Table 1.
Patient and tumor characteristics (n =1843)
| Parameter | Treatment | |||
|---|---|---|---|---|
| Trastuzumab monotherapy | Trastuzumab plus chemotherapy | Trastuzumab plus endocrine therapy only | Total | |
| Number of patients | 228 (12%) | 1346 (73%) | 269 (15%) | 1843 (100%) |
| Age | ||||
| Median (range) [years] | 59.8 (31 – 91) | 58.8 (21 – 87) | 61.8 (31 – 95) | 59.5 (21 – 95) |
| >65 years | 26% | 26% | 36% | 28% |
| >70 years | 16% | 13% | 20% | 14% |
| ECOG performance status | ||||
| 0 | 29% | 30% | 37% | 31% |
| 1 | 56% | 55% | 51% | 54% |
| 2 | 13% | 13% | 11% | 13% |
| 3-4 | 2% | 2% | 1% | 2% |
| Tumor grade | ||||
| G1 | 2% | 3% | 5% | 3% |
| G2 | 49% | 42% | 49% | 44% |
| G3 | 49% | 55% | 46% | 53% |
| M1 disease at primary diagnosis | 24% | 26% | 28% | 26% |
| Relapse-free interval, median [years] | 2.0 | 2.2 | 2.6 | 2.2 |
| Hormone receptor status* | ||||
| Estrogen-receptor positive | 41% | 54% | 84% | 57% |
| Progesterone-receptor positive | 34% | 47% | 68% | 48% |
| At least one positive | 44% | 58% | 87% | 61% |
| Metastatic sites at onset of trastuzumab treatment | ||||
| 0 | 18% | 7% | 14% | 10% |
| 1 | 45% | 42% | 52% | 44% |
| 2 | 25% | 33% | 23% | 31% |
| 3 | 8% | 13% | 9% | 12% |
| ≥4 | 4% | 5% | 1% | 4% |
| Organ site involvement | ||||
| Liver | 34% | 45% | 25% | 41% |
| Lung | 26% | 34% | 21% | 31% |
| Bone | 41% | 45% | 55% | 46% |
| Central nervous system | 8% | 5% | 2% | 5% |
| Pleural effusion | 9% | 12% | 9% | 11% |
| Ascites | 1% | 2% | 1% | 1% |
| Other | 20% | 20% | 19% | 20% |
| Previous treatment | ||||
| Radiotherapy | 68% | 63% | 67% | 64% |
| Adjuvant chemotherapy | 62% | 61% | 54% | 60% |
| Adjuvant endocrine therapy | 30% | 42% | 60% | 43% |
| Palliative chemotherapy | 52% | 36% | 35% | 38% |
| Palliative endocrine therapy | 19% | 28% | 51% | 30% |
| Received anthracycline and taxane | 48% | 37% | 46% | 40% |
| Received trastuzumab | 20% | 7% | 13% | 9% |
| No. of previous palliative chemotherapy regimens (n =692**) | ||||
| 1 | 53% | 56% | 63% | 57% |
| 2 | 20% | 24% | 21% | 23% |
| 3 | 14% | 10% | 9% | 11% |
| 4 | 12% | 8% | 5% | 8% |
| LVEF, median (range) [%] | 65 (30 – 82) | 65 (35 – 95) | 65 (40 – 98) | 65 (30 – 98) |
* unknown in 5% of patients, ** population with palliative cytotoxic pretreatment.
Abbreviations: ECOG Eastern Cooperative Oncology Group, LVEF Left ventricular ejection fraction.