Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial (original) (raw)

Abstract

Background

Microvascular invasion (MVI) is a risk factor for tumor recurrence after hepatectomy in hepatocellular carcinoma (HCC) patients.

Objective

This study aimed to investigate the efficacy and safety of postoperative adjuvant transarterial infusion chemotherapy (TAI) with the FOLFOX regimen for HCC patients with MVI.

Methods

In this prospective, phase III, randomized, open-label, controlled clinical trial, HCC patients with histologically confirmed MVI were randomly assigned (1:1) after hepatectomy to receive either one to two cycles of adjuvant TAI (AT group) or follow-up without any adjuvant treatment (FU group). The primary endpoint was disease-free survival (DFS), while secondary endpoints were overall survival (OS) and safety.

Results

Between June 2016 and April 2019, 127 patients were randomly assigned to the AT group (n = 63) or FU group (n = 64). Clinicopathological characteristics of the two groups were well-balanced. The 6-, 12-, and 18-month OS rates for the AT group were 100.0%, 97.7%, and 97.7%, respectively, and 94.5%, 89.6%, and 78.5% for the FU group, respectively. The 6-, 12-, and 18-month DFS rates for the AT and FU groups were 84.7%, 61.8%, and 58.7%, and 62.9%, 48.1%, and 38.6%, respectively. OS and DFS were significantly better in the AT group than in the FU group (p = 0.037 and 0.023, respectively). No patients in the AT group experienced grade 3 or more severe adverse events.

Conclusions

Adjuvant TAI after hepatectomy may bring survival benefits to HCC patients with MVI.

Trial registration

Trial number: NCT03192618.

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Change history

• 10 April 2021

A Correction to this paper has been published: https://doi.org/10.1245/s10434-021-09813-2

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Funding

This study was supported by the National Natural Science Foundation of China (No. 81871985); Natural Science Foundation of Guangdong Province (No. 2018A0303130098 and 2017A030310203); Science and Technology Planning Project of Guangdong Province (No. 2017A020215112); Medical Scientific Research Foundation of Guangdong Province (No. A2017477); Science and Technology Planning Project of Guangzhou (No. 201903010017 and No. 201904010479); Clinical Trials Project (5010 Project) of Sun Yat-sen University (No. 5010-2017009); and Clinical Trials Project (308 Project) of Sun Yat-sen University Cancer Center (No. 308-2015-014).

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Author notes

1. Shaohua Li, Jie Mei, and Qiaoxuan Wang contributed equally to this work.

Authors and Affiliations

1. Department of Liver Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People’s Republic of China
   Shaohua Li MD, Jie Mei MD, Lianghe Lu MD, Li Xu MD, Minshan Chen MD, Wenping Lin MD, Jingwen Zou MD, Yuhua Wen MD, Wei Wei MD & Rongping Guo MD
2. State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, Guangdong, People’s Republic of China
   Shaohua Li MD, Jie Mei MD, Qiaoxuan Wang MD, Zhixing Guo MD, Lianghe Lu MD, Yihong Ling MD, Li Xu MD, Minshan Chen MD, Lie Zheng MD, Wenping Lin MD, Jingwen Zou MD, Yuhua Wen MD, Wei Wei MD & Rongping Guo MD
3. Department of Radiation Oncology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People’s Republic of China
   Qiaoxuan Wang MD
4. Department of Ultrasound, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People’s Republic of China
   Zhixing Guo MD
5. Department of Pathology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People’s Republic of China
   Yihong Ling MD
6. Department of Radiology, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People’s Republic of China
   Lie Zheng MD

Authors

1. Shaohua Li MD
2. Jie Mei MD
3. Qiaoxuan Wang MD
4. Zhixing Guo MD
5. Lianghe Lu MD
6. Yihong Ling MD
7. Li Xu MD
8. Minshan Chen MD
9. Lie Zheng MD
10. Wenping Lin MD
11. Jingwen Zou MD
12. Yuhua Wen MD
13. Wei Wei MD
14. Rongping Guo MD

Contributions

Rongping Guo, Wei Wei, and Shaohua Li designed the study; Shaohua Li, Jie Mei, Qiaoxuan Wang, Zhixing Guo, Lianghe Lu, Yihong Ling, Li Xu, Minshan Chen, Wenping Lin, Jingwen Zou, and Yuhua Wen collected the data; Shaohua Li, Jie Mei, Qiaoxuan Wang, Zhixing Guo, Wei Wei, and Rongping Guo analyzed and interpreted the data; Lie Zheng performed the radiological evaluation; Shaohua Li and Rongping Guo prepared the final draft; and all authors were involved in the initial drafting, review, and approval of the manuscript and the decision to submit it for publication.

Corresponding authors

Correspondence toWei Wei MD or Rongping Guo MD.

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The original online version of the article has been revised: Wei Wei has been added as a second corresponding author and an author contribution note was added.

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Li, S., Mei, J., Wang, Q. et al. Postoperative Adjuvant Transarterial Infusion Chemotherapy with FOLFOX Could Improve Outcomes of Hepatocellular Carcinoma Patients with Microvascular Invasion: A Preliminary Report of a Phase III, Randomized Controlled Clinical Trial.Ann Surg Oncol 27, 5183–5190 (2020). https://doi.org/10.1245/s10434-020-08601-8

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• Received: 20 January 2020
• Published: 16 May 2020
• Version of record: 16 May 2020
• Issue date: December 2020
• DOI: https://doi.org/10.1245/s10434-020-08601-8