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Pre-Cystectomy 4-Drug Chemotherapy Improves Outcomes Among Patients with Muscle-Invasive Bladder Cancer
New England Journal of Medicine (NEJM)
08/28/2003
By Joene Hendry
A chemotherapy combination of methotrexate, vinblastine, doxorubicin, and cisplatin (M-VAC) can be safely administered to patients with locally advanced bladder cancer before they undergo radical cystectomy. This combined approach resulted in a significantly improved survival compared with patients who undergo cystectomy alone for locally advanced bladder cancer.
"The estimated risk of death was reduced by 33% in the group assigned to receive M-VAC and cystectomy, as compared with the group assigned to undergo cystectomy alone," writes H. Barton Grossman, MD, of M. D. Anderson Cancer Center, Houston, Texas, United States and colleagues. Over an 11-year period, the researchers randomly assigned 307 patients, 251 male and 56 female, median age 63 years, to undergo 3 cycles of neoadjuvant M-VAC therapy followed by radical cystectomy or radical cystectomy alone for stage T2 toT4a muscle-invasive bladder cancer.
The intention-to-treat analysis shows a median survival of 46 months among the cystectomy only group compared with 77 months among the combination therapy group. At the 5-year follow up point, 43% in the cystectomy only group versus 57% of those who received the combination therapy were alive.
While at least one-third of the patients had severe haematologic or gastrointestinal effects, the investigators note that, "all patients recovered, and there were no treatment-related deaths." They add that M-VAC therapy had no adverse affect on the patients' surgery and did not increase the risk of surgery related complication or death.
Success with this 4-drug regimen is dependent upon the selection of patients with adequate renal function and careful monitoring for and treatment of any chemotherapy related toxicity or adverse effect. "Although a single successful clinical trial should not necessarily change standard medical practice," Dr. Grossman and colleagues surmise, "neoadjuvant M-VAC can be offered to patients with locally advanced bladder cancer who are candidates for radical cystectomy."
N Eng J Med 2003;349:859-866.
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