A recent cardiovascular secondary prevention study has given researchers a unique opportunity: to explore the effectiveness of giving a drug to patients before cancer emerges. At the European Society of Cardiology meeting, Paul M. Ridker, MD, director of the Center for Cardiovascular Disease Prevention at BWH, and colleagues presented findings from CANTOS (Canakinumab Anti–inflammatory Thrombosis Outcomes Study). In addition to their cardiovascular results, Ridker and colleagues shared that patients who received the anti–inflammatory therapy canakinumab had a marked reduction in the incidence of lung cancer and lung cancer mortality. In this high–risk population, death from cancer was reduced by half in the group of people who received the highest dosage of the drug.

These findings were detailed in a paper published simultaneously in The Lancet.

“As an inflammatory biologist and cardiologist, my primary interest is in heart disease, but my colleagues and I were aware of experimental research indicating a connection between cancer and inflammation, and we recognized that our cardiovascular clinical trial could be the perfect place to explore this link,” said Ridker. “The data are exciting because they point to the possibility of slowing the progression of certain cancers. However, this is an exploratory study that needs replication.

CANTOS, designed by Ridker and his colleagues and sponsored by Novartis Pharmaceuticals, is a randomized, double–blinded trial of the anti–inflammatory drug canakinumab, with the primary goal of testing whether the drug lowered rates of heart attack, stroke and cardiovascular death. More than 10,000 patients with a history of heart attacks who had high levels of C–reactive protein (hsCRP) were enrolled in the study. None of the participants had been diagnosed with cancer.

Participants in the trial received 50 mg, 150 mg or 300 mg of canakinumab or a placebo, injected subcutaneously every three months. They were followed for up to five–and–a–half years. The researchers observed a marked cut in rates of total cancer death, but especially in death due to lung cancer, as well as in the incidence of lung cancer among patients who received the drug. This effect was dose–dependent – for example, lung cancer rates were reduced 26 percent, 39 percent and 67 percent, respectively, for the low, medium and high doses of canakinumab.

Patients who received the highest dose of the drug (300 mg) had approximately half the rate of total cancer deaths and one–quarter the rate of fatal lung cancer compared to those who received the placebo.

CANTOS evaluated participants with a history of heart attacks who were selected for elevated hsCRP, itself a risk marker for lung cancer. Ridker and colleagues knew that this population – many of whom were smokers – would be at high risk for lung cancer. Therefore, the team had formed an adjudication committee of leading cancer experts as part of their safety monitoring plan, in anticipation of cancer–relevant results.

The research team notes that it’s unlikely canakinumab directly prevents new lung cancers from developing – instead, they believe it’s more probable that the drug helps slow lung cancer progression and invasiveness, consistent with prior studies in animal models.

The team closely monitored for adverse events and found an increased risk of fatal infections among approximately one of every 1,000 patients treated. As reported at ESC, CANTOS met its primary cardiovascular endpoint, reducing risk of a composite of heart attack, stroke and cardiovascular death by 15 percent. The research team also found significant reductions in arthritis, gout and osteoarthritis, due to the drug’s anti–inflammatory properties.