Table 1.
Author | Year | NCT Number | RCT name | Clinical Trial Phase | Intervention | Total (n) | Median Age(range) | Male n(%) | ECOGPS=0 n(%) | MPs Median, months (95% CI) | mOS Median, months (95% CI) | Follow-up (month) Median, months (range or IQR) | Level of evidence according to the GRADE system | Level of evidence according to the Oxford System |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fradet et al. (11) | 2019 | NCT02256436 | KEYNOTE-045 | III | Pembrolizumab | 270 | 67 (29–88) | 200 (74) | 119 (44) | 2.1 (2.0–2.2) | 10.1 (8.0–12.3) | 27.7 (median) | Grade 1 | 1b |
Powles et al. (28) | 2018 | NCT02302807 | IMvigor211 | III | Atezolizumab | 467 | 67 (43–88) | 81 (70) | 61 (53) | NA | 8.6 (7.8–9.6) | 17·3 (range, 0–24·5) | Grade 1 | 1b |
Ohyama et al. (29) | 2019 | NCT 02387996 | CheckMate 275 | II | Nivolumab | 270 | 66 (38–90) | 211 (78) | 145 (54) | 1.9 (1.9–2.3) | 8.6 (6.1–11.3) | 33.7 (minimum) | Grade 2 | 2b |
Rosenberg et al. (30) | 2016 | NCT02108652 | IMvigor210 (Cohort 2) | II | Atezolizumab | 310 | 66 (32–91) | 241 (78) | 117 (38) | 2.7 (2.1–3.9) | 7.9 (6.6–9.3) | 11.7 (IQR, 11·4–12·2) | Grade 2 | 2b |
Sharma et al. (31) | 2016 | NCT01928394 | CheckMate 032 | I/II | Nivolumab | 78 | 66 (31–85) | 54 (69) | 42 (54) | NA | 9.7 (7.3–16.2) | 15.2 (IQR, 12·9–16·8) | Grade 2 | 2b |
Powles et al. (32) | 2017 | NCT01693562 | Study 1108 | I/II | Durvalumab | 191 | 67 (34–88) | 136 (71) | 64 (34) | 1.5 (1.4–1.9) | 18.2 (8.1-NE) | 5.8 (range, 0.4–25.9) | Grade 2 | 2b |
Plimack et al. (33) | 2017 | NCT01848834 | KEYNOTE-012 | Ib | Pembrolizumab | 33 | 70 (44–85) | 23 (70) | 9 (27) | 2 (2–4) | 13 (5–20) | 13 (IQR, 5–23) | Grade 2 | 2b |
Apolo et al. (34) | 2017 | NCT01772004 | JAVELIN Solid (dose-expansion cohort) | Ib | Avelumab | 44 | 68 (63–73) | 30 (68) | 19 (43) | 2.9 (1.5–4.4) | 13.7 (8.5-NE) | 16.5 (IQR, 15.8–16.7) | Grade 2 | 2b |
IQR, interquartile range; HR, hazard ratio; NA, not available, ICI, immune checkpoint inhibitor; Ctl, control.