Drug induced interstitial lung disease in oncology phaseI trials

作者：Yonemori Kan^*; Hirakawa Akihiro; Kawachi Asuka; Kinoshita Fumie; Okuma Hitomi; Nishikawa Tadaaki; Tamura Kenji; Fujiwara Yasuhiro; Takebe Naoko^*

来源：CANCER SCIENCE, 2016, 107(12): 1830-1836.

DOI：10.1111/cas.13087

• Drug induced interstitial lung disease
• investigational new drug
• oncology
• phaseI trial pulmonary toxicity

Interstitial lung disease is a serious drug-related condition that can cause life threatening organ failure. The incidence and risk factors of drug-induced interstitial lung disease (DILD) are unknown in oncology phaseI trials. This study analyzed clinical information from 8906 patients with malignancies who were enrolled in 470 phaseI trials sponsored by the Cancer Therapy Evaluation Program, National Cancer Institute, from 1988 to 2014. Logistic and Cox statistical analyses were utilized to determine clinical differences between patients who developed DILD and patients who did not. In this study, the overall incidence rate of patients with pulmonary toxicity was 2.7%. The overall incidence rate for DILD was 0.77%, whereas for grade3 or 4 DILD it was 0.31%. Median time to occurrence of DILD was 1.4months. The Cox hazard analysis indicated smaller body surface area and a combination of thoracic radiation with investigational drug regimens were significant risk factors for time to occurrence of interstitial lung disease. Investigators should carefully monitor for DILD in oncology patients enrolled in phaseI trials with identified risk factors. A 6-month observation period would be sufficient to detect the onset of most DILD in such patients.

• 出版日期2016-12