Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: Japanese subgroup analysis of the REACH trial
| Autor: | Yoshiyuki Wada, Ryosuke Tateishi, Masafumi Ikeda, Etsuro Hatano, Hiroshi Ishii, Katsuaki Ukai, Andrew X. Zhu, Ling Yang, Sojiro Morita, Takuji Okusaka, Yukio Osaki, Shuichi Kaneko, Masatoshi Kudo, Hirofumi Fujii, Shuntaro Obi, Shinichi Ohkawa, Paolo Abada, Seiji Kawazoe, Osamu Yokosuka, Mitsuo Shimada, Akihito Tsuji, Gen Sugiyama, Toshihiro Kudo, Junji Furuse, Akihide Masumoto |
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| Rok vydání: | 2016 |
| Předmět: |
Adult
Male Niacinamide Oncology medicine.medical_specialty Carcinoma Hepatocellular Population Subgroup analysis Kaplan-Meier Estimate Antibodies Monoclonal Humanized Drug Administration Schedule Ramucirumab 03 medical and health sciences 0302 clinical medicine Double-Blind Method Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Overall survival Humans In patient education Aged Aged 80 and over education.field_of_study Second line treatment business.industry Phenylurea Compounds Liver Neoplasms Gastroenterology Antibodies Monoclonal Middle Aged Sorafenib medicine.disease digestive system diseases Treatment Outcome 030220 oncology & carcinogenesis Hepatocellular carcinoma Female 030211 gastroenterology & hepatology alpha-Fetoproteins business |
| Zdroj: | Journal of Gastroenterology. 52:494-503 |
| ISSN: | 1435-5922 0944-1174 |
| DOI: | 10.1007/s00535-016-1247-4 |
| Popis: | 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.An analysis was performed with the subset of the intent-to-treat population enrolled in Japan (n = 93).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].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. |
| Databáze: | OpenAIRE |
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