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The Effect of Intravesical Mitomycin C on Recurrence of Newly Diagnosed Superficial Bladder Cancer: A Further Report with 7 Years of Followup

Created: 24/1/2006


The Effect of Intravesical Mitomycin C on Recurrence of Newly Diagnosed Superficial Bladder Cancer: A Further Report with 7 Years of Followup

Tolley DA, Parmar MKB, Grigor KM, Lallemand G

Volume 155, Issue 4, Pages 1233-1237 (April 1996)


  • Most malignant tumours of the bladder are of histological stages Ta and T1
  • Disease may recur after complete resection of the tumour in up to 70 percent of patients
  • Tumour cell implantation was an important factor in the aetiology of recurrences
  • Aim of study was to test the hypothesis that either a single instillation of mitomycin C given soon after transurethral resection or 1 instillation at resection plus 4 given at 3-month intervals would be effective in decreasing recurrences in patients with newly diagnosed disease

Materials and methods

  • Multicenter randomized clinical trial involving 502 patients with newly diagnosed superficial bladder cancer (Ta or T1)
  • After complete transurethral resection patients were randomized into 1 of 3 treatment arms: no further treatment, 1 instillation of mitomycin C at resection and 1 instillation at resection and at 3-month intervals for 1 year (total 5 instillations)
  • The dose of mitomycin C used was 40 mg./40 ml water
  • Followup cystoscopy was performed at 3-month intervals for 12 months, then at 6-month intervals for 1 year and annually thereafter
  • End points were interval to first superficial recurrence, recurrence rate (defined as the number of positive cystoscopies during first 2 years) and progression-free interval rate (progression defined as the development of muscle invasive or metastatic disease, or death from bladder cancer).


  • Of 502 patients entered into the study 50 were ineligible for analysis
  • The remaining 452 eligible patients were analyzed on an intention to treat basis
  • There were no obvious imbalances in the distribution of patients and tumour characteristics in the 3 groups
  • Median follow-up in both mitomycin groups was 7 years at time of analysis

Recurrence-free interval

  • Comparing mitomycin C groups 1(single) and 2(multiple) to the controls, 1 and 5 instillations of mitomycin C decrease the risk of subsequent recurrence by an estimated 34% in group 1 and by an estimated 50% in group 2 (p = 0.01 and 0.0001, respectively)
  • No significant difference was found between the mitomycin groups

Recurrence rate (number of positive cystoscopies during the first 2 years)

  • The mitomycin C groups had significantly lower annual recurrence rates than the control group (p < than 0.001 and 0.001, respectively)
  • Estimated decrease in recurrence rates per year was 48% (group1) and 62 % (group 2), respectively

Progression-free interval

  • No evidence of any difference among the 3 groups

NB Superficial bladder cancer can be categorised into 3 groups for subsequent recurrence

low risk - single tumor at presentation and no recurrence at 3 months

medium risk - multiple tumors at presentation or recurrence at 3 months

high risk - multiple tumors at presentation and recurrence at 3 months

Benefit of mitomycin is similar in all 3 groups


  • Study shows benefit in terms of lowering the recurrence rate and increasing recurrence-free interval in patients receiving mitomycin C

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