Pathological Outcomes for Patients Who Failed To Remain Under Active Surveillance for Low-risk Non-muscle-invasive Bladder Cancer: Update and Results from the Bladder Cancer Italian Active Surveillance Project.

BACKGROUND

It has been shown that active surveillance (AS) is feasible and effective in a subset of patients with recurrent low-grade (LG) non-muscle-invasive bladder cancer (NMIBC).

OBJECTIVE

To update a previous preliminary series and investigate pathological outcomes for patients who failed to remain on AS.

DESIGN, SETTING, AND PARTICIPANTS: Prospective observational cohort study started in February 2008, and currently still active, at a tertiary university hospital, including patients with pathologically confirmed NMIBC who experienced recurrence during follow-up.

INTERVENTION

AS monitoring consisted of cytology and in-office flexible cystoscopy every 3 mo for the first year, and every 6 mo thereafter.

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

The primary endpoint was pathological results for patients who failed to remain on AS. The secondary outcome was an update of clinical results from our previous series. Data were complemented by descriptive statistical analysis and univariable and multivariable proportional hazards Cox regression.

RESULTS AND LIMITATIONS

Overall, 167 patients were included. Of 181 AS events, 61 (33.7%) were deemed to require treatment because of positive cytology (n=10), gross haematuria (n=11), and increases in the tumour number (n=15), or size (n=17), or both (n=8). The median time on AS was 12 mo (interquartile range 4-26). Pathological specimens from AS failures did not show any malignancy in 20 cases. Histopathology identified urothelial hyperplasia and oedema, submucosal vascular ectasia, mucosal erosion, polypoid cystitis, von Brunn nest hyperplasia, and squamous metaplasia. The time from first transurethral resection to AS start was inversely associated with recurrence-free survival (hazard ratio 0.97, 95% confidence interval 0.96-1.00; p=0.024). The study lacks statistical subanalyses focusing on patients with failure and negative neoplastic pathological outcomes.

CONCLUSIONS

AS might be a reasonable strategy in patients presenting with small LG pTa/pT1a recurrent bladder tumours. Approximately 30% of patients deemed to have AS failure did not harbour any neoplastic lesion, strengthening the role of AS.

PATIENT SUMMARY

Patients with small low-grade pTa/pT1a recurrent papillary bladder tumours could benefit from an active surveillance protocol with no significant risk of pathological progression to muscle-invasive cancer.