Abstract:Erythropoiesis‐stimulating agents (ESAs) are available to treat chemotherapy‐induced anemia (CIA). In 2007–2008, regulatory notifications advised of venous thromboembolism and mortality risks while the Center for Medicare and Medicaid Services' restricted ESA initiation to patients with hemoglobin <10 g/dl. In 2010, a Risk Evaluation and Mitigation Strategies required consent prior to administration. We evaluated ESA utilization from 2003 to 2012 and obtained private health insurer claims data for persons with… Show more
“…Our study contradicts with results from a study by Schoen et al that uses the IMS LifeLink™ Health Plan Claims Database, which is composed of commercial health plan information [56]. They found that odds of receiving epoetin decreased after risk communications and REMS, but initially increased for darbepoetin after box warnings were disseminated.…”
Erythropoisis stimulating agent (ESA) use was addressed in Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings between 2004 and 2008. FDA safety-focused regulatory actions occurred in 2007 and 2008. In 2007, black box warnings advised of early death and venous thromboembolism (VTE) risks with ESAs in oncology. In 2010, a Risk Evaluation Strategies (REMS) was initiated, with cancer patient consent that mortality and VTE risks were noted with ESAs. We report warnings and REMS impacts on ESA utilization among Veterans Administration (VA) cancer patients with chemotherapyinduced anemia (CIA). Data were from Veterans Affairs database (2003-2012). Epoetin and darbepoetin use were primary outcomes. Segmented linear regression was used to estimate changes in ESA use levels and trends, clinical appropriateness, and adverse events (VTEs) among chemotherapy-treated cancer patients. To estimate changes in level of drug prescription rate after policy actions, model-specific indicator variables as covariates based on specific actions were included. ESA use fell by 95% and 90% from 2005, for epoetin and darbepoetin, from 22% and 11%, respectively, to 1% and 1%, respectively, among cancer patients with CIA, respectively (p<0.01). Following REMS in 2010, mean hematocrit levels at ESA initiation decreased from 30% to 21% (p<0.01). Black box warnings preceded decreased ESA use among VA cancer patients with CIA. REMS was followed by reduced hematocrit levels at ESA initiation. Our findings contrast with privately-insured and Medicaid
“…Our study contradicts with results from a study by Schoen et al that uses the IMS LifeLink™ Health Plan Claims Database, which is composed of commercial health plan information [56]. They found that odds of receiving epoetin decreased after risk communications and REMS, but initially increased for darbepoetin after box warnings were disseminated.…”
Erythropoisis stimulating agent (ESA) use was addressed in Food and Drug Administration (FDA) Oncology Drug Advisory Committee (ODAC) meetings between 2004 and 2008. FDA safety-focused regulatory actions occurred in 2007 and 2008. In 2007, black box warnings advised of early death and venous thromboembolism (VTE) risks with ESAs in oncology. In 2010, a Risk Evaluation Strategies (REMS) was initiated, with cancer patient consent that mortality and VTE risks were noted with ESAs. We report warnings and REMS impacts on ESA utilization among Veterans Administration (VA) cancer patients with chemotherapyinduced anemia (CIA). Data were from Veterans Affairs database (2003-2012). Epoetin and darbepoetin use were primary outcomes. Segmented linear regression was used to estimate changes in ESA use levels and trends, clinical appropriateness, and adverse events (VTEs) among chemotherapy-treated cancer patients. To estimate changes in level of drug prescription rate after policy actions, model-specific indicator variables as covariates based on specific actions were included. ESA use fell by 95% and 90% from 2005, for epoetin and darbepoetin, from 22% and 11%, respectively, to 1% and 1%, respectively, among cancer patients with CIA, respectively (p<0.01). Following REMS in 2010, mean hematocrit levels at ESA initiation decreased from 30% to 21% (p<0.01). Black box warnings preceded decreased ESA use among VA cancer patients with CIA. REMS was followed by reduced hematocrit levels at ESA initiation. Our findings contrast with privately-insured and Medicaid
