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Hepatobiliary Cancer

Expert Point of View: Rachna T. Shroff, MD

Invited discussant of the ClarIDHy trial, Rachna T. Shroff, MD, Associate Professor of Medicine, University of Arizona, and Chief of GI Medical Oncology at the University of Arizona Cancer Center, said positive findings for ivosidenib support the notion that “biliary cancer is a perfect example of...

Hepatobiliary Cancer

ClarIDHy Trial: IDH1 Inhibitor Ivosidenib Benefits Survival in Cholangiocarcinoma

Ivosidenib, an inhibitor of isocitrate dehydrogenase 1 (IDH1), improved overall survival by almost 3 months in previously treated patients with advanced IDH1-mutated cholangiocarcinoma, compared with placebo, researchers of the global phase III ClarIDHy trial reported at the 2021 Gastrointestinal...

Immunotherapy
Gastroesophageal Cancer
Gastrointestinal Cancer
Colorectal Cancer
Bladder Cancer
Skin Cancer
Sarcoma
Hepatobiliary Cancer

FDA Pipeline: Priority Reviews for Immunotherapies in Gastric Cancers, Anal Cancer

The U.S. Food and Drug Administration (FDA) recently granted Priority Review to nivolumab as either adjuvant or first-line therapy in several types of gastric cancers, as well as to a novel PD-1 inhibitor for locally advanced or metastatic squamous cell carcinoma of the anal canal. The FDA also...

hepatobiliary cancer

Andrew X. Zhu, MD, PhD, on IDH1-Mutant Cholangiocarcinoma: Ivosidenib vs Placebo

Andrew X. Zhu, MD, PhD, of Massachusetts General Hospital, discusses final results from the phase III ClarIDHy study, which showed that ivosidenib may improve overall and progression-free survival compared with placebo in patients with previously treated cholangiocarcinoma and an isocitrate dehydrogenase 1 mutation (Abstract 266).

hepatobiliary cancer
immunotherapy

Richard S. Finn, MD, on HCC: Atezolizumab Plus Bevacizumab vs Sorafenib

Richard S. Finn, MD, of the UCLA Medical Center, discusses updated results from the IMbrave 150 study, which showed atezolizumab plus bevacizumab provides the longest overall survival seen in a front-line phase III study in advanced hepatocellular carcinoma, confirming this combination as the standard of care for patients with previously untreated, unresectable disease (Abstract 267).

hepatobiliary cancer

Milind M. Javle, MD, on Cholangiocarcinoma: Treatment With Infigratinib

Milind M. Javle, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II study results showing that the novel tyrosine kinase inhibitor infigratinib may prove to be effective in treating patients with advanced cholangiocarcinoma harboring an FGFR2 gene fusion or rearrangement (Abstract 265).

Hepatobiliary Cancer

IDH Inhibitor Ivosidenib Improves Overall Survival in Previously Treated Patients With Cholangiocarcinoma: ClarIDHy Trial

Ivosidenib, an inhibitor of isocitrate dehydrogenase 1 (IDH1), improved overall survival by almost 3 months compared with placebo in previously treated patients with advanced IDH1-mutated cholangiocarcinoma. Researchers presented results from the global phase III ClarIDHy trial at the 2021...

Hepatobiliary Cancer
Immunotherapy

Meta-analysis of Outcomes With Systemic Therapy in First- and Second-Line Treatments of Advanced HCC

In a systematic review and network meta-analysis reported in JAMA Oncology, Mohamad Bassam Sonbol, MD, of Mayo Clinic Cancer Center, Phoenix, and colleagues, found that atezolizumab plus bevacizumab outperformed other regimens in the first-line treatment of advanced hepatocellular carcinoma (HCC)...

Hepatobiliary Cancer
Immunotherapy

ASCO Releases Guideline on Systemic Therapy for Advanced Hepatocellular Carcinoma

ASCO has released a new evidence-based clinical practice guideline to assist in clinical decision-making for patients with advanced hepatocellular carcinoma.1 “Advanced hepatocellular carcinoma has transitioned from a disease where we had a single approved therapy for patients to one where we now...

