Cancer Research:Early trial shows injectable agent illuminates cancer during surgery ♦ Painkiller tapped to become future cancer-killer ♦ Potential therapy targets for triple-negative breast cancer

Early trial shows injectable agent illuminates cancer during surgery A new injectable agent has been tested that causes cancer cells in a tumor to fluoresce, potentially increasing a surgeon's ability to locate and remove all of a cancerous tumor on the first attempt.

Unusual drug target, drug generate exciting preclinical results in mouse models of metastatic breast cancer A doctor treating a patient with a potentially fatal metastatic breast tumor would be very pleased to find, after administering a round of treatment, that the primary tumor had undergone a change in character – from aggressive to static, and no longer shedding cells that can colonize distant organs of the body. Indeed, most patients with breast and other forms of cancer who succumb to the illness do so because of the cancer’s unstoppable spread.

Painkiller tapped to become future cancer-killer Diclofenac, a common painkiller, has significant anti-cancer properties, according to researchers. Like other drugs examined by the ReDO project, diclofenac is cheap and readily accessible -- and as it's already present in many medicine cabinets, it has been carefully tested.

Study reveals potential therapy targets for triple-negative breast cancer In cancer, cell signaling pathways are the critical chain of events that can either quash or quicken disease progression. A new study has revealed new information about how molecules called long non-coding RNAs (lncRNA) interact with HIF-1, a signaling pathway that is overexpressed in many cancers. HIF-1 has been shown to regulate breast cancer progression.

Cancer Research: Study links gene to aggressive form of brain cancer ♦ National screening program has markedly reduced breast cancer mortality ♦ Daily aspirin could block growth of breast, other cancers

Daily aspirin could block growth of breast, other cancers  A new lab study found that a daily dose of aspirin was effective at blocking breast tumor growth. Previous studies have already shown a similar effect on colon, gastrointestinal, prostate, and other cancers.

New method detects early breast cancer via urine Medical researchers have developed an approach for detecting breast cancer by means of urine samples. The method involves determining the concentration of molecules that regulate cell metabolism and that are often dysregulated in cancer cells. These molecules, referred to as microRNAs, enter into the urine over the blood. By determining the composition of microRNAs in the urine, the scientists succeeded in establishing with 91 percent accuracy whether a test subject was healthy.

Study links gene to aggressive form of brain cancer Scientists have identified a gene mutation linked to the development of an aggressive form of brain cancer. Researchers found that errors in a gene known as TCF12 -- which plays a key role in the formation of the embryonic brain are associated with more aggressive forms of a disease called anaplastic oligodendroglioma.

National screening program has markedly reduced breast cancer mortality Under the Norwegian Breast Cancer Screening Program, all women aged 50 to 69 are invited for mammography screening every two years. The program was launched as a pilot project in four counties in 1995/96 and went national in 2004. The purpose of mammography examination is to detect tumors at an early enough stage to begin effective treatment and reduce mortality.

Cancer Research: Beating deadly hereditary stomach, breast cancers ♦ Evolution of high-risk leukemia ♦ Kidney cancer detected early with urine test + more

Bright new hope for beating deadly hereditary stomach, breast cancers  Deadly familial stomach and lobular breast cancers could be successfully treated at their earliest stages, or even prevented, by existing drugs that have been newly identified by cancer genetics researchers. Continue Reading

Scientists trace genomic evolution of high-risk leukemia  By genomic sequencing of leukemia cells from relapsed patients at different stages, scientists have discovered key details of how acute lymphoblastic leukemia cells mutate to survive chemotherapy.Continue Reading

Kidney cancer detected early with urine test  If kidney cancer is diagnosed early -- before it spreads beyond the kidney -- 80 percent of patients survive. However, finding it early has been among the disease's greatest challenges. Now, researchers have developed a noninvasive method to screen for kidney cancer that involves measuring the presence of proteins in the urine.Continue Reading

Vitamin D may keep low-grade prostate cancer from becoming aggressive  Taking vitamin D supplements could slow or even reverse the progression of less aggressive, or low-grade, prostate tumors without the need for surgery or radiation, scientists say Continue Reading

Regaining normal sexual functioning is 'rare' after prostate operations  Regaining normal erectile function is rare after the most common prostate operation, radical prostatectomy  Continue reading

