Table 1 Clinical and pathological characteristics of ER+ breast cancer patients with advanced disease treated with combined CDK4/6i and endocrine treatment from pilot and validation cohorts according to p-AKT levels.
Parameters | Pilot | Validation | Pilot vs. validation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
p-AKT low | p-AKT high | N | pa | p-AKT low | p-AKT high | N | pa | pilot | validation | N | pa | |
Age at starting CDK4/6i | ||||||||||||
≤50 | 1 | 1 | 2 | 0.33 | 5 | 2 | 7 | 0.63 | 2 | 7 | 9 | 0.65 |
>50 | 13 | 2 | 15 | 62 | 15 | 77 | 15 | 77 | 92 | |||
Site of relapseb | ||||||||||||
Soft tissue | 9 | 1 | 10 | 0.53 | 20 | 5 | 25 | 0.13 | 10 | 25 | 35 | 0.37 |
Bone | 3 | 2 | 5 | 34 | 5 | 39 | 5 | 39 | 44 | |||
Viscera | 2 | 0 | 2 | 13 | 7 | 20 | 2 | 20 | 22 | |||
No metastatic sites | ||||||||||||
1 | 4 | 1 | 5 | 0.86 | 18 | 6 | 24 | 0.62 | 5 | 24 | 29 | 0.16 |
2 | 7 | 1 | 8 | 19 | 3 | 22 | 8 | 22 | 30 | |||
≥3 | 3 | 1 | 4 | 30 | 8 | 38 | 4 | 38 | 42 | |||
Chemotherapyc | ||||||||||||
No | 9 | 1 | 10 | 0.54 | 37 | 8 | 45 | 0.60 | 10 | 45 | 55 | 0.79 |
Yes | 5 | 2 | 7 | 30 | 9 | 39 | 7 | 39 | 46 | |||
Time to recurrence (years) | ||||||||||||
≤5 | 7 | 3 | 10 | 0.28 | 28 | 5 | 33 | 0.35 | 10 | 33 | 43 | 0.29 |
1–10 | 4 | 0 | 4 | 16 | 7 | 23 | 4 | 23 | 27 | |||
>10 | 3 | 0 | 3 | 23 | 5 | 28 | 3 | 28 | 31 | |||
Total | 14 | 3 | 17 | 67 | 17 | 84 | 17 | 84 | 101 | |||