Dose-Dense Chemotherapy for Muscle-Invasive Bladder Cancer: Phase III Trial Toxicity Update
Posted: Tuesday, December 1, 2020
Stéphane Culine, MD, PhD, of the Saint-Louis Hospital, Paris, and colleagues conducted the multicenter phase III GETUG/AFU V05 VESPER trial to compare the safety and efficacy of treatment with experimental dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin with that of standard gemcitabine plus cisplatin in patients with muscle-invasive bladder cancer before or after radical cystectomy. The results of the secondary endpoint analysis, which were published in European Urology, revealed this chemotherapeutic regimen seemed to demonstrate better bladder control rate with manageable toxicities.
“Perioperative chemotherapy has been developed to increase overall survival for nonmetastatic muscle-invasive bladder cancer,” the investigators noted. “International guidelines recommend available neoadjuvant chemotherapy, but the optimal chemotherapy regimen to be delivered remains open to discussion.”
Between February 2013 and March 2018, patients with muscle-invasive bladder cancer received either six cycles of dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (n = 248) every 2 weeks or four cycles of gemcitabine plus cisplatin (n = 245) every 3 weeks. A total of 437 and 56 patients underwent neoadjuvant and adjuvant chemotherapy, respectively.
Hematologic toxicities were the most commonly reported adverse events of grade 3 or higher; they occurred in 52% of the experimental arm and in 55% of the standard arm. Gastrointestinal disorders (P = .003) and asthenia (P < .001) of grade 3 or higher were more frequently observed in the experimental arm. After neoadjuvant chemotherapy and cystectomy, the experimental treatment seemed to produce a higher complete pathologic response rate than the standard treatment (42% vs. 36%; P = .2). More patients in the experimental arm obtained an organ-confined status than those in the standard arm (77% vs. 63%; P = .001).
“Such data have to be confirmed on progression-free survival, with primary endpoint data expected in mid-2021,” the investigators concluded.
Disclosure: The study authors reported no conflicts of interest.