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As reported in The New England Journal of Medicine by Ghassan K. Abou-Alfa, MD, and colleagues, and reviewed in this issue of The ASCO Post, the phase III CELESTIAL trial has demonstrated that cabozantinib (Cabometyx) improved the median overall survival to 10.2 months in comparison to 8 months...
As reported in The New England Journal of Medicine by Ghassan K. Abou‑Alfa, MD, of Memorial Sloan Kettering Cancer Center, and colleagues, the second interim analysis of the phase III CELESTIAL trial has shown a significant improvement in overall and progression-free survival with cabozantinib...
Eileen M. O’Reilly, MD, of Memorial Sloan Kettering Cancer Center, discusses the latest information on locoregional and systemic treatments of hepatocellular carcinoma as well as targeted therapy for biliary cancer.
A pooled analysis of two large U.S. prospective cohort studies reported in JAMA Oncology by Simon et al indicates that regular use of aspirin is associated with a significant reduction in risk for hepatocellular carcinoma (HCC), with an apparent dose- and duration-dependent effect. Study Details...
In a Korean nationwide cohort study reported in JAMA Oncology, Choi et al found that hepatocellular carcinoma (HCC) appeared to be more common with first-line entecavir vs tenofovir treatment for chronic hepatitis B. The study involved data from the Korean National Health Insurance Service...
Compared with placebo, cabozantinib (Cabometyx) significantly improved overall survival and progression-free survival in patients with advanced hepatocellular carcinoma who were previously treated with sorafenib (Nexavar), with no new safety signals, according to data from the phase III CELESTIAL ...
In a phase II trial reported in JAMA Oncology, Sahai et al found that the first-line combination of nab-paclitaxel and gemcitabine—though it did not meet the progression-free survival primary endpoint—may constitute a treatment option in advanced cholangiocarcinoma. Study Details In...
THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) issued the following approvals and prescribing information revisions in August 2018. Lenvatinib Approved for Unresectable Hepatocellular Carcinoma THE FDA approved lenvatinib (Lenvima) for the first-line treatment of patients with unresectable...
Nonalcoholic fatty liver disease is a common disease, and with the incidence of liver cancer rising across the country, little has been understood about the link between it and hepatocellular carcinoma. To establish a better understanding of the link between hepatocellular carcinoma risk and...
Today, the U.S. Food and Drug Administration (FDA) approved lenvatinib capsules (Lenvima) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). REFLECT Trial Approval was based on the international, multicenter, randomized, open-label, noninferiority REFLECT trial ...
The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy designation for atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) as a first-line treatment for people with advanced or metastatic hepatocellular carcinoma (HCC), the most common form of liver...
According to the American Cancer Society, cancer is the leading cause of death for Hispanics and Asian/Pacific Islanders in the United States. However, their cancer burden is less than that of non-Hispanic whites and especially non-Hispanic blacks, who bear the most disproportionate share of the...
As reported in The New England Journal of Medicine by Abou-Alfa and colleagues, the second interim analysis of the phase III CELESTIAL trial has shown a significant improvement in overall and progression-free survival with cabozantinib (Cabometyx) vs placebo in patients with sorafenib...
The U.S. Food and Drug Administration (FDA) recently accepted and granted priority review for a new supplemental biologics license application (sBLA) seeking approval for pembrolizumab (Keytruda) as a second-line treatment for patients with advanced hepatocellular carcinoma. This sBLA, which is...
In a phase III International Liver Tumor Strategy Group trial (SIOPEL 6) reported in The New England Journal of Medicine, Brock et al found that sodium thiosulfate reduced cisplatin-induced hearing loss in pediatric patients with standard-risk hepatoblastoma. Study Details The trial enrolled a...
As reported in The Lancet Oncology by Zhu et al, the phase II KEYNOTE-224 study has shown activity of pembrolizumab in advanced hepatocellular carcinoma (HCC) pretreated with sorafenib. Study Details In the study, 104 eligible patients who were intolerant of or progressed on sorafenib were...
On May 29, the U.S. Food and Drug Administration (FDA) accepted for filing the supplemental new drug application (sNDA) for cabozantinib (Cabometyx) tablets as a treatment for patients with previously treated advanced hepatocellular carcinoma (HCC). The filing has been assigned a Prescription Drug...
