Safety and efficacy of atezolizumab (Atezo) + bevacizumab (Bev) in Japanese patients (pts) with unresectable hepatocellular carcinoma (uHCC): A prospective, multicenter, observational study (ELIXIR) - A preliminary analysis

Background: Atezo + Bev has been approved as first-line treatment in pts with uHCC based on a global phase 3 study (IMbrave 150). However, there is a lack of real-world data worldwide. Thus, we conducted the ELIXIR study to evaluate the safety and efficacy of Atezo + Bev prospectively in 500 real-world Japanese pts. Here, we report the first pre-planned safety assessment in 105 initially registered pts out of 500 pts. Method(s): In this prospective, multicenter, observational study, 500 systemic treatment-naive pts with uHCC and Child-Pugh A received Atezo 1200 mg IV q3w + Bev 15 mg/kg IV q3w. The primary endpoint was adverse events of special interest (AESI). Efficacy outcomes including progression-free survival (PFS) and objective response rate (ORR) were assessed in this analysis. Result(s): A total of 500 pts were enrolled between Apr 2021 and Feb 2022. One hundred and five initially registered pts finished enrollment by Aug 2021 and the median follow-up time was 6.4 mo. A total of 49 AESIs and 35 AESIs Grade >=3 were observed in these pts (Table). Median PFS was 6.0 mo (95% CI, 5.1, 6.7) per RECIST 1.1 and 6.5 mo (95% CI, 5.2, 8.0) per modified RECIST (mRECIST). ORR was 23.8% (95% CI, 16.0, 33.1) per RECIST 1.1 and 34.3% (95% CI, 25.3, 44.2) per mRECIST. [Formula presented]. Conclusion(s): In this analysis, additional safety signals were not observed in Japanese pts. Efficacy data could be underestimated at this time. The ELIXIR study showed that Atezo + Bev is a promising first-line treatment for Japanese pts with uHCC in the real world. Clinical trial identification: UMIN000043463. Editorial acknowledgement: Medical writing assistance for this was provided by Tetsuji Asao, PhD, of SunFlare Co., Ltd. Legal entity responsible for the study: Chugai Pharmaceutical Co., Ltd. Funding(s): Chugai Pharmaceutical Co., Ltd. Disclosure: M. Ikeda: Financial Interests, Personal, Advisory Board: AstraZeneca, Chugai, Eli Lilly Japan, Eisai, NIHON Servier, Novartis, Ono, Takeda, GlaxoSmithKline;Financial Interests, Personal, Invited Speaker: AstraZeneca, Bayer, Bristol Myers Squibb, Chugai, Eli Lilly Japan, Eisai, NIHON SERVIER, Novartis, Taiho, Yakult, Teijin Pharma, AbbVie, Abbott Japan, Fujifilm Toyama Chemical, Incyte Biosciences Japan, ASLAN, Chugai, NIHON SERVIER, Takeda;Financial Interests, Institutional, Invited Speaker: Bayer, Bristol Myers Squibb, Eisai, AstraZeneca, Eli Lilly Japan, Chugai Pharmaceutical, Merck Serono, MSD, Ono, Yakult, Novartis, Takeda, J-Pharma, Pfizer, Chiome Bioscience, NIHON SERVIER, Delta-Fly Pharma, Syneos Health, Merus.N.V. N. Kato: Financial Interests, Personal, Invited Speaker: Gilead Sciences Inc., AbbVie G.K., Ohtsuka Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Chugai Pharmaceutical Co., Ltd., AstraZeneca K.K., Sumitomo Dainippon Pharma Co., Ltd., Takeda Pharmaceutical Co., Ltd., Zeria Pharmaceutical Co., Ltd., Olympus Corporation, Eisai Co., Ltd., Aska Pharmaceutical Co., Ltd., Tsumura & Co., Mochida Pharmaceutical Co., Ltd., Miyarisan Pharmaceutical Co., Ltd., Covidien Japan Inc., Eli Lilly Japan K.K., Nobelpharma Co., Ltd., Kowa Company, Ltd., Incyte Biosciences Japan GK, Yakult Honsha Co.,Ltd., Olympus Marketing, Inc., Taisho Pharmaceutical Co.,Ltd., Janssen Pharmaceutical K.K.;Financial Interests, Institutional, Research Grant: AbbVie G.K., Ohtsuka Pharmaceutical Co., Ltd., Bayer Yakuhin Ltd., Chugai Pharmaceutical Co., Ltd., Mitsubishi Tanabe Pharma Corporation, Sumitomo Dainippon Pharma Co., Ltd., Shionogi & Co., Ltd., Eisai Co., Ltd., Tsumura & Co., Nippon Kayaku Co., Ltd., JIMRO Co., Ltd., Kowa Company, Ltd. T. Kagawa: Financial Interests, Personal, Invited Speaker: AbbVie, Eisai, Chugai, Sumitomo Pharma, Gilead, EA Pharma, Asuka, Takeda, Miyarisan, Otsuka, Eli Lilly, Kowa, Bayer;Financial Interests, Personal, Funding: AbbVie, Chugai, Sumitomo Pharma, Diichi Sankyo, Tanabe Mitsubishi, Takeda, MSD, Eisai, Shionogi, EA Pharma, Otsuka, Kyowa Kirin, Sanofi, Teijin, Eli Lilly. T. Yamashita: Financial Interests, Personal, Invited Speaker: Eisai, Chugai, Lilly, Bayer;inancial Interests, Institutional, Invited Speaker: Bristol Myers Squibb, MSD, Ono. M. Moriguchi: Financial Interests, Personal, Invited Speaker: Eisai Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd.;Financial Interests, Personal, Advisory Board: Eisai Co., Ltd., Bayer Yakuhin, Ltd., Eli Lilly Japan K.K., Chugai Pharmaceutical Co., Ltd.;Financial Interests, Institutional, Funding: MSD K.K. Eisai Co., Ltd., Bristol Myers Squibb K.K., Bayer Yakuhin, Ltd. H. Iijima: Financial Interests, Institutional, Funding: Canon Medical systems, GE healthcare. K. Ohkawa: Financial Interests, Personal, Invited Speaker: Gilead, Eisai, Century Medical, Takeda;Financial Interests, Personal, Research Grant: Towa, Sumitomo Chemical. R. Sugimoto: Financial Interests, Personal, Invited Speaker, Speaker and moderator fees: Eisai Co, Eli Lilly Japan K.K., Ono Pharmaceutical Co., Ltd.;Financial Interests, Personal, Invited Speaker, Speaker fees: Gilead Sciences, Chugai Pharmaceutical Co., Ltd.;Financial Interests, Personal, Invited Speaker, Speaker fees: Bayer Yakuhin Ltd, Nobelpharma Co., Ltd., Takeda Pharmaceutical Company Limited. T. Takehara: Financial Interests, Personal, Invited Speaker: Chugai;Financial Interests, Institutional, Research Grant: Chugai. M. Kudo: Financial Interests, Personal, Invited Speaker: Eisai, Chugai, Eli Lilly, Bayer, Takeda, MSD;Financial Interests, Institutional, Research Grant: Otsuka, Sumitomo Dainippon Pharma, EA Pharma, Taiho, Eisai, AbbVie, Gilead Sciences, Takeda, GE Healthcare, Chugai. K. Yamamoto: Financial Interests, Personal, Invited Speaker: Chugai Pharmaceutical, CMIC holdings, Johokiko, Triceps, Kanagawa Medical Practitioners Association;Financial Interests, Personal, Other, Statistical analysis: Otsuka Pharmaceutical;Financial Interests, Personal, Other, Statistical consultation: J-Pharma, Craif, Kanagawa Prefectural Hospital Organization;Financial Interests, Institutional, Other, unlimited grant: Taiho Pharmaceutical;Financial Interests, Institutional, Other, Unlimited grant: Boehringer Ingelheim, Ono Pharmaceutical, Takeda Pharmaceutical, Bayer Yakuhin, Daiichi-Sankyo, Astellas, Kyowa Kirin, Data Vehicle Inc., EP Croit. All other authors have declared no conflicts of interest. Copyright © 2022

