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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...

Hepatobiliary Cancer
Immunotherapy

FDA Approves Nivolumab/Ipilimumab for Pretreated Patients With Hepatocellular Carcinoma

On March 10, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for patients with hepatocellular carcinoma who have been previously treated with sorafenib. CheckMate 040 Efficacy of the combination was...

Lymphoma
Solid Tumors
Hepatobiliary Cancer

FDA Pipeline: Priority Review in DLBCL, Fast Track Designations in T-Cell Lymphoma and Adenoid Cystic Carcinoma

Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to a combination therapy in diffuse large B-cell lymphoma (DLBCL); gave Fast Track designations for treatments in T-cell lymphoma and adenoid cystic carcinoma; granted Orphan Drug designation to an agent for the ...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: A. Craig Lockhart, MD

The invited discussant of the IMbrave150 trial, 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. “The U.S....

Hepatobiliary Cancer
Immunotherapy

Patient-Reported Outcomes From IMbrave150: Better Quality of Life With Doublet

For the first-line treatment of advanced hepatocellular carcinoma, atezolizumab plus bevacizumab provided a significant overall survival benefit in the pivotal IMbrave150 trial. New findings from a prespecified analysis also showed numerous benefits for the doublet in terms of quality of life,...

Hepatobiliary Cancer

PRH/HHEX Transcription Factor as a Treatment Target in Patients With Cholangiocarcinoma

Treatment of patients with cholangiocarcinoma could be improved by tailoring medication to the levels of a key protein in people with the disease, according to new research published by Kitchen et al in Cancer Research. Researchers have discovered that the proline-rich homeodomain...

hepatobiliary cancer
immunotherapy

Thomas Yau, MBBS, on Advanced Hepatocellular Carcinoma: CheckMate 040 Trial of Nivolumab, Ipilimumab, and Cabozantinib

Thomas Yau, MBBS, of the University of Hong Kong, discusses this triplet combination, which yielded better responses than doublet combination therapy in patients with advanced liver cancer, but with more severe adverse events and more treatment discontinuations (Abstract 478).

hepatobiliary cancer
immunotherapy

Peter R. Galle, MD, on Atezolizumab/Bevacizumab vs Sorafenib for Hepatocellular Carcinoma: Patient-Reported Outcomes

Peter R. Galle, MD, of the University Medical Center, Mainz, discusses patient-reported outcomes from this phase III study, which showed the combination of atezolizumab plus bevacizumab vs sorafenib is well tolerated and may represent a new standard of care in the first-line setting for unresectable liver cancer (Abstract 476).

Multiple Myeloma
Prostate Cancer
Lung Cancer
Hepatobiliary Cancer
Immunotherapy

FDA Pipeline: Priority Reviews in Multiple Myeloma, Prostate Cancer

Over the past week, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for multiple myeloma and prostate cancer; gave Fast Track designation to a targeted gene therapy for lung cancer; granted Orphan Drug designation to a combination therapy for hepatocellular...

Hepatobiliary Cancer

2020 GI Cancers Symposium: Addition of Ramucirumab or Merestinib to Gemcitabine/Cisplatin for Biliary Tract Cancer

According to study results to be presented by Valle et al at the 2020 Gastrointestinal Cancers Symposium (Abstract 477), the addition of either ramucirumab or merestinib to the standard first-line therapy for biliary tract cancer—gemcitabine plus cisplatin—did not improve progression-free survival, ...

Hepatobiliary Cancer
Colorectal Cancer

2020 GI Cancers Symposium: Patient-Reported Outcomes From IMbrave150, BEACON CRC

Patient-reported outcomes from two large studies show that quality of life is maintained longer with newer drug combinations compared with standard-of-care treatments in patients with unresectable hepatocellular carcinoma and BRAF V600E­–mutant metastatic colorectal cancer. The results, from...

Hepatobiliary Cancer

Treatment Resistance and Novel Therapies in FGFR-Mutated Cholangiocarcinoma

A new study has shown how resistance to fibroblast growth factor receptor (FGFR) inhibitor treatment develops in patients with cholangiocarcinoma and suggests that adding another therapy at the time of disease progression might resensitize tumor cells to initial therapy. These findings were...

