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On September 30, 2022, futibatinib was granted accelerated approval for adults with previously treated, unresectable, locally advanced, or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements.1 Supporting Efficacy ...
On September 2, 2022, durvalumab was approved for use in combination with gemcitabine/cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on findings in the double-blind TOPAZ-1 trial (ClinicalTrials.gov...
Robin Kate Kelley, MD, Professor of Clinical Medicine at the University of California, San Francisco, was invited to discuss the results of LEAP-002.1 She said the main takeaway is that lenvatinib monotherapy is active as a preferred first-line agent for fit patients who have contraindications to...
The highly anticipated final analysis of the phase III LEAP-002 trial failed to meet expectations, as first-line treatment with lenvatinib plus pembrolizumab did not significantly improve outcomes in unresectable advanced hepatocellular carcinoma. Both progression-free survival and overall survival ...
A new drug designed to inhibit an enzyme that plays a crucial role in cell division and growth has shown signs of anticancer activity with manageable side effects in patients with liver cancer and up to three lines of previous unsuccessful treatment, according to a new study published by Reig et al ...
The highly anticipated final analysis of the phase III LEAP-002 trial failed to meet expectations, as first-line treatment with lenvatinib plus pembrolizumab did not significantly improve outcomes in unresectable advanced hepatocellular carcinoma. Both progression-free survival and overall survival ...
This is Part 4 of Updates in Hepatobiliary Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Ghassan Abou-Alfa, Richard Finn, and Rachna Shroff discuss the treatment of AJCC stage IV intrahepatic cholangiocarcinoma. The patient is a 60-year-old woman with stage IV metastatic cholangiocarcinoma and an FGFR2 fusion on next-generation sequencing. The faculty discuss treatment options for this patient, reviewing the results of the TOPAZ-1 trial, which established durvalumab plus gemcitabine/cisplatin as standard of care. They discuss targeted approaches in cholangiocarcinoma, including the FGFR2 inhibitors pemigatinib, infigratinib, and futibatinib, and highlight considerations for emerging therapies.
This is Part 3 of Updates in Hepatobiliary Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Ghassan Abou-Alfa, Richard Finn, and Rachna Shroff discuss the role of adjuvant therapy in biliary tract cancer. The patient is a 52-year-old man who is diagnosed with intrahepatic cholangiocarcinoma with one positive periportal lymph node. Surgical resection reveals a 7.2-cm, pT3aN0 stage III mass. Following surgery, the patient has recovered well and is not experiencing symptoms. The faculty discuss the next steps for this patient in a rapidly evolving field: adjuvant capecitabine, gemcitabine plus capecitabine, or imagine surveillance alone? In addition, they explore the possibility of perioperative or neoadjuvant approaches in biliary tract cancer.
This is Part 2 of Updates in Hepatobiliary Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Ghassan Abou-Alfa, Richard Finn, and Rachna Shroff discuss second-line therapy and beyond in hepatocellular carcinoma. The patient is a 63-year-old man with a history of nonalcoholic fatty liver disease who was diagnosed with hepatocellular carcinoma metastatic to the lungs and perihepatic and retroperitoneal lymph nodes. He had no response to atezolizumab plus bevacizumab after 2 months of therapy and now has experienced progression of disease in multifocal lung nodules as well as new right adrenal metastases. The faculty discuss next steps for a patient such as this, highlighting key data for second- and third-line therapy in hepatocellular carcinoma. They also discuss whether there is a role for immunotherapy re-challenge in patients who experience disease progression after immune checkpoint inhibition.
This is Part 1 of Updates in Hepatobiliary Cancer, a four-part video roundtable series. Scroll down to watch the other videos from this Roundtable. In this video, Drs. Ghassan Abou-Alfa, Richard Finn, and Rachna Shroff discuss front-line therapy in metastatic hepatocellular carcinoma. The patient is a 71-year-old woman with a history of hepatitis C, now cured, who presents to the emergency department with severe right-sided, upper-quadrant pain. Computed tomography reveals a 10-cm right liver mass, 10 bilateral lung nodules of up to 2.5 cm, and a 1-cm bone lesion. The faculty debate the need for biopsy for hepatocellular carcinoma in a patient such as this. They also discuss factors to consider when choosing first-line therapy in patients with metastatic hepatocellular carcinoma, reviewing the findings of recent studies such as IMbrave150, HIMALAYA, and LEAP-002. Editor’s Note: This discussion was filmed prior to the approval of tremelimumab plus durvalumab for the first-line treatment of unresectable hepatocellular carcinoma.