Lymphoma
Leukemia
Hepatobiliary Cancer
Symptom Management
Lung Cancer
Immunotherapy

FDA Pipeline: Agents in DLBCL, SCLC, AML, and More

Recently, the U.S. Food and Drug Administration (FDA) has issued regulatory decisions for agents to treat diffuse large B-cell lymphoma (DLBCL), small cell lung cancer (SCLC), acute myeloid leukemia (AML), biliary tract cancer, and graft-vs-host disease. Priority Review for Loncastuximab Tesirine...

Hepatobiliary Cancer
Immunotherapy

ESMO Asia 2020: First-Line Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma

Sintilimab, an anti–PD-1 antibody, in combination with a bevacizumab biosimilar as first-line therapy significantly improved survival compared to sorafenib in patients with advanced hepatocellular carcinoma, according to findings presented by Ren et al at the ESMO Asia Virtual Congress 2020...

Hepatobiliary Cancer

ESMO Asia 2020: Futibatinib for Patients With Refractory Intrahepatic Cholangiocarcinoma and FGFR2 Fusions/Rearrangements

Clinical benefit was provided by the FGFR1–4 inhibitor futibatinib in patients with refractory intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions or other rearrangements, including those enrolled in Asian countries. These findings were presented by Furuse et al at the ESMO Asia Virtual...

Hepatobiliary Cancer

Addition of Ablative Therapy to Transarterial Chemoembolization in Nonmetastatic Unresectable Hepatocellular Carcinoma

In a single-institution cohort study reported in JAMA Network Open, English et al found that the addition of ablative therapy to transarterial chemoembolization improved freedom from local disease progression and overall survival in patients with nonmetastatic unresectable hepatocellular ...

Hepatobiliary Cancer
Pancreatic Cancer

FDA Pipeline: Fast Track Designations in Liver and Pancreatic Cancers

Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designations to novel agents in the treatment of liver and pancreatic cancers. Fast Track Designation for SRF388 in Liver Cancer The FDA granted Fast Track designation to SRF388 for the treatment of patients with...

Hepatobiliary Cancer
Immunotherapy

Systemic Therapy in the First- and Second-Line Treatment of Advanced Hepatocellular Carcinoma: Review and Meta-analysis

In a systematic review and network meta-analysis of 14 trials reported in JAMA Oncology, Sonbol et al found that atezolizumab plus bevacizumab outperformed other regimens in the first-line treatment of advanced hepatocellular carcinoma and identified preferred treatments in refractory disease. As...

Hepatobiliary Cancer

2020 Nobel Prize in Physiology or Medicine Awarded to Team Who Discovered Hepatitis C Virus

This year’s Nobel Prize in Physiology or Medicine was awarded to three scientists who have made a decisive contribution to the fight against blood-borne hepatitis, a major global health problem that causes cirrhosis and liver cancer in people around the world. Harvey J. Alter, MD; Michael Houghton, ...

Hepatobiliary Cancer

Dabrafenib Plus Trametinib for Patients With BRAF V600E–Mutated Cholangiocarcinoma

In a phase II trial reported by Vivek Subbiah, MD, and colleagues in The Lancet Oncology, the combination of dabrafenib, a BRAF inhibitor, and trametinib, a MEK inhibitor, achieved a 51% overall response rate in patients with BRAF V600E­–mutated cholangiocarcinoma. This trial represents the first...

Hepatobiliary Cancer
Immunotherapy

Novel Tremelimumab/Durvalumab Regimen Active in Advanced Hepatocelluar Carcinoma

A single priming dose of tremelimumab and durvalumab, followed by monthly durvalumab, showed clinical activity in a predominantly second-line advanced hepatocellular carcinoma population, in a study reported at the ESMO World Congress on Gastrointestinal Cancer Virtual 2020.1 In a study of 332...

