In a nutshell
This trial examined whether the anti-cancer drug axitinib (Inlyta) is safe and effective in combination with chemotherapy for the treatment of advanced squamous non-small-cell lung cancer (NSCLC). The authors conclude that axitinib is safe and has anti-tumor activity.
Some background
Vascular endothelial growth factor (VEGF) is a protein in the body that can contribute to cancer spreading. Some treatments can specifically target VEGF, such as axitinib. For patients with squamous cell NSCLC, chemotherapy using two agents is the first line of treatment (doublet chemotherapy). Previous studies have shown that other treatments targeting VEGF, such as bevacizumab (Avastin) combined with chemotherapy resulted in an increased survival benefit for patients with advanced squamous cell NSCLC, but with high rates of toxic side effects. The most serious of these side effects was fatal pulmonary hemorrhage (bleeding from the lung). The safety and effectiveness of axitinib combined with chemotherapy is not yet known.
Methods & findings
This study aimed to determine whether axitinib was safe for use in combination with chemotherapy. 38 patients with advanced squamous cell NSCLC were selected and treated with axitinib and doublet chemotherapy.
The objective response rate (response to treatment) was 39.5%. One patient had a complete response (disappearance of the tumor) and 14 (36.8%) had a partial response (more than 30% decrease in tumor size). 9 (23.7%) patients had stable disease and 3 (7.9%) patients had disease progression.
Progression free survival (time from beginning trial to disease progression/death) was an average of 6.2 months. Overall survival (time from beginning trial to death) was an average of 14.2 months. The authors estimated the probability of survival after 2 years as 30.8%.
94.7% of patients reported side effects such as nausea, vomiting, weight loss, hypertension (high blood pressure), anemia (reduced red blood cells) and neutropenia (reduced white blood cells). The most serious side effects were neutropenia and hypertension.
Three patients experienced pulmonary hemorrhage, one of which was fatal.
The bottom line
The authors concluded that combining axitinib with chemotherapy has anti-tumor activity. Side effect levels are comparable with previously reported levels of chemotherapy.
The fine print
This study did not include a group treated by chemotherapy alone for comparison.
This study was funded by Pfizer, the manufacturers of axitinib.
Published By :
BMC cancer
Date :
May 01, 2015
