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This is Part 3 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of localized hepatocellular carcinoma. The patient is a 52-year-old male with a history of hepatitis C virus that has been treated and is in remission. Follow-up surveillance imaging reveals a 5.2-cm liver mass that washes out. His AFP is 6.2, and labs are within normal limits. His ECOG performance status is 1, and he has no history of alcohol or drug use. In the conversation that follows, the faculty discuss the multidisciplinary management of localized hepatocellular carcinoma, whether resection or transplant should be considered, and adjuvant treatment options for high-risk disease.
This is Part 2 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of advanced cholangiocarcinoma. The patient is a 70-year-old female with no major medical history who presents to the ER after an acute episode of nausea/vomiting and abdominal pain. An MRI reveals a large liver mass with multiple satellite nodules, a hallmark of cholangiocarcinoma. Her labs are within normal limits with the exception of some mild electrolyte abnormalities, and her CA 19-9 is 473. A biopsy of the liver mass reveals moderately differentiated adenocarcinoma that is CK7-positive, CK20-negative, and HepPar1-negative. She presents to oncology for further management, where her physical exam is within normal limits and her ECOG performance status is 0. In the conversation that follows, the faculty discuss next steps in the diagnostic workup of this patient, the role of next-generation sequencing in determining the course of treatment, and current first- and second-line therapies for unresectable cholangiocarcinoma.
This is Part 1 of Immunotherapy Strategies for Hepatobiliary Cancers, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable. In this video, Drs. Rachna T. Shroff, Nilo Azad, and Anthony B. El-Khoueiry discuss the management of advanced unresectable hepatocellular carcinoma. The patient is a 67-year-old male with a history of fatty liver disease who presents with abdominal and back pain. Past medical history includes diabetes and hypertension, but no hepatitis. Labs show mild anemia but otherwise normal CBC and chemistries; liver function tests are normal other than mild AST/ALT elevation; and AFP is 47.3. MRI of the abdomen reveals multiple lesions in the liver, and a CT reveals lesions along the spine. The patient presents to oncology for further management, where his physical exam is within normal limits and his ECOG performance status is 1. In the conversation that follows, the faculty discuss current first-line immunotherapy options for hepatocellular carcinoma, including the STRIDE regimen and atezolizumab/bevacizumab; how to balance the risks and benefits of immune checkpoint inhibitors; and what to do after disease progression.
In a retrospective study reported in JAMA Oncology, Fulgenzi et al found evidence that immune checkpoint inhibitor (ICI)-based treatment may improve survival vs best supportive care as first-line therapy in patients with unresectable hepatocellular carcinoma and Child-Pugh class B (CP-B) liver...
In an Indian phase II trial (GECCOR-GB) reported in JAMA Oncology, Ostwal et al found that both adjuvant gemcitabine/cisplatin (GC) and capecitabine and capecitabine given concurrently with chemoradiation therapy (CCRT) showed activity in patients with resected gallbladder cancer. Study Details In...
Based on the results of the multicenter phase II NIFE-AIO-YMO HEP-0315 trial, which were reported in the Journal of Clinical Oncology by Ettrich et al, first-line palliative treatment with nanoliposomal irinotecan plus fluorouracil and leucovorin appears to be safe and active in patients with...
Investigators have uncovered the potential benefit of undergoing alcohol rehabilitation and maintaining abstinence in patients with alcohol dependence at risk of developing alcohol-associated cancers, according to a recent study published by Schwarzinger et al in The Lancet Public Health. The...
A serum fusion-gene machine-learning model may offer early diagnostic accuracy and could help improve the 5-year survival rate in patients with hepatocellular carcinoma, according to a recent study published by Yu et al in The American Journal of Pathology. Background Hepatocellular carcinoma is...
As reported in the Journal of Clinical Oncology by Sangro et al, patient-reported outcome (PRO) analysis in the phase III HIMALAYA trial showed that tremelimumab/durvalumab and durvalumab produced better outcomes than sorafenib in patients with unresectable hepatocellular carcinoma (HCC). The trial ...
On May 16, the U.S. Food and Drug Administration (FDA) announced the final withdrawal of the approval of infigratinib (Truseltiq) for previously treated patients with unresectable, locally advanced, or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other...
Gallbladder cancer rates have been stable or declining for most Americans over the past two decades, but cases have steadily risen among Black Americans, with growing numbers of cases not being diagnosed until later disease stages, according to a study presented at Digestive Disease Week 2024...
As reported in the Journal of Clinical Oncology by Cannon et al, findings in a cohort of the phase II Targeted Agent and Profiling Utilization Registry (TAPUR) basket study showed that the combination of pertuzumab and trastuzumab was active in patients with advanced biliary tract cancer with...
On October 31, 2023, pembrolizumab (Keytruda) was approved for use with gemcitabine/cisplatin in first-line treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on the double-blind KEYNOTE-966 trial...
