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Hepatobiliary Cancer

Real-Time ctDNA Evaluation in Patients With Hepatocellular Carcinoma

In a study published in the Journal of Gastrointestinal Oncology, Mody et al described results from patients with hepatocellular carcinoma undergoing circulating tumor DNA (ctDNA) testing in a real-time clinical context. The authors wrote, “[ctDNA assessment] holds incredible promise for early...

Myelodysplastic Syndromes
Leukemia
Lung Cancer
Solid Tumors
Colorectal Cancer
Hepatobiliary Cancer

FDA Pipeline: Fast Track Designation in Myelodysplastic Syndrome and AML, Plus Multiple Breakthrough Designations

Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to magrolimab in myelodysplastic syndrome and acute myeloid leukemia (AML). The agency also granted Breakthrough Therapy designations in lung cancer and desmoid tumors, as well as Breakthrough Device designations...

Hepatobiliary Cancer
Pancreatic Cancer

Results From the TAPUR Study on Palbociclib for Pancreatic Cancer and Cholangiocarcinoma

New results from ASCO’s Targeted Agent and Profiling Utilization Registry (TAPUR) study have demonstrated that single-agent palbociclib has no meaningful clinical activity in patients with CDKN2A-mutated or -deleted advanced pancreatic adenocarcinoma and cholangiocarcinoma. These findings were...

Hepatobiliary Cancer

Direct-Acting Antiviral Therapy and Reduced Mortality in Patients With Hepatitis C and a History of Liver Cancer

A study published by Singal et al in Gastroenterology demonstrated that treatment with antiviral therapy for hepatitis C reduced liver-related deaths by nearly 50% in patients with a history of liver cancer. Previous Research The finding builds on a December 2018 study by Singal et al also...

hepatobiliary cancer

CD8-Positive, Ki67-Positive T Cells Producing Interferon Gamma as a Biomarker of Response to Sorafenib Therapy in Patients With Advanced HCC

Immunology researchers have uncovered a biomarker that may help explain why some patients respond better than others to sorafenib, a common chemotherapy used in the treatment of hepatocellular carcinoma (HCC). Their analysis of immune responses among patients receiving sorafenib, published by...

hepatobiliary cancer

Outcomes in Nonalcoholic Fatty Liver Disease–Associated HCC

A recent study has found that nonalcoholic fatty liver disease–associated hepatocellular carcinoma (HCC) is associated with greater surgical morbidity and postresection liver failure, but long-term survival was better than in non–nonalcoholic fatty liver disease etiologies. These...

hepatobiliary cancer

Aspirin Use May Improve Liver Function After Embolization for Hepatocellular Carcinoma

According to research published by Boas et al in the American Journal of Roentgenology, aspirin therapy is associated with improved liver function test results and survival after transarterial embolization for hepatocellular carcinoma. Findings In a retrospective review of 304 patients, among the ...

hepatobiliary cancer

Radiofrequency Ablation vs Minimally Invasive Surgery for Small Hepatocellular Carcinoma

In a retrospective analysis published by Si et al in Surgical Endoscopy, researchers found minimally invasive surgery led to higher survival and lower local recurrence in patients with small hepatocellular carcinoma vs radiofrequency ablation, whereas radiofrequency ablation was associated with...

hepatobiliary cancer
immunotherapy

FDA Grants Breakthrough Therapy Designation to Pembrolizumab Plus Lenvatinib in Advanced HCC

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the programmed cell death protein 1 inhibitor pembrolizumab in combination with the multiple kinase inhibitor lenvatinib for the potential first-line treatment of patients with advanced unresectable...

hepatobiliary cancer

Role of IL-6/JAK1 Pathway in the Treatment of Hepatocellular Carcinoma

A recent study published by Chan et al in the Journal of Clinical Investigation found a cellular pathway associated with cancer may be beneficial in reducing side effects and extending duration of immunotherapy in some patients with hepatocellular carcinoma. IL-6/JAK1 Pathway Researchers...

