oropharyngeal cancer

This Is Why Your Drug Prescriptions Cost So Damn Much

Source: www.motherjones.com
Author: Stuart Silverstein



When the Republican-controlled Congress approved a landmark program in 2003 to help seniors buy prescription drugs, it slapped on an unusual restriction: The federal government was barred from negotiating cheaper prices for those medicines. Instead, the job of holding down costs was outsourced to the insurance companies delivering the subsidized new coverage, known as Medicare Part D.

The ban on government price bargaining, justified by supporters on free-market grounds, has been derided by critics as a giant gift to the drug industry. Democratic lawmakers began introducing bills to free the government to use its vast purchasing power to negotiate better deals even before former President George W. Bush signed the Part D law, known as the Medicare Modernization Act.

All those measures over the last 13 years have failed, almost always without ever even getting a hearing, much less being brought up for a vote. That’s happened even though surveys have shown broad public support for the idea. For example, a Kaiser Family Foundation poll found last year that 93 percent of Democrats and 74 percent of Republicans favor letting the government negotiate Part D prescription drug prices.

“I mean, how in the world can one explain that the government actually passed a law saying that you can’t negotiate prices?”

It seems an anomaly in a democracy that an idea that is immensely popular—and calculated to save money for seniors, people with disabilities, and taxpayers—gets no traction. But critics say it’s no mystery, given the enormous financial influence of the drug industry, which rivals the insurance industry as the top-spending lobbying machine in Washington. It has funneled $1.96 billion into lobbying in the nation’s capital since the beginning of 2003 and, in just 2015 and the first half of 2016, has spent the equivalent of $468,108 per member of Congress. The industry also is a major contributor to House and Senate campaigns.

“It’s Exhibit A in how crony capitalism works,” said Rep. Peter Welch (D-Vt.), who has sponsored or co-sponsored at least six bills since 2007 to allow Part D drug price negotiations. “I mean,” he added, “how in the world can one explain that the government actually passed a law saying that you can’t negotiate prices? Well, campaign contributions and lobbying obviously had a big part in making that upside-down outcome occur.”

Wendell Potter, co-author of a book about the influence of money in politics, Nation on the Take, likened the drug industry’s defiance of public opinion to the gun lobby’s success in fending off tougher federal firearms controls and the big banks’ ability to escape stronger regulation despite their role in the Great Recession.

“They are able to pretty much call the shots,” Potter said, referring to the drug industry along with its allies in the insurance industry. “It doesn’t matter what the public will is or what public opinion polls are showing. As long as we have a system that enables industries, big corporations, to spend pretty much whatever it takes to influence the elections and public policy, we’re going to wind up with this situation.”

While Part D is only one of the issues the drug industry pushes in Washington, it is a blockbuster program. According to a report from the trustees of the Medicare system, this year Part D is expected to spend $103 billion to serve an estimated 43 million Americans.

A paper released in August by Harvard Medical School researchers cited the size of the program and its lack of government negotiating clout as among the reasons why Americans pay the highest prices in the world for prescription drugs. A co-author of that paper, Ameet Sarpatwari, estimates that Part D accounts for nearly 30 percent of the nation’s spending on prescription drugs.

What’s more, Part D often pays far more for drugs than do Medicaid or the Veterans Health Administration—which, unlike Part D, mandate government measures to hold down prices. One report found that Part D pays 80 percent more for medicines than the VHA and 73 percent more than Medicaid. While researchers aren’t unanimous in their views, an array of experts have concluded that federal negotiating power—if backed up by other cost controls—would bring Part D drug costs more in line.

The drug industry and its allies acknowledge that, at least in the short term, federal intervention in the marketplace could bring lower drug prices. Yet the industry says such a step would also kill incentives to develop new medicines.

In addition, industry officials and many analysts say substantial cost reductions will come only if the Part D program refuses to pay for drugs that it considers overpriced, possibly reducing seniors’ access to some medicines. They point to the way the VHA strengthens its negotiating leverage by rejecting some expensive medicines. Instead, the veterans’ health care system limits its purchases to a list of approved drugs known as a formulary.

“If you want to have lower prices, you’re going to have fewer medicines,” said Kirsten Axelsen, a vice president at Pfizer, a pharmaceutical giant that leads all drug companies in spending on lobbying and political campaigns at the federal level.

It took intense maneuvering by the Bush White House and GOP leaders to get Part D through Congress in November 2003, when the House and the Senate were under Republican control. The measure came up for a vote in the House at 3 a.m. on the Saturday before Thanksgiving, as lawmakers were trying to finish business before the holiday. But when the bill appeared headed to a narrow defeat after the normal 15 minutes allowed for voting, Republican leaders kept the vote open for an extraordinary stretch of nearly three hours, described in a 2004 scholarly paper as by far the longest known roll-call vote in the history of the House.

With the help of pre-dawn phone calls from Bush and a custom-defying visit to the House floor by Tommy Thompson, then secretary of health and human services, enough members were coaxed to switch their votes to pass the bill, 220-215, shortly before 6 a.m.

Part D was conceived at a time when rapidly rising US drug costs were alarming seniors, prompting some to head to Canada and Mexico to buy medicines at dramatically lower prices. With the 2004 presidential election campaign coming up, Republican leaders saw “an opportunity to steal a long-standing issue from the Democrats,” said Thomas R. Oliver, a health policy expert at the University of Wisconsin-Madison and the lead author of the 2004 paper about the adoption of Part D.

Last year the drug industry retained 894 lobbyists to influence the 535 members of Congress, staffers, and regulators.

A key aim of Part D proponents, Oliver said, was to cover seniors “in a Republican, pro-market kind of way.” That meant including “as much private sector involvement as possible,” which led to insurance companies managing the program. At the same time, it excluded federal price controls, which were anathema to the drug industry.

