Biomarker Pursuit: Keeping Current With Novel Biomarkers in Hematology/Oncology.

In the popular biomarker-focused session at JADPRO Live 2022, presenters paired biomarkers with tumor types for which their expression is most commonly used to determine targeted therapy, identified key assays used to measure common biomarkers, and reviewed recommendations and guidelines for biomarker testing.

Moving beyond ruxolitinib failure in myelofibrosis: evolving strategies for second line therapy.

INTRODUCTION: Ruxolitinib has been the cornerstone of pharmacologic therapy for myelofibrosis for over a decade. However, the last several years have witnessed the regulatory approval of other Janus kinase (JAK) inhibitors for myelofibrosis, i.e. fedratinib, pacritinib, and US approval of momelotinib is widely anticipated in 2023. AREAS COVERED: Due to the multifaceted clinical presentation of myelofibrosis, a watertight definition of ruxolitinib failure has remained elusive, as "progression" on ruxolitinib can take many forms and management is highly nuanced. Yet, the availability of other JAK inhibitors and potential future availability of non-JAK inhibitor agents for myelofibrosis make a consensus on management of ruxolitinib failure critically important. This consensus paper summarizes a discussion between multiple academic and community physician experts, a pharmacist and an advanced practice provider around the issues to be considered for the optimal care of patients with myelofibrosis whose disease is refractory to or does not respond adequately to ruxolitinib, or who exhibit intolerance to ruxolitinib. EXPERT OPINION: The panel identified several areas of consensus, as well as some areas where more data to inform evidence-based practice are needed. In some situations, maintaining ruxolitinib while adding another agent, e.g. to address anemia, is appropriate, whereas in others, switching to a different drug has merit.

Transplantation Referral Patterns for Patients with Newly Diagnosed Higher-Risk Myelodysplastic Syndromes and Acute Myeloid Leukemia at Academic and Community Sites in the Connect® Myeloid Disease Registry: Potential Barriers to Care.

Hematopoietic stem cell transplantation (HCT) is indicated for patients with higher-risk (HR) myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). Age, performance status, patient frailty, comorbidities, and nonclinical factors (eg, cost, distance to site) are all recognized as important clinical factors that can influence HCT referral patterns and patient outcomes; however, the proportion of eligible patients referred for HCT in routine clinical practice is largely unknown. This study aimed to assess patterns of consideration for HCT among patients with HR-MDS and AML enrolled in the Connect® Myeloid Disease Registry at community/government (CO/GOV)- or academic (AC)-based sites, as well as to identify factors associated with rates of transplantation referral. We assessed patterns of consideration for and completion of HCT in patients with HR-MDS and AML enrolled between December 12, 2013, and March 6, 2020, in the Connect Myeloid Disease Registry at 164 CO/GOV and AC sites. Registry sites recorded whether patients were considered for transplantation at baseline and at each follow-up visit. The following answers were possible: "considered potentially eligible," "not considered potentially eligible," or "not assessed." Sites also recorded whether patients subsequently underwent HCT at each follow-up visit. Rates of consideration for HCT between CO/GOV and AC sites were compared using multivariable logistic regression analysis with covariates for age and comorbidity. Among the 778 patients with HR-MDS or AML enrolled in the Connect Myeloid Disease Registry, patients at CO/GOV sites were less likely to be considered potentially eligible for HCT than patients at AC sites (27.9% versus 43.9%; P < .0001). Multivariable logistic regression analysis with factors for age (<65 versus ≥65 years) and ACE-27 comorbidity grade (<2 versus ≥2) showed that patients at CO/GOV sites were significantly less likely than those at AC sites to be considered potentially eligible for HCT (odds ratio, 1.6, 95% confidence interval, 1.1 to 2.4; P = .0155). Among patients considered eligible for HCT, 45.1% (65 of 144) of those at CO/GOV sites and 35.7% (41 of 115) of those at AC sites underwent transplantation (P = .12). Approximately one-half of all patients at CO/GOV (50.1%) and AC (45.4%) sites were not considered potentially eligible for HCT; the most common reasons were age at CO/GOV sites (71.5%) and comorbidities at AC sites (52.1%). Across all sites, 17.4% of patients were reported as not assessed (and thus not considered) for HCT by their treating physician (20.7% at CO/GOV sites and 10.7% at AC sites; P = .0005). These findings suggest that many patients with HR-MDS and AML who may be candidates for HCT are not receiving assessment or consideration for transplantation in clinical practice. In addition, treatment at CO/GOV sites and age remain significant barriers to ensuring that all potentially eligible patients are assessed for HCT.

