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outnumber cases of cervical cancer in women. In response to the rise in HPV-positive oropharyngeal cancer, Erich Sturgis, M.D., professor of Head and Neck Surgery, has joined MD Anderson’s HPV-Related Cancers Moon Shot™ as one of the program’s co-leaders. The goal of the HPV-Related Moon Shot is to identify practical solutions and strategies to improve screening and diagnostic options, and develop novel therapeutics to impact the incidence of and deaths caused by HPV-related malignancies. Currently, there are no screening guidelines for HPVrelated oropharyngeal cancer. The HOUSTON (HPV-related Oropharyngeal and Uncommon Cancers Screening Trial Of meN) study aims to create a screening process. The goal of the HOUSTON study is to identify men at high risk for developing HPVrelated cancers through a biomarker assay and screen them for oropharyngeal, anal and penile cancers and pre-cancers. The study is supported by the Moon Shots Program. “We will use some experimental approaches to see if imaging can identify early oropharyngeal cancers before they are visible to the naked eye,” says Erich Sturgis, M.D., co-leader of MD Anderson’s HPV-Related Cancer Moon Shot. Without screening, most HPV-related cancers are diagnosed at a late stage, requiring complicated care that often includes a combination of radiotherapy, chemotherapy and/or radical surgery. The two goals of the trial are, first, to detect whether serological HPV testing in a high-risk group is an effective screening tool and, second, to identify which tests are most effective for detecting early HPV-related cancers or precancers. Sturgis says, “The central question is, can we establish a screening mechanism for HPV-related oropharyngeal cancer?” Easing side effects through research The principal goal of the Head and Neck Cancer Program is to alleviate suffering caused by cancers of the head and neck region. To accomplish this goal, we conduct research across the entire spectrum of the natural history of these malignancies to improve prevention, cure rates and quality of life for affected individuals. Radiation therapy is curative for many head and neck cancers but can result in dysphagia that decreases patients’ quality of life and puts them at risk of malnutrition and pneumonia. Although concurrent swallowing therapy during radiation therapy to the neck can help patients avoid or decrease the impact of dysphagia, the optimal approach to swallowing therapy remains unknown. To determine the appropriate timing and intensity of swallowing therapy, Kate Hutcheson, Ph.D., associate professor of Head and Neck Surgery and associate director of research in the section of Speech Pathology and Audiology, is leading a multicenter randomized trial. “We have data from small, single-site trials and retrospective studies showing that high-intensity swallowing therapy helps patients maintain their ability to swallow during radiation therapy to the neck,” said Hutcheson. “However, a recent Cochrane review was unable to identify best practice in this area, citing the lack of sufficiently powered randomized clinical trials.” A randomized clinical trial that compares reactive swallowing therapy with two proactive approaches of different intensities has been created to gather data for establishing swallowing therapy guidelines. The trial, named PRO-ACTIVE (No. NCT03455608), recently began enrolling patients who plan to undergo radiation therapy with curative intent for head and neck cancer. The goal of this clinical research study is to compare the effects of RE-ACTIVE therapy with two types of PROACTIVE therapy in patients beginning radiotherapy (RT) for head and neck cancer who are at risk for difficulty swallowing. RE-ACTIVE therapy is started after a patient develops trouble swallowing, while PRO-ACTIVE therapy is started before the problem begins. The PRO-ACTIVE trial is open to patients who will receive radiation therapy to both sides of the neck to a total dose of at least 60 Gy over 6–7 weeks. Patients with dysphagia at enrollment are excluded. At enrollment, each patient is randomly assigned to the RE-ACTIVE, low-intensity PRO-ACTIVE, or high-intensity PRO-ACTIVE treatment arm. The effectiveness of each treatment approach will be determined by assessing patients’ duration of dependence on feeding tubes, swallowing strength as measured by videofluoroscopy, and scores on symptom and quality-oflife questionnaires. Division of Surgery | Surgical Outcomes FY18 25 “We hypothesize that the high-intensity PRO-ACTIVE treatment will have the best results, but it could be that we find that one of the lower-burden, lower-resource treatments offers patients a less demanding way to maintain their ability to swallow,” Hutcheson said Not satisfied with the success rate of the current swallowing therapy programs, researchers continue to address swallowing issues for which treatments are lacking. “Swallowing is a huge quality-of-life issue. The key to improving swallowing function is early and individualized therapy,” Hutcheson said. “A dysphagia-specialized speech pathologist can help maximize a patient’s outcome.” Volumes Thyroid/parathyroid 19% Oropharynx 19% Skin of head & neck 16% Lip & oral cavity 12% Salivary glands 8% Eye and related 7% structures Larynx 6% Sinonasal/skull base 7% Soft tissues of head 2% and neck
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