On October 21, the U.S. Food and Drug Administration (FDA) approved tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer. The novel dose and schedule of the...
Adding stereotactic body radiation therapy (SBRT) to systemic therapy with sorafenib for patients with advanced hepatocellular carcinoma (HCC) may extend overall survival and delay tumor progression without compromising patients’ quality of life, findings from the randomized phase III NRG...
In a Chinese single-center phase II trial reported in JAMA Surgery, Wu et al found neoadjuvant intensity-modulated radiotherapy (IMRT) followed by hepatectomy could be an effective treatment option in patients with centrally located hepatocellular carcinoma. Study Details In the study, 38 patients...
On September 30, the U.S. Food and Drug Administration (FDA) granted accelerated approval to futibatinib (Lytgobi) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or...
Studies show that Hispanic individuals have higher incidence rates of developing liver cancer and higher mortality rates—by 50% or more—than non-Hispanic White individuals for several cancers, including liver cancer. A new study investigating hepatocellular carcinoma among successive generations of ...
Richard S. Finn, MD, of the Geffen School of Medicine at the University of California, Los Angeles, discusses primary phase III results from the LEAP-002 study of pembrolizumab, an anti–PD-1 therapy, plus lenvatinib, the orally available multiple receptor tyrosine kinase inhibitor, vs lenvatinib monotherapy in patients with advanced hepatocellular carcinoma (Abstract LBA34).
On September 2, the U.S. Food and Drug Administration (FDA) approved durvalumab (Imfinzi) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer. TOPAZ-1 Efficacy was evaluated in TOPAZ-1 (ClinicalTrials.gov identifier:...
A team of researchers from the University of Rochester discovered how certain genetic mutations fuel the growth of cholangiocarcinoma, a rare but aggressive type of malignancy that has been on the rise in the United States. Their work, published by Guo et al in Cell Reports this week, details the...
Exposure to a synthetic chemical found widely in the environment may be linked to the development of nonviral hepatocellular carcinoma, according to a new study published by Goodrich et al in JHEP Reports. The chemical—called perfluorooctane sulfate, or PFOS—is one of a class of man-made chemicals...
An interim analysis of the Chinese phase III LAUNCH trial was reported in the Journal of Clinical Oncology by Peng et al. The researchers found that the addition of transarterial chemoembolization to lenvatinib improved overall survival in patients with advanced hepatocellular carcinoma who were...
1,2-Dichloropropane (1,2-DCP) is a synthetic organic solvent used in the printing industry. It was linked to cholangiocarcinoma in 2013, when printing company employees in Osaka, Japan, exposed to 1,2-DCP were diagnosed with the cancer. Thereafter, the International Agency for Research on Cancer...
In some patients with hepatocellular carcinoma, downstaging of disease to within criteria that qualify the patient for a liver transplant leads to excellent 10-year posttransplant outcomes, according to new research published by Tabrizian et al in JAMA Surgery. The results validate current national ...
As reported in The Lancet Oncology by Robin Kate Kelley, MD, and colleagues, the phase III COSMIC-312 trial has shown improved progression-free survival with cabozantinib plus atezolizumab vs sorafenib in patients with advanced hepatocellular carcinoma; interim analysis of overall survival showed...
A study of more than 90,000 postmenopausal women found that those who consumed at least one sugar-sweetened beverage daily faced a 78% higher risk of developing liver cancer compared with people who consumed less than three servings per month of such beverages. These findings were presented by Zhao ...
Akihiro Ohba, MD, of Japan’s National Cancer Center Hospital, discusses phase II data from the HERB trial on fam-trastuzumab deruxtecan-nxki, which showed activity in patients with HER2-expressing unresectable or recurrent biliary tract cancer (Abstract 4006).
Radiation segmentectomy may be an effective treatment for very early– to early-stage hepatocellular carcinoma (HCC) that cannot be treated surgically or thermally. The findings from a multidisciplinary study by researchers at the Icahn School of Medicine at Mount Sinai were published by Kim et al...
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 ...
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)...
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...
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...
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...
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....
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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 ...
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 ...
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...
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...
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....
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...
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...
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.