Table 3.
Multivariable Cox analysis in the combined MONALEESA dataset.
| Cohort | Variable | Adjusted HRa (95% CI) | P value |
|---|---|---|---|
| Ribociclib | Age | 1.01 (1.00–1.02) | 0.24 |
| Race | |||
| Asian | 1.00 (–) | – | |
| White | 0.98 (0.66–1.45) | 0.93 | |
| Other | 1.35 (0.71–2.57) | 0.35 | |
| Unknown | 1.07 (0.56–2.07) | 0.84 | |
| CT yes vs. no | 1.15 (0.84–1.59) | 0.39 | |
| Subtype | |||
| Luminal A | 1.00 (–) | – | |
| Luminal B | 1.16 (0.86–1.57) | 0.32 | |
| HER2E | 1.83 (1.33–2.52) | 0.00022 | |
| Basal-like | 7.22 (3.81–13.70) | <0.0001 | |
| ECOG PS 1 vs. 0 | 1.73 (1.33–2.24) | <0.0001 | |
| De novo disease vs. not | 0.55 (0.34–0.87) | 0.011 | |
| Visceral disease vs. not | 1.27 (0.93–1.74) | 0.14 | |
| Bone only vs. not | 1.03 (0.69–1.54) | 0.88 | |
| Histologic grade | |||
| Poorly differentiated/undifferentiated histologic grade | 1.41 (1.05–1.89) | 0.022 | |
| Unknown histologic grade | 1.35 (0.97–1.89) | 0.073 | |
| Well-differentiated histologic grade | 0.87 (0.52–1.45) | 0.59 | |
| No. of metastatic sites ≥3 vs. fewer | 1.11 (0.84–1.47) | 0.44 | |
| Tumor type (metastatic vs. primary) | 1.11 (0.84–1.48) | 0.46 | |
| ETS1b | 0.76 (0.48–1.20) | 0.24 | |
| ETS2c | 1.28 (0.85–1.91) | 0.24 | |
| ETS3d | 1.24 (0.72–2.12) | 0.44 | |
| Placebo | Age | 1.01 (1.00–1.02) | 0.21 |
| Race | |||
| Asian | 1.00 (–) | – | |
| White | 0.98 (0.67–1.42) | 0.90 | |
| Other | 1.18 (0.56–2.51) | 0.66 | |
| Unknown | 0.55 (0.27–1.14) | 0.11 | |
| CT yes vs. no | 1.55 (1.09–2.21) | 0.016 | |
| Subtype | |||
| Luminal A | 1.00 (–) | – | |
| Luminal B | 1.47 (1.08–2.00) | 0.014 | |
| HER2E | 2.87 (1.93–4.26) | <0.0001 | |
| Basal-like | 2.35 (1.20–4.57) | 0.012 | |
| ECOG 1 vs. 0 | 1.32 (1.00–1.74) | 0.052 | |
| De novo disease vs. not | 1.09 (0.64–1.83) | 0.75 | |
| Visceral disease vs. not | 1.26 (0.89–1.79) | 0.20 | |
| Bone only vs. not | 1.25 (0.82–1.90) | 0.29 | |
| Histologic grade | |||
| Poorly differentiated/undifferentiated histologic grade | 1.11 (0.81–1.52) | 0.53 | |
| Unknown histologic grade | 1.16 (0.80–1.68) | 0.43 | |
| Well-differentiated histologic grade | 0.84 (0.52–1.36) | 0.49 | |
| No. of metastatic sites ≥3 vs. fewer | 1.16 (0.85–1.58) | 0.35 | |
| Tumor type (metastatic vs. primary) | 1.16 (0.84–1.61) | 0.36 | |
| ETS1b | 0.82 (0.51–1.33) | 0.42 | |
| ETS2c | 1.65 (1.04–2.63) | 0.034 | |
| ETS3d | 1.43 (0.70–2.89) | 0.33 | |
| All patients | Age | 1.01 (0.998–1.02) | 0.10 |
| Race | |||
| Asian | 1.00 (–) | – | |
| White | 0.97 (0.74–1.26) | 0.79 | |
| Other | 1.27 (0.79–2.05) | 0.33 | |
| Unknown | 0.79 (0.49–1.28) | 0.34 | |
| CT yes vs. no | 1.32 (1.04–1.67) | 0.021 | |
| Subtype | |||
| Luminal A | 1.00 (–) | – | |
| Luminal B | 1.42 (1.06–1.91) | 0.019 | |
| HER2E | 2.66 (1.82–3.88) | <0.0001 | |
| Basal-like | 2.26 (1.19–4.28) | 0.013 | |
| ECOG PS 1 vs. 0 | 1.52 (1.26–1.83) | <0.0001 | |
| De novo disease vs. not | 0.72 (0.51–1.01) | 0.060 | |
| Visceral disease vs. not | 1.26 (1.01–1.59) | 0.045 | |
| Bone only vs. not | 1.11 (0.83–1.47) | 0.48 | |
| Histologic grade | |||
| Poorly differentiated/undifferentiated histologic grade | 1.28 (1.04–1.59) | 0.021 | |
| Unknown histologic grade | 1.31 (1.03–1.68) | 0.028 | |
| Well-differentiated histologic grade | 0.89 (0.63–1.25) | 0.49 | |
| No. of metastatic sites ≥3 vs. fewer | 1.14 (0.93–1.39) | 0.22 | |
| Tumor type (metastatic vs. primary) | 1.15 (0.94–1.42) | 0.17 | |
| ETS1b | 0.76 (0.55–1.05) | 0.093 | |
| ETS2c | 1.40 (1.04–1.89) | 0.026 | |
| ETS3d | 1.33 (0.87–2.01) | 0.19 | |
| Treatment (ribociclib vs. placebo) | 0.77 (0.60–0.99) | 0.039 | |
| Treatment*luminal B | 0.83 (0.55–1.25) | 0.36 | |
| Treatment*HER2E | 0.69 (0.42–1.12) | 0.13 | |
| Treatment*basal-like | 3.62 (1.51–8.69) | 0.004 | |
Abbreviations: CT, chemotherapy; ECOG PS, Eastern Cooperative Oncology Group performance status; ET, endocrine therapy; ETS, ET sensitive; HER2E, human epidermal growth factor receptor 2–enriched.
aObtained from multivariable Cox model including age, race, prior chemotherapy, ECOG PS, presence of visceral disease (liver/lung metastases), presence of bone-only metastases, histological grade, number of metastatic sites, prior ET, presence of de novo metastatic disease, and tumor type (primary or metastatic) as covariates.
bETS1 includes patients considered ET sensitive who exhibited progression >12 months after end of ET.
cETS2 includes patients considered ET sensitive who exhibited progression at or within 12 months of end of ET.
dETS3 includes patients who received second-line ET.