Nivolumab Could Change Head and Neck Cancer Treatment Paradigm

Source: www.Targetedonc.comAuthor: Laura Panjwani "To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer." - Robert Ferris, MD, PhD With the phase III CheckMate-141 trial being stopped early due to the anti–PD-1 agent nivolumab having met its primary endpoint of overall survival improvement in head and neck cancer, Robert Ferris, MD, PhD, couldn't be more elated. "This is what I've devoted my career to, and it is gratifying to see that really come to pass," said Ferris, professor and chief, Division of Head and Neck Surgery, vice chair for Clinical Operations, associate director for Translational Research, and coleader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute, in an exclusive interview with Targeted Oncology. "To have an anti–PD-1 agent be proven to improve survival in head and neck cancer in a randomized phase III trial, and the potential for a new FDA approval in the near future is a game changer. There is now hope for a lot of patients and physicians who have been frustrated by this difficult-to-treat disease. This opens up a whole new class of therapies for this population." Ferris, who acted as cochair/coprimary investigator for the trial alongside Maura Gillison, MD, PhD, Ohio State University, said the trial pitted nivolumab against the investigator’s choice of cetuximab (Erbitux), methotrexate, or docetaxel in patients with platinum-refractory squamous cell carcinoma [...]

2016-02-16T09:24:23-07:00February, 2016|Oral Cancer News|

Expanded age indication cleared for Gardasil 9 in males

Source: www.FormularyJournal.ModernMedicine.comAuthor: Erin Bastick FDA approved an expanded age indication for Human Papillomavirus 9-valent Vaccine, Recombinant (Gardasil 9, Merck) in males. Seven HPV types in Gardasil 9 (HPV 16, 18, 31, 33, 45, 52, and 58) cause approximately 90% to 95% of HPV-related anal cancers, 90% of cervical cancers, and 80% of high-grade cervical lesions worldwide.These 7 types also cause the majority of HPV-related vulvar and vaginal cancers. Gardasil 9 includes the greatest number of HPV (Human Papillomavirus) types of any available HPV vaccine. Gardasil 9 was previously approved for use in girls and young women aged 9 to 26 years for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 22, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. As for use in male patients, the vaccine was previously approved for use in boys aged 9 to 15 years for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58. With the newest approval, Gardasil 9 is now also indicated for use in males aged 16 to 26 years for the prevention of these diseases. According to the CDC, HPV vaccination rates are unacceptably low compared to rates for other adolescent vaccines, and vaccination coverage in [...]

2015-12-30T18:31:17-07:00December, 2015|Oral Cancer News|

Depressed Head and Neck Cancer Patients Have Lower Survival and Higher Recurrence Risk

Source: www.OncologyNurseAdvisor.comAuthor: Kathy Boltz, PhD Depression is a significant predictor of 5-year survival and recurrence in patients with head and neck cancer, according to a new study published in Pyschosomatic Medicine (doi: 10.1097/PSY.0000000000000256). These findings represent one of the largest studies to report on the impact of depression on cancer survival. Although depression can have obvious detrimental effects on a person's quality of life, its impact on cancer patients is more apparent, explained lead author Eileen Shinn, PhD, assistant professor of Behavioral Science at The University of Texas MD Anderson Cancer Center, in Houston. Increasing evidence shows modest associations between elevated symptoms of depression and greater risk for mortality among patients with lung, breast, ovarian, and kidney cancers. The research team sought to clarify the influence of depression on survival, focusing their analysis on a single cancer type. By limiting the sample set and adjusting for factors known to affect outcome, such as age, tumor size, and previous chemotherapy, they were able to uncover a more profound impact of depression. The researchers followed 130 patients at MD Anderson with newly diagnosed oropharyngeal squamous cell carcinoma (OSCC), a type of cancer in which the tumor originates at the back of the throat and base of the tongue. At the beginning of their radiation therapy, Patients completed a validated questionnaire at the beginning of their radiation therapy to identify symptoms of clinical depression. Researchers monitored the participants, all of whom completed treatment, until their last clinic visit or death, a median period of [...]

2015-12-30T18:15:58-07:00December, 2015|Oral Cancer News|

Head, Neck Cancer Patients May Be at Higher Risk for Suicide: Study

Source: www.health.usnews.comAuthor: Robert Preidt THURSDAY, Nov. 12, 2015 (HealthDay News) -- Head and neck cancer patients may be at raised risk for suicide, new research suggests. However, the overall risk is still small, the findings showed. The study included over 350,000 patients in the United States diagnosed with head and neck cancer between 1973 and 2011. Of those patients, 857 died by suicide. The investigators found that the suicide rate among head and neck cancer patients was three times higher than in the general population. And suicide rates were higher among patients treated with radiation alone compared to surgery alone. Suicide rates were highest among those with cancers of the lower part of the throat, including the larynx ("voice box") and hypopharynx, at five times and 12 times higher, respectively, than in the general population. "This may be linked to these anatomic sites' intimate relationship with the ability to speak and/or swallow. Loss of these functions can dramatically lower patients' quality of life," Dr. Richard Chan Woo Park, of Rutgers New Jersey Medical School, and colleagues wrote. "It is possible that the increased rates of tracheostomy [breathing tube] dependence and dysphagia [difficulty swallowing] and/or gastrostomy [feeding] tube dependence in these patients are . . . factors in the increased rate of suicide observed," the authors added. The study was published online Nov. 12 in the journal JAMA Otolaryngology--Head & Neck Surgery. "While there is a considerable body of research that examines survival outcomes for patients with head and neck cancer, additional [...]