hepatobiliary cancer

Neoadjuvant Radiotherapy vs Surgery Alone for Resectable Hepatocellular Carcinoma With Tumor Thrombus

In a Chinese study reported in the Journal of Clinical Oncology, Wei et al found that neoadjuvant three-dimensional conformal radiotherapy improved outcomes vs hepatectomy alone in patients with resectable hepatocellular carcinoma with portal vein tumor thrombus. Study Details In the multicenter...

hepatobiliary cancer

Ivosidenib for Advanced IDH1-Mutated Advanced Cholangiocarcinoma

Ivosidenib, a small-molecule inhibitor of isocitrate dehydrogenase-1 (IDH1), is currently being studied in a phase I clinical trial assessing its efficacy in patients with IDH1-mutated solid tumors. In a report published by Lowery et al in The Lancet Gastroenterology & Hepatology, researchers...

hepatobiliary cancer

KIR-HLA System Gene Loci Imbalance and Biliary Tract Cancer

Patients with biliary tract cancer have an altered genetic architecture in some immune system receptor systems, according to research published by Cornillet et al in Gastroenterology. Research Findings Researchers at Karolinska Institutet investigated the genetic architecture of two large genetic ...

hepatobiliary cancer

Link Between Poor Oral Health and Increased Liver Cancer Risk

Poor oral health is associated with an increased risk of hepatocellular carcinoma, according to new research published by Jordão et al in the United European Gastroenterology Journal. Methods “Poor oral health has been associated with the risk of several chronic diseases, such as...

hepatobiliary cancer
pancreatic cancer

Serum MicroRNAs for the Diagnosis of Pancreatic and Biliary Tract Cancers

Diagnosis of pancreatic and biliary tract cancers is complex and challenging due to the lack of symptoms and/or the difficulty of direct, invasive, and imaging-based methods of diagnosis. In an effort to develop better diagnostic markers for these diseases, Kim et al analyzed the genome-wide...

colorectal cancer
hepatobiliary cancer
myelodysplastic syndromes
immunotherapy

FDA Pipeline: Designations and Reviews in Myelofibrosis, Myelodysplastic Syndromes, Biliary Tract Cancer, and T-Cell Receptor Therapy

Recently, the U.S. Food and Drug Administration (FDA) granted Fast Track designation for momelotinib in myelofibrosis, granted Priority Review to a biologics license application for luspatercept in myelodyslastic syndromes and beta-thalassemia, granted Orphan Drug designation for a new chemical...

Hepatobiliary Cancer

Actively Recruiting Clinical Trials Focused on Novel Drug Combinations for Gallbladder and Biliary Tract Cancers

The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies that are focused on novel drug regimens in gallbladder and biliary tract cancers. These trials are attempting to determine the best dosages, side-effect profiles, and effectiveness of new...

Hepatobiliary Cancer
Gynecologic Cancers

Aspirin Use and Cancer Prevention: Long-Term Data Needed on Benefits and Risks

In addition to its well-known cardioprotective benefits, aspirin has a substantial body of observational, preclinical, and clinical evidence supporting its efficacy in preventing cancer, most strongly for colorectal cancer.1 The strength of this evidence led the U.S. Preventive Services Task...

Gynecologic Cancers
Hepatobiliary Cancer

Regular Aspirin Use and Risk of Hepatocellular Carcinoma and Epithelial Ovarian Cancer

Data from two large U.S. prospective cohort studies indicate the benefits of regular aspirin use in preventing hepatocellular carcinoma and epithelial ovarian cancer. As reported by Tracey G. Simon, MD, MPH, of Massachusetts General Hospital, Harvard Medical School, and colleagues, in JAMA...

hepatobiliary cancer

Angela Lamarca, MD, PhD, on Biliary Tract Cancers: Active Symptom Control With Oxaliplatin and Fluorouracil

Angela Lamarca, MD, PhD, of The Christie NHS Foundation Trust and the University of Manchester, discusses phase III findings from a multicenter study of active symptom control alone or active symptom control with oxaliplatin and fluorouracil for patients with locally advanced or metastatic biliary tract cancers previously treated with cisplatin and gemcitabine (Abstract 4003).

