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Redefining BCLC B, Intermediate-Stage HCC: Is There A Role For Combination Systemic Therapy
29 January 2021
Currently Hepatocellular Carcinoma (HCC) is a leading cause of cancer-related mortality worldwide with a rising incidence in the United States. BCLC B intermediate stage HCC is defined as patients with unresectable, liver-limited disease and preserved liver function. Locoregional therapies (LRTs), including arterially-directed therapies, are the mainstay of treatment and demonstrate an average survival benefit of approximately 2.5 years. The OPTIMIS trial, a real-world observational study, reported that a total of 507 patients became TACE ineligible during the study, and of those patients, 9% went on to receive systemic therapies like sorafenib (Nexavar). The study suggested that TACE may be overutilized. Another more recent therapy option is the combination of an anti–PD-L1 antibody atezolizumab (Tecentriq) and the anti-VEGF antibody bevacizumab (Avastin). This treatment was evaluated in patients with unresectable HCC in the IMbrave150 trial and reported an overall survival rate of 67.2% at 12 months.

Pembrolizumab Not Cost-Effective For Second-Line Treatment Of HCC In The US
28 January 2021
According to a recent analysis, pembrolizumab may not be a cost-effective second-line therapy for Hepatocellular Carcinoma (HCC). Dr. Chi-Leung Chiang, Department of Clinical Oncology, University of Hong Kong (China) and colleagues conducted an economic evaluation to assess the cost-effectiveness of pembrolizumab from the US payer perspective, using data from the KEYNOTE-240 trial. The team created a specific model to compare the lifetime cost and efficacy of pembrolizumab, including life-years, quality-adjusted life-years (QALYs), lifetime costs, and incremental cost-effectiveness ratio (ICER), which were estimated at a willingness-to-pay threshold of $150,000 per QALY. Pembrolizumab increased the overall cost by $47,057, resulting in an ICER of $340,409 per QALY. To be considered cost-effective, Dr. Chiang and colleagues determined that the price of pembrolizumab would need to be reduced by 57.7% to $2925 per cycle.

FDA Clearance For Hepatica, Perspectum’s Surgical Decision Support Tool For Liver Cancer
28 January 2021
Perspectum has accepted their 501(k), a premarket submission to demonstrate that the device to be marketed is as safe and effective, for Hepatica. Hepatica is a precision oncology decision support tool for liver cancer, which uses non-invasive quantitative MRI to provide a liver health assessment based on AI-driven liver segmentation. A research team has shown that Hepatica could effectively identify if a patient is at risk of poor outcomes from surgery and a longer stay in hospital. “Hepatica provides the surgeon with a measure of liver well-being that allows us to push the boundaries on the one hand whilst avoiding the removal of inappropriate liver volume on the other,” explains Mr. Myrddin Rees, Consultant General and Hepatobiliary Surgeon at HHFT. Perspectum works to deliver cutting-edge digital technologies that help clinicians provide better care for patients with liver disease.

Jellyfish Venom Stops Cancer Cell Growth In Lab Trial
28 January 2021
Researchers from the University of Madras tested crude venom from the Acromitus flagellatus jellyfish against different human cancer cell lines in vitro, and have identified it as a potential cancer therapy. The team's initial results showed that cells from the human liver cancer cell line HepG2 shrank significantly within 48 hours of exposure to the venom. Animal venoms work by targeting and disrupting metabolic processes, and the bioactive compounds in venom attack on a cellular level, destroying cell structures. The ability to target and kill cells or to override biological signals are key elements in modern pharmaceuticals. The team was interested in researching the venom’s cytotoxicity, or its ability to prevent cells from growing and multiplying.

FDA Grants Orphan Drug Designation To Uttroside-B For Liver Cancer
27 January 2021
The FDA has granted Orphan Drug Designation to Uttroside-B for the treatment of Hepatocellular Carcinoma (HCC). Uttroside-B is a small molecule chemotherapeutic created by Q Biomed Inc. “Orphan Drug Designation gives our Uttroside-B program a substantial boost, and we expect it will significantly accelerate development and reduce costs. We are pleased that the FDA recognizes the urgent need for effective treatments for HCC and that the agency sees the potential of Uttroside-B to address this difficult-to-treat cancer,” said Q BioMed CEO Denis Corin in the press release.

