of ESA-associated safety concerns in the United States have resulted in marked decrements in ESA use among cancer patients.
Oncologic drug safety: Separating fact from fiction
August 1st 2008Annually, adverse drug reactions (ADRs) result in costs of $3.6 billion and 140,000 deaths.1 Yet in 2005, only 15,107 reports of fatalities linked to potential drug toxicity were reported to the US Food and Drug Administration.2 This low number suggests that, despite significant morbidity and morality, ADRs remain underappreciated by clinicians. This is particularly troublesome when it comes to ADRs associated with oncology drugs.
Dermatologic Challenges in Cancer Patients and Survivors
November 1st 2007The increased approval of anticancer agents has led to unprecedented results, with improved quality of life and longer survival times, resulting in millions of individuals living with a diagnosis of cancer. Whereas these novel medical, surgical, and radiation regimens, or combinations thereof, are largely responsible for these remarkable achievements, a new, unexpected constellation of side effects has emerged. Most notably, cutaneous toxicities have gained considerable attention, due to their high frequency and visibility, the relative effectiveness of anti–skin toxicity interventions, and the otherwise decreasing incidence of systemic or hematopoietic adverse events. Optimal care dictates that dermatologic toxicities must be addressed in a timely and effective fashion, in order to minimize associated physical and psychosocial discomfort, and to ensure consistent antineoplastic therapy. Notwithstanding the critical importance of treatment-related toxicities, dermatologic conditions may also precede, coincide, or follow the diagnosis of cancer. This review provides a basis for the understanding of dermatologic events in the oncology setting, in order to promote attentive care to cutaneous health in cancer patients and survivors.
Cost Considerations in the Management of Cancer in the Older Patient
This paper provides an overview of several prominent articles and empirical studies on supportive care and cancer-related costs faced by older cancer patients. It focuses primarily on individuals 65 years of age and over and reviews several types of cancer.
Prostate Cancer 2004: Insights From National Disease Registries
September 1st 2004In their article, Drs. Matthew Cooperberg,Sangtae Park, and PeterCarroll summarize four nationalregistries that have studied risk migration,practice patterns, outcomepredictions, and quality-of-life outcomesin prostate cancer. Each of thesefour large registries-the Prostate CancerOutcomes Study (PCOS), the Departmentof Defense Center for ProstateDisease Research (CPDR), the Cancerof the Prostate Strategic Urologic ResearchEndeavor (CaPSURE), and theShared Equal Access Regional CancerHospital (SEARCH)-has a particularstrength that complements theothers. As more patients enroll in theseregistries, researchers will gain greaterinsight into the patterns of care andclinical and health-related quality oflife for diverse cohorts of prostate cancerpatients.
Evaluating the Total Costs of Cancer
January 1st 2003The Northwestern University Costs of Cancer Program consists ofa series of pilot studies that address the costs of cancer care. Theprogram is designed to serve as a template in preparation for undertakinga large-scale study of a nationally representative sample of cancerpatients-ie, in preparation for a cancer costs and services utilizationstudy in the future. In this article, we outline the theoretical frameworkassociated with a study of cancer costs and summarize findings fromour ongoing pilot studies in this area.
Unsafe Blood Still Found in Some Developing Countries
November 1st 2002During the HIV epidemic in the 1980s, more than half of the hemophiliac patients living in many countries, including the United States, France, Denmark, and Japan, became infected with HIV as a result of blood transfusions with contaminated blood or blood products.[1,2] Since the clotting factor needed to treat hemophiliacs was manufactured by pooling plasma from thousands of donors, even one HIV-infected donor could contaminate the entire supply, infecting hundreds.
Tools Help Prostate Cancer Patients Participate in Decision
September 1st 2002With no clearly superior treatment for localized prostate cancer, physicians and patients would like to increase patient participation in the decision-making process. Unfortunately, physicians frequently have difficulty understanding patients’ preferences, and patients often do not have sufficient knowledge to make an informed treatment decision. Shared- decision-making tools, such as decision analyses, may increase patient participation and thereby improve physicians’ understanding of their patients’ views.
