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Vikas Kumar Singh, MD, discusses findings from the phase 3 GETUG-AFU V05 VESPER (NCT01812369) and JAVELIN Bladder 100 (NCT02603432) trials in patients with bladder cancer.
Vikas Kumar Singh, MD, medical oncologist, Baptist Health, discusses findings from the phase 3 GETUG-AFU V05 VESPER (NCT01812369) and JAVELIN Bladder 100 (NCT02603432) trials in patients with bladder cancer.
The VESPER trial compared 2 common regimens for muscle-invasive bladder cancer: dose-dense MVAC (methotrexate, vinblastine, doxorubicin [Adriamycin], and cisplatin) and gemcitabine plus cisplatin, in the neoadjuvant and adjuvant settings, Singh says. Although these regimens are both standard treatments for bladder cancer, the head-to-head VESPER trial aimed to determine which is the superior perioperative therapy, Singh explains.
VESPER randomized patients to receive dose-dense MVAC or gemcitabine/cisplatin either before surgery (the neoadjuvant group) or after surgery (the adjuvant group). The primary end point of VESPER was progression-free survival (PFS) in patients who received perioperative chemotherapy with either dose-dense MVAC or gemcitabine plus cisplatin, Singh notes. This study did not meet its primary end point. In all patients in the study, the 3-year PFS rate was slightly improved in the dose-dense MVAC arm, at 64% vs 56% in the gemcitabine/cisplatin arm. Nevertheless, patients who received dose-dense MVAC had a longer time to progression, with a 3-year rate of 69% vs 58% in the gemcitabine/cisplatin arm.
However, in the neoadjuvant setting, dose-dense MVAC produced slightly higher 3-year PFS rates than gemcitabine plus cisplatin, at 66% vs 56%, respectively. The PFS data from this subgroup indicate that dose-dense MVAC may be more effective than gemcitabine plus cisplatin in the neoadjuvant setting, Singh says. Additionally, organ-confined response occurred more frequently in the dose-dense MVAC arm, at 77% vs 63% in the gemcitabine/cisplatin arm. The overall survival (OS) data for VESPER are still immature, Singh notes.
Findings from the JAVELIN Bladder 100 trial changed the standard of care for patients with metastatic urothelial cancer, Singh says. This study evaluated avelumab (Bavencio) maintenance therapy plus best supportive care (BSC) vs BSC alone in patients with metastatic urothelial carcinoma who had not progressed on prior first-line platinum-based chemotherapy, Singh explains.
Avelumab maintenance therapy led to an improved 1-year OS rate, at 71.3% vs 58.4% with BSC alone, Singh notes. The latest update from this trial, presented at the 2022 ASCO Genitourinary Cancers Symposium, showed that patients who received avelumab maintenance had a median OS of 23.8 months vs 15.0 months with BSC alone, Singh concludes.