Hepatobiliary Cancer
Immunotherapy

First-Line Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma

In a phase Ib trial reported in the Journal of Clinical Oncology, Richard S. Finn, MD, and colleagues found that the combination of lenvatinib and pembrolizumab produced durable responses in patients with unresectable hepatocellular carcinoma who had received no prior systemic chemotherapy. As...

Hepatobiliary Cancer
Immunotherapy

Combination Immunotherapy in Advanced Biliary Tract Cancers

In a subgroup analysis of an Australian phase II trial reported in JAMA Oncology, Klein et al found that the combination of nivolumab and ipilimumab was active in patients with advanced biliary tract cancers. Study Details The phase II trial is enrolling patients with advanced rare cancers. The...

Hepatobiliary Cancer
Immunotherapy

Phase Ib Trial of Atezolizumab With or Without Bevacizumab in Patients With Unresectable Hepatocellular Carcinoma

The combination of atezolizumab and bevacizumab was recently approved by the U.S. Food and Drug Administration for the treatment of unresectable or metastatic hepatocellular carcinoma on the basis of findings from the phase III IMbrave150 trial, which showed superior overall and progression-free...

Hepatobiliary Cancer

Liver Transplantation After Tumor Downstaging in Patients With Hepatocellular Carcinoma

In an Italian phase IIb/III study reported in The Lancet Oncology, Mazzaferro et al found evidence that liver transplantation after tumor downstaging was associated with improved event-free and overall survival in patients with hepatocellular carcinoma. The study was closed early due to changes in...

Hepatobiliary Cancer
Immunotherapy

Atezolizumab Plus Bevacizumab for Unresectable or Metastatic Hepatocellular Carcinoma

On May 29, 2020, atezolizumab in combination with bevacizumab was approved for treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.1-3 Supporting Efficacy Data Approval was based on findings in the international, open-label,...

Hepatobiliary Cancer
Immunotherapy

IMbrave150: A New Standard of Care to Treat Hepatocellular Cancers?

In 2007, sorafenib became the first approved systemic therapy for hepatocellular cancers and the first agent to improve overall survival in these patients.1 In a similar multikinase inhibitor strategy, lenvatinib was found to be noninferior to sorafenib in overall survival in the same patient...

Hepatobiliary Cancer
Immunotherapy

IMbrave150 Trial: Atezolizumab Plus Bevacizumab Improves Survival in Unresectable Hepatocellular Carcinoma

As reported in The New England Journal of Medicine by Richard S. Finn, MD, of Jonsson Comprehensive Cancer Center, Geffen School of Medicine at the University of California, Los Angeles, and colleagues, the phase III IMbrave150 trial has shown that anti–programmed cell death ligand 1 (PD-L1) plus...

Hepatobiliary Cancer

ESMO World GI: Third- or Later-Line Treatment With Infigratinib in Patients With Cholangiocarcinoma and FGFR2 Fusions

At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual, Javle et al reported that third- and later-line treatment with the selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor infigratinib resulted in a progression-free survival and...

Hepatobiliary Cancer

Third- or Later-Line Treatment With Infigratinib in Patients With Cholangiocarcinoma and FGR2 Fusions

At the European Society for Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer 2020 Virtual, Javle et al reported that third- and later-line treatment with the selective fibroblast growth factor receptor (FGFR) 1–3 inhibitor infigratinib resulted in a progression-free survival and...

Hepatobiliary Cancer

Blood Test Improves Screening for Hepatocellular Carcinoma

Researchers at the National Institutes of Health have developed a new test that may help identify individuals who may be likely to develop hepatocellular carcinoma. A study of the new approach was led by researchers at the National Cancer Institute (NCI). The findings were published in the journal...

Hepatobiliary Cancer

SIR 2020 Virtual: Holographic Visualization for Ablation of Liver Tumors

Data from one of the first clinical uses of augmented reality guidance with electromagnetically tracked tools shows that the technology may help doctors quickly, safely, and accurately deliver targeted liver cancer treatments, according to a research abstract presented during a virtual session of...

