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Hepatobiliary Cancer

Combination Immunotherapy Approved for Unresectable or Metastatic Hepatocellular Carcinoma

On April 11, 2025, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo) with ipilimumab (Yervoy) for the first-line treatment of adults with unresectable or metastatic hepatocellular carcinoma. (See here for details on approval of this combination immunotherapy for colorectal...

Hepatobiliary Cancer
Issues in Oncology

Novel Drug/Device Combination May Improve Outcomes in Metastatic Uveal Melanoma

Percutaneous hepatic perfusion using a melphalan hepatic delivery system (melphalan/HDS) may be an effective treatment option in patients with unresectable uveal melanoma that has metastasized to the liver, according to a recent study published by Zager et al in the Annals of Surgical Oncology....

Hepatobiliary Cancer

FDA Approves Nivolumab Plus Ipilimumab for Unresectable or Metastatic HCC

On April 11, 2025, the U.S. Food and Drug Administration approved nivolumab (Opdivo) with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma (HCC). Efficacy was evaluated in CheckMate-9DW (ClinicalTrials.gov identifier...

Solid Tumors
Breast Cancer
Colorectal Cancer
Hepatobiliary Cancer
Issues in Oncology

Awareness of Alcohol-Related Cancer Risks May Be Growing

An increasing proportion of the U.S. public may be aware of the link between consuming alcohol and the elevated risk of later developing cancer, according to a recent survey conducted by the University of Pennsylvania’s Annenberg Public Policy Center (APPC). Background On January 3, 2025, Vivek...

Colorectal Cancer
Hepatobiliary Cancer
Gastrointestinal Cancer

In Case You Missed It: Abstracts on Novel Therapies in Gastrointestinal Cancers

The 2025 ASCO Gastrointestinal Cancers Symposium once again delivered a slate of high-impact studies spanning esophageal, gastric, hepatocellular, pancreatic, biliary tract, and colorectal malignancies. Experts in the field offered fresh perspectives on evolving standards of care, and investigators ...

Hepatobiliary Cancer
Immunotherapy

Outcomes After Complete Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma

In a retrospective study reported in JAMA Network Open, Lim et al found that complete response to immunotherapy as first-line treatment of advanced hepatocellular carcinoma was associated with good outcomes. Study Details The study involved analysis of 228 patients who received atezolizumab and...

Hepatobiliary Cancer
Issues in Oncology

Novel Biomarkers May Improve Diagnosis of Gallbladder Cancer

Plasma proteins may be capable of distinguishing gallbladder cancer from cholecystitis, which could reduce unnecessary procedures and improve treatment options in patients with suspected gallbladder cancer, according to a recent study published by Nouairia et al in JHEP Reports. Gallbladder cancer...

Solid Tumors
Issues in Oncology
Immunotherapy
Colorectal Cancer
Hepatobiliary Cancer
Gastrointestinal Cancer

Anticancer Drug Pharmacokinetics May Differ by Sex

Investigators may have uncovered notable pharmacokinetic differences between male and female patients in at least 14 anticancer drugs, according to a recent study published by Delahousse et al in ESMO Open. Background Many cancer drugs have a narrow therapeutic window. As a result, slight...

Solid Tumors
Issues in Oncology
Breast Cancer
Colorectal Cancer
Gynecologic Cancers
Lung Cancer
Hepatobiliary Cancer

Trends in Cancer Incidence and Mortality in Appalachia

Investigators have found that although fewer patients may be diagnosed with and dying from cancer in Appalachia, cancer incidence and mortality rates remain substantially higher compared with elsewhere in the United States, according to a recent study published by Burus et al in the Journal of the...

Hepatobiliary Cancer

TACE and Durvalumab/Bevacizumab in Unresectable HCC

In the phase III EMERALD-1 trial reported in The Lancet, Sangro et al found that transarterial chemoembolization (TACE) with durvalumab/bevacizumab improved progression-free survival vs placebo in patients with unresectable hepatocellular carcinoma (HCC) amenable to embolization.  Study Details In...

Hepatobiliary Cancer

Tiragolumab Plus Atezolizumab/Bevacizumab in Unresectable, Locally Advanced, or Metastatic Hepatocellular Carcinoma

In a phase Ib-II study (MORPHEUS-Liver) reported in The Lancet Oncology, Finn et al found that the addition of tiragolumab, an anti-TIGIT monoclonal antibody, to atezolizumab/bevacizumab improved objective response rate in patients with unresectable, locally advanced, or metastatic hepatocellular...

