A cocktail regimen of intravesical mitomycin-C, doxorubicin, and cisplatin (MDP) for non-muscle-invasive bladder cancer.
OBJECTIVE
To compare the efficacy and toxicity profiles of 3 intravesical regimens, including doxorubicin alone, bacillus Calmette-Guerin (BCG), and a cocktail regimen, in the prevention of bladder cancer recurrence.


METHODS
Two hundred ninety patients with newly diagnosed non-muscle-invasive bladder cancer treated with transurethral resection (TUR) between March 1996 and December 2004 were analyzed retrospectively. Each cycle of the cocktail regimen contained 30 mg each of sequential weekly intravesical mitomycin-C (MMC), doxorubicin, and cisplatin (MDP). Two cycles of MDP were given within the first 6 weeks of TUR, followed by 1 cycle each at 3, 6, and 12 months, and every 6 months until 36 months after a negative cystoscopy. Doxorubicin and BCG alone was given at similar time points as the MDP and BCG protocols.


RESULTS
There were no demographic differences among the 3 groups. The median follow-up duration was 50 months. Dropout rates due to intolerance and/or poor compliance with the BCG, doxorubicin, and MDP protocols were 22.5%, 16.8%, and 11.0%, respectively. The MDP and BCG groups had similar bladder recurrence rates (37.9% vs. 33.9% at 5 years, respectively; P = 0.69). The doxorubicin group had significantly more recurrences than the BCG or MDP groups (HR = 1.9 (vs. BCG; P = 0.02) and 1.8 (vs. MDP; P = 0.01)). MDP was associated with less major adverse events than BCG (5.8% vs. 15.0%, respectively; P = 0.02).


CONCLUSIONS
Compared with maintenance BCG, the MDP group had a similar recurrence rate but less side effects. Large randomized study is warranted to further determine the benefit of MDP adjuvant intravesical therapy.
Chen
Chung-Hsin
CH
Department of Urology, National Taiwan University Hospital, Taipei, Taiwan.
Yang
Hung-Ju
HJ
Shun
Chia-Tung
CT
Huang
Chao-Yuan
CY
Huang
Kuo-How
KH
Yu
Hong-Jeng
HJ
Pu
Yeong-Shiau
YS
D000283:Administration, Intravesical; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003131:Combined Modality Therapy; D003558:Cystoscopy / Q000009:adverse effects / Q000379:methods*; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D004334:Drug Administration Schedule; D005260:Female; D005334:Fever / Q000209:etiology; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D015999:Multivariate Analysis; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local; D011472:Prostatitis / Q000209:etiology; D012189:Retrospective Studies; D016896:Treatment Outcome; D001749:Urinary Bladder Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*
D001500:BCG Vaccine; D016685:Mitomycin; D004317:Doxorubicin; D002945:Cisplatin