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Feasibility of Integrating Panel-Based Pharmacogenomics Testing for Chemotherapy and Supportive Care in Patients With Colorectal Cancer.

ABSTRACT: INTRODUCTION:Pharmacogenomics is about selecting the "right drug in the right amount for the right patient." In metastatic colorectal cancer, germline pharmacogenomics testing presents a unique opportunity to improve outcomes, since the genes dihydropyrimidine dehydrogenase and UDP-glucuronosyltransferase metabolizing the chemotherapy drugs, 5-fluorouracil, and irinotecan are already well known. In a retrospective analysis of the landmark TRIBE clinical trial [(TRIBE - TRIplet plus BEvacizumab multicenter, phase III trial by the Italian Cooperative GONO (Gruppo Oncologico Nord Ovest) group (NCT00719797)], the proportion of patients with serious adverse events was higher in those with dihydropyrimidine dehydrogenase/UDP-glucuronosyltransferase aberrations and was dose dependent. We aimed to report on the feasibility and the results of incorporating pharmacogenomics testing into clinical practice. METHODS:As a quality improvement initiative and a center of individualized medicine grant, we integrated the use of OneOme RightMed comprehensive test, which reports on 27 genes related to pharmacogenomics and over 300 medications of interest. We limited initial testing to patients with colorectal cancer. Pharmacists provided dosage recommendations based on test results in real-time. RESULTS:At our cancer center, 155 patients underwent pharmacogenomics testing from November 2017 to January 2019. Results were available within 3 to 5 days of testing for most patients and were integrated into treatment decision-making. Of 155 sampled participants, a total of 89 (57.4%) participants had an UGT1A1 variant genotype, NM_000463.2: c.-53_-52[8] *1/*28, n = 74 (47.7%); *28/*28, n = 15 (9.7%). Additionally, 4 (2.6%) participants were heterozygous for dihydropyrimidine dehydrogenase. Two (1.3%) individuals were heterozygous for both UDP-glucuronosyltransferase and dihydropyrimidine dehydrogenase genes. All (100%) the patients had at least 1 actionable aberration related to supportive care medications (CYP-family) of all the possible medications listed on their pharmacogenomics report. CONCLUSION:Preemptive comprehensive pharmacogenomics testing can be integrated into clinical practice in real-time for patients with cancer given faster turnaround and low cost. Pharmacist-driven, patient-specific medication management consults add further value given the number of genes/drugs. This sets the stage for a prospective randomized clinical trial to demonstrate the amount of benefit this can result in these patients.

SUBMITTER: Kasi PM

PROVIDER: S-EPMC6753511 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Feasibility of Integrating Panel-Based Pharmacogenomics Testing for Chemotherapy and Supportive Care in Patients With Colorectal Cancer.

Kasi Pashtoon Murtaza PM Koep Tyler T Schnettler Erica E Shahjehan Faisal F Kamatham Vaishnavi V Baldeo Candice C Hughes Caren L CL

Technology in cancer research & treatment 20190101

<h4>Introduction</h4>Pharmacogenomics is about selecting the "right drug in the right amount for the right patient." In metastatic colorectal cancer, germline pharmacogenomics testing presents a unique opportunity to improve outcomes, since the genes dihydropyrimidine dehydrogenase and UDP-glucuronosyltransferase metabolizing the chemotherapy drugs, 5-fluorouracil, and irinotecan are already well known. In a retrospective analysis of the landmark TRIBE clinical trial [(TRIBE - TRIplet plus BEvac ...[more]

PMID: 31533552

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Project description:Preterm birth affects 8% to 11% of the population and conveys a significant risk of developmental delays. Intervention programs that support child development have been shown to have a positive impact on early motor and cognitive development and on parental well-being. However, these programs are often difficult to implement in a real-life setting due to lack of resources. Hence, our multidisciplinary team developed Mieux Agir au Quotidien (MAQ) to teach developmentally supportive care to parents of preterm infants with the goal of improving child development and parental outcomes. Our intervention included 3 in-person workshops that occurred prior to hospital discharge and a Web-based platform with written and videotaped materials that addressed 5 main themes: (1) infant behavioral cues, (2) flexion positioning; (3) oral feeding support, (4) parent-infant interactions, and (5) anticipation of developmental milestones.This study aimed to test the feasibility and acceptability of the intervention by parents of preterm infants and assess clinical benefits on child neurodevelopment and parental outcomes during the first year of life.A total of 107 infants born at <30 weeks and admitted to Sainte-Justine Hospital neonatal intensive care unit and their parents were enrolled in a nonrandomized controlled before-and-after interventional study (intervention n=55, comparison n=52). Acceptability of the program was assessed with a user satisfaction questionnaire. When the infants were at 4 months' corrected age, all parents completed questionnaires on infant temperament, parenting stress, sense of competence, and parenting satisfaction. At 12 months' corrected age, neurodevelopmental testing was performed on infants using the Alberta Infant Motor Scale and the Bayley Scales of Infant and Toddler Development, Third Edition. Comparisons between the 2 groups were done using independent t tests, Wilcoxon rank-sum tests, and Fisher exact tests.The majority of parents (43/45) were satisfied with the intervention program and all would recommend MAQ to others. MAQ met their need for evidence-based information that proved useful to support their child development. No difference in parental or child neurodevelopmental outcomes was detected in this pilot study for most outcomes except for higher median scores for parental coercive behaviors in the intervention group, although proportions scoring in the coercive range did not differ.Acceptability of the program was high among parents thus supporting the relevance of such intervention. A larger study using a randomized controlled trial design is needed to better document impact on parent and children and investigate how Web-based technologies can efficiently complement individualized intervention to alleviate the burden on health care resources.

Project description:BACKGROUND:Implementation of evidence-based programs (EBPs) for disease self-management and prevention is a policy priority. It is challenging to implement EBPs offered in community settings and to integrate them with healthcare. We sought to understand, categorize, and richly describe key challenges and opportunities related to integrating EBPs into routine primary care practice in the United States. METHODS:As part of a parent, participatory action research project, we conducted a mixed methods evaluation guided by the PRECEDE implementation planning model in an 11-county region of Southeast Minnesota. Our community-partnered research team interviewed and surveyed 15 and 190 primary care clinicians and 15 and 88 non-clinician stakeholders, respectively. We coded interviews according to pre-defined PRECEDE factors and by participant type and searched for emerging themes. We then categorized survey items-before looking at participant responses-according to their ability to generate further evidence supporting the PRECEDE factors and emerging themes. We statistically summarized data within and across responder groups. When consistent, we merged these with qualitative insight. RESULTS:The themes we found, "Two Systems, Two Worlds," "Not My Job," and "Seeing is Believing," highlighted the disparate nature of prescribed activities that different stakeholders do to contribute to health. For instance, primary care clinicians felt pressured to focus on activities of diagnosis and treatment and did not imagine ways in which EBPs could contribute to either. Quantitative analyses supported aspects of all three themes, highlighting clinicians' limited trust in community-placed activities, and the need for tailored education and system and policy-level changes to support their integration with primary care. CONCLUSIONS:Primary care and community-based programs exist in disconnected worlds. Without urgent and intentional efforts to bridge well-care and sick-care, interventions that support people's efforts to be and stay well in their communities will remain outside of-if not at odds with-healthcare.

Dataset Information

Feasibility of Integrating Panel-Based Pharmacogenomics Testing for Chemotherapy and Supportive Care in Patients With Colorectal Cancer.

Publications

Feasibility of Integrating Panel-Based Pharmacogenomics Testing for Chemotherapy and Supportive Care in Patients With Colorectal Cancer.

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