Keeping oncologists current with CDK4/6 inhibitors in HR+ breast cancer: The impact of online education.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e13044-e13044
Author(s):  
Kinjal Parikh ◽  
Mindy Tanzola ◽  
Pamela M. Peters ◽  
Massimo Cristofanilli
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Online Education ◽  
Clinical Trial Data ◽  
Educational Approach ◽  
Chi Square ◽  
Her2 Breast Cancer ◽  
The Impact ◽  
Post Assessment ◽  
Selection Of

e13044 Background: CDK4/6 inhibitors have revolutionized the care of patients with hormone receptor positive (HR+), HER2-negative breast cancer, improving survival outcomes. There are multiple CDK4/6 inhibitors available that differ in their pharmacologic features, reported outcomes, therapeutic indications, and adverse event profiles. Education is needed to empower clinicians to optimally use these agents in practice and personalize breast cancer treatment. The goal of this educational initiative was to increase the knowledge, competence, and confidence of oncologists regarding clinical trial data and factors for selection of CDK4/6 inhibitor. Methods: This educational approach included a 30-minute online video discussion among 3 expert faculty, synchronized with slides to support the discussion. Educational effectiveness was assessed with repeated paired pre/post assessment in which learners served as their own controls. A chi-square test assessed differences from pre- to post-assessment. P values < .05 are statistically significant. Effect size was calculated using Cramer’s V test by determining the strength of the association between CME and the outcomes (V = .16-.26 is considerable and V > .26 is extensive). The activity launched 11/25/2019 and data are reported through 2/4/2020. Results: A total of 889 learners, including 513 physician learners, participated in the activity from 11/2019 through 2/2020. Participation in the education resulted in significant improvements in knowledge among oncologists (n = 81; p < .001; V = 0.16). On average, the proportion of learners who responded correctly to knowledge-based questions about CDK4/6 inhibitors increased from 51% at the pre-assessment to 67% at the post-assessment. Moreover, 41% of oncologists had a measurable positive change in confidence in their ability to incorporate CDK4/6 inhibitors into the treatment of HR+, HER2- advanced breast cancer. Significant improvements in knowledge were observed in the following areas: The clinical trial safety and efficacy data evaluating CDK4/6 inhibitors in the management of patients with HR+/HER2-negative breast cancer (32% vs. 51%, p < .05, V = 0.19). The potential role of patient- and tumor- specific prognostic factors in selection of individual CDK4/6 inhibitors (56% vs. 72%, p < .05, V = 0.17). Conclusions: This CME-certified online discussion resulted in statistically significant gains in oncologists’ knowledge and improved confidence surrounding the personalization of CDK4/6 inhibitor therapy in HR+/HER2- breast cancer.

scholarly journals 488 The impact of education on novel concepts in metastatic melanoma: triplet therapy

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A524-A524
Author(s):  
Kinjal Parikh ◽  
Sara Fagerlie ◽  
Patrick Kugel ◽  
Richard Caracio ◽  
Ryan Sullivan
Keyword(s):  
Clinical Trial ◽  
Checkpoint Inhibitors ◽  
Panel Discussion ◽  
Clinical Trial Data ◽  
Advanced Melanoma ◽  
Trial Data ◽  
Educational Activity ◽  
List Type ◽  
The Impact ◽  
Post Assessment

