Table 4

Treatment efficacy: time-to-event endpoints (ITT)

ParameterGem+E/Cap (n=143)Cap+E/Gem (n=131)HR (95% CI)p Value
Median (months)Median (months)
TTF24.24.21.00 (0.78 to 1.28)1.0
TTF13.22.20.69 (0.54 to 0.89)0.0034
TTFc* †2.02.51.87 (1.31 to 2.66)0.00047
OS6.26.91.02 (0.79 to 1.31)0.90
OSc* †3.25.01.56 (1.09 to 2.22)0.014
  • HR (with Cap+E/Gem sequence as reference throughout all comparisons).

  • *Exploratory analysis, †n=63/77.

  • Cap, capecitabine; E, erlotinib; Gem, gemcitabine; ITT, intention-to-treat analysis; OS, overall survival; OSc, overall survival after start of cross-over 2nd-line therapy; TTF1: time-to-treatment failure after 1st-line therapy; TTF2: time-to-treatment failure after 1st- and 2nd-line therapy; TTFc: time-to-treatment failure after start of cross-over 2nd-line therapy.