2015-11-13T15:34:55-07:00November, 2015|Oral Cancer News|

Why groundbreaking new cancer drugs still don’t work for most patients

Source: www.news.doximity.comAuthor: Brady Dennis Immunotherapy, which aims to harness the body's immune system to fight off certain cancers, has received plenty of attention, praise and investment in recent years. Breakthrough treatments for melanoma and other cancers have shown startling results, giving some patients months and often years of life they almost certainly would not otherwise have had. Yet, for all their promise, immune therapies have not produced such dramatic results for the majority of patients. The same drug that causes metastatic melanoma to vanish in one patient might have no effect on another. At best, only one or two patients out of five will respond to immunotherapy treatments -- remarkable numbers compared to past standards, but still far lower than anyone would like. New research published Monday in the journal Nature explores the molecular mechanisms that prevent immunotherapy drugs from working in some patients, and researchers hope the findings will help make the treatments more effective over time. In short, the researchers studied why certain tumors were able to evade immune therapies designed to unleash the body's defenses to fight cancer. They noted that tumors with a high concentration of "T cells," a type of white blood cell essential to the human immune system, were more responsive to the treatments. Tumors with a low number of T cells inside what researchers call the "cancer microenvironment" were far less responsive to the new drugs. "The tumors are acting to protect themselves," said Weiping Zou, a senior author of the study and a professor of surgery, immunology and biology at the University of Michigan's [...]

2015-10-30T12:28:18-07:00October, 2015|Oral Cancer News|

Less Is More for HPV Oropharyngeal Cancer Reduced-intensity regimen clears disease in 86% of cases

Source: www.medpagetoday.comAuthor: Charles Bankhead SAN ANTONIO -- Less intense treatment of low-risk human papillomavirus (HPV)-related oropharyngeal cancer achieved a high rate of pathologic complete response (pCR) and favorable patient-reported outcomes, a preliminary trial showed. Overall, 37 of 43 (86%) patients achieved pCR with deintensified chemoradiation, including all but one evaluable primary tumor. The pCR rate was virtually identical to historical rates achieved with standard regimens, according to Bhishamjit Chera, MD, of the University of North Carolina (UNC) at Chapel Hill, and colleagues. Selected patient-reported adverse events peaked during the first 6 to 8 weeks and then declined thereafter. About 40% of patients required feeding tubes for a median duration of 15 weeks, but no patients required permanent feeding tubes, they reported here at the American Society for Radiation Oncology meeting. The regimen consists of lower doses of radiotherapy and concurrent cisplatin, administered over 6 weeks. With high-dose therapy, the radiation protocol requires an additional week. "Though we have limited follow-up, the pathological complete response rate with this reduced-intensity chemoradiotherapy regimen is very high in patients with favorable-risk oropharyngeal squamous-cell carcinoma," Chera said. "The early quality-of-life measurements are encouraging, particularly the data on swallowing. We are optimistic that these results with reduced-intensity treatment will translate into good long-term disease control with less toxicity." The study reflects the current trend and momentum in the management of HPV-positive oropharyngeal cancer, said Zain Husain, MD, of Yale Cancer Center in New Haven, Conn. "This is the second study to show that de-escalation of therapy might [...]

2015-10-21T14:59:53-07:00October, 2015|Oral Cancer News|

SA Developed Melanoma Drug Now Seen Effective in Fighting Lung Cancer

Source: www.woai.comAuthor: News Radio 1200 WOAI Staff  Keytruda, a cancer drug developed largely at San Antonio's START Center, has already proven to be effective in treating advanced melanoma to the point that it is the major part of former President Jimmy Carter's treatment.  Now, News Radio 1200 WOAI reports Keytruda has been given 'fast track' approval by the FDA for use in treating lung cancer, the leading cause of cancer deaths in the United States. Dr. Amita Patnaik, a researcher and oncologist at START who helped develop the drug, says the impact of Keytruda on lung cancer patients has been amazing. "Close to 40% of those patients will receive a response," she said.  "And of those patients who receive a response, about 80% of those patients will have a long term response." The life saving potential of Keytruda in fighting non small cell lung tumors is obvious.  An estimated 221,000 Americans are diagnosed with lung cancer each year, and 158,000 die of the disease annually. Dr. Patnaik says Keytruda is becoming the most successful of what are known as 'targeted therapies,' drugs which trigger the body to take action to fight the cancer.  She says both melanoma and lung cancer work essentially the same way to undermine the body's defenses. "The commonality between melanoma and lung cancer is there is a supressive effect of the cancer on the immune system." She says Keytruda essentially overrides that supressive effect, prompting the body to restart its natural immune defenses and fight the [...]