BackgroundAdvanced melanoma treatment selection is guided by BRAF-mutation status and patient and disease-specific factors. Historically, oncologists decided between targeted therapy or immune checkpoint inhibitors (ICI). However, given the differences in onset of activity, response durability, and adverse events combination BRAF/MEK inhibitors and ICI (triplet therapy) are being evaluated to optimize outcomes. With several trials due to report, oncologists need education to stay up-to-date on the available data and contextualize this potential treatment option.MethodsAn online continuing education (CME) activity consisting of a multi-media 30-minute video panel discussion explored the rationale, available clinical trial data, and future directions of triplet therapy for the treatment of advanced BRAF-mutated melanoma. Educational effect was assessed using a repeated pairs pre-assessment/post-assessment study design and compared the pre- and post-assessment responses. A chi-square test was used to identify differences between pre- and post-assessment responses. Effect size was calculated using Cramer’s V test by determining the strength of the association between the activity and the outcomes (V = 0.16–0.26 is considerable and V > 0.26 is extensive). P values were calculated and those < 0.05 were considered statistically significant. Data from oncologist participants were collected between 12/23/2019 through 2/26/20.ResultsParticipation in education resulted in statistically significant improvements and noticeable educational effect for oncologists (n=49; p < 0.05, V =0.136). • 39% of pre-assessment questions were correctly answered increasing to 52% post-assessment • 15% of oncologists had a measurable improvement in confidence regarding the rationale for use of triplet therapy in advanced melanoma• Significant improvement in knowledge regarding clinical trial data in triplet therapy was observed (35% vs. 55%; p < 0.05, V = 0.205)ConclusionsThis online, interactive, expert-led, CME-certified educational activity resulted in significant gains in oncologist knowledge and confidence regarding triplet therapy in the management of melanoma. These results demonstrate the effectiveness of on-demand education but also highlight an ongoing need for education on this topic as further data becomes available.AcknowledgementsThis educational initiative was supported through educational grants from Novartis Pharmaceuticals Corporation and GenentechReferenceSullivan RJ, Salama AKS. Managing Melanoma: Emerging Concepts of Triplet Therapy. https://www.medscape.org/viewarticle/923003

scholarly journals THU0585 ONLINE EDUCATION YIELDS SIGNIFICANT GAINS IN RHEUMATOLOGISTS’ KNOWLEDGE OF THE JAK INHIBITORS MODE OF ACTION AND CLINICAL TRIAL DATA

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 534.2-534
Author(s):  
A. Stan ◽  
M. Calle ◽  
C. Scot-Smith ◽  
R. Van Vollenhoven
Keyword(s):  
Clinical Trial ◽  
Online Education ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Janus Kinase ◽  
Jak Inhibitors ◽  
Research Support ◽  
Educational Grant ◽  
Trial Outcomes ◽  
Post Assessment

Background:Physicians face challenges staying up-to-date with the latest research and accessing the ever-growing field of knowledge is time-consuming. Online education can make these clinician’s tasks more efficient and less time-consuming.Objectives:This study assessed whether the online CME accredited round-table-discussion with title “Meet the JAKs: Understanding the Role of Janus Kinase Inhibition in RA” improves physicians’ understanding mechanism of action (MOA) of current and emerging Janus kinase (JAK) inhibitors and rationale for their development in rheumatoid arthritis (RA).Methods:Rheumatologists participated in an online CME activity (https://www.medscape.org/viewarticle/913625) consisting of a 30-minute video discussion between 2 experts with accompanying slides. Educational effect was assessed using a 4-question repeated pairs, pre-/post-assessment. A chi-square test was used to determine if a statistically significant improvement (P<.05 significance level) existed in the number of correct responses from the pretest and posttest scores. Cramer’s V was used to estimate the level of impact of the education. The CME activity launched on June 4, 2019, and the data were collected through September 3, 2019.Results:A total of 107 rheumatologists completed the pre- and post activity assessments. Overall the activity had a signficiant impact (P<.001) on rheumatologists’ knowledge of JAK inhibitors and relatedclinical trial data with a Cramer’s V value of 0.319 indicating an extensive educational impact. The average percentage of correct responses rose from 47% pre-activity to 78% post-activity. The repeated pairs analysis (each individual learner tracked pre- and post-education) showed that 34% of learners improved their knowledge and 44% reinforced their knowledge. The change in percentage of correct responses from pre- to post-assessment achieved statistical significance for all 3 questions presented: (1) understanding the MOA of JAK inhibitors vs biologics (64% at baseline rising to 82% post acivity;P<0.01), (2) understanding the specificity of different JAK inhibitors (49% at baseline rising to 85% post acivity;P<.001), (3) knowledge of clinical trial outcomes with JAK inhibitors (29% at baseline rising to 67% post acivity;P<.001) and (4) 60% of rheumatologists gained confidence in their ability to describe the MOA of current and emerging JAK inhibitors.Conclusion:This online CME activity significantly improved rheumatologists’ understanding of JAK inhibitors mode of action. However, there is clearly room for further improving physicians’ knowledge of clinical trial outcomes with these agents, since one third of rheumatologists provided incorrect answers to question 3 post-activity) and this topic can be further addressed in future education.Acknowledgments:This CME-certified activity was supported by anindependent educational grant from AbbVie.Disclosure of Interests:Adriana Stan Grant/research support from: The CME-certified activity was supported by anindependent educational grant from Sandoz., Marinella Calle Grant/research support from: This CME-certified activity was supported by anindependent educational grant from Novartis AG, Camille Scot-Smith Grant/research support from: This CME-certified activity was supported by anindependent educational grant from AbbVie, Ronald van Vollenhoven Grant/research support from: BMS, GSK, Lilly, UCB, Pfizer, Roche, Consultant of: AbbVie, AstraZeneca, Biogen, Biotest, Celgene, Gilead, Janssen, Pfizer, Servier, UCB, Speakers bureau: AbbVie, Pfizer, UCB

