FDA grants priority review to Avasopasem for radiotherapy-induced severe oral mucositis

Source: www.onclive.com/ Author: Chris Ryan The FDA has granted priority review to the new drug application (NDA) for avasopasem manganese (GC4419) as a treatment for radiotherapy-induced severe oral mucositis (SOM) in patients with head and neck cancer undergoing standard-of-care treatment.1 The NDA was supported by data from the phase 2b GT-201 (NCT02508389) and phase 3 ROMAN (NCT03689712) trials, which enrolled a total of 678 patients. Findings from GT-201 demonstrated that 90 mg avasopasem induced a significant reduction in median SOM duration compared with placebo (1.5 vs 19 days; P = .024).2 Additionally, 43% of patients treated with avasopasem experienced SOM compared with 65% of patients who received placebo (P = .009). Grade 4 instances of SOM occurred in 16% and 30% of patients in the avasopasem and placebo arms, respectively (P = .045). In the ROMAN confirmatory trial, avasopasem also significantly reduced incidence of SOM.3 Data presented during the 2022 ASCO Annual Meeting showed that through the course of intensity-modulated radiation therapy (IMRT), SOM was reported in 54% of patients administered avasopasem (n = 241) vs 64% of those given placebo (n = 166; relative risk [RR], 0.84; P = .045), meeting the trial’s primary end point. Additionally, when avasopasem was given prior to IMRT, patients experienced a 56% reduction in median duration of SOM compared with placebo (8 vs 18 days, respectively; P = .002). Compared with placebo, these patients also had a 27% reduction in incidence of grade 4 SOM (33% vs 24%; P = .052) and a [...]

2023-02-17T13:22:39-07:00February, 2023|Oral Cancer News|

Precision oncology inches into head and neck cancer paradigm

Source: www.targetedonc.com Author: Nichole Tucker In an interview with Targeted Oncology, to Everett E. Vokes, MD, discussed precision oncology for head and neck cancer and how the molecular biology of head and neck cancers is an opportunity for new investigations and treatment development. Treatment of head and neck cancer is moving away from invasive surgery and chemoradiotherapy and toward precision medicine, according to Everett E. Vokes, MD. But the field still has a long way to go, compared with other solid tumors.1 Patients with squamous cell cancers of the head and neck cancers are typically treated with chemoradiotherapy, said Vokes, the John E. Ultmann Distinguished Service professor of Medicine, professor of Radiation and Cellular Oncology, chair of the Department of Medicine, and physician-in-chief, at University of Chicago Medicine and Biological Sciences, during a presentation at the Inaugural Miami Cancer Institute Precision Medicine Oncology Symposium. The only targeted therapy available is for HRAS-driven tumors. Although the farnesyltransferase inhibitor, tipifarnib (Zarnestra), has achieved anti-tumor activity in the HRAS-positive population, the activity is modest for patients with HRAS-mutated salivary gland cancer.2 Vokes explained that more therapies are needed for these patients, but other investigational strategies like de-escalation are promising.1 For thyroid cancers, the precision medicine landscape is vaster, Vokes said. In addition to immunotherapy, lenvatinib (Lenvima), a tyrosine kinase inhibitor, is FDA approved for multiple indications. Looking ahead, Vokes hopes research leans towards a multidisciplinary approach to get patients with all forms of head and neck cancer to remission. In an interview with [...]

2023-02-06T09:56:45-07:00February, 2023|Oral Cancer News|

New saliva home test can detect early signs of oral and throat cancer ‘with 90% accuracy’

Source: www.euronews.com Author: Josephine Joly Oral and throat cancers are notoriously difficult to detect – but a new saliva test, launched in the US, could change the game and enable much earlier diagnosis for patients. - Copyright Copyright: Canva A new home screening test using artificial intelligence to detect oral and throat cancers from saliva samples has been launched in the United States, with hopes the device could change the future of oral and throat cancer detection. With more than 90 per cent accuracy, the saliva test is the first to detect early signs of oral and throat cancers based on a technology that has received the US Food and Drug Administration’s (FDA) “breakthrough device” designation. Notoriously difficult to detect, these cancers can often go undiagnosed until they have reached an advanced stage due to a lack of effective diagnostics tools, resulting in low survival rates. Current screening methods rely on visual and tactile examinations by a healthcare provider, meaning lesions must grow large enough until they can be detected by the naked eye. Only 28 per cent of patients receive an early diagnosis, and those receiving a late diagnosis face a prolonged battle with oral cancer. The five-year survival rates for oral and oesophageal cancers are 68 and 20.6 per cent respectively, but when detected early, those numbers can jump to more than 86 and 47 per cent. In the US alone, the National Cancer Institute estimates that there will be 54,000 new cases of oral cancer [...]

