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Sorafenib shows modest improvement in PFS for NSCLC patients

Use of sorefenib led to a modest improvement in progression-free survival for patients with advanced non–small cell lung cancer, according to results from a double blind, placebo controlled phase 3 trial.

“The improvement in PFS was modest and there was no improvement in [overall survival (OS)], although an imbalance in post-treatment therapy may have played a role, with 56% of placebo patients and 44% of sorafenib patients receiving one or more post-treatment regimens,” Luis Paz-Ares, MD, PhD, from Seville University Hospital in Spain, said in a press release issued by the International Association for the Study of Lung Cancer. “The biomarker results of this trial were intriguing, suggesting that EGFR mutation may be a predictive biomarker for the efficacy of sorafenib in patients with advanced NSCLC.”

Paz-Ares and colleagues evaluated data from 353 patients who received 400 mg of sorafenib after two to three prior treatment regimens and compared the results with patients who received placebo and supportive care, according to the abstract. The researchers also analyzed whether patients had an EGFR or KRAS mutation using tumor DNA results from blood samples.

There was a similar median OS in both groups (sorafenib group median OS = 8.2 months; placebo group median OS = 8.3 months; HR = 0.99; 95% CI, 0.84–1.17). The median PFS in the sorafenib group was 2.8 months vs. 1.4 months in the placebo group (HR = 0.61; 95% CI, 0.51–0.72), and the time to progression was 2.9 months in the sorafenib group compared with 1.4 months in the placebo group (HR = 0.54; 95% CI, 0.45–0.65), according to the abstract.

For the 89 patients with an EGFR mutation, the OS was significantly higher in the sorafenib group (13.9 months) vs. the placebo group (6.5 months) (HR = 0.48; 95% CI, 0.30–0.76). PFS was also significantly higher in the sorafenib group (2.7 months) compared with the placebo group (1.4 months) (HR = 0.27; 95% CI, 0.16–0.46), according to the researchers. Although OS was similar in patients with wild-type or mutated KRAS receiving either sorafenib or placebo, the PFS was significantly higher in these patients who were receiving sorafenib.

“However, our biomarker results should be interpreted with caution, since the subgroup of patients with available samples for biomarker analysis constituted only 47%, and was not representative of the overall study population,” Paz-Ares said in the association-issued press release. “Additionally, post-study anti-EGFR [tyrosine kinase inhibitor] treatment was more frequently given to patients assigned to the sorafenib arm.” – by Jeff Craven

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