Comparison of Recurrence of Low Risk Superficial Bladder Cancer in Patients with And Without Single Dose Intravesical Doxorubicin Instillation

Abstract

Introduction: Urinary bladder Cancer (UC) is second most common cancer among patients with genitourinary malignancies.  Because of high recurrence rate the patients with Non-muscle-invasive bladder cancer (NMIBC) requires a lifelong surveillance. Doxorubicin has been shown to decrease recurrence rate on long term follow up. However, evidence on its efficacy on short term follow-up is limited. The purpose of the current study was to find out early recurrence rate after Doxorubicin treatment. If found low, this study will reduce the costs and hospital burden for patients needing Re-TURBT. Objective: The study objective was to compare the frequency of recurrence in patients with low risk superficial bladder cancer receiving a single dose intravesical Doxorubicin instillation with placebo. Study Design: Randomized Controlled Trial. Setting: Department of Urology, Khawaja M Safdar Medical College, Sialkot. Duration: One year from 10-03-16 to 09-03-2017. Methodology:  70 patients with Non-muscle-invasive bladder cancer were randomly allocated into 2 groups. Group-A received Doxorubicin treatment while Group-B received Placebo. Patients were followed after 3 months on cystoscopy. All the patients were informed about the procedure. Results: The mean age of the patients was 56.84±7.28 years and majority (n=58, 82.85%) of the patients were male and only 12 (17.14%) patients were female giving a male to female ratio of 4.38:1. The mean age of the patients in Group-A was 56.44±7.10 years while in Group-B it was 57.23±7.50 years. Among Group-A 80% patients were male and 20% were female while in Group-B 82.9% were male and 17.1% were female. However, the difference in term of age and gender was not significant statistically. On follow up at 3 months, 19 (27.14%) patients had recurrence while 51(72.85%) patients were clear of disease. The rate of recurrence was similar across different age groups and gender. Doxorubicin treatment was associated with decreased frequency of recurrence (18.6% vs. 35.7%; p=.023) as compared to Placebo. Conclusion: This comparative randomized control trial showed that intravesical Doxorubicin instillation within 6 hours of TURBT is effective in reducing recurrence in patients with NMIBC.