Ultralow dose of nivolumab offers huge cost savings

Source: www.medscape.com Author: M. Alexander Otto, PA, MMS A randomized clinical trial from India raises the possibility of huge cost savings by using much lower doses of immunotherapy. The researchers used just 6% of the recommended dose of nivolumab instead of the full dose in their treatment of patients with advanced head and neck cancer, and the addition of this low dose to the standard regimen improved 1-year survival by 25%. The study was published on January 10 in the Journal of Clinical Oncology and has been downloaded almost 2000 times. The findings suggest that low doses of immunotherapy might be equivalent to the much higher doses that are approved and are currently used, two medical oncologists comment in a related editorial. If these findings can be extrapolated to other immune checkpoint inhibitors and to other tumor types, switching to the lower doses could save healthcare systems billions of dollars, write Aaron Mitchell, MD, of Memorial Sloan Kettering Cancer Center, New York City, and Daniel Goldstein, MD, of Tel Aviv University, Israel. Improving Access With limited resources, the Indian healthcare system cannot afford full-dose checkpoint inhibitors, and as a result, fewer than 5% of patients have access to them, explained trial investigators led by Vijay Maruti Patil, MD, a medical oncologist at Tata Memorial Hospital, Mumbai, India. The goal of the trial was to see whether lower, less expensive doses were effective for patients with advanced head and neck cancer. The idea is to increase access by making treatment more [...]

What is HPV-type throat cancer, and how can it be prevented?

Source: www.washingtonpost.com Author: Lindsey Bever and Marlene Cimons Tennis great Martina Navratilova has been diagnosed with throat and breast cancer, which she described as a “double whammy” to tennis.com Monday. Calling the illnesses “serious but still fixable,” the 18-time Grand Slam singles winner said she was “hoping for a favorable outcome.” Martina Navratilova smiles during a match on May 19, 2019, in London. (Dan Istitene/Getty Images) Navratilova’s Stage 1 throat cancer is related to the human papillomavirus (HPV), the most prevalent sexually transmitted infection in the United States, and the precursor to several cancers. “HPV-related head and neck cancers are increasing dramatically in the United States,” said Otis Brawley, a professor of oncology at Johns Hopkins University. “The incidence rate has doubled over the last 15 years.” The majority of patients are men, but “anybody can get it,” he said. The Washington Post spoke with several health-care experts to answer common questions about HPV and cancer. What is HPV? HPV is a group of viruses typically transmitted through skin-to-skin contact, including during sexual activity such as oral, anal or vaginal sex. Most people will contract some form of HPV at some point in their lives, experts said. Some people may never know they have it, and the active infection may be short-lived because, in many cases, the body’s immune system suppresses the virus on its own. But in other cases, the virus can lead to certain forms of cancer, including cervical, anal, vaginal and penile and oral cancers. [...]

HPV, PD-L1 move to the forefront of biomarkers for head and neck cancers

Source: www.onclive.com Author: Silas Inman The frontline treatment for patients with head and neck cancer is largely dominated by surgery and radiation therapy, with ongoing efforts to find biomarkers and other strategies to better individualize care. The leading markers used to tailor therapy are human papillomavirus (HPV) status, which typically signals the aggressiveness of the disease, and PD-L1 expression level, which may help guide selection of immune checkpoint inhibitor (ICI) therapy. These markers are gaining notice in different settings. HPV status has broad applicability across head and neck cancers, whereas the clinical utility of PD-L1 expression remains a more nuanced question. HPV-Positive Tumors Approximately 70% of head and neck cancers, specifically oropharyngeal cancers, are positive for HPV, with most cases associated with the HPV-16 subtype. These tumors appear most commonly in nonsmoking White men with a mean age of diagnosis of 60.3 years (SD, 10.8) for oropharyngeal cancer and 63.2 years (SD, 12.7) for other types of head and neck cancers.1,2 Moreover, HPV-positive tumors typically fall into a low- to intermediate-risk category, with 5-year overall survival (OS) outcomes far superior compared with rates for HPV-negative tumors, which are typically caused by smoking. For patients with HPV-associated head and neck cancers, the 5-year OS rate ranges from 75% to 80% compared with 45% to 50% for those with HPV-negative tumors.3 In many cases, although the prognosis is more favorable for patients with HPV-positive tumors, the treatment is the same as it is for HPV-negative tumors. However, with the introduction of ICIs [...]

Novel agent may improve dry mouth resulting from radiation treatment

Source: www.curetoday.com Author: Colleen Moretti Treatment with AAV2-hAQP1 demonstrated clinically meaningful improvements for patients experiencing symptoms of radiation-induced dry mouth, according to positive results of a phase 1 trial. Radiation-induced xerostomia, or oral dryness, can be a result of treatment with radiotherapy to the oral cavity and neck region – common in patients treated for oral, or head and neck cancers. When this happens, the salivary glands in a patient’s mouth do not make enough saliva to keep it wet. Researchers conducting the AQUAx trial AQUAx evaluated AAV2-hAQP1 in one (unilateral group) or both parotid glands (bilateral group) of 24 patients with radiation-induced salivary hypofunction and moderate to severe dry mouth. “We are very encouraged by the clinical data in both unilateral and bilateral cohorts demonstrating the safety, efficacy and durability of AAV2-hAQP1 in grade 2/3 radiation-induced xerostomia,” said Alexandria Forbes, president and chief executive officer of MeiraGTx, the drug’s manufacturer, in a press release. “Not only does this therapy continue to be safe and well tolerated, but we are seeing durability of effect at two and even three years for patients who have reached those timepoints.” In both groups, 75% of patients reported their dry mouth symptoms as “better” following treatment and rated these improvements as “important” or “very important,” according to the release. Although both groups had improvements, those observed in the bilateral group were greater. Of the 12 patients in the bilateral group, 10 reported “better” dry mouth symptoms after six months. Additionally, these 10 patients rated [...]

