دورية أكاديمية
Sorafenib for Patients with Hepatocellular Carcinoma and Child-Pugh B Liver Cirrhosis: Lessons Learned from a Terminated Study.
| العنوان: | Sorafenib for Patients with Hepatocellular Carcinoma and Child-Pugh B Liver Cirrhosis: Lessons Learned from a Terminated Study. |
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| المؤلفون: | Labeur TA; Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.; Cancer Center Amsterdam, Amsterdam, The Netherlands., Achterbergh R; Hospital Pharmacy, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands., Takkenberg B; Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands., Van Delden O; Department of Radiology and Nuclear Medicine, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands., Mathôt R; Hospital Pharmacy, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands., Klümpen HJ; Department of Medical Oncology, Amsterdam University Medical Centers, University of Amsterdam, Meibergdreef 9, Amsterdam, The Netherlands.; Cancer Center Amsterdam, Amsterdam, The Netherlands. |
| المصدر: | The oncologist [Oncologist] 2020 Sep; Vol. 25 (9), pp. e1274-e1279. Date of Electronic Publication: 2019 Oct 23. |
| نوع المنشور: | Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Oxford University Press Country of Publication: England NLM ID: 9607837 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1549-490X (Electronic) Linking ISSN: 10837159 NLM ISO Abbreviation: Oncologist Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: 2022- : Oxford : Oxford University Press Original Publication: Dayton, Ohio : AlphaMed Press, c1996- |
| مواضيع طبية MeSH: | Antineoplastic Agents*/adverse effects , Carcinoma, Hepatocellular*/drug therapy , Liver Neoplasms*/drug therapy, Humans ; Liver Cirrhosis/complications ; Niacinamide/adverse effects ; Phenylurea Compounds/adverse effects ; Sorafenib/therapeutic use ; Treatment Outcome |
| مستخلص: | Lessons Learned: Recruitment of patients with advanced hepatocellular carcinoma and Child-Pugh B for sorafenib treatment and additional pharmacokinetic studies is challenging. Patients with Child-Pugh B liver cirrhosis have high rates of cirrhosis-related adverse events. Background: Few data are available on the pharmacokinetics (PK) of sorafenib in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh B liver cirrhosis. This study aimed to explore the sorafenib PK and its relationship with efficacy and toxicity in these patients. Methods: Patients with advanced HCC and Child-Pugh B7-8 liver function were prospectively recruited at a tertiary center. Adverse events (AEs), progression-free survival (PFS), and overall survival (OS) were recorded. Patients received a starting dose of 200 b.i.d. with toxicity-adjusted dose escalation to a target dose of 400 mg b.i.d. with PK sampling at fixed time points. Results: Between May 2014 and March 2017, 12 patients were screened, of whom 7 progressed to a terminal stage during the screening (n = 6) or shortly after recruitment (n = 1). The five included patients had median PFS of 3.8 months (range, 1.7-10.8) and OS of 7.4 months (range, 1.7-25.8). Three patients had severe AEs and one patient had a partial response with an OS of 25.8 months. In 2017, the trial was aborted for lack of accrual. Conclusion: Because of low accrual, no conclusion can be drawn on the sorafenib PK in patients with advanced HCC and Child-Pugh B liver cirrhosis. The poor survival and frequent cirrhosis-related AEs suggest limited benefit for most of these patients. (© AlphaMed Press; the data published online to support this summary are the property of the authors.) |
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| المشرفين على المادة: | 0 (Antineoplastic Agents) 0 (Phenylurea Compounds) 25X51I8RD4 (Niacinamide) 9ZOQ3TZI87 (Sorafenib) |
| تواريخ الأحداث: | Date Created: 20191025 Date Completed: 20210618 Latest Revision: 20210618 |
| رمز التحديث: | 20240628 |
| مُعرف محوري في PubMed: | PMC7485346 |
| DOI: | 10.1634/theoncologist.2019-0718 |
| PMID: | 31645371 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 1549-490X |
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| DOI: | 10.1634/theoncologist.2019-0718 |