What is it about?

The article discusses the outcomes of patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) who underwent bladder-sparing treatment (BST). The study found no significant difference in the proportion undergoing BST between the BCG-unresponsive relapsing or refractory subgroups. The results suggest that in appropriately selected patients, those with relapsing and refractory disease within the broader FDA definition of BCG-unresponsive NMIBC disease have similar oncological outcomes after BST. The study also found that patients in the early relapsing papillary cohort had the best outcomes after BST with the lowest risk of HG recurrence compared to patients with persistent/recurring CIS. Limitations of this study include case selection bias and a small sample size.

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Why is it important?

This research is important because it evaluates the outcomes of patients with BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) who underwent bladder-sparing treatment (BST). The FDA definition of BCG-unresponsive NMIBC, which includes patients who are refractory as well as those who are disease-free but relapse early following adequate BCG, has spurred multiple clinical trials in this arena. However, the natural history of patients with disease recurrence after BCG immunotherapy can vary. This raises the question of whether single-arm studies, which include all BCG-unresponsive patients without any control group, need to report subcohorts to account for varying response to treatment. The study found no significant difference in the proportion undergoing BST between the BCG-unresponsive relapsing or refractory subgroups. Moreover, there were no significant differences in the rates of HG-recurrence, MIBC/metastasis-progression, radical cystectomy, overall survival, and cancer-specific survival between the subgroups. However, the study did find that patients in the early relapsing papillary cohort had the best outcomes after BST, with the lowest risk of HG recurrence. This study is important because it provides valuable insights into the outcomes of patients with BCG-unresponsive NMIBC who undergo BST. The findings suggest that at least from a drug evaluation/trial design viewpoint, the previously reported single-arm phase II or III studies comprise a relatively homogenous patient cohort. The study also highlights the need to focus on the early relapsing papillary cohort when designing trials for novel therapies. Key Takeaways: 1. The study evaluated the outcomes of patients with BCG-unresponsive NMIBC who underwent bladder-sparing treatment (BST). 2. The FDA definition of BCG-unresponsive NMIBC includes patients who are refractory as well as those who are disease-free but relapse early following adequate BCG. 3. The study found no significant difference in the proportion undergoing BST between the BCG-unresponsive relapsing or refractory subgroups. 4. There were no significant differences in the rates of HG-recurrence, MIBC/metastasis-progression, radical cystectomy, overall survival, and cancer-specific survival between the subgroups. 5. Patients in the early relapsing papillary cohort had the best outcomes

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This page is a summary of: Bacillus Calmette–Guérin (BCG) unresponsive non‐muscle‐invasive bladder cancer: are the subgroups equal?, BJU International, June 2023, Wiley,
DOI: 10.1111/bju.16087.
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