The research, presented at the ESMO European Oncology Congress, is coordinated by the Barts Cancer Institute in London, the Dana Farber Cancer Institute in Boston and the Technical University Munich. The study included oncologists Dr. Daniel Castellano, from Hospital Universitario 12 de Octubre and researcher of the Biomarkers in Genitourinary Tumors Group at i+12; Dr. Oscar Reig, from Hospital Clínic and researcher in the Translational Genomics and Targeted Therapies in Solid Tumors group at IDIBAPS; and Dr. Rafael Morales Barrera, from Hospital Universitario Vall d’Hebron and senior researcher in the Genitourinary Tumors (non-prostate), Central Nervous System, Sarcomas, and Tumors of Unknown Origin Group at VHIO.
A cancer with high risk of recurrence
Muscle-invasive urothelial carcinoma of the bladder is an aggressive cancer in which the tumor has penetrated the muscle layer. The recommended treatment is preoperative chemotherapy followed by surgery (radical cystectomy). When tumoral disease persists after surgery, adjuvant immunotherapy is administered to reduce the risk of relapse and improve patient survival.
In a proportion of patients, this approach is curative, making further treatment unnecessary and avoiding associated side effects. However, the decision to administer adjuvant treatment is based on anatomical pathology parameters, without molecular information to confirm the presence or absence of residual disease. Precise identification of molecular residual disease would allow treatment to be personalized and therapeutic benefit to be optimized for each patient.
Liquid biopsy to guide treatment
The international IMvigor011 study evaluated whether liquid biopsy, a technique analyzing circulating tumor DNA (ctDNA) in blood, can help decide which patients would benefit from receiving immunotherapy after surgery.
This analysis detects disease at a molecular level, even in the absence of visible signs in radiological tests.
The research team monitored more than 750 patients who underwent surgery for bladder cancer over one year. Those found to have ctDNA in the blood were randomly assigned to receive immunotherapy with atezolizumab or placebo. Patients without detectable ctDNA in blood did not receive additional treatment.
Results that may change clinical practice
Results show that patients with ctDNA in the blood have a higher risk of recurrence and lower survival if they do not receive treatment after surgery. In this group, atezolizumab reduced the risk of relapse by around 40% and significantly improved overall survival.
Similar efficacy was observed both in patients who were ctDNA positive from the start and those who became positive during follow-up, reinforcing the value of continuous molecular monitoring of disease after surgery.
On the other hand, patients without detectable ctDNA in blood showed a low rate of recurrence and high survival, suggesting that they can avoid any additional treatment without compromising their health.
Towards more precise and safer medicine
This study shows that liquid biopsy can guide therapeutic decisions and complement traditional criteria based on pathological anatomy. Besides improving clinical outcomes, this approach helps avoid unnecessary additional treatments and optimizes the use of healthcare resources.
Study reference:
Thomas Powles, Ariel G. Kann, Daniel Castellano, Marine Gross-Goupil, Hiroyuki Nishiyama, Sergio Bracarda, Jørgen Bjerggaard Jensen, Lydia Makaroff, Shusuan Jiang, Ja Hyeon Ku, Se Hoon Park, Oscar Reig Torras, Dingwei Ye, Marco Maruzzo, Andrea Necchi, Rafael Morales-Barrera, Emilio Francesco Giunta, Jae Lyun Lee, Giampaolo Tortora, Yüksel Ürün, Lukasz Dolowy, Dilek Erdem, Alvaro Pinto, Fabricio Grando, Wei Zou, Zoe June Assaf,d Jacqueline Vuky, Viraj Degaonkar, Elizabeth E. Steinberg, Joaquim Bellmunt, Jürgen E. Gschwend. ctDNA-Guided Adjuvant Atezolizumab in Muscle-Invasive Bladder Cancer. New England Journal of Medicine, October 20, 2025. doi: 10.1056/NEJMoa2511885