scholarly journals Setting the IMPACT (IMProve Access to Clinical Trial data) Observatory baseline

2018 ◽  
Vol 28 (1) ◽  
Author(s):  
Mersiha Mahmić-Kaknjo ◽  
Josip Šimić ◽  
Karmela Krleža-Jerić
Keyword(s):  
Clinical Trial ◽  
Clinical Trial Data ◽  
Trial Data ◽  
The Impact ◽  
Improve Access

scholarly journals The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Derek G. Kyte ◽  
Olalekan Lee Aiyegbusi ◽  
Anita L. Slade ◽  
Christel McMullan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Case Studies ◽  
Real World ◽  
Clinical Trial Data ◽  
Research Impact ◽  
Trial Data ◽  
Patient Reported ◽  
The Impact

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.

Evaluating the impact of a trial in breast cancer tumor markers: A value of research analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e16524-e16524
Author(s):  
Rahber Thariani ◽  
David K Blough ◽  
William Barlow ◽  
Norah Lynn Henry ◽  
Julie Gralow ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Clinical Trial ◽  
Tumor Marker ◽  
Tumor Markers ◽  
Societal Value ◽  
Cancer Tumor ◽  
The Impact

e16524 Background: Despite not being recommended by clinical guidelines, the tumor markers carcinoembryonic antigen (CEA), cancer antigen (CA)15-3, and CA 27.29 are used by some clinicians to screen for increased risk of breast cancer recurrence. Although additional research may be warranted to evaluate the benefits and risks of breast cancer tumor marker tests, clinical trials would likely need to involve thousands of women and would take many years to complete. We conducted an analysis to assess the societal value of a prospective randomized clinical trial (RCT) for breast tumor marker testing in routine follow-up of high-risk, stage II-III breast cancer survivors Methods: We used value of information techniques to assess the benefits of reducing uncertainty of using breast cancer tumor markers. We developed a decision-analytic model of biomarker testing in addition to standard surveillance at follow-up appointments every 3-6 months for five years. Expected value of sample information (EVSI) was assessed over a range of trial sizes and assumptions. Results: The overall value of research for an RCT involving 9,000 women was $166 million (EVSI). The value of improved information characterizing the survival impact of tumor markers was $81 million, quality-of-life $38 million, and test performance $95 million. Conclusions: Our analysis indicates that substantial societal value may be gained by conducting a clinical trial evaluating the use of breast cancer tumor markers. The most important aspects of the trial in our analysis were information gained on survival improvements as well as quality-of-life parameters associated with testing and test sensitivity and specificity. Our analysis indicates that smaller randomized trials, as well as adding quality of life instruments to existing trials, retrospective, and observational trials can also generate valuable and relevant information.