Changes in Physical Activity, Physical Function, and Depressive Symptoms Associated With the Coronavirus Disease 2019 Pandemic in Japanese Patients Undergoing Hemodialysis

Background: There are concerns about the impact of the coronavirus disease 2019 (COVID-19) pandemic on physical and mental health. This study aimed to investigate changes in physical activity, physical function, and depressive symptoms during the COVID-19 pandemic in Japanese hemodialysis patients. Method(s): This retrospective longitudinal study included 159 clinically stable outpatients (mean age, 66.8+/-10.9 years;men, 62.2%;median hemodialysis vintage, 8 years) who underwent maintenance hemodialysis at two Japanese dialysis centers between April 2019 and March 2021. Participants' physical activity (steps taken per non-dialysis day), physical function (walking speed and leg strength), and depressive symptoms (Center for Epidemiologic Studies Depression [CES-D] score) before and during the COVID-19 pandemic were compared. Result(s): The steps on non-dialysis day was significantly lower during than before the COVID-19 pandemic (P < 0.01). On the other hand, there were no significant differences in walking speed, leg strength, and CES-D score before and during the COVID-19 pandemic (Figure). Conclusion(s): Although a decline in physical activity during the COVID-19 pandemic was not prevented, no negative impacts of declining physical activity on physical function and depressive symptoms were observed. This is likely because we have implemented a long-term disease management program, such as regularly assessing the physical function and mental status of the patients. Our findings may provide insight into disease management in hemodialysis patients after the COVID-19 pandemic.

TCT CONNECT-214 Impact of the COVID-19 Pandemic on Acute Coronary Syndrome and Stroke Volumes in Non-Western Countries

Background: The coronavirus disease-2019 (COVID-19) has profoundly disrupted health care services both by a massive influx of critical COVID-19 patients and through indirect effects, including medical care avoidance behaviors and the decreased efficiency of existing pathways of care. Methods: We conducted a multinational retrospective survey analyzing the overall volume and the delays in presentation of acute coronary syndromes (ACS) and ischemic strokes during the COVID-19 pandemic (January 1, 2020, to April 30, 2020), comparing historical controls (same period in 2019). Eight centers in 4 countries contributed to the survey: Russia (4), Brazil (2), Kindgom of Saudia Arabia (1), and Tunisia (1). Results: While the ACS volume tended to increase in January and February 2020 in comparison to the same period in 2019, in March and April 2020 the number of ST-segment elevation myocardial infarction (STEMI) decreased by 17.6% and 39.2%, respectively, as well as the number of non-NSTEMI (by 9.6% and 26.4%, respectively) in comparison with March and April 2019. A gradual decrease in stroke cases along the first trimester was found (January -1.6%, February -3.1%, March -5.8%) when comparing 2020 to 2019, followed by 3.5% increase in April 2020 in comparison to March 2020. Early STEMI presentation (≤2 h) was less often encountered in the first quadrimester of 2020 in comparison with the first quadrimester of 2019 (36.2% vs. 23.3%;p < 0.001). Conversely, the delays of ischemic strokes were similar between the 2 periods. [Formula presented] Conclusion: The number of ACS patients requiring invasive approach decreased in March and April 2020 whereas no significant change in ischemic stroke volume was found along the first quadrimester of 2020 in comparison with the same period of 2019. Categories: CORONARY: Acute Coronary Syndromes