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...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Guoliang Shao [verfasserIn] Yuxian Bai [verfasserIn] Xianglin Yuan [verfasserIn] Xiaomin Chen [verfasserIn] Shanzhi Gu [verfasserIn] Kangsheng Gu [verfasserIn] Chunhong Hu [verfasserIn] Houjie Liang [verfasserIn] Yabing Guo [verfasserIn] Jufeng Wang [verfasserIn] Chia-Jui Yen [verfasserIn] Victor Ho-Fun Lee [verfasserIn] Chunxiao Wang [verfasserIn] Ryan C. Widau [verfasserIn] Wanli Zhang [verfasserIn] Junjun Liu [verfasserIn] Qiang Zhang [verfasserIn] Shukui Qin [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2022 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
In: EClinicalMedicine - Elsevier, 2018, 54(2022), Seite 101679- |
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| Übergeordnetes Werk: |
volume:54 ; year:2022 ; pages:101679- |
| Links: |
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| DOI / URN: |
10.1016/j.eclinm.2022.101679 |
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| Katalog-ID: |
DOAJ001104624 |
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| 245 | 1 | 0 | |a 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 |
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| 520 | |a 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. | ||
| 650 | 4 | |a Ramucirumab | |
| 650 | 4 | |a Second-line therapy | |
| 650 | 4 | |a Advanced hepatocellular carcinoma | |
| 650 | 4 | |a Phase 3 study | |
| 650 | 4 | |a China | |
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| 700 | 0 | |a Yuxian Bai |e verfasserin |4 aut | |
| 700 | 0 | |a Xianglin Yuan |e verfasserin |4 aut | |
| 700 | 0 | |a Xiaomin Chen |e verfasserin |4 aut | |
| 700 | 0 | |a Shanzhi Gu |e verfasserin |4 aut | |
| 700 | 0 | |a Kangsheng Gu |e verfasserin |4 aut | |
| 700 | 0 | |a Chunhong Hu |e verfasserin |4 aut | |
| 700 | 0 | |a Houjie Liang |e verfasserin |4 aut | |
| 700 | 0 | |a Yabing Guo |e verfasserin |4 aut | |
| 700 | 0 | |a Jufeng Wang |e verfasserin |4 aut | |
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| 700 | 0 | |a Victor Ho-Fun Lee |e verfasserin |4 aut | |
| 700 | 0 | |a Chunxiao Wang |e verfasserin |4 aut | |
| 700 | 0 | |a Ryan C. Widau |e verfasserin |4 aut | |
| 700 | 0 | |a Wanli Zhang |e verfasserin |4 aut | |
| 700 | 0 | |a Junjun Liu |e verfasserin |4 aut | |
| 700 | 0 | |a Qiang Zhang |e verfasserin |4 aut | |
| 700 | 0 | |a Shukui Qin |e verfasserin |4 aut | |
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10.1016/j.eclinm.2022.101679 doi (DE-627)DOAJ001104624 (DE-599)DOAJe806fe3c322947ce9fe7c571dbf725cc DE-627 ger DE-627 rakwb eng R5-920 Guoliang Shao verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Ramucirumab Second-line therapy Advanced hepatocellular carcinoma Phase 3 study China Medicine (General) Yuxian Bai verfasserin aut Xianglin Yuan verfasserin aut Xiaomin Chen verfasserin aut Shanzhi Gu verfasserin aut Kangsheng Gu verfasserin aut Chunhong Hu verfasserin aut Houjie Liang verfasserin aut Yabing Guo verfasserin aut Jufeng Wang verfasserin aut Chia-Jui Yen verfasserin aut Victor Ho-Fun Lee verfasserin aut Chunxiao Wang verfasserin aut Ryan C. Widau verfasserin aut Wanli Zhang verfasserin aut Junjun Liu verfasserin aut Qiang Zhang verfasserin aut Shukui Qin verfasserin aut In EClinicalMedicine Elsevier, 2018 54(2022), Seite 101679- (DE-627)1035271834 25895370 nnns volume:54 year:2022 pages:101679- https://doi.org/10.1016/j.eclinm.2022.101679 kostenfrei https://doaj.org/article/e806fe3c322947ce9fe7c571dbf725cc kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537022004096 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 54 2022 101679- |
| spelling |
