Table 1.
Characteristics of eligible studies.
| NCT number Author (Pabulication year) Acronym |
Phase | Cancer type | ECOG | CDK4/6 inhibitor | Patients enrolled | Patient groups |
Age |
ILD/pneumonitis events |
Events reported | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment, n |
Median/Mean, years |
No. of patients for safety analysis |
All-grade |
≥3 grade or SAEs |
||||||||||
| Control, n | Treatment | Treatment | Control | Treatment | Control | Treatment | Control | |||||||
|
NCT 02513394 Mayer (2021) PALLAS |
III | BC | 0–1 | Palbociclib | 5760 | Palbociclib 125 mg qd + ET (n = 2883) versus ET (n = 2877) | 52 (45–61) | 2840 | 2930 | 13 | 5 | 1 | 0 | Publication |
|
NCT 03155997 Johnston (2020) MONARCHE |
III | BC | 0–1 | Abemaciclib | 5637 | Abemaciclib 150 mg bid + ET (n = 2808) versus ET (n = 2829) | 51 (23–89) | 2791 | 2800 | 76 | 33 | 10 | 1 | Publication |
|
NCT 02675231 Tolaney (2020) MONARCHER |
II | BC | 0–1 | Abemaciclib | 237 | Abemaciclib 150 mg bid + Trastuzumab + Fulvestrant (n = 79) Abemaciclib 150 mg bid + Trastuzumab (n = 79) versus Standard chemotherapy + Trastuzumab (n = 79) |
55 (47–62) 54 (47–62) |
78 77 |
72 / |
3 3 |
1 | 1 1 |
1 | Publication |
|
NCT 02763566 Zhang (2020) MONARCH plus |
III | BC | 0–1 | Abemaciclib | 463 | Abemaciclib 150 mg bid + NSAI (n = 207) versus Placebo + NSAI (n = 99) Abemaciclib 150 mg bid + Fulvestrant (n = 104) versus Placebo + Fulvestrant (n = 53) |
54 (32–83) 60 (36–80) |
207 104 |
99 53 |
13 1 |
3 1 |
1 0 |
1 0 |
Publication |
|
NCT 02422615 Slamon (2019) MONALEESA-3 |
III | BC | 0–1 | Ribociclib | 726 | Ribociclib 600 mg qd + NSAI (n = 484) versus Placebo + NSAI (n = 242) | 63 (31–89) | 327 | 161 | 6 | 2 | 1 | 0 | Publication |
|
NCT 02278120 Im (2019) MONALEESA-7 |
III | BC | 0–1 | Ribociclib | 672 | Ribociclib 600 mg qd + NSAI/Tamoxifen + Goserelin (n = 335) versus Placebo + NSAI/Tamoxifen + Goserelin (n = 337) | 43 (25–58) | 335 | 337 | 1 | 0 | 0 | 0 | Publication |
|
NCT 02246621 Goetz (2017) MONARCH-3 |
III | BC | 0–1 | Abemaciclib | 493 | Abemaciclib 150 mg bid + NSAI (n = 328) versus Placebo + NSAI (n = 165) | 63 (38–87) | 328 | 165 | 1 | 0 | 1 | 0 | Publication |
|
NCT 01740427 PALOMA-2 |
III | BC | 0–2 | Palbociclib | 666 | Palbociclib 125 mg bid + Letrozole (n = 444) versus Placebo + Letrozole (n = 222) | 61.7 | 444 | 222 | 2 | 0 | 2 | 0 | ClinicalTrials.gov |
|
NCT 02107703 MONARCH-2 |
III | BC | 0–1 | Abemaciclib | 669 | Abemaciclib 150 mg bid + Fulvestrant (n = 446) versus Placebo + Fulvestrant (n = 223) | 59.9 | 441 | 223 | 4 | 0 | 4 | 0 | ClinicalTrials.gov |
| NCT 02499120 | II | Head and neck | NA | Palbociclib | 125 | Palbociclib 125 mg qd + Cetuximab (n = 65) versus Placebo + Cetuximab (n = 60) | 59.5 | 64 | 60 | 1 | 1 | 1 | 1 | ClinicalTrials.gov |
| NCT 02450539 | II | NSCLC | 0–1 | Abemaciclib | 159 | Abemaciclib 200 mg bid (n = 106) versus Docetaxel (n = 53) | 63.5 | 106 | 52 | 3 | 1 | 3 | 1 | ClinicalTrials.gov |
|
NCT 02152631 JUNIPER |
III | NSCLC | 0–1 | Abemaciclib | 453 | Abemaciclib 200 mg bid (n = 270) versus Erlotinib (n = 183) | 62.5 | 265 | 175 | 4 | 3 | 4 | 3 | ClinicalTrials.gov |
Abbreviation: ECOG, Eastern Cooperative Oncology Group; SAEs, severe adverse events; T, treatment group; C, control group; BC, breast cancer; NSCLC, non-small cell lung cancer; qd, once daily; bid, twice daily; ET, endocrine therapy; NSAI, nonsteroidal aromatase inhibitor; NA, not available.