Opinion
Video
Author(s):
"Overall, our trial shows promising early oncological efficacy with a favorable toxicity profile," says Gal Wald, MD.
In this video, Gal Wald, MD, shares key findings from the study, “Initial Results Of A Phase II Trial Of Bacillus Calmette-Guérin (BCG) And Intravesical Gemcitabine For Patients With BCG-Exposed High-Grade Non-Muscle Invasive Bladder Cancer (NCT04179162),” which he presented at the Society of Urologic Oncology 25th Annual Meeting in Dallas, Texas. Wald is a fourth-year urology resident at Weill Cornell Medicine in New York, New York.
Video Transcript:
Our primary end point was a complete response at 6 months. This was 94%. We initially set to recruit 43 patients. This is the preliminary results, so this is out of 36 patients. At 12 months, that number drops a little bit, and we have an 81% complete response rate. When you look at the high-grade recurrence-free survival, that comes out to be 85%.
As far as our treatment-related adverse events, the majority of patients had grade 1 or 2 events. This is consistent with many other non–muscle-invasive trials, also consistent with a phase 1 trial that we've conducted in our institution. There were 2 patients who had a grade 3 event; 1 who had a urinary tract infection requiring an IV antibiotic dose in an outside hospital, and then another patient who had BCG-related pneumonitis. It resolved, and that patient is a long-term responder. Overall, our trial shows promising early oncological efficacy with a favorable toxicity profile.
This transcript was AI generated and edited by human editors for clarity.