Hepatobiliary Cancer

Triplet Chemotherapy in Unresectable Locally Advanced or Metastatic Biliary Tract Cancers

In a phase II trial reported in JAMA Oncology, Rachna T. Shroff, MD, and colleagues found that the addition of nab-paclitaxel to standard gemcitabine and cisplatin resulted in promising outcomes in patients with unresectable locally advanced or metastatic biliary tract cancers. The study included...

Hepatobiliary Cancer

FDA Approves Ramucirumab for Hepatocellular Carcinoma

ON MAY 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza) as a single agent for hepatocellular carcinoma in patients who have an alpha fetoprotein (AFP) level ≥ 400 ng/mL and have been previously treated with sorafenib. REACH-2 Trial APPROVAL WAS based on the REACH-2...

hepatobiliary cancer
immunotherapy

Early-Stage Study of Nivolumab Alone or in Combination With Cisplatin/Gemcitabine in Biliary Tract Cancer

In a Japanese phase I trial reported by Ueno et al in The Lancet Gastroenterology & Hepatology, researchers found nivolumab showed activity and had a manageable safety profile in patients with unresectable or recurrent biliary tract cancer. Methods The open-label phase I trial was conducted...

hepatobiliary cancer

Rate of 'Textbook Outcomes' in Curative-Intent Resection of Intrahepatic Cholangiocarcinoma

In a multi-institutional international analysis reported in JAMA Surgery, Merath et al found that a textbook outcome was achieved in a minority of patients undergoing curative-intent resection of intrahepatic cholangiocarcinoma. Study Details The study involved data on 687 patients from 15 major...

hepatobiliary cancer

ARRS 2019: Percutaneous Liver Ablation Intervention vs Surgery for Hepatocellular Carcinoma

Compared to surgery, percutaneous liver ablation interventions in patients with hepatocellular carcinoma were associated with lower in-hospital mortality, length of hospital stay, and hospitalization costs, according to a study presented by Sodagari et al at the American Roentgen Ray Society...

hepatobiliary cancer

ARRS 2019: Arterial-Phase Hyperenhancement for Hepatocellular Carcinoma Treated With SBRT

Although arterial-phase hyperenhancement is a key feature of untreated or recurrent hepatocellular carcinoma, standard response assessment such as modified Response Evaluation Criteria in Solid Tumors (mRECIST) should be used with caution, particularly in the early phases after stereotactic body...

hepatobiliary cancer

FDA Approves Ramucirumab for Hepatocellular Carcinoma

On May 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza) as a single agent for hepatocellular carcinoma in patients who have an alpha-fetoprotein (AFP) level ≥ 400 ng/mL and have been previously treated with sorafenib. REACH-2 Trial Approval was based on the...

Solid Tumors
Hepatobiliary Cancer

Adjuvant Capecitabine After Resection for Biliary Tract Cancer

In the phase III BILCAP trial reported in The Lancet Oncology, John N. Primrose, FMedSci, and colleagues found evidence that adjuvant capecitabine may improve overall survival vs observation following surgery for patients with resected biliary tract cancer.  The open-label study included 447...

hepatobiliary cancer

Minimal Adjuvant Chemotherapy for Pediatric Hepatoblastoma Resected at Diagnosis

In an analysis from the Children’s Oncology Group phase III AHEP0731 trial reported in The Lancet Oncology, Katzenstein et al found that minimal adjuvant chemotherapy with two cycles of cisplatin, fluorouracil, and vincristine was associated with disease control in pediatric patients with...

hepatobiliary cancer

Addition of Nab-paclitaxel to Gemcitabine and Cisplatin in Advanced Biliary Tract Cancers

In a phase II trial reported in JAMA Oncology, Shroff and colleagues found that the addition of nab-paclitaxel to standard gemcitabine and cisplatin resulted in promising outcomes in patients with unresectable locally advanced or metastatic biliary tract cancers. The study included 60 patients...

