Background
The optimal regimen of instillation for patients with non-muscle invasive bladder cancer (NMIBC) and the recurrence-related factors are still needed to be clear.
Methods
The patients underwent transurethral resection of bladder tumor who diagnosed as intermediate or high risk NMIBC were randomized to receive bacillus Calmette–Guérin (BCG) 19, 15 times or epirubicin (EPI) 18 times (2:2:1). The primary end point was disease-free survival (DFS), the secondary end point was progression free survival (PFS). Associations between clinicopathological factors and prognosis were estimated, with accuracy of the prognostic models Spanish Urological Club for Oncological Treatment (CUETO) and European Organization for Research and Treatment of Cancer (EORTC) evaluated.
Results
A total of 93 patients (BCG19 for 35; BCG15 for 37 and EPI18 for 21) were included, with median follow-up time for 33.46 months. Recurrence and progression occurred in 22 and 8 of patients separately, and significant longer recurrence-free survival was noted in the BCG and primary bladder cancer groups. Higher general complication rate was seen in BCG group compared with EPI groups (83.33% and 61.90%, respectively; P = 0.022), but no grade 3–5 adverse events happened in both groups. Concordance indices for the CUETO and EORTC models were 0.766 and 0.741 for all our series and 0.812 and 0.817 for the BCG subgroup, respectively.
Conclusion
BCG instillation significantly reduced the rate of recurrence compared with epirubicin in this population. The EORTC and CUETO models exhibited high accuracies for the prediction of BCG treatment failure.
Trial registration:
This study was approved by Center for Drug Evaluation of National Medical Products Administration (CDENMPA, China) and Ethics Committee of our institute, with the whole process supervised. The registration number in CDE-NMPA was CTR20150840 (website of CDE: http://www.cde.org.cn/).