Expert says Nivolumab Poised to Change Standard of Care in SCCHN

Source: www.onclive.com Author: Laura Panjwani Nivolumab (Opdivo) is a game-changing agent for the treatment of patients with squamous cell carcinoma of the head and neck (SCCHN), according to Robert L. Ferris, MD, PhD. “Recent findings have shown us that this agent is really the new standard-of-care option for all platinum-refractory patients with head and neck cancer,” says Ferris, vice chair for Clinical Operations, associate director for Translational Research, and co-leader of the Cancer Immunology Program at the University of Pittsburgh Cancer Institute. “This is regardless of whether patients are PD-L1–positive or negative or whether they are HPV-positive or negative.” The PD-L1 inhibitor received a priority review designation by the FDA in July 2016 based on the CheckMate-141 study, which demonstrated a median overall survival (OS) with nivolumab of 7.5 months compared with 5.1 months with investigator's choice of therapy (HR, 0.70; 95% CI, 0.51-0.96; P = .0101) in patients with recurrent or metastatic SCCHN. The objective response rate (ORR) was 13.3% with nivolumab and 5.8% for investigator's choice. The FDA is scheduled to make a decision on the application for the PD-1 inhibitor by November 11, 2016, as part of the Prescription Drug User Fee Act. Ferris was the lead author on an analysis that further evaluated preliminary data from CheckMate-141, which was presented at the 2016 ASCO Annual Meeting. In an interview with OncLive, he discusses the findings of this study, potential biomarkers for nivolumab, and questions that remain regarding the use of the immunotherapy in SCCHN. OncLive: What [...]

2016-08-24T13:28:58-07:00August, 2016|Oral Cancer News|

FDA Spends $36 Million on Anti-Chewing Tobacco Ad Campaign

Source: www.freebeacon.comAuthor: Elizabeth Harrington Cans of smokeless tobacco sit in the Tampa Bay Rays dugout before a baseball game between the Rays and the Baltimore Orioles, Wednesday, April 14, 2010, in Baltimore. After hounding Major League Baseball and its players union over steroids, Congress now wants the sport to ban smokeless tobacco. (AP Photo/Rob Carr) The Food and Drug Administration is spending $36 million on an anti-chewing tobacco advertising campaign targeted at white male teenagers in the midwest. The federal agency announced Tuesday it is expanding its “Real Cost” anti-tobacco campaign to “educate rural, white male teenagers” and convince them to stop dipping. “Smokeless tobacco use is culturally ingrained in many rural communities,” the FDA said. “For many, it has become a rite of passage, with these teenagers seeing smokeless tobacco used by role models, such as fathers, grandfathers, older brothers, and community leaders.” The campaign will run television, radio, and print advertisements, as well as put up public signs and billboards and post on social media. An FDA spokesperson told the Washington Free Beacon that the total cost for the campaign is $36 million, which will be financed through taxes on tobacco manufacturers. Paid ads will cost $20 million, and the remaining budget will cover “research, strategic planning, creative development, and contract management.” The agency is also partnering with two dozen minor league baseball teams in the midwest that will host anti-chewing tobacco events and feature advertisements from the campaign. “Amplification of messaging from the campaign will [...]

2016-04-21T10:03:14-07:00April, 2016|Oral Cancer News|

Minimizing Imaging for Recurrence of HPV-Associated Head & Neck Cancer

Source: www.journals.lww.com/oncologytimesAuthor: Robert H. Carlson  SCOTTSDALE, ARIZ.—Most recurrences of HPV-positive oropharyngeal squamous cell carcinoma (OPSCC) can be found through imaging and physical exams within six months after treatment, according to a study from the H. Lee Moffitt Cancer Center & Research Institute in Tampa, Fla. “For most patients with HPV-associated oropharyngeal cancer who have had a negative three-month PET scan, physical exams with history and direct visualization are sufficient to find recurrences,” said Jessica M. Frakes, MD, Assistant Member of the Department of Radiation Oncology at the institute and lead author on the study, in a presentation at the 2016 Multidisciplinary Head & Neck Cancer Symposium. “Minimizing the number of exams that do not compromise outcomes not only helps decrease anxiety and stress for our patients, but also eases the financial burden of cancer care,” she said.    The study also supports the effectiveness of specialist teams in treating HPV-positive OPSCC with definitive radiation therapy. Frakes said local control at three years was 97.8; regional control 95.3 percent; locoregional control 94 percent; and freedom from distant metastases 91.4 percent. Three-year overall survival was 91 percent. “The number of OPSCC patients and survivors is growing, so there is a great need to determine the general time to recurrence and the most effective modes of recurrence detection in order to guide optimal follow-up care,” Frakes said. But National Comprehensive Cancer Network (NCCN) guidelines for treatment of OPSCC are “one size fits all,” she said, with the same follow-up recommendations whether the disease [...]

