Mary K. Caffrey

A partnership between the Pancreatic Cancer Action Network and Perthera, a self-described “concierge” for molecular diagnostic testing, is giving patients with this hard-to-treat cancer the ability to determine the best course of treatment.

The partnership, formed July 1, 2014, has gained momentum in recent months, as more oncologists and patients learn about the “Know Your Tumor” initiative. Through the program, patients newly diagnosed with metastatic pancreatic adenocarcinoma are referred through their oncologists to Perthera, based in McLean, Virginia. (Perthera stands for “Personalized Cancer Therapy Inc.”)

The company is not a developer of diagnostic tests. Instead, it works with the patient and the oncologist to obtain tissue needed for testing, then selects which of the many available tests will be used to evaluate the tumor. Results are presented in a report, which is reviewed by Perthera’s medical advisory panel. The group makes treatment recommendations based on the findings and the best therapies available.

“The hope is that clinical outcomes will be improved because the patients are receiving therapies tailored their molecular profile,” said Emanuel F. Petricoin III, a Perthera co-founder and chairman of its Board of Advisors and Scientific Advisory Board.

As described by the Pancreatic Cancer Action Network, “The results of molecular profiling may help a patient’s oncologist determine the best treatment options, including appropriate clinical trials.”

A major advantage of the “Know Your Tumor” initiative is the time it trims from the testing process. This is important in all cancers but especially in pancreatic cancer, which has a five-year survival rate of just 6 percent. First, the Pancreatic Cancer Action Network is fully funding Perthera’s services for patients in the program. Then, Perthera goes to work to eliminate the delays that often creep into molecular testing.

“It’s in keeping with our whole service model,” says Petricoin. Perthera provides what he calls the “traffic control” to ensure that enough tissue is obtained from the biopsy, that the tissue gets sent quickly to the testing labs, and that each testing company has enough issue. Perthera also deals with insurers on payment and reimbursement issues. (Perthera’s services are separate from the cost of testing and the biopsy, which are billed to insurance.) As Petricoin describes it, the company does all the “bird-dogging” so the patient and the oncologist won’t have to perform these tasks. Perthera aims for turnaround of a month or less from the time of biopsy to the time the oncologist has a full report, he said.

The initiative is among several for the Pancreatic Cancer Action Network, which has an expressed goal of doubling survival rates for pancreatic cancer by 2020. That is no small task, given how difficult the disease is to diagnose and treat.

About 44,000 Americans are diagnosed with pancreatic cancer each year and 37,000 will die, according to the National Cancer Institute (NCI). The statistics for pancreatic cancer are so grim that in January 2013 President Barack Obama signed the Recalcitrant Cancer Research Act, which requires the NCI to come up with better research and treatment plans for pancreatic cancer. The Pancreatic Cancer Action Network was a key force behind the law’s passage.

The characteristics of pancreatic cancer make it difficult to find and treat. It exhibits few symptoms before the cancer reaches later stages. While there are known risk factors, including smoking, obesity and some tendency for the disease to run in families, many who are diagnosed have no known risks. So far, biomarkers that would permit widespread screening have not been identified. Treatment is often challenging due to the location of the pancreas itself and the typical makeup of the dense stroma in the tumors. Work in immunotherapy has shown some promise, however. In July 2014, the FDA granted breakthrough status to a combination of GVAX and CRS-207, a live-attenuated Listeria monocytogenes (Lm), modified to express the protein mesothelin and made safe for human use.

Petricoin said about 100 patients have been referred through “Know Your Tumor” thus far, and 30 have a full molecular profile, based not only on genomic but also proteomic testing. Besides assisting individual patients, the Pancreatic Cancer Action Network is building a database of molecular profiles; it plans to enroll approximately 3000 patients over 3 years. Once a critical mass of molecular profiles accumulates, it will be possible to publish results identifying which therapies worked best for patients with specific molecular profiles.

The mission, Dr Petricoin said, is twofold: find out what works best for patients, and produce results that will guide decisions for pharmaceutical companies and payers. The goal, he said, is to speed development of better therapies for pancreatic cancer, and to ensure that reimbursement goes to “the drugs that are really working.”

The partnership, he said, is just beginning. “We will be ramping up to handle many, many more patients next year.”

Articles

A partnership between the Pancreatic Cancer Action Network and Perthera, a self-described "concierge" for molecular diagnostic testing, is giving patients with this hard-to-treat cancer the ability to determine the best course of treatment.

Through Partnership, Pancreatic Cancer Patients Gain Access to Personal Treatment Options

Eligibility criteria set by the Centers for Medicare & Medicaid Services (CMS) for coverage of low-dose computed tomography (LDCT) for individuals deemed at high risk for lung cancer may actually exclude many potential lung cancer patients who would benefit from screening, according to a new study.

Journal of the American Medical Association

, indicate that efforts to get long-term smokers to quit in recent decades make some former long-term smokers ineligible for screening, because they have not smoked for more than 15 years.

In the study, by Ping Yang MD,  and colleagues at the Mayo Clinic in Rochester, Minn., researchers evaluated trends in the proportion of patients with lung cancer who meet the US Preventive Services Task Force (USPSTF) criteria as being at high risk for lung cancer. CMS used the USPSTF criteria as the basis for its coverage determination.

