Pub Date : 2024-07-01DOI: 10.6004/jadpro.2024.15.8.7
Elizabeth Koselke, PharmD, BCOP, Lisa C. Kaspin-Powell, PhD, Shannon Hough, PharmD, BCOP, Joshua Howell, PharmD, BCOP, Nicholas J. Robert, MD, Marcus A. Neubauer, MD, Susie A. Bullock, DNP, MPH, RN, OCN®, CCRP, Jennifer M. Walberg, MPH, Melissa Rammage, PharmD, MS, BCOP, James E. Butrynksi, MD, David Hakimian, MD, Robert M. Jotte, MD, PhD, Michael W. Meshad, MD, Kashif Ali, MD, David Michael Waterhouse, MD, MPH, Robert L. Coleman, MD, FACOG, FACS, Makenzi Colleen Evangelist, MD
Introduction: The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium™ (MYLUNG) clinical trial platform aims to advance the use of precision medicine in patients with non–small cell lung cancer through a series of prospective and iterative clinical trials. Timely patient accrual onto oncology clinical trials is a known practice challenge and impaired accrual rates can lead to premature trial closure or properly powered trial outcomes. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) initiative to provide remote clinical services to screen patients for enrollment onto MYLUNG Protocol 2. This study aims to evaluate the effect of the remote clinical pharmacist intervention on study enrollment rates. Methods: An oncology-trained clinical pharmacist remotely reviewed systemic chemotherapy treatment orders during normal workflow and, in addition, a weekly custom recruitment report within six community Network practices (149 physicians). The pharmacist identified, screened, and assisted with the communication regarding eligible patients for enrollment. The onsite research team received timely and relevant patient data to facilitate expedited enrollment. Enrollment and intervention data were tracked to monitor the impact of the pharmacist intervention. Monthly enrollment was evaluated using a paired t-test. Results: Over 8 months, the pharmacist screened 506 potentially eligible patients; 34% were enrolled. Average monthly enrollment was significantly greater following the ClinReview intervention (3.4 vs. 6.6 patients/month; p = .02). Among the 289 patients not enrolled, 73% exceeded their eligibility window, 9% died or enrolled into hospice, 4% declined participation, and 13% transferred care or were treated at outside facilities. Conclusions: Incorporating an oncology clinical pharmacist into the clinical research team was associated with improved clinical trial enrollment. Validation of the effect of multidisciplinary interventions across a broader spectrum of differentially resourced oncology practices will be conducted within future MYLUNG iterations.
{"title":"Impact of an Oncology Clinical Pharmacist Intervention on Clinical Trial Enrollment in The US Oncology Network’s MYLUNG Consortium","authors":"Elizabeth Koselke, PharmD, BCOP, Lisa C. Kaspin-Powell, PhD, Shannon Hough, PharmD, BCOP, Joshua Howell, PharmD, BCOP, Nicholas J. Robert, MD, Marcus A. Neubauer, MD, Susie A. Bullock, DNP, MPH, RN, OCN®, CCRP, Jennifer M. Walberg, MPH, Melissa Rammage, PharmD, MS, BCOP, James E. Butrynksi, MD, David Hakimian, MD, Robert M. Jotte, MD, PhD, Michael W. Meshad, MD, Kashif Ali, MD, David Michael Waterhouse, MD, MPH, Robert L. Coleman, MD, FACOG, FACS, Makenzi Colleen Evangelist, MD","doi":"10.6004/jadpro.2024.15.8.7","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.8.7","url":null,"abstract":"Introduction: The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium™ (MYLUNG) clinical trial platform aims to advance the use of precision medicine in patients with non–small cell lung cancer through a series of prospective and iterative clinical trials. Timely patient accrual onto oncology clinical trials is a known practice challenge and impaired accrual rates can lead to premature trial closure or properly powered trial outcomes. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) initiative to provide remote clinical services to screen patients for enrollment onto MYLUNG Protocol 2. This study aims to evaluate the effect of the remote clinical pharmacist intervention on study enrollment rates. Methods: An oncology-trained clinical pharmacist remotely reviewed systemic chemotherapy treatment orders during normal workflow and, in addition, a weekly custom recruitment report within six community Network practices (149 physicians). The pharmacist identified, screened, and assisted with the communication regarding eligible patients for enrollment. The onsite research team received timely and relevant patient data to facilitate expedited enrollment. Enrollment and intervention data were tracked to monitor the impact of the pharmacist intervention. Monthly enrollment was evaluated using a paired t-test. Results: Over 8 months, the pharmacist screened 506 potentially eligible patients; 34% were enrolled. Average monthly enrollment was significantly greater following the ClinReview intervention (3.4 vs. 6.6 patients/month; p = .02). Among the 289 patients not enrolled, 73% exceeded their eligibility window, 9% died or enrolled into hospice, 4% declined participation, and 13% transferred care or were treated at outside facilities. Conclusions: Incorporating an oncology clinical pharmacist into the clinical research team was associated with improved clinical trial enrollment. Validation of the effect of multidisciplinary interventions across a broader spectrum of differentially resourced oncology practices will be conducted within future MYLUNG iterations.