Today, the program remains subject to the pervasive influence of the drug industry. An analysis by FairWarning, based on spending data provided by the Center for Responsive Politics, a nonprofit and nonpartisan research group, has found:

— There are far more lobbyists in Washington working for drug manufacturers and wholesalers than there are members of Congress. Last year the industry retained 894 lobbyists to influence the 535 members of Congress, along with staffers and regulators. From 2007 through 2009, there were more than two drug industry lobbyists for every member of Congress.

— For each of the last 13 years, more than 60 percent of the industry’s drug lobbyists have been “revolvers”—that is, lobbyists who previously served in Congress or who worked as congressional aides or in other government jobs. That raises suspicions that lawmakers and regulators will go easy on the industry to avoid jeopardizing their chances of landing lucrative lobbying work after they leave office.

Probably the most notorious example was the Louisiana Republican Billy Tauzin. He helped shape the Part D legislation while serving as chairman of the House Energy and Commerce Committee. In January 2005, just days after he retired from the House, he became the drug industry’s top lobbyist as president of a powerful trade group, the Pharmaceutical Research and Manufacturers of America, or PhRMA. He remained in that job—which reportedly paid him $2 million a year—until 2010.

“It was pretty blatant but an accurate reflection of the way pharma plays the game, through campaign contributions and, in Billy’s case, way more than that,” said US Rep. Jan Schakowsky, an Illinois Democrat who has been a leading proponent of government price negotiations.

— Since January 2003, drug manufacturers and wholesalers have given $147.5 million in federal political contributions to presidential and congressional candidates, party committees, leadership PACs and other political advocacy groups. Of the total, 62 percent has gone to Republican or conservative causes.

Over the period, four Republican lawmakers from the 2015-16 Congress received more than $1 million in contributions from drug companies. (One of them, former House Speaker John Boehner, R-Ohio, resigned last October.) In all, 518 members of the current Congress—every member of the Senate and more than 95 percent of the House—have received drug industry money since 2003.

Pfizer said that since the beginning of 2003 through the middle of this year it has spent, at the federal level, $145.9 million on lobbying as well as $12.2 million on political contributions through its PACs. In a written statement, the company said, “Our political contributions are led by two guiding principles—preserve and further the incentives for innovation, and protect and expand access for the patients we serve.”

— The big money goes to top congressional leaders as well as chairs and other members of key committees and subcommittees.

The House Energy and Commerce Health Subcommittee, repeatedly a graveyard for Part D price negotiation bills, underscores the pattern. The 16 Republican members have received an average of $340,219 since the beginning of 2003.

The drug industry “knows that you really only need, in many cases, just a small number of influential members to do their bidding. That’s why you see contributions flowing to committee chairs, regardless of who is in power. They flow to Democrats as well as Republicans,” Potter said.

Proponents of negotiations say some economic and political currents may turn the tide in their favor. The main factor: After years of relatively modest price rises for prescription drugs, cost increases have begun to escalate. That’s partly because of expensive new treatments for illnesses such as hepatitis C.

According to Medicare officials, Part D payments are expected to rise 6 percent annually over the coming decade per enrollee, up from only 2.5 percent annually over the last nine years. Already, cost increases are “putting wicked pressure on our hospitals, on our seniors, and on our state governments,” Welch said.

At the same time, both major presidential candidates, Hillary Clinton and Donald Trump, have called for Medicare drug price negotiation. So have doctor groups such as the American College of Physicians and an alliance of more than 100 oncologists, many nationally known, who last year garnered headlines with their plea for Medicare negotiations and other measures to fight skyrocketing costs for cancer drugs.

PhRMA, the trade group, wouldn’t comment for this story on lobbying or campaign spending. In a written statement, however, PhRMA spokeswoman Allyson Funk said, “There is significant price negotiation that already occurs within the Medicare prescription drug program.” Pointing to the private companies that run the program, Funk added, “Large, powerful purchasers negotiate discounts and rebates directly with manufacturers, saving money for both beneficiaries and taxpayers.”

Funk also pointed to skeptical assessments by the Congressional Budget Office about the potential additional savings from federal negotiations. Repeatedly—including in letters in 2004 and 2007—the CBO has said government officials likely could extract only modest savings, at best. The office’s reasoning is that costs already would be held down by bargaining pressure from insurance firms and by drug manufacturers’ fear of bad publicity if they are viewed as jacking up prices too high.

But many analysts, particularly amid recent controversies over skyrocketing costs for essential drugs and EpiPen injection devices, scoff at those CBO conclusions. They fault the CBO for not taking into account other price controls, such as those used by Medicaid and the VHA, that likely would be coupled with price negotiation.

“You would want Medicare to have the option to say, ‘Okay, this is our price, and you’re going to take it. And if you don’t take it, we’re not buying it.'”

What CBO officials “seem to be assuming is that Congress would change the law in a really foolish way,” said Dean Baker, a liberal think tank economist who has studied the Part D program. “It seems to me that if you got Congress to change the law, you would want Medicare to have the option to say, ‘Okay, this is our price, and you’re going to take it. And if you don’t take it, we’re not buying it.”

In fact, related bills proposed during the current Congress by two Illinois Democrats—Schakowsky and Richard J. Durbin, the Senate minority whip—go beyond requiring drug price negotiations. They both provide for federal officials to adopt “strategies similar to those used by other Federal purchasers of prescription drugs, and other strategies…to reduce the purchase cost of covered part D drugs.”

The potential to reduce prices is underscored by a 2015 paper by Carleton University of Ottawa, Canada, and the US advocacy group Public Citizen. It found that Medicare Part D on average pays 73 percent more than Medicaid and 80 percent more than the VHA for the same brand-name drugs. The VHA’s success in holding down costs helped inspire a measure on California’s November ballot, Proposition 61, that would restrict most state-run health programs from paying any more for prescription drugs than the veterans agency does.