In 1996, the National Comprehensive Cancer Network® (NCCN®) published its first set of Clinical Practice Guidelines in Oncology (NCCN Guidelines®) covering 8 tumor types. Guidelines are now published for more than 60 tumor types and topics. Some of the key updates were presented at NCCN’s 23rd...
In the phase III METIV-HCC trial reported in The Lancet Oncology, Rimassa et al found no improvement in overall survival with the investigational MET inhibitor tivantinib vs placebo in patients with advanced hepatocellular carcinoma with high MET expression previously treated with sorafenib...
In a study among California residents reported in the Journal of the National Cancer Institute, Pham et al found that those designated as Asian/Pacific Islanders were at elevated risk of hepatocellular carcinoma (HCC) vs other racial/ethnic groups, with the highest risk observed among Southeast...
Topline results from the phase III REACH-2 study of ramucirumab (Cyramza) as a single agent in the second-line treatment of patients with hepatocellular carcinoma (HCC) were recently announced. The trial met its primary endpoint of overall survival as well as the secondary endpoint of...
THE INCIDENCE of cholangiocarcinoma is rising, and effective therapies are urgently needed. Several classes of experimental molecularly targeted agents might meet this challenge, according to Robin Kate Kelley, MD, Associate Professor of Medical Oncology and leader of the clinical trials program in ...
On March 23, the multiple-receptor tyrosine kinase inhibitor lenvatinib mesylate (Lenvima) was approved in Japan for unresectable hepatocellular carcinoma (HCC). This is the first approval worldwide of lenvatinib mesylate for the indication of unresectable HCC and the first new systemic therapy to...
Anne M. Covey, MD, of Memorial Sloan Kettering Cancer Center, discusses the latest recommendations for screening and diagnosing hepatocellular carcinoma, an aggressive tumor marked by increasing incidence in the United States and a poor 5-year survival rate.
In an investigator-initiated phase III SIRveNIB trial in Asia-Pacific patients reported in the Journal of Clinical Oncology, Chow et al found no difference in overall survival with selective internal radiation therapy, or radioembolization, vs sorafenib (Nexavar) in patients with unresectable...
THE STUDY’S invited discussant, Jordi Bruix, MD, PhD, of the University of Barcelona, Spain, said one of the benefits of the TACTICS study was to evaluate the use of the new unTACEable-based endpoint, which he favors. “The endpoint used in the trial is a good attempt to do something new that may...
SORAFENIB (Nexavar) added to transarterial chemoembolization (TACE) doubled the median progression-free survival over TACE alone in patients with unresectable hepatocellular carcinoma, Japanese investigators reported at the 2018 Gastrointestinal Cancers Symposium.1 The results of the randomized,...
Combining ultrasound imaging with a blood test for high alpha fetoprotein levels may improve detection of early-stage liver cancer by as much as 40%, researchers at UT Southwestern’s Simmons Cancer Center found. Their findings were presented by Tzartzeva et al in Gastroenterology....
In a phase III noninferiority trial reported in The Lancet, Kudo et al found that first-line lenvatinib was noninferior to sorafenib in overall survival of patients with unresectable hepatocellular carcinoma. Study Details In the open-label trial, 954 patients from 154 sites in 20 countries in...
Johns Hopkins Kimmel Cancer Center researchers developed a single blood test that screens for eight common cancer types and also helps identify the location of the cancer. The test, called CancerSEEK, is a unique noninvasive, multianalyte test that simultaneously evaluates levels of eight cancer...
The results of an analysis of the phase III REFLECT trial of lenvatinib mesylate (Lenvima) vs sorafenib (Nexavar) as first-line treatment for unresectable hepatocellular carcinoma based on independent imaging review were presented during the 2018 Gastrointestinal (GI) Cancers Symposium (Abstract...
Andrew X. Zhu, MD, PhD, of Massachusetts General Hospital, discusses study findings on pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (Abstract 209).
Ghassan K. Abou-Alfa, MD, of Memorial Sloan Kettering Cancer Center, discusses phase III study findings on cabozantinib vs placebo in patients with advanced hepatocellular carcinoma who have received prior treatment with sorafenib (Abstract 207).
