JTO Clinical and Research Reports (Nov 2022)
Real-World Data Analysis of Pembrolizumab Monotherapy for NSCLC Using Japanese Postmarketing All-Case Surveillance Data
- Hideki Terai, MD,
- Kenzo Soejima, MD,
- Asanao Shimokawa, PhD,
- Hidehito Horinouchi, MD,
- Junichi Shimizu, MD,
- Tetsunari Hase, MD,
- Ryota Kanemaru, MD,
- Kana Watanabe, MD,
- Kiichiro Ninomiya, MD,
- Naoko Aragane, MD,
- Noriko Yanagitani, MD,
- Yoshihiko Sakata, MD,
- Masahiro Seike, MD,
- Daichi Fujimoto, MD,
- Masashi Kasajima, MD,
- Akihito Kubo, MD,
- Sojiro Kusumoto, MD,
- Yoshitaka Oyamada, MD,
- Keiichi Fujiwara, MD,
- Masahide Mori, MD,
- Midori Hashimoto, MD,
- Masato Shingyoji, MD,
- Masahiro Kodani, MD,
- Jin Sakamoto, MD,
- Toshihiko Agatsuma, MD,
- Kosuke Kashiwabara, MD,
- Minehiko Inomata, MD,
- Motoko Tachihara, MD,
- Kazuhisa Tanaka, MD,
- Kenji Hayashihara, MD,
- Nobuyuki Koyama, MD,
- Kaoru Matsui, MD,
- Koichi Minato, MD,
- Daisuke Jingu, MD,
- Hiroyuki Sakashita, MD,
- Satoshi Hara, MD,
- Tomoyuki Naito, MD,
- Asuka Okada, MD,
- Masayuki Tanahashi, MD,
- Yuki Sato, MD,
- Koichiro Asano, MD,
- Takayuki Takeda, MD,
- Kensuke Nakazawa, MD,
- Toshiyuki Harada, MD,
- Kazuhiko Shibata, MD,
- Tatsuo Kato, MD,
- Etsuo Miyaoka, PhD,
- Ichiro Yoshino, MD,
- Akihiko Gemma, MD,
- Tetsuya Mitsudomi, MD
Affiliations
- Hideki Terai, MD
- Cancer Center, School of Medicine, Keio University, Tokyo, Japan; Department of Internal Medicine (Pulmonary Medicine), School of Medicine, Keio University, Tokyo, Japan
- Kenzo Soejima, MD
- Clinical and Translational Research Center, Keio University Hospital, Tokyo, Japan; Department of Respiratory Medicine, Graduate School of Medicine, University of Yamanashi, Yamanashi, Japan; Corresponding author. Address for correspondence: Kenzo Soejima, MD, Clinical and Translational Research Center, Keio University Hospital, Tokyo 160-8582, Japan.
- Asanao Shimokawa, PhD
- School of Management, Department of Business Economics, Tokyo University of Science, Tokyo, Japan
- Hidehito Horinouchi, MD
- Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan
- Junichi Shimizu, MD
- Department of Thoracic Oncology, Aichi Cancer Center Hospital, Aichi, Japan
- Tetsunari Hase, MD
- Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Aichi, Japan
- Ryota Kanemaru, MD
- Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine, Tokyo, Japan
- Kana Watanabe, MD
- Department of Respiratory Medicine, Miyagi Cancer Center, Miyagi, Japan
- Kiichiro Ninomiya, MD
- Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan
- Naoko Aragane, MD
- Saga University Hospital, Saga, Japan
- Noriko Yanagitani, MD
- Thoracic Oncology Department, The Cancer Institute Hospital of JFCR, Tokyo, Japan
- Yoshihiko Sakata, MD
- Division of Respiratory Medicine, Saiseikai Kumamoto Hospital, Kumamoto, Japan
- Masahiro Seike, MD
- Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School Hospital, Tokyo, Japan
- Daichi Fujimoto, MD
- Internal Medicine III, Wakayama Medical University, Wakayama, Japan
- Masashi Kasajima, MD
- Department of Respiratory Medicine, Kitasato University School of Medicine, Kanagawa, Japan
- Akihito Kubo, MD
- Aichi Medical University Hospital, Aichi, Japan
- Sojiro Kusumoto, MD
- Division of Respiratory Medicine and Allergology Department of Internal Medicine, Showa University Hospital, Tokyo, Japan
- Yoshitaka Oyamada, MD
- Department of Respiratory Medicine, National Hospital Organization Tokyo Medical Center, Tokyo, Japan
- Keiichi Fujiwara, MD
- Department of Respiratory Medicine, National Hospital Organization Okayama Medical Center, Okayama, Japan
- Masahide Mori, MD
- Department of Thoracic Oncology, National Hospital Organization Osaka Toneyama Medical Center, Osaka, Japan
- Midori Hashimoto, MD
- NTT EAST Medical Center Sapporo, Hokkaido, Japan
- Masato Shingyoji, MD
- Division of Respirology, Chiba Cancer Center, Chiba, Japan
- Masahiro Kodani, MD
- Tottori University Hospital, Tottori, Japan
- Jin Sakamoto, MD
- Department of Thoracic Surgery, Shimane Prefectural Central Hospital, Shimane-ken, Japan
- Toshihiko Agatsuma, MD
- Department of Respiratory Medicine, National Hospital Organization Shinshu Ueda Medical Center, Nagano, Japan
- Kosuke Kashiwabara, MD
- Department of Respiratory Medicine, Kumamoto Regional Medical Center, Kumamoto, Japan