Hepatobiliary Cancer
Solid Tumors

Addition of Lenvatinib/Pembrolizumab to TACE in Unresectable Nonmetastatic HCC

As reported in The Lancet by Kudo et al, the phase III LEAP-012 trial has shown a significant progression-free survival benefit with the addition of lenvatinib and pembrolizumab to transarterial chemoembolization (TACE) in patients with unresectable nonmetastatic hepatocellular carcinoma (HCC). A...

Hepatobiliary Cancer
Issues in Oncology

New Study Identifies Potential Dose-Dependent Relationship Among Alcohol Consumption, HBV-Associated Cirrhosis, Hepatocellular Carcinoma

Investigators may have established a dose-dependent model of alcohol consumption on the risks of hepatitis B virus (HBV)-associated cirrhosis and hepatocellular carcinoma, according to a recent study published by Wu et al in the Journal of Clinical and Translational Hepatology. The quantitative...

Hepatobiliary Cancer

Addition of Nab-Paclitaxel to Gemcitabine/Cisplatin in Advanced Biliary Tract Cancers

As reported in the Journal of Clinical Oncology by Shroff et al, the phase III SWOG S1815 trial showed that nab-paclitaxel plus gemcitabine/cisplatin (GAP regimen) did not significantly improve overall survival vs gemcitabine/cisplatin alone in newly diagnosed patients with advanced biliary tract...

Hepatobiliary Cancer
Issues in Oncology

Addition of SBRT to Systemic Therapy May Improve Outcomes in Select Patients With Locally Advanced Hepatocellular Carcinoma

The addition of stereotactic body radiotherapy (SBRT) to systemic therapy with sorafenib may improve progression-free survival and time-to-progression in patients with locally advanced hepatocellular carcinoma compared with sorafenib alone, according to a novel study published by Dawson et al in...

Hepatobiliary Cancer
Immunotherapy
Issues in Oncology

Improving Hepatocellular Carcinoma Outcomes Through Enhanced Immunotherapy

A novel strategy may increase the activity of dendritic cells and improve immunotherapy outcomes in patients with hepatocellular carcinoma, according to a recent study published by Morita et al in Cancer Immunology Research. Background Hepatic cancer is a disease with a poor prognosis. Despite...

Hepatobiliary Cancer

Accelerated Approval Granted to Zanidatamab-hrii for HER2-Positive Biliary Tract Cancer

The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to zanidatamab-hrii (Ziihera), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test. The FDA also...

Hepatobiliary Cancer

HIMALAYA: 5-Year Analysis Confirms Survival Benefit of STRIDE Regimen in Hepatocellular Carcinoma

An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, confirms the benefit for the STRIDE regimen of the monoclonal antibodies durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 [The STRIDE regimen consists of a single priming dose of...

Hepatobiliary Cancer

LEAP-012: Combination of Therapies Extends Progression-Free Survival in Intermediate-Stage Hepatocellular Carcinoma

The combination of the VEGF tyrosine kinase inhibitor lenvatinib, the PD-1 inhibitor pembrolizumab, and transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with intermediate-stage hepatocellular carcinoma (HCC) compared with TACE alone, according to...

Breast Cancer
Lung Cancer
Hepatobiliary Cancer
Gastroesophageal Cancer
Prostate Cancer
Skin Cancer
Immunotherapy

Highlights From the ESMO Congress 2024

The European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona featured several groundbreaking trials with the potential to significantly influence clinical practice. These studies highlighted the benefits of new combination immunotherapy strategies and innovative approaches in the...

Breast Cancer
Leukemia
Hepatobiliary Cancer
Solid Tumors
Hematologic Malignancies

Trastuzumab Duocarmazine in Previously Treated HER2-Positive Metastatic Breast Cancer

The studies summarized below were reported online over the past month in The ASCO Post, generating a high number of visitors.  For comprehensive reviews of these studies and more, visit ASCOPost.com. Trastuzumab Duocarmazine in Previously Treated HER2-Positive Metastatic Breast Cancer In the phase...

Health-Care Policy
Issues in Oncology
Hepatobiliary Cancer

Impact of Food Insecurity on the Incidence of Hepatocellular Carcinoma

At the 2024 American Association for Cancer Research (AACR) Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved, Rebecca D. Kehm, PhD, of Columbia University Mailman School of Public Health, New York, and colleagues presented some of the ...

