ESCAPE: Addition of sorafenib to carboplatin and paclitaxel had no effect on survival in NSCLC

There was no statistically significant difference in OS or PFS for patients with advanced non–small cell lung cancer assigned to sorafenib in addition to carboplatin and paclitaxel, leading researchers to conclude that the oral multikinase inhibitor had no clinical utility with these patients in a first-line setting.

Evaluation of Sorafenib, Carboplatin and Paclitaxel Efficacy in NSCLC (ESCAPE), a multicenter, randomized, placebo-controlled, phase-3 trial, was stopped early after an independent Data Monitoring Committee determined in 2008 that it was unlikely that the trial would meet its primary endpoint.

More than 900 patients with malignant pleural or pericardial effusion stage IIIb or stage IV disease were recruited into the trial. All patients received paclitaxel and carboplatin followed by 400 mg oral sorafenib (n=464; Nexavar, Bayer) or placebo (n=462).

Median OS in the sorafenib arm was 10.7 months vs. 10.6 months for placebo (estimated HR=1.15; 95% CI, 0.94-1.41). Researchers said the difference was not statistically significant. Median PFS was 4.6 months for sorafenib compared with 5.4 months for placebo (HR=0.99; 95% CI, 0.84-1.16).

Overall response rate was 27.4% in the sorafenib arm and 24% in the placebo arm, as measured by RECIST guidelines. Clinical benefit, as assessed by disease control rate, was 50% in the sorafenib arm and 56% in the placebo arm.

Scagliotti G. J Clin Oncol. 2010;doi:10.1200/JCO.2009.26.1321.