Two studies by the inspector general of health and human services that compared drug expenditures under the Part D and Medicaid programs also concluded that Part D pays far more for the same medicines. The more recent inspector general study, released in April 2015, examined spending and rebates on 200 brand-name drugs. It found that, after taking rebates into account, Medicaid, which provides health care for low-income families with children, paid less than half of what Part D did for 110 of the drugs. Part D, on the other hand, paid less than Medicaid for only 5 of 200 drugs.

Those findings provide evidence that “the current reliance on private insurers that negotiate drug prices isn’t working that well,” said Edwin Park, vice president for health policy at the Center on Budget and Policy Priorities, a Washington think tank.

Five Democrats who are leading opponents of the status quo—US Representatives Welch, Schakowsky, and Elijah E. Cummings of Maryland, along with Sens. Durbin and Amy Klobuchar of Minnesota—each have introduced price negotiation bills (HR 3061, HR 3261, HR 3513, S 31 and S 1884) during the current, 114th Congress. All the measures have stalled in committee.

Schakowsky, a House Democratic chief deputy whip, said under Republican control in her chamber, “I think it is virtually impossible for this to ever go to hearings and markups.”

Take, for example, the bill that Welch introduced in the House on July 14, 2015. Within a week, it was referred to two health subcommittees, where it has sat ever since.

The closest Welch ever came to success was in 2007. He was among 198 co-sponsors—all but one, Democrats—of a bill introduced by then-US Rep. John D. Dingell of Michigan. It was approved by the House but then blocked by Republicans from being taken up in the Senate.

“There’s a lot of industry opposition…It doesn’t mean, however, that industry is all-powerful.”

 Lawmakers on committees where Part D bills ordinarily go—the Finance Committee in the Senate, and the Energy and Commerce Committee as well as the Ways and Means Committee in the House—tend to be well funded by the drug industry.

For instance, Sen. Richard Burr (R-N.C.), who sits on the Finance Committee, has received more money from the industry since 2003 than anyone else currently in Congress, $1.3 million. Close behind is Senate Finance Chairman Orrin Hatch, (R-Utah), who has gotten $1.18 million. (The other members of the million-dollar club are Rep. Fred Upton (R-Mich.), House Energy and Commerce chairman, at $1 million, and former House Speaker Boehner, at $1.21 million.)

Burr also is the Senate leader so far in the 2015-16 political cycle, collecting $229,710 from the drug industry. In the House in the current cycle, John Shimkus (R-Ill.), a member of the Energy and Commerce health subcommittee, has snagged $189,000, trailing only Republican Majority Leader Kevin McCarthy ($292,550) and House Speaker Paul Ryan ($273,195). A Burr spokeswoman declined to comment. Hatch and Shimkus did not respond to repeated requests for comment.

Amid the EpiPen controversy and growing concerns about prescription drug prices, Park sees signs that more lawmakers are willing to buck industry opposition to government price negotiation. “There’s a lot of industry opposition. This would affect their bottom line,” Park said. “It doesn’t mean, however, that industry is all-powerful.”

But Baker, co-director of the Center for Economic and Policy Research in Washington, was skeptical about the prospects for reform. “I think it’s pretty clear what you’re seeing is, there’s an industry group that stands to lose a lot of money, and they’re basically using all of the political power they can to make sure that it doesn’t happen.”

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

October, 2016|Oral Cancer News|

Expert Asserts Pembrolizumab to Play Important Role in Head and Neck Cancer Treatment

Source: www.targetedonc.com
Author: Laura Panjwani


The FDA approval of pembrolizumab (Keytruda) as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in August 2016 was extremely significant for this patient population, which previously had limited options following progression on a platinum-based chemotherapy.

The approval was based on the phase Ib KEYNOTE-012 study, which demonstrated that pembrolizumab had an overall response rate (ORR) of 18% and a stable disease rate of 17% in patients with recurrent/metastatic HNSCC.

Several other studies are further evaluating the immunotherapy agent in HNSCC.Preliminary results of the phase II KEYNOTE-055 study—which included 92 evaluable patients who received pembrolizumab after failing platinum and cetuximab therapies—were presented at the 2016 ASCO Annual Meeting.

In an interview with Targeted Oncology, lead study author Joshua M. Bauml, MD, an assistant professor of Medicine, Hospital of the University of Pennsylvania and the Veteran’s Administration Medical Center, discusses the impact of pembrolizumab’s success in HNSCC, the results of the KEYNOTE-055 study, and what he sees on the horizon for the PD-1 inhibitor in this field.

TARGETED ONCOLOGY: What role do you envision pembrolizumab having in this patient population?

Baumi: It is going to play a critical role in head and neck cancer. The other agents that are available have limited efficacy, and are associated with significant toxicities. This is a clear improvement for our patient population with limited options.

TARGETED ONCOLOGY: What were the key takeaways from KEYNOTE-055? Baumi: Patients with recurrent/metastatic head and neck cancer that is refractory to both platinum-based therapy and cetuximab (Erbitux) really have very few options. The historical reference population we usually use is patients treated with methotrexate, which has a response rate of 5% and an overall survival (OS) of only about 6 months. There is a really great need for this. For pembrolizumab, which is an anti–PD-L1 agent, there is biologic rationale to think that it would be active in this patient population. PD-L1 and PD-L2 are unregulated in head and neck cancer.

What KEYNOTE-055 did is really try and create a homogenous patient population. Rather than a large phase I study, here are patients all who have failed both platinum-based therapy and cetuximab. We have really identified the sickest patient population.

What we are able to show in this study was that the drug was well tolerated and it has a response rate of 17% to 18%, which compares favorably for the 5% seen with the prior data with methotrexate. The OS rate was 8 months, which again compares very favorably to the 6 months seen with methotrexate. This was true, even though 85% of patients had received at least 2 prior treatments for head and neck cancer.