2016-04-18T17:27:00-07:00April, 2016|Oral Cancer News|

Head & Neck Cancer Patients Face Social Isolation, Financial Burdens

Source: www.journals.lww.com/oncologytimesAuthor: Robert H. Carlson SCOTTSDALE, Ariz.—Locally advanced head and neck cancer (LAHNC) has high morbidity and is expensive to treat. The cost of the disease, not only in financial burden but also degradation of the patient's quality of life, was highlighted in a recent study from University of Chicago Pritzker School of Medicine. The study, using data from 73 treatment-naïve LAHNC patients, showed that 69 percent relied on one or more lifestyle-altering cost-coping strategies while managing their cancer, including spending savings (62 percent), borrowing money (42 percent), selling possessions (25 percent), and having family members work more hours (23 percent). A more subtle disruption of patients' lives was also identified, that of perceived social isolation— defined as a lack of social support coupled with increased loneliness—as a risk factor for less than optimal medication adherence and use of health care resources during treatment. That meant more days of missed medication, more missed appointments, and longer inpatient hospital stays. The study was presented at the 2016 Multidisciplinary Head & Neck Cancer Symposium, sponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology. “Physical side effects are not the only ones our head and neck cancer patients endure,” said Sunny Kung, a second-year medical student and lead author on the study. “It is important for physicians to screen for social isolation just as we screen for depression and identify patients with high social isolation so we can intervene earlier on before they experience these negative financial side [...]

2016-04-18T17:15:40-07:00April, 2016|Oral Cancer News|

ASCO Urges Aggressive Efforts to Increase HPV Vaccination

Source: www.medscape.comAuthor: Zosia Chustecka Human papillomavirus (HPV) vaccines have now been available for 10 years, but despite many medical professional bodies strongly recommending the vaccine, uptake in the United States remains low. Data from a national survey show that about 36% of girls and 14% of boys have received the full schedule of HPV vaccines needed to provide protection (Vaccine. 2013;31:1673-1679). Now the American Society of Clinical Oncology (ASCO) has become involved, and in a position statement issued today the organization calls for aggressive efforts to increase uptake of the HPV vaccines to "protect young people from life-threatening cancers." "With safe and effective vaccines readily available, no young person today should have to face the devastating diagnosis of a preventable cancer like cervical cancer. But unless we rapidly increase vaccination rates for boys and girls, many of them will," ASCO President Julie M. Vose, MD, said in a statement. "As oncologists, we see the terrible effects of these cancers first hand, and we have to contribute to improving today's alarmingly low vaccination rates," she added. The new policy statement is published online April 11 in the Journal of Clinical Oncology. The statement notes that HPV vaccination has been previously recommended by many US medical societies, including the American Cancer Society, the American College of Obstetrics and Gynecology Committee, the American Dental Association, the American Head and Neck Society, the American Nurses Association, the American Pharmacists Association, the Association of Immunization Managers, the Society for Adolescent Medicine, and the Society of Gynecologic Oncology. [...]

2016-04-18T13:12:04-07:00April, 2016|Oral Cancer News|

Merck Says FDA Accepts Its SBLA For Keytruda For Treatment Of Head & Neck Cancer

Source: www.finchannel.comAuthor: Fin Channel News Editorial Staff The FINANCIAL -- Merck, known as MSD outside the United States and Canada, on April 13 announced that the U.S. Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. The application is seeking approval for KEYTRUDA as a single agent at a dose of 200 mg administered intravenously every three weeks. The FDA granted Priority Review with a PDUFA, or target action, date of Aug. 9; the sBLA will be reviewed under the FDA’s Accelerated Approval program, according to Merck. “Starting in the early days of our development program, we have explored the role of KEYTRUDA for patients with head and neck cancer, a difficult-to-treat and debilitating disease with very few treatment options,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are encouraged by the data emerging from our program in this type of cancer, and welcome today’s news as this is an important step toward making KEYTRUDA available to these patients.” Merck currently has the largest immuno-oncology clinical development program in head and neck cancer and is advancing multiple registration-enabling studies with KEYTRUDA as a single agent and in combination with chemotherapy. *This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness [...]

2016-04-13T11:58:01-07:00April, 2016|Oral Cancer News|

Suicide: A Major Threat to Head and Neck Cancer Survivorship

Source: www.jco.ascopubs.comAuthors: Nosayaba Osazuwa-Peters, Eric Adjei Boakye, and Ronald J. Walker
, Mark A. Varvares TO THE EDITOR: The article by Ringash that was recently published in Journal of Clinical Oncology provided a compelling narrative of both the improvements made in head and neck cancer survivorship, as well as the challenges created by longer-term treatment and associated toxicities. There are currently at least 280,000 head and neck cancer survivors in the United States. As the article by Ringash stated, the upturn in head and neck cancer survivorship in the last three decades has coincided with the emergence of human papilloma virus-positive oropharyngeal cancer, as well as a decrease in tobacco use in the general population. These make it a challenge to isolate survival gains as a function of improved therapy from the natural prognostic value of a diagnosis of human papilloma virus-positive oropharyngeal cancer. Whatever the case, the fact that more than one-quarter million Americans are currently alive after a diagnosis of head and neck cancer means there needs to be a more deliberate effort in longer-term management of treatment-related toxicities, some of which are lifelong. We agree with Ringash’s conclusion that new models of care need to be developed in response to the significant quality-of-life issues faced by patients with head and neck cancer. The Institute of Medicine publication From Cancer Patient to Cancer Survivor: Lost in Transition, also cited by Ringash, called for a clear individualized survivorship plan for cancer patients. There is a serious need for this model to [...]

