Table 3.
Overall |
Rash subgroup |
|||
---|---|---|---|---|
Erlotinib (N=334) | Placebo (N=313) | Erlotinib (N=178) | Placebo (N=278) | |
Mean OS (months) | 7.08 (0.48) | 6.41 (0.44) | 9.08 (0.65) | 6.91 (0.43) |
Mean PFS (months) | 4.95 (0.36) | 3.80 (0.29) | 6.22 (0.51) | 4.19 (0.32) |
Mean PPS (months) | 2.13 (0.250) | 2.61 (0.236) | 2.86 (0.41) | 2.72 (0.27) |
HR (OS) | 0.92 | 0.76 | ||
(95% CI; p value) | (0.79 to 1.08; p value=0.32) | (0.63 to 0.92; p value=0.005) | ||
HR (PFS) | 0.81 | 0.66 | ||
(95% CI; p value) | (0.70 to 0.95; p value=0.0102) | (0.54 to 0.80; p value<0.0001) | ||
Utilities | ||||
Preprogression EQ-5D (mean, SE) | 0.6482 (0.009) | 0.6438 (0.011) | 0.6407 (0.017) | 0.6193 (0.015) |
Postprogression EQ-5D (mean, SE) | 0.5517 (0.016) | 0.5760 (0.014) | 0.5548 (0.0255) | 0.5756 (0.020) |
QALY (years)* | 0.365 (0.0272) | 0.3303 (0.0245) | 0.487 (0.0432) | 0.3472 (0.0260)† |
Incremental QALY (mean SE)‡ | 0.035 (0.0163) | 0.139 (0.0113) |
*This is computed as (preprogression utility)×PFS+(postprogression utility)×PPS.
†Statistically different between erlotinib and placebo (p value: 0.0070).
‡Erlotinib versus placebo.
PFS, progression-free survival; PPS, postprogression survival; OS, overall survival.