10.1016/j.eclinm.2022.101679 doi (DE-627)DOAJ001104624 (DE-599)DOAJe806fe3c322947ce9fe7c571dbf725cc DE-627 ger DE-627 rakwb eng R5-920 Guoliang Shao verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Ramucirumab Second-line therapy Advanced hepatocellular carcinoma Phase 3 study China Medicine (General) Yuxian Bai verfasserin aut Xianglin Yuan verfasserin aut Xiaomin Chen verfasserin aut Shanzhi Gu verfasserin aut Kangsheng Gu verfasserin aut Chunhong Hu verfasserin aut Houjie Liang verfasserin aut Yabing Guo verfasserin aut Jufeng Wang verfasserin aut Chia-Jui Yen verfasserin aut Victor Ho-Fun Lee verfasserin aut Chunxiao Wang verfasserin aut Ryan C. Widau verfasserin aut Wanli Zhang verfasserin aut Junjun Liu verfasserin aut Qiang Zhang verfasserin aut Shukui Qin verfasserin aut In EClinicalMedicine Elsevier, 2018 54(2022), Seite 101679- (DE-627)1035271834 25895370 nnns volume:54 year:2022 pages:101679- https://doi.org/10.1016/j.eclinm.2022.101679 kostenfrei https://doaj.org/article/e806fe3c322947ce9fe7c571dbf725cc kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537022004096 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 54 2022 101679- |
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10.1016/j.eclinm.2022.101679 doi (DE-627)DOAJ001104624 (DE-599)DOAJe806fe3c322947ce9fe7c571dbf725cc DE-627 ger DE-627 rakwb eng R5-920 Guoliang Shao verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Ramucirumab Second-line therapy Advanced hepatocellular carcinoma Phase 3 study China Medicine (General) Yuxian Bai verfasserin aut Xianglin Yuan verfasserin aut Xiaomin Chen verfasserin aut Shanzhi Gu verfasserin aut Kangsheng Gu verfasserin aut Chunhong Hu verfasserin aut Houjie Liang verfasserin aut Yabing Guo verfasserin aut Jufeng Wang verfasserin aut Chia-Jui Yen verfasserin aut Victor Ho-Fun Lee verfasserin aut Chunxiao Wang verfasserin aut Ryan C. Widau verfasserin aut Wanli Zhang verfasserin aut Junjun Liu verfasserin aut Qiang Zhang verfasserin aut Shukui Qin verfasserin aut In EClinicalMedicine Elsevier, 2018 54(2022), Seite 101679- (DE-627)1035271834 25895370 nnns volume:54 year:2022 pages:101679- https://doi.org/10.1016/j.eclinm.2022.101679 kostenfrei https://doaj.org/article/e806fe3c322947ce9fe7c571dbf725cc kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537022004096 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 54 2022 101679- |
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10.1016/j.eclinm.2022.101679 doi (DE-627)DOAJ001104624 (DE-599)DOAJe806fe3c322947ce9fe7c571dbf725cc DE-627 ger DE-627 rakwb eng R5-920 Guoliang Shao verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Ramucirumab Second-line therapy Advanced hepatocellular carcinoma Phase 3 study China Medicine (General) Yuxian Bai verfasserin aut Xianglin Yuan verfasserin aut Xiaomin Chen verfasserin aut Shanzhi Gu verfasserin aut Kangsheng Gu verfasserin aut Chunhong Hu verfasserin aut Houjie Liang verfasserin aut Yabing Guo verfasserin aut Jufeng Wang verfasserin aut Chia-Jui Yen verfasserin aut Victor Ho-Fun Lee verfasserin aut Chunxiao Wang verfasserin aut Ryan C. Widau verfasserin aut Wanli Zhang verfasserin aut Junjun Liu verfasserin aut Qiang Zhang verfasserin aut Shukui Qin verfasserin aut In EClinicalMedicine Elsevier, 2018 54(2022), Seite 101679- (DE-627)1035271834 25895370 nnns volume:54 year:2022 pages:101679- https://doi.org/10.1016/j.eclinm.2022.101679 kostenfrei https://doaj.org/article/e806fe3c322947ce9fe7c571dbf725cc kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537022004096 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 54 2022 101679- |
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10.1016/j.eclinm.2022.101679 doi (DE-627)DOAJ001104624 (DE-599)DOAJe806fe3c322947ce9fe7c571dbf725cc DE-627 ger DE-627 rakwb eng R5-920 Guoliang Shao verfasserin aut 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 2022 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier 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. Ramucirumab Second-line therapy Advanced hepatocellular carcinoma Phase 3 study China Medicine (General) Yuxian Bai verfasserin aut Xianglin Yuan verfasserin aut Xiaomin Chen verfasserin aut Shanzhi Gu verfasserin aut Kangsheng Gu verfasserin aut Chunhong Hu verfasserin aut Houjie Liang verfasserin aut Yabing Guo verfasserin aut Jufeng Wang verfasserin aut Chia-Jui Yen verfasserin aut Victor Ho-Fun Lee verfasserin aut Chunxiao Wang verfasserin aut Ryan C. Widau verfasserin aut Wanli Zhang verfasserin aut Junjun Liu verfasserin aut Qiang Zhang verfasserin aut Shukui Qin verfasserin aut In EClinicalMedicine Elsevier, 2018 54(2022), Seite 101679- (DE-627)1035271834 25895370 nnns volume:54 year:2022 pages:101679- https://doi.org/10.1016/j.eclinm.2022.101679 