دورية أكاديمية
Ramucirumab in the second-line for patients with hepatocellular carcinoma and elevated alpha-fetoprotein: patient-reported outcomes across two randomised clinical trials
| العنوان: | Ramucirumab in the second-line for patients with hepatocellular carcinoma and elevated alpha-fetoprotein: patient-reported outcomes across two randomised clinical trials |
|---|---|
| المؤلفون: | 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 |
| المصدر: | Articles publicats en revistes (Medicina) |
| بيانات النشر: | Elsevier |
| سنة النشر: | 2020 |
| المجموعة: | Dipòsit Digital de la Universitat de Barcelona |
| مصطلحات موضوعية: | Càncer de fetge, Qualitat de vida, Liver cancer, Quality of life |
| الوصف: | 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 ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | 9 p.; application/pdf |
| اللغة: | English |
| تدمد: | 2059-7029 |
| العلاقة: | Reproducció del document publicat a: https://doi.org/10.1136/esmoopen-2020-000797Test; Esmo Open, 2020, vol. 5, num. 4, p. e000797; https://doi.org/10.1136/esmoopen-2020-000797Test; http://hdl.handle.net/2445/178116Test; 706131 |
| الإتاحة: | https://doi.org/10.1136/esmoopen-2020-000797Test http://hdl.handle.net/2445/178116Test |
| حقوق: | cc-by-nc-nd (c) European Society for Medical Oncology, CH, 2020 ; https://creativecommons.org/licenses/by-nc-nd/4.0Test/ ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.787DDE7B |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 20597029 |
|---|