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
143P - Ablation combined with tislelizumab in treating hepatocellular carcinoma: A phase II trial
Presenter: Yangxun Pan
Session: Poster Display
Resources:
Abstract
144P - Integrated clinical and genomic models using machine-learning methods to predict the efficacy of paclitaxel-based chemotherapy in patients with advanced gastric cancer from K-MASTER project
Presenter: Jwa Hoon Kim
Session: Poster Display
Resources:
Abstract
145P - Tislelizumab (TIS) + chemotherapy (Chemo)/chemoradiotherapy (CRT) as neoadjuvant treatment for resectable esophageal squamous cell carcinoma (R-ESCC)
Presenter: Longqi Chen
Session: Poster Display
Resources:
Abstract
146P - Phase (ph) Ib results of bemarituzumab (BEMA) added to capecitabine/oxaliplatin (CAPOX) or S-1/oxaliplatin (SOX) with or without nivolumab (NIVO) for previously untreated advanced gastric/gastroesophageal junction cancer (G/GEJC): FORTITUDE-103 study
Presenter: Keun-Wook Lee
Session: Poster Display
Resources:
Abstract
147P - Four-year overall survival (OS) update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (uHCC)
Presenter: Stephen Chan
Session: Poster Display
Resources:
Abstract
148P - Safety and efficacy of atezolizumab (Atezo) + bevacizumab (Bev) in Japanese patients (pts) with unresectable hepatocellular carcinoma (uHCC): Preliminary analysis of a prospective, multicenter, observational study (ELIXIR)
Presenter: Teiji Kuzuya
Session: Poster Display
Resources:
Abstract
149P - A prospective observational study of MSI screening in unresectable chemotherapy-naïve advanced gastric cancer/gastroesophageal junction cancer: WJOG13320GPS
Presenter: Yukiya Narita
Session: Poster Display
Resources:
Abstract
150P - Anlotinib plus chemotherapy as first-line therapy for gastrointestinal tumor patients with unresectable liver metastasis: Updated results from a multi-cohort, multi-center phase II trial ALTER-G-001-cohort C
Presenter: Junwei Wu
Session: Poster Display
Resources:
Abstract
151P - Relationship between depth of response and early tumor shrinkage with overall survival in advanced pancreatic cancer
Presenter: EMIKA KUROKI
Session: Poster Display
Resources:
Abstract
152P - Interim analysis of the NAPOLEON-2 study: Safety evaluation of nanoliposomal irinotecan with fluorouracil and folinic acid for unresectable pancreatic cancer patients with prior biliary drainage
Presenter: Futa Koga
Session: Poster Display
Resources:
Abstract