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Hepatobiliary Cancer

Novel DELFI AI Blood Test May Aid in Detecting Hepatocellular Carcinoma

A novel artificial intelligence (AI) blood testing technology—known as DELFI (DNA evaluation of fragments for early interception)—may successfully detect more than 80% of hepatocellular carcinomas, according to a new study published by Foda et al in Cancer Discovery. The findings were also...

Hepatobiliary Cancer

Futibatinib for Cholangiocarcinoma With FGFR2 Gene Fusion or Other Rearrangements

On September 30, 2022, futibatinib was granted accelerated approval for adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.1 Supporting Efficacy ...

Hepatobiliary Cancer

Durvalumab Plus Chemotherapy in Advanced Biliary Tract Cancer

On September 2, 2022, durvalumab was approved for use in combination with gemcitabine/cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on findings in the double-blind TOPAZ-1 trial (ClinicalTrials.gov...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: Robin Kate Kelley, MD

Robin Kate Kelley, MD, Professor of Clinical Medicine at the University of California, San Francisco, was invited to discuss the results of LEAP-002.1 She said the main takeaway is that lenvatinib monotherapy is active as a preferred first-line agent for fit patients who have contraindications to...

Hepatobiliary Cancer
Immunotherapy

Lenvatinib Plus Pembrolizumab in Hepatocellular Carcinoma: LEAP-002 Fails to Meet Co-primary Endpoints

The highly anticipated final analysis of the phase III LEAP-002 trial failed to meet expectations, as first-line treatment with lenvatinib plus pembrolizumab did not significantly improve outcomes in unresectable advanced hepatocellular carcinoma. Both progression-free survival and overall survival ...

Hepatobiliary Cancer

Small Study of Experimental Drug to Treat Liver Cancer Shows Evidence of Activity With Manageable Side Effects

A new drug designed to inhibit an enzyme that plays a crucial role in cell division and growth has shown signs of anticancer activity with manageable side effects in patients with liver cancer and up to three lines of previous unsuccessful treatment, according to a new study published by Reig et al ...

Hepatobiliary Cancer

Lenvatinib Plus Pembrolizumab in Hepatocellular Carcinoma: LEAP-002 Fails to Meet Co-primary Endpoints

The highly anticipated final analysis of the phase III LEAP-002 trial failed to meet expectations, as first-line treatment with lenvatinib plus pembrolizumab did not significantly improve outcomes in unresectable advanced hepatocellular carcinoma. Both progression-free survival and overall survival ...

hepatobiliary cancer

Treatment of AJCC Stage IV Intrahepatic Cholangiocarcinoma

This is Part 4 of Updates in Hepatobiliary Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable.   In this video, Drs. Ghassan Abou-Alfa, Dr. Richard Finn, and Dr. Rachna Shroff discuss the treatment of AJCC stage IV intrahepatic cholangiocarcinoma. The patient is a 60-year-old woman with stage IV metastatic cholangiocarcinoma and an FGFR2 fusion on next-generation sequencing.     The faculty discuss treatment options for this patient, reviewing the results of the TOPAZ-1 trial, which established durvalumab plus gemcitabine/cisplatin as standard of care. They discuss targeted approaches in cholangiocarcinoma, including the FGFR2 inhibitors pemigatinib, infigratinib, and futibatinib, and highlight considerations for emerging therapies.

hepatobiliary cancer

Adjuvant Therapy in Biliary Tract Cancer

This is Part 3 of Updates in Hepatobiliary Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable.   In this video, Drs. Ghassan Abou-Alfa, Dr. Richard Finn, and Dr. Rachna Shroff discuss the role of adjuvant therapy in biliary tract cancer. The patient is a 52-year-old man who is diagnosed with intrahepatic cholangiocarcinoma with one positive periportal lymph node. Surgical resection reveals a 7.2-cm, pT3aN0 stage III mass. Following surgery, the patient has recovered well and is not experiencing symptoms.     The faculty discuss the next steps for this patient in a rapidly evolving field: adjuvant capecitabine, gemcitabine plus capecitabine, or imagine surveillance alone? In addition, they explore the possibility of perioperative or neoadjuvant approaches in biliary tract cancer.

