Monthly Archives: April 2016

Researchers link hepatitis C virus to head and neck cancers

Source: lymphomanewstoday.com
Author: Magdalena Kegel

A study from The University of Texas MD Anderson Cancer Center shows the hepatitis C infection, previously linked to liver cancer and non-Hodgkin’s lymphoma, is associated with cancers of the head and neck — a finding that could have immediate implications in how hepatitis-infected patients are screened, and how head and neck cancer patients are treated.

Hepatitis C affects as many as 1.5 percent of the U.S. population, making it the most common blood-borne disease in the country, with an estimated 3.9 million having the chronic infection. This number skyrockets to a whopping 130 million to 150 million when considering the global population. New antivirals with few side effects have, however, made it possible to cure up to 90 percent of all hepatitis C patients.

The study, “Association Between Hepatitis C Virus and Head and Neck Cancers,” was performed at an MD Anderson clinic focusing on the unmet medical needs of patients with hepatitis C. The clinic opened in 2009, and to date remains the only hepatitis-focused clinic among comprehensive cancer centers in the U.S.

“Obviously, a hepatitis C infection could impact how patients respond to their cancer therapy. We also realized that many of our hepatitis patients were excluded from clinical trials. Now that many with hepatitis C can be cured, it is important that we first address and potentially cure the virus, so that they can have access to necessary cancer therapy,” said senior author Harrys A. Torres, in a press release.

The viral infection has long been known to lead to liver cancer, with a risk 48 times higher in hepatitis patients compared to the general population. It has also been associated with a two to three-fold increased risk for non-Hodgkin’s lymphoma. The connection to head and neck cancers has, until now, not been investigated.

“To our surprise, we saw a number of head and neck cancer patients who tested positive for the hepatitis C virus. With this observation, we began to wonder if there was an undiscovered correlation between the two. Our findings tell us that the association between hepatitis C and oropharyngeal and non-oropharyngeal cancers is as high as its link to non-Hodgkin’s lymphoma,” said Torres, who is also an associate professor of Infectious Disease, Infection Control and Employee Health.

The study, published in the Journal of the National Cancer Institute, retrospectively analyzed data on 34,545 patients who had been tested for hepatitis C between 2004 and 2014. Among them were 409 patients with head and neck cancers – 164 with oropharyngeal and 245 with non-oropharyngeal cancer.

Since head and neck cancers are also related to smoking, the research team used another 694 patients suffering smoking-related cancers as a control group. Only 6.5 percent of patients in this group tested positive for hepatitis C.

Patients with head and neck cancers turned out to be much more likely to have a hepatitis infection – 14 percent in patients with oropharyngeal cancer and 20 percent in patients with non-oropharyngeal cancer — compared to only 6.5 percent in the control group.

Expressing it the other way around — a hepatitis C infection increased the risk of various head and neck cancers between 2 and 4.96 times.

Studies of non-Hodgkin’s lymphoma and liver cancer have shown that treating the viral infection might prevent cancer from developing, and even shrink cancers that have already appeared, as recently reported by Lymphoma News Today.

In fact, the National Comprehensive Cancer Network guidelines now recommend clinicians treat the hepatitis first, a recommendation MD Anderson plans to follow.

“What we are trying to make all understand is that this is an infection that has consequences — and it’s an infection we can cure,” Torres said.

April, 2016|Oral Cancer News|

BMS gets US breakthrough status for head & neck cancer

Source: pharmatimes.com
Author: Selina McKee

US regulators have awarded Bristol-Myers Squibb’s immunotherapy Opdivo a breakthrough designation for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). The move, which should help expedite the drug’s development and review, comes after preliminary clinical evidence indicated it could offer a substantial survival benefit to patients with the condition who have already received platinum-based therapy.

A first look at the data from the Phase III CheckMate-141 trial, stopped early in January 2016 after meeting its primary endpoint of overall survival, showed that patients treated with Opdivo (nivolumab) experienced a 30 percent reduction in the risk of death compared to the investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab), with a median overall survival of 7.5 months versus to 5.1 months.

Safety signals were also looking good, with treatment-related adverse events (TRAEs) of any grade occurring in 58.9 percent of patients on Opdivo versus 77.5 percent of patients on investigator’s choice. Grade 3-4 TRAEs were reported in 13.1 percent of patients on Opdivo compared to 35.1 percent taking the investigator’s choice, while two drug-related deaths were reported as related to Opdivo (pneumonitis and hypercalcaemia), and one Grade 5 event of lung infection in the comparator arm.

