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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...

hepatobiliary cancer

Anthony B. El-Khoueiry, MD, on Hepatocellular Carcinoma: Expert Perspective on Novel Additive Strategies

Anthony B. El-Khoueiry, MD, of the University of Southern California, Norris Comprehensive Cancer Center, discusses two key phase III studies of first-line treatment in hepatocellular carcinoma: the LAUNCH trial, which explored lenvatinib combined with transarterial chemoembolization for advanced disease; and the HIMALAYA trial, which studied tremelimumab and durvalumab for unresectable disease. The latter trial may represent a new standard of care, according to Dr. El-Khoueiry.  

hepatobiliary cancer
immunotherapy

Ghassan K. Abou-Alfa, MD, MBA, on Hepatocellular Carcinoma: Open-Label Trial of Tremelimumab and Durvalumab

Ghassan K. Abou-Alfa, MD, MBA, of Memorial Sloan Kettering Cancer Center and Weill Medical College at Cornell University, discusses phase III results of the HIMALAYA trial, which showed the combination of a single priming dose of tremelimumab added to durvalumab is superior to sorafenib for patients with unresectable hepatocellular carcinoma (Abstract 379).

hepatobiliary cancer
immunotherapy

Nilofer Saba Azad, MD, on Novel Treatment Combinations Under Study in Biliary Tract Cancers

Nilofer Saba Azad, MD, of Johns Hopkins Sidney Kimmel Cancer Center, assesses the findings from the phase III TOPAZ-1 trial, a study of durvalumab in combination with gemcitabine plus cisplatin in patients with advanced biliary tract cancer. Dr. Azad explains why the study sets a potential new standard of care of gemcitabine plus cisplatin and durvalumab in unselected patients.

Hepatobiliary Cancer

Neoadjuvant Cemiplimab-rwlc for Patients With Resectable Hepatocellular Carcinoma

In a single-institution phase II trial reported in The Lancet Gastroenterology & Hepatology, Marron et al found that neoadjuvant treatment with the PD-1 inhibitor cemiplimab-rwlc in patients with resectable hepatocellular carcinoma produced a high level of pathologic tumor necrosis at resection ...

Hepatobiliary Cancer
Immunotherapy

Durvalumab/Tremelimumab Improves Overall Survival vs Sorafenib in Patients With Advanced Hepatocellular Carcinoma: HIMALAYA

Results from the randomized international phase III HIMALAYA trial showed that a combination of the anti–PD-L1 immunotherapy durvalumab plus the anti–CTLA-4 immunotherapy tremelimumab reduced the risk of death by 22% in patients with stage III or IV unresectable hepatocellular carcinoma compared to ...

Hepatobiliary Cancer
Immunotherapy

Durvalumab Plus Gemcitabine/Cisplatin Improves Survival in Patients With Advanced Biliary Tract Cancer: TOPAZ-1

Biliary tract cancer is a rare and often fatal disease comprised primarily of bile duct and gallbladder cancers; it is diagnosed in about 12,000 individuals each year in the United States. The cancer has a 5-year relative survival rate of 25% for localized intrahepatic bile duct cancers and just...

Hepatobiliary Cancer

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

A clinical guideline from the American Society for Radiation Oncology (ASTRO) provides guidance on the use of radiation therapy to treat adult patients with primary liver cancers using external-beam radiation therapy (EBRT). Evidence-based recommendations outline indications and optimal EBRT...

Hepatobiliary Cancer
Genomics/Genetics

European Genome-Wide Association Study of Genetic Variants in Alcohol-Related Hepatocellular Carcinoma

In a case-control genome-wide association study among persons of European ancestry reported in The Lancet Oncology, Trépo et al identified common genetic variants associated with the risk of alcohol-related hepatocellular carcinoma (HCC). Study Details The study involved a discovery cohort of 2,107 ...

Hepatobiliary Cancer

Hepatic Arterial Infusion Chemotherapy vs Sorafenib for Advanced Hepatocellular Carcinoma

In a Chinese phase III trial (FOHAIC-1) reported in the Journal of Clinical Oncology, Lyu et al found that hepatic arterial infusion chemotherapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin; HAIC-FO) significantly prolonged overall survival vs sorafenib in patients with advanced...

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-3121 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

First-Line Nivolumab vs Sorafenib in Advanced Hepatocellular Carcinoma: Effect on Overall Survival

As reported in The Lancet Oncology by Thomas Yau, MD, and colleagues, the phase III CheckMate 459 trial has shown no improvement in overall survival with first-line nivolumab vs sorafenib in patients with advanced hepatocellular carcinoma. Study Details In the open-label trial, 743 patients not...

Hepatobiliary Cancer

Impact of Small Cell Undifferentiated Histology on Outcomes in Pediatric Hepatoblastoma

In an analysis from the Children’s Oncology Group study AHEP0731 reported in the Journal of Clinical Oncology, Trobaugh-Lotrario et al found that the presence of small cell undifferentiated histology elements did not appear to adversely affect outcomes in pediatric patients with hepatoblastoma....

Hepatobiliary Cancer
Immunotherapy

Novel Vaccine Platform Plus Pembrolizumab May Boost Immune Response in Advanced HCC

A novel vaccine platform administered in combination with pembrolizumab appears to be safe and effective in patients with advanced hepatocellular carcinoma (HCC), according to data presented by Mark Yarchoan, MD, and colleagues at the Society for Immunotherapy of Cancer (SITC) 2021 Annual Meeting...