hepatobiliary cancer

Second-Line Therapy and Beyond in Hepatocellular Carcinoma

This is Part 2 of Updates in Hepatobiliary Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable.   In this video, Drs. Ghassan Abou-Alfa, Dr. Richard Finn, and Dr. Rachna Shroff discuss second-line therapy and beyond in hepatocellular carcinoma. The patient is a 63-year-old man with a history of nonalcoholic fatty liver disease who was diagnosed with hepatocellular carcinoma metastatic to the lungs and perihepatic and retroperitoneal lymph nodes. He had no response to atezolizumab plus bevacizumab after 2 months of therapy and now has experienced progression of disease in multifocal lung nodules as well as new right adrenal metastases.     The faculty discuss next steps for a patient such as this, highlighting key data for second- and third-line therapy in hepatocellular carcinoma. They also discuss whether there is a role for immunotherapy re-challenge in patients who experience disease progression after immune checkpoint inhibition.

hepatobiliary cancer

Front-Line Therapy in Metastatic Hepatocellular Carcinoma

This is Part 1 of Updates in Hepatobiliary Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable.   In this video, Drs. Ghassan Abou-Alfa, Dr. Richard Finn, and Dr. Rachna Shroff discuss front-line therapy in metastatic hepatocellular carcinoma. The patient is a 71-year-old woman with a history of hepatitis C, now cured, who presents to the emergency department with severe right-sided, upper-quadrant pain. Computed tomography reveals a 10-cm right liver mass, 10 bilateral lung nodules of up to 2.5 cm, and a 1-cm bone lesion.   The faculty debate the need for biopsy for hepatocellular carcinoma in a patient such as this. They also discussfactors to consider when choosing first-line therapy in patients with metastatic hepatocellular carcinoma, reviewing the findings of recent studies such as IMbrave150, HIMALAYA, and LEAP-002.     Editor’s Note: This discussion was filmed prior to the approval of tremelimumab plus durvalumab for the first-line treatment of unresectable hepatocellular carcinoma.

Hepatobiliary Cancer
Immunotherapy

FDA Approves Tremelimumab Plus Durvalumab for Adult Patients With Unresectable HCC

On October 21, the U.S. Food and Drug Administration (FDA) approved tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The novel dose and schedule of the...

Hepatobiliary Cancer

Adding SBRT to Sorafenib May Improve Survival and Time to Disease Progression in Patients With Advanced HCC

Adding stereotactic body radiation therapy (SBRT) to systemic therapy with sorafenib for patients with advanced hepatocellular carcinoma (HCC) may extend overall survival and delay tumor progression without compromising patients’ quality of life, findings from the randomized phase III NRG...

Hepatobiliary Cancer

Neoadjuvant Intensity-Modulated Radiotherapy in Centrally Located Hepatocellular Carcinoma

In a Chinese single-center phase II trial reported in JAMA Surgery, Wu et al found neoadjuvant intensity-modulated radiotherapy (IMRT) followed by hepatectomy could be an effective treatment option in patients with centrally located hepatocellular carcinoma. Study Details In the study, 38 patients...

Hepatobiliary Cancer

FDA Grants Accelerated Approval to Futibatinib for Previously Treated Patients With FGFR2-Mutated Cholangiocarcinoma

On September 30, the U.S. Food and Drug Administration (FDA) granted accelerated approval to futibatinib (Lytgobi) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or...

Hepatobiliary Cancer

Individuals of Mexican Descent May Have Higher Risk of Liver Cancer With Each Successive Generation

Studies show that Hispanic individuals have higher incidence rates of developing liver cancer and higher mortality rates—by 50% or more—than non-Hispanic White individuals for several cancers, including liver cancer. A new study investigating hepatocellular carcinoma among successive generations of ...

hepatobiliary cancer

Richard S. Finn, MD, on Hepatocellular Carcinoma: Recent Data on Lenvatinib Plus Pembrolizumab

Richard S. Finn, MD, of the Geffen School of Medicine at the University of California, Los Angeles, discusses primary phase III results from the LEAP-002 study of pembrolizumab, an anti–PD-1 therapy, plus lenvatinib, the orally available multiple receptor tyrosine kinase inhibitor, vs lenvatinib monotherapy in patients with advanced hepatocellular carcinoma (Abstract LBA34).

Hepatobiliary Cancer
Immunotherapy

FDA Approves Durvalumab-Based Combination for Locally Advanced or Metastatic Biliary Tract Cancer

On September 2, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. TOPAZ-1 Efficacy was evaluated in TOPAZ-1 (ClinicalTrials.gov identifier:...

