Wednesday, August 3, 2011 (Last Updated: 08/04/2011)
WEDNESDAY, Aug. 3 (HealthDay News) -- In patients with pT1/T2N0M0 urothelial bladder cancer, the predictive value of p53 and the benefit of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) adjuvant chemotherapy could not be demonstrated, according to a study published online Aug. 1 in the Journal of Clinical Oncology.
Walter M. Stadler, M.D., from the University of Chicago, and colleagues investigated whether p53 alteration is prognostic for recurrence in 499 patients with urothelial bladder cancer and if there are clinical benefits from MVAC adjuvant therapy. In order to detect an absolute improvement from 0.50 to 0.30 in the probability of recurring by three years, 190 patients with stage pT1/T2N0M0 disease whose tumors demonstrated 10 percent or more nuclear reactivity on centrally performed immunohistochemistry for p53 were planned to be randomly assigned to three cycles of adjuvant MVAC. Of the 272 p53-positive patients, 114 patients were randomly assigned three cycles of MVAC or observed without any treatment, while 227 p53-negative patients were only observed.
The investigators stopped the accrual of participants on the basis of the data and safety monitoring board review of a futility analysis. The overall five-year probability of recurring was 0.20 and was not associated with p53 status. Of the patients randomly assigned to MVAC, only 67 percent received all three cycles, and 12 patients received no treatment. Randomly assigned patients did not show any difference in recurrence (hazard ratio, 0.78; 95 percent confidence interval, 0.29 to 2.08).
"Neither the prognostic value of p53 nor the benefit of MVAC chemotherapy in patients with p53-positive tumors was confirmed, but the high patient refusal rate, lower than expected event rate, and failures to receive assigned therapy severely compromised study power," the authors write.
One of the study authors disclosed financial ties to the pharmaceutical industry.
Hematology & Oncology
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