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"12 7","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141841091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.6004/jadpro.2024.15.8.8
Mona L. Martin, RN, MPA, Kristin Bucklen, BS, MBA, Lise J. Hall, BA, MBA, Dann Wonser, MA, LPC, Genevieve de Renne, MA, OTR/L, FAOTA, Beth Sandy, MSN
Background: The accessibility and quality of network support for people living with lung cancer (PLW) and their support partners (SP) can vary. Virtual platforms provide unique opportunities for PLW/SP peer support and disease education. Methods: Using a novel dual approach, we determined the user-perceived impact of the AstraZeneca-sponsored Facebook community, LVNG With Lung Cancer (facebook.com/LVNGWithLungCancerUS), and measured the social/behavioral impact on PLW/SP. Qualitative 1-hour phone interviews were conducted with community members aged ≥ 18 years. Additionally, inbound community comments (December 2015–October 2016) were retrospectively analyzed and categorized. Results: 18 PLW and 2 SP were interviewed. Mean years since diagnosis was 2.75 (range, 0.08–17). Of the total expressions of benefit (n = 513) made during the interviews, 32% focused on increased health knowledge; 28% on social impacts of the community (e.g., having a supportive environment); and 18% conveyed feelings of empowerment. Community membership led to behavioral change in many respondents: 55% asked their doctor more questions, and 50% gave advice to others. Inbound community comments (24,336 posts from 12,187 unique members) reflected the themes offered during interviews as important reasons to participate: 63% of posts asked for or shared cancer information; 98% provided emotional support/understanding; and 84% were inspirational/optimistic. Conclusions: This analysis of the real-world impact of a virtual community provided insight into the benefit that members derive. We hypothesize that once members’ emotional and educational needs were met, they were empowered and/or inspired to take positive actions leading to better health behaviors and increased quality of life—an outcome that may apply to other diseases.
{"title":"Evaluating the User-Perceived Benefit of a Virtual Lung Cancer Patient Education and Support Community: LVNG With Lung Cancer","authors":"Mona L. Martin, RN, MPA, Kristin Bucklen, BS, MBA, Lise J. Hall, BA, MBA, Dann Wonser, MA, LPC, Genevieve de Renne, MA, OTR/L, FAOTA, Beth Sandy, MSN","doi":"10.6004/jadpro.2024.15.8.8","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.8.8","url":null,"abstract":"Background: The accessibility and quality of network support for people living with lung cancer (PLW) and their support partners (SP) can vary. Virtual platforms provide unique opportunities for PLW/SP peer support and disease education. Methods: Using a novel dual approach, we determined the user-perceived impact of the AstraZeneca-sponsored Facebook community, LVNG With Lung Cancer (facebook.com/LVNGWithLungCancerUS), and measured the social/behavioral impact on PLW/SP. Qualitative 1-hour phone interviews were conducted with community members aged ≥ 18 years. Additionally, inbound community comments (December 2015–October 2016) were retrospectively analyzed and categorized. Results: 18 PLW and 2 SP were interviewed. Mean years since diagnosis was 2.75 (range, 0.08–17). Of the total expressions of benefit (n = 513) made during the interviews, 32% focused on increased health knowledge; 28% on social impacts of the community (e.g., having a supportive environment); and 18% conveyed feelings of empowerment. Community membership led to behavioral change in many respondents: 55% asked their doctor more questions, and 50% gave advice to others. Inbound community comments (24,336 posts from 12,187 unique members) reflected the themes offered during interviews as important reasons to participate: 63% of posts asked for or shared cancer information; 98% provided emotional support/understanding; and 84% were inspirational/optimistic. Conclusions: This analysis of the real-world impact of a virtual community provided insight into the benefit that members derive. We hypothesize that once members’ emotional and educational needs were met, they were empowered and/or inspired to take positive actions leading to better health behaviors and increased quality of life—an outcome that may apply to other diseases.