Parameter | Gem+E/Cap (n=143) | Cap+E/Gem (n=131) | HR (95% CI) | p Value |
Median (months) | Median (months) | |||
TTF2 | 4.2 | 4.2 | 1.00 (0.78 to 1.28) | 1.0 |
TTF1 | 3.2 | 2.2 | 0.69 (0.54 to 0.89) | 0.0034 |
TTFc* † | 2.0 | 2.5 | 1.87 (1.31 to 2.66) | 0.00047 |
OS | 6.2 | 6.9 | 1.02 (0.79 to 1.31) | 0.90 |
OSc* † | 3.2 | 5.0 | 1.56 (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.