The findings are particularly pertinent given the particularly bleak outlook for patients whose disease has progressed after platinum therapy and lack of systemic therapies to improve survival, and thus significant unmet medical need for new options.

Head and neck cancer is the seventh most common cancer globally, with an estimated 400,000 to 600,000 new cases per year and 223,000 to 300,000 deaths per year. The five-year survival rate is reported as less than 4% for metastatic Stage IV disease.

Opdivo is already available in the US to treat certain forms of melanoma, non-small cell lung cancer and renal cell carcinoma. This marks its fifth breakthrough designation from the FDA, and follows that for classical Hodgkin lymphoma issued just days ago.

April, 2016|Oral Cancer News|

Drug Target in Rare, Lethal Glandular Cancer Discovered

Source: www.dddmag.com
Author: Yale University

 

Using a novel cell culture approach, Yale Cancer Center researchers have discovered critical vulnerabilities in adenoid cystic carcinoma (ACC), a rare and lethal glandular cancer with a high recurrence rate and few treatment options. The findings, published April 15th in the journal

Clinical Cancer Research, offer data that ACC and similar cancers could be treated with already available drugs.

ddd1604_yale_cancer

ACC most often occurs in the salivary glands but can originate in the breast, trachea, skin, or other sites. Survival rates at five years are close to 90percent but drop significantly after that with just 40percent surviving at 15 years after diagnosis. It is a slow-growing cancer that affects about 1,200 people each year, with few symptoms in early stages.

Aside from surgery, there are few treatments for ACC, which until now has proven largely resistant to radiation therapy. It is this resistance that prompted Yale researchers to develop a novel cell culture technique to isolate and study ACC cancer stem cells, known to be the root of tumor growth, aggressiveness, and resistance to chemotherapy and radiation, said co-senior author Sergey Ivanov, research scientist in surgery (otolaryngology).

“Within ACC cells, we found the especially aggressive cancer stem cells. As important, we found the Achilles heel of these cells, which is their addiction to NOTCH1, a signaling molecule that helps these cells to survive therapy and multiply,” Ivanov said. “Fortunately, cancer stem cells can be killed by blocking NOTCH1 production.”

The similarities between the ACC stem cells and cancer stem cells derived from other cancers such as melanoma, neuroblastoma, and glioma surprised the researchers, according to co-senior author Wendell Yarbrough, M.D., professor and chief of otolaryngology.

“Our study suggests that drugs, which are now used in clinical trials to block NOTCH signaling in a variety of cancers, could be effective against ACC,” Yarbrough said. “Also, our study highlights that there are good targets for therapeutic development in ACC. These findings should form the basis for clinical trials.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

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

Source: www.freebeacon.com
Author: 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)

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 take place at 25 Minor League Baseball stadiums throughout this summer using a variety of efforts, including sponsoring in-stadium events, the placement of print ads, running of television ad spots, and opportunities for fans to engage with players who support the FDA’s efforts on smokeless tobacco,” said Tara Goodin, an FDA spokesperson.

The list of minor league clubs participating in the campaign includes the Albuquerque Isotopes, the Fargo-Moorhead Redhawks, the Traverse City Beach Bums in Michigan, the Sioux Falls Canaries, and the Burlington Bees, an Iowa farm team for the Los Angeles Angels.

Chewing tobacco has been banned at ballparks in Los Angeles, San Francisco, and Boston, including Fenway Park, and major leaguers can face $250 fines and “are subject to discipline” from Major League Baseball’s Commissioner Rob Manfred if they dip during games.

ESPN reported that signs are now posted in Fenway with a phone number so individuals can call to report on other fans they see chewing tobacco to “alert security.”

The FDA provided an example of one of its new campaign ads, which features a man at a bowling alley with a can of chewing tobacco in his back pocket.

FDA-TRC-Smokeless-Prevention-Campaign-Ad

“This can can cause mouth cancer, tooth loss, brown teeth, jaw pain, white patches, gum disease,” text on the ad reads.

The campaign is targeted at white males aged 12 to 17 who are using smokeless tobacco, which the FDA estimates to be 629,000 nationwide, or 0.19 percent of the U.S. population of 318.9 million.

“Not only is the target audience using smokeless tobacco at a high rate, but many do not fully understand the negative health consequences of their actions,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “In communities where smokeless tobacco use is part of the culture, reaching at-risk teens with compelling messaging is critical to help change their understanding of the risks and harms associated with smokeless tobacco use.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

Chemotherapy + radiation may improve survival for some elderly

Source: journals.lww.com
Author: Carlson, Robert H., Oncology Times

Because the toxicity of concurrent chemoradiation is greater than radiation therapy alone for definitive head and neck cancer treatment, many clinicians have reservations about offering chemoradiotherapy for elderly head and neck cancer patients.

