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1.
Ann Pharmacother ; : 10600280241241531, 2024 Apr 02.
Article in English | MEDLINE | ID: mdl-38566315

ABSTRACT

OBJECTIVE: To review the pharmacology, efficacy, and safety of capivasertib for the treatment of adults with hormone receptor-positive, HER2-negative (HR+/HER2-) locally advanced or metastatic breast cancer with 1 or more PIK3CA/AKT1/PTEN alterations. DATA SOURCES: A literature search was conducted using PubMed and MEDLINE databases, published abstracts, and studies from ClinicalTrials.gov between 2003 and February 2024. Keywords included capivasertib, AZD5363, PI3K/AKT/mTOR pathway, and breast cancer. DATA EXTRACTION: All applicable publications, package inserts, meeting abstracts, and clinical trials with capivasertib were reviewed. DATA SYNTHESIS: Capivasertib is a first-in-class inhibitor of 3 isoforms of AKT (AKT-1, AKT-2, and AKT-3) which is an essential component in the PI3K/AKT/mTOR signaling pathway involved in oncogenesis. In the phase III CAPItello-291 trial, capivasertib in combination with fulvestrant (C+F) demonstrated improved progression-free survival (PFS) (7.3 vs 3.1 months) compared with placebo-fulvestrant (P+F) cohort in AKT-altered pathway patients who had progressed through prior aromatase inhibitor. The most common adverse reactions of any grade reported in the C+F group were diarrhea, cutaneous skin reactions, nausea, fatigue, and vomiting. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE IN COMPARISON WITH EXISTING DRUGS: HR+/HER2- advanced breast cancer patients experience progression following endocrine therapies and cyclin-dependent kinase (CDK) 4/6 inhibitors. Capivasertib is a viable treatment option for patients with PIK3CA/AKT1/PTEN activating mutations following progression on endocrine-based regimens in the metastatic setting or recurrence within 12 months of completing adjuvant therapy. CONCLUSION: Integration of capivasertib into clinical practice is ongoing; intermittent dosing and favorable toxicity are attractive for future novel combination prospective trials.

3.
Cancer Epidemiol Biomarkers Prev ; 32(12): 1675-1682, 2023 12 01.
Article in English | MEDLINE | ID: mdl-37788369

ABSTRACT

BACKGROUND: Supportive care medication use differences may contribute to racial disparities observed in health-related quality of life in patients with pancreatic cancer. METHODS: In this observation study using the Surveillance, Epidemiology, and End Results-Medicare linked database, we sought to examine supportive care medication use disparities in patients with pancreatic cancer from 2005 to 2017 by race and ethnicity. RESULTS: Among 74,309 patients included in the final analysis, racial and ethnic disparities in the use of supportive care medications were identified. After adjustment for confounding factors and compared with non-Hispanic Whites, minorities had significantly less use of opioids [Black: adjusted OR (aOR), 0.84; 95% confidence interval (CI), 0.79-0.88; Asian: aOR, 0.84; 95% CI, 0.79-0.90), and skeletomuscular relaxants (Black: aOR, 0.90; 95% CI, 0.82-0.99; Hispanic: aOR, 0.82; 95% CI, 0.74-0.91; Asian: aOR, 0.59; 95% CI, 0.51-0.68), and increased use of non-opioid analgesics (Hispanic: aOR, 1.16; 95% CI, 1.01-1.14; Asian: aOR, 1.37; 95% CI, 1.26-1.49). Racial and ethnic minorities had less use of antidepressants (Black: aOR, 0.56; 95% CI, 0.53-0.59; Hispanic: aOR, 0.77; 95% CI, 0.73-0.82; Asian: aOR, 0.47; 95% CI, 0.44-0.51), anxiolytics (Black: aOR, 0.78; 95% CI, 0.74-0.82; Hispanic: aOR, 0.66; 95% CI, 0.62-0.71; Asian: aOR, 0.52; 95% CI, 0.48-0.57), and antipsychotics (Hispanic: aOR, 0.90; 95% CI, 0.82-0.99; Asian: aOR, 0.84; 95% CI, 0.74-0.95). CONCLUSIONS: Racial and ethnic disparities in the use of supportive care medications among patients with pancreatic cancer were observed, with the differences unexplained by sociodemographic factors. IMPACT: Future studies should identify strategies to promote equitable use of supportive care medications among racial minorities and explore factors that may influence their use in these populations.


