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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

5964 - Longitudinal Assessment of Multiplex Patient-Specific ctDNA Biomarkers in Bladder Cancer for Diagnosis, Surveillance, and Recurrence

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Karin Birkenkamp-Demtröder

Citation

Annals of Oncology (2018) 29 (suppl_8): viii14-viii57. 10.1093/annonc/mdy269

Authors

K. Birkenkamp-Demtröder1, E. Christensen2, H. Sethi3, S. Sharma3, H. Wu3, A. Taber2, M. Agerbæk4, R. Swenerton3, R. Salari3, D. Hafez3, I. Nordentoft5, P. Lamy5, R. Srinivasan3, M. Balcioglu3, S. Navarro3, Z. Assaf3, B. Zimmermann6, J. Lin6, J. Bjerggaard Jensen7, L. Dyrskjøt2

Author affiliations

  • 1 Molecular Medicine Moma, Aarhus University Hospital / Skejby, 8200 - Aarhus N/DK
  • 2 Dept. Of Molecular Medicine, Aarhus University Hospital, 8200 - Aarhus N/DK
  • 3 -, Natera Inc., San Carlos/US
  • 4 Dept. Of Oncology, Aarhus University Hospital, 88000 - Aarhus/DK
  • 5 -, Aarhus University Hospital, 8200 - Aarhus N/DK
  • 6 Rnd, Natera, 94070 - San Carlos/US
  • 7 Dept. Of Urology, Aarhus University Hospital, 8200 - Aarhus N/DK
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Resources

Abstract 5964

Background

The use of circulating tumor DNA (ctDNA) as a biomarker for disease staging at diagnosis (DX), treatment response, and recurrence monitoring is an emerging field in many cancer types. In bladder cancer, the utility of ctDNA has shown promising results. Here we present a highly sensitive and specific NGS-based approach to ctDNA monitoring.

Methods

A cohort of 50 patients with locally advanced muscle-invasive bladder cancer treated with neoadjuvant chemotherapy were included prospectively. For each patient, a panel of 16 tumor-specific mutations was designed (SignateraTM RUO) based on whole-exome sequencing of tumor and germline DNA. In total, we analyzed ctDNA from longitudinally collected plasma samples from 386 time points procured at diagnosis, during treatment, at cystectomy (Cx), and during monitoring until disease recurrence or up to 2 years follow-up. Results of ctDNA analyses were compared to radiographic imaging and clinical outcomes. ctDNA from longitudinally-collected urine samples will also be analyzed for treatment response and disease recurrence.

Results

At DX, plasma ctDNA status was strongly prognostic of recurrence-free survival. Specifically, 62% (8/13) of the ctDNA+ patients at DX recurred after neoadjuvant treatment and Cx; conversely, none (0/22) of the ctDNA- patients recurred (log-rank; p < 0.0001). In addition, a strong correlation was also observed between presence of ctDNA after CX and disease relapse. Specifically, relapse after Cx was detected in 100% (10/10) of ctDNA+ patients ∼120 days (0–245 days) prior to radiographic imaging, while 0% (0/38) of ctDNA- patients relapsed (log-rank; p < 0.0001).

Conclusions

We demonstrate a strong prognostic potential of ctDNA in bladder cancer at time of DX, suggesting a potential role for ctDNA in the staging of bladder cancer. Furthermore, we show ctDNA is detected in all patients with disease recurrence after Cx. Incorporation of ctDNA analysis into routine follow-up for early detection of relapse may allow earlier initiation of alternate treatment modalities.

Clinical trial identification

Legal entity responsible for the study

The National Committee on Health Research Ethics (#1302183), Denmark.

Funding

Novo Nordisk Foundation, Danish Cancer Society, Natera Inc San Carlos USA.

Editorial Acknowledgement

Disclosure

H. Sethi, S. Sharma, H-T. Wu, R. Swenerton, R. Salari, D. Hafez, R. Srinivasan, M. Balcioglu, S. Navarro, Z. Assaf, B. Zimmermann, J. Lin: Employee, stockownership or options to stock: Natera, Inc. All other authors have declared no conflicts of interest.

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