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Background: Clinical Research Nurses practice across a wide spectrum of roles and settings within the global research enterprise. Clinical Research Nurses working with clinical trials face a dual fidelity in their role, balancing integrity of the protocol and quality care for participants. Aims: The purpose of this study was to describe Clinical Research Nurses' experiences in clinical trials, educational preparation, and career pathways, to gain a deeper understanding of clinical research nursing contributions to the clinical research enterprise. Methods: An internet-based survey was conducted to collect demographic data and free text responses to four open-ended queries related to the experience of nurses working in clinical trials research, educational preparation, and role pathways. Qualitative content analysis was used to analyze free text responses. The study was guided by the Clinical Research Nursing Domain of Practice and Duffy's Quality Caring Model of relationship centered professional encounters. Results: Forty clinical research nurses responded to the open-ended questions with themes related to dual fidelity to study participants and protocols, relationships and nursing care, interdisciplinary team membership and contributing to science, emerging from the data. Gaps in educational preparation and professional pathways were identified. Conclusion: This study provides insights to unique clinical research nurse practice contributions in the clinical trial research enterprise within a context of Duffy's Quality Caring Model. [ABSTRACT FROM AUTHOR]

The article presents questions and answers related to oncology nursing. The first question is about the best strategy for the management of acneiform rashes resulting from gefitinib therapy. The second and final question is about the clinical applications of magnetic resonance imaging in patients with multiple myeloma.

The article discusses the clinical management of epidermal growth-factor receptor inhibitors (EGFRIs) dermatologic toxicities related to nursing. Nursing diagnosis is a clinical judgment about individual, family or community responses to actual health problems. The potential for infection is stated to be high in cases where EGFRIs are combined with chemotherapy. Nurses are suggested to work towards proper patient education about rashes caused in the therapy.

Numerous receptor tyrosine kinases, including vascular endothelial growth factor receptor (VEGFR), epidermal growth factor (EGFR), and platelet-derived growth factor receptor (PDGFR), have been implicated in the pathogenesis of solid and nonsolid tumors such as chronic myelogenous leukemia (CML), acute myeloid leukemia (AML), hereditary endocrine tumors, and gastrointestinal stromal tumor (GIST). Multikinase inhibitors, a new class of targeted compounds, have demonstrated their activity in various cancers (e.g., imatinib in GIST/CML). Targeted therapeutics are designed to increase efficacy and minimize adverse events (AEs) by inhibiting certain proteins with high specificity. Several MKIs are currently under investigation in clinical trials, including AMG 706, an oral MKI with antiangiogenesis and direct antitumor activity. AMG 706 potently inhibits VEGFR, PDGFR, and Kit in preclinical models. A broad phase I trial in subjects with advanced solid tumors has completed, and additional phase 1b and phase 2 mono therapy and combination therapy trials are ongoing in imatinib-resistant GIST, thyroid cancer, breast cancer, NSCLC, colorectal cancer, and others. To familiarize oncology nurses with the mechanism of action (MOA) of MKIs, the most common AEs seen with AMG 706 and strategies for patient care. We explored the toxicities and pharmacokinetics of AMG 706 in 71 patients with solid tumors treated in a dose-escalating phase I study. AEs were manageable and most commonly included hypertension (34%), fatigue (37%), headache (24%), nausea (18%), vomiting (11%), and diarrhea (27%). The AE requiring most attention with AMG 706 monotherapy is hypertension, which may be related to VEGF inhibition. Nurses need to pay special attention to management of hypertension. Patient education is also crucial. Antihypertensive medications are often sufficient, and in cases of uncontrolled hypertension, a dose reduction and/or consultation with a cardiologist are suggested. Importantly, when MKIs are withheld or discontinued, blood pressures usually return to baseline. Other predictable and manageable AEs of AMG 706 include diarrhea and headache. In contrast, some MKIs lead to drug accumulation and/or other toxicities that may require interrupted dosing schedules. MKIs such as AMG 706 are increasingly used for cancer treatment. It is critical for oncology nurses to familiarize themselves with the MOA of MKIs and their potential toxicities. [ABSTRACT FROM AUTHOR]

