Background: Idiopathic pulmonary fibrosis (IPF) often accompanies lung cancer, and life-threatening acute\nexacerbation (AE) of IPF (AE-IPF) is reported to occur in 20 % of IPF patients who undergo lung cancer surgery.\nPirfenidone is an anti-fibrotic agent known to reduce disease progression in IPF patients. A phase II study was\nconducted to evaluate whether perioperative pirfenidone treatment could reduce the incidence of postoperative\nAE-IPF patients with lung cancer.\nMethods: Pirfenidone was orally administered to IPF patients who were candidates for lung cancer surgery; pirfenidone\nwas dosed at 600 mg/day for the first 2 weeks, followed by 1200 mg/day. Surgery was performed after at least 2 weeks\nof 1200-mg/day administration. The primary endpoint was nonââ?¬â??AE-IPF rate during postoperative days 0ââ?¬â??30, compared\nto the null value of 80 %, and the secondary endpoint was safety. Radiologic and pathologic diagnoses of IPF and AE-IPF\nwere confirmed by an independent review committee.\nResults: From June 2012 to January 2014, 43 cases were enrolled, and 39 were eligible (full analysis set [FAS]). Both\npirfenidone treatment and surgery were performed in 36 patients (per protocol set [PPS]). AE-IPF did not occur in 37/39\npatients (94.9 % [95 % confidential interval: 82.7ââ?¬â??99.4 %, p = 0.01]) in the FAS, and in 38/39 patients (97.2 % [95 %\nconfidential interval: 85.5ââ?¬â??99.9 %, p = 0.004] in the PPS. A grade 5 adverse event (death) occurred in 1 patient,\nafter AE-IPF; no other grade 3ââ?¬â??5 adverse events were observed Conclusions: Perioperative pirfenidone treatment is safe, and is promising for reducing AE-IPF after lung cancer\nsurgery in IPF patients.
Loading....