The FDA has granted approval to tremelimumab (Imjudo®, AstraZeneca Pharmaceuticals) in combination with durvalumab for adult patients with unresectable hepatocellular carcinoma (uHCC). "Patients with unresectable liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival," remarked Ghassan Abou-Alfa, MD, MBA, an Attending Physician at Memorial Sloan Kettering Cancer Center, and colleagues, regarding the HIMALAYA trial (NCT03298451), on which approval was ...

The FDA has approved atezolizumab (Tecentriq®, Genentech, Inc.) in combination with bevacizumab (Avastin®, Genentech, Inc.) for patients with locally advanced unresectable or metastatic hepatocellular carcinoma (HCC) who have not previously received systemic therapy. The approval was based on IMbrave150 (NCT03434379), a phase 3 trial that enrolled 501 patients with unresectable HCC. Patients were randomized in a 2:1 ratio to receive atezolizumab 1,200 mg administered intravenously followed by be...

In consultation with the FDA, Bristol Myers Squibb has voluntarily withdrawn nivolumab (Opdivo®) as a single-agent treatment for patients with hepatocellular carcinoma (HCC) who had previously been treated with sorafenib. Nivolumab had previously been granted accelerated approval from the FDA in 2017, which was based on the phase 1/2 CheckMate 040 clinical trial (NCT01658878). The withdrawal of this treatment is due to the lack of statistical significance in the final overall survival results of...

Patients living in low income or rural communities have less access to care for liver disease, leading to worse outcomes and advanced tumor stage at diagnosis for hepatocellular carcinoma (HCC), according to the results of a retrospective analysis now published in the journal Cancer. The investigators, led by first author Robert Wong, MD, of the Department of Gastroenterology and Hepatology at the Veterans Affairs Palo Alto Healthcare System and the Stanford University School of Medicine in Palo...

A recent study presented by Ming Shi, MD, PhD and colleagues at ESMO Virtual Congress 2020 found that hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil, and leucovorin (FOLFOX) yield more effective results in patients with unresectable hepatocellular carcinoma (HCC) compared with transarterial chemoembolization (TACE). In an interview with i3 Health, Dr. Shi shares insights about the significance of these results, as well as the future of treatment for HCC, and advice ...

A study presented at ESMO Virtual Congress 2020 revealed that hepatic arterial infusion chemotherapy (HAIC) with oxaliplatin, fluorouracil, and leucovorin (FOLFOX) yields more effective results in patients with unresectable hepatocellular carcinoma (HCC) compared with transarterial chemoembolization (TACE). For this randomized, multi-center, open-label trial (NCT02973685), results of which are published in Annals of Oncology, 315 patients aged 18 years or older with a primary unresectable HCC tu...

Chemotherapy can be highly effective at treating cancer, but doctors often cannot prescribe the optimal cancer-killing dose due to systemic toxic side effects. When chemotherapy is administered to a cancerous organ via intra-arterial infusion, 50% to 80% of the drug generally does not remain in that organ. The excess passes on to the veins that drain the organ, entering the circulatory system, where it gets distributed to the rest of the body. Researchers from the University of California, Berke...

​The FDA has granted accelerated approval to the combination of nivolumab (Opdivo®, Bristol-Myers Squibb) and ipilimumab (Yervoy®, Bristol-Myers Squibb) for the treatment of patients with hepatocellular carcinoma following treatment with sorafenib. Safety and efficacy were evaluated in Cohort 4 of the phase 1/2 CHECKMATE-040 trial (NCT01658878), in which patients previously treated with sorafenib were randomized to receive either nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every three weeks for fo...

In the phase 3 REFLECT trial, lenvatinib, an oral multikinase inhibitor, showed non-inferior survival compared with sorafenib in patients with untreated, unresectable hepatocellular carcinoma (HCC). However, the assessment of baseline liver function as a prognostic factor for patients with unresectable HCC receiving lenvatinib had not yet been investigated. In a post hoc analysis of the trial, a team of researchers led by Arndt Vogel, MD, Professor of Gastrointestinal Oncology at Hannover Medica...

​In advanced hepatocellular carcinoma (HCC), nivolumab (Opdivo®, Bristol-Meyers Squibb) is superior to sorafenib (Nexavar®, Bayer) with regard to health-related quality of life (HRQOL), according to results of the phase 3 CheckMate 459 trial to be reported on Friday at the 2020 Gastrointestinal Cancers Symposium. For CheckMate 459, 743 patients with advanced HCC were randomized in a 1:1 ratio to receive nivolumab or sorafenib. The researchers reported in September at the 44th European Society fo...

The health benefits of dietary soluble fiber are well established, but according to researchers at the University of Toledo, the source of that fiber makes all the difference: artificially enriching a diet with soluble fiber can cause liver cancer if insoluble fiber is not also consumed. Dietary soluble fiber promotes good health because it is fermented by gut bacteria into short-chain fatty acids. These acids reduce the symptoms of metabolic syndrome, a co-occurring constellation of condit...

Thomas A. Abrams, MD: Clinical deterioration that is not related to obvious AEs of sorafenib has to be regarded as a progression or sorafenib failure, especially if there's corroborating evidence such as biochemical worsening, AFPs going up, worsening liver function, or ascites. Those could be used as a surrogate to progression. If radiological data suggest that the disease is getting worse with new or enlarged lesions, worsening portal venous thrombus, or worsening liver function due to increas...

Patients with advanced hepatocellular carcinoma (HCC) who have progressed on sorafenib can now take FDA-approved pembrolizumab (Keytrudaâ, Merck & Co., Inc.). Approval was based on KEYNOTE 224 (NCT02702414), a single-arm, multicenter trial which enrolled 104 patients with HCC. For trial eligibility, patients were required to have disease progression on or after using sorafenib, measurable disease, and Child-Pugh Class A liver impairment. Patients were administered 200 mg of pembrolizumab as ...

The FDA has now approved cabozantinib (Cabometyx®, Exelixis, Inc.) for patients with hepatocellular carcinoma (HCC) previously treated with sorafenib. The approval was based on CELESTIAL (NCT01908426), a double-blind, multicenter trial of 707 patients with HCC randomized in a 2:1 ratio to receive cabozantinib 60 mg once daily or matching placebo. Eligible patients had been previously treated with sorafenib, had disease progression following at least one systemic treatment for HCC, and could have...

Although hepatitis C infection is one of the leading causes of liver cancer, controversy is widespread regarding whether the direct-acting antiviral (DAA) therapies used to treat it spur tumor recurrence and worsen prognosis for patients who also have hepatocellular carcinoma (HCC), the most common type of liver cancer. A recent study has found that these concerns are unnecessary: DAA therapies do not instigate tumor growth. For the study, published in Gastroenterology, researchers analyzed data...

​Hepatocellular carcinoma (HCC), the most common type of primary liver cancer, is a challenging condition to treat, with reported five-year survival rates ranging from 30% to 50%. Recently, the FDA approved cabozantinib (Cabometyx®, Exelixis, Inc.) as second-line treatment for patients with HCC previously treated with sorafenib. Thomas A. Abrams, MD, Assistant Professor of Medicine at Harvard Medical School, spoke with i3 Health about cabozantinib's approval and about the various options now ava...

​In a single pathogen sensor, researchers have found both a potential therapeutic target and a possible way to improve the efficacy of current immune checkpoint blockade therapies for hepatocellular carcinoma (HCC), the most common type of primary liver cancer. Since HCC is associated with chronic inflammation, and NLRP12, a cytosolic pathogen sensor, is a negative regulator of inflammation, researchers at the University of Texas (UT) Southwestern Medical Center decided to investigate its role i...