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Just In... Meeting News
Key news updates from recent oncology and hematology meetings.

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Sunday, April 26, 2015

 

BY ED SUSMAN

 

SAN DIEGO--Patients with advanced medullary thyroid cancer appear to experience rapid loss of skeletal muscle mass when treated with the tyrosine kinase inhibitor cabozantinib, researchers reported here at ENDO 2015, the Annual Meeting of the Endocrine Society.

 

“Cabozantinib-induced weight loss appears to be related not only to its gastrointestinal effects but also to an independent mechanism that leads to early-onset skeletal muscle and adipose tissue loss,” reported Lily Kwatampora, MD, MPH, a fellow in endocrinology at Baylor College of Medicine, in her poster presentation.

 

In the study, she and her colleagues found that three months after the start of treatment with cabozantinib, 60 percent of 21 patients identified as having progressive medullary cancer had a weight loss of more than five percent (Grade 1), which corresponded to a loss of at least one kilogram of skeletal muscle in 45 percent of patients.

 

“These losses were more pronounced at 12 months,” she said, illustrating that of the 15 surviving patients in the retrospective study, just one patient had gained weight; three had experienced Grade 3 weight loss (more than  20 percent); five others had Grade 2 weight loss (more than 10 percent); and two patients had Grade 1 weight loss.

 

Skeletal muscle changes followed a similar pattern, with nine of 20 patients analyzed having greater than a five percent decrease in skeletal muscle mass at three months; and 11 of 15 survivors exhibiting greater than five percent skeletal muscle loss at 12 months.

 

Four of the 21 patients did not report any diarrhea but had weight loss; two of those patients reported nausea and anorexia. “Of the other two patients who did not report nausea, anorexia, or diarrhea, one had the most profound body composition changes, becoming sarcopenic after only three months,” Kwatampora reported.

 

“Further studies are needed to better understand these independent effects, with the goal of intervening early to prevent deterioration into sarcopenia and cachexia, which impact treatment outcomes and survival.”

 

‘Expands on Known Side-Effects Profile’

Asked for his opinion, Jason Wexler, MD, Clinical Assistant Professor of Medicine at Georgetown University and an attending endocrinologist at MedStar Washington Hospital Center, said:  “This is important information that expands on the known side-effects profile of cabozantinib, which can be very difficult to tolerate for these patients.  

 

“When you put this in the context of the seriousness of this disease, I don’t think that it means you wouldn’t use these drugs in the appropriate circumstances. This study highlights that physicians who are treating patients need to be aware of this particular side effect, not only because of its effect on the patients, but because it may make these patients less likely to respond well to the treatment.”

 

Intervention to mitigate the effects of cabozantinib on muscle and weight loss could include a variety of modalities, Wexler continued. “We might try dose reduction, or we could get these patients early to a cancer-focused dietitian to make sure they are able to maintain proper caloric intake; or we might try to get them into some exercise program so they don’t lose muscle mass and waste away and deteriorate. If that happens they have to come off treatment, and that may accelerate the course of the disease.”

 

He said that the weight loss and muscle loss experienced by the patients in the study may well be due to some mechanism of action of the tyrosine kinase inhibitor because the impact appeared to occur rapidly and robustly, despite, in some patients, the absence of gastrointestinal discomfort.

 

“Even though medullary thyroid cancer is a bad cancer, the time course in which patients with the disease develop that wasting syndrome is a much slower, drawn out process” Wexler said.

 

“I think that the changes they are seeing here are more profound than seen earlier in the disease. I think these changes are much too robust and much faster than you would expect than what would be seen with the natural history of the disease.”

 

Kwatampora noted that previous studies have indicated that cabozantinib--approved by the Food and Drug Administration because it has shown to improve progression-free survival in patients with progressive medullary thyroid cancer--is associated with weight loss.

 

“Although this may partly result from gastrointestinal adverse events such as diarrhea and anorexia, recent evidence suggests a direct inhibition on protein synthesis and on adipose tissue by inhibition of adipogenesis. Skeletal muscle loss—sarcopenia--is linked to poor functional status, decreased treatment response, and reduced overall survival.”