Survey of patients and physicians on shared decision-making in treatment selection in relapsed/refractory multiple myeloma.

Shared decision-making (SDM) is a key component of patient-centered healthcare. SDM is particularly pertinent in the relapsed and/or refractory multiple myeloma (RRMM) setting, in which numerous treatment options can present challenges for identifying optimal care. However, few studies have assessed the extent and relevance of SDM and patient-centered communication (PCC) in RRMM. To describe treatment decision-making patterns between physicians and patients in the RRMM setting, we conducted online surveys of patients and physicians in the USA to compare their perspectives on the process of treatment decision-making. We analyzed the surveys descriptively. Two hundred hematologists/oncologists and 200 patients with RRMM receiving second-line (n = 89), third-line (n = 65), and fourth-line (n = 46) therapy participated. Top treatment goals for physicians and patients included extending overall survival (among 76% and 83% of physicians and patients, respectively) and progression-free survival (among 54% and 77% of physicians and patients, respectively), regardless of the number of prior relapses. Thirty percent of physicians believed patients preferred a shared approach to treatment decision-making, while 40% of patients reported most often preferring a shared role in treatment decision-making. One-fourth of patients most often preferred physicians to make the final treatment decision after seriously considering their opinion. Thirty-two percent of physicians and 16% of patients recalled ≥3 treatment options presented at first relapse. Efficacy was a primary treatment goal for patients and physicians. Discrepancies in their perceptions during RRMM treatment decision-making exist, indicating that communication tools are needed to facilitate SDM and PCC.

Shared decision-making (SDM) is an important facet of patient-centered healthcare. Multiple myeloma (MM) is a cancer of the bone marrow that can return (relapse) after treatment. SDM may be especially pertinent for relapsed MM as there is no uniform standard of care and treatment selection can be complex. Few studies have examined the extent and relevance of SDM and patient-centered communication (PCC) in this relapsed and/or refractory (RRMM) setting. We conducted online surveys of 200 patients who had received 1­3 previous therapies and 200 physicians to compare treatment decision-making patterns in RRMM in the USA. Both physicians and patients felt that extending patient survival was a top treatment goal, regardless of the number of prior relapses. A lower percentage of physicians believed patients preferred a shared approach to treatment decision-making than patients who reported preferring such a shared role. Twice as many physicians than patients recalled ≥3 treatment options presented at first relapse. In conclusion, while improving survival was an important treatment goal for physicians and patients, there are discrepancies in physician and patient perceptions during RRMM treatment decision-making. Thus, communication tools are needed to facilitate SDM and PCC.

The Prevention of COVID-19 in High-Risk Patients Using Tixagevimab-Cilgavimab (Evusheld): Real-World Experience at a Large Academic Center.

BACKGROUND: Coronavirus disease 2019 (COVID-19) is associated with increased morbidity and mortality among immunocompromised patients. Tixagevimab-cilgavimab (Tix-Cil) is a combination of 2 monoclonal antibodies approved for the prevention of COVID-19 complications in this high-risk group. METHODS: We retrospectively reviewed the charts of patients who received Tix-Cil during the Omicron variant period (January 17 to April 23, 2022), with a follow-up period until May 24, 2022. We collected data about patient underlying comorbidities and post Tix-Cil COVID-19 infections, deaths, and hospitalizations. RESULTS: There were 463 patients with a median age of 68 years, of which 51% were male, 79% White, 13.2% Hispanic, 1.7% Black/African American, and 5.8% identified as Other. A total of 18% had undergone a solid organ transplantation or hematopoietic stem cell transplantation. Only 6/98 (6.1%) had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detected by polymerase chain reaction (PCR) at a median 48 days (interquartile range [IQR] 27.5, 69) follow-up. Forty-two patients (9.1%) were hospitalized, and 4 (0.9%) died, but none were attributed to COVID-19 or Tix-Cil. One hospitalized patient had an incidental, asymptomatic, positive SARS-CoV 2 by PCR. The median days from Tix-Cil administration to non-COVID-19-related hospitalization and death were 30 (IQR 17, 55) and 53 (IQR 18, 91), respectively. CONCLUSION: Tix-Cil provides protection against COVID-19 complications in immunocompromised patients with suboptimal immune responses to vaccines.