ACOSOG Z1041 (Alliance): Cardiac events (CE) among those receiving neoadjuvant anthracyclines (A) and taxanes with trastuzumab (T) for HER2+ breast cancer.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 526-526 ◽  
Author(s):  
Michael Ewer ◽  
Vera J. Suman ◽  
Aman Buzdar ◽  
Linda Mackie McCall ◽  
Funda Meric-Bernstam ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Ejection Fraction ◽  
Cardiac Risk ◽  
Operable Breast Cancer ◽  
Cardiac Events ◽  
Her2 Breast Cancer ◽  
A Value ◽  
Significant Difference ◽  
Clinical Trial Information

526 Background: Z1041 randomized women with HER2+ operable breast cancer to: FEC → P+T (Arm 1) or P+T → FEC+T (Arm 2). Treatment administered as 5-FU 500 mg/m2, epirubicin 75 mg/m2 and cyclophosphamide 500 mg/m2 day 1 of a 21-day cycle x 4; paclitaxel 80 mg/m2weekly x 12 and T 4 mg/kg once then 2 mg/kg weekly x 11. T was to continue q3 weeks post-op for 40 weeks. A secondary aim was to examine the cardiotoxicity (CE). Methods: Ejection fraction (EF) was measured at baseline (BL), between regimens (wk 12), prior to surgery (wk 24) and PRN. Eligibility: BL EF ≥ 55%. CEs included decline in EF of > 15%, or >10% points to a value < LLN. Reversibility was adjudicated by blinded investigators as reversible (R: recovery of EF to ≤ 5% below BL), partially reversible (PR: recovery of > 10% points from nadir, but ≤ 5% points below BL), indeterminate (IN: no additional EF data), or irreversible (IRR:follow-up EF studies showed no improvement). Results: Of the 280 patients (Arm 1: 138) who began treatment, 15 pts (Arm 1: 10; Arm 2: 5) did not receive T. The number of weeks of T was 13 (range: 1-18) in Arm 1 and 24 (range: 1-31) in Arm 2. Changes in EF and severe treatment related cardiac toxicities prior to surgery (sx) are tabled below. There were 271 pts (Arm 1: 131) who had post-BL EFs. Prior to sx, there were 11 CE (8.3%) in Arm 1 and 13 CE (9.2%) in Arm 2. CEs were R in 12 pts (Arm 1: 5; Arm 2: 7); PR in 6 pts (Arm 1: 4; Arm 2: 2); IN in 4 pts (Arm 1: 2; Arm 2: 3) and IRR in 1 Arm 2 pt. Conclusions: The number of CE events in arms 1 and 2 showed no significant difference; greater scatter was observed in arm 2 patients. While concern for late cardiac events makes ongoing cardiac surveillance prudent due to A, concomitant use of A and T appear to not be associated with increased cardiac risk. Clinical trial information: NCT00513292. [Table: see text]

Comprehensive assessment of cancer stem cell like cells in prediction of pathologic complete response to preoperative dual anti–HER2 therapy for HER2–positive primary breast cancer.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e12123-e12123
Author(s):  
Jose Rodrigo Espinosa Fernandez ◽  
Teruo Yamauchi ◽  
Chiyo K. Imamura ◽  
Hideko Yamauchi ◽  
Hiromitsu Jinno ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Stem Cells ◽  
Tumor Cells ◽  
Prospective Trial ◽  
Pathologic Complete Response ◽  
Predictive Biomarkers ◽  
Preoperative Therapy ◽  
Her2 Positive ◽  
Her2 Breast Cancer ◽  
The Impact