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"19 24","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141844932","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Background: Patients with head and neck cancer undergoing treatment report many side effects. Using patient-reported outcomes can assist with care management. Objectives: The purpose of this quality improvement project was to implement the patient-reported outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system, reduce patient hydration visits, and measure provider satisfaction with the PRO-CTCAE survey. Methods: Statistical analysis was conducted using IBM SPSS software. Descriptive statistics for means were used to summarize the data for survey completion rate and for the provider satisfaction questionnaire. A Fisher’s exact test was used to compare hydration visits before and after implementation of the PRO-CTCAE survey. Findings: The PRO-CTCAE surveys had a response rate of 91.2% (323/354) when telehealth visits were omitted. Hydration in the presurvey group was 23.5% (150/637) and in the postsurvey group was 38.5% (165/429), a 15% absolute percentage increase (Fisher’s exact p < .001). Among providers, the positive response rate was 100% for five questions and 88.9% for two questions. Implications: The PRO-CTCAE survey allowed the patient to report their symptoms prior to discussing them with their provider. Providers were able to expedite symptom management and get information to patients in a timely manner. The PRO-CTCAE survey should be considered a part of a multidisciplinary approach to caring for patients.
{"title":"Improving Practice in a Head and Neck Oncology Clinic Using the PRO-CTCAE Tool","authors":"Rose Ann Ruddy, DNP, MSN, RN, ACNP-BC, Brigit Carter, PhD, RN, CCRN, FAAN, Maryanne Giuliante, DNP, MBA, RN, GNP, ANP-C, NEA-BC, HEC-C, AnnMarie Lee Walton, PhD, RN, MPH, OCN, CHES, FAAN","doi":"10.6004/jadpro.2024.15.5.2","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.5.2","url":null,"abstract":"Background: Patients with head and neck cancer undergoing treatment report many side effects. Using patient-reported outcomes can assist with care management. Objectives: The purpose of this quality improvement project was to implement the patient-reported outcome version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measurement system, reduce patient hydration visits, and measure provider satisfaction with the PRO-CTCAE survey. Methods: Statistical analysis was conducted using IBM SPSS software. Descriptive statistics for means were used to summarize the data for survey completion rate and for the provider satisfaction questionnaire. A Fisher’s exact test was used to compare hydration visits before and after implementation of the PRO-CTCAE survey. Findings: The PRO-CTCAE surveys had a response rate of 91.2% (323/354) when telehealth visits were omitted. Hydration in the presurvey group was 23.5% (150/637) and in the postsurvey group was 38.5% (165/429), a 15% absolute percentage increase (Fisher’s exact p < .001). Among providers, the positive response rate was 100% for five questions and 88.9% for two questions. Implications: The PRO-CTCAE survey allowed the patient to report their symptoms prior to discussing them with their provider. Providers were able to expedite symptom management and get information to patients in a timely manner. The PRO-CTCAE survey should be considered a part of a multidisciplinary approach to caring for patients.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"2 5","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141849430","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.6004/jadpro.2024.15.5.3
Paula M. Barrenechea, MPAS, PA-C
The gut microbiome is known to influence health and well-being beyond the gastrointestinal system, including metabolism, mood, and cognitive function. Research on the influence of the gut microbiome on cancer and cancer treatment has expanded in recent decades. This review discusses the effects of the gut microbiome on the pathogenesis of certain cancers, as well as the current guidelines and recommendations for health-care professionals for modifying the gut microbiome in cancer patients currently receiving chemotherapy or immunotherapy. The focus of this review is on five major areas of gut microbiome research (colorectal cancer, melanoma, renal cell carcinoma and non–small cell lung cancer, lymphoma, and acute leukemia) in which therapies, and particularly checkpoint inhibitors, have considerably improved survival outcomes. The relationship between microbial species and therapies to cure malignancies is largely unclear. This review will delineate the relationships being studied and conclusions to draw from the research in these areas thus far.
