Category Archives: Oncology

Cancer Research and Care Embrace Technology

Oncology is about to take a huge step toward changing the way that cancer is understood and treated with the development of a breast cancer-specific prototype for a rapid learning system in cancer care. This system takes advantage of health IT advances (such as EHRs) in order to connect oncology practices, measure quality and performance, and provide physicians with decision support in real time.

The prototype is part of the American Society of Clinical Oncology’s (ASCO’s) vision for CancerLinQ  a “system that assembles and analyzes millions of unconnected medical records in a central knowledge base, which will grow ‘smarter’ over time,” according to the organization.

Illustration courtesy of the American Society of Clinical Oncology

As part of ASCO’s focus on quality improvement, the protoype will use clinical practice guidelines and measures of the Quality Oncology Practice Initiative to build quality measurement and clinical decision tools. Next, breast cancer patient records and data (stripped of identifying information) imported from the electronic health records (EHRs) of academic centers and oncology practices will be added.

As a proof of concept, ASCO says that the prototype will:

  • provide the foundational information and lessons learned to allow ASCO to move into a full-scale implementation;
  • provide real-time, standardized, clinical decision support integration within a demonstration EHR;
  • demonstrate a set of value-added tools; including a physician’s ability to measure their performance against a sub-set of QOPI measures in real-time;
  • demonstrate the ability to capture data from a variety of sources and aggregate the data using novel methodologies;
  • and create a demonstration which will allow exploration of data in unprecedented ways and generate hypotheses related to breast cancer.

Once the full technology platform is completed, CancerLinQ ultimately is expected to improve personalized treatment decisions by capturing patient information in real time at the point of care; provide decision support to cancer teams to adapt treatment plans to each patient and his or her cancer; and report on quality of care, compared with clinical guidelines and the outcomes of other patients. It’s also hoped that the system will help to “educate and empower patients by linking them to their cancer care teams and providing personalized treatment information at their fingertips.” Lastly, the system stands to be a powerful new data source for analysis of real-world quality and comparative effectiveness, as well as to generate new ideas for clinical research. It’s hoped that in time, this approach can be adapted to all types of cancer.

Kerri Wachter

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Counties Pursue Safer Drug Disposal

New programs to make it easier and safer for San Francisco Bay Area residents to get rid of unused medications are some of the first to try this on a large scale, and may serve as models for other cities and counties.

Since May 2012, a pilot program in San Francisco has allowed residents to drop off old medications at 13 pharmacies and 10 police stations (where controlled substances must be brought). San Francisco supervisors initially considered forcing drug companies to fund the program, and instead agreed to accept $110,000 from Genentech and the Pharmaceutical Research and Manufacturers of America to fund the program.

(Photo by J. Troha, courtesy of National Cancer Institute)

On July 24, supervisors in Alameda County (which includes East Bay cities such as Oakland and Berkeley) are likely to approve a Safe Drug Disposal Ordinance that would require drug companies to pay for disposal of their products or face fines of up to $1,000 per day, The Bay Citizen reports. Public agencies currently fund 25 drug disposal sites there, and the cash-strapped county wants the comparatively wealthy pharmaceutical industry to take more financial responsibility for the lifecycle of its products in order to reduce overdoses, accidental poisonings, and water pollution.

As we reported earlier this year, making prescription-drug “recycling” a cultural norm is one of five emerging public policies that could help the medical system keep opioids available while reducing the risk of addiction, abuse and accidental overdose, according to Keith N. Humphreys, Ph.D. Smaller versions have met with success, such as a drug take-back day organized by sheriffs in a small town in Arkansas (population 20,000) that brought in 25,000 pills, said Dr. Humphreys, acting director of the Center for Health Care Evaluation, Veterans Health Administration, Menlo Park, Calif., and a professor of psychiatry at Stanford University. He reports having no financial conflicts of interest on this issue.

Not everyone is happy with the idea. Trade associations for the pharmaceutical industry and biomedical companies argue that there’s no evidence that these programs will reduce poisonings, and they haven’t ruled out the possibility of suing to block the Alameda County ordinance, The Bay Citizen reports. The compromise that San Francisco reached for voluntary instead of mandatory funding from the pharmaceutical industry may be a middle ground.

In an era when government agencies have less and less money for public programs, it’s probably inevitable that they’ll pursue alternative financing for programs like this.

If your community has a drug disposal program, let us know how it’s working. Will these programs succeed, and will they reduce abuse, addiction, and accidental overdoses? We’ll keep an eye on this topic, and keep you posted.

–Sherry Boschert (@sherryboschert on Twitter)

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Can HPV Vaccination Be Simplified?

