WEDNESDAY, Oct. 4, 2023 (HealthDay News) — For patients with muscle-invasive bladder cancer (MIBC), treatment with gemcitabine, cisplatin, plus nivolumab facilitates bladder sparing, according to a study published online Oct. 2 in Nature Medicine.
Matthew D. Galsky, M.D., from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted a phase 2 study of 76 patients with MIBC who received four cycles of gemcitabine, cisplatin, plus nivolumab followed by clinical restaging. Patients who achieved a clinical complete response (cCR) could proceed without cystectomy.
Of the patients, 33 achieved a cCR (43 percent); 32 of the 33 opted to forgo immediate cystectomy. The researchers found that the positive predictive value of cCR for a composite outcome of two-year metastasis-free survival in patients forgoing immediate cystectomy or <ypT1N0 in patients electing to receive immediate cystectomy was 0.97. Fatigue, anemia, neutropenia, and nausea were the most common adverse events. The positive predictive value of cCR was not improved by somatic alterations in prespecified genes (ATM, RB1, FANCC, and ERCC2) or increased tumor mutational burden. There was an association noted between the baseline and on-treatment immune contexture with clinical outcomes.
“Treatment for muscle-invasive bladder cancer is in need of major improvements from both a quality-of-life and an effectiveness standpoint,” Galsky said in a statement. “If additional research confirms our findings, this may lead to a new paradigm in the treatment of muscle-invasive bladder cancer.”
Several authors disclosed ties to the biopharmaceutical and medical technology industries.
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