 

Context Important: ‘These Patients Are in Worst Shape’

Wexler pointed out that cabozantinib is a standard treatment for medullary thyroid cancer and that patients who are candidates for a tyrosine kinase inhibitor like cabozantinib are in the worst shape—“These are patients who have progressive metastatic disease. These are patients who are going to die of their disease. Obviously, the risk and benefit of every drug used to treat them has to put in the context of having a fatal disease. There is no question that these drugs have lots of side effects. In many patients they can be really tough to tolerate.”

 

Kwatampora noted that treatment with cabozantinib--despite its adverse effects--has shown to double the time to disease progression.

 

Study Details

To describe the impact of cabozantinib on body composition in patients with advanced medullary thyroid cancer, the researchers performed a retrospective analysis of patients with progressive medullary thyroid cancer treated with cabozantinib between 2006 and 2014 at the University of Texas MD Anderson Cancer Center, collecting data on weight, height, gastrointestinal-related adverse effects, dose adjustments and tumor response during the first 12 months of therapy.

 

A total of 17 men and four women were included in the study, with a median age of 52, and a range of 36 to 71. Median body mass index at baseline was 28 kg/m2, and 13 of the patients in the study were considered to be either overweight or obese at the beginning of their treatment with cabozantinib.

 

Abdominal computer-assisted tomography scans were performed to monitor response. Cross-sectional images of the third lumbar spine were used to measure skeletal muscle and visceral and subcutaneous adipose tissue surface area changes.

 

“Despite most patients falling within ‘normal’ or ‘overweight’ body mass index categories, more than half were sarcopenic during the 12 months of therapy,” Kwatampora stated. “This is contrary to the assumption that most advanced thyroid cancer patients are relatively healthy compared with patients with other advanced cancers.

 

“While our study is limited by small sample size and no comparison group, these findings are similar to other studies investigating tyrosine kinase inhibitor related weight loss in other cancers.”

 

“This study is the first to demonstrate cabozantinib’s effects on body composition in advanced medullary thyroid cancer patients,” the researchers reported. “Understanding these effects on body composition will guide identification of at-risk patients, dose selection at initiation of therapy, and identification of patients who would benefit from interventions to decrease sarcopenia. 

 

“We hope that ultimately ameliorating this adverse event would improve tolerance to therapy, decrease treatment interruptions, and early withdrawal from treatment.”


Sunday, April 26, 2015

 

BY ED SUSMAN

 

SAN DIEGO--Three different sets of guidelines aimed at helping doctors determine if ultrasound images of thyroid cancer require biopsy have about the same level of accuracy, according to research presented here at ENDO 2015, the Annual Meeting of the Endocrine Society.

 

Sean Iwamoto, MD, a hospitalist at California Pacific Medical Center in San Francisco, presented the late-breaking study, which compared the Kim criteria and the guidelines of the Society of Radiologists in Ultrasound (SRU) and the American Association of Clinical Endocrinologists (AACE), showing insignificant scoring differences between them.

 

The Kim criteria say that a fine needle aspiration biopsy should be considered if the suspicious thyroid nodule has one of these characteristics: Marked hypoechogenicity, irregular microlobulated margins, microcalcifications, and a length greater than the width.

 

The SRU guidelines suggest biopsy if:

  • The nodule is at least one centimeter in diameter and there are microcalcifications;
  • The nodule is 1.5 cm or larger in diameter and there are solid/coarse calcifications;
  • The nodule is at least 2 cm in diameter and has mixed/cystic features; or
  • The nodule has shown substantial growth or there are abnormal cervical lymph nodes.

The AACE guidelines say that a biopsy should be performed if the clinician identifies a hypoechoic nodule that also has one of other feature such as irregular margins, a length greater than the width, or microcalcifications.

 

Iwamoto said that going into the analysis the thinking had been that the Kim criteria would be found to be the most sensitive and the AACE guidelines would have the highest specificity, both of which turned out to be the case, but in overall accuracy, all three guidelines were essentially similar in terms of accuracy.

 

Sensitivity was 74.1 percent for the Kim criteria, 57.1 percent for the SRU guidelines, and 14.3 percent for the AACE guidelines. Specificity was 22.9, 56.8, and 70.8 percent, respectively.

