[Skip to Content]
[Skip to Content Landing]
Views 757
Citations 0
Original Investigation
November 27, 2019

Long-term Effects of Repeat Hepatectomy vs Percutaneous Radiofrequency Ablation Among Patients With Recurrent Hepatocellular Carcinoma: A Randomized Clinical Trial

Author Affiliations
  • 1Department of Hepatic Surgery, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China
  • 2Department of Ultrasound Intervention Therapy, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China
  • 3Department of Chinese Traditional Medicine, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China
  • 4Clinical Laboratory, Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer, The Second Military Medical University, Shanghai, China
  • 5Department of General Surgery, the affiliated Zhongda Hospital, Southeast University, Nanjing, China
  • 6Department of Surgery, The Ohio State University, Wexner Medical Center, Columbus
  • 7National Center for Liver Cancer, Key Laboratory of Signaling Regulation and Targeting Therapy of Liver Cancer of the Ministry of Education of China, Shanghai Key Laboratory of Hepatobiliary Tumor Biology, Second Military Medical University, Shanghai, China
  • 8Faculty of Medicine, The Chinese University of Hong Kong, Hong Kong, Special Administrative Region, China
JAMA Oncol. Published online November 27, 2019. doi:https://doi.org/10.1001/jamaoncol.2019.4477
Key Points

Question  What are the long-term survival outcomes after repeat hepatectomy vs percutaneous radiofrequency ablation among patients with recurrent hepatocellular carcinoma?

Findings  In this randomized clinical trial that included 240 patients with early-stage recurrent hepatocellular carcinoma, the 1-year, 3-year, and 5-year overall survival rates after repeat hepatectomy (92.5%, 65.8%, and 43.6%, respectively) vs percutaneous radiofrequency ablation (87.5%, 52.5%, and 38.5%, respectively) were not significantly different in the intention-to-treat population.

Meaning  There did not appear to be a statistically significant difference in survival outcomes after repeat hepatectomy compared with percutaneous radiofrequency ablation in patients with early-stage recurrent hepatocellular carcinoma.

Abstract

Importance  Repeat hepatectomy and percutaneous radiofrequency ablation (PRFA) are most commonly used to treat early-stage recurrent hepatocellular carcinoma (RHCC) after initial resection, but previous studies comparing the effectiveness of the 2 treatments have reported conflicting results.

Objective  To compare the long-term survival outcomes after repeat hepatectomy with those after PRFA among patients with early-stage RHCC.

Design, Setting, and Participants  This open-label randomized clinical trial was conducted at the Eastern Hepatobiliary Surgery Hospital and the National Center for Liver Cancer of China. A total of 240 patients with RHCC (with a solitary nodule diameter of ≤5 cm; 3 or fewer nodules, each ≤3 cm in diameter; and no macroscopic vascular invasion or distant metastasis) were randomized 1:1 to receive repeat hepatectomy or PRFA between June 3, 2010, and January 15, 2013. The median (range) follow-up time was 44.3 (4.3-90.6) months (last follow-up, January 15, 2018). Data analysis was conducted from June 15, 2018, to September 28, 2018.

Interventions  Repeat hepatectomy (n = 120) or PRFA (n = 120).

Main Outcomes and Measures  The primary outcome was overall survival (OS). Secondary outcomes included repeat recurrence–free survival (rRFS), patterns of repeat recurrence, and therapeutic safety.

Results  Among the 240 randomized patients (216 men [90.0%]; median [range] age, 53.0 [24.0-59.0] years), 217 completed the trial. In the intention-to-treat (ITT) population, the 1-year, 3-year, and 5-year OS rates were 92.5% (95% CI, 87.9%-97.3%), 65.8% (95% CI, 57.8%-74.8%), and 43.6% (95% CI, 35.5%-53.5%), respectively, for the repeat hepatectomy group and 87.5% (95% CI, 81.8%-93.6%), 52.5% (95% CI, 44.2%-62.2%), and 38.5% (95% CI, 30.6%-48.4%), respectively, for the PRFA group (P = .17). The corresponding 1-year, 3-year, and 5-year rRFS rates were 85.0% (95% CI, 78.8%-91.6%), 52.4% (95% CI, 44.2%-62.2%), and 36.2% (95% CI, 28.5%-46.0%), respectively, for the repeat hepatectomy group and 74.2% (95% CI, 66.7%-82.4%), 41.7% (95% CI, 33.7%-51.5%), and 30.2% (95% CI, 22.9%-39.8%), respectively, for the PRFA group (P = .09). Percutaneous radiofrequency ablation was associated with a higher incidence of local repeat recurrence (37.8% vs 21.7%, P = .04) and early repeat recurrence than repeat hepatectomy (40.3% vs 23.3%, P = .04). In subgroup analyses, PRFA was associated with worse OS vs repeat hepatectomy among patients with an RHCC nodule diameter greater than 3 cm (hazard ratio, 1.72; 95% CI, 1.05-2.84) or an α fetoprotein level greater than 200 ng/mL (hazard ratio, 1.85; 95% CI, 1.15-2.96). Surgery had a higher complication rate than did ablation (22.4% vs 7.3%, P = .001).

Conclusions and Relevance  No statistically significant difference was observed in survival outcomes after repeat hepatectomy vs PRFA for patients with early-stage RHCC. Repeat hepatectomy may be associated with better local disease control and long-term survival in patients with an RHCC diameter greater than 3 cm or an AFP level greater than 200 ng/mL.

Trial Registration  ClinicalTrials.gov identifier: NCT00822562

Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

Identify all potential conflicts of interest that might be relevant to your comment.

Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.

Err on the side of full disclosure.

If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.

Not all submitted comments are published. Please see our commenting policy for details.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    ×