Improving Cancer Recurrence Detection using ctDNA Measures in Colorectal, Breast, and Non-small Cell Lung Cancers
Author(s)
Ning Yan Gu, PhD1, Chris Waters-Banker, PhD2, Gebra Cuyun Carter, MPH, PhD1, Danielle Badgley, MSc2, Jan Tuzil, PhD2, Aleksandra Vidisheva, MSc2, Melanie Palomares, MD1, Heather Johnson, MSc1, Nathaniel Smith, PhD2;
1Exact Sciences, Madison, WI, USA, 2Maple Health Group, LLC, New York, NY, USA
1Exact Sciences, Madison, WI, USA, 2Maple Health Group, LLC, New York, NY, USA
Presentation Documents
OBJECTIVES: Detecting molecular residual disease (MRD) in solid tumors via circulating tumor DNA (ctDNA) is an emerging practice to assess initial treatment effect following curative intent therapy and to detect risk of recurrence. A systematic literature review was conducted to summarize the clinical validity of ctDNA for detecting cancer recurrence.
METHODS: Searches were executed in PubMed and Embase to identify studies detecting postoperative MRD via ctDNA in adults with solid tumors, from 01/01/2018 to 11/01/2023. Studies reporting sensitivity, specificity, and/or clinical lead times to detect recurrence for colorectal (CRC), breast (BC), and non-small cell lung cancer (NSCLC) (indications with greatest representation) are reported herein.
RESULTS: Out of a total of 4,308 non-duplicate records screened, 24 studies met eligibility criteria and reported ≥1 outcome of interest. Most patients with CRC had stage II/III disease; those with BC or NSCLC primarily had stage I-III. Sample timing, length of follow-up (median 12.5-55 months), and assay types were heterogeneous across studies. Sensitivity for detecting recurrence for single post-surgical and/or post-adjuvant therapy samples ranged from 27.0%-67.0% for CRC (n=5), 79.0% for BC (n=1) and, 26.1%-57.9% for NSCLC (n=5). Sensitivity improved with serial sampling (e.g., every 3-6 months), ranging from 66.7%-100% for CRC (n=5), 85.7%-89.0% for BC (n=2), and 73.2%-87.2% for NSCLC (n=2). Specificity across cancers ranged from 80.1%-100% (n=15). Studies reporting lead time (n=18) showed ctDNA detected recurrence sooner than radiological imaging for all three indications (median range: 1-12.4 months).
CONCLUSIONS: Variability of ctDNA sensitivity for detecting recurrence may relate to sample timing, follow-up duration, assay types, and patient and tumor characteristics. It is important to understand these factors when interpreting test performance data. Evaluating MRD via ctDNA status shows promise for earlier detection of recurrence in CRC, BC, and NSCLC, particularly when serial testing is used.
METHODS: Searches were executed in PubMed and Embase to identify studies detecting postoperative MRD via ctDNA in adults with solid tumors, from 01/01/2018 to 11/01/2023. Studies reporting sensitivity, specificity, and/or clinical lead times to detect recurrence for colorectal (CRC), breast (BC), and non-small cell lung cancer (NSCLC) (indications with greatest representation) are reported herein.
RESULTS: Out of a total of 4,308 non-duplicate records screened, 24 studies met eligibility criteria and reported ≥1 outcome of interest. Most patients with CRC had stage II/III disease; those with BC or NSCLC primarily had stage I-III. Sample timing, length of follow-up (median 12.5-55 months), and assay types were heterogeneous across studies. Sensitivity for detecting recurrence for single post-surgical and/or post-adjuvant therapy samples ranged from 27.0%-67.0% for CRC (n=5), 79.0% for BC (n=1) and, 26.1%-57.9% for NSCLC (n=5). Sensitivity improved with serial sampling (e.g., every 3-6 months), ranging from 66.7%-100% for CRC (n=5), 85.7%-89.0% for BC (n=2), and 73.2%-87.2% for NSCLC (n=2). Specificity across cancers ranged from 80.1%-100% (n=15). Studies reporting lead time (n=18) showed ctDNA detected recurrence sooner than radiological imaging for all three indications (median range: 1-12.4 months).
CONCLUSIONS: Variability of ctDNA sensitivity for detecting recurrence may relate to sample timing, follow-up duration, assay types, and patient and tumor characteristics. It is important to understand these factors when interpreting test performance data. Evaluating MRD via ctDNA status shows promise for earlier detection of recurrence in CRC, BC, and NSCLC, particularly when serial testing is used.
Conference/Value in Health Info
2025-05, ISPOR 2025, Montréal, Quebec, CA
Value in Health, Volume 28, Issue S1
Code
MT6
Topic
Medical Technologies
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, SDC: Oncology