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OBJECTIVE
To report a phase‐1 study of patients with recurrent superficial bladder cancer treated with photodynamic therapy (PDT) using sequential mitomycin C and 5‐aminolaevulinic acid (ALA).
PATIENTS AND METHODS
Twenty‐four patients were treated, the primary endpoint being the safety and tolerability of combined therapy at increasing doses of ALA and light.
RESULTS
Mitomycin C instillation was followed by ALA concentrations of 6%, 8% or 10%; there was no effect on toxicity. The light dose, at a wavelength of 635 nm, was increased from zero to 25 J/cm2, with the upper fluences producing transient symptoms. There were no episodes of skin photosensitivity or systemic toxicity. A total fluence of 25 J/cm2 represented the upper light dose for the tolerability of this procedure by patients. There were no persistently high urinary symptom scores or reduction in functional bladder capacity up to ≥24 months of follow‐up. In this group, cumulative tumour recurrences were none at 4, two at 8, six at 12, nine at 18 and 11 at 24 months after PDT, respectively.
CONCLUSION
Sequential mitomycin C and ALA‐PDT is a safe and well tolerated treatment, with potential for managing difficult‐to‐control superficial transitional cell carcinoma and carcinoma in situ of the bladder.