Background Immune checkpoint inhibitors have shown promising efficacy in the treatment of patients with urothelial carcinoma, but there is limited evidence that anti-PD-1 therapy combined with chemotherapy as a first-line treatment option for advanced patients.
Objective To explore the clinical outcome and safety of first-line anti-PD-1 therapy combined with chemotherapy versus chemotherapy alone in treatment of advanced urothelial carcinoma (UC).
Methods Patients with advanced UC who received first-line treatment from March 2017 to April 2020 in the department of oncology, the First Medical Center of Chinese PLA General Hospital were included in our study. Patients who received gemcitabine or paclitaxel (albumin-bound) combined with platinum-based chemotherapy were in the chemotherapy group (n=51), and patients received PD-1 inhibitors plus chemotherapy were in the combination therapy group (n=30).
Results There was no significant difference between the two groups in baseline data (P > 0.05). The median progression-free survival (PFS) of the combination therapy group (15.8 months, 95% CI: 4.61 - 21.40) was significantly longer than the chemotherapy group (7.17 months, 95% CI: 5.94 - 8.40) (P=0.020). The objective response rates (ORR) of the combination therapy group and the chemotherapy group were 46.7% and 49.0% (P=0.999), and the disease control rates (DCR) were 90.0% and 80.4%, respectively (P=0.353). The incidence of adverse reactions of the combination therapy group and the chemotherapy group were 83.3% and 84.3% (P=0.908), and the incidence of grade III-IV adverse reactions were 33.3% and 35.3% (P=0.858), respectively.
Conclusion In the first-line treatment of patients with advanced UC, anti-PD-1 therapy combined with chemotherapy has better efficacy than chemotherapy alone, while the adverse reactions are similar.
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