The efficacy of immune checkpoint inhibitors therapy versus chemotherapy in the treatment of advanced and metastatic urothelial carcinoma: a meta-analysis

The application of platinum-based chemotherapeutic agents is the traditional treatment paradigm for advanced and metastatic urothelial carcinoma, which has changed with the advent of immune checkpoint inhibitors (ICIs). This study aims to evaluate the efficacy of ICI therapy versus chemotherapy in the treatment of advanced and metastatic urothelial carcinoma. A systematic literature search of Web of Science, Embase, PubMed, and Cochrane Central Register of Controlled Trials was performed by two independent investigators. The primary endpoint was overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and adverse events (AEs). The patients treated with ICI monotherapy had no significant difference in OS than those treated with chemotherapy monotherapy (HR: 0.965, 95% CI 0.865–1.076, p = 0.518). However, the patients treated with ICI monotherapy had a higher ORR and lower incidence of high-grade (≥ grade 3) AEs than those treated with chemotherapy monotherapy (OR: 0.568, 95% CI 0.479–0.675, p < 0.001; OR: 0.614, 95% CI 0.446–0.845, p = 0.003). The patients treated with ICI in combination with chemotherapy had significantly better OS and PFS than those treated with chemotherapy alone (HR: 0.862, 95% CI 0.776–0.957, p = 0.006; HR: 0.788, 95% CI 0.707–0.879, p < 0.001). However, there was no significant difference in ORR or the incidence of grade 3 or higher AEs (OR: 0.951, 95% CI 0.582–1.554, p = 0.841; OR: 0.942, 95% CI 0.836–1.062, p = 0.328). ICI monotherapy did not show statistically significant difference in OS but demonstrated higher ORR and lower incidence of high-grade (≥ grade 3) AEs. And a statistically significant OS and PFS benefit was found in patients treated with first-line ICI in combination with chemotherapy compared to chemotherapy alone.