Radiofrequency Ablation Is Superior to Ethanol Injection in Early-Stage Hepatocellular Carcinoma Irrespective of Tumor Size
et al. (2013) Radiofrequency Ablation Is Superior to Ethanol Injection in Early-Stage
Hepatocellular Carcinoma Irrespective of Tumor Size. PLoS ONE 8(11): e80276. doi:10.1371/journal.pone.0080276
Radiofrequency Ablation Is Superior to Ethanol Injection in Early-Stage Hepatocellular Carcinoma Irrespective of Tumor Size
Zhong-Zhe Lin 0
Wen-Yi Shau 0
Chiun Hsu 0
Yu-Yun Shao 0
Yi-Chun Yeh 0
Raymond Nien-Chen 0
Kuo 0
Chih-Hung Hsu 0
James Chih-Hsin Yang 0
Ann-Lii Cheng 0
Mei-Shu Lai 0
Tetsuo Takehara, Osaka University Graduate School of Medicine, Japan
0 1 Department of Oncology, National Taiwan University Hospital , Taipei, Taiwan , 2 Department of Internal Medicine, College of Medicine, National Taiwan University , Taipei, Taiwan , 3 Division of Health Technology Assessment, Center for Drug Evaluation , Taipei, Taiwan , 4 Graduate Institute of Oncology, College of Medicine, National Taiwan University , Taipei, Taiwan , 5 Center for Comparative Effectiveness Research, National Center of Excellence for Clinical Trial and Research, National Taiwan University Hospital , Taipei, Taiwan, 6 Taiwan Cancer Registry , Department of Health , Taipei, Taiwan , 7 Graduate Institute of Health Policy and Management, College of Public Health, National Taiwan University , Taipei, Taiwan , 8 Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University , Taipei , Taiwan
Background: Randomized trials suggest that radiofrequency ablation (RFA) may be more effective than percutaneous ethanol injection (PEI) in the treatment of hepatocellular carcinoma (HCC). However, the survival advantage of RFA needs confirmation in daily practice. Methods: We conducted a population-based cohort study using the Taiwan Cancer Registry, National Health Insurance claim database and National Death Registry data from 2004 through 2009. Patients receiving PEI or RFA as first-line treatment for newly-diagnosed stage I-II HCC were enrolled. Results: A total of 658 patients receiving RFA and 378 patients receiving PEI treatment were included for final analysis. The overall survival (OS) rates of patients in the RFA and PEI groups at 5-year were 55% and 42%, respectively (p < 0.01). Compared to patients that received PEI, those that received RFA had lower risks of overall mortality and first-line treatment failure (FTF), with adjusted hazard ratios (HRs) [95% confidence interval (CI)] of 0.60 (0.50-0.73) for OS and 0.54 (0.46-0.64) for FTF. The favorable outcomes for the RFA group were consistently significant for patients with tumors > 2 cm as well as for those with tumors < 2 cm. Consistent results were also observed in other subgroup analyses defined by gender, age, tumor stage, and co-morbidity status. Conclusion: RFA provides better survival benefits than PEI for patients with unresectable stage I-II HCC, irrespective of tumors > 2 cm or 2 cm, in contemporary clinical practice.
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Funding: This study was supported by grants DOH99-TD-B-111-001, DOH100-TD-B-111-001, DOH101-TD-B-111-001, DOH102-TD-B-111-001 from the
Department of Health, Taiwan; NSC 101-2314-B-002-164, NSC 102-2314-B-002-128-MY2 from the National Science Council, Taiwan. The funders had no
role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.
These authors contributed equally to this work.
Hepatocellular carcinoma (HCC) is the leading cause of
death from cancer in many countries [1-4]. Surgical resection
provides a potential cure; however, most patients with HCC are
ineligible for surgical resection [5]. For unresectable early-stage
HCCs, a variety of locoregional therapies have been developed
[6]. Among the available locoregional therapies, percutaneous
ethanol injection (PEI) and radiofrequency ablation (RFA) have
been widely used for small unresectable HCCs [7,8]. RFA or
PEI results in complete necrosis of 50-95% of liver tumors
[9,10]. The estimated 5-year survival of patients receiving PEI
or RFA for early-stage HCC exceeds 50% [11,12], and the
5year survival rate for untreated patients is less than 20% [13].
The American Association for the Study of Liver Diseases
(AASLD) [14] claims that PEI and RFA are equally effective for
HCCs smaller than 2 cm, but the efficacy of RFA is superior to
other local therapies for larger tumors.
Several randomized controlled trials (RCTs) compared RFA
to PEI for the treatment of small HCCs in moderate-sized
patient cohorts [15-19]. The efficacy of RFA may exceed that of
PEI [10]; however, the survival advantage of RFA has not been
demonstrated consistently. The three RCTs performed in Asia
[16-18], show that RFA provides a significant survival
advantage compared to PEI, but the two RCTs performed in
Europe [15,19] did not. A comparison of RFA with PEI from the
perspective of survival is still required [17]. Using data
extracted from these RCTs, three indep (...truncated)