Abstract 551P
Background
Comprehensive genomic profiling (CGP) tests have been approved since June 2019 for refractory cancer patients only in Japan under the requirement that all cases undergoing CGP tests are annotated in the molecular tumor board (MTB) held by each government-designated core hospital. The MTBs across all core hospitals are systematically networked to share the information of available clinical trials for investigational new drugs (IND) to improve the proportion of genomically- matched treatments.
Methods
Data on consecutive cases undergoing CGP tests at all core hospitals between the first period (11 hospitals, June 2019 to January 2020) and second period (12 hospitals, February 2020 to January 2021) were collected. We evaluated the proportions of cases receiving matched treatments by CGP results and those recommended to receive genetic counseling.
Results
A total of 754 and 2,295 cases underwent CGP tests at core hospitals in the first and second periods, respectively; 28 (3.7%) and 176 (7.7%) received matched treatments (p<0.001). Also, the proportion of cases enrolled in clinical trials for IND (2.1% vs. 4.7%, p=0.002) and received approved drugs (1.1% vs. 2.3%, p=0.048) were both increased. There was a positive correlation between the number of cases enrolled in clinical trials for IND and the proportion receiving matched treatments in each hospital (rank correlation coefficient, R=0.72). In addition, 18 (2.4%) and 254 (11.1%) cases were recommended to receive genetic counseling in the first and second periods, respectively (p<0.001). The proportion of receiving the counseling was associated with the type of CGP test: tumor-only (N=2,392) vs. tumor-normal paired (N=657) test (12.0% vs. 2.5%; p<0.001; odds ratio, 0.21; 95% CI, 0.12 to 0.35).
Conclusions
Chronological improvement in the proportion of matched treatments and genetic counseling was achieved, suggesting recommendations of available clinical trials in networked MTBs may contribute to increase the numbers of cases receiving matched treatment because of the limited availability of matched treatments with approved drugs. In addition, tumor-normal paired over tumor-only tests can efficiently refer patients to genetic counseling.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
The Ministry of Health, Labour and Welfare, Health Labour Sciences Special Research Grant (19EA1007).
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, Funding: Eisai; Financial Interests, Institutional, Funding: Kyowa Kirin; Financial Interests, Institutional, Research Grant: Chugai; Financial Interests, Institutional, Research Grant: Nipponshinyaku. H. Kage: Financial Interests, Institutional, Research Grant: Konica Minolta. M. Kanai: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical. H. Kenmotsu: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical; Financial Interests, Personal, Invited Speaker: Ono Pharmaceutical; Financial Interests, Personal, Invited Speaker: Boeringar Ingelheim; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: Kyowa Hakko Kirin; Financial Interests, Personal, Invited Speaker: Bristol-Myers Squibb; Financial Interests, Personal, Invited Speaker: MSD; Financial Interests, Personal, Invited Speaker: Novartis Pharma; Financial Interests, Personal, Invited Speaker: Daiichi-Sankyo; Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Invited Speaker: Taiho Pharma; Financial Interests, Institutional, Research Grant: Chugai Pharmaceutical; Financial Interests, Institutional, Research Grant: Novartis Pharma; Financial Interests, Institutional, Research Grant: Daiichi-Sankyo; Financial Interests, Institutional, Research Grant: AstraZeneca. T. Koyama: Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Sysmex; Financial Interests, Personal, Research Grant: PACT. D. Sakai: Financial Interests, Personal, Speaker’s Bureau: Chugai Pharma; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: Lilly Japan; Financial Interests, Institutional, Research Grant: Chugai Pharma; Financial Interests, Institutional, Research Grant: Yakult; 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. S. Kohsaka: Financial Interests, Personal, Research Grant: AstraZeneca; Financial Interests, Personal, Research Grant: Boehringer Ingelheim; Financial Interests, Personal, Research Grant: Eisai; Financial Interests, Personal, Research Grant: Daiichi Sankyo; Financial Interests, Personal, Research Grant: Chordia Therapeutics. T. Yamanaka: Financial Interests, Personal, Invited Speaker: AstraZeneca; Financial Interests, Personal, Invited Speaker: Otsuka; Financial Interests, Personal, Invited Speaker: Ono; Financial Interests, Personal, Invited Speaker: Kyowa Kirin; Financial Interests, Personal, Invited Speaker: Taiho; Financial Interests, Personal, Invited Speaker: Takeda; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Boehringer Ingelheim; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: Gilead Sciences; Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Personal, Invited Speaker: Merck Serono; Financial Interests, Institutional, Research Grant: Taiho; Financial Interests, Institutional, Research Grant: Boehringer Ingelheim; Financial Interests, Institutional, Research Grant: Ono; Financial Interests, Institutional, Research Grant: Chugai; Financial Interests, Institutional, Research Grant: Takeda; Financial Interests, Institutional, Research Grant: Astellas; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Institutional, Research Grant: Daiichi Sankyo; Financial Interests, Institutional, Research Grant: EPS. T. Yoshino: Financial Interests, Personal, Invited Speaker: Taiho; Financial Interests, Personal, Invited Speaker: Chugai; Financial Interests, Personal, Invited Speaker: Eli Lilly; Financial Interests, Personal, Invited Speaker: Merc Biopharma; Financial Interests, Personal, Invited Speaker: Bayer; Financial Interests, Personal, Invited Speaker: 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 Sankyo; Financial Interests, Institutional, Research Grant: Sanofi. All other authors have declared no conflicts of interest.