Japanese Society of Medical Oncology/Japan Society of Clinical Oncology/Japanese Society of Pediatric Hematology/Oncology-led clinical recommendations on the diagnosis and use of immunotherapy in patients with high tumor mutational burden tumors |
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Authors: | Mishima Saori Naito Yoichi Akagi Kiwamu Hayashi Naomi Hirasawa Akira Hishiki Tomoro Igarashi Ataru Ikeda Masafumi Kadowaki Shigenori Kajiyama Hiroaki Kato Motohiro Kenmotsu Hirotsugu Kodera Yasuhiro Komine Keigo Koyama Takafumi Maeda Osamu Miyachi Mitsuru Nishihara Hiroshi Nishiyama Hiroyuki Ohga Shouichi Okamoto Wataru Oki Eiji Ono Shigeru Sanada Masashi Sekine Ikuo Takano Tadao Tao Kayoko Terashima Keita Tsuchihara Katsuya Yatabe Yasushi Yoshino Takayuki Baba Eishi |
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Affiliation: | 1.National Cancer Center Hospital East, Kashiwa, Japan ;2.Saitama Cancer Center, Saitama, Japan ;3.The Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan ;4.Okayama University, Okayama, Japan ;5.Chiba University, Chiba, Japan ;6.Yokohama City University School of Medicine, Yokohama, Japan ;7.Aichi Cancer Center, Aichi, Japan ;8.Nagoya University, Aichi, Japan ;9.The University of Tokyo, Tokyo, Japan ;10.Shizuoka Cancer Center, Shizuoka, Japan ;11.Nagoya University Hospital, Aichi, Japan ;12.Tohoku University, Miyagi, Japan ;13.National Cancer Center Hospital, Tokyo, Japan ;14.Kyoto Prefectural University of Medicine, Kyoto, Japan ;15.Keio University, Tokyo, Japan ;16.Tsukuba University, Ibaraki, Japan ;17.Kyushu University, Fukuoka, Japan ;18.Hiroshima University Hospital, Hiroshima, Japan ;19.Jichi Medical University, Tochigi, Japan ;20.National Hospital Organization Nagoya Medical Center, Aichi, Japan ;21.National Center for Child Health and Development, Tokyo, Japan ; |
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Abstract: | The development of novel antitumor agents and accompanying biomarkers has improved survival across several tumor types. Previously, we developed recommendations for tumor-agnostic treatments in patients with solid tumors with DNA mismatch repair deficient or neurotrophic receptor tyrosine kinase fusions. Recently, immune checkpoint inhibitors have shown efficacy in patient with tumor mutation burden-high (TMB-H) solid tumors and have been established as a third tumor-agnostic agent, making it necessary to develop the guideline prioritized for these patients. Clinical questions regarding medical care were formulated for patients with TMB-H advanced solid tumors. Relevant publications were searched by PubMed and Cochrane Database. Critical publications and conference reports were added manually. Systematic reviews were performed for each clinical question for the purpose of developing clinical recommendations. The committee members identified by Japan Society of Clinical Oncology (JSCO), Japanese Society of Medical Oncology (JSMO), and Japanese society of pediatric hematology/oncology (JSPHO) voted to determine the level of each recommendation considering the strength of evidence, expected risks and benefits to patients, and other related factors. Thereafter, a peer review by experts nominated from JSCO, JSMO, and JSPHO, and the public comments among all societies' members was done. The current guideline describes three clinical questions and seven recommendations for whom, when, and how TMB should be tested, and what is recommended for patients with TMB-H advanced solid tumors. In this guideline, the committee proposed seven recommendations for performing TMB testing properly to select patients who are likely to benefit from immunotherapy. |
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