But a new study shows that combining chemotherapy with radiation therapy improves survival rates for those head and neck cancer patients ages 71 to 79 years who have low comorbidity scores and advanced disease stage, with survival rates similar to that of younger patients.

The study, which used data from the National Cancer Data Base (NCDB), suggests elderly patients are being underrepresented in prospective clinical trials that have defined standards of care for head and neck cancer.

“In the era of improved radiation techniques, improved systemic therapy, and better supportive care, we found that chemoradiotherapy does, in fact, improve survival for a large segment of this population,” said Sana Karam, MD, PhD, Assistant Professor of Radiation Oncology at the University of Colorado School of Medicine in Aurora, and senior author on the study.“

“These findings challenge historical data demonstrating no benefit of chemoradiotherapy for patients older than 70 years,” Karam said.

The study was presented at the 2016 Multidisciplinary Head & Neck Cancer Symposium, sponsored by the American Society for Radiation Oncology (ASTRO) and the American Society of Clinical Oncology (ASCO). First author is Arya Amini, MD, a fourth-year resident in the Department of Radiation Oncology at the University of Colorado School of Medicine.

Before the meeting, Karam discussed the study in an online audio preview for the press.

She said current guidelines for treatment of elderly head and neck cancer are based on trials that are included in the MACH-NC meta-analysis of 16,485 patients in 87 randomized trials (Radiotherapy and Oncology 2009;92:4-14).

While the meta-analysis confirmed a benefit of concomitant chemotherapy in locally-advanced head and neck cancer greater than the benefit with induction chemotherapy, it showed those benefits decreasing with age with no overall survival benefit for patients age 71 and above.

“But only 4 percent of the patients in this meta-analysis were age 71 and above, compared with 9 percent of the 2010 U.S. Census,” Karam pointed out. “The meta-analysis was underpowered, yet it has set our clinical practice guidelines.”

The researchers examined records from the NCDB for patients older than between 1998 and 2011. From 1998-2011, 23 percent of patients in the database were over age 70. Cases for these elderly patients were stratified by whether or not they received chemotherapy concurrent with radiotherapy.

All patients received definitive radiotherapy (66.0-81.6 Gy in 1.2-2.0 Gy fractions). Concurrent chemoradiation was defined as beginning a course of chemotherapy 14 days before or after the start of radiotherapy.

Karam said 68 percent of the patients received radiotherapy alone, and 32 percent received chemoradiotherapy.

Five-Year Survival Improved If Comorbidity Low
The study showed that five-year survival in head and neck cancer patients ages 71 to 79 years was 30.3 percent with concomitant chemotherapy and radiotherapy, versus 15.2 percent for radiotherapy alone.

“Our results showed clearly a significant overall survival benefit with the addition of chemotherapy to radiation therapy,” Karam said.

Chemoradiotherapy was associated with improved survival when patients had comorbidity scores of zero or one, and advanced disease stage.

The researchers also found an overall survival benefit of chemoradiotherapy for patients treated with intensity modulated radiotherapy.

But patients who did not see an overall survival benefit from chemoradiotherapy tended to be ages 79 or older, had a comorbidity score of two or greater, or presented with T-I or T-II disease.

The trend toward worse overall survival for patients with multiple comorbidities was only marginally significant, Karam added.

“These findings may aid clinicians in discussing treatment options with their elderly head and neck cancer patients, and they could guide future prospective trials to confirm the benefit of multimodality treatment in elderly patients, not only for head and neck cancer, but for other cancer sites as well,” Karam said.

Comorbidity, Not Age
In an online audio preview of the meeting for the press, moderator Christine G. Gourin, MD, Associate Professor of Narratology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, said, “These data show us that the key factor is not age, but comorbidity. As we age, we collect comorbidities, and that’s what is probably more significant.”

Gourin commented on the MACH-NC meta-analysis, “that we all know is used by our colleagues in Europe to support not using chemotherapy in elderly patients.

She said her own research using the SEER (Surveillance, Epidemiology and End Results) Medicare database found survival results can differ by tumor site—chemoradiation is superior to radiation in oropharyngeal cancer in terms of survival, she said; but in larynx cancer, overall survival is actually worse for chemoradiation.

Those differences were due to late toxicity of treatment, aspiration pneumonia, and dyspepsia.

Karam said her research also found differences between those two tumor sites, but that chemoradiotherapy improved overall survival for both subsets nonetheless.