Hepatobiliary Cancer

Penpulimab Combination Therapy for First-Line Treatment of Hepatocellular Carcinoma

The National Medical Products Administration (NMPA) of China has accepted a supplemental new drug application (sNDA) for penpulimab, a differentiated PD-1 monoclonal antibody, in combination with the multikinase inhibitor anlotinib for the first-line treatment of advanced hepatocellular carcinoma...

Hepatobiliary Cancer

FDA Grants Accelerated Approval to Zanidatamab-hrii for Previously Treated Unresectable or Metastatic HER2-Positive Biliary Tract Cancer

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to zanidatamab-hrii (Ziihera), a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected by an FDA-approved test. The FDA also approved ...

Hepatobiliary Cancer

Addition of Atezolizumab Plus Bevacizumab to Chemotherapy in Advanced Biliary Tract Cancer

In a phase II trial (IMbrave151) reported in the Journal of Clinical Oncology, Macarulla et al found that atezolizumab/bevacizumab plus chemotherapy produced a “modest” improvement in progression-free survival vs atezolizumab/placebo plus chemotherapy in first-line treatment of patients with...

Gynecologic Cancers
Hepatobiliary Cancer
Lung Cancer

Unexpected Results in Solid Tumors: What We Learned From Negative Findings

Attendees at the European Society for Medical Oncology (ESMO) Congress 2024 heard the results of many positive clinical trials that will advance the field of cancer treatment. However, a few late-stage trials of promising adjuvant therapies unexpectedly reported negative results. The ASCO Post...

Hepatobiliary Cancer

Association Between Pathologic Response and Relapse-Free Survival With Neoadjuvant Immune Checkpoint Inhibitor Therapy for Hepatocellular Carcinoma

In an analysis reported in The Lancet Oncology, D’Alessio et al found that major pathologic response and complete pathologic response to neoadjuvant immune checkpoint inhibitor therapy was associated with improved relapse-free survival in patients with hepatocellular carcinoma. Study Details The...

Hepatobiliary Cancer
Issues in Oncology
Immunotherapy

New Marker for Immunotherapy Response in Hepatocellular Carcinoma

A newly described stage of lymph node–like structures, known as tertiary lymphoid structures, identified in hepatic tumors following presurgical immunotherapy may be vital to successfully treating patients with hepatocellular carcinoma, according to a recent study published by Shu et al in Nature...

Hepatobiliary Cancer
Issues in Oncology

Higher Dosage of Radioembolization With Y-90 Therapy May Improve Survival Rates and Facilitate Curative Treatment in Patients With Hepatocellular Carcinoma

Researchers found that a higher dosage of radioembolization treatment using yttrium (Y)-90 microspheres than previously recommended may benefit patients with hepatocellular carcinoma, according to a recent study published by Chen et al in Liver Cancer. The findings could be practice-changing....

Hepatobiliary Cancer

Addition of Liver Transplantation to Chemotherapy for Permanently Unresectable Colorectal Cancer Liver Metastases

In the European TransMet trial, reported in The Lancet, Adam et al found that liver transplantation plus chemotherapy improved overall survival vs chemotherapy alone in patients with permanently unresectable colorectal cancer liver metastases. Study Details In the open-label trial, 94 patients...

Hepatobiliary Cancer

LEAP-012: Combination of Therapies Extends Progression-Free Survival in Intermediate-Stage Hepatocellular Carcinoma

The combination of the VEGF tyrosine kinase inhibitor lenvatinib, the PD-1 inhibitor pembrolizumab, and transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with intermediate-stage hepatocellular carcinoma (HCC) compared with TACE alone, according to...

Hepatobiliary Cancer

HIMALAYA: 5-Year Analysis Confirms Survival Benefit of STRIDE Regimen in Hepatocellular Carcinoma

An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, confirms the benefit for the STRIDE regimen of the monoclonal antibodies durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 [The STRIDE regimen consists of a single priming dose of...

hepatobiliary cancer

Maeve Lowery, MD, on a Novel Bifunctional Antibody in Advanced Hepatocellular Carcinoma

Maeve Lowery, MD, discusses the results of the phase II DUBHE-H-308 trial, which evaluated QL1706—a bifunctional antibody consisting of iparomlimab and tuvonralimab—plus bevacizumab and/or chemotherapy in the first-line treatment of advanced hepatocellular carcinoma (Abstract LBA38).

