ReCAP: Clinical Trial Accrual Targeting Genomic Alterations After Next-Generation Sequencing at a Non-National Cancer Institute-Designated Cancer Program.

QUESTION ASKED:

Successful clinical trial accrual targeting uncommon genomic alterations will require broad national participation from both National Cancer Institute (NCI)-designated comprehensive cancer centers and community cancer programs. What is the initial experience from three affiliated community-based, non-NCI-designated cancer programs with next-generation sequencing (NGS), and what is the impact on enrollment to genotype-directed therapeutic clinical trials?

SUMMARY ANSWER:

Genotype-directed clinical trial accrual was low (9.2%) and comparable to that of NCI-designated cancer centers. The two major reasons for low clinical trial accrual were: no locally available matching trial (48.6%) and ineligibility (33.6%) resulting from comorbidities or interim clinical deterioration.

METHODS:

Clinical trial participation was reviewed after enrollment of the first 200 patients for comprehensive genomic profiling by NGS as part of an institutional review board-approved protocol at three affiliated hospitals in Rhode Island from August 2014 to June 2015 and compared with published experience from NCI-designated cancer centers.

BIAS, CONFOUNDING FACTORS, DRAWBACKS:

The study consisted of a predominantly GI cancer population. No corresponding germline genomic data were available. Clinical response and survival outcome data were not collected.

REAL-LIFE IMPLICATIONS:

Successful clinical trial accrual targeting uncommon genomic alterations will require broad national participation from both NCI-designated comprehensive cancer centers and community cancer programs. It is estimated that only 15% of patients in the United States are treated at NCI-designated cancer centers. Our observations indicate that in order to maximize the use of NGS testing for accrual to clinical trials, practicing physicians from community cancer centers require support in the areas of cancer biology, genomic interpretation, bioinformatics, patient selection, clinical trial design, and access to clinical trial protocols for their patients.jop;JOP.2015.008433v1/FA1F1FA1FIG 1A.Major genomic alterations identified.

Copyright © 2016 by American Society of Clinical Oncology.

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