Table 1.
Characteristics of patients and treatment received
| Characteristic | Derivation sample (n = 197)a |
|---|---|
| Median age (range) | 53 (26–80) |
| ECOG performance status | |
| 0 | 61.3 % |
| 1 | 38.7 % |
| Missing | 1.5 % |
| Mean baseline Hb [g/dL] (SD) | 12.4 (1.4) |
| Mean baseline WBC [× 109 cells/l] | 5.9 (2.4) |
| Mean baseline platelets [× 109 cells/l] | 243 (79) |
| Median num of metastatic sites (range) | 2 (1–7) |
| Metastatic sites | |
| Liver | 53.8% |
| Bone | 46.2 % |
| Lung | 45.7 % |
| Skin | 18.8 % |
| Brain | 4.1 % |
| Total number of cycles delivered | 1,617 |
| Median number of cycles (range) | 6 (1–36) |
| Grade 1 diarrhea in the prior cycle | 208 events |
| Concomitant 5HT3 antiemetics | In 15 cycles |
| Season treatment was started | |
| Spring | 22.8 % |
| Summer | 17.8 % |
| Fall | 30.0 % |
| Winter | 29.4 % |
| Development of grade ≥ 2 diarrhea | 93 events at median of six, 21 day cycles (5.8 % of cycles) |
| Development of grade ≥ 2 rash | 19 events at median of six, 21 day cycles (1.2 % of cycles) |
ECOG Eastern Cooperative Oncology Group, Hb hemoglobin, WBC white blood count
aPatients who actually received a starting dose of lapatinib (1,250 mg daily) and capecitabine (2,000 mg/m2/day on days 1–14 every 3 weeks) within the trial