Bladder Cancer
Hepatobiliary Cancer

FDA Pipeline: Fast Track/Orphan Drug Designation for Cholangiocarcinoma Treatment, Breakthrough Device Designation for Bladder Cancer Test

This week, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to infigratinib for patients with advanced or metastatic cholangiocarcinoma with a certain genetic mutation, and Orphan Drug designation to the treatment for patients with cholangiocarcinoma. The FDA also granted...

Hepatobiliary Cancer
Immunotherapy

Does Second-Line Pembrolizumab in Patients With Advanced Hepatocellular Carcinoma Previously Treated With Sorafenib Confer a Survival Benefit?

As reported in the Journal of Clinical Oncology by Richard S. Finn, MD, and colleagues, the phase III KEYNOTE-240 trial has shown no statistically significant progression-free or overall survival benefit with pembrolizumab vs placebo in patients with advanced hepatocellular carcinoma who were...

Hepatobiliary Cancer

ClarIDHy and FIGHT-202 Trials Show Positive Results in the Treatment of Patients With Biliary Tract Cancer

Two studies reported at the European Society for Medical Oncology (ESMO) Congress 2019—ClarIDHy and FIGHT-202—demonstrated clinical benefits with novel molecularly targeted agents in the treatment of advanced cholangiocarcinoma. Currently, first-line treatment for locally advanced or metastatic...

Hepatobiliary Cancer
Lymphoma
Neuroendocrine Tumors
Gastrointestinal Cancer
Genomics/Genetics

FDA Pipeline: Recent Designations in Hepatocellular Carcinoma, Cholangiocarcioma, Lymphoma, and More

Over the past few weeks, the U.S. Food and Drug Administration (FDA) granted reviews or designations to treatments for gastrointestinal cancers and lymphoma, and also provided authorizations for products designed to screen for malignancies and tumor mutational burden. Priority Review for Nivolumab...

Hepatobiliary Cancer
Immunotherapy

ESMO Asia 2019: Combination of Atezolizumab and Bevacizumab for Unresectable Hepatocellular Carcinoma

Combination therapy with the programmed cell death ligand 1 inhibitor atezolizumab and the VEGF inhibitor bevacizumab significantly improved overall and progression-free survival in patients with unresectable hepatocellular carcinoma (HCC) compared to sorafenib, according to findings from the phase ...

Immunotherapy
Hepatobiliary Cancer

‘Clinically Meaningful’ Outcomes Seen in Two Studies of First-Line Immunotherapy for Hepatocellular Carcinoma

In the first-line treatment of advanced hepatocellular carcinoma, checkpoint inhibitors led to favorable outcomes in studies reported at the European Society for Medical Oncology (ESMO) Congress 2019—though one study was technically negative. The current first-line standard of care for unresectable ...

Hepatobiliary Cancer

Targeted Treatment Advances in Cholangiocarcinoma

For one of the rarest and most aggressive of tumors—cholangiocarcinoma—two novel molecularly targeted agents yielded encouraging outcomes in advanced disease in studies reported at the European Society for Medical Oncology (ESMO) Congress 2019. In the phase III ClarIDHy trial, the risk of disease...

Hepatobiliary Cancer

Oral Direct-Acting Antiviral Therapy May Improve Survival in Patients With Hepatitis C Virus–Related HCC

Data from a new study presented by Dang et al at The Liver Meeting (Abstract 40) found that patients with hepatitis C virus–related hepatocellular carcinoma (HCC) who achieved sustained virologic response (denoting an undetectable level of the virus) with any oral direct-acting antiviral therapy...

Hepatobiliary Cancer

Hepatic Arterial Infusion of Floxuridine Plus Systemic Gemcitabine/Oxaliplatin for Unresectable Intrahepatic Cholangiocarcinoma

In a single-center phase II trial reported in JAMA Oncology, Andrea Cercek, MD, and colleagues found that hepatic arterial infusion of floxuridine in combination with systemic gemcitabine/oxaliplatin produced high response and disease control rates and was associated with promising overall survival ...

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