- Minehiko Inomata, MD
- First Department of Internal Medicine, Toyama University Hospital, Toyama, Japan
- Motoko Tachihara, MD
- Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Hospital, Hyogo, Japan
- Kazuhisa Tanaka, MD
- Department of General Thoracic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan
- Kenji Hayashihara, MD
- Department of Respiratory Medicine, National Hospital Organization Ibaraki-Higashi National Hospital, Ibaraki, Japan
- Nobuyuki Koyama, MD
- Department of Clinical Oncology, Tokyo Medical University Ibaraki Medical Center, Ibaraki, Japan
- Kaoru Matsui, MD
- Izumi City General Hospital, Tokyo, Japan
- Koichi Minato, MD
- Division of Respiratory Medicine, Gunma Prefectural Cancer Center, Gunma, Japan
- Daisuke Jingu, MD
- Department of Respiratory Medicine, Saka General Hospital, Miyagi, Japan
- Hiroyuki Sakashita, MD
- Department of Respiratory Internal Medicine, Yokosuka Kyosai Hospital, Kanagawa, Japan
- Satoshi Hara, MD
- Itami City Hospital, Hyogo, Japan
- Tomoyuki Naito, MD
- Department of Respiratory Medicine, Mitsui Memorial Hospital, Tokyo, Japan
- Asuka Okada, MD
- Respiratory Medicine, Saiseikai Suita Hospital, Osaka, Japan
- Masayuki Tanahashi, MD
- Division of Thoracic Surgery, Respiratory Disease Center, Seirei Mikatahara General Hospital, Shizuoka, Japan
- Yuki Sato, MD
- Kobe City Medical Center General Hospital, Kobe, Japan
- Koichiro Asano, MD
- Division of Pulmonary Medicine, Department of Medicine, Tokai University School of Medicine, Kanagawa, Japan
- Takayuki Takeda, MD
- Japanese Red Cross Kyoto Daini Hospital, Kyoto, Japan
- Kensuke Nakazawa, MD
- Faculty of Medicine, Division of Clinical Medicine, Department of Pulmonary Medicine, University of Tsukuba, Ibaraki, Japan
- Toshiyuki Harada, MD
- Department of Respiratory Medicine, Japan Community Health Care Organization Hokkaido Hospital, Hokkaido, Japan
- Kazuhiko Shibata, MD
- Division of Medical Oncology, Department of Medicine, Kouseiren Takaoka Hospital, Toyama, Japan
- Tatsuo Kato, MD
- Department of Respiratory Medicine, National Hospital Organization Nagara Medical Center, Gifu, Japan
- Etsuo Miyaoka, PhD
- School of Management, Department of Business Economics, Tokyo University of Science, Tokyo, Japan
- Ichiro Yoshino, MD
- Department of General Thoracic Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan
- Akihiko Gemma, MD
- Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School Hospital, Tokyo, Japan
- Tetsuya Mitsudomi, MD
- Kindai Hospital Global Research Alliance Center and Thoracic Surgery, Kindai University, Osaka-Sayama, Japan
- Journal volume & issue
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Vol. 3,
no. 11
p. 100404
Abstract
Introduction: Pembrolizumab is a programmed death-ligand 1 inhibitor that was initially indicated for monotherapy in patients with advanced lung cancer. The Japanese Lung Cancer Society conducted an observational study on pembrolizumab using confirmative data obtained through postmarketing all-case surveillance (PMACS), which was performed by a pharmaceutical company under the Japanese law in 2017. Methods: This multicenter observational study was conducted by the Japanese Lung Cancer Society using PMACS data with the newly created central registration system regarding patients with NSCLC who received pembrolizumab monotherapy between February 1, 2017 and June 30, 2017; a new database was created by adding the clinical information regarding prognosis for 3 years after therapy to the existing data collected by PMACS. Results: A total of 300 patients from 43 facilities were enrolled in this study. The median overall survival and progression-free survival after pembrolizumab initiation were 558 and 188 days, respectively. Moreover, the 1- and 3-year survival rates were 58.9% and 33.7%, respectively. Results of multivariate analysis revealed performance status (p < 0.0001), histology (p = 0.0118), previous chemotherapy (p = 0.0007), programmed death-ligand 1 expression status (p = 0.0195), and previous steroid use (p = 0.0460) as significant factors that affected overall survival. The toxicity profile was similar to that previously reported. Conclusions: In this first attempt to use PMACS data, we successfully collected clinical information and found the real-world efficacy and safety of pembrolizumab.