TARGETED ONCOLOGY: What did this study tell us about the safety of pembrolizumab in head and neck cancer?

Baumi: The rate of grade 3 through 5 treatment-related adverse events was 12% in our study. Nearly all of the side effects are what you would expect with pembrolizumab; those have been reported in multiple other studies. There was 1 treatment-related death due to pneumonitis, which is a rare side effect of this class of drugs.

Outside of that, it was a really well-tolerated agent. The fact that if you compared grade 3 through 5 toxicities of 12% with cytotoxic chemotherapy, this is a very well-tolerated agent.

TARGETED ONCOLOGY: How common is it for patients to fail both platinum-based therapy and cetuximab?

Baumi: Any patient who has recurrent or metastatic head and neck cancer is going to go through these agents if they survive long enough to get them. Basically, we know that these are the limited tools in our toolbox. We have platinum, we have cetuximab, and then we are really out of options. Many patients have received cetuximab in the locally advanced setting and so we have already lost one of our active treatments. This affects a lot of people.

TARGETED ONCOLOGY: What is next for pembrolizumab in head and neck cancer?

Baumi: There are currently phase III studies evaluating pembrolizumab in head and neck cancer both in combination with and versus traditional cytotoxic chemotherapy to see if we can move up the treatment earlier for patients. The key difference between pembrolizumab and cytotoxics is beyond the improved safety profile. However, we have durable responses; 75% of those patients who responded are still responding to this day. That is really not something that we see.

TARGETED ONCOLOGY: What are the biggest questions that remain regarding the treatment of patients with metastatic head and neck cancer?

Baumi: One of the key questions that relates to immunotherapy—and this covers all tumors—is trying to identify who the 20% of patients are that will respond. Eighty percent of our patients are not responding to our therapies.

Identifying a biomarker to enrich this patient population is very critical. Right now, I would not select patients for pembrolizumab by virtue of PD-L1 status because there were responses in the PD-L1–negative cohorts.

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

September, 2016|Oral Cancer News|

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 were the updated findings from CheckMate-141 presented at ASCO?

Ferris: The data that were presented at the 2016 ASCO Annual Meeting were further evaluations and follow-up on some preliminary data—originally presented at the 2016 AACR Annual Meeting—that listed the OS results.

At ASCO, we recapped the primary endpoint of OS as an important endpoint for immunotherapies because response rate and progression-free survival may not be as accurate. Ultimately, the FDA and people at large want OS. In this study, OS was 36% at 1 year in the nivolumab-treated arm and 16.6% in the comparator arm, which was investigator’s choice of single-agent chemotherapy, consisting of methotrexate, docetaxel, or cetuximab. In this phase III randomized trial, nivolumab was given in a 2:1 randomization: 240 patients received nivolumab and 120 received investigator’s choice.

Also at ASCO, we presented further evaluations consisting of what the regimens are in the comparator arm. There was about 20% each of docetaxel and methotrexate and 12% of cetuximab. Approximately 60% of the patients had prior cetuximab exposure and we stratified by cetuximab as a prior therapy. We also demonstrated the ORR, which was 13.3% in the nivolumab-treated arm versus 5.8% in the investigator’s choice arm.

Therefore, there was an improvement in overall response, but the difference seemed more modest than the OS benefit—which was a doubling—with 20% more patients alive at 1 year. This reinforces the concept that perhaps response rate may not be the best endpoint. Progression-free survival (PFS) was double at 6 months, with about 20% in the nivolumab arm versus about 9.9% in the investigator’s choice arm. The median PFS was not different, but the 6-month PFS was twice as high. The time to response was about 2 months in each arm at the first assessment.

Your analysis also looked at biomarkers. Can you discuss these findings and their significance?

The p16 or HPV-positive group had a better hazard ratio for OS than the overall study population. The hazard ratio was .73 for the overall population, using a preplanned interim analysis. With the HPV-positive group, we had a hazard ratio of .55 and the HPV-negative group had a hazard ratio of .99. It is still favoring the nivolumab-treated patients but, with the curves separated earlier in the HPV-positive group, one could see the improvement with nivolumab at about 1 to 2 months. It took 7 or 8 months with the HPV-negative group to show a separation of the curves in favor of nivolumab.

We looked at PD-L1 levels, and PD-L1—using a 1% or above level—had an improvement in the PD-L1–positive patients in favor of nivolumab in terms of OS and ORR. When we looked at 5% and 10% thresholds of PD-L1, the OS did not seem to improve. Therefore, in all levels above 1%, the OS was similarly beneficial over the PD-L1 less-than-1% group. However, essentially all levels of PD-L1–positivity and PD-L1–negativity still favored nivolumab, but the benefit was more when its levels were greater than 1%.

We could combine HPV status with PD-L1 status and look at subsets; however, essentially every subset benefited, whether it was PD-L1–negative or positive. This indicates that, in this group of patients, who progress within 6 months of platinum-based therapy, that no current systemic therapeutic options benefit patients as well as nivolumab.

With regard to these findings, what are you most excited about?

Head and neck cancer is a difficult disease. Until recently, we didn’t know the impact of this enrichment for HPV-positive virus-induced subsets and we didn’t know if this was an immune responsive cancer. Clearly, it is. We have all of the hallmarks that we have seen for a bright future—based on the melanoma data—and a series of other cancers indicating response rates in the 15% to 20% range, suggesting that we now have a platform of the PD-1 pathway to combine with other checkpoints and to integrate earlier in disease with radiation and chemotherapy.

We have a demonstration of head and neck cancer as an immune-responsive cancer. We are beginning to get an idea of the biomarkers and starting to be able to segment patients who will benefit. Now, we have a large comparative trial with an OS endpoint and tissue to look at biomarkers to try and understand what the best future combinations will be.