Hepatobiliary Cancer
Genomics/Genetics

Study Examines How Genetic Mutations May Contribute to the Development of Cholangiocarcinoma

A team of researchers from the University of Rochester discovered how certain genetic mutations fuel the growth of cholangiocarcinoma, a rare but aggressive type of malignancy that has been on the rise in the United States. Their work, published by Guo et al in Cell Reports this week, details the...

Hepatobiliary Cancer

Does Exposure to 'Forever Chemical' Elevate Risk of Developing Hepatocellular Carcinoma?

Exposure to a synthetic chemical found widely in the environment may be linked to the development of nonviral hepatocellular carcinoma, according to a new study published by Goodrich et al in JHEP Reports. The chemical—called perfluorooctane sulfate, or PFOS—is one of a class of man-made chemicals...

Hepatobiliary Cancer

Addition of Transarterial Chemoembolization to Lenvatinib in First-Line Treatment of Advanced Hepatocellular Carcinoma

An interim analysis of the Chinese phase III LAUNCH trial was reported in the Journal of Clinical Oncology by Peng et al. The researchers found that the addition of transarterial chemoembolization to lenvatinib improved overall survival in patients with advanced hepatocellular carcinoma who were...

Hepatobiliary Cancer
Genomics/Genetics

Study Sheds Light on Mechanisms Driving Cancer Induced by Organic Solvent Used in Printing Industry

1,2-Dichloropropane (1,2-DCP) is a synthetic organic solvent used in the printing industry. It was linked to cholangiocarcinoma in 2013, when printing company employees in Osaka, Japan, exposed to 1,2-DCP were diagnosed with the cancer. Thereafter, the International Agency for Research on Cancer...

Hepatobiliary Cancer

Downstaging Hepatocellular Carcinoma Prior to Liver Transplant: 10-Year Outcomes

In some patients with hepatocellular carcinoma, downstaging of disease to within criteria that qualify the patient for a liver transplant leads to excellent 10-year posttransplant outcomes, according to new research published by Tabrizian et al in JAMA Surgery. The results validate current national ...

Hepatobiliary Cancer

Phase III Trial of Cabozantinib and Atezolizumab vs Sorafenib in Advanced Hepatocellular Carcinoma

As reported in The Lancet Oncology by Robin Kate Kelley, MD, and colleagues, the phase III COSMIC-312 trial has shown improved progression-free survival with cabozantinib plus atezolizumab vs sorafenib in patients with advanced hepatocellular carcinoma; interim analysis of overall survival showed...

Hepatobiliary Cancer

Study Links Sugar-Sweetened Beverage Consumption and Liver Cancer Risk

A study of more than 90,000 postmenopausal women found that those who consumed at least one sugar-sweetened beverage daily faced a 78% higher risk of developing liver cancer compared with people who consumed less than three servings per month of such beverages. These findings were presented by Zhao ...

hepatobiliary cancer
immunotherapy

Akihiro Ohba, MD, on Biliary Tract Cancer: New Findings on Fam-Trastuzumab Deruxtecan-nxki

Akihiro Ohba, MD, of Japan’s National Cancer Center Hospital, discusses phase II data from the HERB trial on fam-trastuzumab deruxtecan-nxki, which showed activity in patients with HER2-expressing unresectable or recurrent biliary tract cancer (Abstract 4006).

Hepatobiliary Cancer

Radiation Segmentectomy for Very Early– and Early-Stage Hepatocellular Carcinoma

Radiation segmentectomy may be an effective treatment for very early– to early-stage hepatocellular carcinoma (HCC) that cannot be treated surgically or thermally. The findings from a multidisciplinary study by researchers at the Icahn School of Medicine at Mount Sinai were published by Kim et al...

Hepatobiliary Cancer

Hepatic Arterial Infusion Pump Chemotherapy vs Resection for Multifocal Intrahepatic Cholangiocarcinoma

In a cohort study reported in JAMA Surgery, Franssen et al found little difference in median overall survival with hepatic arterial infusion pump (HAIP) floxuridine chemotherapy vs resection in patients with multifocal intrahepatic cholangiocarcinoma. Study Details The study population consisted of ...

