Table 1. Studies and Publications for Level 3 Review, After Exclusions at Levels 1 and 2.
| Phase 3 trials screened | Trials included | Median follow-up, ≥24 mo | PR criteriaa | Publications included | Source |
|---|---|---|---|---|---|
| Non–small cell lung cancer | |||||
| CheckMate 017/057 | Yes | No | FT | No | Brahmer et al,30 2015 |
| No | FF | No | Borghaei et al,31 2015 | ||
| No | 0 | No | Horn et al,32 2017 | ||
| Yes | TT | No | Vokes et al,33 2018 | ||
| Yes | TT | Yes | Borghaei et al,6 2021 | ||
| OAK | Yes | No | FF | No | Rittmeyer et al,34 2017 |
| Yes | TT | No | Fehrenbacher et al,35 2018 | ||
| Yes | TT | Yes | Mazieres et al,58 2021 | ||
| KEYNOTE-010 | Yes | No | FF | No | Herbst et al,36 2016 |
| No | TT | No | Herbst et al,37 2020 | ||
| Yes | TT | Yes | Herbst et al,59 2021 | ||
| KEYNOTE-042 | Yes | No | TT | Yes | Mok et al,60 2019 |
| IMpower110 | Yes | No | FT | No | Herbst et al,38 2020 |
| Yes | TT | Yes | Jassem et al,61 2021 | ||
| CheckMate 227 | Yes | No | 0 | No | Hellmann et al,39 2018 |
| Yes | TT | Yes | Hellmann et al,21 2019 | ||
| IMpower132 | Yes | Yes | TT | Yes | Nishio et al,62 2021 |
| KEYNOTE-024 | No | No | FT | No | Reck et al,40 2016 |
| No | FT | No | Reck et al,41 2019 | ||
| Yes | TT | No | Reck et al,42 2021 | ||
| KEYNOTE-189 | No | No | FF | No | Gandhi et al,43 2018 |
| No | FT | No | Gadgeel et al,44 2020 | ||
| Yes | FT | No | Rodríguez-Abreu et al,45 2021 | ||
| KEYNOTE-407 | No | No | FF | No | Paz-Ares et al,46 2018 |
| No | FF | No | Paz-Ares et al,47 2020 | ||
| IMpower130 | No | No | FF | No | West et al,48 2019 |
| IMpower131 | No | No | FF | No | Jotte et al,49 2020 |
| CheckMate 026 | No | No | FF | No | Carbone et al,50 2017 |
| CheckMate 9LA | No | No | FF | No | Paz-Ares et al,22 2021 |
| Yes | FT | No | Reck et al,23 2021 | ||
| EMPOWER-Lung 1 | No | No | FF | No | Sezer et al,51 2021 |
| NCT01285609 | No | Yes | FF | No | Govindan,52 2017 |
| Melanoma | |||||
| CA184-024 | Yes | Yes | TT | No | Robert et al,24 2011 |
| Yes | TT | Yes | Maio et al,12 2015 | ||
| CheckMate 066 | Yes | No | FF | No | Robert et al,53 2015 |
| Yes | TT | No | Ascierto et al,54 2019 | ||
| Yes | TT | Yes | Robert et al,63 2020 | ||
| CheckMate 037 | Yes | Yes | TT | Yes | Larkin et al,64 2018 |
| Urothelial cancer | |||||
| KEYNOTE-045 | Yes | No | FF | No | Bellmunt et al,55 2017 |
| Yes | TT | Yes | Fradet et al,5 2019 | ||
| IMvigor211 | Yes | No | FF | No | Powles et al,56 2018 |
| Yes | TT | Yes | van der Heijden et al,65 2021 | ||
| KEYNOTE-361 | Yes | Yes | TT | Yes | Powles et al,66 2021 |
| IMvigor130 | No | No | FF | No | Galsky et al,57 2020 |
Abbreviations: Cox-TEL, Cox proportional hazards–Taylor expansion adjustment for long-term survival data; PR, piecewise regression; TT, OS KM curve for intention-to-treat population met criteria for Cox-TEL adjustment.
a
PR criteria: annotation indicates whether experimental and control arms met (T, TRUE) or did not meet (F, FALSE) all 3 piecewise regression criteria. The first TRUE/FALSE indicator is for the experimental arm, and the second, for the control arm. For example, FT would indicate: experimental arm did not meet criteria; control arm met criteria.