After multiple treatment failures, clinical practice guidelines recommend that patients with high-risk non-muscle-invasive bladder cancer (HR-NMIBC) undergo radical cystectomy (RC). However, since many patients will be either unfit or averse to radical surgery, additional bladder-sparing therapies are needed.
Herein, we report the efficacy of sequential intravesical valrubicin and docetaxel (Val/Doce) as a salvage therapy for patients with recurrent HR-NMIBC.
We retrospectively identified all patients with recurrent HR-NMIBC treated with Val/Doce between 2013 and 2024 at the University of Iowa. The primary outcome was high-grade recurrence-free survival (HG-RFS). Adverse events were reported using Common Terminology Criteria for Adverse Events version 5. Patients received weekly sequential intravesical instillations of 800 mg valrubicin and 37.5 mg docetaxel for 6 wk. Monthly maintenance of 2 yr was initiated if the patients were disease free at the first follow-up.
The final cohort included 139 patients with a median (interquartile range) follow-up of 25 (10-51) mo. Patients had a median of two prior treatments: 92 (66%) had prior bacillus Calmette-Guérin and 133 (96%) had prior a Gem/Doce treatment. Tumor pathology immediately prior to Val/Doce induction included 53 carcinoma in situ (CIS), 19 T1HG, six T1HG + CIS, 37 TaHG, 21 TaHG + CIS, and three TaLG + CIS cases. Additionally, 27 patients had urothelial carcinoma present in the prostatic urethra/ducts (PUC), and 38 had any history of PUC. The HG-RFS rates at 1, 2, and 3 yr were 58%, 45%, and 41%, respectively. The progression-free survival rates at 1, 3, and 5 yr were 95%, 84%, and 70%, respectively. The cancer-specific survival rate was 91% at 5 yr. Upon a univariate analysis, there were no factors associated with an increased risk of recurrence. However, PUC prior to Val/Doce induction was associated with an increased risk of progression (p = 0.02). Adverse events occurred in 73 patients (53%), including one grade 3 event.
Val/Doce was safe and efficacious in patients with recurrent HR-NMIBC. The capacity to delay progression and avoid RC in a significant proportion of patients highlights its potential as a valuable treatment option in this challenging clinical context and warrants prospective evaluation.
European urology focus. 2025 Jun 26 [Epub ahead of print]
Ian M McElree, Ryan L Steinberg, Helen Y Hougen, Sarah L Mott, Vignesh T Packiam, Michael A O'Donnell
Carver College of Medicine, University of Iowa, Iowa City, IA, USA. Electronic address: ., Department of Urology, University of Iowa, Iowa City, IA, USA., Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA., Division of Urology, Department of Surgery, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ, USA., Department of Urology, University of Iowa, Iowa City, IA, USA; Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, USA.
PubMed http://www.ncbi.nlm.nih.gov/pubmed/40579321