Hepatobiliary Cancer
Pancreatic Cancer
Immunotherapy
Genomics/Genetics

Ipilimumab/Nivolumab in Patients With Metastatic Pancreatic or Biliary Cancer and HRD Pathogenic Germline Variants

In a single-institution case series reported in a research letter in JAMA Oncology, Terrero et al found that the combination of ipilimumab and nivolumab was active in patients with chemotherapy-refractory metastatic pancreatic or biliary cancer with homologous recombination deficiency (HRD)...

Hepatobiliary Cancer
Gastroesophageal Cancer
Genomics/Genetics

Assessment of Cancer Risk Profile for Germline BRCA1 and BRCA2 Pathogenic Variants in Patients With Common Cancers

In a Japanese case-control study reported in JAMA Oncology, Momozawa et al found that germline BRCA1/2 pathogenic variants were associated with an increased risk of biliary tract, esophageal, and gastric cancers, in addition to an increased risk of cancers that have well-established associations...

Hepatobiliary Cancer

Long-Term Survival Outcomes With Adjuvant Capecitabine in Biliary Tract Cancer

As reported in the Journal of Clinical Oncology by Bridgewater et al, long-term follow-up of the phase III BILCAP study has shown a continued survival benefit with adjuvant capecitabine therapy in patients with curatively resected biliary tract cancer. In the multicenter trial, 447 patients with...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: Anthony El-Khoueiry, MD

Anthony El-Khoueiry, MD, Member of the Section of Gastrointestinal Cancers, Director of the phase I program, and Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and USC Norris Comprehensive Cancer Center, said the findings of the...

Hepatobiliary Cancer
Immunotherapy

HIMALAYA Trial: First-Line Tremelimumab Plus Durvalumab Improves Overall Survival in Unresectable Hepatocellular Carcinoma

Patients with advanced, unresectable hepatocellular carcinoma may be gaining another first-line treatment option. In the global phase III HIMALAYA trial, a single priming dose of tremelimumab plus regular-interval durvalumab significantly improved overall survival, according to Ghassan K....

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: Ian Chau, MD

Invited discussant Ian Chau, MD, Consultant Medical Oncologist at The Royal Marsden Hospital in London and Surrey in the United Kingdom, said the findings from COSMIC-312 are not mature enough to establish cabozantinib/atezolizumab as a new front-line option for advanced hepatocellular carcinoma...

Hepatobiliary Cancer
Immunotherapy

COSMIC-312: Cabozantinib Plus Atezolizumab Improves Progression-Free Survival in Advanced Hepatocellular Carcinoma

The phase III COSMIC-312 study has met its primary endpoint, showing a significant improvement in progression-free survival with cabozantinib plus atezolizumab compared with sorafenib in treatment-naive hepatocellular carcinoma (HCC), investigators reported at a European Society for Medical...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: Chris Verslype, MD, PhD

The invited discussant of the RATIONALE 208 trial, Chris Verslype, MD, PhD, Professor of Medicine at University Hospitals Leuven in Belgium, said tislelizumab is an “active and safe” investigational PD-1 antibody, “comparable to other PD-1 agents.” In particular, he noted, the results of RATIONALE...

Hepatobiliary Cancer
Immunotherapy

RATIONALE 208: ‘Durable Clinical Activity’ Reported With Tislelizumab in Advanced Liver Cancer

With the investigational checkpoint inhibitor tislelizumab, durable responses were achieved by some patients with previously treated advanced hepatocellular carcinoma, regardless of the number of prior lines of therapy, in the phase II RATIONALE 208 trial. These findings were presented during the...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: Nilofer Azad, MD

Nilofer Azad, MD, Professor of Oncology at Johns Hopkins University School of Medicine and Co-Director of Cancer Genetics and Epigenetics at the Sidney Kimmel Comprehensive Cancer Center, Baltimore, was invited to discuss the results of the phase III TOPAZ-1 study, which found an overall survival...

Hepatobiliary Cancer
Immunotherapy

TOPAZ-1: Overall Survival Prolonged With First-Line Immunotherapy Plus Chemotherapy in Biliary Tract Cancer

For the first time, a phase III study has shown an overall survival benefit for upfront treatment using immunotherapy plus chemotherapy in advanced biliary tract cancer. In the TOPAZ-1 trial, the addition of the anti–PD-L1 agent durvalumab to gemcitabine plus cisplatin significantly improved...