As reported in The Lancet Oncology by Howard A. Burris III, MD, FACP, FASCO, and colleagues, a patient-reported outcome (PRO) analysis from the phase III TOPAZ-1 trial showed no “detrimental effect” with the addition of durvalumab to gemcitabine/cisplatin in patients with advanced biliary tract...
In a phase III study (ORANGE II PLUS) reported in the Journal of Clinical Oncology, Fichtinger et al found that among patients with indications for hemihepatectomy suitable for both laparoscopic and open approaches, of whom the majority had cancer, the laparoscopic approach was associated with a...
Adding the phosphatidylserine-targeting antibody bavituximab to the immunotherapy agent pembrolizumab may improve response rates without compromising safety in patients with hepatocellular carcinoma, according to a recent study published by Hsieh et al in Nature Communications. The findings...
Adding a personalized antitumor vaccine to the PD-1 inhibitor pembrolizumab may be safe and about twice as effective at shrinking tumors in patients with hepatocellular carcinoma compared with pembrolizumab alone, according to new findings presented by Yarchoan et al at the American Association for ...
Patients with unresectable hepatocellular carcinoma derived significant benefit from the addition of the monoclonal antibody durvalumab and the angiogenesis inhibitor bevacizumab to transarterial chemoembolization (TACE), which alone has been a standard of care for 20 years. Investigators of the...
Milind M. Javle, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II results on tinengotinib, a next-generation FGFR inhibitor that seems to overcome acquired resistance and shows efficacy in patients with cholangiocarcinoma with other FGFR alterations who are not eligible for FGFR2-targeted treatments. A phase III global study is currently enrolling to further evaluate the efficacy and safety of this agent vs physician’s choice in FGFR-altered, chemotherapy- and FGFR-inhibitor–refractory or relapsed disease.
Riccardo Lencioni, MD, of the University of Pisa School of Medicine, discusses phase III results from the EMERALD-1 study of durvalumab plus bevacizumab plus TACE (transarterial chemoembolization) in patients with embolization-eligible unresectable hepatocellular carcinoma. Compared with TACE alone, this combination is the first immune checkpoint inhibitor–based regimen to improve progression-free survival and has the potential to set a new standard of care in this disease, according to Dr. Lencioni (Abstract LBA432).
The addition of durvalumab and bevacizumab to transarterial chemoembolization (TACE) significantly improved progression-free survival in patients with unresectable hepatocellular carcinoma who were eligible for embolization. According to the study authors, this is the first trial to demonstrate...
In a retrospective cohort study reported in the Journal of Clinical Oncology, Daniel Q. Huang, MBBS, and colleagues found that the use of antiviral therapy was associated with improved overall survival among patients with hepatitis B virus (HBV)- or hepatitis C virus (HCV)-related hepatocellular...
As reported in The Lancet Oncology by Josep M. Llovet, MD, and colleagues, the phase III LEAP-002 trial has shown that the addition of pembrolizumab to lenvatinib in the first-line treatment of unresectable hepatocellular carcinoma did not reach statistical superiority thresholds for overall or...
In an Indian phase II trial reported in the Journal of Clinical Oncology, Ostwal et al found that trastuzumab plus gemcitabine/cisplatin was active in treatment-naive patients with advanced HER2-positive biliary tract adenocarcinoma. Study Details In the investigator-initiated multicenter trial, 90 ...
As reported in The Lancet Oncology, Zeng et al developed an artificial intelligence (AI)-based pathology method that distinguished between better and poorer response to treatment with atezolizumab plus bevacizumab in patients with hepatocellular carcinoma (HCC). As stated by the investigators:...
As reported in The Lancet by Shukui Qin, MD, and colleagues, interim analysis of the phase III IMbrave050 trial has shown significantly better recurrence-free survival with adjuvant atezolizumab/bevacizumab vs active surveillance in patients who underwent curative-intent resection or ablation for...
On October 31, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) to be used with gemcitabine and cisplatin for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer. KEYNOTE-966 Efficacy was evaluated in KEYNOTE-966...
In the phase III RATIONALE-301 trial reported in JAMA Oncology, Shukui Qin, MD, PhD, and colleagues found that tislelizumab was noninferior to sorafenib in terms of overall survival as first-line treatment for patients with unresectable hepatocellular carcinoma. Study Details In the open-label...
In a Chinese phase 1b/II trial (COMPASSION-03) reported in The Lancet Oncology, Gao et al found that the anti–PD-1/CTLA-4 bispecific antibody cadonilimab showed activity in previously treated patients with a range of advanced solid tumors, including advanced cervical cancer, esophageal squamous...
On October 9, HistoSonics, the manufacturer of the Edison System and novel histotripsy therapy platforms, announced the marketing authorization of its platform via the U.S. Food and Drug Administration's (FDA) De Novo Classification Request process, a rigorous premarket review pathway for medical...
Gentry King, MD, Assistant Professor in the Division of Hematology and Oncology, University of Washington, and Assistant Professor in the Clinical Research Division of Fred Hutchinson Cancer Center, Seattle, offered his thoughts on the findings of NuTide:121. “Only recently, with TOPAZ-1...
