The treatment outcomes of patients who failed to be randomly assigned after atezo/bev induction therapy in the Chinese TALENTop study.

Authors

null

Yiwen Chen

Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

Yiwen Chen , Huichuan Sun , Feng Shen , Minshan Chen , Zhiyong Huang , Tianqiang Song , Yongyi Zeng , Ming Kuang , Bangde Xiang , Lianxin Liu , Deyu Li , Tianfu Wen , Yongjun Chen , Tao Peng , Xiangcheng Li , Xiaodong Zhu , Jian Zhou , Jia Fan , Xueli Bai , Tingbo Liang

Organizations

Department of Hepatobiliary and Pancreatic Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China, Liver Cancer Institute, Zhongshan Hospital, Fudan University, Key Laboratory of Carcinogenesis and Cancer Invasion of Ministry of Education, Shanghai, China, Department Of Hepatic Surgery, Shanghai Eastern Hepatobiliary Surgery Hospital, Shanghai, China, SYSUCC, Guangzhou, Guangdong, China, Tongji Hospital, Huazhong University of Science and Technology, Wuhan, China, Liver Cancer Center, Tianjin Medical University Cancer Institute & Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin; Tianjin’s Clinical Research Center for Cancer, Tianjin, China, Department of Hepatopancreatobiliary Surgery, Mengchao Hepatobiliary Hospital of Fujian Medical University, Fuzhou, China, Center of Hepato-Pancreato-Biliary Surgery, the First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China, Guangxi Medical University Cancer Hospital, Nanning, China, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China, Department of Hepatobiliary Pancreatic Surgery, Henan Provincial People's Hospital, Zhengzhou, China, West China Hospital, Sichuan University, Chengdu, China, Ruijin Hospital, Shanghai Jiaotong University School, Shanghai, China, The First Affiliated Hospital of Guangxi Medical University, Guangxi, China, Hepatobiliary Center of The First Affiliated Hospital Nanjing Medical University, Nanjing, Jiangsu, Nanjing, China, Fudan University Shanghai Cancer Center, Shanghai (China), Shanghai, China, Department of Liver Surgery and Transplantation, Liver Cancer Institute, Zhongshan Hospital, Fudan University; Key Laboratory of Carcinogenesis and Cancer Invasion (Fudan University), Ministry of Education, Shanghai, China, Liver Cancer Institute and Zhongshan Hospital, Fudan University, Shanghai, China, The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China

Research Funding

Shanghai Roche Pharmaceuticals Ltd., China

Background: Hepatocellular carcinoma (HCC) patients with macrovascular invasion (MVI) are considered to be at an advanced stage of disease with limited treatment options. The combination therapy of atezolizumab (atezo) plus bevacizumab (bev) has become a global standard of care for those patients and made conversion resection possible. The Chinese TALENTop study (NCT04649489) is aiming to clarify whether hepatic resection may provide additional benefit in HCC patients with MVI responding to atezo/bev. For patients without opportunity to receive hepatic resection, subsequent treatment outcomes will be reported. Methods: Potentially resectable HCC patients with MVI and without extrahepatic metastasis are eligible for this study. Eligible patients receive 3 cycles of atezo/bev and 1 cycle of atezo as primary systemic therapy (induction phase). Patients assessed as partial response (PR) or stable disease (SD) per RECIST v1.1 and considered suitable for R0 hepatic resection are randomized in a 1:1 ratio to either Arm A, hepatic resection followed by atezo/bev for 1 year, or Arm B, continuing atezo/bev therapy. The primary endpoint is the time to treatment failure. Patients failed to be randomized will enter the survival follow-up phase. After 296 patients entered induction phase, the patient profile, subsequent treatments per local standard of care and survival of patients who failed to be randomized were analyzed. Results: From Apr 2021 to Jun 2023, 296 patients were enrolled and entered induction phase and 175 patients failed to be randomized and were followed up until Sept 2023. The main reasons for failure to be randomized were disease progression (64.6%), investigator assessment of unsuitability for R0 hepatic resection (14.3%), and others. The 175 patients were characterized with a median age of 52 (26-76), and 166 (95%) had HBV infection. Among them, 165 (94%) had combined PVTT, 24 (14%) had combined HVTT and 5 (3%) had combined IVCTT. At a median follow-up time of 10.9 months (9.7-13.1), the median overall survival (mOS) is 13.8 months (8.9-15.8), 6- and 12-month survival rate were 71% and 53%, respectively. As the result of best response during induction phase, 3 patients (1.7%) achieved PR, 92 patients (52.6%) achieved SD and 65 patients (37.1%) were PD. 123 patients (70%) received subsequent therapy. The mOS of patients received different subsequent therapies was showed below. Conclusions: This study provides data on HCC patients with MVI after receiving atezo/bev. The result shows favorable survival even in patients failed to randomization to receive conversion resection, and subsequent treatment strategy may differ survival outcomes. Clinical trial information: NCT04649489.

Subsequent TherapyPatients (n=175)mOS (months)
NA52 (30%)5.7 (4.0-9.3)
Systemic treatment + Locoregional treatment71 (41%)16.2 (14.1-NE)
Systemic treatment24 (14%)15.4 (5.5-NE)
Locoregional treatment28 (16%)8.0 (6.5-NE)

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Abstract Details

Meeting

2024 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Hepatobiliary Cancer - Advanced/Metastatic Disease

Clinical Trial Registration Number

NCT04649489

Citation

J Clin Oncol 42, 2024 (suppl 16; abstr e16183)

DOI

10.1200/JCO.2024.42.16_suppl.e16183

Abstract #

e16183

Abstract Disclosures

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