What are some questions that you still hope to answer regarding nivolumab in head and neck cancer?

We have to get down deeper into the nonresponders. We should acknowledge that the majority of patients neither had a response nor benefited. Understanding who is more likely to benefit is useful, but we also need to understand the levels of alternative checkpoint receptors or other biomarkers of resistance.

We have sequential lymphocyte specimens from the peripheral blood, tissues, and serum so those are intensively under evaluation. There are interferon gamma signatures that have risen from the melanoma checkpoint field that will certainty be applied, as well.

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

August, 2016|Oral Cancer News|

Henry Schein Donates Medical Supplies In Support of Free Oral Cancer Screening Events throughout the United States

Source: www.mysocialgoodnews.com
Author: Api Potter

Company’s Donation to Support 77 Screening Events in 2016 and 2017 by the Oral Cancer Foundation

Press Release – MELVILLE, N.Y., July 25, 2016 – Henry Schein, Inc. (Nasdaq: HSIC) announced today that it is donating more than $10,000 in medical supplies to the Oral Cancer Foundation (OCF) in support of 77 free oral cancer screening events being held throughout the United States in 2016 and 2017. Each OCF-hosted event aims to boost awareness of the disease and increase early detection.

The Company’s donation of gauze, tongue depressors, and disposable dental mirrors, facemasks, and gloves is an initiative of Henry Schein Cares, the Company’s global corporate social responsibility program, and continues the Company’s support of OCF’s screening events. OCF hosts the events in a range of locations, including pharmacy parking lots, health fairs, farmer’s markets, colleges, and OCF Walk/Run for Awareness events.

“The health of our mouths greatly impacts our ability to eat and drink, communicate thoughts and ideas, and express feelings for loved ones,” said Brian Hill, Founder of the Oral Cancer Foundation. “When cancer affects our mouths, it does more than take away these everyday functions, it too often takes our lives. Our screening events are designed to identify signs of oral cancer before it ever gets that far, and we thank Henry Schein for this generous donation and its continued support of oral cancer awareness and early detection efforts.”

The donation comes at a time when nearly 500,000 people worldwide are diagnosed annually with oral and oropharyngeal cancer, according to data from the International Agency for Research on Cancer’s Globocan 2000 database and the World Health Organization’s Mortality Database. Of that number, between one-third and one-half lose their lives annually while many more suffer from the complications of treatment. Despite the easy accessibility to these body sites by health care providers and the overall impact early detection can have on a person’s overall health, more than two-thirds of these patients are diagnosed in advanced stages where the cancer has already spread to regional lymph nodes or beyond.

“Regular oral cancer screening events raise awareness and enhance early detection and prevention efforts, which are critical to reducing the disease’s incidence and impact,” said Steven W. Kess, Vice President of Global Professional Relations at Henry Schein. “Oral cancer is a stark reminder of the vital importance of good oral health in relation to a person’s overall health, and that’s why Henry Schein is pleased to support the Oral Cancer Foundation.”

Henry Schein’s donation continues the Company’s long-standing commitment to exploring ways of reducing the disease’s global impact. Earlier this year, the Henry Schein Cares Foundation, Inc.—an independent 501(c)(3) organization founded by the Company to foster, support, and promote dental, medical, and animal health by helping to increase access to care in communities around the world—funded the Global Oral Cancer Forum. The Forum gathered many of the world’s foremost experts on oral cancer, as well as clinicians, scientists, epidemiologists, activists, public health experts, nonprofit organizations, government agencies, and other stakeholders who are working to understand how to reduce the global oral cancer burden.

About Henry Schein Cares

Henry Schein Cares stands on four pillars: engaging Team Schein Members to reach their potential, ensuring accountability by extending ethical business practices to all levels within Henry Schein, promoting environmental sustainability, and expanding access to health care for underserved and at-risk communities around the world. Health care activities supported by Henry Schein Cares focus on three main areas: advancing wellness, building capacity in the delivery of health care services, and assisting in emergency preparedness and relief.

Firmly rooted in a deep commitment to social responsibility and the concept of enlightened self-interest championed by Benjamin Franklin, the philosophy behind Henry Schein Cares is a vision of “doing well by doing good.” Through the work of Henry Schein Cares to enhance access to care for those in need, the Company believes that it is furthering its long-term success. “Helping Health Happen Blog” is a platform for health care professionals to share their volunteer experiences delivering assistance to those in need globally. To read more about how Henry Schein Cares is making a difference, please visit our blog: www.helpinghealthhappen.org.

About Henry Schein, Inc.

Henry Schein, Inc. (Nasdaq: HSIC) is the world’s largest provider of health care products and services to office-based dental, animal health and medical practitioners. The Company also serves dental laboratories, government and institutional health care clinics, and other alternate care sites. A Fortune 500® Company and a member of the S&P 500® and the Nasdaq 100® indexes, Henry Schein employs nearly 19,000 Team Schein Members and serves more than one million customers.

The Company offers a comprehensive selection of products and services, including value-added solutions for operating efficient practices and delivering high-quality care. Henry Schein operates through a centralized and automated distribution network, with a selection of more than 110,000 branded products and Henry Schein private-brand products in stock, as well as more than 150,000 additional products available as special-order items. The Company also offers its customers exclusive, innovative technology solutions, including practice management software and e-commerce solutions, as well as a broad range of financial services.

Headquartered in Melville, N.Y., Henry Schein has operations or affiliates in 33 countries. The Company’s sales reached a record $10.6 billion in 2015, and have grown at a compound annual rate of approximately 15 percent since Henry Schein became a public company in 1995. For more information, visit Henry Schein at www.henryschein.com, Facebook.com/HenrySchein and @HenrySchein on Twitter.

