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Detection and Monitoring of Tumor Associated Circulating DNA in Patient Biofluids
Published on: June 8, 2019
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Prospective Feasibility Study for Using Cell-Free Circulating Tumor DNA-Guided Therapy in Refractory Metastatic Solid
Seung Tae Kim1, Kimberly C Banks1, Se-Hoon Lee1
1, , , , , , , , , and , Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea; and , , and , Guardant Health, Redwood City, CA.
JCO Precision Oncology
|September 11, 2020
Summary
This study shows comprehensive cell-free circulating tumor DNA (ctDNA) testing guides effective targeted therapy for advanced cancers. ctDNA-guided matched therapy demonstrated high response rates in non-small-cell lung cancer and gastric cancer patients.
Area of Science:
- Oncology
- Genomics
- Molecular Diagnostics
Background:
- Retrospective studies suggest cell-free circulating tumor DNA (ctDNA) hotspot testing predicts treatment response in advanced non-small-cell lung cancer (NSCLC).
- Prospective studies evaluating comprehensive plasma genomic testing (including all major alteration classes) for ctDNA-guided therapy decisions are lacking.
- This study investigates the clinical utility of comprehensive ctDNA testing for guiding matched therapy in advanced solid tumors.
Purpose of the Study:
- To prospectively evaluate the clinical utility of comprehensive ctDNA-guided matched therapy in patients with advanced solid tumors.
- To assess the feasibility of using plasma-based genomic profiling to identify targetable alterations when tissue is insufficient.
- To determine response rates and disease control in patients receiving ctDNA-guided targeted therapy.
Main Methods:
- A prospective, parallel cohort, open-label clinical trial was conducted.
- Plasma-based digital sequencing identified point mutations, indels, fusions, and copy number amplifications in 70 genes.
- Patients with targetable alterations in metastatic NSCLC, gastric cancer (GC), and other cancers were matched to targeted agent trials.
Main Results:
- Somatic alterations were detected in 78% of GC patients and 85% of NSCLC patients.
- Targetable alterations were identified in 33% of GC patients (e.g., ERBB2, MET) and 47% of NSCLC patients (e.g., EGFR, ALK).
- In GC, 10 patients received matched therapy with a 67% response rate and 100% disease control. In NSCLC, 17 patients received matched therapy with an 87% response rate and 100% disease control.
Conclusions:
- This is the first prospective feasibility study of comprehensive ctDNA-guided treatment in advanced gastric and lung cancers.
- Response rates observed in this interim analysis are comparable to those seen in tissue-based targeted therapy studies.
- Comprehensive ctDNA testing is a viable approach for guiding matched therapy in advanced solid tumors.
