易瑞沙的发展历程.pptVIP

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易瑞沙的发展历程.ppt

* * * * * * 60 % + ve for mutation out of 437 pts tested 437/683 64%could be evaluated for mut gene copy number interaction test: P = .0437 IHCP=0.21 * * * * * The time to event was calculated from the date of first dose to the earliest date of the following events occurring on randomised treatment; CTC grade 3 or 4 AE, worsening from baseline in any laboratory parameter to a CTC grade 3?or 4, or death. * The US IDEAL 2 study recruited a difficult to treat patient population – refractory symptomatic patients who had failed 2 or more previous chemotherapy regimens The rest of world (including Japan) IDEAL 1 study included less refractory patients who had failed 1 or more previous chemotherapy regimens In both IDEAL 1 and IDEAL 2 outcomes were not improved by dosing at 500 mg compared with 250 mg gefitinib daily. References Fukuoka M et al. J Clin Oncol 2003; 21: 2237-2246. Kris MG et al. JAMA 2003; 290: 2149-2158. * * * Reck et al, 2010; Pirker et al, 2009; Lynch et al 2010; Cappuzzo et al 2010; Lee ASCO 2010 abtsr 7504; Gridelli ASCO 2010 abstr 7508; Scagliotti et al 2008; Sandler et al 2010 E4599: Further, in a pre-planned retrospective analysis of E4599 patients with adenocarcinoma histology, bevacizumab increased median OS by 3.9 months from 10.3 months to 14·2 months (HR 0·69). A total of 68.8% of patients had adenocarcinoma histology. * * There was a large amount of subsequent treatment and these treatments differed between randomised groups making overall survival results difficult to interpret. The true effect of the initial randomised first-line treatment on overall survival is likely to have been confounded. In particular, 64% of patients with EGFR mutation-positive tumours randomised to carboplatin/paclitaxel subsequently received an EGFR TKI. 57% of patients with EGFR mutation-negative tumours randomised to gefitinib subsequently received carboplatin/paclitaxel. For patients of unknown EGFR mutation status (64% of the ITT population), fewer pati

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