{"title":"Interaction of the Gut Microbiome With Cancer Treatment","authors":"Paula M. Barrenechea, MPAS, PA-C","doi":"10.6004/jadpro.2024.15.5.3","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.5.3","url":null,"abstract":"The gut microbiome is known to influence health and well-being beyond the gastrointestinal system, including metabolism, mood, and cognitive function. Research on the influence of the gut microbiome on cancer and cancer treatment has expanded in recent decades. This review discusses the effects of the gut microbiome on the pathogenesis of certain cancers, as well as the current guidelines and recommendations for health-care professionals for modifying the gut microbiome in cancer patients currently receiving chemotherapy or immunotherapy. The focus of this review is on five major areas of gut microbiome research (colorectal cancer, melanoma, renal cell carcinoma and non–small cell lung cancer, lymphoma, and acute leukemia) in which therapies, and particularly checkpoint inhibitors, have considerably improved survival outcomes. The relationship between microbial species and therapies to cure malignancies is largely unclear. This review will delineate the relationships being studied and conclusions to draw from the research in these areas thus far.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"12 15","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141849353","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.6004/jadpro.2024.15.8.10
Rebecca Lu, MSN, FNP-C, Joseph D. Tariman, PhD, MBA, ANP-BC, FAAN, Donna Catamero, ANP-BC, OCN, CCRC, Michaela Hillengass, RN, CPT, ACSM, Kimberly Noonan, DNP, ANP-BC, AOCN
Background: Although advancements in multiple myeloma therapy have rapidly evolved, pervasive racial and social inequities prevent uniform benefit across diverse patient populations. This affects access to US Food and Drug Administration–approved treatments and to clinical studies. The impact of health-care inequities is not well understood and thus, the development of effective strategies is inadequate. We identify different disparities including race, age, socioeconomic status, and sexual preference/orientation and their effect on patient care. We explore recommendations for the advanced practitioner to overcome underrepresentation and increase access in myeloma care. Method: We performed a literature review using online databases including PubMed and CINAHL to identify different disparities, barriers to clinical studies, and recommendations to improve access. The following terms were used to identify the most relevant articles: myeloma, bias, diversity, racial disparity, inequity, socioeconomic factors, trial, elderly, sexual orientation, and sexual preference. Findings: Racial and socioeconomic inequities largely affect the survival and quality of care available to underrepresented populations as well as elderly patients. Existing inequities negatively affect study enrollment leading to real world consequences. Structural, clinical, and attitudinal factors further compound the issue of equitable trial engagement. Current recommendations for the advanced practitioner include addressing systemic issues to increase understanding of inequities to mitigate socioeconomic factors that deter equitable access. Conclusion: Understanding the issue of inequities is vital in ensuring myeloma patients are provided appropriate care. Recommendations are rooted in education and improving treatment access. Illuminating the issues of treatment disparities can remove barriers to ensure a more equitable future.
{"title":"Diversity, Equity, and Inclusion in Multiple Myeloma: A Call to Action","authors":"Rebecca Lu, MSN, FNP-C, Joseph D. Tariman, PhD, MBA, ANP-BC, FAAN, Donna Catamero, ANP-BC, OCN, CCRC, Michaela Hillengass, RN, CPT, ACSM, Kimberly Noonan, DNP, ANP-BC, AOCN","doi":"10.6004/jadpro.2024.15.8.10","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.8.10","url":null,"abstract":"Background: Although advancements in multiple myeloma therapy have rapidly evolved, pervasive racial and social inequities prevent uniform benefit across diverse patient populations. This affects access to US Food and Drug Administration–approved treatments and to clinical studies. The impact of health-care inequities is not well understood and thus, the development of effective strategies is inadequate. We identify different disparities including race, age, socioeconomic status, and sexual preference/orientation and their effect on patient care. We explore recommendations for the advanced practitioner to overcome underrepresentation and increase access in myeloma care. Method: We performed a literature review using online databases including PubMed and CINAHL to identify different disparities, barriers to clinical studies, and recommendations to