Dataset Information

Evaluating the Role of Circulating MicroRNAs to Aid Therapeutic Decision Making for Neoadjuvant Chemotherapy in Breast Cancer: A Prospective, Multicenter Clinical Trial.

ABSTRACT:

Objective

To evaluate whether circulating micro ribonucleic acids (miRNAs) predict response to neoadjuvant chemotherapy (NAC) and inform decision-making in breast cancer patients.

Introduction

Deciphering response to NAC remains a challenge. Those unlikely to respond may benefit from NAC de-escalation before completion, while "responders" should complete treatment. Establishing biomarkers which identify response to NAC is imperative to personalize treatment strategies. miRNAs are small noncoding RNA molecules which modulate genetic expression. miRNAs are believed to inform response to NAC.

Methods

This prospective, multicenter trial (NCT01722851) recruited 120 patients treated with NAC across 8 Irish treatment sites. Predetermined miRNAs were quantified from patient whole bloods using relative quantification polymerase chain reactiond. Venous sampling was performed at diagnosis and midway during NAC. Trends in miRNA expression between timepoints were correlated with treatment response. Data analysis was performed using R 3.2.3.

Results

A total of 120 patients were included (median age: 55 years). Overall, 49.2% had luminal breast cancers (59/120), 17.5% luminal B (L/HER2) (21/120), 12.5% human epidermal growth factor receptor-2 positive (HER2+) (15/120), and 20.8% triple negative disease (25/120). In total, 46.7% of patients responded to NAC (56/125) and 26.7% achieved a pathological complete response (pCR) (32/120). For patients with L/HER2, increased Let-7a predicted response to NAC ( P =0.049), while decreased miR-145 predicted response to NAC in HER2+ ( P =0.033). For patients with luminal breast cancers, reduced Let-7a predicted achieving a pCR ( P =0.037) and reduced miR-145 predicted achieving a pCR to NAC in HER2+ ( P =0.027).

Conclusions

This study illustrates the potential value of circulatory miRNA measurement in predicting response to NAC. Further interrogation of these findings may see miRNAs personalize therapeutic decision-making for patients undergoing NAC for early breast cancer.

SUBMITTER: Davey MG

PROVIDER: S-EPMC9534053 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluating the Role of Circulating MicroRNAs to Aid Therapeutic Decision Making for Neoadjuvant Chemotherapy in Breast Cancer: A Prospective, Multicenter Clinical Trial.

Davey Matthew G MG Casey Maire Caitlin MC McGuire Andrew A Waldron Ronan M RM Paganga Maxwell M Holian Emma E Newell John J Heneghan Helen M HM McDermott Ailbhe M AM Keane Maccon M MM Lowery Aoife J AJ Miller Nicola N Kerin Michael J MJ

Annals of surgery 20220725 5

<h4>Objective</h4>To evaluate whether circulating micro ribonucleic acids (miRNAs) predict response to neoadjuvant chemotherapy (NAC) and inform decision-making in breast cancer patients.<h4>Introduction</h4>Deciphering response to NAC remains a challenge. Those unlikely to respond may benefit from NAC de-escalation before completion, while "responders" should complete treatment. Establishing biomarkers which identify response to NAC is imperative to personalize treatment strategies. miRNAs are ...[more]

PMID: 35876391

Similar Datasets

Project description:BACKGROUND:Care of patients with diabetes often occurs in the context of other chronic illness. Competing disease priorities and competing patient-physician priorities present challenges in the provision of care for the complex patient. Guideline implementation interventions to date do not acknowledge these intricacies of clinical practice. As a result, patients and providers are left overwhelmed and paralyzed by the sheer volume of recommendations and tasks. An individualized approach to the patient with diabetes and multiple comorbid conditions using shared decision-making (SDM) and goal setting has been advocated as a patient-centred approach that may facilitate prioritization of treatment options. Furthermore, incorporating interprofessional integration into practice may overcome barriers to implementation. However, these strategies have not been taken up extensively in clinical practice. OBJECTIVES:To systematically develop and test an interprofessional SDM and goal-setting toolkit for patients with diabetes and other chronic diseases, following the Knowledge to Action framework. METHODS:1. Feasibility study: Individual interviews with primary care physicians, nurses, dietitians, pharmacists, and patients with diabetes will be conducted, exploring their experiences with shared decision-making and priority-setting, including facilitators and barriers, the relevance of a decision aid and toolkit for priority-setting, and how best to integrate it into practice.2. Toolkit development: Based on this data, an evidence-based multi-component SDM toolkit will be developed. The toolkit will be reviewed by content experts (primary care, endocrinology, geriatricians, nurses, dietitians, pharmacists, patients) for accuracy and comprehensiveness.3. Heuristic evaluation: A human factors engineer will review the toolkit and identify, list and categorize usability issues by severity.4. Usability testing: This will be done using cognitive task analysis.5. Iterative refinement: Throughout the development process, the toolkit will be refined through several iterative cycles of feedback and redesign. DISCUSSION:Interprofessional shared decision-making regarding priority-setting with the use of a decision aid toolkit may help prioritize care of individuals with multiple comorbid conditions. Adhering to principles of user-centered design, we will develop and refine a toolkit to assess the feasibility of this approach.

