(UroToday.com) The 2023 American Society of Clinical Oncology (ASCO) annual meeting held in Chicago, IL between June 2nd and June 6th was host to a kidney and bladder cancers poster session. Dr. Dickon Hayne presented the rationale/study framework and early results for ANZUP 1301, an open-label randomized phase III trial evaluating the addition of intravesical mitomycin to BCG as adjuvant intravesical therapy for high-risk, non-muscle invasive bladder cancer (NMIBC).
Adjuvant intravesical BCG is currently standard of care treatment for patients with high-risk NMIBC. Despite proven benefits for decreasing recurrence and progression rates in this setting, recurrences still occur in approximately 30% of such patients. Meta-analyses evaluating the addition of intravesical mitomycin to BCG have shown lower rates of recurrence and cancer-specific mortality in NMIBC patients receiving this combination regimen.1 However, phase III randomized controlled trials in this setting are lacking to date. The BCGMM (ANZUP 1301) trial will evaluate the addition of mitomycin to standard BCG following resection of high-risk NMIBC. The investigators emphasized that this is the largest study to date evaluating this approach in high-risk NMIBC, is of particular relevance given the current BCG shortage, and has the potential to change global practice.
The BCGMM trial (NCT02948543) is an open-label phase III trial that will randomize patients in a 1:1 fashion to either:
- Arm A: BCG induction weekly x 6 weeks, followed by monthly x 10 cycles
- Arm B: BCG (given weeks 1, 2, 4, 5, 7, 8, and months 4, 5, 7, 8) plus mitomycin (administered weeks 3, 6, and 9 and months 3, 6, and 9).
Randomization will be stratified by disease stage, site, and presence/absence of carcinoma in situ. This study will be powered at 85% to detect a 10% absolute improvement in 2-year disease-free survival (DFS), at a 2-sided type 1 error of 5%. This trial consists of two stages:
- Stage 1 (n=130): To determine the rates of treatment completion, activity reflected by cystoscopic findings at 3 months, adverse events, resource utilization, and health related quality of life, and feasibility
- Stage 2 (n=370): Will provide information on DFS, time to recurrence and progression, overall survival, and identification of potential predictive biomarkers (estimated completion of accrual by Q2 of 2023).
As of May 10, 2023, recruitment of the 500 patients for Stage 2 was complete (16 Australian and 1 UK site). In stage 1, successful treatment completion, defined as 75% or more of planned treatment doses, was achieved by 76% in the experimental group (BCGMM) versus 60% in the control group (BCG alone).
Presented by: Dickon Hayne, MD, FRCS, MBBS, Professor of Urology, The University of Western Australia, Perth, Australia
Written by: Rashid Sayyid, MD, MSc – Society of Urologic Oncology (SUO) Clinical Fellow at The University of Toronto, @rksayyid on Twitter during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, Chicago, IL, Fri, June 2 – Tues, June 6, 2023.
References:
- Houghton BB, et al. Intravesical chemotherapy plus bacille Calmette-Guérin in non-muscle invasive bladder cancer: a systematic review with meta-analysis. BJU Int 2013;111(6):977-83.