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Diffuse Lung Disease |

Effect of Perioperative Pirfenidone Treatment in Lung Cancer Patients With Idiopathic Pulmonary Fibrosis (West Japan Oncolgy Group 6711L): A Phase II Study

Takekazu Iwata, MD; Ichiro Yoshino, MD; Shigetoshi Yoshida, MD; Norihiko Ikeda, MD; Masahiro Tsuboi, MD; Yuji Asato, MD; Nobuyuki Katakami, MD; Yoshinori Yamashita, MD; Kazuhiro Sakamoto, MD; Arata Azuma, MD; Tae Iwasawa, MD; Kazuyoshi Kuwano, MD; Shuji Sakai, MD; Kenzo Hiroshima, MD; Junya Fukuoka, MD; Kenichi Yoshimura, MD; Hirohito Tada, MD; Kazuhiko Nakagawa, MD; Yoichi Nakanishi, MD
Author and Funding Information

Department of General Thoracic Surgery, Chiba University Graduate School of Medicine / West Japan Oncology Group, Osaka, Japan


Chest. 2015;148(4_MeetingAbstracts):395A. doi:10.1378/chest.2228629
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Abstract

SESSION TITLE: Diffuse Lung Disease Poster Discussions

SESSION TYPE: Original Investigation Poster Discussion

PRESENTED ON: Wednesday, October 28, 2015 at 02:45 PM - 04:00 PM

PURPOSE: Idiopathic pulmonary fibrosis (IPF) is often accompanied by lung cancer, and acute exacerbation (AE) and AE-related mortality are experienced in 10-20% of IPF patinets who underwent surgery for lung cancer. Pirfenidone is an anti-fibrotic agent and proved to reduce disease progression in IPF patients (N Engle J Med 2014;370:2083). To evaluate a reduction effect of perioperative profenidone treatment on postoperative AE in IPF patients with lung cancer, a phase II study, WJOG6711L (UMIN0000077774), was conducted.

METHODS: IPF patients with non-small cell lung cancer (stage I-II) who were planned for surgery were enrolled. Pirfenidone was orally administered with 600 mg/day for the first 2 weeks, and the dose was increased 1200 mg/day for the next 2-4 weeks. Operation was performed after 2 weeks administration of 1200 mg/day. Radiologic and pathologic diagnoses of IPF and AE were confirmed by a central review board. Pirfenidone was up-dosed 1800 mg/day if capable. Primary endpoint was non-AE rate in 30 postoperative days, and secondary endpoint was safety.

RESULTS: During from 1/6/2012 to 17/1/2014, 43 cases were enrolled, and 39 were eligible analyze (Full Analysis Set (FAS)). Male were 33 (84.6%), mean age was 67.5 years, Hugh-Jones I/II was 38 (97.5%). The pirfenidone treatment was performed in 37 patients, and both pirfenidone and surgery were performed in 36 (Per Protocol Set (PPS)). In the PPS, lobectomy was performed in 24 (66.7%) and segmentectomy in 7 (19.4%) and wedge resection in 7 19.4%). Combined resections were performed in 3 (8.3%). AE was recognized in 2 (94.9%[95%confidential interval:82.7-99.4, p=0.01]) of FAS, and in 1 (97.2%[95%confidential interval:85.5-99.9, p=0.004] of PPS. Grade 5 (death) was observed in 1, who was suffered with AE, and no other grade3-5 adverse events were observed. Grade 1 appetite loss was the most observed; 4 before surgery, and 6 after surgery.

CONCLUSIONS: Perioperative pirfenidone treatment is feasible and expected to reduce AE after lung cancer surgery in IPF patients.

CLINICAL IMPLICATIONS: The result of this study presents a promising strategy for performing safer surgery to lung cancer patients with IPF. Further confirmatory trial can be considered.

DISCLOSURE: Ichiro Yoshino: Grant monies (from industry related sources): IY received a research grant from Shionogi & Co. Ltd for the other purpose than this study The following authors have nothing to disclose: Takekazu Iwata, Shigetoshi Yoshida, Norihiko Ikeda, Masahiro Tsuboi, Yuji Asato, Nobuyuki Katakami, Yoshinori Yamashita, Kazuhiro Sakamoto, Arata Azuma, Tae Iwasawa, Kazuyoshi Kuwano, Shuji Sakai, Kenzo Hiroshima, Junya Fukuoka, Kenichi Yoshimura, Hirohito Tada, Kazuhiko Nakagawa, Yoichi Nakanishi

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