Biomarker Jeopardy.

In the popular Biomarker Jeopardy session, Sandra E. Kurtin, PhD, ANP-C, AOCN®, Alyssa Henglefelt, PharmD, BCOP, and Haleigh Mistry, MS, PA-C, paired biomarkers with tumor types for which their expression is most commonly used to determine targeted therapy, identified key assays used to measure common biomarkers, and discussed guidelines for biomarker testing.

Improving patient understanding and outcomes in myelodysplastic syndromes - An animated patient guide to MDS with visual formats of learning.

Objectives: Patient education resources that address barriers to health literacy to improve understanding and outcomes in myelodysplastic syndromes (MDS) are limited. The aim of this study was to evaluate the impact and outcomes benefits of An Animated Patient's Guide to Myelodysplastic Syndromes (MDS) cancer educational modules (which includes the 'You and MDS' website and YouTube hosted resources) related to MDS education, awareness, understanding and health outcomes. Methods: This was a retrospective study of learner feedback, metrics, and utilization data from July 2018 to August 2021. We evaluated audience reach (number of visit sessions, unique visitors, page views) and calculated top views by media type (animation, expert video, patient video, and slide show) and top retention videos from the modules. We also assessed the educational impact and utilization through learner feedback surveys. Results: During the study period, 'You and MDS' had 233,743 views worldwide of which 104,214 were unique visitors and 78,161 (or 76% unique visitors) were from the United States. Of these, 61% were patients; 29% family members or caregivers; 5% were healthcare providers and 5% represented other groups. Most popular topics viewed among the animations were "Understanding Myelodysplastic Syndromes (MDS)" (40,219 views), "Managing and Treating MDS" (19,240 views), "Understanding Erythropoiesis" (17,564 views.) The most popular expert videos viewed were "What is iron overload, and how it is treated?" (20,310 views), "How serious a cancer is MDS? What is the prognosis for MDS?" (8,327 views), "What is MDS?" (3,157 views). Of participants who completed the online feedback survey, ≥ 95% reported improved knowledge gains and commitments to change. Conclusions: MDS patients using 'You and MDS - An Animated Patient's Guide to MDS' and its visual formats of learning represented a wide U.S. and global learner audience. This MDS educational resource had a significant impact on improved understanding among patients, families, and caregivers. Continued efforts should be made to provide patient-effective resources that address health literacy, improve patient understanding, and address educational needs that respond to the concerns of patients to achieve better quality of life and improved health outcomes in MDS.

Implementation of an Oral Antineoplastic Therapy Program: Results From a Pilot Project.

BACKGROUND: The Oncology Care Model requires implementation of processes to reduce urgent care (UC), emergency department (ED), and hospital visits for patients on antineoplastic therapies, including oral antineoplastic agents. OBJECTIVES: The purpose of this project was to develop, implement, and initially evaluate an oral antineoplastic therapy program (OAP) and an oncology antineoplastic nurse navigator (OANN) role aimed at reducing UC, ED, and hospital visits. METHODS: This pilot project used a descriptive correlational design to analyze the impact of the novel role of the OANN on UC, ED, and hospital visits. FINDINGS: The OANN engaged 1,095 patients between January 1, 2019, and December 31, 2020. A reduction in UC, ED, and hospital visits was noted between 2019 and 2020 for patients followed by the OANN and enrolled in the OAP. Patients who were contacted by the OANN three or more times after starting their oral antineoplastic agent were less likely to be seen in UC or the ED or to be hospitalized. The novel role of the OANN within the overall OAP provided a significant benefit in reducing UC and ED visits and hospitalization for patients enrolled in the program.

Biomarker Jeopardy.

The popular Biomarker Jeopardy session returned this year at JADPRO Live 2020. Sandra E. Kurtin, PhD, ANP-C, AOCN®, led the session, and was joined by Alyssa Henglefelt, PharmD, BCOP, and Allyson Price, PA-C. Using a Jeopardy format, they identified specific biomarkers while discussing targeted therapies and class effects APs should be aware of.

Optimizing Treatment of Chronic Lymphocytic Leukemia.