Subject(s)
Pain Management , Pancreatic Neoplasms , Humans , Aged , United States/epidemiology , Quality of Life , Healthcare Disparities , Medicare , Death , Pancreatic Neoplasms/drug therapy
4.
Future Oncol ; 19(27): 1841-1851, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37753702

ABSTRACT

For patients with localized pancreatic cancer with minimal vascular involvement, optimal survivability requires a multidisciplinary approach of surgical resection and systemic chemotherapy. FOLFIRINOX is a combination chemotherapy regimen that offers promising results in the perioperative and metastatic settings; however, it can cause significant adverse effects. Such toxicity can negatively impact some patients, resulting in chemotherapy discontinuation or surgical unsuitability. In an effort to reduce toxicities and optimize outcomes, this investigation explores the safety and feasibility of substituting liposomal irinotecan (nal-IRI) for nonliposomal irinotecan to improve tumor drug delivery and potentially reduce toxicity. This regimen, NALIRIFOX, has the potential to be both safer and more effective when administered in the preoperative setting.


For patients with pancreatic cancer with little to no cancer near the blood vessels, the best life expectancy usually requires surgery and chemotherapy. FOLFIRINOX is a chemotherapy medicine that offers promising results for both patients getting surgery and for patients with widespread disease. However, it can cause harmful side effects. The side effects can be so bad that the chemotherapy has to be stopped or that surgery is no longer possible. In order to reduce the harmful side effects and improve outcomes, this investigation looks into the safety and practicality of using a different version of one of the medicines. The different version hopes to improve drug delivery and reduce harmful side effects. This regimen, NALIRIFOX, can be safer and more effective in patients awaiting surgery. Clinical Trial Registration: UF-STO-PANC-004 (NCT03483038) (ClinicalTrials.gov).


Subject(s)
Adenocarcinoma , Pancreatic Neoplasms , Radiation-Sensitizing Agents , Humans , Irinotecan/therapeutic use , Pancreatic Neoplasms/pathology , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Oxaliplatin/therapeutic use , Adenocarcinoma/pathology , Neoadjuvant Therapy/methods , Fluorouracil/adverse effects , Leucovorin/adverse effects , Radiation-Sensitizing Agents/therapeutic use , Clinical Trials, Phase II as Topic
5.
J Am Heart Assoc ; 12(10): e027981, 2023 05 16.
Article in English | MEDLINE | ID: mdl-37158063

ABSTRACT

Background Anthracyclines remain a key treatment for many malignancies but can increase the risk of heart failure or cardiomyopathy. Specific guidelines recommend echocardiography and serum cardiac biomarkers such as BNP (B-type natriuretic peptide) or NT-proBNP (N-terminal proBNP) evaluation before and 6 to 12 months after treatment. Our objective was to evaluate associations between racial and ethnic groups in cardiac surveillance of survivors of cancer after exposure to anthracyclines. Methods and Results Adult patients in the OneFlorida Consortium without prior cardiovascular disease who received at least 2 cycles of anthracyclines were included in the analysis. Multivariable logistic regression was performed to estimate the odds ratios (ORs) and 95% CIs for receiving cardiac surveillance at baseline before anthracycline therapy, 6 months after, and 12 months after anthracycline exposure among different racial and ethnic groups. Among the entire cohort of 5430 patients, 63.4% had a baseline echocardiogram, with 22.3% receiving an echocardiogram at 6 months and 25% at 12 months. Non-Hispanic Black (NHB) patients had a lower likelihood of receiving a baseline echocardiogram than Non-Hispanic White (NHW) patients (OR, 0.75 [95% CI, 0.63-0.88]; P=0.0006) or any baseline cardiac surveillance (OR, 0.76 [95% CI, 0.64-0.89]; P=0.001). Compared with NHW patients, Hispanic patients received significantly less cardiac surveillance at the 6-month (OR, 0.84 [95% CI, 0.72-0.98]; P=0.03) and 12-month (OR, 0.85 [95% CI, 0.74-0.98]; P=0.03) time points, respectively. Conclusions There were significant racial and ethnic differences in cardiac surveillance among survivors of cancer at baseline and following anthracycline-based treatment in NHB and Hispanic cohorts. Health care providers need to be cognizant of these social inequities and initiate efforts to ensure recommended cardiac surveillance occurs following anthracyclines.


