One Clinician's Perspective

  • From his vantage point in the clinic, Dr. Jorge Garcia–the Division Chief of Solid Tumor Oncology and the George & Edith Richman Distinguished Scientist Chair at UH Seidman Cancer Center–explains how he is personally integrating ctDNA into real-world treatment decisions for bladder cancer patients
  • Dr. Garcia says ctDNA is increasingly reshaping post-surgical decision-making in muscle-invasive bladder cancer, with detectable ctDNA prompting greater consideration of adjuvant therapy despite reassuring pathology, and absent ctDNA offering potential justification to forgo additional treatment even in traditionally high-risk cases.

For bladder cancer specialists navigating an increasingly complex treatment landscape, circulating tumor DNA (ctDNA) is a powerful new decision-making tool. One leading clinician says its real value lies not just in prognostication — but in guiding who should, and should not, receive additional therapy after surgery.

New Data

Citing new data from thethe IMvigor011 study that was published in the New England Journal of Medicine and presented at the 2025 ESMO Conference, Case Western Reserve University’s Dr. Jorge Garcia says, “Some people who may not have circulating tumor, DNA may not need additional therapy and maybe we are overtreating some of them. Yet patients who have detectable circulating tumor DNA, may in fact require additional therapy for us to be able to achieve that goal of cure or complete responses.”

 IMvigor011 Trial Summarized:

  • 761 total patients enrolled

  • 250 ctDNA-positive patients randomized

    • 167 → Atezolizumab

    • 83 → Placebo

  • 357 patients remained ctDNA-negative and were monitored

  • Median DFS:

    • 9.9 months with atezolizumab

    • 4.8 months with placebo

Changing Treatment Paradigms

While historically treatment decisions in muscle-invasive bladder cancer have relied heavily on pathology, ctDNA is beginning to challenge that paradigm. In Dr. Garcia’s view, detectable ctDNA after surgery may signal residual microscopic disease, even when pathology appears reassuring. In those cases, he says he may now be more inclined to recommend adjuvant therapy, reasoning that molecular evidence of disease could indicate a higher likelihood of relapse.

“If you were to have a patient that has a great response to therapy but has circulating tumor DNA, in my opinion, even if their pathology looks good… if you have detectability or circulating tumor DNA, I may be more inclined today to offer you some adjuvant therapy to reduce the risk of recurrence,” Dr. Garcia says.

Conversely, if a patient has traditionally high-risk pathological features but no detectable ctDNA, that absence may provide enough reassurance to reconsider the automatic use of additional therapy. Where adjuvant treatment was once routine, ctDNA negativity may support a more individualized, less aggressive approach.

Dr. Garcia calls ctDNA “a big change in the field” and notes, “this is an area that we continue to explore because that has to be incorporated into future prospective clinical trials.”

A More Personalized Approach

Importantly, Dr. Garcia does not see ctDNA as a simple yes-or-no trigger. Rather, he sees ctDNA as one data point integrated alongside pathology, clinical characteristics, and patient preferences.

“I don’t see this as a binary decision,” Dr. Garcia says. “Let me understand the makeup of your disease, the pathological features, your clinical characteristics, and together make that decision. But, I think it’s very useful.”

While prospective trials are still needed to fully validate this approach, he believes ctDNA is already reshaping conversations in the clinic — offering a more nuanced, personalized way to assess recurrence risk and tailor therapy for bladder cancer patients.