Hepatobiliary Cancer

Ramucirumab After Sorafenib in Advanced Hepatocellular Carcinoma: An Efficacious Therapy With Applicability Challenges

In the 2 years since the U.S. Food and Drug Administration’s (FDA) approval of regorafenib in the treatment of patients with sorafenib-refractory advanced hepatocellular carcinoma, we oncologists have witnessed a veritable avalanche of newly approved medicines for the treatment of advanced...

Hepatobiliary Cancer

Ramucirumab in Sorafenib-Pretreated Patients With Advanced Hepatocellular Carcinoma

In the phase III REACH-2 trial reported in The Lancet Oncology, Andrew X. Zhu, MD, of Harvard Medical School and Massachusetts General Hospital, and colleagues found that ramucirumab improved overall and progression-free survival vs placebo in patients with advanced hepatocellular carcinoma and...

hepatobiliary cancer
issues in oncology

Trends in Liver Cancer Death Rates by Educational Attainment

A new study has found that rising rates of liver cancer deaths in the United States have largely been confined to individuals who have received less education—especially among men. Published by Ma et al in Cancer, the findings emphasize the need for enhanced efforts to address the growing...

hepatobiliary cancer

Capecitabine vs Observation Following Surgery for Resected Biliary Tract Cancer

Watch John Marshall, MD, and BILCAP first author John Neil Primrose, PhD, MBBS, discuss the trial at the 2017 ASCO Annual Meeting. In the phase III BILCAP trial reported in The Lancet Oncology, Primrose and colleagues found evidence that adjuvant capecitabine may improve overall...

Hepatobiliary Cancer

CELESTIAL Trial in Advanced Hepatocellular Carcinoma: Analysis on Quality-Adjusted Life-Years

ON JANUARY 14, 2019, the U.S. Food and Drug Administration (FDA) approved cabozantinib, an orally available receptor tyrosine kinase inhibitor, for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval was based on the results of the phase III...

Kidney Cancer
Bladder Cancer
Prostate Cancer
Hepatobiliary Cancer

Conference Highlights From the 2019 Gastrointestinal and Genitourinary Cancers Symposiums

THIS YEAR saw a huge turnout and a large number of scientific abstracts presented at both the 2019 Gastrointestinal (GI) Cancers Symposium, held on January 17–19, and the 2019 Genitourinary (GU) Cancers Symposium, held on February 14–16, both in San Francisco. The GU Cancers Symposium attracted...

Colorectal Cancer
Neuroendocrine Tumors
Gastrointestinal Cancer
Hepatobiliary Cancer

New Data in Colorectal, Neuroendocrine, Gastric, and Hepatocellular Cancers

THE ANNUAL GASTROINTESTINAL CANCERS SYMPOSIUM took place earlier this year in San Francisco. In addition to important studies captured in our past few issues, The ASCO Post here briefly summarizes additional interesting studies. Adjuvant Hyperthermic Intraperitoneal Chemotherapy in Colon Cancer...

hepatobiliary cancer

Demographic Factors Increasing Risk of Liver Cancer Development in Patients With Fatty Liver Disease

A new study published by Zarrinpar et al in Liver International has found that elderly, diabetic, and Hispanic patients with steatohepatitis—fatty liver disease—may have a higher risk of developing liver cancer. Ali Zarrinpar, MD, PhD, Associate Professor of Surgery at the...

Hepatobiliary Cancer

Cabozantinib for Hepatocellular Carcinoma Previously Treated With Sorafenib

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On January 14, 2019, cabozantinib was approved for the...