The human papillomavirus vaccine was recommended for routine use in 11-12 year old girls in 2007. But by 2010, the most recent year for which data are available, less than half had received one dose of the three-dose series and fewer than a third had received all three. The inconvenience of the need for three separate office visits along with the vaccine’s price – about $130 per Gardasil dose, as of July 2011 – have certainly contributed to the low uptake.

©BVDC/Fotolia.com

Now, some parts of the world – including Mexico, Switzerland, and parts of Canada have moved to either a two-dose schedule, or a so-called “extended dose” schedule, in which the third dose is delayed until 5 years after the second one. (In the current U.S. three-dose schedule, doses two and three are given at 2 and 6 months, respectively, after dose one.)

“There has been emerging interest in HPV vaccine schedules with fewer than three doses, for a variety of reasons. These schedules could facilitate implementation, they may be more convenient for providers, parents, and vaccinees, and of course they would be cost-saving,” said Dr. Lauri Markowitz, of the Centers for Disease Control and Prevention, at a recent meeting of the CDC’s Advisory Committee on Immunization Practices.

No data on the efficacy of fewer than three doses have been published by either Merck or GlaxoSmithKline from their pivotal trials of Gardasil and Cervarix, respectively. But some other data are available for both vaccines. A nonrandomized study in Costa Rica that included more than 1,100 women who had received just one or two doses of Cervarix suggested that two doses or maybe even just one – could be as protective as three doses against infection at 4 years.

And in an as-yet unpublished study done in Canada, immune responses against both HPV 16 and 18 at 3 years were similar between two doses of Gardasil given at age 9-13 years and three doses given at age 16-26 years. But, there are limited efficacy data and no long-term data, Dr. Markowitz said.

Electron micrograph of human papillomavirus (HPV) / Courtesy of the National Cancer Institute

In an e-mail, Deb Wambold of Merck Vaccines said that, while the company does support studies of alternative dosing schedules for HPV vaccination including two-dose regimens, so far those studies are “interesting preliminary explorations in select subpopulations of vaccinees,” and “It is important to note that there are no data on the clinical efficacy or durability of effectiveness with two doses of either of the HPV vaccines, as we have for the recommended three-dose vaccination regimen.”

Dr. Joseph A. Bocchini Jr., who chairs the ACIP HPV vaccine working group, concurred. In an interview at the ACIP meeting, he noted that the long-term efficacy of two doses is “worth looking at,” as is the varying of three-dose schedules. “But, at this point, there are too few data to apply this to recommendations in the United States.”

More data from ongoing trials will be available in the next few years, Dr. Markowitz said.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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“Turning the Tide” on HIV/AIDS

In advance of the upcoming XIX International AIDS Conference, the International AIDS Society and the University of California, San Francisco, have issued the “Washington D.C. Declaration,” a nine-point action plan aimed at broadening global support for “Turning the Tide” of the AIDS epidemic.

Everyone is urged to sign the Declaration.

It calls for:

1) An increase in targeted new investments;
2) Evidence-based HIV prevention, treatment, and care in accord with the human rights of those at greatest risk and in greatest need;
3) An end to stigma, discrimination, legal sanctions, and human rights abuses against those living with and at risk for HIV;
4) Marked increases in HIV testing, counseling, and linkages to services;
5) Treatment for all pregnant and nursing women living with HIV and an end to perinatal transmission;
6) Expanded access to antiretroviral treatment for all in need;
7) Identification, diagnosis, and treatment of tuberculosis;
8) Accelerated research on new tools for HIV prevention, treatment, vaccines, and a cure;
9) Mobilization and meaningful involvement of affected communities.

Turning the Tide is the theme of this year’s biennial conference, which will take place July 22-27 in Washington.  It is expected to draw 25,000 attendees, including HIV professionals, activists, politicians, and celebrities. Sir Elton John will open the conference and Bill Clinton will close it. A large delegation of U.S. members of Congress will participate, and Bill Gates will moderate a session. An enormous “Global Village” outside the D.C. Convention Center will be open to the public. “If you haven’t been, it’s a conference like no other,” conference cochair Dr. Diane V. Havlir said at a press briefing.

The recent optimism regarding HIV/AIDS stems from major advances in knowledge regarding prevention of partner transmission with early patient treatment, pre-exposure prophylaxis, and male circumcision as HIV infection prevention (new data will be released at the meeting), all of which are viewed as breakthroughs  in the fight against HIV/AIDS. “So we have now in our hands the tools. The question is how do we combine those tools together, and how do we roll them out,” said Dr. Havlir, professor of medicine at the University of California, San Francisco, and chief of the HIV/AIDS division at San Francisco General Hospital.

