Sorafenib increases progression-free survival (PFS), time to progression, and disease control rate in patients with non-small cell lung cancer (NSCLC) whose disease has relapsed or in whom 2 or 3 previous treatment regimens failed, a study published in the Journal of Thoracic Oncology has shown.

Sorafenib is a tyrosine kinase inhibitor (TKI) that targets the receptors for vascular endothelial growth factor (VEGF), platelet derived growth factor, and mast/stem cell growth factor.

NSCLC is the most common type of lung cancer. A number of treatment options are available for advanced NSCLC; however, the disease relapses after a period of clinical benefit or fails to respond to treatment in almost all patients. Further therapy is very limited after relapse or failure to respond to 2 previous conventional chemotherapeutic regimens.

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An international team of investigators from 33 countries in Europe, North and South America, and Asia-Pacific conducted the MISSION (Monotherapy admInistration of Sorafenib in patientS wIth nOn-small cell luNg cancer) trial—a phase 3, randomized, double-blind, placebo-controlled trial comparing sorafenib plus best supportive care (N=350) with best supportive care (N=353)—to evaluate the efficacy and safety of sorafenib in the third- or fourth-line setting. Primary end point was overall survival (OS), and PFS and other measures were secondary end points.

The results show median PFS was statistically increased in those receiving sorafenib vs those in the placebo group (2.8 months vs 1.4 months, respectively); however, OS was not different (8.2 months vs 8.3 months, respectively). Time to progression (2.9 months vs 1.4 months) and disease control rate (47.1% vs 24.7%) were greater in the sorafenib group compared with the placebo group, respectively.

In retrospective subgroup analyses, OS (13.9 months vs 6.5 months) and PFS (2.7 months vs 1.4 months) were significantly longer in epidermal growth factor receptor (EGFR) mutation positive patients receiving sorafenib (N=44) compared with those receiving placebo (N=45), respectively.

“The improvement in PFS was modest and there was no improvement in OS, although an imbalance in posttreatment therapy may have played a role, with 56% of placebo patients and 44% of sorafenib patients receiving 1 or more posttreatment regimens,” comment Dr. Luis Paz-Ares, lead author on the study.


1. International Association for the Study of Lung Cancer. Sorafenib modestly increases progression-free survival [news release]. Released November 9, 2015. Accessed November 10, 2015.