2016-03-24T15:06:02-07:00March, 2016|Oral Cancer News|

The Oral Cancer Foundation’s Founder, Brian R. Hill, honored by the Global Oral Cancer Forum – International oral cancer community honor his accomplishments in the field.

Source: www.prnewswire.comAuthor: The Oral Cancer Foundation  NEWPORT BEACH, Calif., March 10, 2016 /PRNewswire-USNewswire/ -- At the recent Global Oral Cancer Forum (GOCF), Brian R. Hill, Executive Director and Founder of the Oral Cancer Foundation (OCF), was honored for his work as an advocate and innovative thinker in the oral cancer arena. The GOCF organizers and community awarded Hill the 2016 Global Oral Cancer Forum Commitment, Courage and Innovation Leadership Award for his dedication and contributions to the field of oral cancer over the last 18 years. Upon accepting the award, Hill received a standing ovation from those in attendance, which included global oral cancer thought leaders, researchers, treatment physicians, other non-profit organizations and representatives from various government agencies, including the National Institutes of Health / National Cancer Institute, and the World Health Organization (WHO). When asked about being honored Hill said, "In the beginning and for many years I was alone at OCF and it was just the seed of an idea. Those grassroots efforts matured into a robust network of important relationships with a common goal. Today OCF is so much more than just me and my singular efforts. Through the benevolence of the many OCF supporters, particularly in the RDH, dental/medical professional communities and survivor groups, OCF has grown into a powerful national force for proactive change of the late discovery paradigm, access to quality information, disease and patient advocacy, funding of research, and patient support." Hill acknowledges that he had the mentorship of some of the brightest minds [...]

2016-03-11T10:35:36-07:00March, 2016|OCF In The News, Oral Cancer News|

Immunotherapy Continues to Advance in Head and Neck Cancer

Source: www.onclive.comAuthor: Megan Garlapow, PhD   Concomitant administration of motolimod with cetuximab (Erbitux) increases the innate and adaptive immune response in the blood and the tumor microenvironment in head and neck squamous cell carcinoma (HNSCC), overcoming negative prognostic biomarkers of cetuximab therapy alone, according to the biomarker data from a recent phase Ib clinical trial that was presented at the 2016 Head and Neck Cancer Symposium. The trial was recently amended to add nivolumab to the combination of cetuximab and motolimod. Dr. Robert Ferris, MD PhD   “We know that PD-1 and PD-L1 are overexpressed in head and neck cancer, and so it was somewhat irresistible to combine our baseline treatment of cetuximab and motolimod with the PD-L1 inhibition pathway. EGFR itself drives PD-L1, so combining cetuximab with anti-PD-1 inhibitor makes sense. So, we’ve amended this trial. We’re now accruing to treatment with cetuximab, motolimod, and the anti–PD-L1 nivolumab in this trial,” said lead author Robert Ferris, MD, PhD, professor, Departments of Otolaryngology, Radiation Oncology, and Immunology, Cancer Immunology Program, University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania. According to the authors of the phase Ib data presented at the symposium, the rationale for combining cetuximab with motolimod (VTX2337) as neoadjuvant therapy was that cetuximab induces cellular immunity that correlates with neoadjuvant clinical response. The phase I dose-escalation and safety of the combination had been established (NCT 01334177). This study of neoadjuvant cetuximab and motolimod had accrued 14 patients with HNSCC that was stage II-IV, resectable, and located in the oropharynx, [...]

2016-02-29T10:49:56-07:00February, 2016|Oral Cancer News|

Study: HPV vaccine reduces HPV incidence in teenage girls

Source: www.upi.comAuthor: Stephen Feller  Just over half of girls have received the HPV vaccination, but a new CDC study shows it has significantly reduced prevalence of the cancer-causing STI among females who have received the vaccine when compared with those who have not. Photo by Adam Gregor/Shutterstock   WASHINGTON, Feb. 22 (UPI) -- The prevalence of human papillomavirus infection among teenage and young adult women is down nearly two-thirds since the U.S. Centers for Disease Control and Prevention started recommending vaccine in 2006, according to a new study. The study is the first to show a drop in prevalence among women in their 20s, and continues to show decreases seen in smaller studies during the last few years, but researchers say the effect could be much stronger. The vaccine is recommended by the CDC and other organizations for girls and boys starting at age 11, experts say, in order to protect children from HPV before they become sexually active and can become infected. Concerns that the vaccine would influence teens' sexual practices have also been unfounded, as research has shown the vaccine does not make children more likely to engage in risky sexual behavior, based on a the lack of an increase in other STI incidence among vaccinated girls. "It's just like putting on your seatbelt before turning on the car," Dr. Alix Casler, medical director of pediatrics for Orlando Health, told UPI. She suggests separating the adolescents' eventual discovery of sex from the effort to prevent life-threatening diseases. Recommendations [...]

2016-02-22T13:59:16-07:00February, 2016|Oral Cancer News|
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