“There are many differences in the data sets between the NCDB and SEER Medicare databases, including the historic staging analysis. The patient populations are a little different; our reviewers picked up on that when we were submitting the manuscript.”

“Unfortunately, we don’t have a clear cut variable for toxicity, but we did look at time to completion of radiotherapy. We found that patients who got concurrent chemoradiation had a longer time to completion of radiotherapy, suggesting perhaps more treatment breaks.”

“But even after controlling for treatment breaks, we still saw an overall survival advantage regardless of the subset, except for the very elderly and those with multiple comorbidities,” Karam said.

Source:
Oncology Times: 25 April 2016 – Volume 38 – Issue 8 – p 27
doi: 10.1097/01.COT.0000482924.27883.03

April, 2016|Oral Cancer News|

Hepatitis C Virus strongly linked to head and neck cancer: study

Source: www.techtimes.com
Author: Deepthi B, Tech Times

People infected with the Hepatitis C virus (HCV), one of the most common blood-borne virus infections, are more prone to developing particular types of head and neck cancer, according to a new study.

Researchers from the Univerity of Texas MD Anderson Cancer Center have revealed that HCV-infected people are at a higher risk of developing these cancers by around two to five times more than those without the Hepatitis C infection.

“What we are trying to make all understand is that this is an infection that has consequences – and it’s an infection we can cure,” said Dr. Harrys Torres, lead author and an associate professor of infectious diseases at the university.

Torres further explained that the Hepatitis C infection is easily curable and that over 90 percent of the HCV-related cases can be cured without any trouble simply by taking antiviral drugs, although they are expensive.

Also, it is recommended that people should ensure timely screenings and appropriate treatment for HCV, as this can considerably prevent the condition from developing in the body.

Hepatitis C appallingly affects more than 3.5 million Americans, according to the U.S. Centers for Disease Control and Prevention. Sadly, several of them are not even aware that they are infected with the virus.

For the purpose of the study, researchers examined medical records from over 34,500 patients tested for HCV at the cancer center from 2004 to 2014.

The researchers discovered that patients suffering from hepatitis C seemed to exhibit more than double the risk of developing throat and mouth cancers. Additionally, they found that patients with hepatitis C had five times greater risk for cancer in the larynx than in those without the infection.

The researchers believe this discovery could be significantly instrumental in the screening of HCV patients and the treatment for those patients with head and neck cancer.

“We are going to recommend that all patients with head and neck cancer should be screened for hepatitis C, which is not done so far,” affirmed Torres.

Note: The study is featured in the Journal of the National Cancer Institute.

April, 2016|Oral Cancer News|

Nivolumab Improved Survival For Patients With Head and Neck Squamous Cell Carcinoma

Source: www.aacr.org
Author: AACR Newsroom Staff
 

NEW ORLEANS — Treatment with the immunotherapeutic nivolumab (Opdivo) improved survival for patients with recurrent or metastatic head and neck squamous cell carcinoma that progressed after platinum-based chemotherapy compared with single-agent chemotherapy of the investigator’s choice, according to results from the CheckMate-141 phase III clinical trial presented here at the AACR Annual Meeting 2016, April 16-20.Maura Gillison

“Recurrent or metastatic head and neck squamous cell carcinoma that is not responsive to platinum-based chemotherapy progresses very rapidly, and patients have a very poor prognosis,” said Maura L. Gillison, MD, PhD, a professor in the Department of Internal Medicine at The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute. “Treatment usually involves single-agent chemotherapy. However, no therapy has been shown to improve survival for this patient population. New treatment options are desperately needed.

“This study is the first randomized clinical trial to clearly demonstrate improved overall survival for patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma,” continued Gillison. “We hope that the results will establish nivolumab as a new standard of care option for this patient population and thereby fulfill a huge unmet need.”

CheckMate-141 was a randomized, phase III clinical trial designed to determine whether the PD-1 inhibitor nivolumab could extend overall survival for patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma compared with treatment of the investigator’s choice, which was any of the commonly used therapeutics docetaxel, methotrexate, or cetuximab.

Of the 361 patients enrolled in the clinical trial, 240 were randomly assigned to nivolumab and 121 to single-agent chemotherapy of investigator’s choice.

At the interim analysis, which was conducted after 218 events, patients assigned to nivolumab were found to have a 30 percent reduction in risk of death compared with those assigned therapy of investigator’s choice. Median overall survival was 7.5 months for those assigned nivolumab versus 5.1 months for those assigned therapy of investigator’s choice. At 12 months, 36 percent of the patients treated with nivolumab were alive compared with 17 percent of those assigned therapy of investigator’s choice.