Subject(s)
Cardiomyopathies , Neoplasms , Adult , Humans , Anthracyclines/adverse effects , Heart , Antibiotics, Antineoplastic/adverse effects , Neoplasms/drug therapy , Neoplasms/chemically induced , Biomarkers
7.
J Natl Med Assoc ; 115(2): 164-174, 2023 Apr.
Article in English | MEDLINE | ID: mdl-36801148

ABSTRACT

Pancreatic ductal adenocarcinoma (PDAC) is currently the third leading cause of cancer mortality and the incidence is projected to increase by 2030. Despite recent advances in its treatment, African Americans have a 50-60% higher incidence and 30% higher mortality rate when compared to European Americans possibly resulting from differences in socioeconomic status, access to healthcare, and genetics. Genetics plays a role in cancer predisposition, response to cancer therapeutics (pharmacogenetics), and in tumor behavior, making some genes targets for oncologic therapeutics. We hypothesize that the germline genetic differences in predisposition, drug response, and targeted therapies also impact PDAC disparities. To demonstrate the impact of genetics and pharmacogenetics on PDAC disparities, a review of the literature was performed using PubMed with variations of the following keywords: pharmacogenetics, pancreatic cancer, race, ethnicity, African, Black, toxicity, and the FDA-approved drug names: Fluoropyrimidines, Topoisomerase inhibitors, Gemcitabine, Nab-Paclitaxel, Platinum agents, Pembrolizumab, PARP-inhibitors, and NTRK fusion inhibitors. Our findings suggest that the genetic profiles of African Americans may contribute to disparities related to FDA approved chemotherapeutic response for patients with PDAC. We recommend a strong focus on improving genetic testing and participation in biobank sample donations for African Americans. In this way, we can improve our current understanding of genes that influence drug response for patients with PDAC.


Subject(s)
Antineoplastic Agents , Black or African American , Carcinoma, Pancreatic Ductal , Pancreatic Neoplasms , Humans , Antineoplastic Agents/pharmacology , Antineoplastic Agents/therapeutic use , Black or African American/genetics , Carcinoma, Pancreatic Ductal/drug therapy , Carcinoma, Pancreatic Ductal/ethnology , Carcinoma, Pancreatic Ductal/genetics , Carcinoma, Pancreatic Ductal/pathology , Pancreatic Neoplasms/drug therapy , Pancreatic Neoplasms/ethnology , Pancreatic Neoplasms/genetics , Pancreatic Neoplasms/pathology , Pharmacogenetics , Molecular Targeted Therapy/methods
8.
Future Oncol ; 2022 Nov 18.
Article in English | MEDLINE | ID: mdl-36399037

ABSTRACT

Immune checkpoint inhibitor therapy represents a significant advance in cancer care. The interaction between PD-1 and PD-L1 induces immune tolerance and the inhibition of this interaction is an effective treatment strategy for numerous malignancies. Despite its demonstrated potential, immunotherapy is not clinically effective in immunogenically 'cold' tumors such as pancreatic cancer, prostate cancer and neuroendocrine tumors. Through the inhibition of VEGF, it may be possible to potentiate the effect of immune checkpoint blockade in tumors that have traditionally shown a lack of clinical response to immunotherapy. This signal-seeking, single-arm, prospective clinical trial aims to determine the objective response of tivozanib and atezolizumab in advanced immunogenically cold solid tumors. Clinical Trial Registration: NCT05000294 (ClinicalTrials.gov).

