Abstract 3104
Background
There is an unmet need for a blood test to detect breast cancer in women with dense breast tissue or clinically aggressive subtypes that may be missed by mammograms. Cell-free DNA in blood has shown 15-58% sensitivity for breast cancer. We evaluated the performance of a circulating tumor cell (CTC) assay as a complimentary biomarker for detecting breast cancer in an Asian population, which has high incidence of dense breast tissue.
Methods
A single-center, IRB-approved, prospective and blinded clinical study was conducted on 114 Taiwanese females with biopsy-confirmed breast cancer, and 50 healthy controls confirmed by ultrasound or mammogram. Four milliliter of blood was collected prior to imaging and processed using the CellMax biomimetic platform (CMx) which enumerates CTCs utilizing selection criteria based on a set of markers (cytokeratin 18, mammaglobin, CD45), cell morphometry (size, N/C ratio) and nucleus morphology. Logistic regression models for CMx CTC counts and patient age were used to assess the classification performance of the CMx test.
Results
Of the 114 cancer (80% were stage 0∼2), the subtypes were confirmed for 102 (62% ER/PR+ HER2-, 22% HER2+, 16% TNBC). CTC count was a significant predictor of cancer status (Likelihood Ratio P-value = 0.0001). At 90% specificity (exact 95% CI: 78.2%, 95.6%) sensitivity was 56.3% (95% CI: 43.3%, 68.6%) for the most common subtype ER/PR+HER2-, 36.4% (17.2%-59.3%) for HER2+, 43.8% (19.8%- 70.1%) for TNBC, 46.5% (37.1%- 56.1%) overall. Sensitivity was 62.5% (35.4%- 84.8%) for late stage (Stage III/IV cancer) and 43.5% (33.2%- 54.2%) for early stage (Stage 0, I or II cancer) patients. In the subset of 41 individuals with an indeterminate classification of BIRADS 3 (likely benign) or BIRADS 4 (likely malignant) sensitivity was 90% and specificity was 47.6% (95% CI: 25.7%, 70.2%).
Conclusions
In this initial study, CTC was a significant predictor of cancer. The CTC assay can easily be combined with cfDNA to enhance detection rates. Proof-of-concept data suggests potential for a rule out test to avoid unnecessary follow-up/biopsies in BIRADS 3/4 patients.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
CellMax Life.
Funding
CellMax Life.
Disclosure
F. Lin: Shareholder / Stockholder / Stock options: CellMax Life. J. Wu: Shareholder / Stockholder / Stock options: CellMax Life. H.B. Hsieh: Shareholder / Stockholder / Stock options: CellMax Life. S. Chang: Shareholder / Stockholder / Stock options: CellMax Life. M. Javey: Shareholder / Stockholder / Stock options: CellMax Life. D. Watson: Shareholder / Stockholder / Stock options: CellMax Life. R. Mei: Shareholder / Stockholder / Stock options: CellMax Life. All other authors have declared no conflicts of interest.
Resources from the same session
733 - Clinical experience: ramucirumab with FOLFIRI/XELIRI as a second line for patients with metastatic gastric cancer
Presenter: Tatiana Titova
Session: Poster Display session 2
Resources:
Abstract
2186 - Efficacy and safety of apatinib for the treatment of AFP-producing gastric cancer
Presenter: Ningning Li
Session: Poster Display session 2
Resources:
Abstract
3172 - Apatinib in combination with docetaxol and S1 chemotherapy in the first line treatment of metastatic gastric cancer
Presenter: Ling Xia
Session: Poster Display session 2
Resources:
Abstract
3982 - Parameters of local cellular immunity in metastatic gastric cancer
Presenter: Aleksandr Sagakyants
Session: Poster Display session 2
Resources:
Abstract
5102 - Germline pathogenic mutations in Chinese patients with gastric cancer identified by next-generation sequencing (NGS)
Presenter: Xiaotian Zhang
Session: Poster Display session 2
Resources:
Abstract
5012 - Inhibition of the PI3K pathway in HER2-positive gastric cancer
Presenter: Sinead Toomey
Session: Poster Display session 2
Resources:
Abstract
4803 - Investigation on gastric cancer susceptibility genes in Chinese early-onset diffuse gastric cancer
Presenter: Yi Feng
Session: Poster Display session 2
Resources:
Abstract
4778 - A correlation analysis between survival rate and the characteristic gene of gastric cancer based on bioinformatics analysis
Presenter: Yi-wen Zhang
Session: Poster Display session 2
Resources:
Abstract
4805 - Phase I study of apatinib combined with POF (paclitaxel plus FOLFOX) in patients (pts) with treatment-naïve advanced gastric cancer (TNAGC)
Presenter: Rongbo LIN
Session: Poster Display session 2
Resources:
Abstract
3248 - Second-line palliative systemic treatment for synchronous metastatic esophagogastric cancer: a population-based study
Presenter: Willemieke Dijksterhuis
Session: Poster Display session 2
Resources:
Abstract