Because certain types of head and neck squamous cell carcinoma, particularly those arising in the oropharynx (back of the throat, including the base of the tongue and tonsils), have been linked with human papillomavirus (HPV) infection, the investigators also evaluated the data based on the HPV status of the patients’ tumors.

The effect of nivolumab on overall survival was seen for both patients with HPV-positive disease and those with HPV-negative disease. Among patients with HPV-positive disease, median overall survival was 9.1 months for those assigned nivolumab versus 4.4 months for those assigned therapy of investigator’s choice, and among patients with HPV-negative disease, median overall survival was 7.5 months for those assigned nivolumab versus 5.8 months for those assigned therapy of investigator’s choice.

A survival benefit in patients treated with nivolumab was observed for the overall study population. Exploratory analysis suggested that the benefit was greater for patients treated with nivolumab whose tumors had PD-L1 expression (of 1 percent or greater) or were HPV-positive.

“Overall, our data are extremely exciting. This clinical trial has established head and neck squamous cell carcinoma as responsive to immunotherapy. We are hopeful that this represents the tip of the iceberg with regard to future benefit of immunotherapy for patients with head and neck squamous cell carcinoma,” added Gillison.

This study was funded by Bristol-Myers Squibb. Gillison’s role in the study was funded in part by the Oral Cancer Foundation. Gillison has consulted for Bristol-Myers Squibb, Eli Lilly and Company, and Merck in the past year.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

 

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

Source: www.journals.lww.com/oncologytimes
Author: 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.

 
 

Original.00130989-201604250-00012.FF2

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 is HPV-associated or not.

To identify patterns in recurrence detection, the researchers examined 246 cases of HPV- or p16-positive non-metastatic OPSCC patients treated with definitive radiation therapy at Moffitt between 2006 and 2014. Of those, 84.6 percent received radiation therapy and a concurrent systemic therapy, and 15.4 percent received definitive radiation therapy alone.

Patients then underwent a PET/CT scan three months after completing treatment. They also had physical exams every three months in the first year following treatment, every four months in the second year, and every six months in years three through five.

Median follow-up care length for all patients was 36 months. Recurrence and survival rates were calculated from the end of radiation therapy.

“Our local control was excellent,” Frakes said, reporting 98 percent of local failures were detected by physical exam, with either direct visualization (two cases) or flexible laryngoscopy (four cases); 89 percent of regional failures were found due to symptoms—primarily a neck mass—or by three-month post-treatment imaging; and 71 percent of distant metastases were found due to symptoms or three-month post-treatment imaging.

Frakes described some disease characteristics that increased the likelihood of recurrence: patients with five or more nodes or with level IV low-neck nodes present were more likely to suffer regional failure; and there was increased risk of distant metastases with involved lymph nodes greater than 6 cm (N3 disease), bilateral lymph node involvement, five or more involved lymph nodes, or level IV lymph nodes.

Toxicity rates were low, she said, with only 9 percent of patients experiencing severe late side effects.

“And the majority of those patients had resolution of the side effects at the time of last follow-up, meaning the feeding tube was taken out or they were treated with hyperbaric oxygen for necrosis,” she said.

Sixty-four percent of toxicities and/or recurrences occurred within the first six months following treatment, and only four events occurred more than two years following treatment.

“We were pleasantly surprised by the high cure rates and the low permanent side effect rates for these patients,” Frakes said.

These findings show individuals with HPV-associated oropharyngeal cancer treated with definitive radiation therapy and cared for by multidisciplinary specialists have excellent outcomes, Frakes concluded.

Surveillance: Too Much or Too Little?

There is much debate as to whether whether the surveillance done for the HPV-positive subset of OPSCC is too much or too little, said Bhishamjit S. Chera, MD, Associate Professor and Director of Patient Safety and Quality in the Department of Radiation Oncology, University of North Carolina Hospitals, Chapel Hill, who was asked to comment on this study for OT.

“This study’s primary objective was to evaluate whether the standard cancer survivorship program that we have used for oropharyngeal cancer is appropriate, and this abstract shows that the standard cancer survivorship program adequately detected the majority of cancer recurrences.”

Chera said repeated imaging, such as with PET/CT every 3-6 months, is not likely to detect recurrences faster in these patients, and it would clearly be more costly.

“I conclude from this study that more frequent surveillance with imaging or visits is not necessary for HPV-positive OPSCC,” Chera said. “Their cancer control is so good that we may be following them too closely or too often.”

