Trial represents ‘first foray’ into molecularly-guided approach to bladder sparing
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A prospective phase 2 trial that evaluated risk-enabled therapy after neoadjuvant chemotherapy for muscle-invasive bladder cancer failed to meet a prespecified threshold of noninferiority, according to study results.
The single-arm RETAIN BLADDER trial included 70 patients (median age, 70 years; range, 47-83; 74% male; 92% white) who completed three cycles of neoadjuvant MVAC chemotherapy.
Those who had genetic mutations in ATM, ERCC2, FANCC or RB1 and who had no clinical evidence of disease by restaging began active surveillance. All others underwent bladder-directed therapy.
At 2 years, nearly half (46%) of the 26 patients in the active surveillance group remained alive with no metastatic disease and had retained their bladders without radiation, results presented at ASCO Genitourinary Cancers Symposium showed.
Landmark 2-year metastasis-free survival fell a couple percentage points shy of the noninferiority threshold.
“The number of patients [for whom] we were able to spare cystectomy and radiation was significant,” researcher Daniel Geynisman, MD, associate professor and chief of the division of genitourinary medical oncology at Fox Chase Cancer Center, told Healio. “It has to be improved upon, but this is the first foray into a molecularly-guided approach to try to spare bladders for these patients.”
Healio spoke with Geynisman about the findings and their potential clinical implications.
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Geynisman D, et al. Abstract 438. Presented at: ASCO Genitourinary Cancers Symposium; Feb. 16-18, 2023: San Francisco.
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