“…Table 4 summarizes the most common complications observed with these therapeutic modalities and the current standards for their management. 90,91,110,[115][116][117][118][119][120][121][122][123][124][125][126][127][128][129][130][131][132] Targeted Therapeutic-Related Complications Targeted therapies represent the subclass of antineoplastic agents deliberately engineered to interfere with oncogenic signal transduction pathways and are divided into smallmolecule inhibitors, monoclonal antibody-based pharmaceuticals, and cell-based agents. In general, targeted agents are less toxic than nonspecific cytotoxic chemotherapeutics; however, because many agents require long-term use, both acute and chronic treatment-related toxicities should be considered (Fig.…”
Section: Table 3 (Continued)mentioning
confidence: 99%
“…• Erythropoiesis-stimulating agents are no longer indicated for cancer-related anemia (Schoen 2020 123 ).…”
“…Both IgE‐mediated allergic and anaphylactoid mechanisms are noted. Table 4 summarizes the most common complications observed with these therapeutic modalities and the current standards for their management 90,91,110,115‐132 …”
Section: Cytotoxic Chemotherapy and Radiotherapy Complicationsmentioning
Patients with advanced cancer generate 4 million visits annually to emergency departments (EDs) and other dedicated, high‐acuity oncology urgent care centers. Because of both the increasing complexity of systemic treatments overall and the higher rates of active therapy in the geriatric population, many patients experiencing acute decompensations are frail and acutely ill. This article comprehensively reviews the spectrum of oncologic emergencies and urgencies typically encountered in acute care settings. Presentation, underlying etiology, and up‐to‐date clinical pathways are discussed. Criteria for either a safe discharge to home or a transition of care to the inpatient oncology hospitalist team are emphasized. This review extends beyond familiar conditions such as febrile neutropenia, hypercalcemia, tumor lysis syndrome, malignant spinal cord compression, mechanical bowel obstruction, and breakthrough pain crises to include a broader spectrum of topics encompassing the syndrome of inappropriate antidiuretic hormone secretion, venous thromboembolism and malignant effusions, as well as chemotherapy‐induced mucositis, cardiomyopathy, nausea, vomiting, and diarrhea. Emergent and urgent complications associated with targeted therapeutics, including small molecules, naked and drug‐conjugated monoclonal antibodies, as well as immune checkpoint inhibitors and chimeric antigen receptor T‐cells, are summarized. Finally, strategies for facilitating same‐day direct admission to hospice from the ED are discussed. This article not only can serve as a point‐of‐care reference for the ED physician but also can assist outpatient oncologists as well as inpatient hospitalists in coordinating care around the ED visit.
“…ЭПО способствует образованию эритроцитов из частично детерминированных клеток -предшественников эритропоэза. Профиль его побочных эффектов включает не только АГ, которая встречается практически у 35% пациентов, но и тромбоэмболические осложнения, ограничивающие применение препарата [47,48]. АГ обычно фиксируется через 2-16 недель после начала применения ЭПО [49].…”
Arterial hypertension (AH) is one of the most common cardiovascular complications of anticancer drug therapy. In this review article, we consider the main groups of anticancer drugs that may cause the development of iatrogenic AH, the pathophysiological mechanisms of increased blood pressure, as well as the clinical significance of AH developed during treatment with cytostatics and targeted drugs in the practice of an oncologist and a cardiologist. It was found that AH is frequently associated with the use of angiogenesis inhibitors, as well as alkylating cytostatics, antimetabolites, taxanes, and proteasome inhibitors. In addition, erythropoietins, glucocorticosteroids, and non-steroidal anti-inflammatory drugs used as part of supportive therapy may contribute to an increase in blood pressure. Management of hypertension in cancer patients is an important part of antitumor treatment therapy whose implementation contributes to improving their quality of life. Research into various clinical and pathophysiological aspects of cardiovascular disorders in cancer patients is becoming increasingly relevant, which is indicated by the rapid development of cardio-oncology, a new interdisciplinary field of knowledge aimed at developing practical recommendations for the prevention, diagnosis, and treatment of cardiovascular toxicity caused by anticancer therapy.
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