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: West Japan Oncology Group 6711 L (PEOPLE Study)

Iwata, Takekazu; Yoshino, Ichiro; Yoshida, Shigetoshi; Ikeda, Norihiko; Tsuboi, Masahiro; Asato, Yuji; Katakami, Nobuyuki; Sakamoto, Kazuhiro; Yamashita, Yoshihisa; Okami, Jiro; Mitsudomi, Tetsuya; Yamashita, Motohiro; Yokouchi, Hiroshi; Okubo, Kan; Okada, Morihito; Takenoyama, Mitsuhiro; Chida, Masayuki; Tomii, Keisuke; Matsuura, Motoki; Azuma, Arata; Iwasawa, Tae; Kuwano, Kazuyoshi; Sakai, Shuji; Hiroshima, Kenzo; Fukuoka, Junya; Yoshimura, Kenichi; Tada, Hirohito; Nakagawa, Kazuhiko; Nakanishi, Yoichi

doi:10.1186/s12931-016-0398-4

Cited by 96 publications

(72 citation statements)

References 30 publications

(46 reference statements)

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“…However, the following Japanese phase 3 clinical trial did not confirm this result [55], and the subsequent multinational phase 3 clinical trials of pirfenidone (CAPACITY and ASCEND) did not report acute exacerbations as an end-point [59,78]. Pirfenidone has also been suggested to reduce the risk of postoperative AE by observational study [79]. Additional data are needed to fully understand the impact of IPF therapies on the risk and outcome of acute exacerbation [4].…”

Section: Preventive Measuresmentioning

confidence: 99%

Recent lessons learned in the management of acute exacerbation of idiopathic pulmonary fibrosis

2017

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Recognising recent advances, the definition and diagnostic criteria for acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) have been updated by an international working group. The new definition describes any acute, clinically significant respiratory deterioration (both idiopathic and triggered events) characterised by evidence of new widespread alveolar abnormality. The new criteria require a previous or concurrent diagnosis of IPF, an acute worsening or development of dyspnoea typically less than 1 month in duration, chest imaging evidence on computed tomography (CT) of new bilateral ground-glass opacity and/or consolidation superimposed on a background imaging pattern of usual interstitial pneumonia not fully explained by cardiac failure or fluid overload. Due to high in-hospital mortality rates, current treatment guidelines say that the majority of patients with AE-IPF should not receive mechanical ventilation. However, new data suggest that the prognosis may have improved. This modest improvement in overall survival seen in more recent studies may be the result of differences in the diagnostic criteria, study design, baseline clinical risk factors and/or improvements in management. Based on our updated knowledge of possible preventive and therapeutic measures, including mechanical ventilation and pharmacological therapies, the current approach to the treatment of AE-IPF requires careful decision-making.

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Section: Preventive Measuresmentioning

confidence: 99%

Recent lessons learned in the management of acute exacerbation of idiopathic pulmonary fibrosis

2017

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“…Perioperative management and lung transplant A Japanese phase II trial assessed the safety and efficacy of pirfenidone for the prevention of IPF acute exacerbations in patients with lung cancer undergoing pulmonary resection (PEOPLE study) [43]. Only one acute exacerbation was observed in 32 patients with IPF who were treated with pirfenidone and underwent surgery.…”

Section: Ae Management In Specific Patient Subgroupsmentioning

confidence: 99%

Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis

et al. 2017

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Pirfenidone is one of two approved therapies for the treatment of idiopathic pulmonary fibrosis (IPF). Randomised controlled clinical trials and subsequent post hoc analyses have demonstrated that pirfenidone reduces lung function decline, decreases mortality and improves progression-free survival. Long-term extension trials, registries and real-world studies have also shown similar treatment effects with pirfenidone. However, for patients with IPF to obtain the maximum benefits of pirfenidone treatment, the potential adverse events (AEs) associated with pirfenidone need to be managed. This review highlights the well-known and established safety profile of pirfenidone based on randomised controlled clinical trials and real-world data. Key strategies for preventing and managing the most common pirfenidone-related AEs are described, with the goal of maximising adherence to pirfenidone with minimal AEs.

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“…Surgery was performed after at least 2 weeks of 1200 mg·day −1 administration. The study demonstrated that acute exacerbations did not occur in 37 out of 39 patients (94.9%, 95% CI 82.7-99.4%; p=0.01) in the full-analysis set and in 38 out of 39 patients (97.2%, 95% CI 85.5-99.9%; p=0.004) in the per protocol set [41]. This study revealed for the first time that the use of pirfenidone before and after surgery is generally safe and significantly reduces the risk of acute exacerbations.…”

Section: When To Stop Therapymentioning

confidence: 87%

“…As in the case of lung transplantation, the use of antifibrotic drugs is not well studied and, so far, there has been much reluctance to use them, especially during or after surgery, because of the possible side-effects. In a recent article, IWATA et al [41] suggested a possible role of pirfenidone in reducing post-operative acute exacerbations of IPF in patients with lung cancer. In that study, pirfenidone was orally administered to IPF patients who were candidates for lung cancer surgery.…”

Section: When To Stop Therapymentioning

confidence: 99%

When to start and when to stop antifibrotic therapies

Torrisi¹,

Pavone²,

Vancheri³

et al. 2017

Eur Respir Rev

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Idiopathic pulmonary fibrosis (IPF) is characterised by progressive changes of the lung architecture causing cough and dyspnoea and ultimately leading to lung failure and death. Today, for the first time, two drugs that may reduce the inexorable progression of the disease are available, suggesting that treatment with specific drugs for IPF should be started as soon as diagnosis is made. This applies to any disease and particularly to IPF, which is marked by a 5-year survival comparable or even worse than many cancers. However, despite common sense and even worse, in spite of scientific data coming from clinical trials, post hoc analysis, long-term safety studies and real-life experiences, the question of when to start and when to stop treatment with antifibrotics is still debated. In IPF, particularly when the disease is diagnosed at an early stage, "wait and watch" behaviour is not rare to observe. This is largely due to the lack of awareness of both patients and clinicians regarding the progression of the disease and its prognosis. Another important issue is when treatment should be stopped. In general, there are two main reasons to stop a therapy: unbearable side-effects and/or lack of efficacy. According to current (although preliminary) evidence, antifibrotic drugs should not be discontinued except for safety issues.

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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: West Japan Oncology Group 6711 L (PEOPLE Study)

Cited by 96 publications

References 30 publications

Recent lessons learned in the management of acute exacerbation of idiopathic pulmonary fibrosis

Recent lessons learned in the management of acute exacerbation of idiopathic pulmonary fibrosis

Pirfenidone safety and adverse event management in idiopathic pulmonary fibrosis

When to start and when to stop antifibrotic therapies

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