Immunotherapy in PD-L1–Positive Advanced Cervical Cancer Pembrolizumab (Keytruda) treatment was active in patients with programmed cell death ligand 1 (PD-L1)–positive advanced cervical cancer enrolled in the phase Ib KEYNOTE-028 trial. The findings were reported by Jean-Sebastien Frenel, MD, of...
In a phase II trial reported in the Journal of Clinical Oncology, Javle et al found that the oral pan-fibroblast growth factor receptor (FGFR) kinase inhibitor BGJ398 was active in FGFR-altered advanced cholangiocarcinoma. It is estimated that FGFR2 fusions/translocations are present in 13% to 17%...
ON SEPTEMBER 22, 2017, nivolumab (Opdivo) was granted accelerated approval for treatment of hepatocellular carcinoma in patients previously treated with sorafenib (Nexavar).1,2 Supporting Efficacy Data APPROVAL WAS based on findings in a 154-patient subgroup of the CheckMate 040 trial consisting...
A French phase III trial has shown no significant survival difference between selective internal radiotherapy with yttrium-90 resin microspheres vs sorafenib (Nexavar) in patients with advanced hepatocellular carcinoma. The findings were reported by Vilgrain et al in The Lancet Oncology. Study...
A new study presented at The Liver Meeting, held by the American Association for the Study of Liver Diseases, found that daily aspirin therapy was significantly associated with a reduced risk in hepatitis B virus (HBV)–related liver cancer (Abstract 223). According to AASLD’s...
A new study presented at The Liver Meeting—held by the American Association for the Study of Liver Diseases—found that eradication of the hepatitis C virus induced by direct-acting antiviral medications is associated with a 71% reduction in the risk of liver cancer (Abstract 142)....
On October 16, Exelixis announced that its global phase III CELESTIAL trial met its primary endpoint of overall survival, with cabozantinib (Cabometyx) providing a statistically significant and clinically meaningful improvement in median overall survival compared to placebo in patients with...
ON SEPTEMBER 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib (Nexavar). CheckMate 040 APPROVAL WAS BASED on a 154-patient subgroup of ...
On September 26, Eisai Inc announced the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for lenvatinib (Lenvima) for potential use in the first-line treatment of patients with hepatocellular carcinoma. “Patients with...
As reported in The Lancet Gastroenterology & Hepatology by Tim Meyer, MBBS, of the University College London, and colleagues, the UK phase III TACE 2 trial has shown no progression-free survival benefit with the addition of sorafenib (Nexavar) to transarterial chemoembolization in patients...
On September 22, 2017, the U.S. Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo) for the treatment of hepatocellular carcinoma in patients who have been previously treated with sorafenib (Nexavar). CheckMate 040 Approval was based on a 154-patient subgroup of...
LIVER TRANSPLANT offers the highest rates of long-term survival for patients with hepatocellular carcinoma, according to Maria Russell, MD, Assistant Professor of Surgery at Emory University, Atlanta. At the 2017 Debates and Didactics in Hematology and Oncology Conference at Sea Island, Georgia,...
In a retrospective study reported in the Journal of Clinical Oncology, Reiss et al found that reducing the starting dose of sorafenib (Nexavar) was associated with noninferior overall survival, reduced cost, and lower risk of discontinuing treatment in patients with advanced hepatocellular...
Manuel Hidalgo, MD, PhD, of Harvard Medical School, discusses updated phase III findings on relapse-free survival and first overall survival results in adjuvant GEMOX (gemcitabine plus oxaliplatin) for biliary tract cancer (LBA29).
PRIMARY LIVER CANCER is the second leading cause of cancer-related death worldwide. Hepatocellular carcinoma accounts for 90% of liver cancer, with around 800,000 new cases diagnosed globally each year.1 In contrast to the stable or declining trends observed for most neoplasms, the incidence and...
NIVOLUMAB (OPDIVO) has been found to produce durable responses in patients with advanced hepatocellular carcinoma in the phase I/II CheckMate 040 trial. These findings were reported in The Lancet by Anthony B. El-Khoueiry, MD, of USC Norris Comprehensive Cancer Center, and colleagues.1 Currently,...
On July 18, the U.S. Food and Drug Administration (FDA) approved a combination tablet (Vosevi) to treat adults with chronic hepatitis C virus genotypes 1–6 without cirrhosis or with mild cirrhosis. This fixed-dose, combination tablet contains two previously approved drugs—sofosbuvir and ...