Table 1.
Baseline characteristics of the 234 women included in the biomarker analysis of EGF100151 clinical trial
| Subset population |
Overall phase III Triala |
|||
| Characteristic | Capecitabine 2500 mg/m2, (n = 125) | Lapatinib 1250 mg plus capecitabine 2000 mg/m2 (n = 109) | Capecitabine 2500 mg/m2 (n = 161) | Lapatinib 1250 mg plus capecitabine 2000 mg/m2 (n = 163) |
| Age, year | ||||
| Median | 50 | 53 | 51 | 54 |
| Range | 28–80 | 26–80 | 28–83 | 26–80 |
| ECOG performance status, n (%) | ||||
| 0 | 85 (68) | 72 (66) | 89 (57) | 96 (61) |
| 1 | 40 (32) | 37 (34) | 68 (43) | 61 (39) |
| Hormone receptor status, n (%) | ||||
| ER+ or PR+ | 60 (48%) | 47 (43%) | 75 (47%) | 78 (48%) |
| ER− and PR− | 58 (46) | 56 (51) | 80 (50) | 80 (49) |
| Unknown | 7 (6) | 6 (6) | 6 (4) | 5 (3) |
| Stage of disease, n (%) | ||||
| IIIB or IIIC | 6 (5) | 4 (4) | 7 (4) | 7 (4) |
| Metastatic | 119 (95) | 105 (96) | 154 (96) | 156 (96) |
| N of advanced or metastatic sites, n (%) | ||||
| <3 | 74 (59) | 59 (54) | 81 (50) | 84 (52) |
| ≥3 | 51 (41) | 50 (46) | 80 (50) | 79 (48) |
| Advanced or metastatic sites, n (%) | ||||
| Visceral | 96 (77) | 78 (72) | 124 (77) | 125 (77) |
| Non-visceral only | 29 (23) | 31 (28) | 37 (23) | 38 (23) |
| Duration of trastuzumab therapy, week | ||||
| Median | 47 | 49 | 44 | 42 |
| Range | 0–329 | 3–296 | 5–329 | 3–296 |
| Median overall response,% (95% CI) | 17 (10–27) | 33 (23–43) | 14 (9–21) | 22 (16–29) |
| Median time to tumor progression, months | 4.0 | 7.6 | 4.4 | 8.4 |
| HR (95% CI) | 0.51 (0.34–0.76) | 0.49 (0.34–0.71) | ||
| P-valueb | <0.001 | <0.001 | ||
CI, confidence interval; ECOG, Eastern Cooperative Oncology Group; ER, estrogen receptor; PR, progesterone receptor.
a
Data from reference [11].
bP-value calculated from log-rank test.