The impact of immunotherapy education on GI cancers.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 479-479
Author(s):  
Kinjal Parikh ◽  
Katie Lucero ◽  
Charlotte Warren ◽  
Emily Sherene Van Laar ◽  
Patrick Kugel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Checkpoint Inhibitors ◽  
Statistical Significance ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Educational Activities ◽  
Cancer Subtypes ◽  
Gi Cancers ◽  
The Impact

479 Background: Gastrointestinal (GI) cancers are a heterogeneous group of cancers with varying underlying pathophysiology and distinct treatment paradigms. Immunotherapy (IO) is unique in each of the subtypes and biomarkers utility varies. With the expansion of IO in each cancer subtypes, education remains essential to optimize patient outcomes through integration of the latest evidence-based data at point of care. Through the partnership between Medscape Oncology and the Society for Immunotherapy of Cancer, 2 educational activities were designed to increase the knowledge and competence of oncologists surrounding the role of IO in patients with advanced GI cancers. Methods: The 2 educational activities included a text based online activity with 3 chapters focused on gastroesophageal cancers, colorectal cancers, and hepatocellular carcinoma (HCC) and a 30-minute online, video discussion with 3 faculty and synchronized slides on HCC. Educational effectiveness was assessed with repeated paired pre/post assessment where learners served as their own controls. A chi-square test was used to identify statistical significance in proportion of correct responses. The first activity launched 11/27/2019 and the second activity launched on 5/8/20. Data were collected and reported through 8/25/2020. Results: A total of 8433 learners, including 1543 oncologists, participated from 11/2019 through 8/2020. Participation in education resulted in significant relative improvements among oncologist learners on IO in GI cancers in (n = 641): 110%: role or eligibility of immune checkpoint inhibitors (ICIs) (p < .001) 38%: clinical trial data of ICIs (p < .001) Subsequent education on unresectable HCC demonstrated a significant relative improvement in both knowledge and competence for oncologist learners (n = 902): 19%: regarding clinical trial data in unresectable HCC (p = .073) 19%; competence identifying role of ICIs in unresectable HCC (p < .05) 59%: competence managing irAEs in unresectable HCC (p < .001). Conclusions: These 2 online CME-certified educational activities resulted in statistically significant gains in oncologist knowledge surrounding the use of IO in advanced GI cancers Follow-up education on HCC demonstrated the value and benefit of multi-modal and sequential activities on improving competence among oncologists caring for patients with unresectable HCC There remains a need for continuous education as more oncologists utilize IO in their practice while the understanding and availability of clinical data continues to expand and evolve in the varying GI cancer subtypes. More than 50% of learners continued to demonstrate a need in understanding the clinical trial data or role of IO in metastatic GI cancers with more than 40% of the learners demonstrating continued need on clinical trial data or role of IO in HCC specifically.

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 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.

Role of Radiation Therapy and Fluoropyrimidines in the Treatment of Gastrointestinal Malignancies

1996 ◽  
Vol 3 (4) ◽  
pp. 319-328
Author(s):  
William W. Wong ◽  
Steven E. Schild ◽  
James A. Martenson
Keyword(s):  
Clinical Trial ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Combined Chemotherapy ◽  
Gastrointestinal Malignancies ◽  
Treatment Regimens ◽  
Improved Outcomes ◽  
Clinical Benefits ◽  
Positive Results

Background The use of combined chemotherapy and radiation for gastrointestinal malignancies has several theoretical advantages, and clinical trials to determine the type and extent of clinical benefits have been performed. Methods The basic science and clinical trial data evaluating such combinations are reviewed, with an emphasis on the interactions between fluoropyrimidines and radiation. Results Improved outcomes from chemoradiotherapy have been demonstrated in patients with selected stages of anal, esophageal, rectal, and pancreatic cancer. Conclusion Despite these positive results, further work is needed to demonstrate even more effective and less toxic treatment regimens.

Response to checkpoint inhibitors (CPI) in sarcomatoid renal cell carcinoma (sRCC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e17095-e17095
Author(s):  
Iris Yeong- Fung Sheng ◽  
Wei Wei ◽  
Kunal Desai ◽  
Kimberly D. Allman ◽  
Allison Martin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Real World ◽  
Systemic Therapy ◽  
Checkpoint Inhibitors ◽  
Cleveland Clinic ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Rank Test ◽  
World Population ◽  
Related Factors

