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No benefit seen in bladder carcinoma treated with cisplatin plus gemcitabine
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Adjuvant chemotherapy with cisplatin plus gemcitabine did not improve survival in patients with muscle-invasive bladder cancer, according to data presented by Francesco Cognetti, MD, of the department of medical oncology at the National Cancer Institute Regina Elena in Rome, during his presentation at the 2008 ASCO Annual Meeting.
Patients with radical cystectomy were randomly assigned to one of two arms: control and standard chemotherapy at relapse (arm A; n=92) or adjuvant chemotherapy with cisplatin and gemcitabine (arm B; n=102).
Patients assigned to adjuvant therapy were then randomly assigned to four courses of gemcitabine 1,000 mg/m2 on days one, eight and 15 plus cisplatin 70 mg/m2 on day two (arm B2; n=50) or the same dose of gemcitabine plus cisplatin 70 mg/m2 on day 15 (arm B15; n=52).
“The incidence of grade-3 and grade-4 thrombocytopenia was higher in the B2 arm compared with the B15 arm (P=.005),” Cognetti said.
Overall and disease-free survival, the primary and secondary endpoints, were similar in the control arm (P=.10) and the adjuvant chemotherapy arm (P=.58). The researchers found no difference in overall and disease-free survival between the control arm (P=.25) and the two chemotherapy (B2 and B15) arms (P=.86).
“To clarify the role of chemotherapy in the adjuvant setting of bladder cancer, other large phase-3 trials are needed, perhaps identifying a subset of patients with worse prognostic factors,” Cognetti said. – by Stacey L. Adams
A positive point from the researchers’ report is that they accrued 190 patients. A second positive feature is they accrued 190 patients, which is much better than we have been doing in the U.S. Intergroup trials. Another positive feature is the researchers reported the data and showed feasibility, and now they have a sample bank that can be accessed and they can complete validation studies that need to be conducted with BRCA-1 and ERCC-1 with a nontreated arm and chemotherapy arm to determine if they are prognostic or predictive.
The limitations are clear. The study is not powered for any meaningful conclusions and the researchers accrued only 190 of 610 patients. The researchers of this adjuvant study provide no guidance as to whether postoperative chemotherapy is or is not useful. The researchers had 80% power to detect a 10% increase in overall survival at five years, so it had a 20% chance, if fully accrued, of a false–negative finding. With less than one-third of the intended patients, this study clearly has a high chance of being false–negative.
At the end of the day, we still do not know if we can substitute postoperative adjuvant therapy for neo-adjuvant therapy.
– Christopher Sweeney, MBBS
Royal Adelaide Hospital at the University of Adelaide
Cognetti F. #5023. Presented at: 2008 ASCO Annual Meeting; May 30-June 2, 2008; Chicago.