Table 1.
Baseline characteristics
| Cediranib group (n=62) | Placebo group (n=62) | |||
|---|---|---|---|---|
| Age (years) | 68·0 (60·4–73·0) | 64·5 (59·7–73·1) | ||
| Sex | ||||
| Female | 28 (45%) | 34 (55%) | ||
| Male | 34 (55%) | 28 (45%) | ||
| Primary tumour site | ||||
| Cholangiocarcinoma | 38 (61%) | 39 (63%) | ||
| Intrahepatic | 14 (23%) | 15 (24%) | ||
| Extrahepatic | 24 (39%) | 24 (39%) | ||
| Gallbladder | 20 (32%) | 19 (31%) | ||
| Ampulla | 4 (6%) | 4 (6%) | ||
| Histological grade | ||||
| Well differentiated | 26 (42%) | 27 (44%) | ||
| Moderately differentiated | 20 (32%) | 21 (34%) | ||
| Poorly differentiated | 13 (21%) | 13 (21%) | ||
| Not specified | 3 (5%) | 1 (2%) | ||
| Previous treatment | ||||
| Adjuvant chemotherapy | 2 (3%) | 1 (2%) | ||
| Other* | 23 (37%) | 22 (35%) | ||
| None | 37 (60%) | 39 (63%) | ||
| ECOG performance status | ||||
| 0 | 27 (44%) | 28 (45%) | ||
| 1 | 35 (56%) | 34 (55%) | ||
| Disease status | ||||
| Locally advanced | 12 (19%) | 8 (13%) | ||
| Metastatic | 50 (81%) | 54 (87%) | ||
| Liver | 36 (58%) | 34 (55%) | ||
| Peritoneum | 19 (31%) | 5 (8%) | ||
| Omentum | 5 (8%) | 4 (6%) | ||
| Lung | 6 (10%) | 9 (15%) | ||
| CA19-9 (IU/mL)† | 298 (38–2258) | 53 (10–492) | ||
Data are median (IQR) or n (%). ECOG=Eastern Cooperative Oncology Group.
*
33 patients had surgery only (16 in the cediranib group and 17 in the placebo group) and 12 had surgery plus biliary stent insertions (seven in the cediranib group and five in the placebo group).
†
CA19-9 was assessable in 59 patients in each group.