Posted: Friday, January 13, 2023
A new combination option for patients with platinum-refractory or cisplatin-ineligible advanced urothelial cancer seems to have emerged in tandem with the results of a single-arm phase II trial published in The Journal of Urology. Using nab-paclitaxel and pembrolizumab together in 36 patients resulted in an overall response rate of 50% (the primary endpoint), including 3 complete and 15 partial responses, and all but five patients experienced some tumor shrinkage, according to Irene Tsung, MD, of the University of Michigan, Ann Arbor, and colleagues.
Patients received a starting dose of 125 mg/m2 of nab-paclitaxel intravenously on days 1 and 8 and of pembrolizumab at 200 mg intravenously on day 1 in 21-day cycles until disease progression, intolerable toxicity, or death. After the planned interim analysis and after some of the first patients had experienced severe adverse events including fatigue and anemia, the team reduced the nab-paclitaxel starting dose to 100 mg/m.2
The 36 patients were divided about equally between those who were platinum-refractory and cisplatin-ineligible, noted the researchers. At a median follow-up of 19.7 months, the median duration of response was 4.4 months, median progression-free survival was 6.8 months, and median overall survival was 18.2 months—results that the team found encouraging. A total of 21 patients experienced grade ≥ 3 adverse events, and 10 patients had immune-mediated adverse events.
This immunotherapy/chemotherapy combination is an “efficacious and feasible option” for this cohort of patients with advanced urothelial cancer, declared Dr. Tsung and co-investigators. Exploration into its potential should continue, they added.
Disclosure: The study authors’ disclosure information can be found at auajournals.org.