Evidence Grows For Avoiding Biopsy In Hepatocellular Carcinoma
27 January 2021
Based on an analysis of the data from the National Cancer Database (NCD), overall survival was lower in HCC patients who underwent preoperative tissue diagnosis compared with clinical diagnosis. Furthermore, researchers insist that doctors should run through all non-invasive methods to diagnose HCC before attempting a biopsy. “Tumor dissemination along the needle tract is a well-documented phenomenon, estimated to occur in 2.5% to 10% of cases,” said Fadi Dahdaleh, MD, a cancer surgeon and clinical assistant professor of surgery at Edward-Elmhurst Health, in Chicago. Using the NCD the team of researchers identified 16,366 patients who matched their criteria. 70.4% of cases had a clinical diagnosis and 29.6% underwent tissue diagnosis, and the team found that patients who underwent tissue diagnosis had decreased overall survival compared with the clinical diagnosis group.

Post-Treatment Alpha-Fetoprotein Reduction Prognostic For Survival Outcomes In HCC
26 January 2021
Ghassan Abou-Alfa, MD from the Memorial Sloan Kettering Cancer Center in New York, discusses results from a study evaluating the association between post-treatment α-fetoprotein reduction and real-world outcomes in US patients with Hepatocellular Carcinoma (HCC). He explains that “In the CELESTIAL study of cabozantinib versus placebo if you recall, the 20% cutoff was brought in. Patients with more than or equal to 20% decrease from baseline α-fetoprotein were associated with longer survival and progression-free survival, regardless of the treatment. However, the association between α-fetoprotein reduction after initiation of first-line therapy with tyrosine kinase inhibitor and outcomes is remaining unclear with advanced Hepatocellular Carcinoma patients.”

Hepatocellular Carcinoma: Support For The Fourth Leading Cancer-Related Cause Of Death
20 January 2021
Hepatocellular Carcinoma (HCC) is a preventable type of cancer, but once HCC is established and symptomatic, survival rates diminish drastically. The four main HCC risk factors are Hepatitis B, Hepatitis C, excessive alcohol consumption, and Nonalcoholic fatty liver disease (NAFLD) leading to nonalcoholic steatohepatitis (NASH). Discussing staging with patients can be difficult, and the literature is often aimed at clinicians Blue Faery: The Adrienne Wilson Liver Cancer Association provides clinically accurate and completely understandable materials to assist doctors and patients in describing the staging and helping patients to understand where they are in the spectrum. The Blue Faery and Exelixis staging discussion pad contain anatomical graphics and easy to understood text. Available to patients is also The Blue Faery Liver Cancer Community. It is a free, HIPAA-compliant online community where patients and caregivers are welcome to join and to seek or exchange information relevant to HCC care.

Patients With Advanced HCC Often Do Not Receive Second-Line Therapy In Real-World Practice
19 January 2021
Arjun Gupta, MD, from Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, discusses results from a study analyzing real-world treatment patterns and associated outcomes for the second-line treatment of advanced Hepatocellular Carcinoma (HCC). His team of researchers used the Concerto HealthAI database and included patients diagnosed with advanced liver cancer between 2017 and January of 2020, which was about 600 patients, and only 330 of these received some sort of therapy. The most commonly used first-line treatment was sorafenib. Of these 330 patients, 207 patients survived 1 month after the end of their first-line therapy and were labeled as being eligible for second-line therapy. Of these 207 patients, only approximately 100 eventually ended up receiving second-line therapy.

