Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind study
Summary: Background: In the global REACH-2 study, ramucirumab significantly improved overall survival (OS) compared with placebo in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP). REACH-2 China study aimed to evaluate the efficacy and safety of ramuciruma...
| Main Authors: | , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2022-12-01
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| Series: | EClinicalMedicine |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2589537022004096 |
| _version_ | 1811195645912940544 |
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| author | Guoliang Shao Yuxian Bai Xianglin Yuan Xiaomin Chen Shanzhi Gu Kangsheng Gu Chunhong Hu Houjie Liang Yabing Guo Jufeng Wang Chia-Jui Yen Victor Ho-Fun Lee Chunxiao Wang Ryan C. Widau Wanli Zhang Junjun Liu Qiang Zhang Shukui Qin |
| author_facet | Guoliang Shao Yuxian Bai Xianglin Yuan Xiaomin Chen Shanzhi Gu Kangsheng Gu Chunhong Hu Houjie Liang Yabing Guo Jufeng Wang Chia-Jui Yen Victor Ho-Fun Lee Chunxiao Wang Ryan C. Widau Wanli Zhang Junjun Liu Qiang Zhang Shukui Qin |
| author_sort | Guoliang Shao |
| collection | DOAJ |
| description | Summary: Background: In the global REACH-2 study, ramucirumab significantly improved overall survival (OS) compared with placebo in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP). REACH-2 China study aimed to evaluate the efficacy and safety of ramucirumab in Chinese patients with advanced HCC (NCT02435433). Methods: REACH-2 China was a randomised, double-blind, placebo-controlled, phase 3 study done at 31 centres in China between Sep 16, 2015, and March 15, 2021. Patients with advanced HCC and AFP ≥400 ng/mL after first-line sorafenib were randomly assigned (2:1) to receive ramucirumab 8 mg/kg intravenously or placebo Q2W, until disease progression or unacceptable toxicity. The primary endpoint was OS. Efficacy was assessed per intention-to-treat, and safety in patients who received any treatment. Findings: Of 104 Chinese patients enrolled (44 in the global study and 60 in the China extension study), 70 received ramucirumab and 34 received placebo. Median OS was 9·1 months in the ramucirumab group and 6·2 months in the placebo group (HR = 0·854 [95% CI: 0·536, 1·359]). The most common grade 3 or worse treatment-emergent adverse event were hypertension (5 [7·1%] of 70 patients in the ramucirumab group vs 1 [2.9%] of 34 in the placebo group), pneumonia (5 [7·1%] vs 1 [2·9%]), and hyponatraemia (4 [5·7%] vs 0 [0%]). Interpretation: Ramucirumab demonstrated clinically meaningful improvement in OS compared to placebo for Chinese patients with advanced HCC and elevated AFP, although lacking statistical superiority. Ramucirumab was well tolerated, with a manageable safety profile. The results are consistent with those of the global REACH-2 study, supporting a favourable risk-benefit profile for ramucirumab in this population. Funding: Eli Lilly and Company, USA. |
| first_indexed | 2024-04-12T00:46:35Z |
| format | Article |
| id | doaj.art-e806fe3c322947ce9fe7c571dbf725cc |
| institution | Directory Open Access Journal |
| issn | 2589-5370 |
| language | English |
| last_indexed | 2024-04-12T00:46:35Z |
| publishDate | 2022-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | EClinicalMedicine |
| spelling | doaj.art-e806fe3c322947ce9fe7c571dbf725cc2022-12-22T03:54:52ZengElsevierEClinicalMedicine2589-53702022-12-0154101679Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind studyGuoliang Shao0Yuxian Bai1Xianglin Yuan2Xiaomin Chen3Shanzhi Gu4Kangsheng Gu5Chunhong Hu6Houjie Liang7Yabing Guo8Jufeng Wang9Chia-Jui Yen10Victor Ho-Fun Lee11Chunxiao Wang12Ryan C. Widau13Wanli Zhang14Junjun Liu15Qiang Zhang16Shukui Qin17Department of Radiology, Zhejiang Cancer Hospital, Hangzhou, ChinaDepartment of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, ChinaDepartment of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, ChinaDepartment of Intervention Therapy, Guangdong Provincial People's Hospital, Guangzhou, ChinaDepartment of Interventional Radiology, Hunan Cancer Hospital, Changsha, ChinaDepartment of Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, ChinaDepartment of Oncology, The Second Xiangya