Helping Low-Literacy Prostate Cancer Patients Choose Rx
July 1st 2002Prostate cancer represents the most common neoplasm and second leading cause of cancer mortality among men in the United States. There are 189,000 new cases of prostate cancer and 32,000 deaths resulting from prostate cancer expected in 2002.[1]
Hairy Cell Leukemia Diagnosis Affects Finances, Lifestyle
May 1st 2002While patients who are cured from cancer can expect to lead long and productive lives, we do not know the extent to which a diagnosis of cancer affects employability, insurability, and lifestyle of individuals with long-term survival.
HBV Vaccination Program Reduces Liver Cancer in Taiwan
April 1st 2002Although liver cancer has a relatively low incidence in the United States, compared with other cancers, it is 10 times more common in many developing countries than in this country.[1] The incidence of liver cancer is highest in sub-Saharan Africa, China, southern Asia, and Japan.[2]
Assessing the Total Cost of Chemotherapy-Induced Toxicities
March 1st 2002Chemotherapy-induced toxicities often adversely affect patients’ health and treatment plans, and can result in large costs for treatment and care. In addition to the costs associated with direct medical care, a large amount of indirect and out-of-pocket costs can be incurred.
National Cancer Prevention Campaign Discussed
February 1st 2002In this second portion of a two-part interview, Linda L. Emanuel, MD, PhD, discusses the future of bioethics. Part I highlighted end-of-life care and physician-assisted suicide, while part II focuses on organizational ethics and future issues in bioethics.
The Future of Bioethics: A Talk With Dr. Linda Emanuel
January 1st 2002In this article (the first of a two-part interview), Linda L. Emanuel, MD, PhD, discusses bioethics. Part I highlights end-of-life care and physician-assisted suicide, while part II, which will appear in an upcoming issue of ONI, focuses on organizational ethics and future issues in bioethics.
Uncertainty in Medicine: A Talk With Dr. Djulbegovic
November 1st 2001In this article (the first of a two-part interview), Benjamin Djulbegovic, MD, PhD, discusses the uncertainty principle in clinical trials, a subject he has written about in The Lancet and elsewhere. Dr. Djulbegovic is associate professor of medicine, Divisions of Blood and Marrow Transplantation, H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa.
Access to Care and Quality of Care ‘Inseparable’ Concepts
July 1st 2001CHICAGO-The Institute of Medicine (IOM) defines health care access as "timely use of affordable, continuous, quality health services which are sensitive to individual needs in order to achieve the best possible health outcomes," Jeanne Mandelblatt, MD, MPH, PhD, said at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University’s annual Health Policy Symposium.
Bridging a Cultural Divide: Cross-cultural Issues in Cancer Care
April 1st 2001This article is the last in a series focusing on ethical issues in cancer care, prepared by researchers at Northwestern University. The articles highlight selected ethical issues, place the issues in the context of relevant literature, and comment on their significance in oncology practice. These issues are discussed in greater depth in Ethical Issues in Cancer Care (Kluwer, 1999).
Communication: From Paternalism to Shared Decision Making
February 1st 2001Physicians who diagnose and treat cancer have an enormous responsibility. They not only have to be aware of the medical aspects of cancer screening, diagnosis, and treatment, but also have the difficult task of talking about these issues with their patients.
Exploring the Hidden Financial Burden of Cancer Therapy
January 1st 2001Approaches to cancer treatment have rapidly grown complex and costly, causing heightened awareness among patients, physicians, employers, and insurance providers. Annual costs for cancer are about $107 billion, accounting for 20% of all health care costs.[1]
Poor Reading Skills Present Barrier to Cancer Care and Health
November 1st 2000Technological ad-vances in cancer prevention and therapy have dramatically reduced cancer mortality, yet literacy continues to be a formidable obstacle to the treatment and prevention of cancer. Patients with low literacy skills who are unable to read and comprehend medical information vital to their health cannot take advantage of these innovative early detection programs and treatments.
Improving Minority Access to Genetic Counseling for Cancer Risk
October 1st 2000The Second Annual Robert H. Lurie Comprehensive Cancer Center Health Policy Symposium, held last year in Chicago, was entitled “Cancer, Reaching Medically Underserved Populations: Low Literacy and Culturally Specific Barriers.”This is the fourth in a series of reports on the conference presentations, prepared for ONI by researchers at Northwestern Medical School, that will put the discussions into a broader context. This month’s article reviews a presentation by Chanita Hughes, PhD, Georgetown University Medical Center, Lombardi Cancer Center, Washington, DC.