Pembrolizumab Monotherapy May Play Role In Treatment-Naive HCC
18 January 2021
Results from a recent study show that Pembrolizumab (Keytruda) monotherapy showed antitumor activity survival in patients with previously untreated Hepatocellular Carcinoma (HCC). In the study, 51 patients were enrolled and treated with Keytruda, and 22 of which demonstrated at least some reduction in the size of their target lesion. The overall response rate (ORR) was 16%, with 70% of patients estimated as having a response duration of 12 months or more. The team reported the progression-free survival (PFS) rate at 12 months was 24%, and the median overall survival (OS) was 17 months. “These findings support further evaluation of pembrolizumab-based regimens in the therapeutic landscape of HCC,” Jean-Luc Van Laethem, MD, Ph.D., of Hôpital Erasme–Université Libre de Bruxelles (ULB), Brussels, Belgium.

Hepatocellular Carcinoma Treatment Landscape Evolving By The Minute
17 January 2021
Ghassan K. Abou-Alfa, MD, a medical oncologist at the Memorial Sloan Kettering Cancer Center in New York, discusses the rapid evolution observed in the treatment landscape of Hepatocellular Carcinoma (HCC) over the last few years. According to Abou-Alfa, the treatment landscape did not begin rapidly evolving until more recently, after about 20 years of minimal advances. He focuses on the treatment combination of pembrolizumab (Keytruda), an immune checkpoint inhibitor (ICI), and lenvatinib (Lenvima) a tyrosine kinase inhibitor (TKI). He points out that the FDA had approved the combination of atezolizumab (Tecentriq) plus bevacizumab (Avastin), in May 2020 for unresectable or metastatic HCC.

Second-Line Pembrolizumab Shows Continued OS And PFS Improvement In Advanced HCC
17 January 2021
Positive updated data from phase 3 KEYNOTE-240 has been reported. The phase 3 trial enrolled adult patients with confirmed diagnoses of advanced HCC who experienced progression after or were intolerance to sorafenib (Nexavar). The median progression-free survival (PFS) was 3.3 months with pembrolizumab, compared with 2.8 months with a placebo, and the estimated 24-month PFS rates were 11.8% and 4.8%, respectively while the estimated 36-month PFS rates were 9% and 0%, respectively. According to a presentation given at the 2021 Gastrointestinal Cancers Symposium, at a median follow-up of 39.6 months for pembrolizumab and 39.8 months for placebo, the median overall survival (OS) was 13.9 months with pembrolizumab versus 10.6 months with a placebo.

Japanese Team Develops Cancer Detector Using Mosquito's Sense Of Smell
15 January 2021
A Japanese research team led by University of Tokyo Professor Shoji Takeuchi has developed a small sensor to detect an odor substance found in the breath of cancer sufferers using mosquito olfactory receptors. When an odorant receptor connects with a specific odorant molecule, a hole opens up on the cellular membrane to let ions enter the cell, allowing the smell to be detected. Takeuchi team created an artificial cellular membrane embedded with a mosquito odorant receptor that detects octenol, a chemical that is found in human perspiration and can be used as a biomarker of liver cancer. A lunch box-sized prototype detected octenol at a concentration of 0.5 part per billion in breath samples within 10 minutes, according to the team's study.

Lenvatinib Monotherapy Demonstrates Efficacy In The First Line For HCC
15 January 2021
Lenvatinib was approved as monotherapy in patients with HCC in August 2018 based on the phase 3 REFLECT trial. A team of researchers conducted a retrospective, real-world analysis of patients with unresectable HCC in the United States to observe that lenvatinib (Lenvima) alone was effective as a first-line treatment. The average dose of lenvatinib was 12 mg. The median progression-free survival (PFS) and overall survival (OS) with lenvatinib had not been reached in any of the sub-categories at the 9-month follow-up. The landmark PFS was 85% at 6 months and 65% at 12 months in the overall cohort. The provider-reported best response was complete response (CR) in 21% of patients in the overall cohort, partial response (PR) in 44%, and stable disease (SD) in 26%.

Validated Risk Score Predicts Post-Transplant Survival In HCC
15 January 2021
Using the national registry data, David Goldberg, MD, MSCE, from the division of digestive health and liver diseases at the University of Miami Miller School of Medicine, and a team of researchers performed a retrospective cohort study of 6,502 adult HCC liver transplant recipients. They developed a risk score to predict post-transplant survival for patients with Hepatocellular Carcinoma (HCC) which will help prioritize patients who are waitlisted for a transplant, based on predicted survival. Absolute predicted survival time from the Liver Transplant Expected Survival HCC score was calculated and compared with available risk scores.

