TY - JOUR
T1 - A phase II trial evaluating the efficacy and safety of perioperative pirfenidone for prevention of acute exacerbation of idiopathic pulmonary fibrosis in lung cancer patients undergoing pulmonary resection
T2 - West Japan Oncology Group 6711 L (PEOPLE Study)
AU - West Japan Oncology Group
AU - Iwata, Takekazu
AU - Yoshino, Ichiro
AU - Yoshida, Shigetoshi
AU - Ikeda, Norihiko
AU - Tsuboi, Masahiro
AU - Asato, Yuji
AU - Katakami, Nobuyuki
AU - Sakamoto, Kazuhiro
AU - Yamashita, Yoshinori
AU - Okami, Jiro
AU - Mitsudomi, Tetsuya
AU - Yamashita, Motohiro
AU - Yokouchi, Hiroshi
AU - Okubo, Kenichi
AU - Okada, Morihito
AU - Takenoyama, Mitsuhiro
AU - Chida, Masayuki
AU - Tomii, Keisuke
AU - Matsuura, Motoki
AU - Azuma, Arata
AU - Iwasawa, Tae
AU - Kuwano, Kazuyoshi
AU - Sakai, Shuji
AU - Hiroshima, Kenzo
AU - Fukuoka, Junya
AU - Yoshimura, Kenichi
AU - Tada, Hirohito
AU - Nakagawa, Kazuhiko
AU - Nakanishi, Yoichi
N1 - Publisher Copyright:
© 2016 The Author(s).
PY - 2016/7/22
Y1 - 2016/7/22
N2 - Background: 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. Methods: 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. Results: 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. Conclusions: Perioperative pirfenidone treatment is safe, and is promising for reducing AE-IPF after lung cancer surgery in IPF patients. Trial registration: This clinical trial was registered with the University Hospital Medical Information Network (UMIN) on April 16th, 2012 (Registration Number: UMIN000007774).
AB - Background: 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. Methods: 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. Results: 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. Conclusions: Perioperative pirfenidone treatment is safe, and is promising for reducing AE-IPF after lung cancer surgery in IPF patients. Trial registration: This clinical trial was registered with the University Hospital Medical Information Network (UMIN) on April 16th, 2012 (Registration Number: UMIN000007774).
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U2 - 10.1186/s12931-016-0398-4
DO - 10.1186/s12931-016-0398-4
M3 - Article
C2 - 27450274
AN - SCOPUS:84979009556
VL - 17
JO - Respiratory Research
JF - Respiratory Research
SN - 1465-9921
IS - 1
M1 - 90
ER -