Maximizing intravesical therapy options:  is there an advantage to the administration of perioperative mitomycin C prior to an induction course of BCG?
BACKGROUND
This study sought to evaluate cancer-specific outcomes among patients who received perioperative mitomycin C (MMC) prior to induction BCG versus those who received induction BCG alone.


METHODS
Between January 2000 and August 2010, 260 patients were identified who underwent a course of induction BCG with or without concomitant perioperative MMC. Specifically, patients who received 40 mg MMC following transurethral resection of all visible tumor followed by an induction course of BCG were compared to a similar cohort of patients who received induction BCG alone. The primary endpoints were overall and recurrence-free survival (RFS).


RESULTS
A total of 212 patients were identified who received induction BCG alone, and 48 who received perioperative MMC with induction BCG. The aggregate patient cohort was comprised of those with non-muscle invasive disease (NMI), and there was no difference between groupings with respect to common demographic and pathologic variables. Over a median follow up of 34.5 months, there was no difference in overall survival between cohorts. RFS was superior among patients who received combined therapy (5 year survival: 37.5% versus 56.3%, p = 0.023). Nevertheless, the regimen of intravesical therapy did not reach significance as an independent predictor (HR 0.61, p = 0.055, CI 0.36-1.01).


CONCLUSIONS
Although the combination therapy group demonstrated a significant RFS advantage, the intravesical therapy regimen did not independently modulate this benefit. Further investigation is warranted to determine if immediate MMC prior to a course of induction BCG confers a benefit to RFS. Nevertheless, this pilot investigation sets an important precedent on the management of NMI bladder cancer, nonwithstanding the absence of contemporary large scale, randomized trials.
Department of Urology, Columbia University Medical Center, New York, New York 10032, USA.
Gina M
GM
Badalato
Gregory
G
Hruby
Mani
M
Razmjoo
James M
JM
McKiernan
D000283:Administration, Intravesical; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000008:administration & dosage / Q000627:therapeutic use*; D002295:Carcinoma, Transitional Cell / Q000628:therapy*; D003131:Combined Modality Therapy; D015653:Cystectomy; D018572:Disease-Free Survival; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000627:therapeutic use*; D059035:Perioperative Period; D012189:Retrospective Studies; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000628:therapy*
D000903:Antibiotics, Antineoplastic; D001500:BCG Vaccine; D016685:Mitomycin