Project description:Background: Opportunistic prostate-specific antigen (PSA) screening may reduce prostate cancer mortality risk but is associated with false positive results, biopsy complications and overdiagnosis. Although different organisations have emphasised the importance of shared decision making (SDM) to assist men in deciding whether to undergo prostate cancer screening, recent evaluations show that the available decision aids fail to facilitate SDM, mainly because they do not consider the patients' perspective in their design. We aim to systematically develop and test a patient decision aid to promote SDM in prostate cancer screening, following the Knowledge to Action framework. Methods: (1) Feasibility study: a quantitative survey evaluating the population and clinician (urologists and general practitioners) knowledge of the benefits and risks derived from PSA determination and the awareness of the available recommendations. Focus groups to explore the challenges patients and clinicians face when discussing prostate cancer screening, the relevance of a decision aid and how best to integrate it into practice. (2) Patient decision aid development: Based on this data, an evidence-based multicomponent SDM patient decision aid will be developed. (3) User-testing: an assessment of the prototype of the initial patient decision aid through a user-testing design based on mix-methods (questionnaire and semi-structured review). The decision aid will be refined through several iterative cycles of feedback and redesign. (4) Validation: an evaluation of the patient decision aid through a cluster-randomised controlled trial. Discussion: The designed patient decision aid will provide balanced information on screening benefits and risks and should help patients to consider their personal preferences and to take a more active role in decision making. Conclusions: The well-designed patient decision aid (PDA) will provide balanced information on screening benefits and risks and help patients consider their personal preferences.

Project description:BackgroundYoung adults ages 18 to 25 with first episode psychosis (FEP) have an increased risk of discontinuation antipsychotic medications and psychiatric service disengagement that lead to symptom exacerbation and deterioration. We seek to (1) examine the feasibility, usability, and potential impact of a Shared Decision Making (SDM) Antipsychotic Medication Decision Aid (DA) on decision-making, adherence to the decision made, and service engagement among young adults with FEP and (2) understand the role of additional patient-level factors on SDM.MethodsA randomized controlled trial is being conducted in a coordinated specialty care community program for FEP in an urban setting. Eligible patients are randomly assigned to receive an intervention, the Antipsychotic Medication Decision Aid, or treatment as usual. Patients receive their assigned intervention before their medication appointment with the psychiatrist and complete four interviews: before the appointment (T0), after the appointment (T1), and at 3- and 6-month follow-ups (T2 and T3). The study staff and participating psychiatrists are not blinded to the intervention. The data are de-identified to maintain blinding during the analysis process. The primary aims are feasibility of intervention delivery and research procedures and preliminary impact of the intervention on SDM-related outcomes, medication adherence, and service engagement. As a secondary aim, we will explore the contribution of personality and motivation variables, clinical relationships, cognitive functioning, and mental-health-related stigma to SDM. If the sample size permits, we plan to conduct parametric tests such as independent-samples t tests at T1 to compare differences in SDM, adherence, and engagement scales. In the case of a small sample size, we will use non-parametric tests and descriptive statistics.DiscussionThis protocol outlines the methodology for a feasibility pilot comparing the effect of a novel SDM Antipsychotic Medication encounter DA with treatment as usual on SDM, medication adherence, and service engagement in FEP care. SDM is endorsed as a framework for use in FEP and antipsychotic pharmacotherapy, but its impact on adherence and health outcomes is unclear. Understanding the potential contribution of an SDM Antipsychotic Medication DA compared with usual care in psychosis pharmacotherapy is critical. The study will help answer several key questions new to SDM research, including the contribution of personality and clinical relationships to SDM in mental health and psychosis in particular. The study will serve to gather feasibility data to inform future studies and scale-up.Trial registrationEthics approval was obtained through Temple University's institutional review board (IRB) and the City of Philadelphia's Department of Public Health IRB. The study has been retrospectively registered with ClinicalTrials.gov as NCT04373590 on 29 April 2020. https://clinicaltrials.gov/ct2/show/NCT04373590?term=NCT04373590&draw=2&rank=1.

Project description:ObjectiveThe objective was to develop a decision aid (DA) to facilitate shared decision making (SDM) around whether to obtain computed tomography (CT) imaging in patients presenting to the emergency department (ED) with suspected uncomplicated ureterolithiasis.MethodsWe used evidence-based DA development methods, including qualitative methods and iterative stakeholder engagement, to develop and refine a DA. Guided by the Ottawa Decision Support Framework, International Patient Decision Aid Standards (IPDAS), and a steering committee made up of stakeholders, we conducted interviews and focus groups with a purposive sample of patients, community members, emergency clinicians, and other stakeholders. We used an iterative process to code the transcripts and identify themes. We beta-tested the DA with patient-clinician dyads facing the decision in real time.ResultsFrom August 2018 to August 2019, we engaged 102 participants in the design and iterative refinement of a DA focused on diagnostic options for patients with suspected ureterolithiasis. Forty-six were ED patients, community members, or patients with ureterolithiasis, and the remaining were emergency clinicians (doctors, residents, advanced practitioners), researchers, urologists, nurses, or other physicians. Patients and clinicians identified several key decisional needs including an understanding of accuracy, uncertainty, radiation exposure/cancer risk, and clear return precautions. Patients and community members identified facilitators to SDM, such as a checklist of signs and symptoms. Many stakeholders, including both patients and ED clinicians, expressed a strong pro-CT bias. A six-page DA was developed, iteratively refined, and beta-tested.ConclusionsUsing stakeholder engagement and qualitative inquiry, we developed an evidence-based DA to facilitate SDM around the question of CT scan utilization in patients with suspected uncomplicated ureterolithiasis. Future research will test the efficacy of the DA in facilitating SDM.

Dataset Information

Evaluating the Role of Circulating MicroRNAs to Aid Therapeutic Decision Making for Neoadjuvant Chemotherapy in Breast Cancer: A Prospective, Multicenter Clinical Trial.

Objective

Introduction

Methods

Results

Conclusions

Publications

Evaluating the Role of Circulating MicroRNAs to Aid Therapeutic Decision Making for Neoadjuvant Chemotherapy in Breast Cancer: A Prospective, Multicenter Clinical Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets