Matthew Galsky, MD, reported at the 2021 ASCO annual meeting that transurethral resection of bladder tumor + gemcitabine, cisplatin, plus nivolumab achieves stringently defined clinical complete response in a large subset of patients with muscle invasive bladder cancer.
Phase 2 clinical trial: ASCO Abstract Hi I'm Matt kowalski. I'm a medical oncologist at the Icahn School of Medicine at Mount Sinai and in the tissue cancer institute and at Ascot. This year I'm presenting results of a clinical trial eight c r N g u 16 to 57 which involved patients with muslim invasive bladder cancer. The standard treatment for muscle invasive bladder cancer for decades has been to give chemotherapy with a drug called CISplatin plus gem side of being followed by cyst ectomy to remove the bladder. We know that in a subset of patients when the bladder is removed and analyzed by a pathologist, there's no more cancer left in the bladder and that's called a pathological complete response, A pathological complete responses associated with a very favorable long term prognosis. However, we only know that information after the bladder has already been removed and this has raised the concept. Could we determine which patients have had their bladder cancer is eradicated with a transfer re throw resection of the tumor, a by urologist. Plus systemic therapy like chemotherapy without having to remove the bladder and thereby offer this as a bladder sparing treatment paradigm. So we set out to test this concept in a prospective clinical trial. We use that standard chemotherapy but we added in immunotherapy drug called the Volume AB, which has shown to be an effective part of the treatment regimen for patients with metastatic bladder cancer. We gave four cycles of this combination treatment, chemotherapy plus immunotherapy. And then after that patients underwent a series of studies, they underwent imaging of their bladder to see if there was any um that was visible on cat scan or MRI. They underwent urine cytology to look for cancer cells in the urine and they underwent a cyst Oscar p with their urologist a scope of the bladder with biopsies of the bladder. If there was no evidence of cancer on those investigations, then patients were offered the opportunity to proceed with standard treatment, which would be to remove the bladder or to not have their bladders removed and undergo an additional four months of immunotherapy alone. The trial was designed to determine what the complete clinical response rate was with this regimen, meaning the absence of any cancer that could be detected on those investigations after treatment and to determine whether or not a complete clinical response predicted which patients remained long term free of cancer with an intact bladder. The trial enrolled 76 patients at the time of the day to lock 64 of those patients had completed the four cycles of treatment and had undergone that series of investigations. Among those patients, 31 patients had no evidence of cancer on those investigations. A complete clinical response rate of 48%. Our follow up of those patients is still somewhat immature. It's a little bit more than a year, but Among those 31 patients, only one patient chose not to have um uh not to be followed with observation, only one patient chose immediate suspect to me to remove their bladder. And in in that case, there was a very low stage cancer residual. In the 30 patients who opted not to have their bladders removed. So far, we have many patients out beyond one year who have had no evidence of recurrence over their cancer and whose bladder remains intact. So in summary, a transfer re throw resection of bladder tumor by Iran oncologist, plus systemic therapy with chemotherapy and immunotherapy in this clinical trial was a feasible approach, led to a relatively high clinical complete response rate and demonstrated than in a subset of patients. Long term bladder intact. Disease free survival as possible. But this trial requires much longer follow up to ensure the durability of those responses in patients whose bladders have been left intact. Um, and so this is not yet a standard approach that should be applied without longer follow up, but potentially one day will be part of our standard treatment approach to muscle invasive bladder cancer. Thank you for your attention.