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 patients2931
Sex (no. of patients)0.361a
    Male2119
    Female812
Age, mean (S.D.) (years)63 (7)67 (8)0.123
ECOG performance status (no. of patients)0.008a
    0820
    11811
    230
Body surface area, mean (S.D.) (m2)1.59 (0.17)1.54 (0.15)0.333
Prior therapy0.438a
    None2727
    Chemoradiotherapy using 5-FU for LAPC24
Clinical stageb0.697a
    IVa23
    IVb2728
Subsequent line chemotherapy after gemcitabine0.045a
    None2927
    Yes04
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 response00
    Partial response01
    Stable disease222
    Progressive disease240
    Not evaluable38
  • 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.