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

Knowledgeability, Attitude and Behavior of Primary Care Providers Towards Oral Cancer: a Pilot Study

Source: www.link.springer.com
Authors: Neel Shimpi, Aditi Bharatkumar, Monica Jethwani, Po-Huang Cyou, Ingrid Glurich, Jake Blamer, Amit Acharya


The objective of this study was to assess current knowledgeability, attitudes, and practice behaviors of primary care providers (PCPs) towards oral cancer screening. Applying a cross-sectional design, a 14-question survey was emailed to 307 PCPs practicing at a large, multi-specialty, rurally based healthcare system. Survey data were collected and managed using REDCap and analyzed applying descriptive statistics. A 20 % response rate (n = 61/307) was achieved for survey completion. Approximately 70 % of respondents were physicians, 16 % were nurse practitioners, and 13 % were physician assistants. Nearly 60 % of respondents were family medicine practitioners. Limited training surrounding oral cancer screening during medical training was reported by 64 %. Although 78 % of respondents reported never performing oral cancer screening on patients in their practice, >90 % answered knowledge-based questions correctly. Frequency rate for specialist referral for suspicious lesions by PCPs was 56 % “frequently”. Optimal periodicity for oral cancer screening on all patients selected by respondents was 61 % “annually”, 3 % “every 6 months”, 3 % “every visit”, 2 % “not at all”, and 31 % “unsure”. This study established a baseline surrounding current knowledgeability, practice patterns, and opinions of PCPs towards oral cancer screening at a single, large, regional healthcare system. In the absence of evidence-based support for population-based cancer screening, this study result suggests a need for better integration of oral cancer surveillance into the medical setting, supplemented by education and training with emphasis on assessment of high-risk patients to achieve early detection. Prospectively, larger studies are needed to validate these findings.

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

July, 2016|Oral Cancer News|

Aspen Dental Practices Donate More Than $20,000 To The Oral Cancer Foundation For Oral Cancer Awareness Month

Source: www.pharmiweb.com.org
Author: Aspen Dental

SYRACUSE, N.Y., May 31, 2016 /PRNewswire/ — Aspen Dental–branded practices will donate $22,375 to The Oral Cancer Foundation (OCF) as part of a program that contributed $5 for each ViziLite® oral cancer screening conducted during April for Oral Cancer Awareness Month. In total, more than 4,000 patients were screened across more than 550 practices in 33 states.

Since 2010, Aspen Dental-branded practices have donated more than $105,000 to OCF.

“Approximately 48,250 people in the U.S. will be diagnosed with an oral or oropharyngeal cancer this year; and of those only about 57% will be alive in five years,” said Natalie Riggs, Director of Special Projects for The Oral Cancer Foundation. In 2016 we estimate that 9500 individuals will lose their lives to oral cancers and we are grateful for the support from Aspen Dental practices in helping us raise awareness and aiding in our efforts to fight this disease.”

Oral cancer is frequently preceded by visible pre-malignant lesions and can be diagnosed at a much earlier stage (I or II) with ViziLite® Plus, a specially designed light technology.  When caught early and treated, the survival rate is 80 to 90 percent.

“We’re working to educate our patients about the risk factors, warning signs and symptoms associated with oral cancer so that we can help them catch the disease before it progresses,” said Dr. Murali Lakireddy, a general dentist who owns Aspen Dental offices in Ohio. “Many of our patients do not think about oral cancer when they go to the dentist, but in fact, oral cancer screenings are just as much a part of your routine dental visit as a deep clean from the hygienist.”

To learn more about oral cancer screenings, visit the OFC website at http://www.oralcancerfoundation.org/dental/how_do_you_know.html.

About Aspen Dental Practices
Dentists and staff at Aspen Dental practices believe everyone has the right to quality, affordable oral health care. As one of the largest and fastest-growing networks of independent dental care providers in the U.S., local Aspen Dental practices – more than 550 of them across 33 states – offer patients a safe, welcoming and judgment-free environment to address their dental challenges. Every Aspen Dental-branded practice offers a full range of dental and denture services – including comprehensive exams, cleanings, extractions, fillings, periodontal treatment, whitening, oral surgery, crown and bridge work – allowing patients to have the peace of mind that they are taken care of and protected, so they can focus on getting the healthy mouth they deserve. In 2015, Aspen Dental-branded practices recorded more than 3.7 million patient visits and welcomed nearly 785,000 new patients.

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.


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.com
Author: The Oral Cancer Foundation

Bryan R. Hill receiving the award at the Global Oral Cancer Forum. (PRNewsFoto/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 of the non-profit world to build his understanding of appropriate governorship of an entity such as OCF, as well as support from core researchers and treatment professionals in the oral cancer arena. “To paraphrase someone far more famous, if I was able to see farther than others had going before me, it was because I stood on the shoulders of many highly accomplished others who helped me achieve my goals,” says Hill.

Hill, a stage four oral cancer survivor, became a student of the disease after his own diagnosis left him looking for answers. Since founding OCF and overseeing the path and initiatives of the foundation for more than a decade and a half, Hill often finds the advocacy role suits him well. He has championed anti-tobacco legislation within the political system, and is an advocate at various government entities such as the CDC regarding vaccination of boys against the virus known to be the primary cause of most oropharyngeal cancers.  He also sits on two National Institutes of Health (NIH) oversight committees—one at the National Cancer Institute (NCI), which oversees clinical trials in immunotherapies in head and neck cancers, the other at the National Institute of Dental and Craniofacial Research (NIDCR) reviewing trials looking at long-term outcomes and complications of treatment in head and neck cancers. In addition, Hill still one-on-one counsels patients, participates in OCF’s online Patient Support Forum, and is often the voice for a community that has lost its own, through many diverse media interviews and lectures.

