Lancet Oncol: Phase 3 | Comparison of the efficacy of pembrolizumab combined with chemotherapy or as a first-line treatment for advanced urothelial cancer!

PD-1 and PD-L1 inhibitors have therapeutic activity in metastatic urothelial carcinoma, but there is still a lack of random data to support their use as first-line treatments.

In the KEYNOTE-361 trial, Thomas and other researchers evaluated the prognosis of patients with advanced urothelial cancer who had not been treated with pembrolizumab alone or combined chemotherapy or chemotherapy alone as first-line treatment.

This is a randomized, open-label Phase 3 clinical trial conducted in 201 medical centers in 21 countries, recruiting 18-year-old, untreated, locally advanced, unresectable, or metastatic urinary tract Skin cancer patients were randomly divided into three groups at 1:1:1 and received intravenous pembrolizumab (200 mg/3 weeks) combined with chemotherapy (gemcitabine 1000 mg/m2 + cisplatin or carboplatin 70 mg/m2), or pembrolizumab alone Or chemotherapy.

From October 19, 2016 to June 29, 2018, a total of 1010 patients were recruited: 351 in the pembrolizumab + chemotherapy (combination) group, 307 in the pembrolizumab group, and 352 in the chemotherapy group.

Overall survival and progression-free survival of the combination group and chemotherapy group

Compared with the chemotherapy group, the combination group failed to significantly prolong progression-free survival (median progression-free survival: 8.

Overall survival and progression-free survival of the total population in the pembrolizumab group and chemotherapy group

The overall survival of the pembrolizumab single-agent group and the chemotherapy-only group was similar , both in the overall population (15.

In summary, in the platinum-based first-line chemotherapy regimen for advanced urothelial cancer, adding pembrolizumab does not significantly improve the therapeutic effect, and should not be widely used in the treatment of advanced urothelial cancer .

Thomas Powles, et al.