Table 1.
Patient demographics and stratification and prognostic factors
| Lapatinib 1,250 mg QD plus vinorelbine 20 mg/m2 (N = 75) | Lapatinib 1,250 mg QD plus capecitabine 2,000 mg/m2 (N = 37) | |
|---|---|---|
| Patient demographics | ||
| Median age, years (range) | 57 (32–79) | 58 (36–83) |
| Ethnicity, n (%) | ||
| Hispanic or Latino | 11 (15) | 3 (8) |
| Not Hispanic or Latino | 64 (85) | 34 (92) |
| Median time since initial diagnosis, months (range) | 36.6 (1–178) | 24.3 (8–240) |
| ErbB2 (HER/neu) IHC status, n (%) | ||
| 0–1+ | 0 | 0 |
| 2+ | 6 (8) | 6 (16) |
| 3+ | 67 (89) | 31 (84) |
| Unknown | 2 (3)a | 0 |
| ErbB2 (HER/neu) FISH status, n (%) | ||
| Positive | 10 (13) | 7 (19) |
| Negative or borderline | 0 | 0 |
| Unknown | 65 (87) | 30 (81) |
| ErbB2 (HER/neu) CISH status, n (%) | ||
| Positive | 9 (12) | 4 (11) |
| Negative or borderline | 0 | 0 |
| Unknown | 66 (88) | 33 (89) |
| Estrogen receptor status, n (%) | ||
| Positive | 37 (49) | 19 (51) |
| Negative | 38 (51) | 18 (49) |
| Not available/unknown | 0 | 0 |
| Progesterone receptor status, n (%) | ||
| Positive | 25 (33) | 14 (38) |
| Negative | 50 (67) | 23 (62) |
| Not available/unknown | 0 | 0 |
| Stratification and prognostic factors | ||
| Receipt of prior therapy for advanced or MBC, n (%) | ||
| No | 27 (36) | 12 (32) |
| Yes | 48 (64) | 25 (68) |
| Visceral or non-visceral disease, n (%) | ||
| Visceral only | 29 (39) | 17 (46) |
| Bone only | 5 (7) | 1 (3) |
| Visceral and non-visceral | 41 (55) | 19 (51) |
| Stage at initial diagnosis, n (%) | ||
| 0–I | 7 (9) | 4 (11) |
| II (a–b) | 23 (31) | 12 (33) |
| III (a–c) | 31 (41) | 15 (40) |
| IV | 12 (16) | 6 (16) |
| Unknown | 2 (3) | 0 |
| Measureable disease, n (%) | ||
| Yes | 65 (87) | 31 (84) |
| No | 10 (13) | 6 (16) |
| Prior anticancer therapy, n (%) | ||
| Any therapy | 73 (97) | 37 (100) |
| Chemotherapy | 72 (96) | 35 (95) |
| Hormonal therapy | 29 (39) | 15 (41) |
| Immunotherapy | 0 | 0 |
| Biological therapy | 63 (84) | 32 (86) |
| Small-molecule targeted therapy | 2 (3) | 0 |
| Radiotherapy | 14 (19) | 5 (14) |
| Surgery | 70 (93) | 34 (92) |
| Unknown | 1 (1) | 0 |
aErbB2 (HER/neu) status was confirmed as positive by FISH in both cases. CISH chromogenic in situ hybridization; FISH fluorescence in situ hybridization; HER human epidermal growth factor receptor; IHC immunohistochemistry; MBC metastatic breast cancer; QD once daily