improve access. The following terms were used to identify the most relevant articles: myeloma, bias, diversity, racial disparity, inequity, socioeconomic factors, trial, elderly, sexual orientation, and sexual preference. Findings: Racial and socioeconomic inequities largely affect the survival and quality of care available to underrepresented populations as well as elderly patients. Existing inequities negatively affect study enrollment leading to real world consequences. Structural, clinical, and attitudinal factors further compound the issue of equitable trial engagement. Current recommendations for the advanced practitioner include addressing systemic issues to increase understanding of inequities to mitigate socioeconomic factors that deter equitable access. Conclusion: Understanding the issue of inequities is vital in ensuring myeloma patients are provided appropriate care. Recommendations are rooted in education and improving treatment access. Illuminating the issues of treatment disparities can remove barriers to ensure a more equitable future.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"347 3","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141839081","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.6004/jadpro.2024.15.8.9
Sarah Donahue, MPH, NP, Joanne C. Ryan, PhD, RN, Kimberly Podsada, MSN, NP-C
Advanced practice providers in oncology are now likely to encounter real-world data (RWD) studies in addition to data from randomized controlled trials (RCTs) in their practice. Real-world evidence derived from RWD can provide important information about a therapeutic agent’s effectiveness outside of the confines of RCTs. It is important to understand how these studies are conducted and how data from these two types of studies can be interpreted and integrated for practical clinical use and shared decision-making. The goal of this manuscript is to provide an overview of the fundamental aspects of RWD studies and what is required to conduct a robust RWD study. Recently published studies are cited to demonstrate how RWD studies complement RCTs.
{"title":"A Real-World Evidence Primer for Advanced Practice Providers: Integrating P-Reality X Into Shared Decision-Making for People With HR+/HER2− Metastatic Breast Cancer","authors":"Sarah Donahue, MPH, NP, Joanne C. Ryan, PhD, RN, Kimberly Podsada, MSN, NP-C","doi":"10.6004/jadpro.2024.15.8.9","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.8.9","url":null,"abstract":"Advanced practice providers in oncology are now likely to encounter real-world data (RWD) studies in addition to data from randomized controlled trials (RCTs) in their practice. Real-world evidence derived from RWD can provide important information about a therapeutic agent’s effectiveness outside of the confines of RCTs. It is important to understand how these studies are conducted and how data from these two types of studies can be interpreted and integrated for practical clinical use and shared decision-making. The goal of this manuscript is to provide an overview of the fundamental aspects of RWD studies and what is required to conduct a robust RWD study. Recently published studies are cited to demonstrate how RWD studies complement RCTs.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"70 10","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141840709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.6004/jadpro.2024.15.8.11
Barbara Dean, DMSc, PA-C, DFAAPA
The standard adjuvant treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) is endocrine therapy (ET). Despite this treatment, 20% of patients will have their disease recur. Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors with ET have shown overall survival (OS) benefit in ER-positive, HER2-negative breast cancer in the metastatic setting. Clinical trials are studying the role of oral CDK4/6 inhibitors in the adjuvant treatment of ER-positive, HER2-negative EBC patients who are clinically and pathologically at high risk for recurrence while on standard ET. The monarchE phase III, randomized, controlled trial, looked at one arm of high-risk ER-positive, HER2-negative EBC patients receiving standard ET and the second arm receiving standard ET with a CDK4/6 inhibitor, abemaciclib. Primary endpoint data showed improvement in invasive disease-free survival of 92.2% in the ET and abemaciclib arm vs. 88.7% in the ET arm at 2 years. At 5 years, a preplanned interim analysis showed continued absolute improvement in invasive disease-free survival. Secondary endpoint data for OS have not yet matured. Abemaciclib is approved for use with ET in patients with high-risk, ER-positive, HER2-negative EBC. This article aims to review a case study and the rationale for using oral CDK4/6 inhibitors as adjuvant treatment for this high-risk subset of patients.