9.
JCO Oncol Pract ; 18(8): e1289-e1296, 2022 08.
Article in English | MEDLINE | ID: mdl-35544740

ABSTRACT

PURPOSE: Drug shortages are a clear and growing challenge. Prominent shortages included oncology medications and supportive care products essential for the care of patients with cancer. Oncology drug shortages often result in disruptions in the timing of chemotherapy treatments, alterations in the dose or regimen administered, or even missed doses when alternative agents are unavailable. The purpose of this survey was to characterize the impact of oncology drug shortages across the United States, including the experiences of health care organizations, resource implications, and the impact on patient safety, patient care, and clinical trials. METHODS: A 36-item online survey was distributed to membership of the Hematology/Oncology Pharmacy Association to gather information on shortages of oncology drugs (ie, all drugs essential in the care of patients with cancer, including supportive care agents). RESULTS: Sixty-eight US organizations participated in the survey between December 2019 and July 2020. Sixty-three percent of institutions reported one or more drug shortages per month, with a 34% increase in 2019 from 2018. Treatment delays, reduced doses, or alternative regimens were reported by 75% of respondents. The most difficult agents to obtain were vincristine, vinblastine, intravenous immunoglobulin, leucovorin, and Bacillus Calmette-Guerin. CONCLUSION: A survey of US oncology pharmacists indicated that oncology drug shortages occurred frequently in 2020. Shortages led to delays in chemotherapy and changes in treatment or omission, complicated clinical research, and increased risk of medication errors and adverse outcomes.


Subject(s)
Hematology , Neoplasms , Pharmacy , Humans , Medical Oncology , Neoplasms/drug therapy , Surveys and Questionnaires , United States
10.
Cancer Treat Rev ; 105: 102376, 2022 Apr.
Article in English | MEDLINE | ID: mdl-35303547

ABSTRACT

As cancer treatment evolves in the era of precision oncology, molecularly targeted agents (MTAs) have become frontline therapy for many cancers. MTAs are biologically targeted and thought to have less off-target toxicity; however, the eye is particularly susceptible to off-target toxicities given its unique microenvironment. In this review, we present commonly used FDA-approved MTAs, any associated ocular toxicities and review the mechanisms, frequency, severity, and management. Increased awareness and communication between clinicians caring for cancer patients is needed for individualized risk assessment, earlier diagnosis, and mitigation of ocular toxicities.


Subject(s)
Antineoplastic Agents , Neoplasms , Oncologists , Antineoplastic Agents/therapeutic use , Humans , Molecular Targeted Therapy , Neoplasms/drug therapy , Precision Medicine , Tumor Microenvironment
11.
J Am Coll Clin Pharm ; 5(12): 1284-1296, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36844700

ABSTRACT

There is surmounting levels of evidence on the health disparities within cancer treatment in the United States (US). Most of the research focused on cancer specific factors including anticancer incidence, screening, treatment and follow-up, and clinical outcomes such as overall survival (OS). Less is known about the disparities present with supportive care medication use in cancer patients. Supportive care utilization during cancer treatment has been linked to improved quality of life (QoL) and OS among patients. The goal of this scoping review is to summarize findings of current literature on the relationship between race and ethnicity and the receipt of supportive care medications during cancer treatment for pain and chemotherapy-induced nausea and vomiting (CINV). This scoping review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA-ScR) guidelines. Our literature search included quantitative studies, qualitative studies, and grey literature written in the English language with clinically relevant outcomes pertaining to pain and CINV management in cancer treatment published from 2001-2021. Articles that met the predefined inclusion criteria were considered for inclusion in the analysis. The initial search yielded 308 studies. Following de-duplication and screening, 14 studies met the predefined inclusion criteria, with majority of the studies being quantitative studies (n=13). Collectively, results were mixed results regarding the presence of racial disparities for supportive care medication use. Half of the studies (n=7) supported this finding whereas, the other half (n=7) did not identify any racial disparities. In our review, multiple studies illustrate the existence of disparities in the use of supportive care medications in some cancer types. Clinical pharmacists should strive to eliminate supportive medication use disparities as part of a multidisciplinary team. In order to develop strategies to prevent supportive care medication use disparities in this population, further research and analysis of external factors that influence them are needed.

