Articles

February 18, 2013- March 15, 2013

ASCO's Swain Discusses Sequester's Potential Impact On Cancer Care, Research.

The front page of the Feb. 15 The Cancer Letter features an interview with Sandra Swain, president of the American Society of Clinical Oncology, in which she discusses the potential impact of sequestration "on the practice of oncology and cancer research." According to Swain, "I think it's very clear that sequestration will have a shattering impact on the entire cancer enterprise in the United States." Swain added, "The cuts would be really far-reaching and widely felt, and-ultimately-it's the cancer patient, fighting for his or her life, who's going to feel the most profound impact from reductions in clinical cancer research, slowdowns in the drug review and approval process, and the oncologists being squeezed by cuts to reimbursement."

HHS Finalizes ACA Essential Benefits Rule.

HHS Offers Guidance For Colonoscopies, Breast Cancer, Autism. The AP (2/21, Alonso-Zaldivar) reports that on Wednesday, HHS released guidance clarifying that "taking out such precancerous growths as part of a routine colon cancer screening procedure will now be considered preventive care," which is free under most insurance plans thanks to the Affordable Care Act. In a notice on its website, HHS wrote, "Polyp removal is an integral part of a colonoscopy." The notice also addressed "genetic testing for breast cancer, coverage of over-the-counter products such as aspirin for heart care and nicotine patches for smoking, and birth control for women."

Data Show Mammography Systems Prices Rising.

Modern Healthcare (2/28, Lee, Subscription Publication, 71K) reports that the "most recent Modern Healthcare/ECRI Institute Technology Price Index," indicates that the "average cost of digital mammography systems continues to rise as providers maintain interest in the 3-D digital breast tomosynthesis system." ECRI Institute's Operations Director Jason Launders said, "Prices of the really advanced systems are going through the roof." The average cost of a digital mammography system, such as "Hologic's Selenia Dimensions 3-D system," which the FDA approved in 2011, "is $333,379." That price is "more than double the price of a base imaging model, Launders said. The average cost of the newer technology rose less than 1% from November to December of last year, but increased 28.2% during 2012."

ASCO Warns About Impact Of Sequestration On Cancer Research.

Medscape (3/2, Nelson) reported that sequestration's cuts to the National Institutes of Health will be "devastating to research, scientists, and most of all cancer patients, according to statements released by...the American Society of Clinical Oncology (ASCO)." According to ASCO, the cuts will have "a shattering impact on the entire cancer enterprise in the United States." As ASCO President Sandra M. Swain said in a statement, "It's the cancer patient, fighting for his or her life, who's going to feel the most profound impact from reductions in clinical cancer research, slowdowns in the drug review and approval process, and oncology practices being squeezed by cuts to reimbursement."

PTSD May Be Common In Patients Diagnosed With Breast Cancer.

MedPage Today (3/2, Struck) reported, "Nearly a quarter of women newly diagnosed with breast cancer experienced post-traumatic stress disorder (PTSD), with blacks, Asians, and women younger than 50 reporting distress more often," according to a study published online in the Journal of the National Cancer Institute. Researchers found that, "of 1,139 participants culled from the 2006-2010 Breast Cancer Quality of Care Study (BQUAL), 23% reported PTSD at baseline of 2 to 3 months post diagnosis." The investigators found that "symptoms diminished over time, with 16.5% of participants reporting PTSD symptoms 4 months after diagnosis, and 12.6% reporting it at 6 months."

Australian Law Firm Files Appeal On Gene-Patent Ownership Ruling.

Bloomberg News (3/4, Schneider) reported that the office of Maurice Blackburn announced Monday that it has entered an appeal "in the Federal Court of Australia" against Myriad Genetics' Feb. 15 "court victory" in which Australian Federal Court Justice John Nicholas ruled "that the method used by Myriad and Genetic Technologies of purging a gene of biological material is a manufacturing process that can be patented." The Melbourne-based law firm said it filed the appeal on behalf of "Yvonne D'Arcy, a Brisbane resident diagnosed with breast cancer," who, along with Cancer Voices Australia, sued Myriad and Genetic Technologies in 2010, to prevent them "from patenting an isolated DNA associated with an increased risk of breast and ovarian cancers." Bloomberg News adds that the Myriad "case returns to the US Supreme Court this year after the US high court agreed Nov. 30 to hear the Association for Molecular Pathology's appeal" against a US Court of Appeals for the Federal Circuit ruling that genes can be patented.

EU Approves New Treatment For Breast Cancer.