Hepatobiliary Cancer

Addition of Palliative Radiotherapy to Best Supportive Care in Painful Hepatic Cancer

As reported in The Lancet Oncology by Laura A. Dawson, MD, of the University Health Network–Princess Margaret Cancer Centre, University of Toronto, and colleagues, the Canadian phase III CCRG HE1 trial showed that the addition of a single fraction of palliative radiotherapy to best supportive care...

hepatobiliary cancer

Josep M. Llovet, MD, PhD, on Treatment Options in Hepatocellular Carcinoma

Josep M. Llovet, MD, PhD, presented the results of the LEAP-012 trial during the Presidential Symposium I at the ESMO Congress 2024 (Abstract LBA3). In this brief summary, Dr. Llovet talks further about how management of hepatocellular carcinoma differs across stages.

hepatobiliary cancer

Josep M. Llovet, MD, PhD, on Intermediate-Stage Hepatocellular Carcinoma: Addition of Lenvatinib Plus Pembrolizumab to TACE

Josep M. Llovet, MD, PhD, presented the results of the phase III LEAP-012 trial, which evaluated the addition of lenvatinib plus pembrolizumab to transarterial chemoembolization (TACE), during the Presidential Symposium I at the ESMO Congress 2024 (Abstract LBA3). For more insights into the treatment of hepatocellular carcinoma, view Dr. Llovet's discussion here.

hepatobiliary cancer

Ghassan K. Abou-Alfa, MD, MBA, FASCO, and Lorenza Rimassa, MD, on Doublet Immunotherapy Options for Unresectable Hepatocellular Carcinoma

In light of the landmark 5-year overall survival results from HIMALAYA, Ghassan K. Abou-Alfa, MD, MBA, FASCO, of Memorial Sloan Kettering Cancer Center, New York, and Lorenza Rimassa, MD, discuss how to choose among the various doublet immunotherapy options for unresectable hepatocellular carcinoma. For more on the HIMALAYA trial, view part 1 of this discussion.

hepatobiliary cancer

Ghassan K. Abou-Alfa, MD, MBA, FASCO, and Lorenza Rimassa, MD, on Unresectable Hepatocellular Carcinoma: 5-Year Overall Survival Results From the HIMALAYA Trial

Ghassan K. Abou-Alfa, MD, MBA, FASCO, of Memorial Sloan Kettering Cancer Center, New York, and Lorenza Rimassa, MD, of Humanitas Cancer Center, Milan, discuss the 5-year overall survival results from the phase III HIMALAYA trial evaluating tremelimumab plus durvalumab in unresectable hepatocellular carcinoma (Abstract 947MO). For more on the HIMALAYA trial, view part 2 of this discussion. �

Hepatobiliary Cancer

5-Year Analysis of Phase III HIMALAYA Confirms Survival Benefit of STRIDE in Hepatocellular Carcinoma

An updated overall survival analysis of the phase III HIMALAYA study, now at 5 years, has confirmed the robust benefit for the STRIDE regimen of durvalumab plus tremelimumab in unresectable hepatocellular carcinoma.1 At the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract...

Hepatobiliary Cancer

LEAP-012: Pembrolizumab Plus Lenvatinib Added to TACE Improved Progression-Free Survival in HCC

According to results of the first interim analysis of the phase III LEAP-012 trial, the anti–PD-1 therapy pembrolizumab plus the tyrosine kinase inhibitor lenvatinib, in combination with transarterial chemoembolization (TACE), significantly improved progression-free survival compared with TACE...

Hepatobiliary Cancer

Advanced Biliary Tract Cancers: Bevacizumab/Erlotinib Maintenance vs Active Surveillance

In an Indian phase II trial (BEER BTC) reported in the Journal of Clinical Oncology, Ramaswamy et al found that maintenance therapy with bevacizumab/erlotinib improved progression-free survival vs active surveillance in patients with advanced biliary tract cancers who had at least stable disease...

Hepatobiliary Cancer

High-Risk Localized HCC: Efficacy of Neoadjuvant Immunotherapy vs Upfront Surgery

Hepatocellular carcinoma is the most common type of primary liver cancer, accounting for about 80% of all primary liver cancers in the United States, and is currently the sixth most common cancer and the fourth most common cause of cancer-related deaths. Although immunotherapy is now a mainstay for ...