12.
J Oncol Pharm Pract ; 28(8): 1832-1847, 2022 Dec.
Article in English | MEDLINE | ID: mdl-34693814

ABSTRACT

INTRODUCTION: The coronavirus of 2019 pandemic has necessitated vast and rapid changes in the way oncology pharmacy services are delivered around the world. METHODS/AIMS: An international survey of oncology pharmacists and technicians was conducted via the International Society of Oncology Pharmacy Practitioners and collaborating global pharmacy organisations to determine the impact that the coronavirus of 2019 has had on pharmacy service delivery, pharmacy practitioners and oncology practice. RESULTS: The survey received 862 responses from 40 different countries from September to October 2020. The majority of respondents were pharmacists (n = 841, 97.6%), with 24% involved in the direct care of patients with the coronavirus of 2019. Of the survey participants, 55% increased their time working remotely, with remote activities including dispensing, patient assessment/follow-up and attending multi-disciplinary rounds. Respondents reported a 72% increase in the use of technology to perform remote patient interaction activities and that participation in educational meetings and quality improvement projects was reduced by 68% and 44%, respectively. Workforce impacts included altered working hours (50%), cancelled leave (48%) and forced leave/furloughing (30%). During the pandemic, respondents reported reduced access to intensive care (19%) and anti-cancer (15%) medications. In addition, 39% of respondents reported reduced access to personal protective equipment, including N95 masks for chemotherapy compounding. Almost half of respondents (49%) reported that cancer treatments were delayed or intervals were altered for patients being treated with curative intent. A third of practitioners (30%) believed that patient outcomes would be adversely impacted by changes to pharmacy services. Sixty-five percent of respondents reported impacts on their mental health, with 12% utilising support services. CONCLUSION: The coronavirus of 2019 pandemic has altered the way oncology pharmacy services are delivered. These results demonstrate the adaptability of the oncology pharmacy profession and highlight the importance of formal evaluation of the varied practice models to determine the evidence-based practices that enhance pharmacy services and, thus, should be reinstated as soon as practical and reasonable.


Subject(s)
Coronavirus Infections , Coronavirus , Neoplasms , Pharmaceutical Services , Pharmacy , Humans , Medical Oncology , Pharmacists , Neoplasms/drug therapy , Surveys and Questionnaires
13.
Front Cardiovasc Med ; 8: 645122, 2021.
Article in English | MEDLINE | ID: mdl-33996940

ABSTRACT

Multiple myeloma (MM) is the second most frequent hematologic cancer in the United States. Carfilzomib (CFZ), an irreversible proteasome inhibitor being used to treat relapsed and refractory MM, has been associated with cardiotoxicity, including heart failure. We hypothesized that a multi-omics approach integrating data from different omics would provide insights into the mechanisms of CFZ-related cardiovascular adverse events (CVAEs). Plasma samples were collected from 13 MM patients treated with CFZ (including 7 with CVAEs and 6 with no CVAEs) at the University of Florida Health Cancer Center. These samples were evaluated in global metabolomic profiling, global proteomic profiling, and microRNA (miRNA) profiling. Integrative pathway analysis was performed to identify genes and pathways differentially expressed between patients with and without CVAEs. The proteomics analysis identified the up-regulation of lactate dehydrogenase B (LDHB) [fold change (FC) = 8.2, p = 0.01] in patients who experienced CVAEs. The metabolomics analysis identified lower plasma abundance of pyruvate (FC = 0.16, p = 0.0004) and higher abundance of lactate (FC = 2.4, p = 0.0001) in patients with CVAEs. Differential expression analysis of miRNAs profiling identified mir-146b to be up-regulatein (FC = 14, p = 0.046) in patients with CVAE. Pathway analysis suggested that the pyruvate fermentation to lactate pathway is associated with CFZ-CVAEs. In this pilot multi-omics integrative analysis, we observed the down-regulation of pyruvate and up-regulation of LDHB among patients who experienced CVAEs, suggesting the importance of the pyruvate oxidation pathway associated with mitochondrial dysfunction. Validation and further investigation in a larger independent cohort are warranted to better understand the mechanisms of CFZ-CVAEs.