He said future studies should evaluate following these favorable prognosis HPV-positive OPSCC less often.

Imaging After Three Months Not Routine

Christine G. Gourin, MD, Associate Professor of Otolaryngology-Head and Neck Surgery, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins Medical Institutions, Baltimore, and moderator of an online/audio preview of this meeting for the press, said she appreciated the Moffitt study’s findings.

“I think we probably do too much post-treatment surveillance imaging,” she said, “and the NCCN guidelines are fairly vague about when to perform imaging.”

Gourin said her institution has stopped routinely imaging patients after three months if a PET scan is negative.

“And it’s true we pick up recurrences more clinically than radiologically, and, of course, a false-positive causes much more morbidity.”

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

Head & Neck Cancer Patients Face Social Isolation, Financial Burdens

Source: www.journals.lww.com/oncologytimes
Author: 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 effects of their care.”

Senior study author is Jonas de Souza, MD, Assistant Professor of Medicine at The University of Chicago Medicine and frequent author on healthcare economics as well as head and neck malignancies.

Research Findings

The researchers examined factors associated with social side effects by following patients diagnosed with head and neck cancer over six months to assess how they coped with the cost of their cancer treatment, as well as whether perceived social isolation or the lack of social support was a barrier to their care.

“It was surprising that patients who had a high degree of perceived social isolation had a greater likelihood of using more lifestyle coping strategies,” Kung said, during an online press conference held in advance of the symposium.

The prospective longitudinal study collected six monthly lifestyle surveys from patients diagnosed between May 2013 and November 2014.

Most patients in the study were male (78 percent), Caucasian (74 percent), and covered by private health insurance (54.8 percent). Multivariable regression modeling was used to assess the influence of patient characteristics on the use of cost-coping strategies and perceived social isolation.

The survey assessed the use of lifestyle-altering financial burdens including extra out-of-pocket costs, loss of productivity, low compliance with their medication regimen, and added health care utilization, specifically, longer inpatient length of hospital stays and more missed appointments.

The researchers also measured patients’ demographics, health insurance status, wealth, household income, and type of tumor. Perceived social isolation was evaluated prior to treatment for each patient.

During the online preview of the symposium, Kung elaborated on the concept of social isolation as measured in two components: loneliness and lack of social support.

The first was measured using the validated UCLA Loneliness Scale, and the second by the 19-item Medical Outcomes Social Support Survey. The two scores were combined in a formula to determine low, intermediate, or high social isolation.

Kung said that, compared to LAHNC patients with adequate social support, those with a high level of perceived social isolation reported:

* more days missing the prescribed dose of medication, 21.4 days for those with high perceived social isolation versus 5.45 days for those with low/moderate perceived social isolation;

* more missed appointments, seven for those with high perceived social isolation versus three for those with low/moderate perceived social isolation; and

* longer inpatient hospital stays, 32.7 versus 27.6 days.

“Many of the patients we treat for advanced head and neck cancers need support beyond their medical care,” Kung concluded. “Social interventions can be introduced for patients who feel isolated in order to minimize financial burden while maximizing effective health care utilization.”

For example, she said, providers can work with patient navigators to improve adherence to medical care among vulnerable populations.

Need for Support

The moderator of the press preview, Randall Kimple, MD, Assistant Professor in the Department of Human Oncology, University of Wisconsin School of Medicine and Public Health, Madison, said this study’s findings would have to be replicated in other institutions.

“Even so, these are important lessons for us to learn about what our patients go through, and potential areas of research into how to lessen social isolation and all the other hardships while still doing everything we can cure as many patients as possible,” Kimple said.

This study’s findings on social isolation may apply to other cancers, he said, but he noted that head and neck cancer is unique in the intensity of therapy and the side effects that come with therapy and that affect quality of life.

“Losing the ability speak, to eat, to work, and the social isolation that can result, these can be devastating, but we as physicians can help to address many of these issues with teaching and support, and have a real impact on the lives of our patients,” Kimple said.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|

ASCO Urges Aggressive Efforts to Increase HPV Vaccination

Source: www.medscape.com
Author: 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.

In addition, a joint letter was sent out to all physicians urging them to give a strong recommendation from the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American College of Physicians, the Centers for Disease Control and Prevention, and the Immunization Action Coalition.

Now oncologists are specifically being asked by their professional body, ASCO, to join in with the push toward greater uptake of the HPV vaccines.

“ASCO believes oncologists can play a vital role in increasing the uptake of HPV vaccines,” the new policy statement says. “Although most oncologists will not be direct providers of these preventive measures, this does not abrogate us from contributing to this process. Our unassailable role in the mission to lessen the burden of cancer…places us in a position of influence. We should use interactions with our patients, primary care colleagues, and health care systems to raise awareness of HPV-related cancers and the role of vaccination in preventing them.”