While OCF has received many awards for its advocacy work and contributions to the battle against oral cancer, including recognition from the NIH/NIDCR, WHO, Great Non-Profits, various universities and professional medical and dental societies, and even Internet guru Mashable.com for innovations in applying technology to serve its health oriented goals, receiving recognition from this forums organizers and some of the  leading authorities on oral cancer in the international community is particularly meaningful. Those in attendance are recognized as experts in the field and understand the challenges and importance of the work OCF has undertaken. Sponsored by the Henry Schein Cares Foundation, the benevolent arm of the powerful Henry Schein Inc., known for its long-term commitment to improve issues related to oral care, The Global Oral Cancer Forum’s vision is to build partnerships that will promote the changes required for a substantial impact on the incidence, morbidity, and mortality of oral cancer worldwide. The importance of the Schein organization’s leadership in creating this venue cannot be overstated.

Top oral cancer experts and advocates from around the world, representing countries as far away as Japan, China, and India as well as from the Americas, convened over the weekend to attend the inaugural forum. Attendees included clinicians, scientists, epidemiologists, activists, public health experts, as well as OCF Directors and other NPO organization heads who are working hard to find impactful avenues to reduce the global oral cancer burden. Attendees met to exchange ideas and learn from one another about what is and isn’t working in the global realm of this disease. Delegates from thirty-three countries presented new research findings and discussed their unique challenges and approaches to understanding and addressing one of the leading burdens of the cancer world.

Globally, the incidence rate for oral cancer is growing and has reached what many experts are calling epidemic proportions. This year approximately half a million patients will be newly diagnosed with an oral or oropharyngeal cancer. Among the topics discussed by GOCF panelists were the rise in disease incidence and the regional disparities and factors affecting global populations. Communities throughout much of South East Asia report a high percentage of the population chewing betel and areca nut, a significant risk factor for the development of oral cancer. Meanwhile in the U.S. and other developed countries the prevalence of the HPV virus is the leading contributor to the rising rates of oropharyngeal cancers. Identifying these differences is vital to the development of effective prevention, public policy, and treatment strategies. Advancement of a universal understanding of what the problems are and what initiatives are working around the globe, reveals commonalities, and within them the group will find its beginning joint efforts to effect change.

Looking forward there is clearly much work to be done. The good news is that there are significant strides being made in research and treatment; but balancing those positives, there are also significant shortcomings in current governmental policies, prevention, and public awareness and understanding. Hill said, “While I and OCF are very proud to have been chosen by the organizers, and the global oral cancer community to receive this award, it only serves to motivate us to strive to accomplish more. We have built relationships here that will translate into new avenues of endeavor for OCF in the future.” Jamie O’Day, OCF’s Director of Operations, also attended the conference and spent her time networking with her counterparts from around the world. Many new ideas were garnered from these discussions that will be applied in future OCF initiatives and support OCF’s mission to reduce the suffering caused by this disease both nationally and globally.

About the Oral Cancer Foundation:
The Oral Cancer Foundation, founded by oral cancer survivor Brian R. Hill, is an IRS registered non-profit 501(c)(3) public service charity that provides vetted information, patient support, sponsorship of research, as well as disease and risk factor reduction advocacy related to oral cancer. Oral cancer is the largest group of those cancers that fall into the head and neck cancer category. Common names for it include such things as mouth cancer, tongue cancer, tonsil cancer, head and neck cancer, and throat cancer. The Oral Cancer Foundation maintains the websites: www.oralcancer.org , www.oralcancernews.org , www.oralcancersupport.org , which receive millions of hits per month. Supporting the foundation’s goals is a scientific advisory board composed of leading cancer authorities from varied medical and dental specialties, and from prominent educational, treatment, and research institutions in the United States. The foundation also manages the Bruce Paltrow Oral Cancer Fund, a collaboration between the Paltrow family represented by Ms. Blythe Danner (Paltrow), Gwyneth Paltrow, Jake Paltrow and the Oral Cancer Foundation.

Media Contact: Jamie O’Day / The Oral Cancer Foundation (949) 723-4400 jamie@oralcancerfoundation.org

Immunotherapy Continues to Advance in Head and Neck Cancer

Source: www.onclive.com
Author: 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.

Robert-FerrisDr. 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, oral cavity, hypopharynx, or larynx. These patients were biopsied, treated with cetuximab and motolimod for 4 weeks, and then underwent surgery. The endpoints of the trial were the modulation of immune biomarkers.

Interferon-inducible cytokine IP-10 increased after the patients were administered neoadjuvant cetuximab and motolimod (P = .0001). After the neoadjuvant treatment, the peripheral blood lymphocytes had an increased frequency of EGFR-specific CD8 T cells. After the neoadjuvant treatment, regulatory T cells had decreased suppressive receptors and transforming growth factor-β, which induces Foxp3. Also, after the neoadjuvant treatment, circulating MDSCs had decreased PD-L1 (P <.07) and macrophages had increased CD16 expression (P <.07).

After the neoadjuvant treatment with cetuximab and motolimod, genotyping of T-cell receptors showed increased clonality in peripheral blood lymphocytes (P = .003 by Wilcox signed rank test) and tumor-infiltrating lymphocytes (P = .081 by Wilcox signed rank test). Most patients are more oligoclonal than healthy individuals, and some are very clonal with highly prominent expanded clones. Genotyping of T-cell receptors found that clonality was increased by the combination of cetuximab and motolimod compared with treatment with cetuximab alone.

Recent studies have indicated that the PD-1/PD-L1 pathway is upregulated in the HNSCC microenvironment, and that EGFR blockade prevents interferon-γ-mediated upregulation of PD-L1. Thus, this study has been amended to add nivolumab to the adjuvant treatment with cetuximab and motolimod. The endpoints are still the modulation of immune biomarkers.

The aim is to target the tumor microenvironment, such that tumor immune escape is reversed and T cells eliminate HNSCC. Antitumor T cells are reprogrammed to reverse inhibitory signals. Combining the toll-like receptor agonist, motolimod, with cetuximab and with PD-1 pathway inhibitors, such as nivolumab, may enhance the priming and activity of T cells.

