Table 1.
Characteristics of included studies.
| First Author, Year (Study Name) | Phase | Population | Experimental Arm (n) | Control Arm (n) | Endocrine Status | Median PFS Exp Arm | Median PFS Ctrl Arm | HR (95% CI) |
|---|---|---|---|---|---|---|---|---|
| Hortobagyi GN, 2018 (MONALEESA-2) | III | Post-menopausal AI-sensitive |
Ribociclib + Letrozole (334) | Letrozole + Placebo (334) | Sensitive | 25.3 (23.0–30.3) | 16 (13.4–18.2) | 0.568 (0.457–0.704) |
| Slamon DJ, 2018 (MONALEESA-3) | III | Post-menopausal AI-sensitive/resistant |
Ribociclib + Fulvestrant (484) | Fulvestrant + Placebo (242) | Mixed | 20.5 (18.5–23.5) | 12.8 (10.9–16.3) | 0.593 (0.480–0.732) |
| Tripathy D, 2018 (MONALEESA-7) | III | Pre-menopausal AI-sensitive |
Ribociclib + Tamoxifene or NSAI (335) | Placebo + Tamoxifene or NSAI (337) | Mixed | 23.8 (19.2–NR *) | 13.3 (11.0–16.4) | 0.553 (0.441–0.694) |
| Sledge GW, 2019 (MONARCH-2) | III | Pre/Post-menopausal AI-resistant |
Abemaciclib + Fulvestrant (446) | Fulvestrant + Placebo (223) | Resistant | 16.4 (not reported) | 9.3 (not reported) | 0.553 (0.449–0.681) |
| Johnston S, 2019 (MONARCH-3) | III | Pre/Post-menopausal AI-sensitive |
Abemaciclib + NSAI (328) | Placebo + NSAI (165) | Sensitive | 28.1 (not reported) | 14.7 (not reported) | 0.540 (0.418–0.698) |
| Finn RS, 2015 (PALOMA-1) | II | Pre/Post-menopausal AI-sensitive |
Palbociclib + Letrozole (84) | Letrozole (81) | Sensitive | 20.2 (13.8–27.5) | 10.2 (5.7–12.6) | 0.488 (0.319–0.748) |
| Rugo HS, 2019 (PALOMA-2) | III | Pre/Post-menopausal AI-sensitive |
Palbociclib + Letrozole (444) | Letrozole (222) | Sensitive | 27.6 (22.4–30.3) | 14.5 (12.3–17-1) | 0.563 (0.461–0.687) |
| Cristofanilli M, 2016 (PALOMA-3) | III | Pre/Post-menopausal AI-resistant |
Palbociclib + Fulvestrant (521) | Fulvestrant + Placebo (347) | Resistant | 9.5 (9.2–11.0) | 4.6 (3.5–5.6) | 0.46 (0.36–0.59) |
* NR, not reached.