Table 6.
RR for ORR of arm A over arm B.
| CHARACTERISTICS | ARM A (45) | ARM B (38) | P-VALUE | ||
|---|---|---|---|---|---|
| NUMBER | % | NUMBER | % | ||
| Age (At time of metastases) | |||||
| 18–<40 | 2 | 4 | 3 | 7 | 0.09 |
| 40–<51 | 9 | 20 | 10 | 26 | 0.08 |
| 51–<65 | 16 | 36 | 14 | 37 | 0.15 |
| 65–70 | 18 | 40 | 11 | 30 | 0.06 |
| Age (median) | 53 | – | 50 | – | 0.9 |
| Body mass index (BMI) | |||||
| <25 | 0 | 0 | 22 | 58 | – |
| 25–29.9 | 0 | 0 | 16 | 42 | – |
| ≥30% | 45 | 100 | 0 | 0 | – |
| BMI (median) | 33 | – | 21 | – | 0.04 |
| Performance status (ECOG) | |||||
| 0 | 22 | 49 | 24 | 58 | 0.09 |
| 1 | 15 | 34 | 10 | 27 | 0.06 |
| 2 | 8 | 17 | 6 | 15 | 0.09 |
| Performance status (median) | 0 | – | 0 | – | 0.1 |
| Pathological classification | |||||
| Ductal | 41 | 91 | 32 | 84 | 0.06 |
| Lobular | 4 | 9 | 6 | 16 | 0.08 |
| Pathological grade | |||||
| 1 | 0 | 0 | 0 | 0 | – |
| 2 | 19 | 42 | 18 | 47 | 0.09 |
| 3 | 26 | 58 | 20 | 53 | 0.07 |
| Grade (median) | 3 | – | 3 | – | 0.1 |
| Initial stage (pathological) | |||||
| I–II | 15 | 33 | 10 | 27 | 0.06 |
| III | 14 | 31 | 13 | 34 | 0.09 |
| IV | 16 | 36 | 15 | 39 | 0.08 |
| Number of positive lymph node | |||||
| 0 | 2 | 4 | 2 | 5 | 0.1 |
| 1–3 | 13 | 29 | 8 | 21 | 0.07 |
| 4–9 | 14 | 31 | 10 | 26 | 0.08 |
| >9 | 3 | 7 | 4 | 11 | 0.06 |
| Unknown | 13 | 29 | 14 | 37 | 0.06 |
| Lymph node number (median) | 5 | – | 4.5 | 0.1 | |
| Metastases site | |||||
| Lung | 15 | 33 | 12 | 32 | 0.09 |
| Liver | 20 | 45 | 16 | 42 | 0.07 |
| Both | 5 | 11 | 3 | 8 | 0.08 |
| Bone | 1 | 2 | 2 | 5 | 0.06 |
| Bone and visceral | 4 | 9 | 5 | 13 | 0.06 |
| Receptor status: Her 2 neu | |||||
| Positive | 16 | 35 | 13 | 34 | 0.1 |
| Negative | 29 | 65 | 25 | 66 | 0.1 |
| Invasion | |||||
| Lymphatic | 14 | 31 | 18 | 47 | 0.06 |
| Vascular/Perineural | 10 | 22 | 12 | 31 | 0.06 |