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RISS 인기검색어
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- 저자 : ( Shuichiro Shiina ) (검색결과 3 건)
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Current Approaches to the Treatment of Early HCC in Japan
( Shuichiro Shiina ) 대한간학회 2020 춘·추계 학술대회 (KASL) Vol.2020 No.1
Hepatocellular carcinoma (HCC) is the 4th most common cause of cancer-related deaths in Japan. In Japan, the most common etiology of HCC is HCV, which is different from that in most Asian countries, where HBV is the most prevalent. About a half of HCC is HCV-related, although the ratio has been gradually decreasing. Since the ethanol injection period, we have had strong argument regarding which treatment is superior for HCC, surgical resection or percutaneous ablation. The Japanese clinical practice guidelines for HCC (4th JSH-HCC guidelines) recommends both surgery and ablation for patients with HCC who have three or fewer lesions, each 3 cm or less in diameter, and whose liver functions are in Child-Pugh grade A or B. Comparison of surgical resection with ablation is considerably difficult; the indications are somewhat different between the two treatments. Patients with a large lesion tend to undergo surgical resection while those with multiple lesions, advanced age, or more deteriorated liver function tend to receive ablation. Furthermore, both treatments are highly operator-dependent and their indications may be different from institution to institution. Thus, a patient who is decided by medical professionals to undergo ablation or surgical resection at an institution may not be given the same treatment at others. There were four randomized controlled trials (RCTs) to compare surgery with RFA; one showed superiority of surgery in survival while the remaining three did not show the difference in survival between the two therapies. To compare surgery with radiofrequency ablation, we conducted a multicenter RCT (SURF trial) in Japan. We recruited patients with primary HCC at 49 hospitals who had three or fewer lesions, each 3 cm or less in diameter ≤ 3 cm, and whose liver functions were in Child-Pugh score of 7 or lower, age between 20 and 79 years. Before randomization, technical and liver functional feasibility for both treatment arms were confirmed by joint chart review by surgeons and hepatologists. Patients were then randomly assigned in a 1:1 ratio to surgery and RFA, stratified by age, infection of HCV, number of tumors, tumor size and institution. The primary endpoints were recurrence free survival (RFS) and overall survival (OS). Between April 2009 and August 2015, a total of 308 patients were enrolled to this trial. Seven patients were excluded because of ineligibility, therefore 150 patients were assigned to surgery and 151 patients to RFA. There was no perioperative mortality. Under the median follow-up of 5 years, the 3-year RFSs of patients who were assigned to surgery and RFA were 49.8% and 47.7%, respectively (hazard ratio [HR] 0.96, 95% CI 0.72-1.28; p = 0.793). The RCT trial did not show difference in RFS between surgery and RFA. In parallel with the RCT, we also conducted SURF Cohort trial. In this cohort trial, HCC patients who fulfilled the enrollment criteria but did not give consent to participate in the RCT were enrolled. Baseline characteristics, such as sex, HCV positivity, size, Child-Pugh score, and platelet count were significantly different between the two treatment groups. Patient’s age was not significantly different between the two treatment. However, it might be due to the age limitation of 79 years in the eligibility criteria. The imbalance in background characteristics may reflect a real-world clinical practice of choosing a treatment. In the cohort study, RFS was not significantly different, either between surgery group and RFA group after adjustment of inversed probability of treatment weighting. SURF trial is ongoing for the final analysis of 5-year overall survival. OS will be assessed after August 2020 as scheduled in the protocol. New-generation MWA systems incorporating water or gas antenna cooling and high-power generation have recently attracted attention. New-generation MWA may create a more predictable ablation zone, a larger ablation volume in a shorter time period. Many high volume centers of ablation have introduced new-generation MWA for liver tumor ablation in Japan. However, its clinical data have been insufficient compared with that of RFA. There have been four RCTs to compare new-generation MWA with RFA. None of them have proved superiority of MWA over RFA from the viewpoint of overall survival. Further studies are mandatory especially in terms of long-term survival. Both surgery and ablation are highly operator-dependent. The skills and outcomes are very different from operator to operator. In surgery, the Japanese Society of Hepato-Biliary-Pancreatic Surgery has a board-certification system for expert surgeons. On the other hand, in ablation, there is no established training system yet. Because the procedure appears to be relatively simple, we are afraid that ablation is sometimes done without sufficient training. It is mandatory to have the system which enhances acquisition of knowledge and skills for successful ablation. In Japan, more than 80% of liver tumor ablation is performed by gastroenterologists or hepatologists. The remaining are done by surgeons or radiologists. The result of final analysis in SURF trial is not coming yet. However, we expect ablation would be proved to be the first-line treatment even for solitary HCC. Ablation would play a more important role in the aging society. In ablation, it is mandatory to establish the system to exchange knowledge and experience and standardize the procedure.
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