Researchers looked at 140,000 residents in Olmstead County, Minn., aged 20 or older, from 1984 through 2011. All confirmed cases of lung cancer were identified using the Rochester Epidemiology Project database, adjusting for age and gender distribution in the US population in 2000.

The proportion of cases meeting USPSTF criteria was identified and represented asymptomatic adults aged 55 to 80 years with a 30 pack—year smoking history. This means the person smoked the equivalent of one pack a day for 30 years; a person could also have smoked two packs a day for 15 years. To be screened, a person must be a current smoker or have quit within the past 15 years. Under the Medicare criteria, the age cutoff for LDCT coverage is 77 years.

Researchers identified 1351 patients with a new diagnosis of primary lung cancer between 1984 and 2011. However, the proportion of patients with lung cancer who smoked more than 30 pack-years declined, and the proportion of former smokers, especially those who quit more than 15 years ago, increased.

Of note, the share of lung cancer patients meeting the USPSTF criteria declined over time, with 57 percent of patients eligible for screening from 1984 to 1990 and only 43 percent eligible from 2005 to 2011. The drop-off in eligibility was greater among women—from 52 percent to 37 percent; for men the drop-off was 60 percent to 50 percent.

“Our findings may reflect a temporal change in smoking patterns in which the proportion of adults with a 30 pack—year smoking history and having quit within 15 years declined,” the authors write. “The decline in the proportion of patients meeting USPSTF high-risk criteria indicates that an increasing number of patients with lung cancer would not have been candidates for screening. More sensitive screening criteria may need to be identified while balancing the potential harm from computed tomography.”

CMS’ decision to screen current and former smokers for lung cancer was based on the results of the National Lung Screening Protocol Trial Protocol, which found that patients who received screening had a 15% to 20% lower risk of dying from lung cancer; results published in 2013 showed that targeting screening toward those at greatest risk produced the most effective results.

Eligibility criteria set for coverage of low-dose computed tomography for individuals deemed at high risk for lung cancer may actually exclude many potential lung cancer patients who would benefit from screening, according to a new study.

Study Suggests Lung Cancer Screening Criteria May Not Capture All Smokers Who Need It

Medicare will immediately cover lung cancer screening with low-dose computed tomography (LDCT) for high-risk individuals, including current and former smokers, according to a national coverage determination (NCD) released by CMS.

The decision to cover the procedure was announced in November 2014, following months of consternation after the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) voted against coverage in late April 2014.

“This is the first time that Medicare has covered lung cancer screening. This is an important new Medicare preventive benefit since lung cancer is the third most common cancer and the leading cause of cancer deaths in the United States,” Patrick Conway, chief medical officer and deputy administrator for innovation and quality for CMS, said in a statement.

The decision will allow Medicare beneficiaries aged 55 to 77 who are either current smokers or have quit smoking within the past 15 years to receive LDCT screening once a year. This includes those with a tobacco smoking history of at least 30-pack years, which is at least a pack a day for 30 years (for example, if a person smoked two packs a day for 15 years, that equals 30-pack years). Additionally, the individual must have a written order from a physician or qualified non-physician practitioner that meets certain requirements, which are contained in the NCD.

Coverage will include a visit for counseling on the benefits and risks of LDCT screening. The announcement also included data collection and eligibility requirements for radiologists and imaging centers consistent with the National Lung Screening Trial (NLST) Protocol.

“We believe this final decision strikes an appropriate balance between providing access to this important preventive service and ensuring, to the best extent possible, that Medicare beneficiaries receive maximum benefit from a lung cancer screening program,” Conway said.

The CMS announcement comes a little more than a year after the US Preventive Services Task Force (USPSTF) finalized its “B” recommendation for annual lung cancer screenings with LDCT; that recommendation was for adults aged 55 to 80 who had smoked 30-pack years. USPSTF’s recommendation was based on results of the NLST, which found that patients who received screening had a 15 percent to 20 percent lower risk of dying from lung cancer; results published in 2013 showed that targeting screening toward those at greatest risk produced the most effective results.

The decision to pay for widespread screening is not without controversy. In a paper published in 

 in December 2014, authors expressly discouraged CMS from paying for screening. This is difficult under the Affordable Care Act, since the law requires commercial insurers to pay due to the B recommendation. The authors argued that screening in the general population may not be limited to high-risk smokers outside a clinical trial, and may cause unnecessary harm due to radiation and false positives. The authors also questioned whether screenings would be performed in qualified radiation centers.

Lung cancer is the leading cause of cancer death in the United States; according to the CDC, with nearly 157,000 people in the United States dying from lung cancer in 2011. The vast majority of deaths from lung cancer are caused by tobacco use.

Medicare will immediately cover lung cancer screening with low-dose computed tomography (LDCT) for high-risk individuals, including current and former smokers, according to a national coverage determination (NCD) released by CMS.


Mary K. Caffrey

Through Partnership, Pancreatic Cancer Patients Gain Access to Personal Treatment Options

Study Suggests Lung Cancer Screening Criteria May Not Capture All Smokers Who Need It

Medicare Begins Coverage of Lung Cancer Screening for High-Risk Individuals

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