雌激素受体（ER）阳性、人类表皮生长因子受体 2（HER2）阴性早期乳腺癌（EBC）的标准辅助治疗方法是内分泌治疗（ET）。尽管采用了这种治疗方法，但仍有 20% 的患者病情会复发。细胞周期蛋白依赖性激酶4和6（CDK4/6）抑制剂与ET一起使用，对ER阳性、HER2阴性的转移性乳腺癌患者的总生存期（OS）有好处。临床试验正在研究口服 CDK4/6 抑制剂在ER 阳性、HER2 阴性 EBC 患者辅助治疗中的作用，这些患者在接受标准 ET 治疗的同时，在临床和病理上都有很高的复发风险。monarchE III 期随机对照试验的研究对象是接受标准 ET 治疗的 ER 阳性、HER2 阴性高风险 EBC 患者，以及接受标准 ET 和 CDK4/6 抑制剂 Abemaciclib 治疗的患者。主要终点数据显示，2年后，ET和abemaciclib治疗组的无侵袭性疾病生存率为92.2%，而ET治疗组为88.7%。5年后，一项预先计划的中期分析显示，无侵袭性疾病生存率继续得到绝对改善。OS的次要终点数据尚未成熟。Abemaciclib已被批准与ET一起用于ER阳性、HER2阴性的高危EBC患者。本文旨在回顾一个病例研究，以及将口服 CDK4/6 抑制剂作为这类高风险亚群患者辅助治疗的理由。
{"title":"Beyond Standard Endocrine Therapy: A New Adjuvant Treatment in High-Risk Early Breast Cancer","authors":"Barbara Dean, DMSc, PA-C, DFAAPA","doi":"10.6004/jadpro.2024.15.8.11","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.8.11","url":null,"abstract":"The standard adjuvant treatment of estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) is endocrine therapy (ET). Despite this treatment, 20% of patients will have their disease recur. Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors with ET have shown overall survival (OS) benefit in ER-positive, HER2-negative breast cancer in the metastatic setting. Clinical trials are studying the role of oral CDK4/6 inhibitors in the adjuvant treatment of ER-positive, HER2-negative EBC patients who are clinically and pathologically at high risk for recurrence while on standard ET. The monarchE phase III, randomized, controlled trial, looked at one arm of high-risk ER-positive, HER2-negative EBC patients receiving standard ET and the second arm receiving standard ET with a CDK4/6 inhibitor, abemaciclib. Primary endpoint data showed improvement in invasive disease-free survival of 92.2% in the ET and abemaciclib arm vs. 88.7% in the ET arm at 2 years. At 5 years, a preplanned interim analysis showed continued absolute improvement in invasive disease-free survival. Secondary endpoint data for OS have not yet matured. Abemaciclib is approved for use with ET in patients with high-risk, ER-positive, HER2-negative EBC. This article aims to review a case study and the rationale for using oral CDK4/6 inhibitors as adjuvant treatment for this high-risk subset of patients.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"69 9","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141844110","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-07-01DOI: 10.6004/jadpro.2024.15.5.4
Nicole Ross, MSN, CRNP, AOCNP
Carcinoid heart disease (CHD) is a rare but potentially life-threatening sequela of advanced neuroendocrine neoplasm with carcinoid syndrome. These tumors can secrete vasoactive substances of which serotonin is the most prevalent. Carcinoid heart disease typically involves the right-sided heart valves and eventually leads to right heart failure. Monitoring N-terminal pro–B-type natriuretic peptide and 5-hydroxyindoleacetic acid at diagnosis and during treatment, as well as cardiac echocardiogram, helps to screen for CHD. Many patients are not screened for this appropriately. Multidisciplinary care for patients with CHD is ideal and involves medical oncology, cardiology, and cardiothoracic surgery.
