Esbriet Reduces Risk of Acute Flares Following Cancer Removal Surgery in IPF Patients, Study Finds

Treatment with Esbriet (pirfenidone) before and after cancer removal surgery reduces the risks of acute flares following the procedure in people with idiopathic pulmonary fibrosis (IPF) and lung cancer, a study finds.

The findings were reported in “Perioperative pirfenidone treatment for lung cancer patients with idiopathic pulmonary fibrosis,” a study published in the journal Surgery Today.

IPF is a chronic lung disease of unknown origin that leads to the formation of scar tissue in the lungs, making it hard for patients to breathe. During the course of the disease, many people with IPF experience acute exacerbations that may lead to severe respiratory failure and death.

People with IPF are known to have an increased risk of developing lung cancer. Further, patients with both conditions “often suffer acute exacerbation (AE) after lung resection [removal],” according to the researchers.

“Postoperative AE is the leading cause of death after lung cancer surgery and associated with mortality rates of 33.3–100%,” they said.

Due to this risk, a prophylactic, or preventive treatment is urgently needed to reduce the risks of complications following cancer removal surgery in people with IPF. Recent studies have suggested that treatment with Esbriet before patients undergo surgery “may reduce the incidence of AE without reducing curability.”

Esbriet, marketed by Genentech, is an approved antifibrotic medication that reduces lung tissue scarring by cutting down the production of a pro-inflammatory molecule called transforming growth factor-beta (TGF-β). It is one of the medications currently recommended to manage the symptoms of IPF, and slow disease progression.

In this study, investigators from the University of Occupational and Environmental Health in Japan reported the findings of a retrospective review evaluating the efficacy and feasibility of perioperative pirfenidone (Esbriet) treatment (PPT) in people with IPF and lung cancer. Perioperative means around the time of surgery, with treatment usually lasting from the time the patient goes into the hospital or doctor’s office for surgery until the time the patient goes home.

The team reviewed data from 100 people with IPF who were diagnosed with lung cancer and had surgery between January 2011 and April 2018 to remove the primary tumor. Among these patients, 28 were treated with pirfenidone before and after surgery (the PPT group), while 72 did not receive any pirfenidone treatment (the non-PPT group).

The Japanese Association for Chest Surgery (JACS) risk score was used to calculate the risk each individual had of experiencing an acute flare after surgery. The incidence of postoperative acute flares was compared between patients from the PPT and non-PPT groups who had similar JACS risk scores.

The JACS risk score was found to be higher among those who were treated with Esbriet before and after surgery, compared with those who did not receive treatment (mean score of 10.9 versus 9.4).

Among those who had a less than 10% chance of having acute flares after surgery — the low-risk group based on the JACS risk score — the incidence of such flares within the first 30 and 90 days following surgery was slightly higher for patients from the non-PPT group, compared with those from the PPT group — 6.5% versus 0%.

However, for individuals who had a 10-25% chance of acute flares after surgery — the intermediate-risk group — and those with a more than 25% chance — the high-risk group — the incidence of acute flares was much higher among those who never received Esbriet than in those who did. The incidence of acute flares within the first 30 days after surgery was 19.5%  among those not taking Esbriet versus 4.5% among those who did take the medication. Within the for first 90 days after surgery, the incidence of acute flares was 24.4% among those not given Esbriet versus 4.5% among those who were.

No serious treatment-related adverse events were observed in any of the patients.

“This suggests that pirfenidone may help lower the risk of postoperative AE even in higher-risk patients, at least in the short-term following surgery,” the researchers said.

“PPT is also feasible for lung cancer patients with IPF because of the lack of pirfenidone-related postoperative complications and serious preoperative events, consistent with previous reports,” they added.

A Phase 3 trial (PIII-PEOPLE study) is currently underway in Japan to confirm the effects of Esbriet on the prevention of postoperative acute flares in people with IPF and non-small cell lung cancer (NSCLC).