Real-World Utilization of Tissue-Free ctDNA MRD Testing in Non-Small Cell Lung Cancer Across Asia-Pacific and the Middle East: A Descriptive Cohort Analysis and Illustrative Case Series
8 affiliations
- 1Department of Oncology, National Cheng Kung University Hospital, Tainan 704, Taiwan
- 2Medical Affairs Department, Guardant Health Pte Ltd., Singapore 138567, Singapore
- 3Department of Internal Medicine, National Taiwan University Hospital Hsinchu Branch, Hsinchu 300, Taiwan
- 4The Helmsley Cancer Center, Shaare Zedek Medical Center, Jerusalem 9103102, Israel
- 5Cancer Institute of St. Luke’s Medical Center, Bonifacio Global City, Taguig 1634, Metro Manila, Philippines
- 6Medical Oncology, reVIVE Oncology and Cancer Centre, Hong Kong, China
- 7St Luke’s Medical Center, Quezon City 1112, Metro Manila, Philippines
- 8Department of Oncology, Taipei Veterans General Hospital, Taipei City 112201, Taiwan
Abstract
Introduction: Circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) testing is emerging as a tool to refine relapse risk and guide surveillance after curative-intent therapy for non-small cell lung cancer (NSCLC). Tissue-free (plasma-only) MRD assays may improve feasibility where tumor tissue is limited. Prospective and trial-embedded studies have established that ctDNA MRD detected after curative-intent therapy is prognostic for recurrence in NSCLC, but how tissue-free MRD testing is deployed in routine care in Asia-Pacific and the Middle East (AMEA) has not been described. We characterized ordering patterns and first-test positivity in an AMEA cohort. In this descriptive cohort (159 NSCLC patients; 257 samples), 40.9% of patients underwent more than one MRD test, with a median interval of 4.9 months between the first two tests; first-test MRD positivity was 15.7% (25/159; 95% CI 10.9–22.2) with rates of 0% (0/9; 95% CI 0.0–29.9), 8.8% (5/57; 95% CI 3.8–18.9), 21.5% (17/79; 95% CI 13.9–31.8) and 21.4% (3/14; 95% CI 7.6–47.6), respectively, across stages I, II, III, and oligometastatic stage IV disease. No hypothesis testing was performed, and the stage I and oligometastatic stage IV subgroups are small, so the confidence intervals overlap widely and apparent between-stage differences should not be interpreted as a stage effect. Case Presentation: Six illustrative cases involving patients with stage II–IVB describe the use of MRD testing in routine clinical care. The cases were selected purposively, not consecutively, to span the contexts in which the results were interpreted: a positive result shortly before radiographic nodal recurrence (Case 1); a positive result during long-term adjuvant osimertinib preceding isolated mediastinal relapse (Case 2); a transient positive result with subsequent clearance and radiographic regression (Case 3); a positive result that prompted PET-CT revealing occult metastatic disease (Case 4); serially negative results concordant with sustained radiographic remission (Case 5); and a positive result that prompted comprehensive genomic profiling identifying an actionable KRAS G12C alteration (Case 6). Conclusions: Across Asia-Pacific and the Middle East, tissue-free MRD testing in NSCLC was used primarily during surveillance and often serially; first-test positivity was 15.7% (95% CI 10.9–22.2) overall, with wide and mutually overlapping confidence intervals across stages. The cases illustrate that MRD results may prompt diagnostic evaluation when interpreted alongside imaging and other clinical findings, but they are purposively selected, and treatment changes that followed a result are reported as description, not as evidence of benefit. No assay performance characteristic is estimated. These findings are hypothesis-generating; prospective, MRD-directed trials with standardized timepoints, thresholds, confirmatory strategies and pre-specified clinical actions are needed before MRD results can guide treatment.
