Table 1.
Study(year) | Trial | Pathwayinhibited | Diseasestage | Interventionarm | Age(years)a | Samplesize | Postmenopausalstatus (%) | HR+ status (%) | PET | ECOGPS (%)(0/1) | MedianPFS(months) | Outcomes |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Sledge et al(2017)23 | MONARCH 2 | CDK4/6 | ABC | Abemaciclib + fulv Placebo + fulv |
59 (32–91) 62 (32–87) |
446 223 |
83.2% 80.7% |
ER+: 100% PR+: 76.0% ER+: 100% PR+: 76.7% |
AI | 59.2/39.5 61.0/39.0 |
16.4 9.3 |
PFS/ORR |
Musolino et al(2017)27 | — | FGFR | LABC/MBC | Dovitinib + fulv Placebo + fulv |
63 (44–82) 63 (38–82) |
47 50 |
NR | ER+ and/or PR+: 100% | Tam and/ or AI |
59.6/38.8 56.0/40.0 |
5.5 | PFS/ORR |
Kornblum et al(2018)31 | PrECOG 0102 | mTOR | MBC | Everolimus + fulv Placebo + fulv |
61 (35–92) | 66 65 |
NR | ER+ and/or PR+: 100% | AI | 61/39 58/42 |
19.3 | PFS/ORR |
Baselga et al(2017)25 | BELLE-2 | PI3K | LABC/MBC/ | Buparlisib + fulv Placebo + fulv |
62 (55–69) 61 (54–68) |
576 571 |
NR | ER+ and/or PR+: 100% | AI | 58.0/40.0 60.0/37.0 |
6.9 5.0 |
PFS/ORR |
Krop et al(2016)28 | FERGI | PI3K–mTOR | LABC/MBC | Pictilisib + fulv Placebo + fulv |
60 (36–90) 63 (40–82) |
89 79 |
NR | ER+: 100% PR+: 65% ER+: 100% PR+: 73% |
AI | NR | 6.6 5.1 |
PFS/ORR |
Cristofanilliet al (2016)15 | PALOMA-3 | CDK4/6 | MBC | Palbociclib + fulv Placebo + fulv |
57 (30–88) 56 (29–80) |
347 174 |
79% 79% |
ER+ and PR+: 43% ER+ and PR+: 40% |
AI | 59.0/41.0 67.0/33.0 |
9.5 4.6 |
PFS/ORR |
Clemons et al(2014)29 | OCOG ZAMBONEY | VEGF | MBC | Vandetanib + fulv Placebo + fulv |
61.6 57.7 |
61 68 |
NR | ER+: 92% PR+: 77% ER+: 94% PR+: 69% |
Tam and/ or AI |
54.0/44.0 53.0/40.0 |
5.8 4.8 |
PFS |
Adelson et al(2016)30 | New York Cancer Consortium | — | LABC/MBC | Bortezomib + fulv Fulv |
59 (31–80) 57 (31–83) |
57 59 |
NR | ER+: 100% ER+: 100% |
PET | 65/33 64/34 |
2.73 2.69 |
PFS |
Di Leo et al(2017)24 | BELLE-3 | PI3K | LABC/MBC | Buparlisib + fulv Placebo + fulv |
60 (54–68) 62 (55–69) |
289 143 |
NR | NR | PET | 60/39 64/34 |
8.3 12.0 |
PFS/ORR |
Slamon et al(2018)22 | MONALEESA-3 | CDK4/6 | ABC | Ribociclib+ fulv Placebo + fulv |
63 (31–89) 63 (34–86) |
484 242 |
NR | ER+: 99.4% PR+: 72.9% ER+: 99.6% PR+: 69.0% |
Tam and/ or AI |
64.0/35.7 65.3/34.3 |
20.3 12.8 |
PFS |
Zaman et al(2015)26 | SAKK 21/08 | SAKK 21/08 | ABC | Selumetinib + fulv Placebo + fulv |
66 (40–79) 69 (46–79) |
22 20 |
NR | ER and/or PR ≥10% | Tam and/ or AI |
73 65 |
3.7 5.6 |
PFS/ORR |
Note:
Age data presented as median (range) or mean.
Abbreviations: ABC, advanced breast cancer; AI, aromatase inhibitor; CDK4/6, cyclin-dependent kinase 4/6; ECOG PS, Eastern Cooperative Oncology Group performance status; ER+, estrogen-receptor positive; FGFR, fibroblast growth factor receptor; fulv, fulvestrant; LABC, locally advanced breast cancer; MBC, metastatic breast cancer; NR, not reported; ORR, objective response rate; PET, prior endocrine therapy; PI3K, phosphatidylinositol 3-kinase; PFS, progression-free survival; PR+, progesterone-receptor positive; Tam, tamoxifen.