Presented by: Brusabhanu Nayak MD
All India Institute of Medical Sciences, New Delhi

Introduction

Bladder cancer (BC) is one of the most common urological malignancy. The current international guidelines recommend a single instillation of intravesical Mitomycin C in the immediate postoperative period following TURBT . The recent NCCN guidelines recommends gemcitabine as preferred agent for immediate intravesical therapy . Till date no randomized trial is available comparing the intravesical gemcitabine with intravesical MMC

 

Materials

It was a 2 arm randomized controlled trial. Patients were followed for efficacy(recurrence) and tolerance (side effects). The consort diagram is provided in the figure 1

 

Results

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During the 2 years of accrual (one year of enrolment and one year of follow up) total 0f 215 patients were screened, out of which 54 patients met eligibility criteria

Out of the 26 patients in gemcitabine group and 27 in the Mitomycin group, 3 patients in the gemcitabine arm(11.53%) and 3 patients in the Mitomycin arm(11.11%) experienced a recurrence at 1 year follow up. Out of these 6 recurrences ,  one patient in mitomycin C arm showed progression in T stage on Re TURBT. No progression was seen in respect to grade of tumour. 

Injection gemcitabine was found to be slightly less costly than Injection mitomycin C. ($24.47 vs $26.559)

There was no grade 3 or above adverse events. Dysuria /voiding pain were the most common adverse events (more in mitomycin arm ) followed by haematuria and culture positive UTI.

 

Conclusion

Gemcitabine was found to be as effective as Mitomycin C in decreasing bladder cancer recurrence and progression especially in low grade/low risk tumour over short follow up period. Intravesical gemcitabine is better tolerated than mitomycin. Cost and availability of these drugs is not an important issue in Indian setup. Larger multi-institutional prospective randomized studies with longer follow up are required to establish superiority of one intravesical agent over other.

Funding

None

Lead Authors

Nitish Aggarwal, MD
All India Institute of Medical Sciences

Amlesh Seth, MD
All India Institute of Medical Sciences

Prabhjot Singh, MD
All India Institute of Medical Sciences

Rishi Nayyar, MD
All India Institute of Medical Sciences

S N Dwivedi, MD
All India Institute of Medical Sciences