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Annapolis, MD, United States

Rogstad A.S.,University of Maryland, Baltimore | Meisenberg B.R.,DeCesaris Cancer Institute | McCarthy E.F.,Johns Hopkins Hospital | Streeten E.A.,University of Maryland, Baltimore
Endocrinologist | Year: 2010

Objective: To present an unusual case of high bone mass (HBM) in a patient subsequently diagnosed with metastatic breast cancer. Methods: We describe the clinical presentation of our case and discuss its management. Results: A 41-year-old woman with pancytopenia was referred for HBM. Initial evaluations for malignancy, osteopetrosis II, mastocytosis, hepatitis C, and fluorosis were negative including normal whole body bone scan, mammogram, and 2 iliac crest bone marrow biopsies. Three months after initial presentation, she was hospitalized for abdominal pain, nausea, and vomiting. A CT scan of the abdomen and pelvis revealed diffuse bowel wall thickening and endoscopy showed friable mucosa throughout the GI tract. Pathology showed metastatic lobular breast carcinoma. The patient was treated with chemotherapy and had good responses of tumor markers, GI symptoms, and bone marrow function. Conclusion: Clinicians should be aware of the possibility of occult malignancy as a cause of HBM, even in the absence of the overt findings suggestive of metastatic bone disease. Copyright © 2010 by Lippincott Williams & Wilkins.

Edwards I.R.,Uppsala Monitoring Center | Felix T.,Amgen Inc. | Graze P.R.,DeCesaris Cancer Institute | Litten J.B.,Amgen Inc. | And 2 more authors.
Expert Opinion on Biological Therapy | Year: 2013

Introduction: Biosimilars are biologic medicines that are highly similar to approved biologics, notwithstanding minor differences in clinically inactive components. Since 2007, biosimilars have been approved for use in patients in the European Union (EU) and other regions. European experience provides several lessons as the United States (US) healthcare system prepares for biosimilar approvals. These lessons emphasize the need for adequate efficacy and safety studies, post-marketing surveys and a robust pharmacovigilance system that can accurately track and trace biologics, including biosimilars and their reference products, from the patient to the manufacturer. Areas covered: We review the EU experience with biosimilar pharmacovigilance and discuss the implications for biosimilar pharmacovigilance in the USA. Furthermore, we review several aspects of biosimilar pharmacovigilance, including cohort event monitoring, traceability, biosimilar interchangeability, pharmacovigilance system development, nomenclature and counterfeit tracking. Expert opinion: The availability of biosimilars as lower-cost biologics must carefully consider issues of safety, efficacy and traceability. Stringent pharmacovigilance procedures are required to detect potential differences in safety signals between biosimilars and their reference products. Pharmacovigilance of biologics should include processes that are easily used by prescribing practitioners to ensure that data are consistent and new safety signals are properly reported and assigned to the correct product. © 2013 Informa UK, Ltd.

Bellemare R.H.,DeCesaris Cancer Institute | Cheruserry J.,DeCesaris Cancer Institute | Meisenberg B.,DeCesaris Cancer Institute | Maxted W.C.,DeCesaris Cancer Institute
Journal of Clinical Outcomes Management | Year: 2015

Background: Acute stroke or cerebrovascular accident (CVA) is a common indication for hospitalization and can have devastating consequences, particularly in the setting of recurrence. Cardiac sources are potentially remediable; thus, a transthoracic echocardiogram (TTE) is frequently ordered to evaluate for a cardiac source of embolism. Objective: To evaluate the utility of performing TTE on patients experiencing a CVA or transient ischemic attack (TIA) to evaluate for a cardiac source of embolism. Methods: Retrospective review of TTE reports and patient electronic medical records at Anne Arundel Medical Center, a 385-bed community hospital. Medical charts for all CVA patients receiving a TTE between February 2012 to April 2013 were reviewed for TTEs showing unequivocal cardiac sources of embolism as evaluated by the reviewing cardiologist. Patient information and clinical morbidities were also noted to construct a composite demographic of CVA patients. Results: One TTE of 371 (0.270%) identified a clear cardiac embolus. Risk factors for stroke included hypertension (n = 302), cardiovascular disease (n = 204), cardiomyopathy (n = 131), and diabetes (n = 146). Conclusion: In the setting of stroke, TTE is of limited value when determining the etiology of stroke and should be used provisionally rather than routinely in evaluating patients experiencing CVA or TIA.

