内容紹介
Characteristics of and Risk Factors for Interstitial Pneumonia Due to TS-1® Capsule Administration―Case Reviews from a Drug Use Results Survey on Non-Small Cell Lung Cancer Patients and Spontaneous Reports
Summary
A drug use results survey for the TS-1® capsule was conducted on patients with non-small cell lung cancer. A total of 1,784 patients were registered for the survey, 1,669 of whom were evaluated for safety. The incidence of adverse drug reactions was 67.9%(1,134/1,669). The overall incidence of interstitial pneumonia was 1.38%(23/1,669), while it was 1.34% in patients treated with TS-1® alone(14/1,046). The risk factors for interstitial pneumonia according to this survey included allergic predisposition, concomitant diseases(including interstitial pneumonia), past medical history(including interstitial pneumonia), and combination with anticancer drugs(excluding cisplatin). Among the spontaneous reports of interstitial pneumonia as an adverse drug reaction from physicians, test images were available in 39 cases. These images were analyzed by the Safety Review Committee for interstitial pneumonia, consisting of external medical experts. In addition, the imaging patterns, settings of occurrence, and patient's backgrounds were reviewed. Twenty-five of the 39 cases were assessed to be possible interstitial pneumonia, of which 10 were confirmed to have an imaging pattern of diffuse alveolar damage. Based on the above findings, it is essential to check the patient's medical history for conditions such as lung disorder through a medical interview and an imaging test, prior to starting treatment with TS-1®.
要旨
非小細胞肺癌症例を対象にティーエスワン®配合カプセル使用成績調査を実施した。1,784例が登録され,安全性評価症例数は1,669例であった。副作用発現率は67.9%(1,134/1,669例),間質性肺炎発現率は調査全体で1.38%(23/1,669例),単剤例では1.34%(14/1,046例)であった。間質性肺炎の発現リスク因子としてアレルギー体質,合併症(間質性肺炎あり),既往歴(間質性肺炎あり),併用抗癌剤(シスプラチン以外)が抽出された。一方,医師より自発的に間質性肺炎の副作用として報告され,かつ画像が入手できた39例について外部医学専門家により組織された間質性肺炎判定委員会で画像判定を行い,間質性肺炎の画像パターンと発現状況および患者背景などを検討した。39例のなかから間質性肺炎の可能性ありと判断した25例において,10例のdiffuse alveolar damage(DAD)画像パターンが確認された。以上のことから,本剤の投与前には問診,画像検査による肺障害などの病歴確認が重要であると考えられた。
目次
Summary
A drug use results survey for the TS-1® capsule was conducted on patients with non-small cell lung cancer. A total of 1,784 patients were registered for the survey, 1,669 of whom were evaluated for safety. The incidence of adverse drug reactions was 67.9%(1,134/1,669). The overall incidence of interstitial pneumonia was 1.38%(23/1,669), while it was 1.34% in patients treated with TS-1® alone(14/1,046). The risk factors for interstitial pneumonia according to this survey included allergic predisposition, concomitant diseases(including interstitial pneumonia), past medical history(including interstitial pneumonia), and combination with anticancer drugs(excluding cisplatin). Among the spontaneous reports of interstitial pneumonia as an adverse drug reaction from physicians, test images were available in 39 cases. These images were analyzed by the Safety Review Committee for interstitial pneumonia, consisting of external medical experts. In addition, the imaging patterns, settings of occurrence, and patient's backgrounds were reviewed. Twenty-five of the 39 cases were assessed to be possible interstitial pneumonia, of which 10 were confirmed to have an imaging pattern of diffuse alveolar damage. Based on the above findings, it is essential to check the patient's medical history for conditions such as lung disorder through a medical interview and an imaging test, prior to starting treatment with TS-1®.
要旨
非小細胞肺癌症例を対象にティーエスワン®配合カプセル使用成績調査を実施した。1,784例が登録され,安全性評価症例数は1,669例であった。副作用発現率は67.9%(1,134/1,669例),間質性肺炎発現率は調査全体で1.38%(23/1,669例),単剤例では1.34%(14/1,046例)であった。間質性肺炎の発現リスク因子としてアレルギー体質,合併症(間質性肺炎あり),既往歴(間質性肺炎あり),併用抗癌剤(シスプラチン以外)が抽出された。一方,医師より自発的に間質性肺炎の副作用として報告され,かつ画像が入手できた39例について外部医学専門家により組織された間質性肺炎判定委員会で画像判定を行い,間質性肺炎の画像パターンと発現状況および患者背景などを検討した。39例のなかから間質性肺炎の可能性ありと判断した25例において,10例のdiffuse alveolar damage(DAD)画像パターンが確認された。以上のことから,本剤の投与前には問診,画像検査による肺障害などの病歴確認が重要であると考えられた。