Table 3. Univariate log-rank analyses.
| Patients | Deaths | 12-month survival (%) | Median survival (95% CI) | χ2LR, p (χ2W, p) | HR (95% CI) | |
|---|---|---|---|---|---|---|
| Overall survival | 653 | 612 | 17 | 4.7 (4.2, 5.1) | — | — |
| Trial | ||||||
| BB128 | 414 | 392 | 17 | 4.2 (3.6, 4.8) | 2.28, P=0.13 | 1.0 |
| BB193 | 239 | 220 | 18 | 5.4 (4.8, 6.0) | 0.88 (0.75, 1.04) | |
|
Demographics
| ||||||
| Age group (years) | ||||||
| <=63 | 343 | 320 | 21 | 5.1 (4.3, 5.8) | 4.42, P=0.036 | 1.0 |
| >63 | 310 | 292 | 13 | 4.3 (3.5, 4.9) | (7.55, P=0.006) | 1.18 (1.01, 1.39) |
| Ethnic group | ||||||
| White | 590 | 554 | 18 | 4.6 (4.1, 5.1) | 0.20, P=0.65 | 1.0 |
| Other | 62 | 57 | 12 | 5.2 (3.5, 6.0) | 1.06 (0.80, 1.41) | |
| Sex | ||||||
| Female | 285 | 267 | 18 | 4.9 (4.2, 5.8) | 0.73, P=0.39 | 1.0 |
| Male | 368 | 345 | 17 | 4.5 (3.9, 5.1) | 1.07 (0.91, 1.26) | |
| Treatment | ||||||
| Gemcitabine | 222 | 204 | 18 | 5.5 (4.7, 5.9) | 2.79, P=0.095 | 1.0 |
| Marimistat | 431 | 408 | 17 | 4.2 (3.5, 4.9) | 1.15 (0.98, 1.36) | |
|
Tumour information
| ||||||
| Cancer stage | ||||||
| Early (I/II) | 104 | 92 | 26 | 6.8 (5.7, 8.2) | 14.72, P<0.001 | 1.0 |
| Late (III/IV) | 543 | 514 | 16 | 4.1 (3.5, 4.7) | 1.53 (1.26, 1.86) | |
| Metastases | ||||||
| M0 | 194 | 176 | 30 | 6.8 (5.9, 8.4) | 35.47, P<0.001 | 1.0 |
| M1 | 436 | 414 | 12 | 3.5 (3.2, 4.0) | 1.69 (1.43, 1.99) | |
| Missing | 23 | 22 | 17 | 5.5 (4.9, 7.5) | 1.35 (0.88, 2.09) | |
| Lymph nodes | ||||||
| N0 | 243 | 226 | 20 | 5.5 (4.8, 6.0) | 6.73, P=0.035 | 1.0 |
| N1 | 251 | 240 | 18 | 4.5 (3.5, 5.4) | 1.19 (1.00, 1.43) | |
| Missing | 159 | 146 | 11 | 3.8 (3.2, 4.9) | 1.29 (1.04, 1.59) | |
| Tumour stage | ||||||
| Early (0/1/2) | 310 | 291 | 16 | 4.3 (3.7, 4.9) | 1.63, P=0.44 | 1.0 |
| Late (3/4) | 287 | 268 | 18 | 4.9 (4.2, 5.8) | 0.91 (0.77, 1.08) | |
| Missing | 56 | 53 | 18 | 5.8 (3.5, 7.9) | 0.87 (0.66, 1.16) | |
|
Serum chemistry and haematology
| ||||||
| AST (SGOT) | ||||||
| Normal | 538 | 499 | 19 | 5.1 (4.6, 5.7) | 14.17, P<0.001 | 1.0 |
| Abnormal | 86 | 84 | 12 | 2.8 (2.2, 3.9) | (5.99, P=0.014) | 1.55 (1.18, 2.04) |
| Total bilirubin | ||||||
| Normal | 464 | 429 | 20 | 5.1 (4.7, 5.7) | 9.32, P=0.002 | 1.0 |
| Abnormal | 165 | 159 | 11 | 3.8 (3.3, 4.4) | (6.27, P=0.012) | 1.32 (1.09, 1.61) |
| Alkaline phosphatase | ||||||
| Normal | 442 | 411 | 20 | 5.5 (5.0, 6.1) | 20.20, P<0.001 | 1.0 |
| Abnormal | 187 | 177 | 13 | 3.1 (2.6, 3.5) | (56.05, P<0.001) | 1.49 (1.23, 1.81) |
| Albumin | ||||||
| Normal | 583 | 544 | 19 | 5.1 (4.6, 5.6) | 31.37, P<0.001 | 1.0 |
| Abnormal | 45 | 43 | 7 | 1.5 (1.0, 2.7) | (74.34, P<0.001) | 2.36 (1.49, 3.72) |
| LDH | ||||||
| Normal | 543 | 505 | 20 | 5.2 (4.8, 5.8) | 37.05, P<0.001 | 1.0 |
| Abnormal | 78 | 75 | 5 | 2.1 (1.5, 2.8) | (36.16, P<0.001) | 2.08 (1.50, 2.88) |
| BUN | ||||||
| Normal | 407 | 382 | 20 | 5.1 (4.3, 5.7) | 3.43, P=0.064 | 1.0 |
| Abnormal | 213 | 199 | 13 | 4.4 (3.5, 5.1) | (5.28, P=0.022) | 1.17 (0.98, 1.40) |
| CA19/9 | ||||||
| Normal | 98 | 86 | 28 | 6.3 (4.8, 8.0) | 7.74, P=0.005 | 1.0 |
| Abnormal | 508 | 481 | 16 | 4.6 (4.0, 5.1) | (4.84, P=0.028) | 1.38 (1.12, 1.70) |
| Haemoglobin | ||||||
| Normal | 79 | 77 | 8 | 3.7 (3.3, 5.1) | 6.88, P=0.009 | 1.0 |
| Abnormal | 533 | 495 | 20 | 4.9 (4.4, 5.6) | (10.64, P=0.001) | 0.73 (0.55, 0.95) |
| WBC | ||||||
| Normal | 483 | 446 | 21 | 5.5 (4.9, 5.9) | 34.36, P<0.001 | 1.0 |
| Abnormal | 129 | 126 | 8 | 2.9 (2.4, 4.0) | (46.52, P<0.001) | 1.78 (1.40, 2.26) |
HR=hazard ratio; LR=log-rank statistic; W=Wald χ2 statistic.