Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: Japanese subgroup analysis of the REACH trial
Background REACH evaluated ramucirumab in the second-line treatment of patients with advanced hepatocellular carcinoma. In the intent-to-treat population (n = 565), a significant improvement in overall survival (OS) was not observed. In patients with an elevated baseline α-fetoprotein (AFP) level (400 ng/mL or greater), an improvement in OS was demonstrated. An analysis of the Japanese patients in REACH was performed. Methods An analysis was performed with the subset of the intent-to-treat population enrolled in Japan (n = 93). Results The median OS was 12.9 months for the ramucirumab arm (n = 45) and 8.0 months for the placebo arm (n = 48) [hazard ratio (HR) 0.621 (95 % confidence interval (CI) 0.391–0.986); P = 0.0416]. The median progression-free survival was 4.1 months for the ramucirumab arm and 1.7 months for the placebo arm [HR 0.449 (95 % CI 0.285–0.706); P = 0.0004]. The objective response rates were 11 % for the ramucirumab arm and 2 % for the placebo arm (P = 0.0817). The grade 3 or higher treatment-emergent adverse events occurring in more than 5 % of patients with a higher incidence for the ramucirumab arm (n = 44) than for the placebo arm (n = 47) were ascites (7% vs 2 %), hypertension (7 % vs 2 %), and cholangitis (7 % vs 0 %). In patients with a baseline AFP level of 400 ng/mL or greater, the median OS was 12.9 months for the ramucirumab arm (n = 20) and 4.3 months for the placebo arm (n = 22) [HR 0.464 (95 % CI 0.232–0.926); P = 0.0263]. Conclusions In the Japanese patients in REACH, ramucirumab treatment improved OS, including in patients with a baseline AFP level of 400 ng/mL or greater; improvements in progression-free survival and objective response rate were also demonstrated. The safety profile of ramucirumab was acceptable and well tolerated in Japanese patients. ClinicalTrials.gov identifier NCT01140347..
| Medienart: |
Artikel |
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| Erscheinungsjahr: |
2016 |
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| Erschienen: |
2016 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:52 |
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| Enthalten in: |
Journal of gastroenterology - 52(2016), 4 vom: 22. Aug., Seite 494-503 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kudo, Masatoshi [VerfasserIn] |
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| Links: |
Volltext [lizenzpflichtig] |
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| Themen: |
α-Fetoprotein |
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| Anmerkungen: |
© Japanese Society of Gastroenterology 2016 |
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| doi: |
10.1007/s00535-016-1247-4 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
OLC2107315663 |
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| LEADER | 01000naa a22002652 4500 | ||
|---|---|---|---|
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| 100 | 1 | |a Kudo, Masatoshi |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: Japanese subgroup analysis of the REACH trial |
| 264 | 1 | |c 2016 | |
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| 500 | |a © Japanese Society of Gastroenterology 2016 | ||
| 520 | |a Background REACH evaluated ramucirumab in the second-line treatment of patients with advanced hepatocellular carcinoma. In the intent-to-treat population (n = 565), a significant improvement in overall survival (OS) was not observed. In patients with an elevated baseline α-fetoprotein (AFP) level (400 ng/mL or greater), an improvement in OS was demonstrated. An analysis of the Japanese patients in REACH was performed. Methods An analysis was performed with the subset of the intent-to-treat population enrolled in Japan (n = 93). Results The median OS was 12.9 months for the ramucirumab arm (n = 45) and 8.0 months for the placebo arm (n = 48) [hazard ratio (HR) 0.621 (95 % confidence interval (CI) 0.391–0.986); P = 0.0416]. The median progression-free survival was 4.1 months for the ramucirumab arm and 1.7 months for the placebo arm [HR 0.449 (95 % CI 0.285–0.706); P = 0.0004]. The objective response rates were 11 % for the ramucirumab arm and 2 % for the placebo arm (P = 0.0817). The grade 3 or higher treatment-emergent adverse events occurring in more than 5 % of patients with a higher incidence for the ramucirumab arm (n = 44) than for the placebo arm (n = 47) were ascites (7% vs 2 %), hypertension (7 % vs 2 %), and cholangitis (7 % vs 0 %). In patients with a baseline AFP level of 400 ng/mL or greater, the median OS was 12.9 months for the ramucirumab arm (n = 20) and 4.3 months for the placebo arm (n = 22) [HR 0.464 (95 % CI 0.232–0.926); P = 0.0263]. Conclusions In the Japanese patients in REACH, ramucirumab treatment improved OS, including in patients with a baseline AFP level of 400 ng/mL or greater; improvements in progression-free survival and objective response rate were also demonstrated. The safety profile of ramucirumab was acceptable and well tolerated in Japanese patients. ClinicalTrials.gov identifier NCT01140347. | ||
| 650 | 4 | |a α-Fetoprotein | |
| 650 | 4 | |a Clinical trial | |
| 650 | 4 | |a Japan | |
| 650 | 4 | |a Liver neoplasms | |
| 650 | 4 | |a Vascular endothelial growth factor receptor 2 | |
| 700 | 1 | |a Hatano, Etsuro |4 aut | |
| 700 | 1 | |a Ohkawa, Shinichi |4 aut | |
| 700 | 1 | |a Fujii, Hirofumi |4 aut | |
| 700 | 1 | |a Masumoto, Akihide |4 aut | |
| 700 | 1 | |a Furuse, Junji |4 aut | |
| 700 | 1 | |a Wada, Yoshiyuki |4 aut | |
| 700 | 1 | |a Ishii, Hiroshi |4 aut | |
| 700 | 1 | |a Obi, Shuntaro |4 aut | |
| 700 | 1 | |a Kaneko, Shuichi |4 aut | |
| 700 | 1 | |a Kawazoe, Seiji |4 aut | |
| 700 | 1 | |a Yokosuka, Osamu |4 aut | |
| 700 | 1 | |a Ikeda, Masafumi |4 aut | |
| 700 | 1 | |a Ukai, Katsuaki |4 aut | |
| 700 | 1 | |a Morita, Sojiro |4 aut | |
| 700 | 1 | |a Tsuji, Akihito |4 aut | |
| 700 | 1 | |a Kudo, Toshihiro |4 aut | |
| 700 | 1 | |a Shimada, Mitsuo |4 aut | |
| 700 | 1 | |a Osaki, Yukio |4 aut | |
| 700 | 1 | |a Tateishi, Ryosuke |4 aut | |
| 700 | 1 | |a Sugiyama, Gen |4 aut | |
| 700 | 1 | |a Abada, Paolo Benjamin |4 aut | |
| 700 | 1 | |a Yang, Ling |4 aut | |
| 700 | 1 | |a Okusaka, Takuji |4 aut | |
| 700 | 1 | |a Zhu, Andrew Xiuxuan |4 aut | |
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