During JADPRO Live Virtual 2020, Sandra Kurtin, PhD, ANP-C, AOCN®, described personalization of the treatment of chronic lymphocytic leukemia (CLL) using molecular attributes of the disease, as well as patient characteristics. Dr. Kurtin discussed front-line treatment in previously untreated patients, treatment for relapsed or refractory CLL, and how to prevent, mitigate, and manage adverse events in order to optimize treatment.

Real-world diagnostic testing patterns for assessment of ring sideroblasts and SF3B1 mutations in patients with newly diagnosed lower-risk myelodysplastic syndromes.

INTRODUCTION: The presence of ring sideroblasts (RS) and mutation of the SF3B1 gene are diagnostic of lower-risk (LR) myelodysplastic syndromes (MDS) and are correlated with favorable outcomes. However, information on testing and reporting in community-based clinical settings is scarce. This study from the Connect® MDS/AML Disease Registry aimed to compare the frequency of RS and SF3B1 reporting for patients with LR-MDS, before and after publication of the 2016 World Health Organization (WHO) MDS classification criteria. METHODS: Ring sideroblasts assessment and molecular testing data were collected from patients with LR-MDS at enrollment in the Registry. Patients enrolled between December 2013 and the data cutoff of March 2020 were included in this analysis. RESULTS: Among 489 patients with LR-MDS, 434 (88.8%) underwent RS assessment; 190 were assessed prior to the 2016 WHO guidelines (Cohort A), and 244 after (Cohort B). In Cohort A, 87 (45.8%) patients had RS identified; 29 (33.3%) patients had RS < 15%, none of whom underwent molecular testing for SF3B1. In Cohort B, 96 (39.3%) patients had RS identified; 31 (32.3%) patients had < 15% RS, with 13 undergoing molecular testing of which 10 were assessed for SF3B1. CONCLUSIONS: In the Connect® MDS/AML Registry, only 32% of patients with <15% RS underwent SF3B1 testing after the publication of the WHO 2016 classification criteria. There was no change in RS assessment frequency before and after publication, despite the potential impact on diagnostic subtyping and therapy selection, suggesting an unmet need for education to increase testing rates for SF3B1 mutations.

Diagnostic and molecular testing patterns in patients with newly diagnosed acute myeloid leukemia in the Connect® MDS/AML Disease Registry.

Diagnostic and molecular genetic testing are key in advancing the treatment of acute myeloid leukemia (AML), yet little is known about testing patterns outside of clinical trials, especially in older patients. We analyzed diagnostic and molecular testing patterns over time in 565 patients aged ≥ 55 years with newly diagnosed AML enrolled in the Connect® MDS/AML Disease Registry (NCT01688011) in the United States. Diagnostic data were recorded at enrolment and compared with published guidelines. The percentage of bone marrow blasts was reported for 82.1% of patients, and cellularity was the most commonly reported bone marrow morphological feature. Flow cytometry, karyotyping, molecular testing, and fluorescence in situ hybridization were performed in 98.8%, 95.4%, 75.9%, and 75.7% of patients, respectively. Molecular testing was done more frequently at academic than community/government sites (84.3% vs 70.2%; P < .001). Enrolment to the Registry after 2016 was significantly associated with molecular testing at academic sites (odds ratio [OR] 2.59; P = .023) and at community/government sites (OR 4.85; P < .001) in logistic regression analyses. Better understanding of practice patterns may identify unmet needs and inform institutional protocols regarding the diagnosis of patients with AML.

Clinical Trial Design and Drug Approval in Oncology: A Primer for the Advanced Practitioner in Oncology.

Evidenced-based practice requires timely and accurate integration of scientific advances. This presents a challenge for the oncology clinician given the robust pace of scientific discovery and the increasing number of new drug approvals and expanded indications for previously approved drugs. All currently available antineoplastic therapies have been developed through the clinical trials process. Advanced practitioners (APs) in oncology are often involved in the conduct of clinical trials as primary investigators, sub-investigators, study coordinators, or in the delivery and monitoring of care to patients enrolled in these trials. A prerequisite to evidenced-based practice is understanding how clinical trials are conducted and how to critically analyze published results of studies leading to U.S. Food & Drug Administration approval. Any AP involved in the clinical management and supportive care of patients receiving antineoplastic therapies should be able to critically review published data to glean findings that warrant a change in practice. The goals of this manuscript are to summarize key elements of the clinical trial process for oncology drug development and approval in the United States and to provide a primer for the interpretation of clinical data.