Lung Cancer
Hepatobiliary Cancer

FDA Approves Combination Regimens in NSCLC, HCC

On May 29, 2020, the U.S. Food and Drug Administration (FDA) approved two combination regimens: ramucirumab (Cyramza) was approved in combination with erlotinib for the first-line treatment of patients with metastatic non–small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR)...

Hepatobiliary Cancer
Immunotherapy

FDA Approves Atezolizumab Plus Bevacizumab for Patients With Unresectable or Metastatic HCC

On May 29, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) for the treatment of people with unresectable or metastatic hepatocellular carcinoma (HCC) who have not received prior systemic therapy. The review of this application...

Hepatobiliary Cancer

Ivosidenib for IDH1-Mutant Chemotherapy-Refractory Cholangiocarcinoma

As reported by Ghassan K. Abou-Alfa, MD, and colleagues in The Lancet Oncology, the phase III ClarIDHy trial has shown that the isocitrate dehydrogenase-1 (IDH1) inhibitor ivosidenib improved progression-free survival vs placebo in patients with advanced IDH1-mutant chemotherapy-refractory...

Hepatobiliary Cancer

Pemigatinib for Previously Treated Cholangiocarcinoma With FGFR2 Rearrangement or Fusion

On April 17, 2020, pemigatinib was granted accelerated approval for the treatment of adults with previously treated unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by a U.S. Food and Drug...

Hepatobiliary Cancer
Immunotherapy

Atezolizumab Plus Bevacizumab vs Sorafenib in Treatment-Naive Patients With Unresectable Hepatocellular Carcinoma

As reported in The New England Journal of Medicine by Richard S. Finn, MD, and colleagues,  the phase III IMbrave150 trial has shown that anti–programmed cell death ligand 1 (PD-L1) plus anti-VEGF therapy with atezolizumab plus bevacizumab improved progression-free and overall survival vs sorafenib ...

hepatobiliary cancer

Andrew X. Zhu, MD, PhD, on Hepatocellular Carcinoma: Atezolizumab Combined With Bevacizumab

Andrew X. Zhu, MD, PhD, of Massachusetts General Hospital, discusses an exploratory analysis seeking to identify tumor-based molecular biomarkers that may be associated with clinical response or resistance to the combination treatment of atezolizumab and bevacizumab in patients with advanced hepatocellular carcinoma (Abstract CT044).

Gastrointestinal Cancer
Lung Cancer
Leukemia
Hepatobiliary Cancer
Kidney Cancer
Immunotherapy

FDA Pipeline: Two Breakthrough Therapy Designations for Fam-Trastuzumab Deruxtecan-nxki, and More

Over the past few weeks, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designations for an antibody-drug conjugate in the treatment of gastric and lung cancers. The Agency has also issued Orphan Drug designations for agents being investigated in chronic myeloid...

Hepatobiliary Cancer
Immunotherapy

Nivolumab for Advanced Refractory Biliary Tract Cancer

In a phase II trial reported in JAMA Oncology, Kim et al found that nivolumab showed antitumor activity in patients with advanced refractory biliary tract cancer. As noted by the investigators, there currently is no established second-line systemic treatment for biliary tract cancer. Study Details...

Hepatobiliary Cancer
Immunotherapy

AACR 2020: Atezolizumab Alone or in Combination With Cobimetinib for Biliary Tract Cancer

A randomized multicenter study of a combination of immunotherapy with a targeted therapy improved cancer control for some patients with biliary tract cancer, according to research presented by Yarchoan et al at the American Association for Cancer Research (AACR) Virtual Annual Meeting (Abstract...

Hepatobiliary Cancer

A Clinical Trial Saved My Life

In the fall of 2009, I began experiencing some abdominal discomfort, pain in my right shoulder, and severe fatigue that were easily explained away as the result of gallstones and by my career as a paramedic. I had many of the risk factors for gallbladder disease, and both my mother and sister...

Immunotherapy
Hepatobiliary Cancer

Nivolumab/Ipilimumab in Patients With Sorafenib-Pretreated Hepatocellular Carcinoma

On March 10, 2020, the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) was granted accelerated approval for treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.1-3 Supporting Efficacy Data The approval was based on findings in a cohort...