 

A total of 192 of the nodules examined proved to be non-malignant, and seven were malignant--identified as six papillary carcinomas and one Hürthle cell carcinoma.

 

“Of the sonographic features examined, the presence of microcalcifications had the greatest positive predictive value, with 5.8 percent of nodules with this feature being malignant,” Iwamoto reported. “Hypoechogenicity had the highest accuracy.

 

‘Art of Medicine’

Asked for his perspective, Dennis Kraus, MD, Director of the Center for Head & Neck Oncology and Co-director of the Center for Thyroid & Parathyroid Surgery at Lenox Hill Hospital in New York, explained that although ultrasound is helpful in locating the thyroid nodules, determining which one requires biopsy and which ones can be left alone remains controversial.

 

Just the fact that there are at least three sets of guidelines for ultrasound-guided fine needle biopsy shows that figuring out treatment of these lesions can be a test for clinicians, he said.  “If you focus on one of these sets of criteria over the others, it is not going to be that useful. You have to take each one of these parameters and put it in your own clinical judgment formula to decide when to do a biopsy. Unequivocally, this is still an area where the art of medicine has to be used.

 

“There are at least seven criteria you can use to determine if a nodule is suspicious, so if you have 2 or 3 of these criteria, I think you are going to end up doing a needle biopsy,” he said.

 

Added Maria Guoth, MD, Assistant Professor of Medicine at Yale University School of Medicine: “What you are mainly looking at with these guidelines is how to treat indeterminate nodules. Thee guidelines are looking at the features by ultrasound that have been found by different groups that work the best. When you take an ultrasound picture you see a lot of nodules in the thyroid. If I were to do a thyroid ultrasound on anybody 50 years of age or older you would see thyroid nodules. Fifty percent or more of people older than 50 have thyroid nodules.”

 

The question, she said, is which of those nodules can be a problem. The guidelines look at size as a determining factor, “but we know that size is not the only feature that make a nodule suspicious--it can be one with irregular margins or length. Different groups suggest that different characteristics are important.

 

“The conclusions, using the two guidelines that offer the most sensitivity and specificity, are the guidelines that I teach my fellows.”

 

Supports What Is Done in Clinical Practice

Kraus said that the finding of only seven cancers among 200 patients undergoing biopsy means that these criteria are not very successful in finding malignancy: “The malignancy rate varies tremendously in one’s practice setting. There will be settings in which the rate is less than 3.5 percent and then for people who have specialized and well-defined practices there may be a much higher rate.”

 

“This is a fairly small sample size--just 200 nodules in two years,” he continued. “I think what the researchers have found here really supports what we are doing in clinical practice. These are fairly well-established criteria.”

 

Limitations

Iwamoto said that the study was limited by the size of the sample and possibly for selection bias in patients with multiple nodules, and that most of the nodules biopsies were larger than one centimeter, creating the possibility of bias based on size.

 

In performing the study, the research team analyzed nodules biopsied between December 2011 and December 2013. All the malignant nodules were confirmed with postoperative pathology.

 

‘Most Rapidly Increasing Cancer’

Kraus said the study of the criteria is important because thyroid cancer has become the most rapidly increasing cancer in the United States. “We are not sure why this is occurring. It may be due to genetics, it might be something in the environment or a combination of these things, or it may be that we are just better at detecting thyroid cancer than we used to be.”

 

He said that in his practice, in which many patients are referred from primary care and community hospitals, he often will examine a patient referred by an primary care physician who reports a palpable lesion--“and I can’t find a darn thing; the onus is on us to figure out which is the right nodule to treat.”


Thursday, April 23, 2015

 

The presence of a known driver of non-small cell lung cancer (NSCLC)—fibroblast growth factor receptor (FGFR)—has been found to also be present in small cell lung cancer (SCLC), according to research reported at the American Association for Cancer Research Annual Meeting (Abstract 558).

 

This implies, a news release notes, that promising treatments in development for NSCLC may also be applicable to patients with SCLC, the rarer and more aggressive form of lung cancer.

"There is an unmet need in small cell lung cancer. There have been no significant new therapies developed in 20 years," said the senior author of the poster study presented on Sunday, Fred R. Hirsch, MD, PhD, Associate Director for International Programs at the University of Colorado Cancer Center and CEO of the International Association for the Study of Lung Cancer.

