(HealthDay News) — Gemcitabine and cisplatin (GC) plus ipilimumab is associated with a 69% objective response rate and 61% one-year overall survival for patients with metastatic urothelial cancer, according to a study published in European Urology.

Matthew D. Galsky, MD, from the Icahn School of Medicine at Mount Sinai in New York City, and colleagues conducted a multicenter phase 2 study enrolling 36 chemotherapy-naive patients with metastatic urothelial cancer. All patients underwent peripheral blood flow cytometry and 28 patients underwent whole exome sequencing of archival tumor tissue. Patients received 2 cycles of GC followed by 4 cycles of GC plus ipilimumab.

The researchers found that 81% of patients had grade ≥3 adverse events, most of which were hematologic. There was a 69% objective response rate; one-year overall survival was 61%. After GC alone, there were no significant changes in the composition and frequency of circulating immune cells. With the addition of ipilimumab, there was a significant expansion of circulating CD4 cells, which correlated with improved survival. A significantly higher response rate was seen in patients with deleterious somatic DNA damage response mutations

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“Because chemotherapy and immunotherapy are the two pillars of treatment for metastatic bladder cancer, we sought to better understand how these treatments might be best given together,” Galsky said in a statement. “Already the results of this trial have inspired the creation of two more trials that seek to better the treatment of bladder cancer patients by combining chemotherapy with immunotherapy.”

The study was funded by Bristol-Myers Squibb.

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Galsky MD. Wang H, Hahn NM, et al. Phase 2 Trial of Gemcitabine, Cisplatin, plus Ipilimumab in Patients with Metastatic Urothelial Cancer and Impact of DNA Damage Response Gene Mutations on Outcomes. Eur Urol. May 2018;73(5):751–759. DOI: 10.1016/j.eururo.2017.12.001