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수록범위 : 2012권1호(2012)~2020권1호(2020) |수록논문 수 : 3,129
춘·추계 학술대회 (KASL)
2020권1호(2020년 08월) 수록논문
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1Pharmacological Treatment of Alcoholic Hepatitis

저자 : Gyongyi Szabo

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 2-2 (1 pages)

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Severe alcoholic hepatitis (AH) is an acute and often devastating form of alcohol-associated liver disease. Clinically, AH is characterized by elevated bilirubin, MELD >20, and nonspecific symptoms that are caused by underlying inflammation, hepatocyte injury, and impaired intestinal barrier function. Compromised immune defense in AH contributes to infections, sepsis and organ failure. To date, corticosteroids are the only recommended treatment for severe AH, however it does not provide survival benefits beyond one month. Recent preclinical and early clinical studies in AH aided understanding of the disease and presented opportunities for new therapeutic options targeting inflammation, oxidative stress, liver regeneration and modification of intestinal microbiota. In this comprehensive review, we discuss promising preclinical results and ongoing clinical trials evaluating novel therapeutic agents for the treatment of severe AH.

2Pharmacologic Therapy for the Treatment of NASH

저자 : Manal Abdelmalek

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 3-5 (3 pages)

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Nonalcoholic steatohepatitis is a leading cause of chronic liver disease worldwide. Although lifestyle modification remains the primary recommendation NAFLD/NASH, sustaining lifestyle changes is challenging for the majority of patients. There are currently no FDA approved drugs for the treatment of NASH, many pharmacologic approaches are being evaluated to prevent the developed of progressive hepatic fibrosis, cirrhosis and its associated complications. While there are a vast number of targets in preclinical and early clinical development, few have progressed to late phase clinical trials. Focus in this presentation will be paid only on the primary mechanisms of action of specific drugs entering or currently in phase 3 clinical studies. Of note, NASH is likely a heterogeneous disease, with patients arriving at a common phenotype by different mechanisms. In the future, there may be an era of personalized medicine and/or use of combination therapy by which clinicians can select specific therapies based on a patient's genetic, histologic or clinical phenotype.
Currently available pharmacotherapy for treatment of NASH include pioglitazone and vitamin E. Both pioglitazone can improve NASH. Based on these data, the AASLD and the EASL guidelines on NASH state that pioglitazone can be considered in patients with biopsy-proven NASH, taking into account the risks of weight gain, loss of bone density, and bladder cancer. Two placebo-controlled studies, one in children and one in adults, did show a benefit of vitamin E, although only in some patients in both groups. However, using therapeutic doses of vitamin E may not be completely benign, as studies have suggested an increased risk of cardiovascular disease. The society guidelines recommend that vitamin E be considered in noncirrhotic, nondiabetic patients with biopsy- proven NASH at a dose of 800 IU of the natural form (i.e, rrr-α-tocopherol).

3New Horizon of Immuno-Oncologic Therapy

저자 : Amit Singal

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 6-7 (2 pages)

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4Past, Present, and Future of Precision Hepatology: Where Do We Need to Go?

저자 : W. Ray Kim

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 10-11 (2 pages)

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Precision Medicine commonly refers to methods by which to tailor medical treatment by classifying individuals according to their susceptibility to a particular disease, prognosis in case the disease does develop and likelihood of response to a specific treatment for the condition. Predicting health outcomes is a key ingredient of precision medicine.
It is long held that health outcomes are a result of interaction between the genes of the individual and their environment. It follows then by acquiring complete information about the genes and the environment and developing tools to integrate the information, precise prediction of health outcomes would be possible.
Artificial intelligence has received much attention as a new tool to revolutionalize precision medicine. AI has been used in image analysis, modeling decision making and outcome prediction as well as a number of other applications. Machine learning represents a group of new tools that recognize patterns in data that may be used for medical decision making.
We have recently completed a study in which we developed a machine learning model to predict clinically significant liver fibrosis (>F2) among patients with NAFLD. Out of a number of algorithms tested, random forest performed the best compared, for example, to the conventional multivariable logistic regression analysis and existing markers of fibrosis such as FIB-4 and NFS. The model now termed Steatosis Associated Fibrosis Estimator (SAFE) score has a high negative predictive value - patients with a good SAFE score may be considered 'safe' from the risk of long term complications of NAFLD.
When the SAFE score is applied to a population-based followup data, a low SAFE score (<35) portended no in-crease m mortality compared to individuals without NAFLD. Increasing SAFE score was associated with progressively higher risk of mortality. This is a diagnostic study which is an example where AI/ML methods my enhance medical decision making compared to traditional statistical analysis.
MELD 3.0 may be a counter-example where human intelligence guiding conventional tools may be more helpful than machine learning. MELD 3.0 is the latest innovation in MELD which incorporates additional variables (female sex and albumin) as well as a number of further refinements. While the model fits the latest waitlist data better than the original MELD or MELDNa, it also addresses gender inequality in waitlist outcomes. In light of the nuances that exist in organ allocation decisions and the need for transparency, the traditional Cox regression was considered the tool of choice. In addition, the superiority of AI/ML algorithsm in predicting future events (e.g.,, waitlist death) compared to existing statistical models remains to be proven.
In summary, increasing availability of more data and better analytic tools holds promises to precision medicine for the future. The SAFE and MELD3.0 examples highlight that as of today, artificial intelligence may be well-suited for correlational diagnostic analysis, whereas human intellignce guiding computing power remains an important tool for precision medicine today, especially for prediction of future events.

