Idiopathic pulmonary fibrosis (IPF) often accompanies lung cancer, and life-threatening acute exacerbation (AE) of IPF (AE-IPF) is reported to occur in 20 % of IPF patients who undergo lung cancer surgery. Pirfenidone is an anti-fibrotic agent known to reduce disease progression in IPF patients. A phase II study was conducted to evaluate whether perioperative pirfenidone treatment could reduce the incidence of postoperative AE-IPF patients with lung cancer. Pirfenidone was orally administered to IPF patients who were candidates for lung cancer surgery; pirfenidone was dosed at 600 mg/day for the first 2 weeks, followed by 1200 mg/day. Surgery was performed after at least 2 weeks of 1200-mg/day administration. The primary endpoint was non–AE-IPF rate during postoperative days 0–30, compared to the null value of 80 %, and the secondary endpoint was safety. Radiologic and pathologic diagnoses of IPF and AE-IPF were confirmed by an independent review committee. From June 2012 to January 2014, 43 cases were enrolled, and 39 were eligible (full analysis set [FAS]). Both pirfenidone treatment and surgery were performed in 36 patients (per protocol set [PPS]). AE-IPF did not occur in 37/39 patients (94.9 % [95 % confidential interval: 82.7–99.4 %, p = 0.01]) in the FAS, and in 38/39 patients (97.2 % [95 % confidential interval: 85.5–99.9 %, p = 0.004] in the PPS. A grade 5 adverse event (death) occurred in 1 patient, after AE-IPF; no other grade 3–5 adverse events were observed. Perioperative pirfenidone treatment is safe, and is promising for reducing AE-IPF after lung cancer surgery in IPF patients. This clinical trial was registered with the University Hospital Medical Information Network (UMIN) on April 16th, 2012 (Registration Number: UMIN000007774 ).
Postoperative acute interstitial pneumonia is a subset of post-surgical acute respiratory distress syndrome (ARDS) and is responsible for one third of in-hospital deaths following lung resection in patients with primary lung cancer. We evaluated the usefulness of computed tomography (CT) for detection of interstitial pneumonia (IP) as a risk factor of postoperative ARDS. Preoperative chest CT of patients who underwent thoracotomy for primary lung cancer was reviewed retrospectively and IP findings in the chest CT were detected. A total of 1148 patients with primary lung cancer underwent thoracotomy. Fifteen patients (1.3%) developed postoperative ARDS. Eleven of these 15 patients died of ARDS. Three of 41 patients who received induction therapy developed postoperative ARDS. Induction therapy was a risk factor of postoperative ARDS (p<0.01). Eleven out of the 15 patients who developed postoperative ARDS had IP findings (10: localized, 1: diffuse) in their chest CT. Two of three patients who had postoperative ARDS after induction therapy also had IP findings. Chest CTs of 834 patients were retrospectively analyzed; 91 patients (10.9%) had IP-findings (diffuse 1.8%, localized 9.1%). Postoperative ARDS occurred in 8.8% of IP-positive patients, and in 0.4% of IP-negative patients (p<0.001). Detection of IP by chest CT is useful for the selection of high-risk patients who may have postoperative ARDS following thoracotomy.
18 September 2008 in Interactive CardioVascular and Thoracic Surgery
Purpose: Several small studies have reported that acute exacerbation (AE) of idiopathic interstitial pneumonia (IIP) can occur after lung resection for patients with non-small cell lung cancer, though the incidence rate is unclear. Methods: We examined our institutional data and performed a search of the MEDLINE database for publications regarding AE of IIP following surgery for lung cancer. Studies reporting the incidence rates of IIP and AE were included. Results: Eleven studies including our institutional data were determined to be eligible. Seven studies designated the incidence of IIP. Of 4749 patients (from 7 studies) who underwent lung resection for NSCLC, 277 had IIP, for an incidence rate of 5.8% (range 1.1%–11.7%). Eleven studies designated the incidence of AE from IIP patient, 67 (15.8%) of 424 IIP patients (from 11 studies) developed AE after surgery, of whom 38 (56.7%) died during the postoperative course. Conclusion: Coexistent IIP in patients with lung cancer increases the risk of lung cancer surgery. Furthermore, AE of IIP may be a major cause of operation-related death.