Cancer Research: Popular Soda Ingredient Ups Cancer Risk--Milk proteins to treatment cancer-- Cancer treatment with new laser tech-- Drug target in certain breast and ovarian cancers

Popular Soda Ingredient Ups Cancer Risk  Public health researchers have analyzed soda consumption data in order to characterize people's exposure to a potentially carcinogenic by product of some types of caramel color. Caramel color is a common ingredient in colas and other dark soft drinks. Continue Reading

Milk proteins show promise in prevention and treatment of cancer  In a review of existing research, a team of Australian researchers found that milk proteins, consisting of short sequences called peptides, are potential candidates for the development of anticancer agents and can be generated by enzymatic action, such as those experienced during digestion or food processing, including fermentation. Their findings are in the recent issue of … Continue Reading

Potentially faster and more accurate mode of cancer treatment with new laser technology  Surgeons rely on 200-year-old technology when removing cancer -- sight and touch -- to determine how much to remove and what to leave alone. Laser technology has the promise to help a surgeon better determine if an area is cancer or healthy tissue. Moreover, when combined with laser treatment for cancer, this work lays the groundwork for laser robotic treatment of cancer.Continue Reading

Promising drug target in certain breast and ovarian cancers Scientists indicate that the pool of patients who can benefit from the drug olaparib is potentially much wider – and offers a ready means of identifying them. Continue Reading

Novel strategy to prevent progression of inflammation-associated cancers  By targeting the specific pathological function of the 'culprit' molecule rather than inhibiting its gene expression, new approach facilitates development of cancer drugs with fewer side effects  Continue Reading

Chicken Products Recalled Due to Staphylococcal Enterotoxin Contamination

Murry’s Inc.is recalling approximately 31,689 pounds of gluten free breaded chicken products that may be contaminated with Staphylococcal enterotoxin, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today.

The products have a best by date of August 9, 2015. The following products are subject to recall: [View Label (PDF Only)]

• 12-oz. boxes of “Bell & Evans Gluten Free Breaded Chicken Breast Nuggets.”
• 10.5-oz. boxes of “Bell & Evans Gluten Free Breaded Chicken Breast.”

The products subject to recall bear the establishment number “P-516” inside the USDA mark of Staphylococcal food poisoning is a gastrointestinal illness. It is caused by eating foods contaminated with toxin-producing Staphylococcus aureus.

Staphylococcus aureus is a common bacterium found on the skin and in the noses of healthy people and animals.Staphylococcus aureus can produce seven different toxins that are frequently responsible for food poisoning.

Staphylococcal enterotoxins are fast acting, sometimes causing illness in as little as 30 minutes. Symptoms usually develop within one to six hours after eating contaminated food. Patients typically experience several of the following: nausea, vomiting, stomach cramps, and diarrhea. The illness is usually mild and most patients recover after one to three days.

To prevent Staphylococcal contamination, keep kitchens and food-serving areas clean and sanitized.  Keep hot foods hot (over 140°F) and cold foods cold (40°F or under). Make sure to wash hands and under fingernails vigorously with soap and water before handling and preparing food. Do not prepare food if you have an open sore or wound on your hands or if you have a nose or eye infection.

Anyone concerned about a reaction should contact a healthcare provide

3D Technologies Poised to Change How Doctors Diagnose Cancers

Scientists at the Food and Drug Administration are studying the next generation of screening and diagnostic devices, some of which borrow from the world of entertainment. Soon, three-dimensional (3D) images in actual 3D might help your doctor find hidden tumors and better diagnose cancers, thanks to the regulatory work being done by a team at FDA’s Division of Imaging, Diagnostics, and Software Reliability.

The team is led by Division Director Kyle Myers, a physicist with a Ph.D. in optical sciences. It includes Aldo Badano, Ph.D., a world-renowned expert in display evaluation technology, and Brian Garra, M.D., a diagnostic radiologist doing research in regulatory science at FDA.

They are studying how clinicians receive visual information and analyze it to diagnose a disease. At the center of their research are breast cancer screening devices, which are making the leap from traditional two-dimensional (2D) screening such as mammography to 3D breast tomosynthesis, 3D ultrasound and breast computerized tomography (CT). This technology is very exploratory and years away from becoming standard in your doctor’s office.