14.
Cardiooncology ; 7(1): 10, 2021 Mar 18.
Article in English | MEDLINE | ID: mdl-33736707

ABSTRACT

BACKGROUND: Immune checkpoint inhibitors (ICIs) are a novel class of anticancer agents that have demonstrated clinical response for both solid and hematological malignancies. ICIs are associated with development of immune-related adverse events including cardiotoxicity. We estimated the incidence of newly diagnosed cardiovascular disease in patients treated with ICIs at a large, tertiary care center. METHODS: All patients with a cancer diagnosis who received any ICI treatment in the University of Florida's Integrated Data Repository from 2011 to 2017 were included. Cardiovascular disease was defined as a new ICD diagnosis code for cardiomyopathy, heart failure, arrhythmia, heart block, pericardial disease, or myocarditis after initiation of ICI treatment. RESULTS: Of 102,701 patients with a diagnosis of malignancy, 424 patients received at least one ICI. Sixty-two (14.6%) patients were diagnosed with at least one new cardiovascular disease after initiation of ICI therapy. Of the 374 patients receiving one ICI, 21 (5.6%) developed heart failure. Of the 49 patients who received two ICIs sequentially, three (6.1%) developed heart failure and/or cardiomyopathy. Incident cardiovascular disease was diagnosed at a median of 63 days after initial ICI exposure. One patient developed myocarditis 28 days after receiving nivolumab. Mortality in ICI treated patients with a concomitant diagnosis of incident cardiovascular disease was higher compared to those who did not (66.1% vs. 41.4%, odds ratio = 2.77, 1.55-4.95, p = 0.0006). CONCLUSIONS: This study suggests a high incidence of newly diagnosed cardiovascular disease after the initiation of ICI therapy in a real-world clinical setting.

15.
J Oncol Pharm Pract ; 26(3): 647-654, 2020 Apr.
Article in English | MEDLINE | ID: mdl-31474214

ABSTRACT

OBJECTIVES: The emergence of immune checkpoint inhibitors has transformed treatment paradigms for various malignancies. Patients with cancer are at increased risk of complications and hospitalizations from influenza; therefore, it is recommended that they receive inactivated influenza vaccination. However, efficacy and safety of inactivated influenza vaccination in patients receiving immune checkpoint inhibitors is uncertain. The objective of this prospective case series was to evaluate the incidence of immune-mediated adverse events (imAEs) following inactivated influenza vaccination in patients receiving immune checkpoint inhibitors. Changes in cytokine and chemokine levels were also evaluated. METHODS: Patients receiving immune checkpoint inhibitors during the 2017-2018 influenza season were eligible for study participation. Peripheral blood samples were collected prior to administration of inactivated influenza vaccine and two post-vaccination time points. Evaluation of new or worsening imAEs occurred via patient questionnaire and review of medical records for 60 days following inactivated influenza vaccination. Baseline imAEs were evaluated from review of medical records for 60 days prior to inactivated influenza vaccination. Serum cytokines and chemokines were measured using a multiplex Luminex assay. RESULTS: Twenty-four patients were enrolled in this study. Seven patients experienced any grade imAE (one patient having 2) within 60 days following inactivated influenza vaccination. The majority were Grades 1-2, including rash (n = 3), hypothyroidism, myalgia, and colitis (n = 1 each). Two patients experienced severe imAEs (grade 3 nephritis and grade 4 diabetes). No significant changes (p > 0.05) in serum cytokine or chemokine concentrations were observed. CONCLUSIONS: Although small, our study suggests that inactivated influenza vaccine may be safely administered to patients receiving immune checkpoint inhibitors. The majority of imAEs following inactivated influenza vaccination were Grades 1-2 and did not require changes in immune checkpoint inhibitor therapy.