Scoring System To Redefine How U.S. Patients Prioritized For Liver Transplant
13 January 2021
A team of researchers, along with Sylvester Comprehensive Cancer Center at the University of Miami Miller School of Medicine are collaborating with faculty at the University of Pennsylvania to develop a risk score that more comprehensively prioritizes liver cancer patients for transplantation. Currently, liver transplant priority in the U.S. goes to the sickest patients and does not consider other important factors, including how long patients are likely to survive post-transplant. The team's paper documenting the development and validation of the LiTES-HCC score to predict post-transplant survival for Hepatocellular Carcinoma, or liver cancer, patients were published in the Journal of Hepatology. Dr. Goldberg, the principal investigator for an ongoing National Institutes of Health grant, states: “There are two large subsets of patients awaiting liver transplantation: those who have cirrhosis and complications from that, and then about 20% to 25% of transplants are for people who have liver cancer, which is a known complication of cirrhosis.”

Zhongchao Inc. Promotes Standardized Liver Cancer Diagnosis And Treatment
13 January 2021
Zhongchao Inc. co-sponsored the National Annual Conference for Standardized Liver Cancer Diagnosis and Treatment with the China Association of Health Promotion and Education and the Chinese Society of Liver Cancer. Jia Fan, Chinese Academy of Sciences Fellow, President of Zhongshan Hospital at Fudan University, and General Supervisor of the Guidelines, stated in the Annual Conference, “prolonging patients' life is the most pressing issue in the field of liver cancer treatment in China. We draft and continuously update the Guidelines based on research developments and lead doctors' clinical practice.” In 2020, Zhongchao worked with medical associations and experts to accomplish a multi-year online education project on the diagnosis and treatment of primary liver cancer.

Frontline Treatment Arsenal Expands In Advanced HCC
11 January 2021
Currently, there are three FDA-approved front-line treatment options for patients with unresectable HCC. These treatments are the tyrosine kinase inhibitor (TKI) sorafenib (Nexavar), approved in 2008; TKI lenvatinib (Lenvima), approved in 2018; and immunotherapy with the combination of atezolizumab (Tecentriq) and bevacizumab (Avastin), approved in 2020. A team of doctors further discusses how to choose between the treatments for their current patients. Although sorafenib was the first drug to show a survival benefit in patients with advanced HCC, Tanios S. Bekaii-Saab, MD, explains that “the dose was challenging, and everyone came up with their dosing schedule and regimen [to reduce the risk of toxicities].” However, Pierre Gholam, MD said, “How might one manage or mitigate the risk of bleeding in the setting of cirrhosis? An important thing to remember and consider is that the risk of having varices or, perhaps, more importantly, large varices, increases as the Child-Pugh score increases.”

Liver Stiffness Before Hepatitis C Treatment Predicts Liver Cancer Risk
11 January 2021
Over time, hepatitis C can lead to liver fibrosis, cirrhosis and extracellular carcinoma (HCC). An imaging method known as transient elastography, or FibroScan, measures liver stiffness which can be used as an indicator of fibrosis and the likelihood of developing liver cancer. A liver stiffness measurement taken before beginning direct-acting antiviral (DAA) therapy for hepatitis C may help predict HCC risk in people who have attained a sustained virological response (SVR). One particular study conducted in Denmark, observing over 700 people, found that people with a pre-treatment liver-stiffness measurement (LSM) higher than 17.5 kPa, the incidence of liver cancer rose 10-fold compared with people who had a measurement below this value.