Dr. Diane V. Havlir / Photo by Miriam E. Tucker

Monday’s plenary session will include an address from Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, on “Ending the HIV Epidemic: From Scientific Advances to Public Health Implementation.” Other plenary topics during the week will include viral eradication, vaccines, TB and HIV, and HIV/AIDS in specific populations including minorities, women, youth, and men who have sex with men. On Friday, there will be a plenary talk that may be of particular interest to the primary care community, “The Intersection of Noncommunicable Diseases and Aging in HIV.”

Plenaries and other conference sessions will be webcast at http://globalhealth.kff.org/aids2012.

-Miriam E. Tucker (@MiriamETucker on Twitter)

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Can Cancer Trial Apps Boost Enrollment?

Participation in clinical trials — and cancer trials in particular — is agonizingly low. The National Cancer Institute has estimated that less than 5% of patients participate in cancer trials.  But that could possibly change with the growing availability of applications for smart phones and tablets that instantly link clinicians and patients with ongoing trials.

Screenshot of Lilly Oncology Clinical Trials Resource

Just as the American Society for Clinical Oncology was starting off its annual meeting, Eli Lilly announced that it was launching a clinical trials app.  According to Lilly, the free app is available for the Apple iPad and iPhone, the RIM BlackBerry, and the Google Android. Physicians — or patients — can use the app to search oncology trials that are enrolling new patients by disease state, molecule being studied, study phase, country, state, and keyword.

The Lilly app also links patients and clinicians to resources such as support groups, financial help, and nutritional counseling, for instance.  Because it was developed by a drug maker, it also prominently features a search tool for Lilly-sponsored trials. Other than that, it appears to be very comprehensive and easy to use.

Lilly is not the first manufacturer to venture into a trials app. Last June, GlaxoSmithKline, in partnership with MedTrust Online LLC, launched a similar app that lets users search for trials for all cancer types. Unlike the Lilly app, it does not try to push users towards GSK-sponsored trials. It, too, appears to be very comprehensive and easy to use.

Screenshot of MedTrust search

The National Cancer Institute also has a free app, but only lets patients search for trials at the National Institutes of Health campus in Bethesda, Md.  As I attempted to explore the app, however, it crashed multiple times. Not a good omen.

Similarly, the Seattle Cancer Care Alliance has created an app – but it is narrowly focused only on trials for  acute myeloid leukemia at its member facilities.

iHealthVentures LLC has created an app with the snappy name of “Clinical Research Trials” that allows users to search all of clinicaltrials.gov database. It costs $1.99.

As more Americans turn to smartphones and tablets to manage their lives and health, these trial apps could come in handy. And maybe even save or extend lives by getting people enrolled earlier in protocols that could help them.

Just an aside — OncologyPractice.com has a link to ongoing trials on its website here.  And it has just launched a free app that features the latest news and views in the field.

–Alicia Ault (@aliciaault on Twitter)

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The U.S. Obesity Epidemic and Surging Liver Cancer

If there is one truism that trumps everything else these days about U.S. health, it’s that America is a chubby country that keeps getting fatter.

The consequences seep into every corner of the nation’s medical state, including the surprising fact that obesity and the type 2 diabetes it causes are likely pushing up the incidence of liver cancer—hepatocellular carcinoma—to unprecedented heights.

courtesy Wikimedia Commons

When I covered Digestive Disease Week in San Diego recently, one of the biggest stories I heard was that U.S. liver-cancer rates tripled from 1975-2007, and that the numbers continued to rise from the mid to the late 2000s. (My full report on this is here).

Granted, factors other than just obesity play into the liver cancer surge, notably the sizable number of Americans infected with either hepatitis B or C virus, and the fact that as they age their risk for developing hepatocellular carcinoma rises.

But new U.S. infections by hepatitis B and C are largely under control these days (although people infected elsewhere continue to emigrate to the United States). The part of the booming liver-cancer story that is by no means under control is the obesity part.

Every time I see a new CDC map for U.S. obesity prevalence, the colors on it keep getting redder and darker (the CDC’s code for higher prevalence rates).

courtesy CDC

courtesy CDC

Earlier this year, the CDC reported a 36% obesity prevalence rate for the entire U.S. population–and still on the rise–and just a few weeks ago we heard that obesity among children and adolescents had hit a new high of 17%. With obesity seemingly on an unchanging upward trajectory, one can only wonder what rates of liver cancer it might produce in the future. Obesity carries a special relationship with the liver, and it’s not pretty. Just consider any goose headed to a foie-gras future.