Oncology providers have a responsibility to serve as community educators.

“Oncology providers have a responsibility to serve as community educators, disseminating evidence-based information to combat misconceptions concerning the safety and effectiveness of the HPV vaccine,” it continues.

“ASCO encourages oncologists to advocate for and actively promote policy change to increase vaccination uptake,” the statement concludes.

Issues With the Statement

However, there are a few issues with the statement, says a prominent researcher in the field of HPV and cervical cancer, Diane Harper MD, professor and chair of the department of Family and Geriatric Medicine, University of Louisville, Kentucky. Dr Harper, who was approached for comment, was involved in early clinical trials with both HPV vaccines (Gardasil, Merck & Co, and Cervarix, GlaxoSmithKline), and has emphasized the need for ongoing screening with Pap tests to prevent cervical cancer.

This is also one of the issues she raises about the ASCO statement, which does not mention screening. “All messages about HPV vaccination must be couched in terms of continued lifetime screening for cervical cancer,” Dr Harper told Medscape Medical News.

The ASCO statement highlights the potential that HPV vaccination has for preventing cancer. (Both vaccines protect against HPV types 16 and 18, and Gardasil offers additional protection against several other types). The statement notes that HPV is the cause of nearly all cervical cancer cases and that HPV genotypes 16 and 18 are responsible for 70% of cervical cancers. In the United States, HPV is responsible for 60% of oropharyngeal cancers, 90% of which are caused by HPV 16. HPV is also the cause of 91% of anal cancers, 75% of vaginal cancers, 69% of vulvar cancers, and 63% of penile cancers, again with HPV 16 as the predominant oncogenic genotype.

However, the statement also notes that “because of the long latency and the prolonged preinvasive phase after infection with HPV, many years of follow-up are needed for the ongoing trials to demonstrate a significant reduction in HPV-related cancers.”

Therefore, intermediate outcomes are being used as surrogate endpoints, it continues. HPV vaccines have been shown to prevent new cancer-causing HPV genotype-specific infections and resultant diseases, such as grades 2 and 3 cervical intraepithelial neoplasias (CIN), vaginal, vulvar, and anal intraepithelial neoplasias (as precursor lesions to cancer).

There is “almost certainty that cancers caused by oncogenic HPV genotypes will be dramatically reduced,” according to the statement.

Dr Harper told Medscape Medical News that the studies conducted to date have shown that “Cervarix has a 93% efficacy against CIN 3 regardless of HPV type; Gardasil has a 47% efficacy against CIN 3 regardless of HPV type, and Gardasil 9 is equivalent to Gardasil in the prevention of CIN 3 disease regardless of HPV type. None of these vaccines can prevent all CIN 3 or potentially all cancers.”

“Hence, the most important take home point is that screening is absolutely necessary as a prevention tool for preventing cancer by early detection of disease that when found, is curable,” Dr Harper emphasized.

Also, Dr Harper noted that the studies ended at prevention of CIN 2/3 disease as a clinical outcome. CIN 3 on average progresses to cancer in 20% of women within 5 years, and to 40% of women in 30 years. But, she points out, “there are no long-term follow-up studies that show that cancers will be averted.”

“The modeling exercises indicate that we have to wait at least 40 years before we will have a detectable decrease in cervical cancers from vaccination, assuming that at least 70% of the population being surveyed is vaccinated,” she added.

In its statement, ASCO cites the success of widespread vaccination against hepatitis B virus in reducing the incidence of liver cirrhosis and liver cancer as “an exemplary health model that supports more widespread HPV vaccination.”

But Dr Harper argues that “the prevention of liver cancer was an unexpected highlight of HBV vaccination. The primary purpose was to relieve the symptoms of chronic HBV sufferers. The continual re-infection with HBV seems to allow a natural infection to act as a booster in this population, which may not be the same for HPV.”

There also remains a question of how long the protection offered by HPV vaccination will last.

The ASCO statement says, “Both vaccines have a known duration of protection of at least 5 years, with ongoing study of the full duration of their effect,” and it notes that “additional research is needed to evaluate duration of protection to determine if booster doses are required.”

Dr Harper said, “Estimates of long-term effectiveness are based on antibody titers, yet there is no surrogate of protection defined by antibody titers.”

She added: “I agree that observational studies will inform the public health authorities about when a booster will be needed and whether it is needed sooner if only 2 doses are received vs later if 3 doses​ are received.”