Reuters (3/5, Bart) reports that Roche has received European approval for its breast cancer treatment, Perjeta (pertuzumab), which it will combine with Herceptin (trastuzumab) in order to treat the HER2-positive variant of breast cancer. The FDA cleared the treatment for use in the US last year. Reuters notes that HER2-positive breast cancer has no cure, and makes up around a quarter of breast cancer cases.

FDA Approves First Lymph-Node Mapping Drug In 30 Years.

The AP (3/14) reports that the US Food and Drug Administration approved Navidea Biopharmaceuticals' "radioactive imaging agent" Lymphoseek (technetium Tc 99m tilmanocept), which is "intended to help determine if breast cancer or melanoma has spread to a patient's lymph nodes." The approval was based on data from two clinical trials, "involving 332 patients with breast cancer or melanoma," that tested the safety of the diagnostic imaging drug, as well its ability to map lymph nodes in comparison to "an older drug." In a statement, announcing the approval, the FDA noted that Lymphoseek is the "first new drug" approved for locating lymph nodes "in more than 30 years." In 1981, the agency approved "isosulfan blue" for lymph node mapping.

Medscape (3/14, Chustecka) points out that "results from the clinical trial supporting the approval were presented at the annual meeting of the American Society of Clinical Oncology in 2011, and reported at the time by Medscape Medical News."

Data Indicate Double Mastectomies On The Rise Among Breast Cancer Patients.

In a 1,400-word article titled "Why More Women Are Choosing Double Mastectomies," CNN (3/13, Gilbert) reports, "The number of women with early stage breast cancer who went on to remove both breasts (even though only one breast had cancer) increased by more than 150% between 1998 and 2003, according to a study presented by Dr. Kelly Hunt at the annual conference for the American Society of Clinical Oncology." According to "unpublished reports released to CNN, 8% of patients sought prophylactic removal of their unaffected breast at MD Anderson Cancer Center in Houston in 2010. The percentage increased to 12.6% in 2011, and rose again to 14.1% in 2012, according to Hunt, who is chief of breast surgery at MD Anderson." Meanwhile a similar trend has been seen at New York's Memorial Sloan-Kettering Cancer Center. Research published in 2011 in the Journal of Clinical Oncology indicated that in 1997, the rate of women opting to have a double mastectomy even when cancer has been found in only one breast climbed from 6.7% in 1997 to 24% just eight years later. The article discusses several potential drivers of this trend, including plastic surgery advances and increased access to genetic screening.

Radiation For Breast Cancer Linked To Increased Risk Of Heart Problems.

Research linking radiation therapy to an increased risk of certain heart problems received a substantial amount of coverage in print and online. Despite the risk, experts said it does not mean that the treatment should not be used in breast cancer patients. Meanwhile, some experts pointed out that radiation treatments now pose less of a danger to the heart than during the time the patients in the study were treated. The Wall Street Journal (3/14, Beck, Subscription Publication, 2.29M) reports that, according to research published in the New England Journal of Medicine, women who undergo radiation therapy to treat breast cancer may face a higher risk of certain cardiovascular problems.

The Los Angeles Times (3/13, Brown, 692K) "Booster Shots" blog reports, "Writing in an editorial that accompanied the study, Dr. Javid Moslehi, co-director of the Cardio-Oncology Program at Brigham and Women's Hospital in Boston, argued that the findings should bolster efforts to offer cancer patients specialized cardiac treatment as they battle their disease." Dr. Moslehi "also suggested that the breast cancer-radiotherapy study might represent merely 'the tip of the iceberg' - that exposure to radiation might also increase risks of conditions like pericardial disease and arrhythmias." Additionally, "cancer treatments beyond radiation therapy might also increase heart disease risk, he said."

The Boston Globe (3/14, Kotz, 250K) "Daily Dose" blog reports, however, that some "oncologists...caution that the study findings may not apply to modern radiation treatments for breast cancer, which deliver lower doses using more targeted methods to minimize exposure to the heart." Meanwhile, study co-author Dr. Candace Correa said, "Breast cancer patients who are candidates for radiation should still receive radiation." Also covering the story are Reuters (3/14, Emery), MedPage Today (3/14), HealthDay (3/14, Doheny), and Medscape (3/14, Lowry).

DNA Test May Help Guide Care For Patients With Metastatic Breast Cancer.

