Abstract 407P
Background
Circulating tumor DNA (ctDNA) has emerged as a promising biomarker to monitor molecular residual disease (MRD) in solid tumors after curative-intent treatment. Since imaging and plasma-derived protein biomarkers both have limited sensitivity and specificity, ctDNA could complement conventional methods to guide post-operative monitoring and treatment plans for patients. This study evaluated the clinical utility of our tumor-informed, personalized ctDNA assay to identify patients at high risk of recurrence.
Methods
This prospective multi-center study enrolled 510 patients with liver, colorectal, breast, lung, gastric and ovarian cancers who were eligible for curative-intent surgery. Genomic DNA extracted from tumor tissue and paired white blood cells was subjected to massively parallel sequencing of 150 cancer-related genes. A proprietary algorithm ranked the top somatic mutations unique to each patient, which were then used to detect ctDNA in serial plasma samples.
Results
The pre-operative detection rate of ctDNA was 91%, 97%, 62%, 65%, 57%, and 46% for colorectal, liver, lung, ovarian, high-risk breast cancer, and gastric cancer respectively; the specificity was >99% as ctDNA was not detected in the plasma from healthy donors. Our interim analysis after a 20-month follow-up demonstrated that 88% of patients with recurrence and/or metastasis (35/40) had ctDNA detected in their post-operative plasma samples. On average, such ctDNA detection was 5 months (up to 13 months) earlier than clinical diagnosis. Post-operative ctDNA was also found as an independent prognostic factor for disease-free survival in multiple types of cancer (p<0.001).
Conclusions
K-Track™ assay provides longitudinal ctDNA monitoring that showed clinical utility in predicting disease-free survival and early relapse detection in cancer patients. This simplified and cost-effective approach enables MRD monitoring to be more accessible in routine clinical practice in developing countries.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Medical Genetics Institute, Ho Chi Minh City, Vietna.
Funding
Gene Solutions JSC, Ho Chi Minh city, Vietnam.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
62P - Combination of chemotherapy with endocrinal therapy as upfront treatment of metastatic breast cancer in hormone receptor- positive, HER2 -negative disease: A phase II randomised clinical trial
Presenter: Mariam Saleh
Session: Poster Display
Resources:
Abstract
63P - Efficacy and safety of eribulin plus carboplatin combination for HER2-negative metastatic breast cancer
Presenter: Mengqian Ni
Session: Poster Display
Resources:
Abstract
64P - Unmet needs following metastatic breast cancer in a middle-income Asian country
Presenter: Nirmala Bhoo-Pathy
Session: Poster Display
Resources:
Abstract
66P - Utidelone-based therapy in metastatic solid tumors after failure of standard therapies: A prospective, multicenter, single-arm trial
Presenter: Jianjun Zhang
Session: Poster Display
Resources:
Abstract
67P - Efficacy and safety of trastuzumab biosimilar in HER2+ve metastatic breast cancer: A multicenter phase III study
Presenter: krishna Mohan
Session: Poster Display
Resources:
Abstract
68P - Neratinib in combination with fulvestrant and or palbociclib can overcome endocrine resistance in HER2-low/ ER+ breast cancer
Presenter: Maryam Arshad
Session: Poster Display
Resources:
Abstract
69P - A multicenter, retrospective, real-world study of inetetamab combined with pyrotinib and vinorelbine as treatment for HER2-positive metastatic breast cancer
Presenter: Nan Jin
Session: Poster Display
Resources:
Abstract
70P - Overall survival of eribulin, trastuzumab, and pertuzumab as first-line therapy for patients with HER2-positive metastatic breast cancer: A phase II, single-arm clinical trial
Presenter: Kenichi Inoue
Session: Poster Display
Resources:
Abstract
71P - Efficacy and safety of disitamab vedotin after trastuzumab for HER2 -positive breast cancer: A real-world data of retrospective study
Presenter: Chao Li
Session: Poster Display
Resources:
Abstract
72P - Real-world data on the efficacy of T-DM1 biosimilar for the treatment of HER2-positive metastatic breast cancer patients: Outcomes from a single center retrospective study in India
Presenter: Kaushal Patel
Session: Poster Display
Resources:
Abstract