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Patel S.,University of Washington | Meisenberg B.,DeCesaris Cancer Institute | Flannery T.,Princeton Radiation Oncology | Patel A.,Abington Memorial Hospital | And 3 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2012

Purpose: The new standard treatment of glioblastoma multiforme is concurrent radiotherapy (RT) and temozolomide. The proliferation of high-grade gliomas might be partly dependent on protein kinase C-mediated pathways. Tamoxifen has been shown in vitro to inhibit protein kinase C through estrogen receptor-independent antineoplastic effects. This Phase I trial was designed to determine the maximal tolerated dose (MTD) of tamoxifen when given with temozolomide and concurrent RT to patients with high-grade gliomas. Methods and Materials: A total of 17 consecutive patients in four cohorts with World Health Organization Grade 3 (n = 2) and 4 (n = 15) gliomas were given tamoxifen twice daily during 6 weeks of concurrent RT and temozolomide. Eligibility included histologic diagnosis, age >18 years old, Karnofsky performance status ≥60, and no previous brain RT or chemotherapy. The starting dose was 50 mg/m 2 divided twice daily. If no dose-limiting toxicities (DLTs) occurred in 3 patients, the dose was escalated in 25-mg/m 2 increments until the MTD was reached. When ≥2 patients within a cohort experienced a DLT, the MTD had been exceeded. Temozolomide was given with RT at 75 mg/m 2. A dose of 60 Gy in 2 Gy/d fractions to a partial brain field was delivered. Results: A total of 6 patients in Cohort 4 had received tamoxifen at 125 mg/m 2. One patient was excluded, and the fourth patient developed Grade 4 thrombocytopenia (DLT). Thus, 3 more patients needed to be enrolled. A deep venous thrombosis (DLT) occurred in the sixth patient. Thus, the MTD was 100 mg/m 2. Conclusions: The MTD of tamoxifen was 100 mg/m 2 when given concurrently with temozolomide 75 mg/m 2 and RT. Tamoxifen might have a role in the initial treatment of high-grade gliomas and should be studied in future Phase II trials building on the newly established platform of concurrent chemoradiotherapy. © 2012 Elsevier Inc.


Casadevall N.,Hopital Saint Antoine | Edwards I.R.,Uppsala Monitoring Center | Felix T.,Amgen Inc. | Graze P.R.,DeCesaris Cancer Institute | And 3 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.


Milburn M.,University of Maryland Baltimore County | Rosman M.,DeCesaris Cancer Institute | Mylander C.,DeCesaris Cancer Institute | Tafra L.,DeCesaris Cancer Institute
Breast Journal | Year: 2013

Oncotype DX has been criticized for not providing significantly more prognostic information than histopathologic analysis. Oncotype DX was validated in cohorts that included poor prognostic factors (HER2-positive, low-estrogen receptor [ER] expression), raising the question: if patients with known high recurrence rates are excluded, is the Recurrence Score (RS) still valid? Our purpose was to determine if RS can be predicted with readily available measures. One hundred and twenty samples from August 2006 to November 2010 that underwent Oncotype DX testing were analyzed. Data included RS, ER, progesterone receptor (PR), HER2, and Ki67 status by immunohistochemistry (IHC). IHC data were used to create two linear regression models to predict RS. SAS's JMP-7 was used for statistical analysis. When comparing Oncotype DX- and IHC-derived ER and PR values, there were 21 discordant samples. The linear regression model PRS-F created with IHC data (ER, PR, HER2, Ki67) from all samples (n = 120) had an adjusted R2 = 0.60 indicating a good model for predicting RS. The PRS-R model was built without low-ER and HER2-positive samples (n = 110). It had an adjusted R2 = 0.38 indicating poor prediction of RS. Oncotype DX data showed good concordance with IHC for ER- and PR-expression in this cohort. Low-ER samples had high RS. After removing low-ER and HER2-positives, calculating RS with PRS-R from remaining data showed poor predictive power for RS (adjusted R2 = 0.38). This result questions whether RS is prognostic in this subgroup (who would most benefit from further clarification of recurrence risk) and independent of pathology, or is simply producing random RS values. Data bases available to Genomic Health can resolve this issue. © 2013 Wiley Periodicals, Inc.


Hahn E.,DeCesaris Cancer Institute | Brady-Copertino C.J.,DeCesaris Cancer Institute | Meisenberg B.R.,DeCesaris Cancer Institute
Journal of Community and Supportive Oncology | Year: 2015

