In a nutshell
This trial looked at the effectiveness of the immunotherapy nivolumab (Opdivo) for patients with advanced non-small-cell lung cancer (NSCLC). The authors concluded that nivolumab resulted in similar survival rates compared to chemotherapy. They did however state that it was safer in terms of side effects.
Some background
Chemotherapy has long been the treatment of choice for those with advanced NSCLC. However, the survival rate is moderate and side effects are common. Immunotherapy treatments are used to activate the immune system to kill cancer cells. Nivolumab (Opdivo) is an immunotherapy that acts on a protein called PD-1 to activate the immune system. Scientists are now exploring biomarkers which would show whether a patient would be more likely to benefit from immunotherapy than chemotherapy. So far, it is thought that patients with many genetic mutations (changes) would respond better to immunotherapy.
Methods & findings
This trial compared nivolumab to chemotherapy in patients with stage IV or recurrent NSCLC that have the PD-1 protein.
423 patients were included and treated with either nivolumab (group 1) or chemotherapy (group 2).
Average progression free survival (time from beginning trial until disease progression) was 4.2 months for patients in group 1 and 5.9 months for patients in group 2. Average overall survival (time from beginning trial until death from any cause) was 14.4 months for group 1 patients and 13.2 months for group 2 patients.
For patients with many genetic mutations, PFS was 9.7 months for group 1 patients and 5.8 months for group 2 patients. There was no significant difference in overall survival for this subgroup of patients.
Side effects occurred in 71% of group 1 patients compared to 92% of group 2 patients. Of these, 18% of group 1 patients experienced severe side effects, while 51% of group 2 patients experienced severe side effects.
The bottom line
The authors concluded that treatment with nivolumab did not result in longer PFS or greater OS than chemotherapy for patients with stage IV or recurrent NSCLC. However, they also stated that nivolumab had a more favorable safety profile.
The fine print
This study was funded in part by the manufacturers of nivolumab.
Published By :
The New England Journal of Medicine
Date :
Jun 22, 2017