caa a22 4500 605490635 CHVBK 20210128100505.0 cr unu---uuuuu 210128e20151201xx s 000 0 eng 10.1007/s10147-015-0834-3 doi (NATIONALLICENCE)springer-10.1007/s10147-015-0834-3 Clinical features and risk factors of panitumumab-induced interstitial lung disease: a postmarketing all-case surveillance study [Elektronische Daten] [Masahiro Osawa, Shoji Kudoh, Fumikazu Sakai, Masahiro Endo, Tetsuya Hamaguchi, Yumiko Ogino, Miyo Yoneoka, Motonobu Sakaguchi, Hiroyuki Nishimoto, Akihiko Gemma] Background: Drug-induced interstitial lung disease (ILD) is one of the most serious adverse reactions associated with the molecularly targeted drugs. Panitumumab has been approved for advanced or recurrent colorectal cancer. Although there were no adverse reaction reports of ILD in panitumumab monotherapy, 4 cases in combination chemotherapy were reported prior to its approval in Japan in 2010. Several studies also reported that the incidence of drug-induced ILD was higher in Japan than in other countries. The clinical features of ILD and the associated risk factors therefore need investigation. Methods: We analyzed the data from 3085 unresectable, advanced or recurrent colorectal cancer patients enrolled in a postmarketing all-case surveillance study of panitumumab in Japan. ILD case reports were assessed based on the clinical and radiologic findings by a committee of external experts. Multivariate analysis using Cox's hazard model identified the risk factors. Results: ILD incidence (1.3%) and mortality rates (51.3%) were similar to those of patients receiving another anti-epidermal growth factor receptor (EGFR) monoclonal antibody in Japan. No specific onset timing was determined. Although panitumumab-specific ILD findings were not observed in computed tomography images or clinical practice, panitumumab can induce ILD with diffuse alveolar damage, as do the other anti-EGFR targeting drugs. A history/complication of ILD, male sex, poor general condition, and 65years or older were identified as ILD risk factors, and no history of previous drug treatment was an apparent risk factor. Conclusion: Panitumumab-induced ILD can occur at any time after initiation, and close and regular monitoring is needed. The Author(s), 2015 Colorectal cancer nationallicence Interstitial lung disease nationallicence Panitumumab nationallicence Postmarketing surveillance nationallicence Risk factors nationallicence Osawa Masahiro Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut Kudoh Shoji Fukujuji Hospital, Kiyose, Japan aut Sakai Fumikazu Department of Diagnostic Radiology, Saitama International Medical Center, Saitama Medical University, Hidaka, Japan aut Endo Masahiro Division of Diagnostic Radiology, Shizuoka Cancer Center, Nagaizumi-Cho, Shizuoka, Japan aut Hamaguchi Tetsuya Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan aut Ogino Yumiko Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut Yoneoka Miyo Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut Sakaguchi Motonobu Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut Nishimoto Hiroyuki Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut Gemma Akihiko Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan aut International Journal of Clinical Oncology Springer Japan 20/6(2015-12-01), 1063-1071 1341-9625 20:6<1063 2015 20 10147 https://doi.org/10.1007/s10147-015-0834-3 text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s10147-015-0834-3 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Osawa Masahiro Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut NATIONALLICENCE 700 1- Kudoh Shoji Fukujuji Hospital, Kiyose, Japan aut NATIONALLICENCE 700 1- Sakai Fumikazu Department of Diagnostic Radiology, Saitama International Medical Center, Saitama Medical University, Hidaka, Japan aut NATIONALLICENCE 700 1- Endo Masahiro Division of Diagnostic Radiology, Shizuoka Cancer Center, Nagaizumi-Cho, Shizuoka, Japan aut NATIONALLICENCE 700 1- Hamaguchi Tetsuya Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan aut NATIONALLICENCE 700 1- Ogino Yumiko Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut NATIONALLICENCE 700 1- Yoneoka Miyo Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut NATIONALLICENCE 700 1- Sakaguchi Motonobu Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut NATIONALLICENCE 700 1- Nishimoto Hiroyuki Pharmacovigilance Department, Takeda Pharmaceutical Company Limited, 4-9, Hiranomachi 2-chome, Chuo-ku, 541-0046, Osaka, Japan aut NATIONALLICENCE 700 1- Gemma Akihiko Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan aut NATIONALLICENCE 773 0- International Journal of Clinical Oncology Springer Japan 20/6(2015-12-01), 1063-1071 1341-9625 20:6<1063 2015 20 10147