Colorectal Cancer
Hepatobiliary Cancer
Issues in Oncology

Liver Transplantation vs Standard Therapies in Patients With Colorectal Cancer Liver Metastasis

Certain patients with colorectal cancer that has metastasized to the liver may experience improved progression-free survival with liver transplantation compared with standard therapies, according to a recent study published by Byrne et al in JAMA Surgery. Background Colorectal cancer often...

Hepatobiliary Cancer
Cardio-oncology

Do Nonstatin Cholesterol-Lowering Drugs Influence the Risk of Hepatic Cancer?

Investigators examined whether nonstatin cholesterol-lowering drugs may affect the risk of hepatic cancer, according to a recent study published by Zamani et al in Cancer. Background Hepatic cancer is the sixth most common cancer type across the world and the third leading cause of cancer-related...

Gastroesophageal Cancer
Hepatobiliary Cancer
Immunotherapy
Issues in Oncology

Fecal Microbiota Transplant May Help Patients With Gastrointestinal Cancers Overcome Immunotherapy Resistance

Fecal microbiota transplants may improve the effectiveness of immunotherapy in patients with gastrointestinal cancers, according to a recent study published by Kim et al in Cell Host & Microbe. Background Although immune checkpoint inhibitors have revolutionized cancer treatment, many patients...

hepatobiliary cancer

Localized Hepatocellular Carcinoma

This is Part 3 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable.   In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of localized hepatocellular carcinoma. The patient is a 52-year-old male with a history of hepatitis C virus that has been treated and is in remission. Follow-up surveillance imaging reveals a 5.2-cm liver mass that washes out. His AFP is 6.2, and labs are within normal limits. His ECOG performance status is 1, and he has no history of alcohol or drug use.   In the conversation that follows, the faculty discuss the multidisciplinary management of localized hepatocellular carcinoma, whether resection or transplant should be considered, and adjuvant treatment options for high-risk disease.

hepatobiliary cancer

Advanced Cholangiocarcinoma

This is Part 2 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable.   In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of advanced cholangiocarcinoma. The patient is a 70-year-old female with no major medical history who presents to the ER after an acute episode of nausea/vomiting and abdominal pain. An MRI reveals a large liver mass with multiple satellite nodules, a hallmark of cholangiocarcinoma. Her labs are within normal limits with the exception of some mild electrolyte abnormalities, and her CA 19-9 is 473. A biopsy of the liver mass reveals moderately differentiated adenocarcinoma that is CK7-positive, CK20-negative, and HepPar1-negative. She presents to oncology for further management, where her physical exam is within normal limits and her ECOG performance status is 0.   In the conversation that follows, the faculty discuss next steps in the diagnostic workup of this patient, the role of next-generation sequencing in determining the course of treatment, and current first- and second-line therapies for unresectable cholangiocarcinoma.

hepatobiliary cancer

Advanced Unresectable Hepatocellular Carcinoma

This is Part 1 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable.   In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of advanced unresectable hepatocellular carcinoma. The patient is a 67-year-old male with a history of fatty liver disease who presents with abdominal and back pain. Past medical history includes diabetes and hypertension, but no hepatitis. Labs show mild anemia but otherwise normal CBC and chemistries; liver function tests are normal other than mild AST/ALT elevation; and AFP is 47.3. MRI of the abdomen reveals multiple lesions in the liver, and a CT reveals lesions along the spine. The patient presents to oncology for further management, where his physical exam is within normal limits and his ECOG performance status is 1.   In the conversation that follows, the faculty discuss current first-line immunotherapy options for hepatocellular carcinoma, including the STRIDE regimen and atezolizumab/bevacizumab; how to balance the risks and benefits of immune checkpoint inhibitors; and what to do after disease progression.

Hepatobiliary Cancer
Immunotherapy

Immunotherapy in Unresectable HCC With Child-Pugh Class B Dysfunction

In a retrospective study reported in JAMA Oncology, Fulgenzi et al found evidence that immune checkpoint inhibitor (ICI)-based treatment may improve survival vs best supportive care as first-line therapy in patients with unresectable hepatocellular carcinoma and Child-Pugh class B (CP-B) liver...

Hepatobiliary Cancer

Adjuvant Therapeutic Regimens for Gallbladder Cancer

In an Indian phase II trial (GECCOR-GB) reported in JAMA Oncology, Ostwal et al found that both adjuvant gemcitabine/cisplatin (GC) and capecitabine and capecitabine given concurrently with chemoradiation therapy (CCRT) showed activity in patients with resected gallbladder cancer. Study Details In...

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