Abstract 1519TiP
Background
Comprehensive genomic profiling tests are approved for refractory cancer patients in Japan with the condition that all tests be annotated by a molecular tumor board (MTB), at 12 core and 33 hub government-designated hospitals. Our study assessing the MTB performance of all core hospitals using 50 simulated cases indicated that sharing information on available matched therapies, particularly for genomic alterations with low evidence levels by the Japanese classification (PMID: 33249514), is needed to improve the quality of recommendations by MTBs (Kage H, et al #1097 ESMO 2021). Based on these results, we initiated the Japanese Society of Medical Oncology/Health Authority of the Japanese Government cooperative virtual educational program for Improving clinical annotation.
Trial design
Eligibility included each MTB at hub hospitals or individual medical oncologists at core hospitals and they had to complete the clinical annotation of all 50 simulated cases. The 50 simulated cases were randomly divided into 2 groups (n=25 each) by a central biostatistician based on concordance between the consensus annotation and the MTB annotations at the core hospitals. After submitting the treatment recommendations of the first 25 cases, the participants will learn the consensus annotation of these cases at a workshop; they will then submit the treatment recommendations of the next 25 cases. The primary endpoint is the frequency of participants who meet the acceptance criteria at post-workshop study: 90% and 40% concordance with the consensus annotation for genomic alterations with high and low evidence levels, respectively. The threshold acceptance rate is assumed to be 20%, and the planned sample size is > 24 participants. Secondary endpoints include improvements in the concordance rates of the pre- and post-workshop studies at each hospital and the concordance rate of each evidence level. A study evaluating the clinical annotation using artificial intelligence is also underway. The recruitment of participants has started, and the workshop is scheduled for July 18, 2021.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Japanese Ministry of Health, Labour and Welfare.
Disclosure
K. Sunami: Financial Interests, Personal, Speaker’s Bureau: Chugai; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Sysmex; Financial Interests, Personal, Speaker’s Bureau: Amgen . Y. Naito: Financial Interests, Personal, Speaker’s Bureau: AstraZeneca; Financial Interests, Personal, Speaker’s Bureau: Bayer; Financial Interests, Personal, Speaker’s Bureau: Chugai; Financial Interests, Personal, Speaker’s Bureau: Eisai; Financial Interests, Personal, Speaker’s Bureau: Eli Lilly; Financial Interests, Personal, Speaker’s Bureau: Fuji Film Toyama Chemistry; Financial Interests, Personal, Speaker’s Bureau: Gardant; Financial Interests, Personal, Speaker’s Bureau: Nihon Kayaku; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Ono; Financial Interests, Personal, Speaker’s Bureau: Pfizer; Financial Interests, Personal, Speaker’s Bureau: Taiho; Financial Interests, Personal, Speaker’s Bureau: Takeda; Financial Interests, Personal, Research Grant: ABBVIE; Financial Interests, Personal, Research Grant: Boehringer Ingelheim; Financial Interests, Personal, Research Grant: Chugai; Financial Interests, Personal, Research Grant: Daiichi Sankyo; Financial Interests, Personal, Research Grant: Ono; Financial Interests, Personal, Research Grant: Pfizer; Financial Interests, Personal, Research Grant: Roche; Financial Interests, Personal, Research Grant: Taiho. D. Ennishi: Financial Interests, Institutional, Other, Honoraria : Eisai Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Other, Honoraria: Kyowa Kirin Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical Co., Ltd.; Financial Interests, Institutional, Research Grant: Nipponshinyaku Pharmaceutical Co., Ltd.. H. Kage: Financial Interests, Institutional, Research Grant: Konica Minolta, Inc.. M. Kanai: Financial Interests, Personal, Other, Honoraria : Chugai Pharmaceutical Co., Ltd. H. Kenmotsu: Financial Interests, Personal, Other, Honoraria : Chugai Pharmaceutical Co, Ltd.; Financial Interests, Personal, Other, Honoraria : Ono Pharmaceutical Co, Ltd; Financial Interests, Personal, Other, Honoraria: Boeringer Ingelheim; Financial Interests, Personal, Other, Honoraria: Eli Lilly K.K; Financial Interests, Personal, Other, Honoraria: Kyowa Hakko Kirin Co., Ltd; Financial Interests, Personal, Other, Honoraria: Bristol-Myers Squibb; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: Novartis Pharma K.K; Financial Interests, Personal, Other, Honoraria: Daiichi-Sankyo Co., Ltd; Financial Interests, Personal, Other, Honoraria: AstraZeneca K.K; Financial Interests, Personal, Other, Honoraria: Pfizer; Financial Interests, Personal, Other, Honoraria: Taiho Pharma; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical Co, Ltd.; Financial Interests, Institutional, Research Grant: Novartis Pharma K.K.; Financial Interests, Institutional, Research Grant: Daiichi-Sankyo Co., Ltd; Financial Interests, Institutional, Research Grant: AstraZeneca K.K.. T. Koyama: Financial Interests, Personal, Other, Honoraria : Chugai; Financial Interests, Personal, Other, Honoraria : Sysmex; Financial Interests, Personal, Research Grant: PACT. D. Sakai: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharma; Financial Interests, Institutional, Research Grant: Chugai Pharma; Financial Interests, Institutional, Research Grant: Lilly Japan; Financial Interests, Institutional, Research Grant: Chugai Pharma; Financial Interests, Institutional, Research Grant: Yakult Honsha; Financial Interests, Institutional, Research Grant: Ono Pharmaceutical; Financial Interests, Institutional, Research Grant: Astellas Pharma; Financial Interests, Institutional, Research Grant: Incyte; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical; Financial Interests, Institutional, Research Grant: Eisai. K. Ichiro: Financial Interests, Personal, Other, Honoraria : Pfizer Inc.; Financial Interests, Personal, Other, Honoraria : Chugai Pharmaceutical Co.; Financial Interests, Personal, Other, Honoraria : Bayer Pharmaceutical Co.; Financial Interests, Personal, Other, Honoraria : AstraZeneca Inc.. T. Kozuki: Financial Interests, Personal, Other, Honoraria : AstraZeneca; Financial Interests, Personal, Other, Honoraria : Eli-Lilly Japan; Financial Interests, Personal, Other, Honoraria : Taiho Pharmaceutical Co.; Financial Interests, Personal, Other, Honoraria : Chugai Pharmaceutical Co.; Financial Interests, Personal, Other, Honoraria : MSD; Financial Interests, Personal, Other, Honoraria : Bristol-Myers Squibb; Financial Interests, Personal, Other, Honoraria : Ono Pharmaceutical Co.; Financial Interests, Personal, Other, Honoraria : Pfizer Japan; Financial Interests, Personal, Other, Honoraria : Nippon Boehringer Ingelheim; Financial Interests, Personal, Other, Honoraria : Merck Biopharma; Financial Interests, Personal, Other, Honoraria : Nippon Kayaku; Financial Interests, Personal, Other, Honoraria: Novartis; Financial Interests, Personal, Other, Honoraria: Daiichi-Sankyo; Financial Interests, Personal, Other, Honoraria: Kyowa Hakko Kirin; Financial Interests, Institutional, Research Grant: Chugai Pharmaeutical Co.; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Eli Lilly Japan; Financial Interests, Institutional, Research Grant: Taiho Pharmaceutical Co.; Financial Interests, Institutional, Research Grant: Bristl-Myers Squibb; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Kyowa Hakko Kirin; Financial Interests, Institutional, Research Grant: Merck Biopharma. H. Sakashita: Financial Interests, Personal, Other, Honoraria : CHUGAI PHARMACEUTICAL CO.; Financial Interests, Personal, Other, Honoraria : TAIHO PHARMACEUTICAL CO.; Financial Interests, Personal, Other, Honoraria : DAIICHI SANKYO CO.; Financial Interests, Personal, Other, Honoraria : AstraZeneca; Financial Interests, Personal, Other, Honoraria : Nippon Boehringer Ingelheim CO.; Financial Interests, Personal, Other, Honoraria : ONO PHARMACEUTICAL CO.; Financial Interests, Personal, Other, Honoraria : Bristol Myers Squibb; Financial Interests, Personal, Other, Honoraria : MSD; Financial Interests, Institutional, Research Grant: SBI PHARMACEUTICAL CO; Financial Interests, Institutional, Research Grant: TAIHO PHARMACEUTICAL CO.; Financial Interests, Institutional, Research Grant: Pfizer Japan Inc.; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Nippon Boehringer Ingelheim CO.; Financial Interests, Institutional, Research Grant: Novartis; Financial Interests, Institutional, Research Grant: CHUGAI PHARMACEUTICAL CO.; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Nihon Servier. S. Kohsaka: Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Chordia Therapeutics. T. Yoshino: Financial Interests, Personal, Other, Honoraria : Taiho; Financial Interests, Personal, Other, Honoraria : Chugai; Financial Interests, Personal, Other, Honoraria : Eli Lilly; Financial Interests, Personal, Other, Honoraria : Merc Biopharma; Financial Interests, Personal, Other, Honoraria : Bayer; Financial Interests, Personal, Other, Honoraria : Ono; Financial Interests, Institutional, Research Grant: Taiho; Financial Interests, Institutional, Research Grant: Sumitomo Dainippon; Financial Interests, Institutional, Research Grant: Ono; Financial Interests, Institutional, Research Grant: Chugai; Financial Interests, Institutional, Research Grant: Amgen; Financial Interests, Institutional, Research Grant: Parexel International; Financial Interests, Institutional, Research Grant: MSD; Financial Interests, Institutional, Research Grant: Daiichi Snakyo; Financial Interests, Institutional, Research Grant: Sanofi. All other authors have declared no conflicts of interest.