Study | DAWNA- 2 | PALOMA- 1 | PALOMA- 2 | PALOMA- 4 | MONALEESA- 2 | MONALEESA- 7 | MONARCH- 3 | MONARCH PLUS A | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Treatment | dalpi + AI | AI | palbo + letro | pla + letro | palbo + letro | pla + letro | palbo + letro | pla + letro | ribo + letro | pla + letro | ribo + AI | pla + AI | abema + NSAI | pla + NSAI | abema + NSAI | pla + NSAI |
N | 303 | 153 | 84 | 81 | 444 | 222 | 169 | 171 | 334 | 334 | 248 | 247 | 328 | 165 | 207 | 99 |
PFS (HR and 95%CI) | 0.51(0.38–0.69) | 0.49(0.32–0.75) | 0.56(0.46–0.69) | 0.68(0.53–0.87) | 0.57(0.46–0.70) | 0.57(0.44–0.74) | 0.54(0.42–0.70) | 0.50(0.35–0.72) | ||||||||
OS (HR and 95%CI) | NA | 0.90(0.62–1.29) | 0.96(0.78–1.18) | NA | 0.76(0.63–0.93) | 0.80(0.62–1.04) | 0.80(0.64–1.02) | NA | ||||||||
ORR | 174/303 | 73/153 | 36/84 | 27/81 | 187/444 | 77/222 | 63/169 | 54/171 | 142/334 | 96/334 | NA | 163/328 | 61/165 | 116/207 | 30/99 | |
CBR | 263/303 | 122/153 | 68/84 | 47/81 | 377/444 | 156/222 | 134/169 | 137/171 | 267/334 | 244/334 | NA | 256/328 | 118/165 | 171/207 | 62/99 | |
De-novo metastatic disease (HR and 95%CI) | 0.50(0.32–0.80) | NA | 0.61(0.44–0.85) | 0.54(0.31–0.96) | 0.57(0.38–0.84) | NA | 0.47(0.31–0.71) | 1.35(0.59–3.10) | ||||||||
previous endocrine therapy (HR and 95%CI) | 0.50(0.29–0.85) | 0.46(0.22–0.96) | 0.54(0.42–0.71) | 0.68(0.50–0.93) | NA | NA | NA | NA | ||||||||
Postmenopausal (HR and 95%CI) | 0.52(0.36–0.75) | 0.49(0.32–0.75) | 0.56(0.46–0.69) | 0.68(0.53–0.87) | 0.57(0.46–0.70) | NA | 0.54(0.42–0.70) | 0.50(0.35–0.72) | ||||||||
Premenopausal (HR and 95%CI) | 0.53(0.33–0.85) | NA | NA | NA | NA | 0.57(0.44–0.74) | NA | NA | ||||||||
ECOG 0 (HR and 95%CI) | 0.43(0.28–0.66) | 0.43(0.25–0.77) | 0.65(0.48–0.87) | 0.62(0.43–0.90) | 0.58(0.44–0.77) | NA | 0.54(0.39–0.75) | 0.45(0.25–0.81) | ||||||||
ECOG 1 (HR and 95%CI) | 0.61(0.41–0.90) | 0.40(0.22–0.72) | NA | 0.71(0.51–1.00) | 0.54(0.39–0.77) | NA | 0.53(0.35–0.79) | 0.53(0.33–0.85) |