“Targeting the tumor microenvironment requires understanding as well as reversal of immune escape mechanisms in the cellular compartment. Reprogramming antitumor T cells to reverse inhibitory signals can be done by directly disrupting those inhibitory signals, the so-called checkpoint receptor field, and can be done potentially by combining proinflammatory signals, such as toll-like receptor agonists, to chemo-attract cells into the microenvironment and to create good inflammation to overcome suppressive factors,” said Ferris.

Recent findings have shown tremendous promise for nivolumab in head and neck cancer. Bristol-Myers Squibb (BMS) announced in January 2016 that nivolumab improved overall survival versus investigator’s choice of therapy for patients with platinum-refractory squamous cell carcinoma of the head and neck in the phase III CheckMate-141 trial. Findings from the study are being discussed with the FDA and other health authorities, according to BMS.

*This news story was resourced by the Oral Cancer Foundation, and vetted for appropriateness and accuracy.
February, 2016|Oral Cancer News|

NCCN Is ‘Vague,’ So Study Clarifies H&N Cancer Follow-up

Source: www.medscape.com
Author: Nick Mulcahy

Clinical guidelines can sometimes be slow to respond to epidemiology.

Take the case of oropharyngeal cancers that are associated with human papillomavirus (HPV) infection. They are increasingly common in the United States and, as several studies have demonstrated, have better survival than cancers of this type that are not HPV-positive.

Nonetheless, one of the beacons in oncology care, the National Comprehensive Cancer Network (NCCN), recommends the same follow-up care guidance for oropharynx squamous cell carcinoma whether it is associated with HPV or not, according to two experts.

For post-treatment follow-up, including recurrence detection, “the NCCN guidelines are one-size-fits-all,” said Jessica Frakes, MD, a radiation oncologist at the Moffitt Cancer Center and Research Institute in Tampa, Florida.

She spoke during a press briefing at the Multidisciplinary Head and Neck Cancer Symposium 2016 in Scottsdale, Arizona.

“You are exactly right: the NCCN is fairly vague about when to perform imaging,” said Christine Gourin, MD, an otolaryngologist at Johns Hopkins University in Baltimore, who moderated the press briefing.

Dr Frakes and her colleagues have stepped into this informational breach with a new study that might help clinicians gain clarity on the use of surveillance imaging in HPV-positive oropharyngeal cancer and reduce its frequency.

“The purpose of our study is to determine when these patients fail and when they have side effects so we know how to guide optimal follow-up,” Dr Frakes explained.

The study authors examined 246 cases of nonmetastatic HPV-positive oropharynx squamous cell carcinoma treated with radiation therapy at Moffitt from 2006 to 2014. Most patients (84.6%) received radiation therapy and a concurrent systemic therapy; a minority (15.4%) received radiation alone. Most patients had locally advanced disease.

The team’s major finding was that the great majority of recurrences and toxicities can be detected with imaging 3 months after treatment with definitive radiation therapy and physical exams during the 6 months after treatment.

Specifically, all six local failures were detected by sight or with flexible laryngoscopy conducted during physical exams in that 6-month period.

Eight of the nine regional recurrences (89%), 12 of the 13 locoregional failures (92%), and 15 of the 21 distant recurrences (71%) were detected from symptoms or with a PET/CT scan 3 months after treatment

“For most patients with HPV-associated oropharynx cancer, after a negative 3-month PET scan, physical exams with history and direct visualization are sufficient to find recurrences,” said Dr Frakes in a press statement.

The findings — and the suggestion that PET scans can be suspended after 3 months — are akin to what happens in clinical practice at Johns Hopkins, Dr Gourin reported.

“We have stopped routinely imaging patients after 3 months if a PET is negative, and it’s true that we do pick up more recurrences clinically than radiologically,” she said.

Cutting down on PET scans in this patient population is a good thing, suggested Dr Gourin. “I think we probably do too much post-treatment surveillance imaging,” she said.

There are multiple benefits to suspending imaging, including potentially lowering patient stress because they know their recurrence risk is low and don’t have anxiety related to test results.

Plus, there is a cost reduction.

“A PET scan costs $1500 [for the patient],” said Dr Frakes. Dr Gourin noted that the test is even more expensive in her geographic region.

Factors That Increase Recurrence Risk

The study authors also identified disease characteristics that increase the likelihood of recurrence.

Both regional and distant failures were more common in patients who presented with five or more positive lymph nodes or who had level IV lymph nodes (P < .05).

And the risk of developing distant metastases was greater in patients with a lymph node larger than 6 cm or with bilateral lymphadenopathy (P < .05).

But overall, the results are “excellent,” said Dr Frakes. Within 3 years, the rate of local control was 97.8%, of regional control was 95.3%, of locoregional control was 94.0%, and of freedom from distant metastases was 91.4%. The rate of 3-year overall survival was 91.0%.

Toxicities were also low, which is an endorsement of the multidisciplinary care, said Dr Frakes.

Only 9% of patients experienced severe late toxicities, including 19 grade 3 toxicities and two grade 4 toxicities. These were resolved in 16 of 21 toxicities (76%) at the time of last follow-up.

Most of the toxicities and/or recurrences (64%) occurred in the first 6 months after treatment; only four events occurred more than 2 years after treatment.

Dr Gourin questioned the low rate of serious late toxicities seen with this nonsurgical management of patients. Such a low rate “has not been our experience” at Johns Hopkins, she said.

Dr Frakes and Dr Gourin have disclosed no relevant financial relationships.

Multidisciplinary Head and Neck Cancer Symposium (MHNCS) 2016: Abstract 6. Presented February 19, 2016.

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

February, 2016|Oral Cancer News|