Real-World Findings In REFINE Study Support Use Of Regorafenib In HCC
8 January 2021
Richard S. Finn, MD, an assistant professor of clinical medicine at the Geffen School of Medicine at the University of California, Los Angeles (UCLA) discusses the real-world findings from the REFINE study and the RESORCE study. The REFINE study observed the outcomes of patients with unresectable Hepatocellular Carcinoma (HCC) who received treatment with regorafenib (Stivarga), while patients in the RESORCE study received sorafenib. In both studies, more than half of the doctors started their patients on the full dose as prescribed, while others started patients at 80 or 120 mg per day. Regardless, the efficacy and side effect profiles were similar between those treated in the real world versus the clinical trial setting, explains Finn. “Patients who were on sorafenib for a shorter period, they still received a similar magnitude of benefit with regorafenib, and vice versa”, Finn says.

Liver Cancer Cells Cause Stromal Cells To Secrete Protein That Enhances Tumor Growth
6 January 2021
In hope of finding a novel target for drug development, researchers led by Osaka University decided to focus on specific cells and processes that occur in the area around liver tumors. They found that cultured liver cancer cells together with HSCs, created a significant increase in the number of cancer cells, suggesting that the HSCs promoted cancer cell growth. Senior author Tetsuo Takehara stated, “Most importantly though when we then examined the association between GDF15 expression and clinical outcome, we found that patients with higher levels of GDF15 had a poorer prognosis than those with only low levels of GDF15 expression, which highlighted the role of GDF15 in HCC progression.” Using a mouse model of liver cancer and analysis of gene expression, the team found that the cancer cells induced autophagy, the digestion of cellular constituents by enzymes of the same cell, in the HSCs, which in turn caused the HSCs to secrete a protein called GDF15, which promoted tumor growth. Using these findings, new therapies targeting GDF15 expression by HSCs are a prospect for the treatment of HCC.

Immunotherapy With Radiotherapy Could Improve Outcomes Of Cancers In Liver
6 January 2021
A team of researchers from the University of Michigan found that tumors in the liver remove critical immune cells, thus making immunotherapy ineffective. Using mice with liver metastases, researchers delivered radiation therapy directly to the tumors in the liver, preventing T-cell death. With the T cells restored, an immune checkpoint inhibitor was then able to activate the immune system to eliminate cancer throughout the body. Thus, treatment with immunotherapy in combination with radiotherapy to the livers of mice restored the immune cell function and led to better outcomes. The team looked at data from 718 patients who had received immunotherapy. Those with liver metastases had worse responses to immunotherapy. Dr. Michael Green noted that patients with liver metastases who received chemotherapy or targeted therapies did not have worse outcomes compared to those with other types of metastases.

Comparable Survival Observed With Regorafenib In HCC In Real-World Versus Clinical Settings
5 January 2021
The addition of regorafenib to the armamentarium as a treatment for patients with Hepatocellular Carcinoma (HCC), has brought about an exciting advance for the field over the last few years. According to findings from the phase 3 RESORCE study, regorafenib (Stivarga) demonstrated encouraging findings in HCC patients. “The RESORCE study was the first positive phase 3 study in liver cancer since sorafenib in 2007,” stated Richard S. Finn, MD, an assistant professor of clinical medicine at the Geffen School of Medicine at the University of California, Los Angeles (UCLA). The ongoing REFINE study is aimed to explore the safety, tolerability, and efficacy of regorafenib in the real world compared with patients who received regorafenib in the clinical trial setting using data from patients in the RESORCE study.

Immunicum AB Receives FDA Orphan Drug Designation For Ilixadencel As A Treatment HCC
31 December 2020
The FDA has granted Orphan Drug Designation to ilixadencel, a cell-based, off-the-shelf immune primer, for the treatment of Hepatocellular Carcinoma (HCC). The designation was based on data from a Phase I/II clinical trial of ilixadencel in patients with unresectable and/or metastatic HCC. Ilixadencel is a cell-based cancer immunotherapy developed for the treatment of solid tumors. Its active ingredient is activated allogeneic dendritic cells which are derived from healthy blood donors. Injection of these cells in the patient’s tumor generates an inflammatory response which in turns leads to tumor-specific activation of the patient’s cytotoxic T cells. In various trials, including the Phase II MERECA trial, Ilixadencel has maintained a positive safety and tolerability profile and demonstrated signs of efficacy.

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