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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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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...
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).
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).
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).
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...
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...
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....
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...
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...
The burden of mortality related to liver cancer is increasing worldwide. Prevention and control of viral hepatitis will be vital in combating this burden, but curbing the growing epidemic of obesity must also be seen as a key part of liver cancer prevention, according to Rosmawati Mohamed, MD, of...
On August 16, 2018, lenvatinib (Lenvima) was approved for the first-line treatment of patients with unresectable hepatocellular carcinoma.1,2 Supporting Efficacy Data Approval was based on the findings of a phase III open-label noninferiority trial (REFLECT), in which 954 patients with previously...
In a late-breaking presentation at the 30th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Zev Wainberg, MD, reported on results from a phase II international clinical trial of dabrafenib (Tafinlar) plus trametinib (Mekinist), which showed some activity in 36 patients ...
ON NOVEMBER 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib (Nexavar). KEYNOTE-224 APPROVAL WAS based on KEYNOTE-224, a...
When detected early, liver cancer is highly treatable and, in many cases, curable, yet the number of new cases of liver cancer in the United States has increased by 43% in the past 16 years, whereas the incidence of other cancers is on the decline. This past October, during Liver Cancer Awareness...
In a Chinese retrospective study reported in JAMA Surgery, Xu et al found that risk of late recurrence (> 2 years) of hepatocellular carcinoma (HCC) after curative liver resection was associated with male sex, presence of cirrhosis, and aggressive characteristics of the initial HCC. The study...
On November 9, 2018, the U.S. Food and Drug Administration (FDA) granted accelerated approval to pembrolizumab (Keytruda) for patients with hepatocellular carcinoma who have been previously treated with the kinase inhibitor sorafenib. KEYNOTE-224 Approval was based on KEYNOTE-224, a single-arm,...
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...