Table 1.
Study | Year | Country | Recruitment period | Total patients (ITT) | Median age, years (range) | No. of gender (male/female) | Endpoints (primary/secondary) | Median follow-up duration (months) |
---|---|---|---|---|---|---|---|---|
Albers et al. (12) | 2011 | Germany | 2001–2005 | Treatment arm: 48 Control arm: 48 |
Treatment arm: 63.9 (42.8–80.6) Control arm: 65.1 (42.8–79.4) |
NA | OS/PFS, ORR, toxicity | NA |
Bellmunt et al. (13) (NCT00315237) | 2009 | Europe and USA | 2003–2006 | Treatment arm: 253 Control arm: 117 |
64.3 (34.9–86.3) | NA | OS/ORR, PFS, DCR | Treatment arm: 21.5 Control arm: 22.3 |
Bellmunt et al. (14) | 2013 | Europe and USA | 2003–2006 | Treatment arm: 253 Control arm: 117 |
64.3 (34.9–86.3) | NA | OS/NA | Treatment arm: 42 Control arm: 45 |
Harshman et al. (15) | 2013 | Europe and USA | 2003–2006 | Treatment arm: 167 Control arm: 84 |
62.5 (34.6–82.3) | NA | OS/NA | Treatment arm: 21.5 Control arm: 22.3 |
Powles et al. (16) (NCT00949455) | 2017 | United Kingdom | 2007–2013 | Treatment arm: 116 Control arm: 116 |
Treatment arm: 70.7 (63.9–77.2) Control arm: 71.1 (63.8–76.3) |
Treatment arm: 88/28 Control arm: 84/32 |
PFS/OS, ORR, toxicity | NA |
Bellmunt et al. (18) (NCT02256436, KEYNOTE-045) | 2017 | Multi-nation | 2014–2015 | Treatment arm: 270 Control arm: 272 |
Treatment arm: 67 (29–88) Control arm: 65 (26–84) |
Treatment arm: 200/70 Control arm: 202/70 |
OS, PFS/ORR, DOR, toxicity | 14.1 |
Powles et al. (19) (NCT02302807, IMvigor211) | 2018 | Multi-nation | 2015–2016 | Treatment arm: 467 Control arm: 464 |
Treatment arm: 67 (33–88) Control arm: 67 (31–84) |
Treatment arm: 357/110 Control arm: 361/103 |
OS/PFS, ORR, DOR, toxicity | 17.3 |
OS, overall survival; ORR, overall response rate; PFS, progression-free survival; DCR, disease control rate; NA, non-available, DOR; duration of response.