 

One promising new strategy in the treatment of NSCLC is inhibition of FGFR, which helps to signal uncontrolled growth in about 21 percent of those cancers. The new research showed positivity for FGFR1 amplification, mRNA, and/or protein expression in about 23 percent of patient samples (17 of 75) of SCLC tumors.

 

SCLC accounts for 10 to 15 percent of all lung cancers, and five-year survival rates are less than half those for patients with NSCLC. Because small-cell lung cancer shows symptoms much later than non-small cell lung cancer, it is usually diagnosed much later in the course of the disease—typically after it has already metastasized.

 

The study identifies a subset of SCLC patients with potentially overactivated FGFR1 pathways as shown by gene amplification, increased FGFR1 messenger-RNA (mRNA) levels, and high protein expression.

 

"This clearly demonstrates that FGFR1 is important in a subgroup of small cell lung cancers,” Hirsch said. “I would say this will lead to a clinical trial of drugs targeting FGFR in small cell lung cancer. The progress of existing drugs targeting FGFR1 means that we could be much closer to offering treatment options to people with small cell lung cancer than if we had been forced to start with a new compound."

 

His coauthors were Hui Yu, Andrzej Badzio, Theresa Boyle, Xian Lu, Christopher J. Rivard, Ashley Kowalewski, Brad Rikke, Kim Ellison, Leslie Rozeboom, and Biftu Hassan—all from the University of Colorado Anschutz Medical Campus; and second author Andrzej Badzio, from Medical University of Gdansk in Poland.


Thursday, April 16, 2015

 

 

BY PEGGY EASTMAN

 

WASHINGTON—Speakers at the American Cancer Society Cancer Action Network National Forum on the Future of Health Care here explored new models of delivering high-quality, cost-effective care to cancer patients in this time of rising costs.

 

Coincidentally, the forum—“Transforming Delivery and Payment of Cancer Care--Breaking Down Barriers”--held at the National Press Club, took place on Tuesday, the day that Congress cast a historic vote to repeal the Medicare Sustainable Growth Rate (SGR) formula, a thorn in the side of physicians for 13 years because of its unpredictable threat of cuts in reimbursement. American Society of Clinical Oncology President Peter Paul Yu, MD, said in a statement, “The Congressional bipartisan, bicameral leadership that forged this much-anticipated resolution has taken an important step to restore stability and confidence in Medicare.”

 

Yu, Director of Cancer Research at the Palo Alto Medical Foundation, added that ASCO looks forward to making sure the new law “is effectively implemented and paves the way to new payment models that foster high-quality, value-based health care for all Americans with cancer.”

 

The American Society for Radiation Oncology also praised the Congressional vote, stating that “Repealing the SGR has been an ASTRO priority for years, and passage of this legislation represents a long-awaited, historic victory for our patients.”

 

At the forum, ACS CAN President Christopher W. Hansen noted that “Innovative payment models are already showing promise,” and added: “We need to find out what’s working, and see how we can apply these models system-wide.” He noted that today “We have a lot of models,” some of which are more macro models while some are more micro models. “We need to keep talking about this. We’re at a tipping point.”

 

Oncology Care Model

In February of this year the Centers for Medicare and Medicaid Services announced a new model for cancer care that will begin in 2016, the Oncology Care Model (OCM). Under this five-year model, Medicare will encourage participating oncology practices to improve care and lower costs through episode-based payment surrounding chemotherapy administration to cancer patients. Practices participating in the new model will receive monthly care management payments during an episode of care (defined as six months of chemotherapy treatment) for each fee-for-service Medicare beneficiary, with the goal of moving away from fee-for-service payment based on the number of procedures and toward performance-based reimbursement.

 

The Oncology Care Model is one of a number of new delivery models being tested by CMS, noted Rahul Rajkumar, MD, JD, Acting Deputy Director of CMS’s Center for Medicare & Medicaid Innovation (CMMI). He said that by the end of 2016, CMS hopes that 30 percent of its payment for care will be in new models.