5Current Evidences and Future Perspectives for the Treatment of Advanced Hepatocellular Carcinoma

저자 : Jeong Won Jang

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 14-15 (2 pages)

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Hepatocellular carcinoma (HCC) is the sixth most common cancer and the third leading cause of cancer deaths worldwide. For most patients with HCC, the diagnosis is delayed and the prognosis is poor, especially in patients with advanced HCC. Until recently, few therapies have shown to effectively improve the prognosis of advanced HCC.
Since it was first approved as a treatment option in 2007, sorafenib has remained the only therapy with proven efficacy in advanced HCC over the past decade. In 2018, the phase III trial of lenvatinib showed non-inferior survival versus sorafenib and remains another first-line option for advanced HCC. Other tyrosine kinase inhibitors (TKI), regorafenib and cabozantinib, also provided significantly improved survival in the second-line setting in patients who were refractory to sorafenib. Ramucirumab, a VEGF inhibitor, was also shown to offer survival benefits as a second-line option specifically for sorafenib-refractory patients with AFP ≥ 400 ng/dL.
More recently, another type of therapeutics, immune check point inhibitors (ICI), has presented a major breakthrough in treatment of advanced HCC. Nivolumab and pembrolizamab, an anti-PD-1 inhibitor, showed promising results and durable responses in Phase II trials, and thus achieved conditional FDA-approval as the second- line option. However, recent phase III tirlas of these agents have failed to meet their prespecified endpoints on treatment outcomes. Other immuno-targets, such as PD-L1 (durvalumab, atezolimumab, avelumab) or CTLA4 (tremelimumab, Ipilimumab) are currently being studied in clinical trials of advanced HCC.
The favorable treatment outcomes and acceptable toxicity profiles of ICI brought a treatment paradigm shift from a single therapy to combination strategies: ongoing trials are evaluating combination of anti-PD-1/anti-PD-L1/anti-CTLA4 as a backbone with TKIs, VEGF inhibitors, locoregional therapies, or even other ICI agents in hopes of further increasing objective responses and overall survival in this patient population. The IMbrave150 trial investigating the combination of atezolizumab (anti-PD-L1) and bevacizumab (anti-VEGF antibody) in patients with advanced HCC with no history of prior systemic therapy demonstrated a significant improvement in both OS and PFS over sorafenib. Based on the promising results, atezolizumab plus bevacizumab regimen was granted FDA approval for patients with unresectable HCC who have not received prior systemic therapy. This regimen not only gives insights into a new standard of first-line therapy for advanced HCC but also changing landscape of systemic therapy.
Currently, several combinations of anti-PD-1/anti-PD-L1 plus TKIs are being tested in different stages of HCC, including lenvatinib + pembrolizumab, camrelizumab + apatinib, atezolizumab + cabozantinib. These TKIs have reportedly immune modulatory effects as well as anti-angiogenic effects in tumor microenvironment, and thus are expected to enhance the antitumor property of ICI. Another promising combination strategy includes anti-PD-1/anti-PD-L1 plus anti-CTLA4 combination agents to achieve antitumor synergy. Trials of nivolumab plus ipilimumab, durvalumab plus tremelimumab, and triplet combination of cabozantinib, nivolumab, and ipilimumab for patients with sorafenib failure or advanced HCC are underway. Preliminary results of some studies are promising with more than twice objective response rates than a single agent as well as acceptable toxicity profiles, highlighting the increased antitumor effects of ICI combination therapy.
With the recent introduction of effective TKIs and ICIs, therapeutic options for advanced HCCs are rapidly expanding. While this progress is likely to offer improved outcomes for patients with advanced HCC, it has raised important issues regarding the optimal selection and sequencing of individual treatments. Based on a better knowledge of HCC therapeutics and differences in trial design, future efforts should be directed toward the development of biomarker-based therapy and new combination or sequential therapies with synergistic antitumor effects that can target multiple oncogenic pathways, which will provide the best therapeutic option for individual patients.

