Side effects occurred in 73.1 percent of patients, with fatigue and signs of liver damage seen in more than 10 percent, and serious side effects, including one death, seen in 25 percent. “This has been an incredible year and positive time regarding our therapies for (patients with) liver cancer,” says Ghassan K. Abou-Alfa, M.D., a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City. As a firstline treatment, researchers are testing a combination of the checkpoint inhibitors Imfinzi (durvalumab) and tremelimumab in the HIMALAYA study. All rights reserved. At the beginning of 2017, patients with inoperable hepatocellular carcinoma (HCC), or liver cancer, were hungry for novel treatments: It had been a decade since the targeted drug Nexavar (sorafenib) was approved by the Food and Drug Administration (FDA). The kinase inhibitor Cabometyx (cabozantinib), an inhibitor of the protein c-MET, looks promising for secondline treatment. In June 2017, the results of a phase 3 trial showed that the median overall survival with Lenvima was 13.6 months compared with 12.3 months for Nexavar, numbers that are statistically considered to be on par with each other. Opdivo is an immunotherapy known as a checkpoint inhibitor because it targets a protein that would normally keep the immune system in check; this frees up the immune system to fight harder against cancer. He is also quite hopeful about approaches to treatment that are local, rather than systemic. Lenvima (lenvatinib) was compared with Nexavar in a clinical trial, and no meaningful difference in survival outcomes was found, he says. In a phase 3 trial, median overall survival was 10.6 months with Stivarga plus best supportive care compared with 7.8 months for placebo plus best supportive care. A year from now, with more data in, Abou-Alfa expects that the scientific community will have more answers about whether Opdivo will best Nexavar in firstline treatment, as well as whether Imfinzi and tremelimumab, used together, will bring meaningful benefit. Mark Pimentel, MD, is director of the Medically Associated Science and Technology Program at Cedars-Sinai. If the phase 3 CheckMate-459 trial proves that Opdivo is more effective than Nexavar as a first-line treatment, and other studies also favor initial immunotherapy, patients will expect doctors to use checkpoint inhibitors as an initial treatment, pushing TKIs into the second-line setting, Abou-Alfa says, adding that there aren’t yet enough data to guess which TKIs will be used before others.. Other potential treatments are farther out on the horizon. In 2018, Cedars-Sinai’s team of digestive and liver disease experts revealed breakthroughs in research and patient care with improved diagnostics tools and treatment protocols. Now, additional targeted drugs and immunotherapies are moving through the pipeline, along with a virus designed to infect and kill liver cancer cells but spare surrounding healthy cells. Another TKI seems likely to be approved for the initial treatment of liver cancer, according to Abou-Alfa. But when Cabometyx was studied versus placebo in a broader group of previously treated patients — those whose liver cancers expressed mutated c-MET and those whose disease was negative for the protein — the trial brought hopeful results, Abou-Alfa says. 2018: New Research and Treatments for Digestive, Liver Diseases, Initiative Created to Accelerate Drug Development, Researchers Explore Role of S-adenosylmethionine, Research Identifies Gut Gas Linked to Diarrhea, COVID-19 Update: Surge Preparedness, Vaccine Distribution, Long-Term Impacts of COVID-19: Your Mental Health, Today: The 2 Holiday Scenarios When You Should Wear a Mask at Home, Three Brothers Bond Over Shared Rare Disease, Study: TB Vaccine Linked to Lower Risk of Contracting COVID-19, Holiday Travel Tips From an Infectious Disease Specialist. Mobile Health and Food Symptom Tracker: Researchers tested a new questionnaire called the Food and Symptom Tracker (FAST) and successfully validated it against existing measures. Results released at the Gastrointestinal Cancers Symposium showed that the medication sparked a response in 16.1 percent of patients with advanced liver cancer, previously treated with Nexavar, who participated in a trial. Stivarga, which disables proteins that help grow the blood vessels that feed tumors, is meant to be used after Nexavar if disease progression occurs. Lenvima was more effective at prolonging progression-free survival, however, with a median 7.4 months versus 3.7 months with Nexavar. A 501(c)(3) non-profit organization. “This includes advances in early diagnosis and treatment of inflammatory bowel disease (IBD) that are being fueled by new genetic research and interdisciplinary approaches to managing the disease.”