TEST:

AlphaLiquid® 100

Among patients with advanced BTC, ctDNA-based genotyping showed acceptable concordance with tissue genomic profiling. Liquid biopsy using ctDNA could be a valuable complement to tissue-based genomic analysis in BTC.

Genotyping of MPE supernatant cfDNA is feasible in clinical practice, in addition to plasma and tumor testing, to improve diagnostic yield and extend patients' benefit from targeted therapies.

Patients with mBC with higher concentrations of cfDNA or higher VAF of ctDNA had shorter survival. PIK3CA and TP53 mutation, as detected with liquid biopsy, could be used as a poor prognostic biomarker for mBC patients.

In the liquid biomarker analysis in the MET-dysregulated cancer patients who were treated with tepotinib, the presence of ctDNA METalteration at baseline was associated with a higher response rate but shorter PFS and OS. The molecular response was well correlated with the radiological response and associated with better outcomes. (Funded by Merck KGaA, Darmstadt, Germany, ClinicalTrials.gov number, NCT04647838.)

In addition, the fold changes in ctDNA dynamics during treatment significantly correlated with changes in tumor size and CEA levels, as well as with droplet digital PCR copy number fold changes. In a patient with MET amplification, ctDNA NGS identified MET Y1230H as a potential acquired resistance mutation after crizotinib treatment, which responded to cabozantinib but not to capmatinib.Conclusions Initial tumor profiling using ctDNA NGS yielded outcomes comparable to those of tumor tissue NGS in guiding treatment for patients with newly diagnosed mCRC, thereby suggesting its utility as an initial profiling method in mCRC.

Blood samples collected post-targeted therapies revealed additional acquired mutations. The AlphaLiquid®100 ctDNA assay demonstrates robust analytical validity, offering clinically important information for NSCLC patients.

Patients with mBC with higher concentrations of ctDNA or higher mutated allelic frequency of ctDNA at baseline showed significantly shorter PFS. PIK3CAmt and TP53mt detected by liquid biopsy could be used as a poor prognostic biomarkers for mBC patients.

Lastly, patients with high ctDNA VAF showed poor prognosis in gemcitabine-cisplatin based chemotherapy in both overall survival and progression-free survival (p = 6.9 x 10-6 and p = 9.8 x 10-10), respectively. Conclusions ctDNA-based genotyping demonstrated acceptable concordance with tissue genomic profiling in patients with advanced BTC. Thus, liquid biopsy using ctDNA could complement the limitation of tissue-based genomic analysis in BTC.