Efficacy of sorafenib after liver transplantation in patients with primary hepatic carcinoma exceeding the Milan criteria: a preliminary study
Authors: Ji-Ye Zhu
Guang-Ming Li
Lei Huang
Zhao Li
Xi-Sheng Leng
Tao Li
Journal: OncoTargets and Therapy (2012)
Discipline: CLINICAL MEDICINE
Keywords: chemotherapy; follow up; recurrence; side effect; survival rate
Affiliations: Center of Hepatobiliary Surgery, Peking University People's Hospital, Peking University, Beijing, People's Republic of China.

Abstract:  Background: The purpose of this study was to determine the efficacy of sorafenib in preventing and treating tumor recurrence after liver transplantation in patients with primary hepatic carcinoma exceeding the Milan criteria. Methods: Thirty patients with primary hepatic carcinoma exceeding the Milan criteria underwent liver transplantation at our hospital between March 2008 and June 2010. Matched for age and gender, the patients were randomized to treatment with sorafenib 400 mg bid or capecitabine (control group, 1500 mg bid, administered for 2 weeks followed by a 2-week rest interval in each cycle). Treatments were discontinued 18 months after transplantation if no recurrence occurred. Patients who experienced tumor recurrence continued their allocated treatment until they were deemed no longer suitable for the medication. Sorafenib and capecitabine were stopped or their dose was reduced in patients with severe adverse reactions. Results: The one-year recurrence rates were 53.3% and 86.6% in patients treated with sorafenib and capecitabine, respectively (œá(2) = 3.968, P &lt; 0.05), and the one-year survival rates were 93.3% and 46.6%, respectively (œá(2) = 7.777, P &lt; 0.05). Mean survival time was significantly longer in the sorafenib group (24.6 ¬± 1.7 [range 7-28] months) than in the capecitabine group (16.4 ¬± 2.7 [range 5-34], months (œá(2) = 7.154, P &lt; 0.05). Most treatment-emergent adverse reactions in both treatment groups were of grade 1 or 2 in severity. The incidence of diarrhea and hand-foot syndrome tended to be higher in the sorafenib group. Conclusion: For patients with primary hepatic carcinoma exceeding the Milan criteria, sorafenib may reduce or delay tumor recurrence after liver transplantation and prolong patient survival, with tolerable side effects. 

Retracted: No

PubPeer comments:
 2020 Expression of Concern. https: doi.org 10.2147 OTT.S257418 The Editor-in-Chief and Publisher of OncoTargets and Therapy wish to issue an Expression of Concern for the published article. Concerns have been raised that the study described in the article did not adhere to ethical guidelines as outlined in the Declaration of Helsinki and the Declaration of Istanbul and guidance from the World Health Organization and the World Medical Association regarding the source of transplanted human organs. Specifically, the British Medical Journal Open (BMJ Open) published an article highlighting many papers in which there is concern that transplanted organs were harvested from executed prisoners in China. In response to these concerns we contacted the authors to clarify the source of the transplanted organs received by the patients described in their study. However, despite multiple attempts to contact the authors and their institutions, no response was received. The Editors of OncoTargets and Therapy would like to alert readers of this. We will provide an update if we receive any further information. OncoTargets and Therapy publishes research adhering to internationally accepted ethical standards and is committed to upholding the Declaration of Helsinki and Declaration of Istanbul. Dove Medical Press endorses the ethics guidelines described by the World Health Organization (WHO) and the World Medical Association (WMA). ,