(UroToday.com) The 2023 American Urological Association (AUA) annual meeting held in Chicago, IL, was host to a non-invasive bladder cancer podium session. Dr. Wei Shen Tan presented the results of an analysis of long-term survival outcomes of patients with BCG unresponsive, non-muscle invasive bladder cancer (NMIBC) managed with bladder-sparing treatments.
Dr. Wei Shen Tan began by emphasizing that radical cystectomy remains the recommended treatment for BCG-unresponsive NMIBC. However, most patients remain reluctant to undergo a radical cystectomy and seek bladder-sparing treatment. Emerging bladder-sparing treatments appear to have 12-month complete response (CR) rates of approximately 19 to 45%.1-3 However, are we sacrificing cancer-specific survival in attempts at bladder preservation?
The investigators conducted a retrospective analysis of all patients with BCG-unresponsive NMIBC (FDA definition), diagnosed between January 2000 and September 2021. All patients had received adequate BCG, including induction and maintenance courses, and had proceeded to either early radical cystectomy or bladder-sparing treatment(s). The primary endpoints were cancer-specific and overall survivals.
The study flow chart is summarized below. 114 patients with BCG-unresponsive NMIBC were identified, of whom 38 underwent early radical cystectomy and 76 underwent initial bladder sparing treatment. Of these 76 patients, 27 underwent a delayed radical cystectomy. Of note, the median time to radical cystectomy was 2.1 months in the early radical cystectomy group versus 11.7 months in the delayed radical cystectomy group.
Baseline patient demographics are summarized below. Of note, there was a higher proportion of ex-smokers or current smokers in the bladder sparing treatment group (74% versus 50%). The number of prior BCG instillations was significantly higher in the bladder-sparing treatment group (93% versus 34% with ≥10 previous instillations). Variant histology was present in 5.3% and 2.6% of patients in each arm, respectively. The median follow-up was 71 months.
No significant between-group differences were observed with regards to overall survival (HR: 1.40, 95% CI: 0.68 – 2.89, p =0.4) or cancer-specific survival (HR: 0.88, 95% CI: 0.22 – 3.55, p=0.9).
On multivariable analysis, the only variable predictive of high-grade recurrence in the bladder sparing treatment group was current smoking status with a HR of 4.44 (95% CI: 1.41 – 4.0, p=0.011).
Among patients undergoing delayed radical cystectomy, 73% had evidence of NMIBC, with 7% and 19% having pT2 and pT3-4 disease, respectively.
Dr. Wei Shen Tan concluded that:
- Bladder sparing treatment may be a safe option in well-selected patients
- Survival outcomes were non-inferior to early RC treatment
- These results may help in counseling patients and allay fears in select BCG unresponsive patients who are interested in a trial of bladder-sparing treatment
Presented by: Wei Shen Tan, MD, PhD, Society of Urologic Oncology Fellow, MD Anderson Cancer Center, Houston, TX
Written by: Rashid K. Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Urological Association (AUA) Annual Meeting, Chicago, IL, April 27 – May 1, 2023References:
- Balar et al. Pembrolizumab monotherapy for the treatment of high-risk non-muscle-invasive bladder cancer unresponsive to BCG (KEYNOTE-057): an open-label, single-arm, multicentre, phase 2 study. Lancet Oncol, 2021.
- Boorjian et al. Intravesical nadofaragene firadenovec gene therapy for BCG-unresponsive non-muscle-invasive bladder cancer: a single-arm, open-label, repeat-dose clinical trialLancet Oncol, 2021
- Chamie et al. IL-15 Superagonist NAI in BCG-Unresponsive Non–Muscle-Invasive Bladder Cancer. NEJM Evid, 2022.
Long-Term Survival Outcomes in Patients with BCG Unresponsive Non-Muscle Invasive Bladder Cancer: Evaluating Bladder-Sparing Treatment - Wei Shen Tan