 

Rajkumar stressed that CMS wants to work with the private sector in implementing new methods of health care delivery: “In everything that we do, especially in the oncology model, we are working with private sector practices. We think this is a tremendous and historic opportunity to improve care for cancer patients.”

 

'Standardization of Process of Care = Consistency of Care'

One key to moving toward performance-based care is standardization of the process of care, which leads to consistency of care, said John D. Sprandio, MD, Co-founder and Chairman of Oncology Management Services, a company whose goal is to help oncology practices improve the value of cancer care through the Oncology Patient-Centered Medical Home (OPCMH) model.

 

In this value-based model, oncologists strive to control the use of unnecessary resources (such as emergency department visits, hospitalizations, imaging, and laboratory tests) and assume responsibility for the costs associated with potentially avoidable complications--“If you standardize the process of care, it allows you to practice the art of medicine in an individualized way,” he said.

 

“I think it’s really important to focus on reducing unnecessary resource utilization,” added Sprandio, noting that the OPCMH model has reduced emergency department use and hospital admissions in the sickest cohort of cancer patients. He has worked collaboratively with several national organizations in promoting the OPCMH, including ASCO, the National Committee for Quality Assurance, the National Comprehensive Cancer Network, and the Agency for Healthcare Research and Quality.

 

Sprandio told OT that the cancer care delivery system has been moving along a line away from fee-for-service delivery through treatment pathways, to the OPCMH and toward the episode (budgeted) payment model. He said that insurers want the episode-based payment model because it minimizes risk. “There are also benefits to providers because it streamlines billing,” he added.

 

Asked by OT about outliers, cancer patients who develop costly problems (such as infections) that put them over the amount allowed for an episode-based payment, Sprandio said standardization of the process of cancer care can help to reduce outliers. In his vision, he said, the process of care is team-based and seamless, and includes patient navigation, tracking, staging, guideline adherence, data coordination, communication, symptom management, standardized care plans and shared decision-making.

 

‘Drug Costs Are a Wild Card’

In an interview, ACS Deputy Chief Medical Officer J. Leonard Lichtenfeld, MD, MACP, who attended the forum, noted that the concept of an episode-based (budgeted) care model has been discussed over several years. The concept, he said, “is really global payment for cancer care.” The entrance of costly new targeted cancer therapies onto the market represents a glitch for episode-based cancer care, because “the drugs costs are a wild card.”

 

Lichtenfeld said that with the episode-based care model, “the insurers are really handing off risk,” whereas their traditional role has been to handle risk. “You need data and actuarial models” to predict risk, Lichtenfeld said, and most hospitals don’t have a large enough data base to capture risk accurately.

 

“There are certainly points of light in moving in this direction, but we have a long way to go,” he said, noting that today care coordination is not ideal. “It’s tragic that cancer patients can’t get their records from point A to point B.” Also, he stressed, “We need to be equitable in our payment methodologies.”

 

He said that under a new payment model such as the episode-based one, there has to be a provision for reimbursing cancer centers of excellence at a higher rate, and predicted that “they will be able to command a premium for their care.”

 

In addition, Lichtenfeld said, there needs to be risk adjustment in a new cancer care payment model to take into account health disparities in disadvantaged areas where residents may not have access to preventive care and regular cancer screenings and thus tend to be diagnosed at later stages.

 

One way to implement risk adjustment, he said, is to adjust payment based on certain zip codes. Rajkumar said that CMS is studying how to come up with a better risk-adjustment model, but “we are limited by claims data,” and thus CMS is trying to gather other electronic data, such as cancer stage and histology.

 

Team-Based Approach

Forum speakers generally agreed that moving toward new models of cancer care delivery requires a team-based approach. Harvey J. Hamrick, Jr., MD, Chief of Oncology at Kaiser Permanente of Georgia, described leading a team of some 20 oncologists, nurses, and other health professionals (including palliative care specialists) who work together to treat Kaiser Permanente beneficiaries in the metropolitan Atlanta area.

 

Hamrick used a patient vignette of a 55-year-old woman with rectal cancer to illustrate how a multidisciplinary team of specialists came together and dedicate time to reviewing the woman’s case extensively, involving the patient and her husband in a discussion of her options.