Hepatobiliary Cancer

BRAF/MEK Targeting May Yield Benefit in Treating Biliary Tract Cancer

ROUTINE TESTING for BRAF V600E mutations in patients with biliary tract cancer may prove to be a good idea, based on the findings of a phase II study in which treatment with dabrafenib plus trametinib showed activity.1 The results suggest there may be a benefit to testing patients with biliary...

hepatobiliary cancer

Adjuvant Gemcitabine Plus Oxaliplatin vs Surveillance in Resected Biliary Tract Cancer

In a French phase III trial (PRODIGE 12-ACCORD 18-UNICANCER GI) reported in the Journal of Clinical Oncology, Edeline et al found that adjuvant gemcitabine plus oxaliplatin (GEMOX) did not significantly improve relapse-free survival vs surveillance following resection for localized biliary tract...

hepatobiliary cancer

Ramucirumab in Sorafenib-Pretreated Patients With Advanced HCC and Increased α-Fetoprotein

In the phase III REACH-2 trial reported in The Lancet Oncology, Zhu et al found that ramucirumab improved overall and progression-free survival vs placebo in patients with advanced hepatocellular carcinoma (HCC) and increased α-fetoprotein levels who had previously received sorafenib. Study...

hepatobiliary cancer

Andrew X. Zhu, MD, PhD, on Liver Cancer: Outcomes in the REFLECT Study on Lenvatinib

Andrew X. Zhu, MD, PhD, of the Massachusetts General Hospital Cancer Center, discusses an analysis of survival and objective response in patients with hepatocellular carcinoma who took part in a phase III study of lenvatinib (Abstract 186).

hepatobiliary cancer

Heinz-Josef Lenz, MD, on BRAF V600E–Mutated Biliary Tract Cancer: Results From the ROAR Basket Trial

Heinz-Josef Lenz, MD, of the University of Southern California Norris Comprehensive Cancer Center, discusses the efficacy and safety of dabrafenib and trametinib in patients with BRAF V600E–mutated biliary tract cancer (Abstract 187).

hepatobiliary cancer
immunotherapy

Ahmed Omar Kaseb, MD, on Liver Cancer: Results From an Immunotherapy Trial

Ahmed Omar Kaseb, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II study findings on nivolumab alone vs nivolumab plus ipilimumab in patients with resectable hepatocellular carcinoma (Abstract 185).

Hepatobiliary Cancer

FDA Approves Cabozantinib in Previously Treated Hepatocellular Carcinoma

On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval of this oral tyrosine kinase inhibitor was based on the results of the phase III...

hepatobiliary cancer
immunotherapy

2019 GI Cancers Symposium: Nivolumab vs Nivolumab Plus Ipilimumab in Resectable Hepatocellular Carcinoma

Anti–programmed cell death protein 1 and anti–cytotoxic T-lymphocyte–associated protein 4 antibodies have shown activity in hepatocellular carcinoma. Based on these earlier findings, researchers sought to examine the safety, efficacy, and tolerability of perioperative treatment...

hepatobiliary cancer

FDA Approves Cabozantinib for Previously Treated Hepatocellular Carcinoma

On January 14, the U.S. Food and Drug Administration (FDA) approved cabozantinib (Cabometyx) tablets for patients with hepatocellular carcinoma who have been previously treated with sorafenib. The FDA’s approval of cabozantinib was based on results from the phase III CELESTIAL trial....

hepatobiliary cancer
issues in oncology

Role of Donor Race in Liver Transplant Outcomes in African American Patients With Hepatocellular Carcinoma

Among African American adults undergoing liver transplant to treat hepatocellular carcinoma, patients whose organ donor was also African American lived significantly longer than those with a racially unmatched donor, report authors of a new study using national data. Their findings were published...

Hepatobiliary Cancer
Immunotherapy

Pembrolizumab in Sorafenib-Pretreated Hepatocellular Carcinoma

ON NOVEMBER 9, 2018, pembrolizumab (Keytruda) was granted accelerated approval for treatment of patients with hepatocellular carcinoma previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS BASED on durable responses in the phase II KEYNOTE-224 trial...

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