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BibTeX
@article{lee2026realworld,
title = {{Real-World Utilization of Tissue-Free ctDNA MRD Testing in Non-Small Cell Lung Cancer Across Asia-Pacific and the Middle East: A Descriptive Cohort Analysis and Illustrative Case Series}},
author = {Chun-Hui Lee and Suyog Jain and Lun-Che Chen and Nir Peled and Gerardo H. Cornelio and Kenny Kim Pong Ng and Hsiao-Yu Jen and Katherina Oh and Orielle Kyra B. Castro-Maddela and Vince Nigel Blanco and Chun-Ming Tsai},
journal = {Cancers},
year = {2026},
month = oct,
doi = {10.3390/cancers18203296},
url = {https://www.mdpi.com/2072-6694/18/20/3296},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Real-World Utilization of Tissue-Free ctDNA MRD Testing in Non-Small Cell Lung Cancer Across Asia-Pacific and the Middle East: A Descriptive Cohort Analysis and Illustrative Case Series
AU - Chun-Hui Lee
AU - Suyog Jain
AU - Lun-Che Chen
AU - Nir Peled
AU - Gerardo H. Cornelio
AU - Kenny Kim Pong Ng
AU - Hsiao-Yu Jen
AU - Katherina Oh
AU - Orielle Kyra B. Castro-Maddela
AU - Vince Nigel Blanco
AU - Chun-Ming Tsai
PY - 2026
DA - 2026/10/01
JO - Cancers
DO - 10.3390/cancers18203296
UR - https://www.mdpi.com/2072-6694/18/20/3296
AB - Introduction: Circulating tumor DNA (ctDNA)-based molecular residual disease (MRD) testing is emerging as a tool to refine relapse risk and guide surveillance after curative-intent therapy for non-small cell lung cancer (NSCLC). Tissue-free (plasma-only) MRD assays may improve feasibility where tumor tissue is limited. Prospective and trial-embedded studies have established that ctDNA MRD detected after curative-intent therapy is prognostic for recurrence in NSCLC, but how tissue-free MRD testing is deployed in routine care in Asia-Pacific and the Middle East (AMEA) has not been described. We characterized ordering patterns and first-test positivity in an AMEA cohort. In this descriptive cohort (159 NSCLC patients; 257 samples), 40.9% of patients underwent more than one MRD test, with a median interval of 4.9 months between the first two tests; first-test MRD positivity was 15.7% (25/159; 95% CI 10.9–22.2) with rates of 0% (0/9; 95% CI 0.0–29.9), 8.8% (5/57; 95% CI 3.8–18.9), 21.5% (17/79; 95% CI 13.9–31.8) and 21.4% (3/14; 95% CI 7.6–47.6), respectively, across stages I, II, III, and oligometastatic stage IV disease. No hypothesis testing was performed, and the stage I and oligometastatic stage IV subgroups are small, so the confidence intervals overlap widely and apparent between-stage differences should not be interpreted as a stage effect. Case Presentation: Six illustrative cases involving patients with stage II–IVB describe the use of MRD testing in routine clinical care. The cases were selected purposively, not consecutively, to span the contexts in which the results were interpreted: a positive result shortly before radiographic nodal recurrence (Case 1); a positive result during long-term adjuvant osimertinib preceding isolated mediastinal relapse (Case 2); a transient positive result with subsequent clearance and radiographic regression (Case 3); a positive result that prompted PET-CT revealing occult metastatic disease (Case 4); serially negative results concordant with sustained radiographic remission (Case 5); and a positive result that prompted comprehensive genomic profiling identifying an actionable KRAS G12C alteration (Case 6). Conclusions: Across Asia-Pacific and the Middle East, tissue-free MRD testing in NSCLC was used primarily during surveillance and often serially; first-test positivity was 15.7% (95% CI 10.9–22.2) overall, with wide and mutually overlapping confidence intervals across stages. The cases illustrate that MRD results may prompt diagnostic evaluation when interpreted alongside imaging and other clinical findings, but they are purposively selected, and treatment changes that followed a result are reported as description, not as evidence of benefit. No assay performance characteristic is estimated. These findings are hypothesis-generating; prospective, MRD-directed trials with standardized timepoints, thresholds, confirmatory strategies and pre-specified clinical actions are needed before MRD results can guide treatment.
SN - 2072-6694
ER -