 

“We have found this invaluable,” Hamrick said of the multidisciplinary team approach. “In a fee-for-service model, it’s not worth the doctor’s time.” Hamrick said that under the Kaiser model, cancer patients receive palliative care even if they are receiving care with curative intent. While the patient in this case had a difficult time and required a temporary colostomy, today she is “doing great” and has been free of cancer for two years, Hamrick said.

 

He noted that Kaiser has an advantage with its centralized electronic medical record, but said, “At the end of the day you still have to put a care team together” that takes ownership for the patient’s needs, which is not easy.  “You’re really engineering a culture.”

 

Integral Role of Nurses

Nurses at the forum described their integral role as part of the patient care team. All of the patients at the Johns Hopkins Breast Center have a patient nurse navigator, said Lillie D. Shockney, RN, MAS, Administrative Director of the center and a two-time breast cancer survivor. “One of our biggest challenges is that Hopkins is designed in silos,” noted Shockney, who is also Director of Cancer Survivorship Programs at Hopkins’ Kimmel Cancer Center.

 

She described working with one patient’s medical oncologist to ensure that the patient’s chemotherapy regimen minimized peripheral neuropathy, since the patient wanted to be a concert pianist.

 

“I use the term ‘survivorship life plan’ to determine the patient’s goals,” Shockney said.

 

Also at the forum, Alec Stone, MA, MPA, Director of Health Policy for the Oncology Nursing Society, asked about reimbursement of nurses for patient education as part of the cancer care team. Stone told OT that the ONS has signature legislation, the Improving Cancer Treatment Education Act, which requests one-hour reimbursement through Medicare for symptom-management education provided by an oncology nurse. The bill states that patients with cancer benefit from an educational session in advance of treatment, which teaches them how to manage the adverse effects of cancer treatment, reduce its risks and maximize their well-being as survivors.

 

Stone said that ONS will work with members of Congress to pass the bill, emphasizing the critical role of oncology nurses in cancer care. The bill’s sponsor is Rep. Steve Israel (D-NY).

 

Several speakers emphasized that new cancer care delivery models must not derail the biomedical innovation that extends lives. “There’s a lot of innovation; there are more breakthroughs today,” said Elizabeth Fowler, PhD, JD, Vice President for Global Health Policy at Johnson & Johnson, former Special Assistant to the President for Healthcare and  Economic Policy at the National Economic Council in the White House, and former Chief Health Counsel to Senate Finance Committee Chairman Max Baucus.

 

“I think this vision [of new care models] is achievable, and is consistent with where we’re heading in innovation,” she said, cautioning, though, about high prices: “We have to recognize that treating cancer is costly.”


Thursday, April 09, 2015

 

BY PEGGY EASTMAN

 

WASHINGTON—At a news briefing at the National Press Club here, speakers presented key findings from the April 2015 issue of the journal Health Affairs, which contains a cluster of articles on the cost and quality of cancer care.

 

Taken together, the articles show that the costs for cancer care continue to rise; that there is wide variation in the cost of cancer care; that over-diagnosis costs the United States billions; that there are disparities in the early adoption of technologies such as gene expression profiling; and that uninsured patients continue to bear a heavy burden of costs. But U.S. cancer care is lengthening survival, especially for women with localized breast cancer.

 

Asked by OT why the journal chose to spotlight cancer care at this time, Health Affairs Editor-in-Chief Alan R. Weil, JD, said, “We are always looking for topics that are of interest to the policy community.” He added that cancer care is “a big topic” from the standpoint of quality of care for both patients and costs. Weil called these specific articles on cancer in the April issue “a follow-on” to the Oct. 2014 issue highlighting specialty pharmaceuticals, many of which were cancer drugs.

 

False-Positive Mammograms & Breast Cancer Overdiagnoses

In the United States, expenditures for false-positive mammograms and breast cancer over-diagnoses are estimated at $4 billion a year, according to data from a study by Mei-Sing Ong, PhD, and Kenneth D. Mandl, MD, MPH, which Mandl, Professor at Harvard Medical School; holder of the Boston Children’s Hospital Chair in Biomedical Informatics and Population Health; and Chair of the Board of Scientific Counselors of the National Library of Medicine at the National Institutes of Health, discussed at the briefing.