New Era in Breast Cancer Detection

There are many new technologies being developed for breast cancer screening, especially 3D alternatives that may eventually replace today’s 2D mammography. FDA has already approved two of these state-of-the-art devices: The Selenia Dimensions 3D System, which provides 3D breast tomosynthesis images of the breast for breast cancer diagnosis; and the GE Healthcare SenoClaire, which uses a combination of 2D mammogram images and 3D breast tomosynthesis images.

The technologies under development include 3D breast tomosynthesis, which artificially creates 3D images of the breast from a limited set of 2D images. Tomosynthesis reveals sections of the breast that can be hidden by overlapping tissue in a standard mammogram.

“The problem of overlapping shadows has confounded breast cancer screening because mammograms don’t show cancers that are hidden by overlapping tissue,” Myers says. And compounding the problem is overlapping tissue that can look like cancer but isn’t. “The new technologies we’re studying overcome these barriers,” she adds.

Another benefit of 3D breast tomosynthesis: It’s more accurate than mammography in pinpointing the size and location of cancer tumors in dense breast tissue, Myers says. With 3D breast tomosynthesis, doctors can detect abnormalities earlier and better see small tumors because the images are clearer and have greater contrast.

“Clinical studies have shown that 3D breast tomosynthesis can increase the cancer detection rate, reduce the number of women sent for biopsy who don’t have cancer, or achieve some balance of these two goals of this new screening technology,” she adds.

There’s also a lot of research and development in 3D ultrasound, which automatically scans the breast and generates 3D data that can be sliced and examined from any direction. Garra, who is a leader in this field, says 3D ultrasound improves breast cancer detection in women with dense breast tissue.

“Both 3D breast tomosynthesis and 3D ultrasound detect breast cancer. But for radiologists and other doctors, there are many more images to examine, and that can reduce the speed at which studies can be interpreted,” he says.

Another promising technology—the dedicated breast CT system—creates a full 3D representation of the breast. The scan is taken while the patient lies face down on a bed with her breast suspended through a cup and the X-ray machine rotates around it. For patients, the procedure is more comfortable than regular mammography because the breast isn’t compressed. Also, there’s less radiation exposure than during a CT exam of the entire chest because only the breast is exposed to X-rays.

Health care practitioners using this technology have to learn how to read and interpret hundreds of high-resolution images produced by the scanner. But what makes the task easier is that the images have less distortion than mammography, and the system is optimized to differentiate between the breast’s soft tissue and cancer tissue.

“These images will be very different from 2D mammograms. They’re truly 3D images of the breast from any orientation. You can scroll through the slices—up and down, left and right—and get a unique view of the breast like never before,” Myers says. “It gives doctors tremendous freedom in how they look at the interior of the breast and evaluate its structures. It’s almost like seeing the anatomy itself.”

New Era in How We See

How can radiologists look at these images and convert them into three dimensions? That’s where Badano’s work comes in. His research lab is exploring various display device technologies to improve how radiologists review 3D images. The studied technologies include devices supported by mobile technologies and special-purpose 3D displays developed specifically for 3D imaging systems.

“These are no longer conventional images, so you need to examine them in the 3D space,” he says. “Using a 2D display might no longer be ideal.” Device manufacturers are building on technologies developed primarily for other markets, including the gaming industry, to show 3D images in actual 3D. But the work is painstaking and far from ready for a medical use.

“As people have experienced in movie theaters and when playing videogames, 3D displays have problems, including the image resolution and added noise. When wearing 3D glasses, our brain needs to separate the images from the left eye and the right eye and reconstruct a 3D object,” Badano says. “In the lab, we’re doing experiments to see how different technologies handle these tradeoffs.”

One of the challenges is that 3D displays for medical imaging require better resolution. For a medical use, the specifications are high—“and so are the stakes,” he adds.

Canada: Grilled Chicken Breast Strips Recalled Due to Listeria

Freshouse Foods Ltd. is recalling Kirkland Signature brand Grilled Chicken Breast Strips from the marketplace due to possible Listeria contamination. Consumers should not consume the recalled product described below.

The following product is known to have been sold in Ontario, Quebec, New Brunswick, Nova Scotia, Newfoundland and Labrador, but may also have been sold in other provinces.