Few Americans are aware of links between alcohol and cancer risk

Source: www.cancerhealth.com Author: American Association for Cancer Research staff Despite conclusive research that shows that all alcoholic beverages, including wine, increase the risk of many types of cancer, Americans demonstrated low awareness of this risk, and some perceived alcohol as having health benefits, according to results published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research. Awareness varied significantly for various types of alcohol, the study showed. “Alcohol is a leading modifiable risk factor for cancer in the United States and previous research has shown that most Americans don’t know this,” said the study’s lead author, Andrew Seidenberg, MPH, PhD, who conducted this research while serving as a Cancer Prevention Fellow at the National Cancer Institute. Seidenberg cited research that shows that alcohol contributed to an average of more than 75,000 cancer cases and almost 19,000 cancer deaths per year between 2013-2016. All beverage types containing ethanol, such as wine, beer, and liquor, increase cancer risk. To date, seven cancer types have been linked to alcohol consumption, including cancers of the breast, mouth, and colon. To assess Americans’ awareness of the links between alcohol and cancer, Seidenberg and colleagues analyzed data from the 2020 Health Information National Trends Survey 5 Cycle 4, encompassing survey responses from 3,865 adults. Respondents were asked, “In your opinion, how much does drinking the following types of alcohol affect the risk of getting cancer?” Responses were recorded for wine, beer, and liquor. Further questions assessed the respondents’ awareness of [...]

2022-12-31T11:35:54-07:00December, 2022|Oral Cancer News|

A strange anomaly on scans turned out to be an entirely new organ, hidden within your face

Source: www.iflscience.com Author: James Felton, Senior Staff Writer Image Credit: Valstar et al., Radiotherapy and Oncology, 2020 (CC BY-NC-ND 4.0) You'd think after centuries of cracking open humans and taking a poke around inside we'd have discovered every organ there is to be found in there, but you'd be wrong. In fact, they seem to be popping up all the time. In 2018, researchers discovered the largest organ in the body, interconnected fluid-filled sacs that run through the collagen and elastin structures in the areas beneath our skin and between other organs and tissues in our bodies. Well, wouldn't you know it, scientists have just found another new organ inside us. It's getting pretty crowded in here. Oncologists at the Netherlands Cancer Institute were using a new kind of scan as part of their research into patients with head and neck cancer. They used positron emission tomography/computed tomography with prostate-specific membrane antigen ligands (PSMA PET/CT) scans, which have been shown to be an effective way of tracking the spread of prostate cancer around the body. Patients are injected with radioactive glucose before the scan, which highlights tumors within the patient by glowing brightly. While using this scan on patients, however, the team noticed two areas in the head unexpectedly lit up. As they kept scanning patients, they kept finding the same area lighting up. It turned out all 100 people scanned had bright spots. It wasn't an anomaly, it was potentially an entirely new organ. The new discovery, [...]

2022-12-29T16:44:33-07:00December, 2022|Oral Cancer News|

One-day jaw reconstruction: George’s story

Source: www.roswellpark.org Author: staff When a toothache turned out to be cancer, George quickly learned the state-of-the-art treatment he needed was right here in Buffalo, NY. Buffalo born-and-bred George Hofheins is happy with his “new” life and looking forward to becoming a Florida snowbird. On October 20, he marked the first anniversary of having his jaw replaced, in an innovative One-Day Jaw Reconstruction surgical procedure now offered at Roswell Park Comprehensive Cancer Center as a definitive treatment for oral cancer. “My life is good again. I’m thrilled that I’m living it the way I am,” he says. “The one-day surgery was what really convinced me to go with Roswell Park and I was very impressed with the teamwork and the people and the results.” Before the surgery, George had been healthy all of his 75 years, except for a few glitches he says were mostly minor and fixable: “I pride myself on exercising regularly, keeping a more-or-less healthy diet, maintaining a proper weight give or take a few pounds, and not indulging in any seriously bad habits, unless you count a glass of wine with dinner or an occasional martini.” But in June 2021, when he got a toothache and thought it might be an impacted wisdom tooth, George went to see his dentist. His dentist looked at the troublesome tooth and decided to refer George to an endodontist, who extracted the aching molar. George thought that was that. “A few months later the gum socket had not healed. So [...]

2022-12-29T16:36:18-07:00December, 2022|Oral Cancer News|
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