title: Sequential bacillus Calmette-Guérin/Electromotive Drug Administration of Mitomycin C as the Standard Intravesical Regimen in High Risk Nonmuscle Invasive Bladder Cancer: 2-Year Outcomes.
abstract: Sequential bacillus Calmette-Guérin/electromotive drug administration of mitomycin C is reported to be superior to bacillus Calmette-Guérin alone but it has not been widely adopted. We aimed to determine the efficacy and tolerability of sequential bacillus Calmette-Guérin/electromotive drug administration of mitomycin C in high risk, nonmuscle invasive bladder cancer.
  
  
  
  Starting in 2009 bacillus Calmette-Guérin/electromotive drug administration of mitomycin C was introduced as the standard induction regime in patients with high risk, nonmuscle invasive bladder cancer undergoing bladder conservation. As induction bacillus Calmette-Guérin was administered in weeks 1 and 2. Mitomycin C was administered in electromotive fashion (40 mg and 20 mA current for 30 minutes) in week 3 and repeated thrice for a total of 9 weeks. As maintenance 3 doses of bacillus Calmette-Guérin were given 3 months after induction and then every 6 months for 3 years. Outcome measures were disease recurrence at first check, 1 and 2-year cystoscopy, and treatment tolerability.
  
  
  
  Of the 151 patients with high risk, nonmuscle invasive bladder cancer treated between June 2009 and 2013, 44 underwent primary cystectomy and 107 received sequential bacillus Calmette-Guérin/electromotive drug administration of mitomycin C. Disease was high grade Ta/T1 in 86 patients (80%), of whom 34 (32%) also had carcinoma in situ. A total of 19 patients (18%) had primary carcinoma in situ and 2 had recurrent large volume, low grade disease. Of 107 patients 104 underwent first check cystoscopy, including 90 (87%) who were clear. Of the 90 complete responders 86 underwent 1-year cystoscopy, including 74 (86%) who were recurrence-free. Of the 74 patients 71 underwent 2-year cystoscopy, of whom 66 (93%) remained recurrence-free. The full induction schedule was not completed in 30 patients (28%), including 16 and 14 with minor and major schedule alterations, respectively. There was no difference in recurrence between patients who received a full vs a reduced induction schedule.
  
  
  
  This study confirms the excellent oncologic efficacy of sequential bacillus Calmette-Guérin/electromotive drug administration of mitomycin C in cases of high risk, nonmuscle invasive bladder cancer. Tolerability is a challenge but alterations to the 9-week schedule appeared to have a negligible impact on outcomes.
authors: Urology Centre, Guy's and St. Thomas' National Health Service Trust, London, United Kingdom. Electronic address: christinegan@doctors.org.uk.
authors: Christine
authors: C
authors: Gan
authors: Urology Centre, Guy's and St. Thomas' National Health Service Trust, London, United Kingdom.
authors: Suzanne
authors: S
authors: Amery
authors: Urology Centre, Guy's and St. Thomas' National Health Service Trust, London, United Kingdom.
authors: Kathryn
authors: K
authors: Chatterton
authors: Urology Centre, Guy's and St. Thomas' National Health Service Trust, London, United Kingdom.
authors: Muhammad Shamim
authors: MS
authors: Khan
authors: Urology Centre, Guy's and St. Thomas' National Health Service Trust, London, United Kingdom.
authors: Kay
authors: K
authors: Thomas
authors: Urology Centre, Guy's and St. Thomas' National Health Service Trust, London, United Kingdom.
authors: Tim
authors: T
authors: O'Brien
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage* / Q000009:adverse effects; D000283:Administration, Intravesical; D000368:Aged; D000477:Alkylating Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003558:Cystoscopy; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage* / Q000009:adverse effects; D009163:Mycobacterium bovis; D009361:Neoplasm Invasiveness / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000473:pathology; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000276:Adjuvants, Immunologic; D000477:Alkylating Agents; D016685:Mitomycin
keywords: Mycobacterium bovis; drug delivery systems; mitomycin; treatment outcome; urinary bladder neoplasms