Table 3

Toxicities according to WHO criteria

NLV5FU2-CDDPGemcitabinep Value*
Line 1Arm AArm B
N=101N=96
 All toxicities80 (79%)61 (64%)0.018
 Haematological toxicities50 (50%)33 (35%)0.03
 Non-haematological toxicities54 (53%)44 (46%)0.317
 Nausea and vomiting13 (13%)8 (8%)0.359†
Line 2Arm BArm A
N=55N=69
 All toxicities38 (69%)51(74%)0.476
 Haematological toxicities18 (33%)40 (58%)0.004
 Non-haematological toxicities28 (51%)35 (51%)0.828
 Nausea and vomiting8 (15%)3 (4%)0.065†
Overall toxicities (lines 1 and 2)Arm AArm B
N=101N=96
 All toxicities87 (86%)77 (80%)0.256
 Haematological toxicities60 (59%)41 (43%)0.015
 Non-haematological toxicities70 (69%)60 (63%)0.311
 Nausea and vomiting14 (14%)15 (16%)0.748
 Toxicities grade 3/4Line 1Line 2p
LV5FU2-CDDPArm AArm B
N=69N=55
 All toxicities56 (81%)38 (69%)0.16
 Haematological toxicities41 (59%)18 (33%)0.004
 GemcitabineArm BArm A
N=55N=69
 All toxicities30 (55%)51(74%)0.017
 Haematological toxicities19 (35%)40 (58%)0.007

  • ↵* All two side Pearson tests without missing value modality.

  • ↵† All two-sided Fisher exact tests.

  • LV5FU2-CDDP, 5-fluorouracil, folinic acid and cisplatin combination.