Background There is increased interest among oncology and palliative professionals in providing appropriately timed hospice services for cancer patients. End of life (EoL) metrics have been included in oncology quality programs, but accurate EoL data and benchmarks are hard to obtain. Objective To improve EoL care by measuring patterns of care among recently deceased patients. Methods Care utilization among deceased patients was analyzed by using software integrated with patient electronic health records. The data was verified by chart review. Results Of 179 cancer deaths, tumor registry data differed from chart review in 7% of cases with regard to dates and/or location of death. Institutional EoL metrics were significantly affected by a large number of patients (37%) with advanced illnesses who had clinical diagnoses of cancer made at the end of life, but who had not been managed by oncologists. This population of patients who had not been managed by oncologists was older, less likely to use hospice, and more likely to use the intensive care unit than were oncologist-managed cancer patients. Among the patients of individual oncologists, the median stay in hospice ranged from 6-28 days. Data collection and chart review took an average of 27 minutes per case with combined efforts by a data analyst and oncology practitioner. Limitations Single institution with comprehensive electronic medical record; some patients were treated outside of the system. Conclusion Acquiring accurate data on EoL metrics is time consuming. Compared with chart review, other data sources have inaccuracies and include some patients who have not been managed by oncologists. Accurate attribution to individual physicians requires chart review by an experienced clinician. © 2015 Frontline Medical Communications.


Meisenberg B.R.,DeCesaris Cancer Institute | Hahn E.,DeCesaris Cancer Institute | Binner M.,DeCesaris Cancer Institute | Weng D.,DeCesaris Cancer Institute
Journal of Oncology Practice | Year: 2016

Purpose Hospital readmissions are often cited as a marker of poor quality of care. Limited data suggest some readmissions may be preventable depending upon definitions and available outpatient support. Methods General criteria to define preventable and not preventable admissions were developed before data collection began. The records of sequential nonsurgical oncology readmissions were reviewed independently by two reviewers. When the reviewers disagreed about assigning admissions as preventable or not preventable, a third reviewer was the tie breaker. The reasons for assigning admissions as preventable or not preventable were analyzed. Results Seventy-two readmissions occurring among 69 patients were analyzed. The first two reviewers agreed that 18 (25%) of 72 were preventable and that 29 (40%) of 72 were not. A third reviewer found four of the split 25 cases to be preventable; therefore, the consensus preventability rate was 22 (31%) of 72. The most common causes of preventability were overwhelming symptoms in patients who qualified for hospice but were not participating in hospice and insufficient communication between patients and the care team about symptom burden. The most common reason for assignment of a not preventable admission was a high symptom burden among patients without strong indications for hospice or for whom aggressive outpatient management was inadequate. The median survival after readmission was 72 days. Conclusion A substantial proportion of oncology readmissions could be prevented with better anticipation of symptoms in high-risk ambulatory patients and enhanced communication about symptom burden between patients and physicians before an escalation that leads to an emergency department visit. Managing symptoms in patients who are appropriate for hospice is challenging. Readmission is a marker of poor prognosis. © 2016 by American Society of Clinical Oncology.


Meisenberg B.R.,DeCesaris Cancer Institute | Graze L.,DeCesaris Cancer Institute | Brady-Copertino C.J.,DeCesaris Cancer Institute
Journal of Community and Supportive Oncology | Year: 2014

Background Most cancer patients have symptoms from their disease or treatment. Symptoms are not ideally managed in the context of busy clinics, resulting in potentially avoidable emergency department (ED) visits and hospitalizations. Adjunct supportive care clinics (SCCs) may more effectively address patient needs, but they contribute to fractionation of care if different personnel are involved. Objective We describe an SCC embedded within a physician practice in which an employed nurse practitioner delivered most of the care. We measured the disposition of patients from the SCC to the ED, and the effect on ED visits and admissions for symptom management. Methods We conducted a retrospective review of the patients attending the SCC over a period of 11 months. Demographics and disposition outcomes were tracked and compared with pre-intervention controls. Results In all, 340 visits were recorded from 330 unique patients. Same-day and next-day appointments with a nurse practitioner were arranged for 62% and 25% of patients, respectively. The most common complaints related to pain and gastrointestinal issues. Most of the patients were discharged home. A few needed hospitalization or ED-level care. Admissions for symptom-related care fell by 31%. An estimated 66 ED visits were avoided by patients accessing the SCC. Limitations The study was retrospective. It did not include detailed fnancial data. Results may not be generalizable because of the high level of central planning and use of a shared electronic medical record system, which may be lacking in some practices. Conclusions An embedded supportive care clinic allowed rapid access to experienced oncology care under supervision by the patient's own oncologists. The clinic was associated with less use of the ED and need for hospitalization. New methods of reimbursing medical care will increasingly require oncology practices to improve patient access to symptom-related care to avoid unnecessary admissions. An embedded SCC can accomplish these goals while avoiding further fractionation of care. © 2014 Frontline Medical Communications.


