Foco cáncer de pulmón y oncologÃa gastrointestinal
Foco cáncer de pulmón y oncologÃa gastrointestinal Foco cáncer de pulmón y oncologÃa gastrointestinal
Erlo2nib vs BSC in second line (BR.21): study design Stra2fied by: • Centre • PS 0/1 vs 2/3 • Response to prior Rx (CR/ PR:SD:PD) • Prior regimens (1 vs 2) • Prior pla2num (yes vs no) R A N D O M I S E Erlo@nib* 150 mg daily Placebo ‘150 mg’ daily *2.1 randomisa@on CR=complete response; PR=par@al response SD=stable disease; PD=progressive disease Shepherd, et al. NEJM 2005
Erlo2nib showed overall survival advantage in pre-‐treated NSCLC (BR.21) 100 Erlo@nib (n=488) Placebo (n=243) Survival probability (%) 75 50 25 Median survival (months) 6.7 4.7 HR=0.73 (0.60–0.87), p=0.001* 27% reduc@on in risk of death with erlo@nib 42.5% increase in median survival with erlo@nib 0 0 5 10 15 20 25 30 Survival @me (months) *Adjusted for stra@fica@on factors (except centre) and EGFR status Shepherd, et al. NEJM 2005 Tarceva SmPC
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Erlo2nib vs BSC in second line (BR.21): <br />
study <strong>de</strong>sign <br />
Stra2fied by: <br />
• Centre <br />
• PS 0/1 vs 2/3 <br />
• Response to prior Rx (CR/<br />
PR:SD:PD) <br />
• Prior regimens (1 vs 2) <br />
• Prior pla2num (yes vs no) <br />
R <br />
A <br />
N <br />
D <br />
O <br />
M <br />
I <br />
S <br />
E <br />
Erlo@nib* 150 mg daily <br />
Placebo ‘150 mg’ daily <br />
*2.1 randomisa@on <br />
CR=complete response; PR=par@al response <br />
SD=stable disease; PD=progressive disease <br />
Shepherd, et al. NEJM 2005