Sorafenib for hepatocellular carcinoma patients beyond Milan criteria after orthotopic liver transplantation: a case control study

Chieh-Lin Teng, Wen-Li Hwang, Yi-Ju Chen, Kuang-Hsi Chang, Shao-Bin Cheng, Chieh-Lin Teng, Wen-Li Hwang, Yi-Ju Chen, Kuang-Hsi Chang, Shao-Bin Cheng

Abstract

Background: Orthotopic liver transplantation (OLT) is one of the most effective treatments for patients with hepatocellular carcinoma (HCC) within the Milan criteria. However, for patients beyond these criteria, the recurrence rate is higher and the prognosis is worse. Sorafenib is the only drug showing survival benefits in advanced HCC patients; however, its role in patients beyond the Milan criteria after OLT remains unclear and requires further investigation.

Methods: As a case-control study, we retrospectively analyzed 17 Chinese patients beyond Milan criteria undergoing OLT for HCC. These patients were stratified into adjuvant (n = 5), palliative (n = 6), and control groups (n = 6).

Results: Nine of 11 patients who received sorafenib after OLT needed dose reduction due to more than grade 2 side effects. The disease-free survival rates for patients with or without adjuvant sorafenib were 100% versus 37.5% (p = 0.034) at 6 months, 66.7% versus 9.4% (p = 0.026) at 12 months, and 66.7% versus 0.0% (p = 0.011) at 18 months, respectively. The overall survival rates for patients in palliative and control groups were 66.7% versus 40.0% (p = 0.248) at 6 months, 66.7% versus 40.0% (p = 0.248) at 12 months, and 50.0% versus 20.0% (p = 0.17) at 18 months, respectively. Patients in the adjuvant group had better overall survival rates than those in the palliative and control groups (p = 0.031) at 24-month follow-up.

Conclusions: Adjuvant sorafenib could possibly extend both disease-free and overall survival for HCC patients beyond Milan criteria after OLT.

Figures

Figure 1
Figure 1
The disease-free survival rate was analyzed by the Kaplan-Meier method. In patients with or without adjuvant sorafenib, it was 100% versus 37.5% (p = 0.034) at 6 months, 66.7% versus 9.4% (p = 0.026) at 12 months, and 66.7% versus 0.0% (p = 0.011) at 18 months, respectively. Adjuvant sorafenib could significantly improve disease-free survival in patients beyond the Milan criteria after orthopedic liver transplantation.
Figure 2
Figure 2
Overall survival rates for patients in the palliative and control groups were 66.7% versus 40.0% (p = 0.248) at 6 months, 66.7% versus 40.0% (p = 0.248) at 12 months, and 50.0% versus 20.0% (p = 0.17) at 18 months, respectively. There were no statistical differences between these two groups.
Figure 3
Figure 3
At 24-month follow up, the overall survival rates for patients in adjuvant, palliative, and control group were 100% (5/5), 50% (3/6), and 16.7% (1/6), respectively. Patients in the adjuvant group had better overall survival than those in the palliative and control groups (p = 0.031).

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Source: PubMed

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