Table 4 Comparative evaluation between the EMBRACE and the ERIBEX studies
EMBRACE | ERIBEX | |
|---|---|---|
Population | ||
Patients (n) | 503 (EM) | 258 |
Age (years) | 55 | 59 |
Triple-negative tumour (%) | 18 | 22.5 |
HER2+ tumour (%) | 16 | 10.2 |
Prior hormonal therapy (%) | 85 | 76.7 |
Prior anthracycline or taxane treatment (%) | 99 | 100 |
Prior capecitabine treatment (%) | 73 | 90.7 |
Median prior metastatic chemotherapies; n (range) | 4 (1–7) | 4 (1–9) |
Metastatic sites | ||
Bone (%) | 61 | 68.2 |
Liver (%) | 60 | 67.4 |
Node (%) | 44 | 45.7 |
Lung (%) | 38 | 38 |
Chemotherapy | ||
Median number of EM cycles (range) | 5 (1–23) | 5 (1–19) |
Efficacy | ||
Median overall survival (month, 95 %CI) | 13.1 | 11.2 (9.3–12.12 |
Median progression-free survival (month, 95 %CI) | 3.7 | 3.8 (3.2–4.2) |
Overall response rate (%) | 12 | 26 |
Clinical benefit rate | 23 | 36 |
Safety | ||
Side effects (grade 1–4, %) | 99 | 94.2 |
Side effects most commonly encountered | ||
Asthenia (%) | 54 | 60.9 |
Neutropenia (%) | 52 | 38.4 |
Peripheral Neuropathies (%) | 35 | 43 |
Nausea (%) | 35 | 10.5 |
Alopecia (%) | 45 | 19.4 |
Grade 3 toxicity (%) | 36.2 | 39.5 |
Grade 4 toxicity (%) | 27.2 | 17 |
Grade 3–4 neutropenia | 21 %/24 % | 20.9 % grade 3–4 |
Grade 3-/4 peripheral neuropathy | 8 %/<1 % | 3.9 % grade 3–4 |
Treatment discontinuation due to toxicity (%) | 13 | 13.1 |