PURPOSE - Sequential BCG/EMDA-MMC is reported to be superior to BCG alone but is not widely adopted. This study aimed to determine the efficacy and tolerability of sequential BCG/EMDA-MMC in HR-NMIBC.
MATERIALS AND METHODS - From 2009, BCG/EMDA-MMC was introduced as the standard induction regime for patients with HR-NMIBC undergoing bladder conservation.
Induction: BCG in weeks one and two, EMDA-MMC (40mg, 20mA current for 30 minutes) in week three, repeated thrice for nine weeks in total. Maintenance: three doses of BCG three months after induction, then six-monthly for three years.
OUTCOME MEASURE - disease recurrence at first-check, one and two-year cystoscopy, and treatment tolerability.
RESULTS - 151 patients with HR-NMIBC treated between June 2009 - 2013. 44/151 underwent primary cystectomy; 107/151 received sequential BCG/EMDA MMC. 86 patients (80%) had high grade Ta/T1, of whom 34 (32%) also had CIS. 19 (18%) had primary CIS. 2 had recurrent large-volume low-grade disease. 104/107 underwent first-check cystoscopy, and 90/104 (87%) were clear at first check. Of the 90 complete responders, 86 underwent one-year cystoscopy, and 74/86 (86%) were recurrence-free. 71/74 underwent two-year cystoscopy, and 66/71 (93%) remained recurrence-free. 30 patients (28%) did not complete the full induction schedule. Of these, 16/30 had minor schedule alterations and 14/30 had major alterations. There was no difference in recurrence between patients who received full or reduced induction schedules.
CONCLUSIONS - This study confirms the excellent oncological efficacy of sequential BCG / EMDA-MMC in HR-NMIBC. Tolerability is a challenge but alterations to the nine-week schedule appear to have negligible impact on outcomes.
The Journal of urology. 2016 Feb 01 [Epub ahead of print]
Christine Gan, Suzanne Amery, Kathryn Chatterton, Muhammad Shamim Khan, Kay Thomas, Tim O'Brien
The Urology Centre, Guy's & St Thomas' NHS Trust, London, United Kingdom. The Urology Centre, Guy's & St Thomas' NHS Trust, London, United Kingdom. , The Urology Centre, Guy's & St Thomas' NHS Trust, London, United Kingdom. , The Urology Centre, Guy's & St Thomas' NHS Trust, London, United Kingdom. , The Urology Centre, Guy's & St Thomas' NHS Trust, London, United Kingdom. , The Urology Centre, Guy's & St Thomas' NHS Trust, London, United Kingdom.