This trial was designed to understand whether we could risk stratify patients with early-stage lung cancer and determine who is at highest risk for recurring cancer, and then offer those patients a chance at chemotherapy. We’ve always known that cure is highest when you have early-stage cancer, and so after surgery chemotherapy has its standard role in the treatment of stage 2 and 3 non-small cell lung cancer.

Even early stage 2, like stage 2a cancers and stage 1a and 1b cancers, the decision to give chemotherapy can sometimes be different. This study was designed to use a gene classifier to identify patients at highest risk for their cancer to come back, and then ask the question would chemotherapy reduce that risk or not?

What was the methodology, and what were the findings?

This was a randomised trial designed to look at the endpoint of disease free survival. The study actually was stopped early by the Data Safety Monitoring Board because of the overwhelming DFS advantage at the two-year point. So recall patients on the study all had early-stage lung cancer, stage 1a, 1b, and 2a non-small cell lung cancer, importantly non-squamous cancer. They were then assessed using this 14-gene classifier and determined to have low-, intermediate-, or high-risk disease.

If you had low-risk scores, you weren’t included in the study, but if you had intermediate- or high-risk scores you were then entered into a randomised trial. Those patients either received four cycles of platinum doublet chemotherapy, or they were observed, standard of care.

This study again stopped early because the 24-month DFS was significantly in favour of the patients that got chemotherapy. The hazard ratio was 0.22 in favour of the group that got chemotherapy. In other words, there was a 78% reduction in the risk of recurrent disease or death if you received adjuvant chemotherapy compared with standard of care observation.

What are the clinical implications of these findings?

I think this is a tool now that can be used to gather more information in a conversation with patients and their families when someone has early-stage non-squamous non-small cell lung cancer and they’re trying to make a decision about is there a role for platinum doublet chemotherapy or not, this can provide other information to help patients make better informed decisions.

Is there anything else you would like to add?

Now that the test is available and is something that’s not so different from what is done in breast cancer, and colon and prostate cancer when you’re trying to assess someone’s risk of cancer coming back and helping them make that decision in an informed way about whether it’s worth doing additional therapy like chemotherapy or not.