6When Should We Consider Systemic Therapy in BCLC Stage B Hepatocellular Carcinoma?

저자 : Hyung Joon Yim

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 16-17 (2 pages)

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The Barcelona Clinic Liver Cancer (BCLC) classification includes 5 disease stages (0, A-D). The BCLC stage B consists of patients with cirrhosis with 1) underlying liver function of Child-Pugh class A or B, 2) multiple tumors beyond Milan criteria, but no vascular invasion, no extrahepatic lesions, and 3) tolerable performance status for anti-cancer therapy. As the definition of BCLC stage B is broad, it includes a heterogeneous population. Hence, response to transarterial chemoembolization (TACE) which is the standard treatment for BCLC B may not be uniform. In some instances, patients who are not suitable for TACE can exist in this stage. If the tumor is not controlled by an initial TACE, the same therapy can be repeated. However, if repeated TACEs do not achieve complete necrosis of tumors, it should be considered as TACE failure or refractoriness, which requires alternative therapies for HCC. If the tumor is localized and the underlying liver function is good, surgical resection may be an option. If there is no vascular invasion and no extrahepatic lesions, extended criteria for liver transplantation could be applied. However, most of the patients experiencing TACE failure are not the candidate for such surgical therapies, mainly due to its nature of the BCLC B stage. Currently, there are new pharmacologic therapeutic agents for unresectable or advanced HCCs (BCLC C stage); sorafenib, lenvatinib, regorafenib, cabozantinib, ramucirumab, nivolumab, and atezolizumab plus bevacizumab. Hence, timely adjustment of treatment strategy should be undertaken for the best outcomes. Previously, Raoul et al. suggested that patients who show progression after two cycles of TACE need switching therapy to sorafenib. Likewise, Japan Society of Hepatology defined the TACE failure as follows and recommended modifying therapies to molecular targeting agents (MTTs); 1) Intrahepatic lesion with two or more consecutive insufficient responses (viable lesion >50%) or those with two or more consecutive progressions in the liver (tumor number increases as compared with tumor number before the previous TACE procedure) even after having changed the chemotherapeutic agents and/or reanalysis of the feeding artery seen on response evaluation CT/MRI at 1-3 months after having adequately performed selective TACE, 2) Continuous elevation of tumor makers immediately after TACE even though a slight transient decrease in observed, 3) Appearance of vascular invasion, and 4) Appearance of extrahepatic spread. A recent survey conducted in Korea indicated that nearly half of Korean clinicians prefer to consider TACE failure after more than three times of repeated TACEs, and sorafenib and radiotherapy were subsequent choices in that situation. So far, there is no concrete definition of TACE failures, but 2 or 3 times of TACE session would be the reasonable limit for deciding the next treatment. A single-center study also suggested no objective response after two consecutive TACEs is related to poorer survival. Well-designed clinical trials and further discussions should be warranted to improve the patients' survival in patients with TACE failures.
Recently, a proof of concept study compared lenvatinib and TACE in BCLC stage B patients with Child A liver function and multiple tumors exceeding up-to-7 criteria.8 The lenvatinib group showed a significantly better objective response rate and significantly longer progression-free survival as well as overall survival than the TACE group. Hence, the early application of an MTT agent could be a better choice for patients with BCLC stage B patients. Combination of immunotherapeutics and MTT is a promising strategy in patients with TACE failure considering results of atezolizumab plus bevacizumab clinical trial which included treatment-experienced patients up to 52%.
In the future, choosing an appropriate time point of treatment modification and the best next option will lead to the improvement of clinical outcomes.

