Table 1.
First‐line immunotherapy outcomes in the pivotal RCTs, real‐world studies, and present study
| First author, year | Study design (country) | Drug | Patients, n | Age median (range) | Gender: males, n (%) | PS ≥ 2, n (%) | CNS metastases, n (%) | Median PFS, mo | Median OS, mo | 1‐year OS, % |
|---|---|---|---|---|---|---|---|---|---|---|
| Reck, 2016 & 2019 [11, 12] | RCT, multicentric | Pem | 154 | 64.5 (33–90) | 92 (59.7) | 1 (0.6) | 18 (11.7) | 10.3 | 30.0 | 70.3 |
| Ksienski, 2019 [34] | Observational, multicentric (Canada) | Pem | 141 | 70.0 (41–91) a | 97 (51.1) a | 65 (34.2) a | 26 (13.7) a | 3.7 a | 24.3 | ND |
| Velcheti, 2019 [39] | Observational, multicentric (U.S.) | Pem | 188 | 72.0 (46–84) | 90 (47.9) | 0 | 23 (12.2) | 6.8 | 19.1 | 60.4 |
| Amrane, 2019 [24] | Observational, multicentric (France) | Pem | 108 | 67.0 (37–87) | 70 (64.8) | 25 (23.1) | 19 (17.6) | 10.1 | 15.2 | ND |
| Tamiya, 2019 [32] | Observational, multicentric (Japan) | Pem | 213 | 71 (39–91) | 176 (82.6) | 41 (19.2) | ND | 8.3 | 17.8 | ND |
| Tambo, 2020 [40] | Observational, multicentric (Japan) | Pem | 95 | 72.0 (51–89) | 71 (74.7) | 21 (22.1) | ND | 6.1 | NR | 58.3 |
| Current study | Observational, single center (Slovenia) | Pem | 26 | 65.5 (39–78) | 16 (62.0) | 3 (11.0) | 4 (15.0) | 9.3 | NR | 62.0 |
a
Reported for 190 patients, of which 49 were treated in second‐line setting.
Abbreviations: CNS, central nervous system; ND, no data; NR, not reached; OS, overall survival; Pem, pembrolizumab; PFS, progression‐free survival; PS, performance status; RCT, randomized clinical trial.