2015-10-06T11:11:27-07:00October, 2015|Oral Cancer News|

Patient Support in Oral Cancer: From Sydney to New York to London, survivors and patients interact through an important portal to get through difficult times

Source: www.prnewswire.comAuthor: Press Release NEWPORT BEACH, Calif., Sept. 28, 2015 -- The word "cancer" will incite fear in anyone. When that word comes at the end of a sentence that began with your name, the impact can be life changing. "I had a great job, a beautiful house and a happy family life," recalls oral cancer survivor and Oral Cancer Foundation (OCF) Director of Patient Support Services, Christine Brader. "All that changed once I got sick." Those affected by oral cancer, like Christine, are saddled not only with the physical challenges of treating and surviving the disease, but they must also live with the emotional uncertainty and anxiety that accompanies a diagnosis. OCF's Patient Support Forum (oralcancersupport.org) was created specifically to provide patients with the information, guidance, and support they need to face a cancer diagnosis. Now in its 15th year, it has helped tens of thousands navigate a difficult path. It was nearly 16 years ago that oral cancer survivor and OCF founder Brian Hill began his search for answers. "When I was first diagnosed," Hill recalls, "I was scrambling for the right information. Once inside the treatment world I was faced with decisions about which treatment path was right for me, uncertainties of what would lay ahead, the arrival of complications unexpected, pain, and ultimately a sense of the loss of control and a resulting fear." While hospital support groups and some online chat rooms existed at the time, they fell short of providing the insights, guidance and accessibility necessary [...]

2015-09-29T10:04:16-07:00September, 2015|OCF In The News, Oral Cancer News|

FDA Grant Forwards Listeria-Based Throat Cancer Vaccine

Source: www.targetedonc.comAuthor: Sandra Kear An experimental immunotherapy for human papillomavirus-, or HPV-, related throat cancers, which is driven by the Listeria bacteria (that wreaks havoc when ingested), may now move forward due to a $1.1 million dollar grant from the FDA to researchers at Baylor College of Medicine.   “Immunotherapy, such as axalimogene filolisbac, which targets HPV proteins expressed in cancer cells is a great example of using a cancer’s own unique biology against it.” said principal investigator Andrew Sikora, MD, PhD, leader of the head and neck cancer program in the NCI Comprehensive Designated Dan L. Duncan Cancer Center and an associate professor of otolaryngology at Baylor College, in an interview with Targeted Oncology.   "This is hopefully the first step toward development of more targeted treatment approaches that reduce side effects and cancer treatment-related morbidity by uniquely targeting only virus-infected cells.” 
The Listeria-based HPV immunotherapy, axalimogene filolisbac (ADXS11-001), is developed by Advaxis, and functions by stimulating an immune response against HPV proteins, thus killing infected cells.   The drug is currently being evaluated in phase I-II study3 alone or in combination with MedImmune’s durvalumab, in patients with cervical or HPV-positive head and neck cancer. The study has three arms: axalimogene filolisbac alone, durvalumab alone, and the two drugs combined. Primary outcomes established for the study are: number of subjects with adverse events (AEs) in each dose level, number of subjects with AEs in the combination dose, and progression-free survival.   Patients must have measurable disease by RECIST criteria, as well [...]

2015-09-17T09:22:55-07:00September, 2015|Oral Cancer News|

AstraZenica, Inovio strike deal to find HPV cancer vaccine

Source: www.philly.comAuthor: David Sell  Local drugmakers - big and small - struck a deal to try to develop a vaccine to prevent a form of cervical, head and neck cancer.  MedImmune, which is the biologics and research division with AstraZeneca, said Monday it will collaborate with Inovio Pharmaceuticals to develop an early stage cancer vaccine designed to treat human pappilomavirus.  AstraZeneca will pay Inovio $27.5 million upfront. If the compound reaches development and commercial milestones, Inovio could get up to $700 million, along with "double-digit tiered royalties" on product sales. However, sales are a long way off because the compound is only in phase I and phase II of what is normally a three-phase clinical trial process.  AstraZeneca is moving its headquarters from London to Cambridge in the United Kingdom, and has operations in Wilmington and Fort Washington. The MedImmune division is headquartered in Gaithersburg, Md.  Inovio is based in Blue Bell and its basic scientific premise is to use DNA to develop vaccines. unlike most current vaccines.  The companies have worked together before. The compound at the heart of the latest deal is called INO-3112. The early clinical trials are examining cervical and head and neck camcers and the compound tries to generate "killer T-cell responses that are able to destroy HPV 16- and 18- driven tumors. These HPV types are responsible for more than 70 per cent of cervical pre-cancers and cancers, " according to the statement. The full statement from AstraZeneca is here. *This news story was [...]

2015-08-10T12:01:54-07:00August, 2015|Oral Cancer News|
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