Many researchers determined that the clinical significance of circulating tumor DNA (ctDNA) in detecting minimal residual disease (MRD) surpasses the sensitivity of traditional imaging techniques. However, most MRD detection methods primarily target mutation identification and rely on cancer tissue samples, posing limitations such as high costs, limited accessibility to cancer tissue, and challenges in addressing tumor heterogeneity. To overcome these drawbacks, SeekInCure offers a cost-effective and multi-dimensional MRD test that does not necessitate cancer tissue analysis. The prospective study aimed to assess the broader clinical applicability of SeekInCure in detecting MRD among patients diagnosed with hepatocellular carcinoma (HCC).
For a study, researchers enrolled 34 patients with HCC who were scheduled to undergo radical surgery at Peking University Shenzhen Hospital. Peripheral blood samples were collected from each patient, amounting to 8 mL before and after the surgical procedure. These blood samples were subjected to analysis using the SeekInCure assay, which incorporated the assessment of protein tumor marker (AFP) levels, as well as the evaluation of cancer genomic characteristics, including copy number aberrations and fragment size derived from circulating tumor DNA (ctDNA). Patients exhibiting positive results for AFP and/or ctDNA in either the preoperative or post-operative samples were categorized as MRD-positive (MRD+), while those with negative results were categorized as MRD-negative (MRD-).
Out of the 34 patients included in the study, 73.5% (25/34) were diagnosed at early stages (stages I/II: 61.8%/11.8%), and 61.8% (21/34) underwent adjuvant therapies. The median follow-up period was 279.5 days, from 90 to 1,253 days. In the preoperative samples, 82% (28/34) of the patients tested positive for minimal residual disease (MRD+), demonstrating significant sensitivity in a cohort where over 70% were in the early stages. These findings corroborated our previous results, indicating that preoperative MRD+ patients exhibited poorer survival outcomes than MRD- patients. Following radical surgery, 26.5% (9/34) of the patients remained MRD+. The MRD+ patients experienced worse survival outcomes, with a median overall survival (OS) time of 298 days, while the OS time for MRD- patients was indeterminate (not reached) (P < 0.01). Notably, the six patients who tested negative for MRD in both pre-and post-operative samples demonstrated exceptionally favorable outcomes, achieving 100% OS. Conversely, the nine patients with positive MRD results exhibited the poorest prognosis in both samples.
Additionally, the analysis revealed that MRD- patients who received adjuvant therapies did not experience a survival benefit compared to those without. However, among MRD+ patients, those who received adjuvant therapies exhibited better OS than those without (P = 0.026).
The study’s findings provided further validation of the exceptional efficacy of SeekInCure assay, which obviated the need for cancer tissue analysis in effectively detecting minimal residual disease (MRD) and highlighting its prognostic significance in patients with hepatocellular carcinoma (HCC). Notably, the results indicated that adjuvant therapy does not impact overall survival, particularly in MRD-negative (MRD-) patients, suggesting that a significant proportion of HCC patients, approximately one-third, may not require additional adjuvant treatment.