 

The study measured actual expenditure data from a major U.S. health care insurance plan (what the plan paid) for 702,154 women in the years 2011 to 2013, identifying costs due to false-positive mammograms and breast cancer over-diagnoses among women age 40 to 59.

 

The authors found that the average expenditures for each false-positive mammogram, invasive breast cancer and ductal carcinoma in situ (DCIS) in the 12 months following diagnosis were $852, $51,837 and $12,369, respectively. Mandl said the costs--which translate to $4 billion annually in the United States--appear to be much higher than previously documented.

 

He said that while screening has the potential to save lives, currently “screening is being dialed back” due to its possible harms, including the additional diagnostic workup and psychological distress of a false-positive finding. In 2009, he noted, the U.S. Preventive Services Task Force recommended against mammogram screening for women age 40 to 49.

 

“Most DCIS is probably over-diagnosis,” he said, noting that the rate of DCIS has gone up 500 percent due to screening—“this is imprecision medicine.” He suggested that one way to reduce the rate of false-positive findings and over-diagnosis is to personalize breast cancer screening based on a woman’s risk factors, such as age, family history, and genetic predisposition.

 

Older Women with Localized Breast Cancer

While false positives and over-diagnosis are not good news, rising survival rates for women with localized breast cancer are very good news, noted another speaker, Cary P. Gross, MD, Professor of Medicine and Co-Director of the Robert Wood Johnson Foundation Clinical Scholars Program at Yale University School of Medicine, coauthor of another study in the issue.

 

Noting that few studies have evaluated the association between trends in cancer care costs and survival outcomes, that team examined breast cancer costs and survival rates for two time periods. “We saw dramatic increases in costs,” Gross said.  But, he noted, at five years post-diagnosis “the increase in survival was substantial,” especially for stage III breast cancer patients.

 

He and his colleagues studied women age 67 to 94 diagnosed with Stages II or III breast cancer in two time periods: 1994-1996 and 2004-2006. The median cancer-related costs increased from $12,335 to $17,396 among women with stage II disease, and from $18,107 to $32,598 among women with stage III disease.

 

Gross noted that although the costs for surgery actually declined during the interval between the two study periods, the median cost for chemotherapy and radiation therapy increased markedly, leading to a rise in overall costs. Adjusted overall five-year survival during this time increased from 67.8 to 72.5 percent for women with stage II disease and from 38.5 to 51.9 percent for those with stage III disease.

 

“I view this as a glass half full,” Gross said. “We are growing very worried… The trajectory of cancer costs is not sustainable.” Citing a hypothetical costly new treatment with small incremental benefits, he said, “At some point we’re going to have to say no.”

 

Cancer Mortality Reductions Greatest in Countries Where Cancer Care Spending Rose the Most

If cost were no object, continuing to spend at an increasing rate on cancer care might lead to further mortality reductions, judging by another study discussed at the briefing. First author Warren Stevens, PhD, MSc, Senior Economist at Precision Health Economics, said: “We conducted an international comparison of cancer spending by countries, and grouped them by level of cancer spend.” A high level of spending on care was found to be clearly correlated with greater reductions in cancer mortality.

 

Among the 16 countries studied during 1995 to 2007, reductions in cancer mortality were greatest among the countries where cancer care spending rose the most. Specifically, Stevens said that the countries that increased spending on cancer the most had a 17 percent decrease in amenable mortality, compared with eight percent in countries with the lowest growth in cancer cost spending.

 

“One of the key roles of a health system is to integrate innovation as quickly and effectively as possible,” he said. “Progress accelerates more quickly than expected in high-spending countries, given their baseline mortality.” It could be, he said, that having the multiple treatment options available through biomedical innovations in high-spending countries improves outcomes.

 

Wide Variation In Payments for Medicare Beneficiary Oncology Services

In the United States, there is wide variation in payments for the oncology services used by fee-for-service Medicare beneficiaries across oncology practices, noted Jeffrey D. Clough, MD, MBA, a general internist and health services researcher at Duke University’s Clinical Research Institute; faculty member in Duke’s Division of General Medicine; and former medical officer in the Policy and Programs Group at the Centers for Medicare & Medicaid Services (CMS) Innovation Center.