Hepatobiliary Cancer

FDA Approves Pemigatinib for Patients With Cholangiocarcinoma and an FGFR2 Rearrangement or Fusion

On April 17, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pemigatinib (Pemazyre) for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or...

Colorectal Cancer
Gastrointestinal Cancer
Hepatobiliary Cancer
Pancreatic Cancer

Aspirin Use and Risk of Cancers of the Digestive Tract

Aspirin may be associated with a reduction in the risk of developing several cancers of the digestive tract. The largest and most comprehensive analysis to date of the link between aspirin and digestive tract cancers, published by Bosetti et al in Annals of Oncology, found reductions in the risk of ...

Hepatobiliary Cancer
Immunotherapy

Camrelizumab for Previously Treated Advanced Hepatocellular Carcinoma

In a Chinese phase II study reported in The Lancet Oncology, Qin et al found that the programmed cell death protein 1 (PD-1) inhibitor camrelizumab showed activity in patients with previously treated advanced hepatocellular carcinoma. Study Details In the open-label multicenter trial, 217 evaluable ...

Hepatobiliary Cancer
Global Cancer Care

Trends in Global Rates of Liver Cancer From 1990 to 2017

New research published by Liu et al in the journal Cancer has revealed rising rates of liver cancer around the world, despite advances aimed at preventing the disease; however, some steps towards alleviation have been made due to control of hepatitis. Methods To obtain trends and estimates of liver ...

Hepatobiliary Cancer

Pemigatinib for Previously Treated Advanced Cholangiocarcinoma

In the phase II FIGHT-202 study reported in The Lancet Oncology, Ghassan K. Abou-Alfa, MD, and colleagues found that the fibroblast growth factor receptor 1 (FGFR1), FGFR2, and FGFR3 inhibitor pemigatinib was active in patients with previously treated locally advanced or metastatic...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: A. Craig Lockhart, MD

A. Craig Lockhart, MD, Professor of Medicine, University of Miami Sylvester Comprehensive Cancer Center, applauded the study for making patient-reported outcomes a prespecified endpoint and described the value of having this information. Dr. Lockhart was the invited discussant. “The U.S. Food and...

Hepatobiliary Cancer
Immunotherapy

IMbrave150 Prespecified Analysis Adds Improved Quality-of-Life to Survival Benefits Reaped With Atezolizumab Plus Bevacizumab

New findings from a prespecified analysis of the pivotal IMbrave150 trial revealed improved quality of life for patients with advanced hepatocellular carcinoma treated with atezolizumab plus bevacizumab in the first-line setting. These results were reported by Peter R. Galle, MD, at the 2020...

Gastroesophageal Cancer
Gastrointestinal Cancer
Colorectal Cancer
Hepatobiliary Cancer
Pancreatic Cancer

Conference Highlights From the 2020 Gastrointestinal Cancers Symposium

This past January, the 2020 Gastrointestinal Cancers Symposium was held in San Francisco. More than 3,600 individuals attended and more than 900 abstracts and posters were presented. Among the highlights presented at the meeting and reported in the pages of The ASCO Post, several studies in...

Hepatobiliary Cancer

Does Aspirin Use Lower the Risk of Hepatocellular Carcinoma and Liver-Related Mortality in Patients With Chronic Viral Hepatitis?

In a study reported in The New England of Medicine, Tracey G. Simon, MD, MPH, and colleagues found that low-dose aspirin use was associated with a reduced risk of hepatocellular carcinoma and liver-related mortality among patients with chronic hepatitis B or C infection. Study Details The study...

Colorectal Cancer
Hepatobiliary Cancer
Immunotherapy

Selected Abstracts on Novel Treatments in Colon, Hepatocellular, and Biliary Tract Cancers

The ASCO Post has reported on the pivotal trials presented at the 2020 Gastrointestinal Cancers Symposium in several issues. Featured here are the findings of several additional abstracts worthy of mention. Intermittent Oxaliplatin in Stage II or III Colon Cancer As adjuvant treatment for stage II...

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