e17095 Background: sRCC have a generally poor prognosis though recent clinical trial data suggest improved outcomes with CPI. We present a real-world experience of metastatic sRCC patients (pts) treated with a variety of CPI. Methods: Pts with sRCC treated with CPI Cleveland Clinic from 1/1/2015 to 12/31/2019 were identified. Overall survival (OS) was estimated using Kaplan-Meier and compared by log rank test. Results: Of 28 eligible pts identified with sRCC, median age 58, 82% Caucasian, all KPS score > 80%, 86% had IMDC intermediate/poor risk disease, 75% were clear cell, and 71% had prior nephrectomy. 46.4% had prior non-CPI systemic therapy. CPI therapy in this cohort included: 46% nivolumab monotherapy, 18% axitinib/pembrolizumab, 21% ipilimumab/nivolumab, 4% atezolizumab/bevacizumab, 7% atezolizumab, 4% carboplatin/pemetrexed/pembrolizumab. At a median follow up of 13.6 months (range 6.5-31.4), ORR was 36% (4% CR, 32% PR) and median OS was 13.8 months (95% CI: 9.23-NA). Median time to response was 3.2 months (range 2.4-13.1) and median duration of response was 8.1 months (range 0-25.5). Ten of the 13 patients started subsequent therapy due to progression. At the time of analysis, 39% were still alive and 25% of patients were still on initial I/O therapy (7+ -30+ months). There were no clear correlations between specific disease-related factors (including IMDC risk, time-to treatment of > or < 1 year, or prior systemic therapy) and response (all were p > 0.05). Conclusions: ORR and CR rates were lower in this real-world population of metastatic sRCC pts compared to clinical trial data, which should be a result of various CPI treatments and lines of treatment. However, these data highlight the heterogeneity of sRCC in general and need for additional investigations into impact of percentage of sarcomatoid features, genomic analyses, line of therapy, and CPI choice to optimize outcomes in sRCC pts.

Emerging Role of Interleukins for the Assessment and Treatment of Liver Diseases

2021 ◽  
Vol 21 ◽  
Author(s):  
Aaliya L. Ali ◽  
Namrata P. Nailwal ◽  
Gaurav M. Doshi
Keyword(s):  
Hepatocellular Carcinoma ◽  
Clinical Trial ◽  
Liver Disease ◽  
Alcoholic Liver Disease ◽  
Liver Diseases ◽  
Clinical Trial Data ◽  
Trial Data ◽  
Alcoholic Fatty Liver ◽  
Assessment And Treatment

Background: The most common liver diseases are fibrosis, alcoholic liver disease, non-alcoholic fatty disease, viral hepatitis, and hepatocellular carcinoma. These liver diseases account for approximately 2 million deaths per year worldwide, with cirrhosis accounting for 2.1% of the worldwide burden. The most widely used liver function tests for diagnosis are alanine transaminase, aspartate transaminase, serum proteins, serum albumin, and serum globulins, whereas antivirals and corticosteroids have been proven to be useful for the treatment of liver diseases. A major disadvantage of these diagnostic measures is the lack of specificity to a particular tissue or cell type, as these enzymes are common to one or more tissues. The major adverse effect of current treatment methods is drug resistance. To overcome these issues, interleukins have been investigated. The balance of these interleukins determines the outcome of an immune response. Interleukins are considered interesting therapeutic targets for the treatment of liver diseases. In this review, we summarize the current state of knowledge regarding interleukins in the diagnosis, treatment, and pathogenesis of different acute and chronic liver diseases. Objective: To understand the role of interleukins in the assessment and treatment of different types of liver diseases. Methods: A literature search was conducted using PubMed, Science Direct, and NCBI with the following keywords: Interleukins, Acute Liver Failure, Alcoholic Liver Disease, Non-Alcoholic Fatty Liver Disease, Liver Fibrosis, Hepatocellular Carcinoma, Inflammation, Liver injury, Hepatoprotective effect. Clinical trial data on these interleukins have been searched on Clinicaltrials.gov. Results: Existing literature and preclinical and clinical trial data demonstrate that interleukins play a crucial role in the pathogenesis of liver diseases. Conclusion: Our findings indicate that IL-1, IL-6, IL-10, IL-17, IL-22, IL-35, and IL-37 are involved in the progression and control of various liver conditions via the regulation of cell signaling pathways. However, further investigation on the involvement of these interleukins is necessary for their use as a targeted therapy in liver diseases.

Expectations in the Care of Lung Cancer

2015 ◽  
pp. e420-e424
Author(s):  
Rogerio Lilenbaum ◽  
Natasha B. Leighl ◽  
Marcus Neubauer
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Decision Making ◽  
Clinical Practice ◽  
Statistical Significance ◽  
Real Life ◽  
Clinical Trial Data ◽  
Routine Clinical Practice ◽  
Trial Data ◽  
Decision Making Process

One of the main challenges oncologists face in the care of patients with lung cancer is the decision to incorporate new clinical trial data into routine clinical practice. Beyond the question of statistical significance, which is a more objective metric, are the results meaningful and applicable to a broader population? Furthermore, in an era of value care, do the results justify a potential increase in costs? This article discusses the main points that clinicians consider in their decision-making process and illustrates the arguments with real-life examples.

Sign in / Sign up

Export Citation Format

Share Document