Publications by authors named "Mulvey T"

Optimal timing and dosing of adjuvant cyclin-dependent kinase (CDK) 4/6 inhibitor in early breast cancer is controversial. This prospective phase II clinical trial investigated tolerability and safety of two ribociclib dosing schedules. Patients with stage I-III hormone receptor-positive (HR+)/HER2- breast cancer on adjuvant endocrine therapy (ET) were randomized to two ribociclib dosing schedules: 400 mg continuous vs 600 mg intermittent, with initiation in early (prior ET < 2 years) vs delayed (prior ET ≥ 2 years) setting.

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Purpose: To update the American Society of Clinical Oncology (ASCO)-Oncology Nursing Society (ONS) standards for antineoplastic therapy administration safety in adult and pediatric oncology and highlight current standards for antineoplastic therapy for adult and pediatric populations with various routes of administration and location.

Methods: ASCO and ONS convened a multidisciplinary Expert Panel with representation of multiple organizations to conduct literature reviews and add to the standards as needed. The evidence base was combined with the opinion of the ASCO-ONS Expert Panel to develop antineoplastic safety standards and guidance.

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Purpose: Long-term outcomes of patients with stage I human epidermal growth factor receptor 2 (HER2)-positive breast cancer receiving adjuvant trastuzumab emtansine (T-DM1) remain undefined, and prognostic predictors represent an unmet need.

Methods: In the ATEMPT phase II trial, patients with stage I centrally confirmed HER2-positive breast cancer were randomly assigned 3:1 to adjuvant T-DM1 for 1 year or paclitaxel plus trastuzumab (TH). Coprimary objectives were to compare the incidence of clinically relevant toxicities between arms and to evaluate invasive disease-free survival (iDFS) with T-DM1.

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Purpose: To update the ASCO-Oncology Nursing Society (ONS) standards for antineoplastic therapy administration safety in adult and pediatric oncology and highlight current standards for antineoplastic therapy for adult and pediatric populations with various routes of administration and location.

Methods: ASCO and ONS convened a multidisciplinary Expert Panel with representation of multiple organizations to conduct literature reviews and add to the standards as needed. The evidence base was combined with the opinion of the ASCO-ONS Expert Panel to develop antineoplastic safety standards and guidance.

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The American Nurses Association Enterprise (ANA Enterprise) Research Advisory Council plays a vital role in bringing nursing voices together and shaping the dynamic landscape of nursing research. Historically, its priorities have revolved around 4 pivotal research priorities: advancing research capacity, promoting interprofessional collaboration, enhancing data structures and governance, and propelling practice-based nursing research. In a remarkable transition, the 2024 Research Priorities of the ANA Enterprise Research Advisory Council align with the vision and strategic goals of the ANA Enterprise.

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Delivering oncologic care via telemedicine has presented a unique set of benefits and challenges. Discussions of sensitive topics between patients and providers can be difficult on a virtual platform. Although it was imperative to utilize telemedicine to keep cancer patients safe during the height of the pandemic, its continued use in the postvaccination era has provided important conveniences to both providers and patients.

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The negative impact and management of disruptive behavior are discussed in the article by Monika Kumar, et al.

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Background: Sacituzumab govitecan (SG), a novel antibody-drug conjugate (ADC) targeting TROP2, is approved for pre-treated metastatic triple-negative breast cancer (mTNBC). We conducted an investigator-initiated clinical trial evaluating neoadjuvant (NA) SG (NCT04230109), and report primary results.

Patients And Methods: Participants with early-stage TNBC received NA SG for four cycles.

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Purpose: There is a demand for improved care delivery surrounding genomic testing and clinical trial enrollment among patients with metastatic breast cancer (MBC). We sought to improve the current process via real-time informal consultation and prescreening assessment for patients with MBC treated by community and academic medical oncologists by implementing a virtual molecular and precision medicine (vMAP) clinic.

Methods: The vMAP program used a virtual referral system directed to a multidisciplinary team with precision medicine expertise.

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Background: Incident reporting systems were developed to identify possible and actual harm in healthcare facilities. They have the potential to capture important safety trends and to enable improvements that can mitigate the risk of future patient harm and suffering. We recently developed and validated a taxonomy specific for medical oncology designed to enhance the identification, tracking, and trending of incidents that may lead to patient harm.

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.This article describes the care of a young patient with aggressive breast cancer, declining performance status, and multiple hospital admissions who died shortly after being discharged home without essential medications or an adequate plan for follow-up. The patient's death due to her malignancy was unavoidable, but she had inadequate resources before her death, leading to avoidable suffering.

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To raise nurses' voices and promote nurse-led research, the American Nurses Credentialing Center's Research Council 2022 Research Priorities included disseminating a research agenda for practice-based research, promoting interprofessional research, and encouraging equitable and inclusive participation on research teams. Expressions of nurses from around the world, however, described how organizational constraints and financial barriers are real challenges that nurse researchers must face, along with forming interdisciplinary teams to work with human subjects. Entities doing research seem to have a heavy focus on academic research where clinical bedside nurses feel separated from nursing research.

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Objective: The aim of this study was to develop research priorities for positive practice environments identified by Pathway to Excellence® (Pathway) leaders and appraisers.

