Table 1.
Summary of study characteristics (n = 5)
Reference | Trial numbers | Setting | Study region | Upper urinary tract carcinoma included | Neoadjuvant pretreatment allowed | Radiation pretreatment allowed | Drug | Sample size; % female | Survival end point for gender analysis | Follow-up period | Quality of life data included | Special features |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Aragaki et al. (2022) | IMvigor 210, 406 patients from TCGA MIBC | Phase II, metastatic and advanced disease, multi-centric | North America | Yes | No | Yes | Atezolizumab | 406; 26.4 (for TCGA data) | OS | No detailed information in publication | No | Detailed analysis for gender-specific biomarkers |
Bajorin et al. (2021) | CheckMate 275 | Phase III, adjuvant for advanced and high-risk, multi-centric | North and South America, Europe, Asia, Australia | Yes | Yes | No | Nivolumab | 709; 23.8 (analysis with 353 with 24.9% females) | DFS; RFS and recurrence rates | Median 20.9 months | Yes | – |
Bellmunt et al. (2017) | Keynote-045 | Phase III, metastatic and advanced, second-line, multi-centric | North America, Europe | Yes | Yes | No | Pembrolizumab | 542; 25.8 | OS; death rates | Median 14.1 months | No | – |
Bellmunt et al. (2021) | IMvigor 010 | Phase III, adjuvant for advanced and high-risk, multi-centric | North America | Yes | Yes | No | Atezolizumab | 809; 21.1 (analysis with 406 with 20.7% females) |
Median DFS disease rates |
Median 21.9 months | No | – |
Hoffman-Censits et al. (2019) [Abstract] | PCD4989g, IMvigor 210, IMvigor 211, SAUL | Pooled Analysis, locally advanced and metastatic disease, multi-centric | Worldwide | Yes | Yes | No | Atezolizumab |
1995; 22.6 pooled analysis for: A) PCD4989g: 95; 24.2 B) IMvigor 211 atezo: 467; 23.6 |
Median OS, ORR; disease rates | Different among included studies | No | – |