ASCO GU 2024: Longitudinal Tumor-Informed ctDNA Assay and Patient Outcomes in Testicular Cancer

(UroToday.com) The 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) cancers symposium held in San Francisco, CA between January 25th and 27th was host to a renal cell, adrenal, and testicular cancers rapid oral abstract session. Dr. Reuben Ben-David presented the results of an analysis of a longitudinal tumor-informed circulating tumor DNA (ctDNA) assay and patient outcomes in testicular cancer.


Serum-based tumor marker, namely alpha-fetoprotein, β-HCG, and LDH are currently utilized for the surveillance of testicular cancer patients; however, these markers lack sufficient sensitivity and specificity for the detection of molecular residual disease. ctDNA holds promise as a prognostic biomarker across various malignancies. Yet, its clinical utility in testicular cancer remains underexplored. The study objective was to evaluate the utility of longitudinal ctDNA monitoring as a reliable prognostic marker in testicular cancer patients.

A total of 145 plasma samples were collected from 35 patients with stages I to Ill testicular cancer. Longitudinal cDNA testing was performed using a personalized, tumor-informed cDNA assay (Signatera™ bespoke mPCR-NGS assay) that has been clinically validated across multiple tumor types. ctDNA was evaluated during both the ‘molecular residual disease’ (1-12 weeks post-orchiectomy) and surveillance period (>12 weeks post-orchiectomy, post-adjuvant chemotherapy, or post-retroperitoneal lymph node dissection [RPLND]) windows. The correlation between ctDNA status and event-free survival (EFS) was assessed. EFS was defined as the interval from radical orchiectomy to the date of radiological recurrence or any evidence of residual/persistent disease after the completion of adjuvant chemotherapy or RPLND. 

The baseline patient characteristics of the 35 study patients are summarized below. Notably, 43% underwent surveillance, 23% chemotherapy alone, 9% RPLND, and 26% RPLND and chemotherapy. Pre-operative serum tumor markers were elevated in 79% of patients, and 49% had elevations anytime post-operatively. The total follow-up duration was 10 months, and the event-free survival was 8 months.

In the flow chart below, the incidence of positive ctDNA during the pre-orchiectomy, molecular residual disease, surveillance, and anytime post-orchiectomy windows are summarized below:incidence of positive ctDNA during the pre-orchiectomy, molecular residual disease, surveillance, and anytime post-orchiectomy
ctDNA proved to be a prognostic marker in the molecular residual disease window (i.e., 1 – 12 weeks post-orchiectomy), with the 4 ctDNA positive patients having a 12-months EFS of 25% only, compared to 76.5% who were ctDNA during this window.ctDNA positive patients having a 12-months EFS
Similarly, a positive ctDNA status during the surveillance window was associated with significantly worse EFS (0% versus 87%) among the 3 patients with a positive ctDNA.ctDNA status during the surveillance windowctDNA status during the surveillance window dynamic event table
What about the correlation between ctDNA status and serum tumor markers? Among patients with normal markers, 2/21 had a positive ctDNA, and both of these patients relapsed. Conversely, among the 3 patients with a positive ctDNA status during surveillance, 2/3 had normal markers.ctDNA status and serum tumor markers
Dr. Ben-David concluded that:

  • This is one of the first reports that utilizes longitudinal tumor-informed ctDNA testing to assess clinical outcomes and disease status in patients with testicular cancer.
  • cDNA status during the molecular residual disease and surveillance windows is significantly associated with event-free survival in patients with testicular cancer.
  • Future prospective studies are needed to assess the utility of ctDNA in patients with testicular cancer.

Presented by: Reuben Ben-David, MD, Society of Urologic Oncology Fellow, Icahn School of Medicine at Mount Sinai, New York, NY

Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2024 American Society of Clinical Oncology Genitourinary (ASCO GU) Cancers Symposium, San Francisco, CA, January 25th – January 27th, 2024