USA Today (3/13, Szabo, 1.71M) reports, "A study in Wednesday's New England Journal of Medicine provides 'a window into the future' of breast cancer therapy, experts say." Investigators "looked at a new way to track a cancer's growth: measuring the amount of DNA that shakes loose from a cancer cell and floats freely in the blood, called circulating tumor DNA." Physicians "hope to use these measurements to assess how a patient's tumor responds to treatment, according to the study, which included 30 women with advanced breast cancer and was led by the University of Cambridge in the United Kingdom."

Medscape (3/14, Lowry) reports that the investigators "found that circulating tumor DNA was superior to the other 2 blood tests. Circulating tumor DNA was successfully detected in 29 of the 30 women (97%) with metastatic breast cancer receiving systemic therapy in whom somatic genomic alterations were identified." Comparatively, "CA 15-3 was detected in 21 of 27 women (78%) and circulating tumor cells were detected in 26 of 30 women (87%)."

HealthDay (3/14, Norton) reports that according to senior researcher Dr. Carlos Caldas, "The take-home message is that circulating tumor DNA is a better monitoring biomarker than the existing Food and Drug Administration-approved ones."

The Daily Telegraph (UK) (3/14, Adams, 871K) reports that "larger trials are underway to validate the test and see if it can help patients live longer."

High-Fat Dairy Products Linked To Lower Survival After Breast Cancer.

The San Francisco Chronicle (3/15, Colliver, 220K) reports, "People who are diagnosed with breast cancer and then go on to consume a steady diet of high-fat dairy foods increase their chances of dying years earlier than those who consumed low- to non-fat milk products, according to a new study" published in the Journal of the National Cancer Institute. Investigators "looked at the dietary habits of nearly 1,900 women, mostly Northern California Kaiser [Permanente] patients, who were diagnosed with relatively early-stage, invasive breast cancer between 1997 and 2000." The researchers found that "those who consumed one or more servings per day of high-fat dairy products - such as whole milk and cream, condensed or evaporated milk, ice cream and custards - had a 49 percent increased risk of dying from breast cancer during the 12-year follow-up than those patients who limited their amount of high-fat products, the study found."

Reuters (3/15, Begley) reports that the patients who consumed one or more high-fat dairy servings per day also had a 64 percent higher risk of death from all causes during the follow-up period.

HealthDay (3/15, Doheny) reports that the research was "supported by the U.S. National Cancer Institute."

Researchers Criticize Data Linking HRT To Breast Cancer.

MedPage Today (3/15, Walsh) reports, "The evidence as to whether hormone replacement therapy (HRT) plays a causal role in breast cancer is insufficient to support that hypothesis, and there are major flaws in studies analyzing the data, researchers stated" online in the Journal of Family Planning and Reproductive Health Care. During "the years immediately following the publication of the Women's Health Initiative (WHI) in 2002, the use of HRT plummeted, but rates of breast cancer have not consistently followed that pattern, explained Samuel Shapiro, MB, of the University of Cape Town in South Africa, and colleagues." Additionally, "two initial studies assessing the effect on breast cancer incidence following that decline - often cited as providing strong evidence for an association - do not hold up under scrutiny, Shapiro's group argued."

Seven Groups Say HRT Most Effective Treatment For Menopause Symptoms. MedPage Today (3/15, Gever) reports, "Hormone replacement therapy (HRT) is the most effective available treatment for menopause symptoms, according to a consensus statement" released by "the American Society for Reproductive Medicine, the Asia Pacific Menopause Federation, the Endocrine Society, the European Menopause and Andropause Society, the International Menopause Society, the International Osteoporosis Foundation, and the North American Menopause Society." Regarding breast cancer risk, the statement said, "The risk of breast cancer attributable to [HRT] is small and the risk decreases after treatment is stopped," although it did not offer explicit recommendations as to how this risk can be minimized.

Medscape (3/15, Garcia) reports, "The statement was published in the April issue of Climacteric and also in Maturitas."

Trastuzumab For HER2-Positive Breast Cancer May Be Linked To CNS Metastases.

Medscape (3/15, Lowry) reports, "Women with HER2-positive breast cancer who receive adjuvant trastuzumab (Herceptin, Genentech/Roche) have a significant risk for metastases in the central nervous system (CNS) as the site of first recurrence, according to a report published online March 4 in the Annals of Oncology." Investigators looked at data from four trials. They found that, "of the 4921 patients who received adjuvant trastuzumab, 125 developed CNS metastases as the site of first recurrence, for an overall incidence of 2.56% (95% confidence interval [CI], 2.07% - 3.01%)." In comparison, "of the 4099 patients who did not receive trastuzumab, there were 78 CNS events, for an incidence of 1.94% (95% CI, 1.54% - 2.38%)."