. If all or many of these drugs get approved, scientists and doctors will be left grappling with the question of which should be used as initial treatments and which in the second line. After 10 years without a new drug for liver cancer, two approvals and a promising pipeline are changing the landscape. “I am very happy to see, and very proud that I am involved in, the effort with Pexa-Vec, which is being looked at as an intratumoral injection on top of sorafenib,” Abou-Alfa says of the oncolytic virus, designed to specifically target and kill liver cancer cells. The results of the genetic research suggest a closer look at gender may provide important insights into the severity with which IBD develops in male and female patients. “More importantly,” he says, “we will see some efforts regarding answers about the sequencing, and I would like to see more activity from the novel components I mentioned, such as the Pexa-Vec virus or CAR T-cell therapy.”, By My Side As an Oncology Nurse — And a Friend, Oncology Nurses Are Compassionate, Empathetic and Knowledgeable, Fertility Preservation Boosts Birth Rate After Breast Cancer Treatment, Friday Frontline: NCI Research Project Identifies Genomic Mutations That Helped “Exceptional Responders”, a 15-Year-Old Cancer Survivor Dies of COVID-19, And More. "We have found that many of our discoveries are helping grow the pipeline of novel diagnostics and therapeutics available to patients here and around the world,” said Mark Pimentel, MD, director of the Medically Associated Science and Technology (MAST) Program. That second-line designation could change, however, when results of a large phase 3 trial, Checkmate-459, come in, Abou-Alfa says; the trial is considering whether Opdivo might be more effective than Nexavar in the firstline setting. In the past, the experimental drug tivantinib, which also inhibits c-MET, did not prove effective when compared with placebo in c-MET-positive patients with liver cancer. A different class of drug was approved in September 2017. In a study of the make-up and behavior of “creeping fat,” investigators found that specific gut bacteria migrate to the fat tissue outside of the gut and stimulate that area of fat to grow. Six months out, of those initial responders, 43.1 percent continued to derive benefit from the drug and 77.9 percent had not experienced disease progression. It’s not yet certain whether using immunotherapies and TKIs together will improve outcomes, but the idea is on the table, Abou-Alfa says. In the trial that led to the approval, the most common serious or severe side effects associated with Stivarga were hypertension, hand-foot skin reaction, fatigue and diarrhea. All rights reserved. Abou-Alfa describes this sequencing issue as one of his biggest challenges. “It is an impressive effort,” he continues, “but the other thing that will have a lot of potential, though we haven’t seen any data yet, will be CAR (chimeric antigen receptor)-T cell therapy.” This involves removing immune cells from patients, engineering them to recognize and kill cancer cells associated with specific proteins, and reinfusing the powerful T cells. Researchers cited a median overall survival of 10.2 months with Cabometyx versus 8 months for placebo, and a median progressionfree survival of 5.2 months with Cabometyx versus 1.9 months with placebo. Serious side effects were more common with Lenvima than with Nexavar (57 percent versus 49 percent, respectively). It is ongoing, and we will see where it’s going to take us. © 2020 MJH Life Sciences™ and Cure Today. “Creeping Fat” around intestines of IBD patients: Most Crohn’s disease patients develop what is known as “creeping fat” around sites of inflammation in the intestines. At the beginning of 2017, patients with inoperable hepatocellular carcinoma (HCC), or liver cancer, were hungry for novel treatments: It had been a decade since the targeted drug Nexavar (sorafenib) was approved by the Food and Drug Administration (FDA). Highlights from Cedars-Sinai’s programs in digestive and liver diseases over the course of 2018 include: © document.write(new Date().getFullYear()); Cedars-Sinai. In the second-line setting, Keytruda (pembrolizumab), another checkpoint inhibitor, is being tested.
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