Table I. Clinical and laboratory data of patients with short term or long term survival.
Survival time was calculated from the date of starting gemcitabine therapy until the date of death from cancer. Wilcoxon test was applied to assess differences in values. 5-FU, 5-fluorouracil; LAPC, locally advanced pancreatic cancer; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; Cmax, peak concentration; AUC, area under the curve.
| Short term survivor (<100 days) | Long term survivor (>400 days) | p | |
|---|---|---|---|
| No. of patients | 29 | 31 | |
| Sex (no. of patients) | 0.361a | ||
| Male | 21 | 19 | |
| Female | 8 | 12 | |
| Age, mean (S.D.) (years) | 63 (7) | 67 (8) | 0.123 |
| ECOG performance status (no. of patients) | 0.008a | ||
| 0 | 8 | 20 | |
| 1 | 18 | 11 | |
| 2 | 3 | 0 | |
| Body surface area, mean (S.D.) (m2) | 1.59 (0.17) | 1.54 (0.15) | 0.333 |
| Prior therapy | 0.438a | ||
| None | 27 | 27 | |
| Chemoradiotherapy using 5-FU for LAPC | 2 | 4 | |
| Clinical stageb | 0.697a | ||
| IVa | 2 | 3 | |
| IVb | 27 | 28 | |
| Subsequent line chemotherapy after gemcitabine | 0.045a | ||
| None | 29 | 27 | |
| Yes | 0 | 4 | |
| Leukocytes, mean (S.D.) (×103/mm3) | 7.6 (3.6) | 5.2 (1.3) | 0.002 |
| Platelets, mean (S.D.) (×104/mm3) | 24.5 (7.6) | 20.2 (4.6) | 0.020 |
| Hemoglobin, mean (S.D.) (g/dl) | 11.7 (1.6) | 11.7 (1.5) | 0.491 |
| Albumin, mean (S.D.) (g/dl) | 3.4 (0.4) | 3.7 (0.3) | 0.014 |
| Creatinine, mean (S.D.) (mg/dl) | 0.70 (0.23) | 0.68 (0.23) | 0.726 |
| AST, mean (S.D.) (IU/liter) | 40 (25) | 26 (15) | 0.010 |
| ALT, mean (S.D.) (IU/liter) | 51 (44) | 27 (19) | 0.037 |
| ALP, mean (S.D.) (units/liter) | 728 (632) | 337 (160) | 0.026 |
| Pharmacokinetic parameters of gemcitabine | |||
| Cmax, mean (S.D.) (μg/ml) | 24.02 (7.52) | 24.91 (6.22) | 0.610 |
| AUC, mean (S.D.) (h·μg/ml) | 10.24 (2.83) | 10.75 (2.32) | 0.270 |
| α1-Antitrypsin,c mean (S.D.) | 64.6 (66.8) | 16.9 (7.9) | 0.0003 |
| α1-Antichymotrypsin,c mean (S.D.) | 706.4 (416.0) | 389.0 (216.5) | 0.0005 |
| Tumor responsed | <0.0001a | ||
| Complete response | 0 | 0 | |
| Partial response | 0 | 1 | |
| Stable disease | 2 | 22 | |
| Progressive disease | 24 | 0 | |
| Not evaluable | 3 | 8 |
a Calculated by χ2 test.
b According to Ref. 23.
c Intensity of the corresponding peak measured by quantitative mass spectrometry.
d Evaluated after the first two cycles of gemcitabine monotherapy.