In a nutshell
This study compared the effectiveness and safety of nivolumab (Opdivo) and docetaxel (Taxotere) for the treatment of advanced squamous-cell non-small-cell lung cancer (NSCLC). The study concluded that nivolumab is more effective and safer than docetaxel for this type of cancer.
PD-L1 is a protein that decreases the activity of the immune system by blocking certain types of immune cells. This protein is present in some NSCLC tumors. Nivolumab is a drug used to stop the immune cells from interacting with PD-L1, therefore restoring the immune response.
Docetaxel is a chemotherapy often used as treatment for advanced NSCLC. Chemotherapy can cause a high number of side effects. Nivolumab may lead to fewer negative side effects than docetaxel.
Methods & findings
The study included 260 patients with advanced squamous cell NSCLC. The patients were randomly assigned to one of two groups. 131 patients in group 1 were treated with nivolumab. 129 patients in group 2 were treated with docetaxel. Patients were followed for an average of 11 months.had regular follow ups and overall survival (OS), objective response rate (ORR – patients with tumors that decrease by at least 50%) progression free survival (PFS-time following treatment before disease progresses) and adverse side effects were reported.
Overall survival (time from treatment until death from any cause) was 9.2 months for group 1 compared to 6 months in group 2. Average objective response rate (patients with tumors that decreased by at least 50%) was 20% for group 1 and 9% for group 2. Progression-free survival (time from treatment until disease progression) was 3.5 months for group 1 and 2.8 months for group 2.
In group 1, 58% patients had adverse effects, and 7% were severe. In group, 2 86% of patients had adverse effects and 55% were severe. The main side effects reported from both groups included fatigue, nausea, decreased appetite, hair loss, low levels of immune cells and weakness.
The bottom line
Nivolumab has better activity in patients with advanced squamous NSCLC and has a better safety profile than docetaxel.
The fine print
This study was funded in part by Bristol-Myers Squibb, the manufacturers of nivolumab.
Patients with advanced squamous cell NSCLC should speak to their doctor regarding nivolumab.
Published By :
The New England Journal of Medicine
May 31, 2015