Purpose: Ibrutinib has transformed the management of chronic lymphocytic leukemia (CLL), though its use is limited by toxicity and resistance. In this study, we utilized an "add on" approach for patients who had been treated with ibrutinib in the front-line or relapsed/refractory settings with detectable MRD. Umbralisib and ublituximab (U2) were added on to ibrutinib, patients were treated until achieving undetectable-MRD (U-MRD), and then they entered a period of treatment-free observation (TFO)., Patients and Methods: Patients were eligible if they received ibrutinib in any line of therapy for at least 6 months and had detectable MRD (flow cytometry, <1 cell in 10-4 cutoff for U-MRD). U2 was added to ibrutinib, and patients were monitored serially for MRD. Once U-MRD was achieved or a total of 24 cycles were administered, patients entered a period of TFO. The primary study objective was rate of U-MRD. Secondary endpoints included safety and durability of clinical benefit after treatment discontinuation., Results: Twenty-eight patients were enrolled of whom 27 were evaluable for efficacy. Patients received ibrutinib for a median of 21 months (range 7-67) prior to study enrollment. Fourteen patients (52%) have achieved U-MRD per protocol whereas 78% had at least one U-MRD evaluation. Seventeen patients (63%) have entered TFO after a median of 6.4 months on triplet therapy. Progression-free survival at 12 months was estimated at 95%. Grade ≥3 adverse events were hypertension 7%, diarrhea 4%, and increased ALT/AST 4%., Conclusions: This triplet approach utilizes the addition of U2 to ibrutinib as an MRD-driven time-limited therapy. This therapy was well tolerated and effective. TFO following this therapy appears durable in ongoing follow-up., (©2022 American Association for Cancer Research.)

Purpose: AMG 706 is an investigational, orally bioavailable inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, platelet-derived growth factor receptor, and stem-cell factor receptor. This phase I, dose-finding study evaluated the safety, pharmacokinetics, and pharmacodynamics of AMG 706 in patients with refractory advanced solid tumors., Patients and Methods: AMG 706 was administered at escalating doses of 50 to 175 mg once daily or 25 mg bid for the first 21 days of a 28-day cycle. The 125-mg once-daily dose was also administered continuously. The maximum-tolerated dose (MTD), safety, pharmacokinetics, tumor response, and serum levels of proangiogenic markers were determined., Results: Seventy-one patients received AMG 706. The MTD was 125 mg once daily administered continuously. The most frequent adverse events were fatigue (55%), diarrhea (51%), nausea (44%), and hypertension (42%). Plasma AMG 706 concentrations increased in a dose-proportional manner with no accumulation after multiple doses. Five patients (7%) had a partial response, 35 patients (49%) had stable disease (at least through day 50), and 31 patients (44%) had progressive disease. Changes in tumor size correlated significantly with an increase in placental growth factor (P = .003) and a decrease in soluble kinase domain receptor (P = .001)., Conclusion: In this study of patients with advanced refractory solid tumors, AMG 706 was well tolerated and displayed favorable pharmacokinetics and evidence of antitumor activity. Additional studies of AMG 706 as monotherapy and in combination with various agents are ongoing.

Objectives: To update the success and obstacles using therapies targeted to the epidermal growth factor receptor including IMC-C225, ZD1839, and OSI-774., Data Sources: Research articles, textbooks, clinical protocols, case studies., Conclusions: Ongoing studies show promise using monoclonal antibodies and small-molecule tyrosine kinase inhibitors in the treatment of non-small cell lung cancer and other malignancies. Such therapies can be delivered with limited toxicity to the host, and initial studies have shown single-agent efficacy and efficacy in combination with chemotherapy and/or radiation therapy., Implications for Nursing Practice: Nurses are directly involved in the delivery of these novel therapies and the management of associated toxicities. They serve to coordinate treatment protocols and help to ensure patient understanding and compliance.