Foco cáncer de pulmón y oncología gastrointestinal

Foco cáncer de pulmón y oncología gastrointestinal Foco cáncer de pulmón y oncología gastrointestinal

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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

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

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