Biomarker BINGO.

This JADPRO Live session tested attendees' knowledge on biomarkers and their use in determining targeted therapy for certain tumor types, key assays used to measure common biomarkers, and guideline-endorsed biomarker testing recommendations.

Integrating Touchscreen-Based Geriatric Assessment and Frailty Screening for Adults With Multiple Myeloma to Drive Personalized Treatment Decisions.

PURPOSE: Geriatric assessment (GA) results predict toxicity/survival in older adults, yet GA is not routinely used in care for patients with multiple myeloma (MM). We tested a tablet-based modified GA (mGA) providing real-time results to clinicians. METHODS: One hundred sixty-five patients with MM aged ≥ 65 years facing a treatment decision from 4 sites completed a tablet-based mGA with Katz Activities of Daily Living (ADL), Lawton Instrumental ADL, Charlson Comorbidity Index, and variables from the Cancer and Aging Research Group's Chemotherapy Toxicity Calculator. Providers reviewed the assessment results at the treatment visit. RESULTS: Patients were white (72%; n = 86), mean age was 72 years (range, 65-85 years), and averaged 7.71 minutes (range, 2-17 minutes) for survey completion. Providers averaged 3.2 minutes (range, 1-10 minutes) to review mGA results. Using International Myeloma Working Group frailty score, patients were fit (39%; n = 64), intermediate fit (33%; n = 55), or frail (28%; n = 46). Providers selected more aggressive treatments in 16.3% of patients and decreased treatment intensity in 34% of patients; treatment intensification was more common for fit patients and milder treatments for frail patients (χ2 = 20.02; P < .0001). Transplant eligibility significantly correlated with fit status and transplant ineligibility with frail status (P = .004). Outcomes on 144 patients 3 months post study visit showed 19.4% (n = 28) had grade ≥ 3 hematologic toxicities, 38.9% (n = 56) had dose modifications, and 18% (n = 26) had early therapy cessation. CONCLUSION: Limited patient time required for survey completion and provider time for results review show mGA can be easily incorporated into clinical workflow. Real-time mGA results indicating fit/frailty status influenced treatment decisions.

Interdisciplinary Management of Acute Leukemia Across the Continuum of Care.

OBJECTIVE: To describe the interdisciplinary management of acute leukemias across the continuum of care. DATA SOURCE: Literature review and experiential knowledge. CONCLUSION: Acute leukemia, including acute myelogenous leukemia, acute promyelocytic leukemia, and acute lymphoblastic leukemia, represent a heterogeneous group of hematologic malignancies with complex diagnostic requirements that drive risk-adapted treatment selection. Involvement of clinicians from a variety of specialties and disciplines is required to ensure safe and effective treatment, mitigate adverse events, and maintain or improve quality of life. Patient-centered communication, shared decision-making, and interdisciplinary communication are integral to patient outcomes. IMPLICATIONS FOR NURSING PRACTICE: Oncology clinicians play a primary role in coordinating the interdisciplinary team and navigating the patient and caregiver experience across the acute leukemia continuum.

Pain Management in the Cancer Survivor.

OBJECTIVES: To describe assessment and interdisciplinary management of pain in the cancer survivor over the continuum of cancer care. DATA SOURCES: Review of the literature and treatment standards. CONCLUSION: Pain remains a primary concern throughout the cancer trajectory across all age groups and diagnoses, emphasizing the need to integrate pain assessment and management across the continuum of cancer survivorship and across care settings. Types of pain, pain patterns, assessment of cancer pain in cancer survivors, current strategies and challenges for management, and effective communication and documentation of the process are described. Communication between and among health care clinicians in a way that effectively articulates the individual patient experience, including documentation in the electronic medical record, requires consistent workflows and terminology. The opioid crisis increases the urgency in effective strategies for interdisciplinary pain assessment and management. IMPLICATIONS FOR NURSING PRACTICE: Oncology clinicians must be able to adequately assess pain, track pain over time, understand and implement a cadre of strategies to manage pain, and effectively pursue any suspicious pain patterns that may indicate recurrence or progression of cancer or other underlying etiologies. The oncology nurse is at the core of patient-clinician communication, critical to effectively describing pain as experienced by the individual patient and continues to play a key role in maintaining consistency of message that is necessary to manage pain over the continuum of cancer survivorship.