类癌性心脏病（CHD）是一种罕见但可能危及生命的晚期神经内分泌肿瘤类癌综合征后遗症。这些肿瘤可分泌血管活性物质，其中最常见的是血清素。类癌性心脏病通常累及右侧心脏瓣膜，最终导致右心衰竭。在诊断和治疗期间监测 N 端前 B 型利钠肽和 5-羟基吲哚乙酸以及心脏超声心动图有助于筛查类癌性心脏病。许多患者没有得到适当的筛查。对患有冠心病的患者进行多学科治疗是理想的选择，其中包括肿瘤内科、心脏内科和心胸外科。
{"title":"Carcinoid Heart Disease","authors":"Nicole Ross, MSN, CRNP, AOCNP","doi":"10.6004/jadpro.2024.15.5.4","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.5.4","url":null,"abstract":"Carcinoid heart disease (CHD) is a rare but potentially life-threatening sequela of advanced neuroendocrine neoplasm with carcinoid syndrome. These tumors can secrete vasoactive substances of which serotonin is the most prevalent. Carcinoid heart disease typically involves the right-sided heart valves and eventually leads to right heart failure. Monitoring N-terminal pro–B-type natriuretic peptide and 5-hydroxyindoleacetic acid at diagnosis and during treatment, as well as cardiac echocardiogram, helps to screen for CHD. Many patients are not screened for this appropriately. Multidisciplinary care for patients with CHD is ideal and involves medical oncology, cardiology, and cardiothoracic surgery.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"15 2","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141853968","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-16DOI: 10.6004/jadpro.2024.15.8.2
Gabriel Schwartz, MSN, FNP-BC, AOCNP, Julianne O. Darling, PharmD, BCOP
Cholangiocarcinoma is a cancer of the bile duct frequently diagnosed at a late stage with a poor prognosis. Selective fibroblast growth factor receptor (FGFR) inhibitors have demonstrated efficacy in the treatment of cholangiocarcinoma with FGFR2 fusions or rearrangements, but are associated with hyperphosphatemia, fatigue, and ocular, dermatologic, and gastrointestinal adverse events (AEs). Treatment adherence and patient outcomes can be improved by anticipating and effectively managing the AEs associated with FGFR inhibitors and providing appropriate intervention and patient education. The multidisciplinary care team for patients with cholangiocarcinoma can involve optometrists and advanced practice providers, including nurse practitioners, physician assistants, pharmacists. This review provides practical insights for advanced practice providers on the management of these common AEs associated with selective FGFR inhibitors in the real-world setting, focusing on pemigatinib and futibatinib. Impacts of renal or hepatic impairment, drug–drug interactions, and drug–food interactions are discussed. Also presented are practical recommendations for prophylaxis and supportive care measures, and resources for health-care professionals and patients.
{"title":"Practical Management of Adverse Events Associated With FGFR Inhibitors for Cholangiocarcinoma for the Advanced Practice Provider","authors":"Gabriel Schwartz, MSN, FNP-BC, AOCNP, Julianne O. Darling, PharmD, BCOP","doi":"10.6004/jadpro.2024.15.8.2","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.8.2","url":null,"abstract":"Cholangiocarcinoma is a cancer of the bile duct frequently diagnosed at a late stage with a poor prognosis. Selective fibroblast growth factor receptor (FGFR) inhibitors have demonstrated efficacy in the treatment of cholangiocarcinoma with FGFR2 fusions or rearrangements, but are associated with hyperphosphatemia, fatigue, and ocular, dermatologic, and gastrointestinal adverse events (AEs). Treatment adherence and patient outcomes can be improved by anticipating and effectively managing the AEs associated with FGFR inhibitors and providing appropriate intervention and patient education. The multidisciplinary care team for patients with cholangiocarcinoma can involve optometrists and advanced practice providers, including nurse practitioners, physician assistants, pharmacists. This review provides practical insights for advanced practice providers on the management of these common AEs associated with selective FGFR inhibitors in the real-world setting, focusing on pemigatinib and futibatinib. Impacts of renal or hepatic impairment, drug–drug interactions, and drug–food interactions are discussed. Also presented are practical recommendations for prophylaxis and supportive care measures, and resources for health-care professionals and patients.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"47 49","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139961259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-01DOI: 10.6004/jadpro.2024.15.1.7
Catherine Joseph, MSN, APN, AGACNP-BC
Magnetic resonance imaging (MRI) of the brain is an important diagnostic tool used by neurologists. This article explores the workup and management for a patient with a brain lesion and highlights the importance of neuroimaging. Similarities and differences in MRI findings for meningioma, central nervous system lymphoma, and glioblastomas are discussed, along with common MRI sequences and their utility.
{"title":"Guess What Is in My Brain","authors":"Catherine Joseph, MSN, APN, AGACNP-BC","doi":"10.6004/jadpro.2024.15.1.7","DOIUrl":"https://doi.org/10.6004/jadpro.2024.15.1.7","url":null,"abstract":"Magnetic resonance imaging (MRI) of the brain is an important diagnostic tool used by neurologists. This article explores the workup and management for a patient with a brain lesion and highlights the importance of neuroimaging. Similarities and differences in MRI findings for meningioma, central nervous system lymphoma, and glioblastomas are discussed, along with common MRI sequences and their utility.","PeriodicalId":17176,"journal":{"name":"Journal of the Advanced Practitioner in Oncology","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139887061","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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