7Therapeutic Efficacy of Transarterial-Based Treatment vs. Targeted Therapy in Advanced Hepatocellular Carcinoma

저자 : Sadahisa Ogasawara

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 18-18 (1 pages)

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For the past several decades, transarterial chemoembolization (TACE) has been one of the most common treatments used for hepatocellular carcinoma (HCC). At the moment, TACE is the recommended therapy in patients with intermediate-stage HCC in both Eastern and Western guidelines. In 2007, the first oral molecular target agent, sorafenib was demonstrated to prolong overall survival (OS) in a phase III clinical trial in advanced HCC in a Western population. This result was replicable in other phase III trials, including advanced HCC patients from Asia-Pacific regions. After sorafenib approval, several studies have demonstrated the effectiveness of the conversion from TACE to sorafenib at the time of TACE refractoriness in patients with intermediate-stage HCC. Nowadays, several anticancer agents have become systemic therapies in HCC patients, and conversion from TACE to systemic therapies has become a more common treatment choice.
In 2019, atezolizumab combined with bevacizumab for the first-line treatment of patients with advanced HCC prolonged OS and progression-free survival compared with sorafenib, according to the results of a global phase III trial (IMbrave150). The result of IMbrave150, the first phase III study of combination setting with ICIs or ICI-based therapies in patients with advanced HCC that released outcomes, showed a large magnitude of impacts that resulted from the combination of atezolizumab and bevacizumab as the first regimen to prove superiority of OS compared with sorafenib, with longer durable responses and tolerable safety profiles. These results suggest that combination setting with ICIs or ICI-based therapies, including atezolizumab combined with bevacizumab, may have the potential to become “a game changer” in the landscape of HCC treatment. Although TACE has been standard treatment procedure for intermediate stage HCC, ICI-based therapies strongly expect to replace from TACE in patients with intermediate stage HCC, especially limited high burden intermediate stage HCC population. This is one of the leading clinical issue in HCC. In this session, results of latest researches will be shared and this newest clinical issue will be discussed.

8Optimizing Therapeutic Efficacy with Systemic Therapy & Radiotherapy in Hepatocellular Carcinoma

저자 : Jinsil Seong

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 19-20 (2 pages)

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For most solid cancers, multimodality treatment is a general principle particularly for locally advanced ones while single modality reserved for early cancers. However, this notion hasn't been well reflected in current therapeutic guidelines for hepatocellular carcinoma (HCC), which show a single modality as a standard of care for each stage of HCC.
HCC shows significant heterogeneity particularly in advanced stage. Although current guidelines recommend systemic agent as a standard of care, efficacy has been limited with gaining only a few months of survival. Recent studies on phylogenetic analysis reported that sorafenib-targeted genetic alteration was identified in only limited case, explaining why response was less than satisfactory. It also suggests that combination strategy needs to be adopted particularly in advanced HCC. Applying a single agent to a disease with extreme heterogeneity can hardly produce therapeutic success, warranting subclassification of the disease and optimal therapy accordingly. Advanced HCC needs to be classified into 2 catogories; advanced but confined to liver and advanced to beyond liver.
In advanced HCC confined to liver, combination strategy may involve maximizing local control by local modality as well as systemic agent preventing tumor spread either intrahepatically or extrahepatically. Our group has long been practicing local radiotherapy concurrently with hepatic arterial chemotherapy (liver-directed CCRT) followed by adjuvant hepatic arterial chemotherapy for substantial period. More recently we reported a phase 2 trial results of liver-directed CCRT followed by sorafenib. The result was quite encouraging with 24.6 months of median survival time, which corresponds to double the time in those with sorafenib alone. The beauty of this approach is that 19% of the patients underwent curative surgery by tumor downsizing/downstaging. In advanced HCC beyond liver, systemic therapy is a mainstay without any argument. Now, a concept discriminating oligometastasis from full metastasis has been proposed, which has been well established in most solid cancers. While systemic therapy is undergoing, local treatment, either radiotherapy or surgery, can effectively control oligometastasis that can result in prolonged overall survival.
Taken together, systemic therapy and radiotherapy can be combined in various scenario, ultimately aiming at improved therapeutic efficacy in advanced Hepatocellular Carcinoma.

9Current Approaches to the Treatment of Early HCC in Japan

저자 : Shuichiro Shiina

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 22-23 (2 pages)

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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.

10Current Approaches to the Treatment of Early HCC in Korea

저자 : Myeong Jun Song

발행기관 : 대한간학회 간행물 : 춘·추계 학술대회 (KASL) 2020권 1호 발행 연도 : 2020 페이지 : pp. 24-26 (3 pages)

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