دورية أكاديمية
Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib: Patient-focused outcome results from the randomised phase III REACH study
| العنوان: | Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib: Patient-focused outcome results from the randomised phase III REACH study |
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| المساهمون: | College of Medicine, Dept. of Internal Medicine, Ian Chau, Markus Peck-Radosavljevic, Christophe Borg, Peter Malfertheiner, Jean Francois Seitz, Joon Oh Park, Baek-Yeol Ryoo, Chia-Jui Yen, Masatoshi Kudo, Ronnie Poon, Davide Pastorelli, Jean-Frederic Blanc, Hyun Cheol Chung, Ari D. Baron, Takuji Okusaka, L. Bowman, Zhanglin Lin Cui, Allicia C. Girvan, Paolo B. Abada p, Ling Yang, Andrew X. Zhu, Chung, Hyun Cheol |
| بيانات النشر: | Elsevier Science Ltd |
| سنة النشر: | 2017 |
| مصطلحات موضوعية: | Adult, Aged, 80 and over, Antibodies, Monoclonal/administration & dosage, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Carcinoma, Hepatocellular/drug therapy, Disease-Free Survival, Double-Blind Method, Female, Humans, Kaplan-Meier Estimate, Liver Neoplasms/drug therapy, Male, Middle Aged, Niacinamide/administration & dosage, Niacinamide/analogs & derivatives, Phenylurea Compounds/administration & dosage, Quality of Life, Hepatocellular carcinoma, Patient-focused outcomes, Performance status, Ramucirumab, Sorafenib |
| الوصف: | PURPOSE: To report patient-focused outcomes as measured by quality of life (QoL) and performance status (PS) in REACH, a phase III placebo-controlled randomised study, assessing ramucirumab in advanced hepatocellular carcinoma (HCC) patients who received prior sorafenib. METHODS: Eligible patients had advanced HCC, Child-Pugh A, PS 0 or 1 and prior sorafenib. Patients received ramucirumab (8 mg/kg) or placebo (1:1) on day 1 of a 2-week cycle. QoL was assessed by FACT Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL (EQ-5D) at baseline; cycles 4, 10, and 16; and end of treatment. PS was assessed at baseline, each cycle, and end of treatment. Deterioration in FHSI-8 was defined as a �돟3-point decrease from baseline and PS deterioration was defined as a change of �돟2. Both intention-to-treat and pre-specified subgroup of patients with baseline serum alpha-fetoprotein (AFP) �돟400 ng/mL were assessed. RESULTS: There were 565 patients randomised to ramucirumab and placebo. Compliance with FHSI and EQ-5D was high and similar between groups. In the ITT population, deterioration in FHSI-8, EQ-5D, and PS was similar between ramucirumab and placebo. In patients with baseline AFP �돟400 ng/mL, ramucirumab significantly reduced deterioration in FHSI-8 at the end of treatment compared with placebo (P = 0.0381), and there was a trend towards a delay in the deterioration of symptoms in FHSI-8 (HR 0.690; P = 0.054) and PS (HR 0.642; P = 0.057) in favour of ramucirumab. CONCLUSIONS: We report one of the most comprehensive data sets of QoL and symptom burden in patients undergoing systemic therapy for advanced HCC. Ramucirumab was associated with no worsening of QoL. In patients with baseline AFP �돟400 ng/mL, the significant survival benefit observed in patients treated with ramucirumab was coupled with a trend in patient-focused outcome benefits. ; restriction |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0959-8049 1879-0852 |
| العلاقة: | EUROPEAN JOURNAL OF CANCER; J00809; OAK-2017-03199; https://ir.ymlib.yonsei.ac.kr/handle/22282913/160322Test; https://www.sciencedirect.com/science/article/pii/S0959804917309334Test; T201702091; EUROPEAN JOURNAL OF CANCER, Vol.81 : 17-25, 2017 |
| DOI: | 10.1016/j.ejca.2017.05.001 |
| الإتاحة: | https://doi.org/10.1016/j.ejca.2017.05.001Test https://ir.ymlib.yonsei.ac.kr/handle/22282913/160322Test https://www.sciencedirect.com/science/article/pii/S0959804917309334Test |
| حقوق: | CC BY-NC-ND 2.0 KR ; https://creativecommons.org/licenses/by-nc-nd/2.0/krTest/ |
| رقم الانضمام: | edsbas.A9AB657F |
| قاعدة البيانات: | BASE |
| تدمد: | 09598049 18790852 |
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| DOI: | 10.1016/j.ejca.2017.05.001 |