Background: Identifying research priorities achieves 2 goals: 1) advancing research agendas that impact improving practice environments, and nurse and patient outcomes; and 2) informing nursing leaders, researchers, and funders of potential research projects to conduct and support.

Methods: Research topics related to the 6 Pathway standards were developed and then rated for importance through 3 rounds of a Delphi survey by leaders at Pathway-designated organizations and Pathway appraisers.

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Objective: Quantify differential attainment by ethnicity in undergraduate medical assessments and evaluate whether institutional efforts to reduce the attainment gap have had impact.

Design: Observational cohort study.

Setting: A single UK MBBS medical programme.

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Purpose: To explore the immunogenicity of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines in patients with breast cancer based on type of anticancer treatment.

Methods: Patients with breast cancer had anti-spike antibody concentrations measured ⩾14 days after receiving a full SARS-CoV-2 vaccination series. The primary endpoint was IgA/G/M anti-spike antibody concentration.

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It is imperative that we listen to our nation's nurses, who have a unique vantage point from their clinical environments. Clinical research nurses have greatly contributed to studying the delivery of care over the years; however, since 2020, COVID-19 has brought unprecedented changes within the nursing profession. Each wave of the pandemic has created a worrisome landscape where nurse researchers face multiple challenges in implementing and funding practice-based nursing-led research projects.

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The excellent outcomes seen in patients treated with adjuvant trastuzumab emtansine (T-DM1) in the ATEMPT trial and the favorable toxicity profile associated with this agent make T-DM1 a potential therapeutic option for select patients with stage I HER2-positive breast cancer. Moreover, T-DM1 is an established adjuvant treatment for patients with HER2-positive breast cancer with the residual invasive disease after neoadjuvant therapy. Given that cardiotoxicity is the most significant adverse event of trastuzumab, which is a main molecular component of T-DM1, we conducted a sub-analysis of the ATEMPT trial to determine the cardiac safety of adjuvant T-DM1.

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Purpose: To provide standards and practice recommendations specific to telehealth in oncology.

Methods: A systematic review of the literature on telehealth in oncology was performed, including the use of technologies and telecommunications systems, and other electronic methods of care delivery and sharing of information with patients. The evidence base was combined with the opinion of the ASCO Telehealth Expert Panel to develop telehealth standards and guidance.

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Article Synopsis
  • The study investigates chemotherapy-related amenorrhea (CRA) as an indicator of ovarian toxicity and its implications for women's fertility and menopause risks, comparing rates between two treatments: paclitaxel-trastuzumab (TH) and ado-trastuzumab emtansine (T-DM1).
  • Patients with early-stage HER2-positive breast cancer from the ATEMPT trial were monitored for menstrual changes over 18 months after receiving either TH or T-DM1, with findings showing a 50% CRA rate in TH recipients compared to 24% in T-DM1 recipients (p=0.045).
  • The conclusion emphasizes that T-DM1 is associated with a lower
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Purpose: The ATEMPT trial was designed to determine if treatment with trastuzumab emtansine (T-DM1) caused less toxicity than paclitaxel plus trastuzumab (TH) and yielded clinically acceptable invasive disease-free survival (iDFS) among patients with stage I human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC).

Methods: Patients with stage I centrally confirmed HER2+ BC were randomly assigned 3:1 to T-DM1 or TH and received T-DM1 3.6 mg/kg IV every 3 weeks for 17 cycles or T 80 mg/m IV with H once every week × 12 weeks (4 mg/kg load →2 mg/kg), followed by H × 39 weeks (6 mg/kg once every 3 weeks).

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Effective delivery of cancer care via telehealth requires a planned care system that accounts for myriad patient, provider, and practice/cancer center resources before, during, and after the care episode. Telehealth is broadly defined as a method to have virtual, bidirectional communication between patients and providers. Telehealth can include methods such as audio-only, video-consultation, and tele-monitoring, which can occur in a synchronous, asynchronous, or blended format.

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Background: Inhibitors of cyclin-dependent kinases 4 and 6 (CDK4/6i) are widely used as first-line therapy for hormone receptor-positive metastatic breast cancer (HR+ MBC). Although abemaciclib monotherapy is also FDA-approved for treatment of disease progression on endocrine therapy, there is limited insight into the clinical activity of abemaciclib after progression on prior CDK4/6i.

Patients And Methods: We identified patients with HR+ MBC from 6 cancer centers in the United States who received abemaciclib after disease progression on prior CDK4/6i, and abstracted clinical features, outcomes, toxicity, and predictive biomarkers.

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Article Synopsis
  • Patient-reported outcomes (PROs) like quality of life (QOL) and symptom burden are linked to the clinical outcomes in cancer patients, but their relationship with treatment response is not well-studied.
  • A study involving 112 patients with advanced gastrointestinal cancer found that higher physical symptom scores and lower functional QOL scores were associated with poorer treatment responses and increased hospitalization risks.
  • The analysis indicates that baseline PROs can help predict treatment outcomes, healthcare utilization, and survival in these patients, emphasizing the importance of assessing physical symptoms and functional well-being.
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