Our results suggest a strong association between supratherapeutic concentrations and morbidly obese patients when dosed at 4 mg/kg actual body weight. Dosing voriconazole based on an ideal body weight or adjusted body weight may be appropriate for morbidly obese patients.
1531 Background: Relative lack of prior success of genomic technology has been a function of suboptimal target detection and poor timely implementation. We set out to improve patient access to targeted therapy through use of whole genome sequencing (WGS) to optimize targets and operational implementation to identify clinical trials and secure off-label drugs. Methods: We performed a retrospective analysis of our first 100 patients (Feb-Nov 2016) with metastatic disease whose tumors and matched blood were analyzed using whole genome (WGS) and transcriptome sequencing, as well as targeted proteomic analysis in a CLIA setting (NantOmics). Most common tumor types were Colorectal (20%), Breast (15%), and Ovarian (10%). Patients were seen in dedicated precision genomics clinics with results reviewed by a multi-disciplinary molecular tumor board. A dedicated service line with staff to match patients to clinical trials, medication acquisition, and genetic counseling for germline findings was provided. Results: 85% of patients had a finding either on WGS or proteomic analysis that pointed to an FDA approved drug or clinical trial. Common findings included: mutations in the PI3K pathway (15%), BRCA1&2/ATM (15%), and cell cycle genes (11%). Other markers of note include: HER2, TMB/MSI for immune checkpoint therapy, IDH1/2, and MET. WGS also enabled identification of rare actionable findings, particularly translocations, and viral integration for trials requiring HPV-positivity. Cancer predisposition germline findings were observed in 3 patients. Of the 85 patients with actionable findings, 22 went on to be treated with a genomically-directed agent, 13 did not follow recommendations or were sent to hospice, 4 were lost to follow-up, and 46 still remain on their therapy prescribed prior to sequencing. Conclusions: A higher proportion of patients in our program went on to be treated with a genomically-directed agent than previously reported in the literature secondary to comprehensive whole genome multi-omics profiling and a clinical service line dedicated to medication acquisition and matching to clinical trials.
Elizabeth Koselke, PharmD, BCOP, of The US Oncology Network, describes a clinical pharmacist intervention to screen patients and improve clinical trial enrollment. Christa Braun-Inglis, DNP, APRN, FNP-BC, AOCNP®, of the University of Hawai‘i Cancer Center, details a team approach to both increase clinical trial accrual and improve clinical trial conduct.
1503 Background: The Molecularly Informed Lung Cancer Treatment in a Community Cancer Network: A Pragmatic Consortium (MYLUNG) clinical trial platform aims to advance the use of precision medicine in non-small cell lung cancer patients through a series of prospective and iterative clinic trials. “Protocol 2” is evaluating the patient and tissue journey of newly diagnosed lung cancer patients presenting for care. Timely patient accrual to oncology clinical trials is a known practice challenge. The US Oncology Network recently implemented a clinical pharmacist (ClinReview) to provide remote clinical services to support Protocol 2 enrollment. Methods: An oncology-trained clinical pharmacist remotely reviewed chemotherapy regimen orders and a weekly custom recruitment report within six community network practices (n = 149 physicians). The ClinReview pharmacist identified, screened, and assisted with recruitment of eligible patients for enrollment in the MYLUNG study. Relevant and concise patient data were provided to the on-site research team to facilitate ease of enrollment. Enrollments and intervention data were tracked to monitor the impact of the pharmacist intervention. The primary outcome of monthly enrollment was evaluated using a paired t-test. Results: Over a 6-month period, the ClinReview pharmacist screened 367 potentially eligible patients, 325 patients were recommended for enrollment, and 103 patients (32%) were consented and enrolled. Enrollment due to this ClinReview intervention increased monthly and ranged from 5 in first month to 33 enrollments in month 6. Average monthly enrollment was significantly greater after ClinReview intervention (3.4 patients/month vs. 6.8 patients/month; p = 0.008). Of the 154 patients recommended for enrollment that were not enrolled, 104 (68%) exceeded their eligibility window allowed by the trial, 15 (10%) were deceased or enrolled into hospice care, 10 (6%) declined trial participation, and 25 (16%) transferred care or were treated at outside facilities. Conclusions: We demonstrate that incorporation of an oncology clinical pharmacist in clinical research teams significantly enhanced clinical trial enrollment. The remote pharmacist easily adapted into clinic workflows in community practices. Validation across a broader spectrum of differentially resourced oncology practices will be conducted as the MYLUNG clinical trials platform is executed. [Table: see text]
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