Cattaneo S.M.,DeCesaris Cancer Institute | Geronimo M.C.M.,DeCesaris Cancer Institute | Putscher T.M.J.,DeCesaris Cancer Institute | Brady-Copertino C.,DeCesaris Cancer Institute | Meisenberg B.R.,DeCesaris Cancer Institute
Journal of Clinical Outcomes Management | Year: 2014

• Objective: To describe the development and outcomes of a centralized evaluation service for patients with abnormalities on thoracic imaging to allow prompt and standardized review by an experienced multidisciplinary team. • Methods: Patients with abnormal thoracic imaging studies, whether symptom-related or incidental, were referred to a specialized multidisciplinary team by radiologists, primary care physicians, or other providers. Recommendations for immediate or delayed follow-up were made based on professional society guidelines and patient characteristics. Follow-up was maintained within the program with close communication with primary care physicians. • Results: 238 patients were referred over a 27-month period, 227 with abnormal findings on chest imaging. 171 patients (75%) accepted participation in the program. Radiologists were the most frequent referrers. Pulmonary symptoms were present in 74% of cases but were often unrelated to the findings. Patients and primary care physicians were contacted within a median of 2 days after imaging. Lung cancer was eventually diagnosed in 72 patients (32%), 51% with stage IA-IIB, at a median time of 16 days from first imaging. Physician satisfaction with the program was high. • Conclusion: The program provided rapid and evidence-based evaluation and management of patients with thoracic imaging abnormalities, resulting in short time to diagnosis and high referring physician satisfaction.

Meisenberg B.R.,DeCesaris Cancer Institute | Meisenberg B.R.,Anne Arundel Health System Research Institute | Varner A.,DeCesaris Cancer Institute | Ellis E.,U.S. National Cancer Institute | And 4 more authors.
Oncologist | Year: 2015

Background and Purpose. The cost of illness in cancer care and the subsequent distress has attracted scrutiny. Guidelines recommend enhanced discussion of costs, assuming this will reduce both stress and costs. Little is known about patient attitudes about cost considerations influencing treatment decisions. Methods. A convenience-sample survey of patients currently receiving radiation and/or intravenous chemotherapy at an outpatient cancer center was performed. Assessments included prevalence and extent of financial burden, level of financial distress, attitudes about using costs to influence treatment decisions, and frequency or desirability of cost discussions with oncologists. Results. A total of 132 participants (94%) responded. Overall, 47% reported high financial stress, 30.8% felt well informed about costs prior to treatment, and 71% rarely spoke to their oncologists about cost. More than 71% of patients did not want either society’s or personal costs to influence treatment, and this result did not change based on degree of financial stress. Even when asked to assume that lower cost regimens were equally effective, only 28% would definitely want the lower cost regimen. Patients did not believe it was the oncologist’s duty to perform cost discussions. Conclusion. Even insured patients have a high degree of financial distress. Most, including those with the highest levels of distress, did not speak often with oncologists about costs and were strongly adverse to having cost considerations influence choice of regimen. The findings suggest that patients are not cost sensitive with regard to treatment decisions. Oncologists will require improved tools to have meaningful cost discussion, as recommended by the American Society of Clinical Oncology. Implications for Practice: This study raises important questions regarding optimal communication with patients about costs. If patients are not cost sensitive regarding treatment decisions, they will not be full partners in the desire to reduce financial burden and financial distress by lowering costs. Better patient educational tools are needed to help increase not just cost awareness but also awareness of value. To master this mode of discourse and to help ease patients’ financial toxicity, oncologists will need to master a new set of data and develop new skills. This new knowledge and proficiency are as vital to good oncology care as all other clinical acumen. © AlphaMed Press 2015.

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