 

In the study he coauthored, he and his colleagues used Medicare fee-for-service claims to measure annual payments for key service categories delivered to fee-for-service Medicare beneficiaries receiving care from 1,534 medical oncology practices in 2011 to 2012.

 

The study found a $3,866 difference in spending (including administration and supportive care drugs) per cancer patient on chemotherapy drugs between oncology practices at the 75th (upper) and 25th (lower) percentiles as ranked by spending. Differences between the upper-end spending practices and lower-end spending practices were $1,872 for acute medical hospitalizations, and $439 for advanced medical imaging. 

 

Supportive care drugs, bevacizumab and positron emission tomography accounted for the greatest percentage of variation among oncology practices.

 

“I think the most important thing is to elucidate the factors that are driving variation,” Clough said. “In our study everyone was under one payment model, so we can’t say that it was the cause of variation. Data like this suggest where the opportunities are.” 

 

Alternative payment models might be one way to tackle the variation in costs for cancer care among practices, but he noted that “we have a long way to go in determining which models should be implemented nationally.” Alternative payment models vary; Clough called one such model, bundling, “aggressive.”

The American Society of Clinical Oncology’s new Director of Value and Performance Policy, John Young, PhD, asked Clough a question about the risk to practices of alternative payment models. Young, who came to ASCO from the CMS Innovation Center, told OT, “When you get into the risk model, there are some organizations that are more prepared to take on risk than others.”

 

Early Diffusion of Gene Expression Profiling in Breast Cancer Patients Associated with High Income Inequality

As other studies have shown, disparities in U.S. cancer care persist, according to a study discussed by Ninez A. Ponce, MPP, PhD, Professor in the Department of Health Policy and Management at the Fielding School of Pubic Health and Associate Center Director at the UCLA Center for Health Policy Research.

 

Ponce and her coauthors found that while gene expression profiling is a potentially cost-effective innovation that can guide chemotherapy decisions in early-stage breast cancer, U.S. adoption of this technology has been uneven.

 

“We’re finding disparities by race and income,” she said. Specifically, during the initial diffusion period of 2006 to 2007, in areas with high income inequality, gene expression profiling was associated with a 10.6 percentage point gap between high-income women (who were most likely to receive the test) and low-income women (who were least likely to receive it).

 

Even among insured women, income inequality may indirectly shape diffusion of gene expression profiling, the researchers concluded--with benefits accruing to the highest-income women in areas with the most income inequality.

 

For Uninsured Cancer Patients, Outpatient Charges Can Be Costly, Putting Treatments Out Of Reach Being uninsured continues to be a heavy burden for cancer patients, noted Stacie B. Dusetzina, PhD, Assistant Professor at the University of North Carolina (Chapel Hill) in the Division of Pharmaceutical Outcomes and Policy in the Eshelman School of Pharmacy and the Gillings School of Global Public Health.

 

For cancer patients with no insurance, outpatient charges can be so costly that they put treatments out of reach, she and her co-authors found. Specifically, they found that uninsured cancer patients faced potential prices for chemotherapy that were two to 43 times as much as the total Medicare-allowed amount and two to five times as much as the private insurance-allowed amount.

 

Charges for outpatient chemotherapy and office visits were markedly higher than insurer-reimbursed amounts, thus underscoring “the pressure that the current system places on the people who are least able to pay,” she said.

 

‘Put More Burden Back on the System’

Also speaking at the news briefing was Ann M. Geiger, PhD, MPH, Acting Associate Director of the new Healthcare Delivery Research Program within the National Cancer Institute’s Division of Cancer Control and Population Sciences. She said the NCI is interested in research on better, more carefully planned systems of cancer care.

 

“We are interested in having the best outcomes possible,” she said, noting the importance of studying patient satisfaction. “We’ve put a lot on the [cancer] patient at a difficult time,” she said. “We’re interested in putting more burden back on the system.”

 

The vision of the new Healthcare Delivery Research Program within NCI, as stated, is patient-centered, evidence-based care that minimizes the burden of cancer on individuals and society. Geiger told OT: “We’re having very important discussions on this issue now at a senior level.”