e12123 Background: Chemotherapy for breast cancer destroys non–stem cells while sparing cancer stem cells (CSCs). In contrast, anti–HER2 therapy may eliminate resistant cells because HER2 may be a key driver of CSCs. CSC biomarkers have been found to be prognostic of poor outcome and predictive of resistance to therapy. However, there are no comprehensive studies of the impact of anti-HER2 therapies on CSC–related biomarkers. We conducted a prospective biomarker determination study of breast CSCs characterized by CD44v expression and increased aldehyde dehydrogenase 1 (ALDH1) enzymatic activity or expression. Methods: In a prospective trial (ClinicalTrials.gov: NCT01688609), 18 patients with operable primary HER2+ breast cancer (≥T2 excluding inflammatory, any N; median age of 54 yrs) were treated with preoperative anti–HER2 therapy following the NeoALTTO trial dual therapy arm regimen, with a goal of identifying novel predictive biomarkers for pCR. Proportions of tumor cells with CSC characteristics, defined as CD44v+ and ALDH1+, were estimated at baseline, at 6 weeks (after therapy with lapatinib/trastuzumab) and at 18 weeks (after therapy with lapatinib/trastuzumab and paclitaxel) to assess adaptive response. We determined changes in the quantity and characteristics of CSC–related biomarkers during preoperative therapy and correlated them to tumor response. Results: Out of 18 patients, 8 (44%) had a pCR; 5 of these 8 patients (62%) were positive for CD44v staining on tumor cells at baseline and none were positive on the 6–week biopsy. In contrast, 6 of the 10 patients without pCR exhibited persistent levels, or enrichment of CD44v proportion and expression at 6 and 18 weeks (p = 0.0128). ALDH1 expression and other biomarkers were not statistically significant predictors of pCR. Conclusions: Enrichment of CD44v+ tumor cells after double anti–HER2 therapy may predict poor response to dual anti–HER2 therapy with cytotoxic chemotherapy. A second biopsy after the start of preoperative therapy may reflect biological changes useful for the guidance and application of therapeutic strategies for patients with HER2+ breast cancer. Clinical trial information: NCT01688609.

Selection of natural health products for clinical trials: a preclinical template

2009 ◽  
Vol 87 (5) ◽  
pp. 371-378 ◽  
Author(s):  
S. Vohra ◽  
D. Adams ◽  
J.B. Hudson ◽  
J.A. Moore ◽  
S. Vimalanathan ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Pediatric Population ◽  
Echinacea Purpurea ◽  
Phytochemical Analysis ◽  
Natural Health Products ◽  
Product Identity ◽  
Health Products ◽  
Ethanol Extracts ◽  
The Impact ◽  
Selection Of

In preparation for a clinical trial on the efficacy of Echinacea products with a pediatric population, a rational method for selection of test products was developed, based on phytochemical and bioassay evaluation. Ten currently available commercial products of Echinacea angustifolia (EA) or Echinacea purpurea (EP) were selected, and 3 bottles of each of 2 different lots were purchased for each product. Investigators were blinded to product identity before phytochemical analysis. Lot-to-lot variation was small, but product variation due to species and formulation was large. Products derived from ethanol extracts had low polysaccharide content and high levels of alkamides (EA), echinacoside (EA), cynarin (EA), cichoric acid (EP), and caftaric acid (EP). These products possessed high antiviral activities that differed between EA and EP products, but limited immune activation properties. In contrast, products derived without ethanol extraction had higher polysaccharide levels, but low levels of other components. These aqueous compounds showed immunostimulant activity as measured in a mouse macrophage model and a somewhat different antiviral profile. The choice of Echinacea product for clinical trial must therefore consider the impact of immune enhancement, the specific viral infection targeted, and the potential to reduce symptoms via antiinflammatory activity. Product selection may also depend on whether the intent of the trial is prophylaxis or treatment.

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