P3.04-029 A Prospective Randomized Trial of Perioperative Administration of Neutrophil Elastase Inhibitor in Patients with Interstitial Pneumonias: Topic: Miscellaneous II

Abstract

Although the acute exacerbation of interstitial pneumonia is a lethal complication after pulmonary resection for lung cancer patients with idiopathic interstitial pneumonias (IIPs), there are no established methods to prevent its occurrence. This prospective randomized study was conducted to evaluate whether the perioperative administration of neutrophil elastase inhibitor prevents the acute exacerbation of interstitial pneumonia. Between October 2009 and April 2015, 130 IIP patients with suspected lung cancer tumors were randomly assigned to two groups before surgery: in Group A (n=65), sivelestat sodium hydrate was perioperatively administered for 5 days; in Group B (n=65), no medications were administered. The primary endpoint was the frequency of the acute exacerbation of IIPs. The secondary endpoints were perioperative changes in the patients’ LDH, CRP, KL-6, SP-D and SP-A values, and the safety of the preoperative administration of sivelestat sodium hydrate. Multivariate analyses were performed using a logistic regression model to identify the predictors of acute exacerbation. IIPs was radiologically classified into the following patterns: usual interstitial pneumonia (UIP) (n=23), possible UIP (n=28) and inconsistent with UIP (n=23). Sublobar resection, lobectomy and pneumonectomy were performed in 16, 112, and 2 patients, respectively. There were no statistically significant differences in patient characteristics between the groups. Two patients in group A and one patient in group B developed an acute exacerbation of IIPs. A preoperative partial pressure oxygen (PaO2) level of < 70mmHg was the only predictive factor identified in the multivariate analysis (p = 0.019, HR 19.2). The administration of neutrophil elastase was not associated with the development of an acute exacerbation, or with short- or long-term mortality. The KL-6, SP-D, SP-A levels on postoperative days 1 and 5 were lower in group A than in group B, and the LDH and CRP levels on postoperative day 5 were lower in group B than in group A; however the differences were not statistically significant. No subjective adverse events that could potentially be attributed to the administration of neutrophil elastase inhibitor were observed. The perioperative administration of neutrophil elastase inhibitor appeared to be safe; however, it could not prevent the development of acute exacerbation after pulmonary resection in lung cancer patients with IIPs.