kostenfrei https://doaj.org/article/e806fe3c322947ce9fe7c571dbf725cc kostenfrei http://www.sciencedirect.com/science/article/pii/S2589537022004096 kostenfrei https://doaj.org/toc/2589-5370 Journal toc kostenfrei GBV_USEFLAG_A SYSFLAG_A GBV_DOAJ GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_73 GBV_ILN_74 GBV_ILN_95 GBV_ILN_105 GBV_ILN_110 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_206 GBV_ILN_213 GBV_ILN_230 GBV_ILN_285 GBV_ILN_293 GBV_ILN_602 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2038 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2110 GBV_ILN_2112 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2153 GBV_ILN_2190 GBV_ILN_2336 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4338 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 AR 54 2022 101679- |
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Guoliang Shao @@aut@@ Yuxian Bai @@aut@@ Xianglin Yuan @@aut@@ Xiaomin Chen @@aut@@ Shanzhi Gu @@aut@@ Kangsheng Gu @@aut@@ Chunhong Hu @@aut@@ Houjie Liang @@aut@@ Yabing Guo @@aut@@ Jufeng Wang @@aut@@ Chia-Jui Yen @@aut@@ Victor Ho-Fun Lee @@aut@@ Chunxiao Wang @@aut@@ Ryan C. Widau @@aut@@ Wanli Zhang @@aut@@ Junjun Liu @@aut@@ Qiang Zhang @@aut@@ Shukui Qin @@aut@@ |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">DOAJ001104624</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230307021412.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">230225s2022 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1016/j.eclinm.2022.101679</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)DOAJ001104624</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)DOAJe806fe3c322947ce9fe7c571dbf725cc</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="050" ind1=" " ind2="0"><subfield code="a">R5-920</subfield></datafield><datafield tag="100" ind1="0" ind2=" "><subfield code="a">Guoliang Shao</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">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</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2022</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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. 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Guoliang Shao misc R5-920 misc Ramucirumab misc Second-line therapy misc Advanced hepatocellular carcinoma misc Phase 3 study misc China misc Medicine (General) 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 |
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R5-920 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 Ramucirumab Second-line therapy Advanced hepatocellular carcinoma Phase 3 study China |
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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 |
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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 |
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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 |
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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 |
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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 |
| abstract |
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. |
| abstractGer |
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. |
| abstract_unstemmed |
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. |
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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 |
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https://doi.org/10.1016/j.eclinm.2022.101679 https://doaj.org/article/e806fe3c322947ce9fe7c571dbf725cc http://www.sciencedirect.com/science/article/pii/S2589537022004096 https://doaj.org/toc/2589-5370 |
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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 |
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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 |
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10.1016/j.eclinm.2022.101679 |
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R5-920 |
| up_date |
2024-07-03T18:26:24.204Z |
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