As a first-line treatment for advanced biliary tract cancer, an experimental formulation of gemcitabine, NUC-1031, given with cisplatin failed to improve outcomes over standard gemcitabine/cisplatin in the global phase III NuTide:121 trial.1 “NuTide:121 has not advanced the field in biliary tract...
As reported in the Journal of Clinical Oncology by Nakamura et al, findings in a cohort of the phase II SGNTUC-019 basket study showed that tucatinib plus trastuzumab was active in previously treated patients with HER2-positive metastatic biliary tract cancer who had not received prior...
The HER2-targeting bispecific antibody zanidatamab generated rapid and durable responses in patients with HER2-amplified, locally advanced, unresectable or metastatic biliary tract cancer previously treated with gemcitabine, investigators from the global phase IIb HERIZON-BTC-01 study reported at...
ASCO EXPERT Peter Paul Yu, MD, FACP, FASCO, commented on the implications of the study presented by Zhao et al. Dr. Yu is Physician-in-Chief at the Hartford HealthCare Cancer Institute. “Tumor microbiome studies are at the cutting edge of precision medicine metabolomics,” Dr. Yu stated....
In patients with advanced hepatocellular carcinoma (HCC), gut microbiome characteristics differed between those who had durable responses to immunotherapy and those who did not, according to a retrospective study presented at the 2023 ASCO Breakthrough meeting.1 The presence of Clostridium...
In a systematic review and meta-analysis reported in JAMA Oncology, Xie et al explored outcomes associated with immune checkpoint inhibition among patients with advanced hepatocellular carcinoma with Child-Pugh B vs Child-Pugh A liver function. Study Details The analysis included 22 studies...
Researchers have developed a personalized calculator that may be capable of predicting the reduced risk of early recurrence in patients with hepatocellular carcinoma, according to a recent study published by Chen et al in eGastroenterology. Background Hepatocellular carcinoma is the most common...
Approximately 65% of adults in the United States consume sugar-sweetened beverages daily. Researchers led a study examining the associations among intake of sugar-sweetened or artificially sweetened beverages and the incidence of liver cancer and chronic liver disease mortality in a large cohort of ...
In a largely Asian phase III study (CARES-310) reported in The Lancet, Qin et al found that the combination of camrelizumab and rivoceranib (also known as apatinib) significantly prolonged progression-free and overall survival vs sorafenib in the first-line treatment of unresectable or metastatic...
Investigators have found that overall survival rates may not vary significantly among patients with gallbladder cancer who have had different volumes of their livers resected, as long as the cancer is completely removed, according to a study published by Vega et al in the Annals of Surgical...
In the phase IIb HERIZON-BTC-01 trial reported in The Lancet Oncology, James J. Harding, MD, and colleagues found that zanidatamab—a bispecific antibody targeting two distinct HER2 epitopes—showed activity in previously treated patients with HER2-positive advanced biliary tract cancer. Study...
A genetic marker involving the EGFR and ERBB2 genes may be predictive of which patients with hepatocellular carcinoma are most likely to develop resistance to lenvatinib, according to a study published by Lim et al in Gastroenterology. The new findings could help researchers develop alternative...
The HER2-targeted bispecific antibody zanidatamab demonstrated durable responses in patients with treatment-refractory HER2-positive biliary tract cancer, according to research presented by Shubham Pant, MD, and colleagues at the 2023 ASCO Annual Meeting (Abstract 4008). The results were also...
Adjuvant treatment with the combination of atezolizumab and bevacizumab achieved a statistically significant and clinically meaningful improvement in recurrence-free survival compared with active surveillance alone in patients with high-risk hepatocellular carcinoma following curative-intent...
Investigators have found that in the majority of countries studied, the recent mortality rates for all major cancer types have decreased except for lung cancer among female patients and hepatic cancer among male patients—where increasing rates were observed in most countries, according to a novel...
Immigrant adult patients who have hepatocellular carcinoma and reside in the United States may have higher rates of survival compared with those who have the disease and were born in the United States, according to a new study published by Zhou et al in the Journal of the National Cancer Institute. ...
Researchers have revealed the impacts of several new developments in screening and treating patients with biliary tract cancer and colorectal cancer—including the development of patient-derived organoids to test chemotherapy response, the use of nonsteroidal anti-inflammatory drugs (NSAIDs) to...
The addition of the checkpoint inhibitor pembrolizumab to chemotherapy with cisplatin/gemcitabine as first-line therapy improved overall survival in patients with advanced biliary tract cancer, according to results of the KEYNOTE-966 trial presented at the 2023 American Association for Cancer...
Elena Garralda, MD, MSc, Director of Early Drug Development at Vall d’Hebron University Hospital and Director of the Phase I Unit at NEXT Oncology, Barcelona, was invited to discuss the KRYSTAL-1 findings. “In KRYSTAL-1, adagrasib monotherapy has demonstrated clinically meaningful activity in a...