Hepatobiliary Cancer

Ivosidenib vs Placebo for Previously Treated Advanced IDH1-Mutated Cholangiocarcinoma: Final Overall Survival Analysis of the ClarIDHy Trial

As reported in JAMA Oncology by Andrew X. Zhu, MD, PhD, and colleagues, the final overall survival analysis of the pivotal phase III ClarIDHy trial showed prolonged overall survival with ivosidenib vs placebo in previously treated patients with unresectable or metastatic cholangiocarcinoma and an...

Colorectal Cancer
Hepatobiliary Cancer
Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

Recent FDA Approvals in Gastrointestinal Cancer

Over the past year, the U.S. Food and Drug Administration granted approval to several novel drugs and new indications for older therapeutic agents used in gastrointestinal oncology. Cetuximab Plus Encorafenib On September 28, 2021, cetuximab (Erbitux) was approved in combination with encorafenib...

Hepatobiliary Cancer
Immunotherapy

Sequencing of Drug Combinations Could Amplify Antitumor Immune Response in Liver Cancer

A new therapeutic strategy for hepatocellular carcinoma (HCC) that initially primes the tumor with an immune checkpoint inhibitor before using a multikinase inhibitor has shown efficacy in a study published in the Journal of the National Cancer Institute. Kikuchi et al reported that the new...

Hepatobiliary Cancer

Characteristics of Nonalcoholic Fatty Liver Disease–Related HCC vs HCC From Other Causes

In a meta-analysis reported in The Lancet Oncology, Tan et al found that patients with nonalcoholic fatty liver disease (NAFLD)-related hepatocellular carcinoma (HCC) were more likely to have metabolic/cardiovascular comorbidity, less likely to have cirrhosis, and less likely to undergo...

Hepatobiliary Cancer

ASTRO Issues Clinical Guideline on External-Beam Radiation Therapy for Primary Liver Cancers

A new clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance on the use of external-beam radiation therapy (EBRT) to treat adults with primary liver cancers. The guideline, ASTRO’s first for primary liver cancers, is published in Practical Radiation ...

Hepatobiliary Cancer

Study Evaluates Effectiveness of Existing Risk Stratification System for Hepatoblastoma

A new study published by Zhou et al in JAMA Network Open independently verified the value of a system that assesses hepatoblastoma risk in children. The researchers also discovered the potential for tumor histology to predict a patient’s hepatoblastoma prognosis.  Hepatoblastoma is a rare childhood ...

Hepatobiliary Cancer

H1-Antihistamine Use and Risk of Hepatocellular Carcinoma in Persons With Hepatitis B Virus, Hepatitis C Virus, or Dual Infection

In a Taiwanese study reported in the Journal of Clinical Oncology, Shen et al found that use of H1-antihistamines was associated with reduced risk of hepatocellular carcinoma in patients with hepatitis B virus (HBV), hepatitis C virus (HCV), or dual HBV/HCV infection. Study Details The study...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: Anthony El-Khoueiry, MD

Anthony El-Khoueiry, MD, Member of the Section of Gastrointestinal Cancers, Director of the phase I program, and Associate Professor of Clinical Medicine at the Keck School of Medicine of the University of Southern California and USC Norris Comprehensive Cancer Center, said the findings of the...

Hepatobiliary Cancer
Immunotherapy

HIMALAYA Trial: First-Line Tremelimumab Plus Durvalumab Improves Overall Survival in Unresectable Hepatocellular Carcinoma

Patients with advanced, unresectable hepatocellular carcinoma may be gaining another first-line treatment option. In the global phase III HIMALAYA trial, a single priming dose of tremelimumab plus regular-interval durvalumab significantly improved overall survival, according to Ghassan K....

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: Nilofer Azad, MD

Nilofer Azad, MD, Professor of Oncology at Johns Hopkins University School of Medicine and Co-Director of Cancer Genetics and Epigenetics at the Sidney Kimmel Comprehensive Cancer Center, Baltimore, was invited to discuss the results of the phase III TOPAZ-1 study, which found an overall survival...

Hepatobiliary Cancer
Immunotherapy

TOPAZ-1: Overall Survival Prolonged With First-Line Immunotherapy Plus Chemotherapy in Biliary Tract Cancer

For the first time, a phase III study has shown an overall survival benefit for upfront treatment using immunotherapy plus chemotherapy in advanced biliary tract cancer. In the TOPAZ-1 trial, the addition of the anti–PD-L1 agent durvalumab to gemcitabine plus cisplatin significantly improved...

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