Table 5. OS in capecitabine and in BSC patients evaluated by log-rank test.
| Variable | Capecitabine treatment (N = 58) |
p-value # | No. patients (%) | BSC (N = 55) |
||||
|---|---|---|---|---|---|---|---|---|
| No. patients (%) | No. events | Median OS (95%CI) | No. events | Median OS (95%CI) | p-value # | |||
| Age | ||||||||
| < = 70 | 35 (60.3) | 27 (62.8) | 12 (8.6–15.1) | 0.1673 | 22 (40.0) | 19 (37.3) | 6.5 (4.2–13.9) | 0.1277 |
| >70 | 23 (39.7) | 16 (37.2) | 15.8 (9.7–22.8) | 33 (60.0) | 32 (62.7) | 10.8 (7.2–14.6) | ||
| Aetiology | ||||||||
| Non viral | 16 (27.6) | 8 (18.6) | 22.8 (13.9–28.5) | 0,0006 | 19 (34.6) | 17 (33.3) | 9.0 (6.0–13.9) | 0.4124 |
| Viral | 42 (72.4) | 35 (81.4) | 10.9 (8.6–13.0) | 36 (65.4) | 34 (66.7) | 8.2 (4.8–14.9) | ||
| Aetiology II | ||||||||
| HBV | 11 (18.9) | 10 (23.3) | 7.5 (5.6–10.7) | — | — | — | — | |
| Non viral + HCV | 47 (81.1) | 33 (76.7) | 15.1 (12.0–20.2) | 0.0001 | — | — | — | |
| Child-pugh score | ||||||||
| a | 52 (89.6) | 39 (90.7) | 12.0 (10.7–15.8) | — | 52 (94.5) | 48 (94.1) | 9.0 (7.2–13.9) | — |
| b | 6 (10.4) | 4 (9.3) | — | 3 (5.5) | 3 (5.9) | — | ||
| PS ECOG | ||||||||
| 0 | 40 (69.0) | 30 (69.8) | 12.0 (10.9–15.8) | 0.9904 | 34 (61.8) | 31 (60.8) | 13.9 (7.2–15.6) | 0.0063 |
| 1, 2 | 18 (31.0) | 13 (30.2) | 13.0 (8.2–22.8) | 21 (38.2) | 20 (39.2) | 6.7 (3.9–8.2) | ||
| Portal hypertension | ||||||||
| No | 44 (75.9) | 33 (76.7) | 13.0 (10.9–19.7) | 0.8785 | 35 (63.6) | 33 (64.7) | 9.0 (4.7–14.6) | 0.6907 |
| Yes | 14 (24.1) | 10 (23.3) | 8.5 (6.8–26.3) | 20 (36.4) | 18 (32.3) | 8.2 (6.0–14.0) | ||
| Meld index | ||||||||
| < = 10 | 23 (79.3) | 18 (75.0) | 12 (8.2–20.2) | 0.7075 | 44 (80.0) | 41 (80.4) | 10.8 (7.2–14.6) | 0.0027 |
| > 10 | 6 (20.7) | 6 (25.0) | 8.1 (4.1-NE) | 11 (20.0) | 10 (19.6) | 4.7 (1.3–10.4) | ||
| LDH | ||||||||
| < = 220 | 16 (50.0) | 11 (52.4) | 12 (8.8–20.1) | 0.3531 | 15 (37.5) | 14 (37.8) | 15.6 (7.2–20.9) | 0.0041 |
| > 220 | 16 (50.0) | 10 (47.6) | 12 (8.5-NE) | 25 (62.5) | 23 (62.2) | 7.2 (4.8–13.9) | ||
| Sorafenib duration (months) | ||||||||
| < = 3 months | 29 (50.0) | 19 (44.2) | 10.9 (8.8–13.7) | 0.0211 | 42 (76.4) | 39 (76.5) | 7.2 (5.0–9.0) | 0.0566 |
| > 3 months | 29 (50.0) | 24 (55.8) | 15.8 (10.7–20.2) | 13 (23.6) | 12 (23.5) | 15.8 (13.9–19.0) | ||
| Best overall response | ||||||||
| PD | 31 (53.5) | 24 (55.8) | 9.1 (8.2–11.7) | 0.0001 | 39 (70.9) | 37 (72.5) | 6.7 (4.7–9.0) | 0.0004 |
| SD + PR + CR | 27 (46.5) | 19 (44.2) | 20.7 (13.0–25.0) | 16 (29.1) | 14 (27.5) | 15.8 (13.9–20.9) | ||
| Stage BCLC | ||||||||
| b | 7 (12.1) | 6 (14.0) | 20.2 (6.6-NE) | 0.8944 | 10 (18.2) | 10 (19.6) | 15.8 (3.8–23.3) | 0.0006 |
| c | 51 (87.9) | 37 (86.0) | 12.0 (10.7–15.8) | 45 (81.8) | 41 (80.4) | 7.2 (5.2–11.8) | ||
| Pre-treatment AFP | 21 (42.9) | 19 (42.2) | 7.2 (4.7–13.9) | 0.2553 | ||||
| < = 400 | 30 (60.0) | 22 (57.9) | 12.0 (9.1–15.8) | 0.7363 | 28 (57.1) | 26 (57.8) | 9.0 (6.2–15.8) | |
| > 400 | 20 (40.0) | 16 (42.1) | 10.9 (7.5–19.7) | |||||