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Oncologist. 2017 Oct;22(10):1169-1177. doi: 10.1634/theoncologist.2017-0020. Epub 2017 Jul 12.

Clinical Application of Targeted Deep Sequencing in Solid-Cancer Patients and Utility for Biomarker-Selected Clinical Trials.

Author information

1
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
2
Division of Gasteroenterology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
3
Departments of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
4
Samsung Genome Institute, Samsung Medical Center, Seoul, Korea.
5
Innovative Cancer Medicine Institute, Samsung Cancer Center, Seoul, Korea.
6
Samsung Advanced Institute of Health Science and Technology, Sungkyunkwan University, Seoul, Korea.
7
Department of Biomedical Informatics, Harvard Medical School, Boston, Masachusetts, USA.
8
Departments of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
9
Departments of Radiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
10
Departments of Thoracic Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
11
Biostatistics and Clinical Epidemiology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
12
Samsung Genome Institute, Samsung Medical Center, Seoul, Korea woongyang@skku.edu jyunlee@skku.edu.
13
Department of Molecular Cell Biology, Sungkyunkwan University School of Medicine, Seoul, Korea.
14
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea woongyang@skku.edu jyunlee@skku.edu.

Abstract

Molecular profiling of actionable mutations in refractory cancer patients has the potential to enable "precision medicine," wherein individualized therapies are guided based on genomic profiling. The molecular-screening program was intended to route participants to different candidate drugs in trials based on clinical-sequencing reports. In this screening program, we used a custom target-enrichment panel consisting of cancer-related genes to interrogate single-nucleotide variants, insertions and deletions, copy number variants, and a subset of gene fusions. From August 2014 through April 2015, 654 patients consented to participate in the program at Samsung Medical Center. Of these patients, 588 passed the quality control process for the 381-gene cancer-panel test, and 418 patients were included in the final analysis as being eligible for any anticancer treatment (127 gastric cancer, 122 colorectal cancer, 62 pancreatic/biliary tract cancer, 67 sarcoma/other cancer, and 40 genitourinary cancer patients). Of the 418 patients, 55 (12%) harbored a biomarker that guided them to a biomarker-selected clinical trial, and 184 (44%) patients harbored at least one genomic alteration that was potentially targetable. This study demonstrated that the panel-based sequencing program resulted in an increased rate of trial enrollment of metastatic cancer patients into biomarker-selected clinical trials. Given the expanding list of biomarker-selected trials, the guidance percentage to matched trials is anticipated to increase.

IMPLICATIONS FOR PRACTICE:

This study demonstrated that the panel-based sequencing program resulted in an increased rate of trial enrollment of metastatic cancer patients into biomarker-selected clinical trials. Given the expanding list of biomarker-selected trials, the guidance percentage to matched trials is anticipated to increase.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02141152.

KEYWORDS:

Clinical trials; Metastatic cancer; Molecular screening; Next‐generation sequencing

PMID:
28701572
PMCID:
PMC5634774
[Available on 2018-10-01]
DOI:
10.1634/theoncologist.2017-0020
[Indexed for MEDLINE]

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