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http://hdl.handle.net/2445/178116
Title: | Ramucirumab in the second-line for patients with hepatocellular carcinoma and elevated alpha-fetoprotein: patient-reported outcomes across two randomised clinical trials |
Author: | Zhu, Andrew X. Nipp, Ryan D. Finn, Richard S. Galle, Peter R. Llovet i Bayer, Josep Maria Blanc, Jean Frederic Okusaka, Takuji Chau, Ian Cella, David Girvan, Alicia Gable, Jonathon Bowman, Lee Wang, Chunxiao Hsu, Yanzhi Abada, Paolo Kudo, Masatoshi |
Keywords: | Càncer de fetge Qualitat de vida Liver cancer Quality of life |
Issue Date: | 1-Jan-2020 |
Publisher: | Elsevier |
Abstract: | Background: Symptoms of advanced hepatocellular carcinoma (HCC) represent a substantial burden for the patient and are important endpoints to assess when evaluating treatment. Patient-reported outcomes were evaluated in subjects with advanced HCC and baseline alpha-fetoprotein (AFP) ≥400 ng/mL treated with second-line ramucirumab. Patients and methods: Patients with AFP≥400 ng/mL enrolled in the REACH or REACH-2 phase 3 studies were used in this analysis. Eligible patients had advanced HCC, Child-Pugh A, Eastern Cooperative Oncology Group performance status 0/1 and prior sorafenib. Patients received ramucirumab 8 mg/kg or placebo once every 2 weeks. Disease-related symptoms and health-related quality of life (HRQoL) were assessed with the Functional Assessment of Cancer Therapy Hepatobiliary Symptom Index (FHSI)-8 and EuroQoL-5-Dimensions (EQ-5D) instruments, respectively. Time to deterioration (TTD) (≥3-point decrease in FHSI-8 total score;≥0.06-point decrease in EQ-5D score, from randomisation to first date of deterioration) was determined using Kaplan-Meier estimation and the Cox proportional hazards model. Both separate and pooled analyses for REACH AFP≥400 ng/mL and REACH-2 patients were conducted. Results: In the pooled population with AFP ≥400 ng/mL (n=542; ramucirumab, n=316; placebo, n=226), median TTD in FHSI-8 total score was prolonged with ramucirumab relative to placebo (3.3 vs 1.9 months; HR 0.725; (95% CI 0.559 to 0.941); p=0.0152), including significant differences in back pain (0.668; (0.497 to 0.899); p=0.0044), weight loss (0.699; (0.505 to 0.969); p=0.0231) and pain (0.769; (0.588 to 1.005); p=0.0248) symptoms. TTD in EQ-5D score was not significantly different between ramucirumab and placebo groups (median 2.9 vs 1.9 months). Results in the individual trials were consistent with these findings. Conclusions: Ramucirumab in second-line treatment of advanced HCC demonstrates consistent benefit in the delay of deterioration in disease-related symptoms with no worsening of HRQoL. Taken with previously demonstrated ramucirumab-driven survival benefits in this setting, these data may inform patient-clinician discussions about the benefit-risk profile of this therapy. |
Note: | Reproducció del document publicat a: https://doi.org/10.1136/esmoopen-2020-000797 |
It is part of: | Esmo Open, 2020, vol. 5, num. 4, p. e000797 |
URI: | http://hdl.handle.net/2445/178116 |
Related resource: | https://doi.org/10.1136/esmoopen-2020-000797 |
ISSN: | 2059-7029 |
Appears in Collections: | Articles publicats en revistes (Medicina) |
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