Hospital of Central South University, Changsha, ChinaDepartment of Oncology and Southwest Cancer Centre, Southwest Hospital, Army Medical University, Chongqing, ChinaDepartment of Infectious Diseases, Nanfang Hospital, Southern Medical University, Guangzhou, ChinaDepartment of Oncology, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, ChinaDepartment of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, TaiwanDepartment of Clinical Oncology, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, ChinaEli Lilly and Company, Indianapolis, USAEli Lilly and Company, Indianapolis, USAEli Lilly and Company, Shanghai, ChinaEli Lilly and Company, Shanghai, ChinaEli Lilly and Company, Shanghai, ChinaCancer Centre of Jinling Hospital, Nanjing University of Chinese Medicine, Nanjing, China; Corresponding author at: Cancer Centre of Jinling Hospital, Nanjing University of Chinese Medicine, Nanjing 210002, China.Summary: Background: In the global REACH-2 study, ramucirumab significantly improved overall survival (OS) compared with placebo in patients with advanced hepatocellular carcinoma (HCC) and elevated alpha-fetoprotein (AFP). REACH-2 China study aimed to evaluate the efficacy and safety of ramucirumab in Chinese patients with advanced HCC (NCT02435433). Methods: REACH-2 China was a randomised, double-blind, placebo-controlled, phase 3 study done at 31 centres in China between Sep 16, 2015, and March 15, 2021. Patients with advanced HCC and AFP ≥400 ng/mL after first-line sorafenib were randomly assigned (2:1) to receive ramucirumab 8 mg/kg intravenously or placebo Q2W, until disease progression or unacceptable toxicity. The primary endpoint was OS. Efficacy was assessed per intention-to-treat, and safety in patients who received any treatment. Findings: Of 104 Chinese patients enrolled (44 in the global study and 60 in the China extension study), 70 received ramucirumab and 34 received placebo. Median OS was 9·1 months in the ramucirumab group and 6·2 months in the placebo group (HR = 0·854 [95% CI: 0·536, 1·359]). The most common grade 3 or worse treatment-emergent adverse event were hypertension (5 [7·1%] of 70 patients in the ramucirumab group vs 1 [2.9%] of 34 in the placebo group), pneumonia (5 [7·1%] vs 1 [2·9%]), and hyponatraemia (4 [5·7%] vs 0 [0%]). Interpretation: Ramucirumab demonstrated clinically meaningful improvement in OS compared to placebo for Chinese patients with advanced HCC and elevated AFP, although lacking statistical superiority. Ramucirumab was well tolerated, with a manageable safety profile. The results are consistent with those of the global REACH-2 study, supporting a favourable risk-benefit profile for ramucirumab in this population. Funding: Eli Lilly and Company, USA.http://www.sciencedirect.com/science/article/pii/S2589537022004096RamucirumabSecond-line therapyAdvanced hepatocellular carcinomaPhase 3 studyChina |
| spellingShingle | Guoliang Shao Yuxian Bai Xianglin Yuan Xiaomin Chen Shanzhi Gu Kangsheng Gu Chunhong Hu Houjie Liang Yabing Guo Jufeng Wang Chia-Jui Yen Victor Ho-Fun Lee Chunxiao Wang Ryan C. Widau Wanli Zhang Junjun Liu Qiang Zhang Shukui Qin Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind study EClinicalMedicine Ramucirumab Second-line therapy Advanced hepatocellular carcinoma Phase 3 study China |
| title | Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind study |
| title_full | Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind study |
| title_fullStr | Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind study |
| title_full_unstemmed | Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind study |
| title_short | Ramucirumab as second-line treatment in Chinese patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after sorafenib (REACH-2 China): A randomised, multicentre, double-blind study |
| title_sort | ramucirumab as second line treatment in chinese patients with advanced hepatocellular carcinoma and elevated alpha fetoprotein after sorafenib reach 2 china a randomised multicentre double blind study |
| topic | Ramucirumab Second-line therapy Advanced hepatocellular carcinoma Phase 3 study China |
| url | http://www.sciencedirect.com/science/article/pii/S2589537022004096 |
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