Subject(s)
Influenza Vaccines/adverse effects , Neoplasms/immunology , Programmed Cell Death 1 Receptor/antagonists & inhibitors , Vaccination/adverse effects , Adult , Aged , Aged, 80 and over , Cytokines/blood , Female , Humans , Male , Middle Aged , Neoplasms/drug therapy , Prospective Studies
16.
Am J Pharm Educ ; 83(8): 7357, 2019 10.
Article in English | MEDLINE | ID: mdl-31831908

ABSTRACT

Objective. To develop, implement, and assess student performance and confidence in a pharmacy capstone course that used case-based instruction and the Pharmacist's Patient Care Process (PPCP) to develop patient work-up skills in third-year Doctor of Pharmacy (PharmD) students. Methods. A skills-based capstone course was developed by a team of faculty members and instructional designers that focused on patient evaluation skills and applying the steps of the PPCP to complex patient cases housed in a simulated electronic health record (SEHR). The acuity of the cases increased over the course of the semester. For each patient case, students were expected to identify drug-related problems and develop an assessment and plan based on the information provided in the SEHR. Results. Students (n=134) were assessed through weekly quizzes and two practical examinations. The average score for all quizzes was 81%. A significant correlation was found between average quiz scores and performance on the end-of-course practical examination. Student scores significantly improved from the first to the second practical examination (10.4 vs 12.9, respectively), and student confidence with regard to all course objectives significantly improved from the beginning to the end of the semester. Conclusion. A capstone course that applied the PPCP framework successfully taught third-year PharmD students the patient care skills they would need in advanced pharmacy practice experiences.


Subject(s)
Education, Pharmacy/methods , Patient Care/methods , Curriculum , Educational Measurement/methods , Humans , Pharmaceutical Services , Pharmacists , Students, Pharmacy
17.
Ann Pharmacother ; 52(1): 60-68, 2018 Jan.
Article in English | MEDLINE | ID: mdl-28831813

ABSTRACT

OBJECTIVE: To summarize and evaluate immunotherapy agents targeting programmed cell death protein-1 (PD-1) and programmed death ligand-1 (PD-L1) recently approved for the treatment of metastatic urothelial carcinomas (UC). DATA SOURCES: A literature review was performed using PubMed (2012 to June 2017), the American Society of Clinical Oncology abstract databases (2012 to June 2017 Annual Meetings/symposia), and the America Association for Cancer Research symposia (2012 to June 2017). A search using clinicaltrials.gov was conducted to identify studies for atezolizumab, avelumab, durvalumab, nivolumab, and pembrolizumab. STUDY SELECTION AND DATA EXTRACTION: English language phase I to III studies assessing PD-1 and PD-L1 in UC were incorporated. DATA SYNTHESIS: Atezolizumab, avelumab, durvalumab, nivolumab, and pembrolizumab have demonstrated clinical efficacy with tolerable toxicities in patients with metastatic UC with disease progression following platinum-based chemotherapy. Anti-PD-1/PD-L1 therapies may provide overall survival advantage; these are currently being evaluated in ongoing phase 3 studies. Greater objective response rates seem to be observed in PD-L1-positive patients versus PD-L1-negative patients, but methodologies in this assessment differ among clinical trials. The identification of biomarkers that provide greater insight into patients who positively respond to PD-1/PD-L1 therapies are needed. CONCLUSIONS: Treatment options for metastatic UC have expanded to include PD-1/PD-L1 therapies. These agents should be strongly considered as second-line therapy over single-agent chemotherapy for patients who fail or progress after platinum-based treatment.


