A clinical trial evaluating the benefit of adding the drug sorafenib to the combination of carboplatin/paclitaxel chemotherapy for lung cancer patients has been stopped based on results from an interim analysis, after an independent data monitoring committee concluded that the study would not meet its primary endpoint of improved overall survival.
In a late-breaking abstract presented at the 1st European Lung Cancer Conference jointly organized by the International Association for the Study of Lung Cancer (IASLC) and the European Society for Medical Oncology (ESMO), Prof. Giorgio Scagliotti from the University of Torino, Italy presented data from the clinical trial stopped in February.
For some patients, the drug results in worse outcomes. "Based on a planned interim analysis the study showed a clear inferiority from adding sorafenib to carboplatin/paclitaxel in first-line non-small-cell lung cancer patients with squamous histology," Prof. Scagliotti said.
Sorafenib is an oral multikinase inhibitor with anti-angiogenic and antiproliferative activity. The drug, marketed as Nexavar by Bayer, is already approved for use in more than 40 countries for liver cancer and more than 70 countries for renal cell cancer.
The latest trial included 926 patients with unresectable stage IIIB/IV non-small-cell lung cancer who had received no prior systemic treatment. Patients were randomized to receive carboplatin plus paclitaxel, combined with either sorafenib 400 mg or placebo.
After a formal review of the ongoing study, the trial's data monitoring committee recommended termination. Preliminary results showed a median overall survival of 10.7 months in the sorafenib group vs 10.6 months in the placebo arm. Sorafenib-treated patients with squamous-cell non-small-cell lung cancer had a greater mortality rate than those with non-squamous histology.
"To date there is no evidence of any detrimental effect from sorafenib in additional subgroups of patients," Prof. Scagliotti said.
He noted that researchers are still studying the drug in lung cancer, including an ongoing study examining adding it to the combination of cisplatin and gemcitabine.