At two years, overall survival was 61%, local bladder failure occurred in only 17% of patients, and the predominant pattern of failure was distant metastases. Toxicity was minimal, with late grade 3+ genitourinary and gastrointestinal toxicity reported in only 7% and 5% of cases, respectively. These findings reinforce the value of bladder preservation strategies for patients with advanced bladder cancer who are medically inoperable or decline cystectomy and underscore the need for enhanced systemic therapies for distant metastatic spread.
Building on these results, the upcoming CONSOLIDATE trial (NCT06434350) will investigate the combination of Enfortumab Vedotin (EV), a Nectin-4-targeting antibody-drug conjugate, with hypofractionated RT for the treatment of locally advanced bladder cancer. The primary objectives of this phase I/II study are to assess progression-free survival compared to historical controls, establish the safety of concurrent EV and RT, and evaluate health-related quality of life for trial participants. Translational objectives, including tumor biomarker analysis, aim to refine patient selection and enhance therapy precision. Our findings validate the potential of RT-based regimens while the CONSOLIDATE trial explores a next-generation strategy integrating precision systemic therapies with advanced RT techniques. Together, these efforts demonstrate a commitment to improving outcomes for patients with bladder cancer while preserving quality of life.
Written by: Patrick Carriere,1 Omar Alhalabi,2 Jianjun Gao,2 Osama Mohamad,1 Matthew T. Campbell,2 Amishi Shah,2 Sangeeta Goswami,2 Kelly Bree,3 Byron Lee,3 Neema Navai,3 Henry Mok,1 Lauren Mayo,1 Charles Guo,4 Quynh Nguyen,1 Sean McGuire,1 Ryan Park,1 Shalin Shah,1 Karen Hoffman,1 Steven Frank,1 Chad Tang,1 Seungtaek Choi,1 Ashish Kamat,3 Comron Hassanzadeh1
- Department of Genitourinary Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
- Department of Genitourinary Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
- Department of Urologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
- Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.