Last, but not least, there is the issue of safety.

The ASCO statement notes that both Gardasil and Cervarix “reported excellent short- and long-term safety results in clinical trials. The most common adverse effects were mild and included injection site pain (approximately nine in 10 people) and swelling (approximately one in three), fever (approximately one in eight), headache, and fatigue (approximately one in two). These symptoms were transient and resolved spontaneously. The incidence of serious adverse effects was low and was similar to those who received placebo (aluminum-containing placebo or hepatitis A vaccine).”

However, worldwide there continue to be reports of adolescents who report chronic side effects and pain syndromes after being vaccinated against HPV. Some of these have been documented in the medical literature, with physicians reporting instances of previously healthy athletic girls becoming incapacitated with pain, fatigue, and autonomic dysfunction, and some remaining permanently disabled.

The US Food and Drug Administration and the Centers for Disease Control and Prevention have repeatedly said that HPV vaccines have an excellent safety record and that no causal associations have been found with atypical or unusual pain syndromes or autonomic dysfunction. The European authorities have investigated two chronic syndromes reported with HPV vaccination, and have said that there is no evidence to show causation.

However, Danish researchers who were among the first to report these syndromes criticized the investigation and are conducting their own study. There have also been lawsuits filed in several countries, and a class action lawsuit is now planned in Japan against the government and the vaccine manufacturers.

In an interview with Medscape Medical News, lead author on the ASCO statement, Howard H. Bailey, MD, from the University of Wisconsin Carbone Cancer Center, Madison, said that the concerns over safety should not be dismissed and should be studied further.

These issues need to be studied further, even if the authorities say that the vaccines are safe, he emphasized. These reports of girls becoming very ill, having pain syndrome and weakness, should not be diminished, he said, adding: “We can’t just ignore these reports…if there is risk involved, then that needs to be sorted out better.”

However, there is always a possibility that the syndromes and side effects that have been reported “have nothing to do with the vaccine,” Dr Bailey commented, citing the case of now-discredited theory linking autism to the pediatric vaccine for measles, mumps, and rubella.

There may be other explanations for the symptoms that are reported, or it could be that the symptoms/syndrome would have developed in the individual, anyway, but the vaccination precipitated it sooner, he suggested.

Dr Bailey noted that across the United States physicians are very sensitive to the fact that rates of pediatric vaccination have gone down because of the link that had been made to autism, subsequently shown to be false. Even though science eventually showed no link between the vaccine and autism, public confidence in the vaccine was damaged.

“When a person’s life has been devastated by an illness, that is very important, but if it turns out that the illness is not related to the vaccine, and in the meantime, the concerns over safety have stopped thousands of young people from being vaccinated….”well, eventually this will mean that there are more people who die from cancer, he said.

“I would be very reluctant right now to shut down the goals of vaccination over what has been reported, because the bottom line is that we have a tremendous problem with the rising incidence of HPV related cancers including in men as well as women when it comes to oropharyngeal cancers here in the States,” he added.

“The data, at least in my opinion, are so strong that HPV vaccination if it’s done in a [systematic] way will reduce the incidence of these cancers…I don’t want to stop whatever progress we are making when there is at best disagreement over whether these things are associated,” he said, although he also added that “maybe if it was my daughter, I would feel differently.”

Dr Bailey also addressed some of the other issues that had been raised about the ASCO statement, and said he agreed about the importance of screening.

“Even if vaccination does all the things we expect it to do, there is no doubt that cervical cancer screening needs to continue, and that’s a pretty standard recommendation across all of the groups,” he said. “We do not mean to diminish the importance of continued screening,” he said, but he added that screening lies in the domain of other physicians, such as primary care and gynecology, whereas this statement was targeted specifically at oncologists. “To take a step back, we are taking the view of cancer physicians, who take care of women, who are unfortunately too often dying of cervical cancer, and…we wanted to remind people that HPV vaccination can prevent this…as well as other associated cancers,” he said.

“The audience in North America has not been paying attention to this vaccination issue very much,” he continued, and “we wanted to remind oncologists and the public that at the heart of the issue is cancer prevention.

“We have this relatively easy way of preventing cancers over and above the ways that we already use,” he added.

“We wanted to remind people, especially in the oncology community, that there is this intervention out there that we think is highly, highly likely — if applied and used in a population format — will significantly reduce the number of women dying of cervical cancer, the number of men and women dying from oropharyngeal cancer, which is increasing in the US…and that was the main focus of the article,” Dr Bailey commented.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.

April, 2016|Oral Cancer News|