Subject(s)
Antineoplastic Agents/therapeutic use , Immunotherapy/methods , Urinary Bladder Neoplasms/drug therapy , B7-H1 Antigen/immunology , Humans , Programmed Cell Death 1 Receptor/immunology , Treatment Outcome
19.
J Oncol Pharm Pract ; 23(1): 10-17, 2017 Jan.
Article in English | MEDLINE | ID: mdl-26471738

ABSTRACT

Secondary failure of platelet recovery (SFPR) is a serious complication observed in approximately 20% of allogeneic hematopoietic stem cell transplant (HSCT) recipients. Although the standard therapeutic approach has been frequent platelet transfusions, romiplostim, a thrombopoietin receptor agonist, may have utility in treating SFPR. The primary objective of this single-center retrospective analysis was to assess effectiveness of romiplostim for SFPR and to evaluate patient factors which may influence clinical outcomes. The primary outcome measure of response was defined as achievement of platelet count ≥ 50 × 109/L without transfusions for ≥ 7 consecutive days. During the study period, 93 patients underwent HSCT and 13 (13.9%) received romiplostim for SFPR. Seven patients (53.8%) responded to romiplostim, requiring a median of three doses (range 1-6) to achieve independence from platelet transfusions. Disease relapse occurred in 38.5% of all patients, two responders and three nonresponders. Median survival post-HSCT was 753 days among responders and 266 days among nonresponders ( p = 0.0375). No serious adverse events were reported, and rates of graft-versus-host disease did not increase following administration of romiplostim. Thrombopoietin receptor agonists including romiplostim offer a treatment option for persistent thrombocytopenia following HSCT. Positive clinical response to romiplostim post-HSCT is associated with improved outcomes.


Subject(s)
Blood Platelets/drug effects , Graft vs Host Disease/drug therapy , Receptors, Fc/therapeutic use , Recombinant Fusion Proteins/therapeutic use , Thrombopoietin/therapeutic use , Adolescent , Adult , Aged , Female , Graft vs Host Disease/metabolism , Hematopoietic Stem Cell Transplantation , Humans , Male , Middle Aged , Platelet Count/methods , Receptors, Thrombopoietin/metabolism , Retrospective Studies , Thrombocytopenia/drug therapy , Thrombocytopenia/metabolism , Young Adult
20.
J Pharm Pract ; 30(4): 400-405, 2017 Aug.
Article in English | MEDLINE | ID: mdl-27432462

ABSTRACT

BACKGROUND: Etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH)-containing regimens are frequently utilized in non-Hodgkin's lymphoma, however, the incidence of febrile neutropenia (FN) in patients receiving inpatient versus outpatient EPOCH has not been described. Additionally, no comparisons have been made regarding financial implications of EPOCH administration in either setting. This study's primary objective was to compare hospital admissions for FN in patients receiving inpatient or outpatient EPOCH. METHODS: A single-center, institutional review board-approved review was conducted for adults receiving EPOCH beginning January 2010. Clinical and financial data were collected through chart review and the institution's financial department. Descriptive statistics were utilized for analysis. RESULTS: A total of 25 patients received 86 cycles of an EPOCH-containing regimen (61 [70.9%] inpatient). Five (8.2%) inpatient cycles resulted in an admission for FN compared to 4 (16%) outpatient cycles. Prophylactic antifungal and antiviral agents were prescribed more often after inpatient cycles (>80%) compared to outpatient cycles (<50%). Overall, 27 (31.4%) of 86 cycles did not receive granulocyte colony-stimulating factor support. Outpatient EPOCH administration was associated with a cost savings of approximately US$141 116 for both chemotherapy costs and hospital day avoidance. CONCLUSION: EPOCH-containing regimens can be safely administered in the outpatient setting, which may result in cost savings for healthcare institutions.


Subject(s)
Ambulatory Care/economics , Antineoplastic Combined Chemotherapy Protocols/economics , Costs and Cost Analysis/standards , Hospitalization/economics , Lymphoma, Non-Hodgkin/drug therapy , Lymphoma, Non-Hodgkin/economics , Adult , Aged , Aged, 80 and over , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Cyclophosphamide/administration & dosage , Cyclophosphamide/economics , Doxorubicin/administration & dosage , Doxorubicin/economics , Drug Administration Schedule , Etoposide/administration & dosage , Etoposide/economics , Female , Humans , Inpatients , Male , Middle Aged , Outpatients , Prednisone/administration & dosage , Prednisone/economics , Prospective Studies , Retrospective Studies , Vincristine/administration & dosage , Vincristine/economics
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