Table 2 Tumour response (WHO) (Miller et al, 1981) (ITT and PP populations)

From: Gemcitabine, oxaliplatin and 5-FU in advanced bile duct and gallbladder carcinoma: two parallel, multicentre phase-II trials

 

BDC study

GBC study

 

ITT population Number (%) of evaluable patients ( n =37)

PP population Number (%) of evaluable patients ( n =34)

ITT population Number (%) of evaluable patients ( n =35)

PP population Number (%) of evaluable patients ( n =31)

CR

0 (0)

0 (0)

0 (0)

0 (0)

PR

7 (19)

7 (20)

8 (23)

8 (26)

NC

20 (54)

20 (59)

16 (46)

16 (52)

PD

6 (16)

6 (18)

6 (17)

6 (19)

Not assessable

4 (11)

1 (3)

5 (14)

1 (3)

Overall response (CR+PR)

7 (19)

7 (20)

8 (23)

8 (26)

Disease control (CR+PR+NC)

27 (73)

27 (79)

24 (69)

24 (77)

  1. Abbreviations: BDC=bile duct cancer; CR=complete response; GBC=gallbladder cancer; ITT population=intention-to-treat-population; NC=no change; PD=progressive disease; PR=partial response; PP population=per-protocol-population (both populations have been defined in the text; see ‘Statistical methods and analysis’ section).