Until now, the evidence linking obesity and liver cancer, and type 2 diabetes and liver cancer has been epidemiologic. Compelling, but just an association. At DDW, a new study provided more observational data on the diabetes-liver cancer link, and while still circumstantial it further supports the notion and also carries an intriguing punchline.

The study, done in Taiwan, examined 97,000 hepatocellular carcinoma patients and 195,000 matched controls. The analysis showed that people with diabetes had a two-fold increased risk for liver cancer compared with those without diabetes. Even more striking, the analysis also showed that people with diabetes treated with the oral hypoglycemic drug metformin had their risk for liver cancer cut in half compared with those not on metformin, and those with diabetes treated with a glitazone drug (such as pioglitazone–Actos) had their risk cut nearly in half.

The best solution would be if people avoided obesity and type 2 diabetes all together. Both conditions cause a lot of medical problems, and this new evidence indicates more strongly than ever before that liver cancer is one of them.

—Mitchel Zoler (on Twitter @mitchelzoler)

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HPV Changes the Face of Head/Neck Cancer

Just a few years ago, tobacco and alcohol use were presumed to be the main causes of head and neck cancers. Evidence of oropharyngeal cancer associated with human papillomavirus (HPV) first appeared about 10 years ago, but it wasn’t until 2010, with the publication of 2 papers showing far greater survival among HPV-positive patients with head and neck cancer, that oncologists suddenly realized that they were likely dealing with two distinct diseases.

“It’s become clear that the disease we thought was one disease related to tobacco and alcohol is now being parsed into two major categories,” Dr. Maura L. Gillison said last week in Phoenix at the 2012 Multidisciplinary Head and Neck Cancer Symposium. At the meeting, she presented her group’s data showing that the overall prevalence of oral HPV infection in people aged 14-69 years is 6.9%, and that the prevalence is much higher among men than women. The Merck-supported trial paper was published online in JAMA on January 26, coinciding with her presentation.

Tissue section from a head and neck cancer patient / Courtesy of Tom Carey, Ph.D.

In a separate talk, Dr. Gillison summarized previous work from her group showing that the incidence of HPV-related cancer is rising while HPV-negative cancer is declining, consistent with the decline in tobacco use and changes in sexual behavior that increase HPV transmission. Overall survival of head and neck cancer has improved over the last decade, a trend that is likely due both to the improved prognosis among HPV-positive patients and to the decline in tobacco use rather than to advances in treatment, she said.

This recently heightened role of HPV in head and neck cancer  – and the awareness of it – has impacted the field of oncology in several ways. For one, it has dramatically changed the way research is done, conference chair Dr. Ezra Cohen told me. “It has made a tremendous difference in the way clinical trials are conducted, because it makes absolutely no sense to lump these patients together. Now all clinical trials will either stratify for HPV status or design completely separate studies, because they truly are two biologically different diseases.”

Clinically, patients with head and neck cancers are now routinely tested for HPV. This wasn’t the case prior to 2010. And those who test positive are counseled differently, since their prognosis is better. Indeed, Dr. Cohen said, HPV-positive head/neck cancer patients appear to respond better to just about every type of treatment, including surgery.

What’s more, Dr. Gillison told me, HPV has essentially upended some of the tools oncologists use to predict outcomes in head and neck cancer patients. One example is the current tumor staging system, which doesn’t take into account HPV status. A Stage 3 or 4 cancer which carries a poor prognosis among HPV-negative patients might carry the prognosis now associated with Stage 1 cancer among those who are HPV-positive. And another factor that has been shown to predict poor outcome in HPV-negative patients, the presence of extracapsular extension, appears to have little impact in those who are HPV-positive.

“So all these things that we take as firmly established and drivers of treatment decisions in this new setting are all in question,” she said.

Tissue section from the same head/neck cancer, with brown stain of an HPV marker protein called p16 / Courtesy of Tom Carey, Ph.D.

Thus far there have been no major changes in treatment, but Dr. Cohen believes that is likely to change as more data become available. He is currently leading a clinical trial  in collaboration with Novartis Pharmaceuticals looking at treatment with reduced radiation doses – and thereby reduced toxicity – for patients who have a good response to induction chemotherapy. Such patients are usually HPV positive.

Another study, funded by the National Cancer Institute, randomizes HPV positive patients to radiation combined with either chemotherapy or a monoclonal antibody, with the hypothesis that the latter will be better tolerated.

Dr. Cohen cautioned that treatment changes won’t come immediately. “Many of us in the field believe that there will be different therapies developed for [HPV-positive] patients, but it takes time to do that. It’s hard to make those changes, especially when we are curing the majority of these patients.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

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