Abstract
Introduction
To compare survival outcomes of radiotherapy (RT) prior to transcatheter arterial chemoembolization (TACE) (RT + TACE) with TACE followed with RT (TACE + RT) in patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombus (PVTT).
Methods
A randomized controlled study was conducted from August 2016 to December 2019 on patients with unresectable HCC and PVTT. The patients were randomly assigned to RT + TACE group or TACE + RT group in a 1:1 ratio. Evaluation of therapeutic effects on the primary tumor was based on the modified Response Evaluation Criteria in Solid Tumors (mRECIST), while that on PVTT was based on the changing of Cheng’s PVTT classification. The primary end-point was overall survival (OS).
Results
The 120 patients who entered this study were evenly assigned to two groups. In the intention-to-treat (ITT) population, the OS rates for RT + TACE group at 1, 2 and 3 years were 61.7%, 27.4% and 15.6%, compared with 45.0%, 16.1% and 4.7% in TACE + RT group. The median OS was increased in patients with RT + TACE compared with those who had TACE + RT with a marginally significance (15.4 versus 11.5 months, HR = 0.68, 95% CI 0.46–1.01, p = 0.054). The median progression-free survival (PFS) in RT + TACE group was 6.6 months versus 4.2 months in TACE + RT group (HR = 0.66, 95% CI 0.46–0.96, p = 0.030). The corresponding disease control rate (DCR) at 3 months was 86.7% versus 66.7% (p = 0.017) and 61.7% versus 46.7% (p = 0.099) at 6 months. In subgroup analyses, RT + TACE was associated with better OS (HR, 0.48; 95% CI 0.33–0.99, p = 0.048) and PFS (HR, 0.55; 95% CI 0.33–0.93, p = 0.026) versus TACE + RT among patients with type III/IV PVTT. There were 3 patients in RT + TACE group and 2 in TACE + RT group had adverse events ≥ grade 3.
Conclusion
Applying RT prior to TACE provided better survival outcomes than TACE followed by RT for patients with HCC and PVTT, which may act as an optimized regional modality to further improve local control rates (Trial registration: ChiCTR ChiCTR2000033573.)
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Data availability statement
All data generated or analyzed during this study are included in this article and its online suppl. Material files. Further inquiries can be directed to the corresponding author.
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Funding
Supported by the Clinical Research Plan of Shanghai Shenkang Hospital Development Center (No: SHDC2020CR1004A); the State Key Program of National Natural Science Foundation of China (No: 81730097); the Natural Science Foundation of China (No: 82102941; No: 82072618); the San Hang Program of Navy Medical University; the Project of Shanghai Municipal Science and Technology Commission (20Y11908800).
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Conception and design: SC, YM, LG, XW, SF. Administrative support: SC, YM, WYL. Provision of study materials or patients: JS, WG, JZ, SC. Collection and assembly of data: LG, XW, SF, JZ. Data analysis and interpretation: LG, XW, SF. Manuscript writing: All authors. Final approval of manuscript: All authors.
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Lei Guo, Xubiao Wei, Shuang Feng, Jian Zhai, Weixing Guo, Jie Shi, Wan Yee Lau, Yan Meng, Shuqun Cheng have no conflicts of interest to declare.
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This study protocol was approved by Ethics Committee of Eastern Hepatobiliary Surgery Hospital, approval number (EHBHKY2016-02–012). Written informed consent was obtained from all participants in this study.
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Guo, L., Wei, X., Feng, S. et al. Radiotherapy prior to or after transcatheter arterial chemoembolization for the treatment of hepatocellular carcinoma with portal vein tumor thrombus: a randomized controlled trial. Hepatol Int 16, 1368–1378 (2022). https://doi.org/10.1007/s12072-022-10423-7
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DOI: https://doi.org/10.1007/s12072-022-10423-7