Real‐world treatment patterns and oncological outcomes in early relapse and refractory disease after bacillus Calmette‐Guérin failure in non‐muscle‐invasive bladder cancer

Abstract

Objective To assess real‐world oncological outcomes between the radical cystectomy (RC) group and non‐RC group for early relapse and refractory disease. Methods We retrospectively analyzed 953 patients with recurrent non‐muscle‐invasive bladder cancer (NMIBC) who received bacillus Calmette‐Guérin (BCG) at 31 affiliated hospitals from 2000 to 2019. Patients with missing data on the timing of failure were excluded and 871 patients remained eligible, of whom 447, 357, and 67 were classified as early relapse/refractory disease, intermediate/late relapse disease, and intolerant disease, respectively. For early relapse/refractory disease, patients were divided into two salvage treatment groups: RC and non‐RC. The clinicopathological variables of each group were examined using Kaplan–Meier plots and proportional Cox hazard ratios with matched score analyses to compare oncological outcomes between the two groups. Results Significantly worse progression‐free survival and cancer‐specific survival (CSS) were confirmed in the early relapse/refractory disease group compared to the intermediate/late relapse group. Of the 88 salvage patients in the RC group with early relapse/refractory disease, ≤pT1 was observed in 47, pT2 in 11, and ≥pT3 in 28 (two patients with unknown pT category). In early relapse/refractory disease, the RC group showed significantly high‐risk tumor compared to the non‐RC group. However, no significant difference was observed in CSS after matched score analyses (p = 0.45) between the RC and non‐RC groups. Conclusions This study found that the RC group showed no significant superiority compared to the non‐RC group in CSS for early relapse/refractory disease in terms of first salvage therapy.

Editorial Comment from Dr Leow et al. to Real‐world treatment patterns and oncological outcomes in early relapse and refractory disease after bacillus Calmette‐Guerin failure in non‐muscle invasive bladder cancer

“…The latter may be a viable option for non‐cystectomy candidates or patients who outright refuse RC, not uncommon in Asian real‐world practice. However, RC should still be the first option offered, particularly given the lack of overall survival (OS) data from this study 1 . The Japan Urological Oncology Group reported poor 5‐year OS rates of 46.6% among patients with the highest‐risk status who had BCG‐unresponsive NMIBC and a pathological upstaging rate of 34% 3 …”

“…Although the EAU guidelines assert that “treatments other than RC must be considered oncologically inferior in patients with BCG‐unresponsive tumours,” this was based on Level 3 evidence. The Authors add important real‐world data reflecting current trends where bladder‐sparing options predominate 1 . This highlights an unmet need for new therapeutics and/or bladder‐sparing strategies in this group of patients.…”

“…Murakami and colleagues assessed real‐world outcomes of high‐risk non‐muscle invasive bladder cancer (NMIBC) patients who suffered an early relapse or bacillus Calmette‐Guerin (BCG)‐refractory disease, providing valuable insight into the role of radical cystectomy (RC) 1 …”

Editorial Comment from Dr Ide to Real‐world treatment patterns and oncological outcomes in early relapse and refractory disease after bacillus Calmette–Guérin failure in non‐muscle‐invasive bladder cancer

“…This study by Murakami et al examined the difference in prognosis between early relapse/refractory and intermediate/late relapse groups in NMIBC patients treated with BCG and compared the prognosis between the RC and non‐RC groups in early relapse/refractory groups 4 . Using propensity score matching, this study showed that there was no significant difference in the prognosis between the RC and non‐RC groups in early relapse/refractory NMIBC patients treated with BCG.…”

Editorial Comment from Dr Naselli and Dr Pirola to Real‐world treatment patterns and oncological outcomes in early relapse and refractory disease after bacillus Calmette‐Guérin failure in non‐muscle‐invasive bladder cancer

“…Murakami et al are therefore to be congratulated for their thoroughly insight in a large study population. Real‐life data are always welcomed because they encompass a thoughtful mix of clinical guidelines and reasoning and may help physicians to counsel patients 3 …”