Hepatobiliary Cancer
Genomics/Genetics

Association of KRAS Variants With Outcomes After Curative Resection of Intrahepatic Cholangiocarcinoma

In a Chinese single-institution cohort study reported in JAMA Surgery, Zhou et al found that the presence of somatic G12 KRAS variants was associated with poorer overall and disease-free survival in patients who had undergone curative resection of intrahepatic cholangiocarcinoma. Study Details The ...

Hepatobiliary Cancer

Modified FOLFIRINOX vs Cisplatin/Gemcitabine for Advanced Biliary Tract Cancer

In the phase II portion of a French phase II/III trial (PRODIGE 38 AMEBICA) reported in the Journal of Clinical Oncology, Phelip et al found that modified (m) FOLFIRINOX (oxaliplatin, irinotecan, leucovorin, and fluorouracil) did not improve 6-month progression-free survival vs the combination of...

Hepatobiliary Cancer

Hepatic Arterial Infusion of FOLFOX vs Transarterial Chemoembolization for Unresectable Large Hepatocellular Carcinoma

In a Chinese phase III trial reported in the Journal of Clinical Oncology, Li et al found that hepatic arterial infusion chemotherapy with FOLFOX (fluorouracil, leucovorin, and oxaliplatin; FOLFOX-HAIC) improved overall survival vs transarterial chemoembolization (TACE) as first-line treatment for...

Hepatobiliary Cancer

Study Examines Use of External-Beam Radiotherapy as a Bridging Therapy for Patients With HCC Awaiting Transplant

Patients with hepatocellular carcinoma (HCC) awaiting liver transplantation may benefit from noninvasive treatment with external-beam radiotherapy (EBRT) but are rarely given this therapy, according to a new analysis of U.S. national data. Findings were presented by Nima Nabavizadeh, MD, at the...

Hepatobiliary Cancer

Addition of Liposomal Irinotecan to Fluorouracil and Leucovorin as Second-Line Treatment for Metastatic Biliary Tract Cancer

In a Korean phase IIb trial (NIFTY) reported in The Lancet Oncology, Yoo et al found that the addition of liposomal irinotecan to fluorouracil/leucovorin improved progression-free survival as a second-line treatment for patients with metastatic biliary tract cancer whose disease had progressed on...

Skin Cancer
Gynecologic Cancers
Prostate Cancer
Breast Cancer
Solid Tumors
Hepatobiliary Cancer
Gastroesophageal Cancer
Immunotherapy

FDA Pipeline: Recent Reviews, Designations, Applications, and Authorizations in the Oncology Space

Over the past month, the U.S. Food and Drug Administration (FDA) issued several regulatory decisions for novel treatments for patients with cancer. Priority Review for Relatlimab and Nivolumab Fixed-Dose Combination in Unresectable or Metastatic Melanoma The FDA accepted for Priority Review the...

Hepatobiliary Cancer

Addition of Ramucirumab or Merestinib to First-Line Chemotherapy in Advanced Biliary Tract Cancer

In a phase II trial reported in The Lancet Oncology, Juan W. Valle, MD, and colleagues found that no progression-free survival benefit was achieved with the addition of either the VEGFR2 inhibitor ramucirumab or the MEK inhibitor merestinib to first-line cisplatin/gemcitabine chemotherapy in...

Hepatobiliary Cancer
Genomics/Genetics

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...

Hepatobiliary Cancer
Issues in Oncology

Are Rates of Hepatocellular Carcinoma Rising in Rural Areas of the United States?

Historically, rates of hepatocellular carcinoma (HCC) have been lower in rural areas than urban regions. However, a recent study published by Zhou et al in Clinical Gastroenterology and Hepatology shows that while cases of HCC have begun slowing in urban communities in the United States, the...

Hepatobiliary Cancer

Ivosidenib for Previously Treated IDH1-Mutant Advanced or Metastatic Cholangiocarcinoma

On August 25, 2021, ivosidenib was approved for adults with previously treated, locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation, as detected by a U.S. Food and Drug Administration (FDA)-approved test.1 The FDA simultaneously approved the Oncomine Dx Target Test as a...

Hepatobiliary Cancer

FDA Approves Ivosidenib for Advanced or Metastatic IDH1-Mutated Cholangiocarcinoma

On August 25, the U.S. Food and Drug Administration (FDA) approved ivosidenib (Tibsovo), a small-molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), for adult patients with previously treated locally advanced or metastatic cholangiocarcinoma with an IDH1 mutation as detected by an FDA-approved ...

Hepatobiliary Cancer
Immunotherapy

Pertuzumab and Trastuzumab in Previously Treated Patients With HER2-Positive Metastatic Biliary Tract Cancer

As reported in The Lancet Oncology by Milind Javle, MD, and colleagues, findings in a cohort of the phase IIa MyPathway multiple basket study showed that the combination of pertuzumab and trastuzumab produced responses in some previously treated patients with HER2-positive metastatic biliary tract...

Hepatobiliary Cancer
Immunotherapy

Tremelimumab, Durvalumab, or Both in Unresectable Hepatocellular Carcinoma

In a randomized expansion phase of a phase I/II study reported in the Journal of Clinical Oncology, Robin Kate Kelley, MD, and colleagues found that a novel regimen consisting of a single priming dose of tremelimumab in combination with durvalumab was associated with good outcomes in patients with...

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