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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

DC FieldValueLanguage
dc.contributor.author정현철-
dc.date.accessioned2018-07-20T07:36:06Z-
dc.date.available2018-07-20T07:36:06Z-
dc.date.issued2017-
dc.identifier.issn0959-8049-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/160322-
dc.description.abstractPURPOSE: 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 ≥3-point decrease from baseline and PS deterioration was defined as a change of ≥2. Both intention-to-treat and pre-specified subgroup of patients with baseline serum alpha-fetoprotein (AFP) ≥400 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 ≥400 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 ≥400 ng/mL, the significant survival benefit observed in patients treated with ramucirumab was coupled with a trend in patient-focused outcome benefits.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherElsevier Science Ltd-
dc.relation.isPartOfEUROPEAN JOURNAL OF CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.rightshttps://creativecommons.org/licenses/by-nc-nd/2.0/kr/-
dc.subject.MESHAdult-
dc.subject.MESHAged-
dc.subject.MESHAged, 80 and over-
dc.subject.MESHAntibodies, Monoclonal/administration & dosage-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols/therapeutic use*-
dc.subject.MESHCarcinoma, Hepatocellular/drug therapy*-
dc.subject.MESHDisease-Free Survival-
dc.subject.MESHDouble-Blind Method-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHKaplan-Meier Estimate-
dc.subject.MESHLiver Neoplasms/drug therapy*-
dc.subject.MESHMale-
dc.subject.MESHMiddle Aged-
dc.subject.MESHNiacinamide/administration & dosage-
dc.subject.MESHNiacinamide/analogs & derivatives-
dc.subject.MESHPhenylurea Compounds/administration & dosage-
dc.subject.MESHQuality of Life-
dc.titleRamucirumab 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-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine-
dc.contributor.departmentDept. of Internal Medicine-
dc.contributor.googleauthorIan Chau-
dc.contributor.googleauthorMarkus Peck-Radosavljevic-
dc.contributor.googleauthorChristophe Borg-
dc.contributor.googleauthorPeter Malfertheiner-
dc.contributor.googleauthorJean Francois Seitz-
dc.contributor.googleauthorJoon Oh Park-
dc.contributor.googleauthorBaek-Yeol Ryoo-
dc.contributor.googleauthorChia-Jui Yen-
dc.contributor.googleauthorMasatoshi Kudo-
dc.contributor.googleauthorRonnie Poon-
dc.contributor.googleauthorDavide Pastorelli-
dc.contributor.googleauthorJean-Frederic Blanc-
dc.contributor.googleauthorHyun Cheol Chung-
dc.contributor.googleauthorAri D. Baron-
dc.contributor.googleauthorTakuji Okusaka-
dc.contributor.googleauthorL. Bowman-
dc.contributor.googleauthorZhanglin Lin Cui-
dc.contributor.googleauthorAllicia C. Girvan-
dc.contributor.googleauthorPaolo B. Abada p-
dc.contributor.googleauthorLing Yang-
dc.contributor.googleauthorAndrew X. Zhu-
dc.identifier.doi10.1016/j.ejca.2017.05.001-
dc.contributor.localIdA03773-
dc.relation.journalcodeJ00809-
dc.identifier.eissn1879-0852-
dc.identifier.pmid28591675-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S0959804917309334-
dc.subject.keywordHepatocellular carcinoma-
dc.subject.keywordPatient-focused outcomes-
dc.subject.keywordPerformance status-
dc.subject.keywordQuality of life-
dc.subject.keywordRamucirumab-
dc.subject.keywordSorafenib-
dc.contributor.alternativeNameChung, Hyun Cheol-
dc.contributor.affiliatedAuthorChung, Hyun Cheol-
dc.citation.volume81-
dc.citation.startPage17-
dc.citation.endPage25-
dc.identifier.bibliographicCitationEUROPEAN JOURNAL OF CANCER, Vol.81 : 17-25, 2017-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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