Lenalidomide plus rituximab (R2 ) in previously untreated marginal zone lymphoma: subgroup analysis and long-term follow-up of an open-label phase 2 trial.

Lack of consensus for first-line marginal zone lymphoma (MZL) treatment and toxicities associated with currently available systemic therapies have inspired evaluation of immunotherapeutic agents yielding robust outcomes with improved tolerability. We previously reported durable efficacy with first-line lenalidomide and rituximab (R2 ) in follicular lymphoma, MZL and small lymphocytic lymphoma with a subsequent long-term follow-up shown here in MZL patients. This phase 2 investigator-initiated study included previously untreated, stage III/IV MZL patients treated with lenalidomide 20 mg/day on days 1-21 and rituximab 375 mg/m2 on day 1 of each 28-day cycle, continuing in responders for ≥6-12 cycles. The primary endpoint was overall response rate (ORR); secondary endpoints were complete and partial response (CR, PR), safety, and progression-free survival (PFS). The ORR was 93% with 70% attaining CR/CR unconfirmed. At median follow-up of 75·1 months, median PFS was 59·8 months and 5-year OS was 96%. Most non-haematological adverse events (AE) were grade 1/2. Grade 3 haematological AEs were neutropenia (33%) and leucopenia (7%), and grade 4 were leucopenia (3%) and thrombocytopenia (3%). Two patients died of secondary malignancies; no treatment-related fatalities occurred. With extended follow-up, outcomes for MZL patients receiving R2 were robust with no unexpected late or delayed toxicities.

Consensus Building to Identify Nursing Research Priorities Among Oncology Nurses: A Delphi Study in a National Cancer Institute-Designated Comprehensive Cancer Center.

BACKGROUND: To advance oncology nursing science and clinical practice, researchers and clinicians must understand the important real-world concerns of nurses who provide direct care to people with cancer or manage processes that support patient care. OBJECTIVE: This study developed a comprehensive compendium of real-world concerns among oncology nurses and built consensus regarding their importance. METHODS: Using Delphi survey methodology, this prospective, descriptive study was performed in 3 phases: (1) identification of experts, defined as registered nurses (RNs) employed within a comprehensive cancer center; (2) qualitative content analysis of 353 responses from 267 RNs who responded to the question, "What do you see as nursing research concerns, problems, and/or issues on your unit or in your work environment that needs to be studied?"; and (3) rating the importance of 62 research themes identified from the qualitative content analysis (n = 247 RNs). RESULTS: The top research priority was patient safety followed by patient education, oncologic emergencies, patient expectations and adherence with care, team communication, patient psychosocial needs, patient-reported outcomes and quality of life, healthcare team burnout, workload, and nurse burnout. CONCLUSIONS: The findings support the nursing discipline's fundamental focus on patient safety, the top-rated nursing research priority, along with other patient-related and work environment issues. IMPLICATIONS FOR PRACTICE: Oncology nursing is complex and complicated. This study identified and prioritized the real-world concerns, issues, and problems of oncology RNs who provide direct care or manage the processes that support care, supporting the need to focus on patient-related and work environment research.

Implementation and Evaluation of a Clinical Trial Communication Tool for Frontline Clinical Staff.

The safe care of individuals enrolled in clinical trials requires careful communication and coordination between research and clinical staff. An interprofessional team developed a process improvement plan to design, implement.

Reconciliation and Disposal of Oral Medication: Creating a Safe Process for Clinical Research Personnel.

Clinical research nurses and non-licensed study coordinators observed variation in procedures for reconciliation and disposal of oral investigational medications across the institution. An academic medical center implemented a quality improvement project to standardize the process of reconciliation and disposal of oral investigational medications. An interprofessional collaborative workgroup was formed, which led to multiple interventions to standardize practice, including revision of three policies and procedures, redesign of specific work areas to establish drug-counting rooms, review of personal protective equipment requirements, revision of educational training, and regular cleaning of potentially contaminated workstations.

Ethical Challenges Encountered by Clinical Trials Nurses: A Grounded Theory Study.

OBJECTIVES: To investigate the ethical challenges experienced by oncology clinical trials nurses (OCTNs) during the management of CTs and to examine how they resolve those conflicts. SAMPLE & SETTING: 12 licensed RNs who had been practicing as full- or part-time OCTNs for a minimum of two years at various academic medical centers in the United States. METHODS & VARIABLES: Classical grounded theory (CGT), an inductive methodology used to explore a social process in which little is known and to develop a theory grounded in the data, was used, in addition to CGT data analysis strategies. RESULTS: CGT data analysis revealed the OCTNs' main concern (implementing an undefined job) and the way in which the OCTNs resolve this concern through the process of figuring it out. Figuring it out consists of learning as they go, utilizing their assets, standing their ground, and managing hope. IMPLICATIONS FOR NURSING: Although some nursing research provides examples of ethical challenges OCTNs might encounter in practice, there is little information regarding how nurses manage those encounters. A theoretical understanding of the OCTNs' experiences managing ethical challenges fills a gap in the nursing literature and provides a framework for how OCTNs manage and respond to challenges in professional practice.

Immune-Mediated Therapies in Lymphoma.

OBJECTIVE: To review types of lymphoma, risk factors, and evaluate novel immune-mediated therapies, including side effects and management of immune-mediated toxicities. DATA SOURCE: Published literature, national statistics, and Web sites. CONCLUSION: Novel biologic agents are being developed with the potential to improve outcomes. However, these novel agents pose unique and sometimes serious adverse events. IMPLICATIONS FOR NURSING PRACTICE: The immune-mediated adverse events require a multidisciplinary approach and early identification. It is imperative providers and nurses are educated on the management of the unique toxicities caused by lymphoma treatment.

Toxicity Management: Development of a Novel and Immune-Mediated Adverse Events Algorithm
.

BACKGROUND: Novel immunotherapy and biologic agents are being developed with the potential to improve outcomes and reduce long-term toxicities among individuals with hematologic malignancies. These emerging drugs affect neoplastic cells and the surrounding microenvironment, causing unique immune-mediated toxicities.
. OBJECTIVES: The aim was to develop an algorithm for clinical staff to manage unique toxicities associated with next-generation immunotherapies indicated in the hematologic population, using a system-focused approach.
. METHODS: Data were collected using specific toxicities based on the four major novel biologic classes. Immune-mediated adverse events were reported across studies. Based on published literature, institutional experience, and group consensus, a novel algorithm for managing immune-mediated toxicities was created.
. FINDINGS: The development of this treatment algorithm provides a more streamlined approach for managing common but unique toxicities and improves safety, compliance, patient outcome, and quality of life with novel immuno-oncologic agents.