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
2672 - Changes in clinico-pathological characteristics of vulvar cancer in Japan: increasing oldest-old, stage-shifting, and decreasing cohort-level survival
Presenter: Shin Nishio
Session: Poster Display session 2
Resources:
Abstract
4306 - Tumor Treating Fields (200 kHz) concomitant with weekly paclitaxel for platinum-resistant ovarian cancer: Phase 3 INNOVATE-3/ENGOT-ov50 study
Presenter: Ignace Vergote
Session: Poster Display session 2
Resources:
Abstract
5136 - Randomized, phase 1b/2 study of M6620 + avelumab + carboplatin vs standard care (sc) in patients (pts) with platinum-sensitive poly (ADP-ribose) polymerase inhibitor-(PARPi)-resistant ovarian cancer
Presenter: Susana Banerjee
Session: Poster Display session 2
Resources:
Abstract
2296 - An umbrella study of biomarker-driven targeted therapy in patients with platinum-resistant recurrent ovarian cancer: A Korean Gynecologic Oncology Group study (KGOG 3045), AMBITION
Presenter: Jung-Yun Lee
Session: Poster Display session 2
Resources:
Abstract
2732 - A phase 2 study of pembrolizumab in combination with doxorubicin in advanced, recurrent or metastatic endometrial cancer
Presenter: Ana Oaknin
Session: Poster Display session 2
Resources:
Abstract
4404 - ENGOT-EN9/LEAP-001: a phase 3, randomized, open-label study of pembrolizumab plus lenvatinib versus chemotherapy for first-line treatment of advanced or recurrent endometrial cancer
Presenter: Christian Marth
Session: Poster Display session 2
Resources:
Abstract
4564 - Phase 1/2 trial of tisotumab vedotin plus bevacizumab, pembrolizumab, or carboplatin in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8)
Presenter: Ignace Vergote
Session: Poster Display session 2
Resources:
Abstract
4933 - Updated data of Epitopes-HPV02 trial and external validation of efficacy of DCF in prospective Epitopes-HPV01 study in advanced anal squamous cell carcinoma. Pooled analysis of 115 patients
Presenter: Stefano Kim
Session: Poster Display session 2
Resources:
Abstract
2301 - Pre-specified pilot analysis of a randomised pilot/phase II/III trial comparing standard dose vs dose-escalated concurrent chemoradiotherapy (CRT) in anal cancer (PLATO-ACT5)
Presenter: Alexandra Gilbert
Session: Poster Display session 2
Resources:
Abstract
5773 - A prospective study of diffusion-weighted magnetic resonance imaging for predicting outcome following chemoradiotherapy, in squamous cell carcinomas of the anus.
Presenter: Rebecca Muirhead
Session: Poster Display session 2
Resources:
Abstract