Table 4

Response and survival to treament according to the group of treatment

LV5FU2-CDDPGemcitabine
Arm A N=102Arm B N=100p Value
n%n%
Best tumorous response in second lineN= 69N = 550.8*
 Complete response (CR)0012
 Partial response71035
 Stable disease19282138
 Progression25362138
 Not evaluable0012
 Unknown1826815
Best tumorous response in first lineN = 102N = 100
 Complete response (CR)3333
 Partial response12121616
 Stable disease33322929
 Progression27272525
 Not evaluable3311
 Unknown24242626
Overall best tumorous response
 Complete response (CR)3344
 Partial response16161818
 Stable disease39383737
 Progression24231717
 Not evaluable2211
 Unknown18182323
Progression-free survival (PFS)
 Median PFS in months (95% CI)3.4 (2.4 to 4.4)3.5 (2.4 to 4.1)0.67
 Median PFS in months (95% CI) after second line5.03 (4.3 to 5.9)5.8 (4.3 to 7.8)0.61
Overall survival (OS):
 Median OS in months (95% CI)6.7 (5.4 to 8.6)8.03 (5.9 to 9.8)0.83
 1 year OS28.8% (20.4% to 37.8%)32.7% (23.7% to 42.0%)
 2 years OS7.5% (3.2% to 14.1%)4.1% (1.3% to 9.4%)
Death949298
 Death without registered progression30293232
 Alive without registered progression3300
Second line
 Patients receiving a second line696855550.13*
 Second line due to progression456548870.006*
  • * χ2 or Fisher exact test.

  • Log-rank test.

  • LV5FU2-CDDP, 5-fluorouracil, folinic acid and cisplatin combinatio