دورية أكاديمية
Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade
| العنوان: | Efficacy and safety of cabozantinib for patients with advanced hepatocellular carcinoma based on albumin-bilirubin grade |
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| المؤلفون: | Kelley, Robin Kate, Miksad, Rebecca, Cicin, Irfan, Chen, YenHsun, Klümpen, Heinz-Josef, Kim, Stefano, Lin, Zhong-Zhe, Youkstetter, Jillian, Hazra, Saswati, Sen, Suvajit, Cheng, Ann-Lii, El-Khoueiry, Anthony B., Meyer, Tim, Abou-Alfa, Ghassan K. |
| المساهمون: | Exelixis |
| المصدر: | British Journal of Cancer ; volume 126, issue 4, page 569-575 ; ISSN 0007-0920 1532-1827 |
| بيانات النشر: | Springer Science and Business Media LLC |
| سنة النشر: | 2021 |
| مصطلحات موضوعية: | Cancer Research, Oncology |
| الوصف: | Background Albumin-bilirubin (ALBI) grade is an objective measure of liver function for patients with hepatocellular carcinoma (HCC). The tyrosine kinase inhibitor cabozantinib is approved for patients with advanced HCC who have received prior sorafenib based on the phase 3 CELESTIAL trial (NCT01908426). Cabozantinib improved overall survival (OS) and progression-free survival (PFS) versus placebo in patients with previously treated HCC. Methods Patients were randomised 2:1 to receive cabozantinib 60 mg or placebo orally every day. Clinical outcomes in patients with ALBI grade 1 or 2 at baseline were evaluated in CELESTIAL. ALBI scores were retrospectively calculated based on baseline serum albumin and total bilirubin, with an ALBI grade of 1 defined as ≤ −2.60 score and a grade of 2 as a score of > −2.60 to ≤ −1.39. Results Cabozantinib improved OS and PFS versus placebo in both ALBI grade 1 (hazard ratio [HR] [95% CI]: 0.63 [0.46–0.86] and 0.42 [0.32–0.56]) and ALBI grade 2 (HR [95% CI]: 0.84 [0.66–1.06] and 0.46 [0.37–0.58]) subgroups. Adverse events were consistent with those in the overall population. Rates of grade 3/4 adverse events associated with hepatic decompensation were generally low and were more common among patients in the ALBI grade 2 subgroup. Discussion These results provide initial support of cabozantinib in patients with advanced HCC irrespective of ALBI grade 1 or 2. Trial registration number ClinicalTrials.gov number, NCT01908426. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1038/s41416-021-01532-5 |
| الإتاحة: | https://doi.org/10.1038/s41416-021-01532-5Test https://www.nature.com/articles/s41416-021-01532-5.pdfTest https://www.nature.com/articles/s41416-021-01532-5Test |
| حقوق: | https://creativecommons.org/licenses/by/4.0Test ; https://creativecommons.org/licenses/by/4.0Test |
| رقم الانضمام: | edsbas.7AC6EAC8 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1038/s41416-021-01532-5 |
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