PubMed | DeCesaris Cancer Institute
Type: Journal Article | Journal: Journal of oncology practice | Year: 2016

The role of multidisciplinary care (MDC) on cancer care processes is not fully understood. We investigated the impact of MDC on the processes of care at cancer centers within the National Cancer Institute Community Cancer Centers Program (NCCCP).The study used data from patients diagnosed with stage IIB to III rectal cancer, stage III colon cancer, and stage III nonsmall-cell lung cancer at 14 NCCCP cancer centers from 2007 to 2012. We used an MDC development assessment toolwith levels ranging from evolving MDC (low) to achieving excellence (high)to measure the level of MDC implementation in seven MDC areas, such as case planning and physician engagement. Descriptive statistics and cluster-adjusted regression models quantified the association between MDC implementation and processes of care, including time from diagnosis to treatment receipt.A total of 1,079 patients were examined. Compared with patients with colon cancer treated at cancer centers reporting low MDC scores, time to treatment receipt was shorter for patients with colon cancer treated at cancer centers reporting high or moderate MDC scores for physician engagement (hazard ratio [HR] for high physician engagement, 2.66; 95% CI, 1.70 to 4.17; HR for moderate physician engagement, 1.50; 95% CI, 1.19 to 1.89) and longer for patients with colon cancer treated at cancer centers reporting high 2MDC scores for case planning (HR, 0.65; 95% CI, 0.49 to 0.85). Results for patients with rectal cancer were qualitatively similar, and there was no statistically significant difference among patients with lung cancer.MDC implementation level was associated with processes of care, and direction of association varied across MDC assessment areas.


PubMed | DeCesaris Cancer Institute
Type: Journal Article | Journal: The Journal of community and supportive oncology | Year: 2014

Most cancer patients have symptoms from their disease or treatment. Symptoms are not ideally managed in the context of busy clinics, resulting in potentially avoidable emergency department (ED) visits and hospitalizations. Adjunct supportive care clinics (SCCs) may more effectively address patient needs, but they contribute to fractionation of care if different personnel are involved.We describe an SCC embedded within a physician practice in which an employed nurse practitioner delivered most of the care. We measured the disposition of patients from the SCC to the ED, and the effect on ED visits and admissions for symptom management.We conducted a retrospective review of the patients attending the SCC over a period of 11 months. Demographics and disposition outcomes were tracked and compared with pre-intervention controls.In all, 340 visits were recorded from 330 unique patients. Same-day and next-day appointments with a nurse practitioner were arranged for 62% and 25% of patients, respectively. The most common complaints related to pain and gastrointestinal issues. Most of the patients were discharged home. A few needed hospitalization or ED-level care. Admissions for symptom-related care fell by 31%. An estimated 66 ED visits were avoided by patients accessing the SCC.The study was retrospective. It did not include detailed fnancial data. Results may not be generalizable because of the high level of central planning and use of a shared electronic medical record system, which may be lacking in some practices.An embedded supportive care clinic allowed rapid access to experienced oncology care under supervision by the patients own oncologists. The clinic was associated with less use of the ED and need for hospitalization. New methods of reimbursing medical care will increasingly require oncology practices to improve patient access to symptom-related care to avoid unnecessary admissions. An embedded SCC can accomplish these goals while avoiding further fractionation of care.


PubMed | DeCesaris Cancer Institute
Type: Journal Article | Journal: The Journal of community and supportive oncology | Year: 2015

There is increased interest among oncology and palliative professionals in providing appropriately timed hospice services for cancer patients. End of life (EoL) metrics have been included in oncology quality programs, but accurate EoL data and benchmarks are hard to obtain.To improve EoL care by measuring patterns of care among recently deceased patients.Care utilization among deceased patients was analyzed by using software integrated with patient electronic health records. The data was verified by chart review.Of 179 cancer deaths, tumor registry data differed from chart review in 7% of cases with regard to dates and/or location of death. Institutional EoL metrics were significantly affected by a large number of patients (37%) with advanced illnesses who had clinical diagnoses of cancer made at the end of life, but who had not been managed by oncologists. This population of patients who had not been managed by oncologists was older, less likely to use hospice, and more likely to use the intensive care unit than were oncologist-managed cancer patients. Among the patients of individual oncologists, the median stay in hospice ranged from 6-28 days. Data collection and chart review took an average of 27 minutes per case with combined efforts by a data analyst and oncology practitioner.Single institution with comprehensive electronic medical record; some patients were treated outside of the system.Acquiring accurate data on EoL metrics is time consuming. Compared with chart review, other data sources have inaccuracies and include some patients who have not been managed by oncologists. Accurate attribution to individual physicians requires chart review by an experienced clinician.


PubMed | DeCesaris Cancer Institute
Type: Journal Article | Journal: Journal of cancer education : the official journal of the American Association for Cancer Education | Year: 2015

There has been an increase in the use of cancer as a political metaphor, most recently to describe the threat of international terrorism. The powerful cancer metaphor implies a particular political problem is serious, progressive and deadly. As such to use a cancer metaphor prepares the public for a set of serious, intense and prolonged actions. While politically useful for a governmental to communicate policy, there are negative consequences to the use of the cancer metaphor. It perpetuates among the public and patients old stereotypes of cancer prognosis and therapies that oncologists have tried to combat through education. These education efforts are designed to help patients avoid overly aggressive treatments, surveillance, monitoring and surgeries. It is hard to successfully educate the general public and patients when they continuously receive alternative messages from political leaders who use the cancer metaphor for a different purpose. Professional cancer educators and clinicians should be aware of this trend and redouble efforts to educate that the political metaphor is for politics only and misleading in the public health and clinical arenas.

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