Recalled products

Brand Name	Common Name	Size	Code	UPC
Kirkland Signature	Grilled Chicken Breast Strips	2 x 500 g	Best Before APR13-APR26, inclusive	0 96619 70787 4

What you should do

Check to see if you have recalled products in your home. Recalled products should be thrown out or returned to the store where they were purchased.

Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still make you sick. Symptoms can include vomiting, nausea, persistent fever, muscle aches, severe headache and neck stiffness. Pregnant women, the elderly and people with weakened immune systems are particularly at risk. Although infected pregnant women may experience only mild, flu-like symptoms, the infection can lead to premature delivery, infection of the newborn or even stillbirth. In severe cases of illness, people may die.

Cancer Deaths Declining from 4 Types of Cancer

The CDC's Annual Report to the Nation on the Status of Cancer, covering the period 1975–2010, showed death rates for lung cancer, which accounts for more than one in four cancer deaths, dropping at a faster pace than in previous years. The recent larger drop in lung cancer deaths is likely the result of decreased cigarette smoking prevalence over many years.

The lung cancer death rate decline, as well as declines in colorectal, breast, and prostate cancer death rates, has also helped drive decreases in death rates for all cancers types combined, a trend that began about 20 years ago. The decreased death rates for these four cancers accounted for more than two-thirds of the overall reduction in cancer death rates in the period 2001–2010.

However, the report showed that death rates increased for some cancers, including cancers of the liver and pancreas for both sexes, cancers of the uterus in women, and, in men only, melanoma of the skin and cancers of the soft tissue in this 10-year period.

During the period of 2001–2010, overall cancer incidence rates decreased by 0.6 percent per year among men, were stable among women, and increased by 0.8 percent per year among children (ages 0 through 14 years), continuing trends from recent reports.

The special feature of this year's report highlights the prevalence of other disease conditions, (diabetes, chronic lung disease, cardiovascular disease, and 13 others) in cancer patients over 65 years of age, and how they affect survival.

As in previous years, this year's study was conducted by the Centers for Disease Control and Prevention in collaboration with the American Cancer Society, the National Cancer Institute, and the North American Association of Central Cancer Registries.

Nipple Aspirate Test is No Substitute for Mammogram

Many women admit that getting a mammogram is no fun, and may wish there was an easier, more comfortable way to screen for breast cancer in its earliest and most treatable stages.

Some companies today are promoting a test in which a breast pump is used to collect fluid from a woman's nipple to screen for abnormal and potentially cancerous cells. This test—called a nipple aspirate—is being marketed as the latest and greatest tool in early breast cancer screening, one that is easier, more comfortable and less painful than the mammogram.

However, there is no clinical evidence to support these claims, says David L. Lerner, M.D., a medical officer at the Food and Drug Administration (FDA) and a specialist in breast imaging.

"FDA's concern is that the nipple aspirate test is being touted as a stand-alone tool to screen for and diagnose breast cancer as an alternative to mammography," Lerner explains. "Our fear is that women will forgo a mammogram and have this test instead." This could result in serious health consequences if breast cancer goes undetected, he notes.

FDA is unaware of any valid scientific data to show that nipple aspirate tests, when used on their own, are an effective screening tool for any medical condition, including the detection of breast cancer or other breast disease, Lerner says. Researchers are still studying whether these tests may one day be used, in conjunction with other medical devices, to screen for disease.

In February 2013 FDA issued a warning letter to Atossa Genetics, Inc. that, among other things, informed the company that their test was misbranded in that its labeling was false or misleading. The agency asked the firm to take prompt action to correct the violations addressed in the warning letter. In October 2013, Atossa initiated a voluntary recall to remove the ForeCYTE Breast Health Test from the market.

Unsubstantiated Claims

In addition to stating that the test can help women 18 years and older determine their risk level for breast cancer, Atossa claimed that its test was "literally a Pap smear for breast cancer." According to FDA medical officer Michael Cummings, M.D., who reviews obstetrical and gynecological devices for the agency, this claim is unsubstantiated.

"The cervical Pap smear has a known clinical benefit supported by extensive clinical studies over many years," Cummings says. "Its scientific ability to screen for cervical cancer is unquestioned." The nipple aspiration test has no such evidence supporting it, he attests.

In addition, Lerner explains that if a Pap smear shows abnormal cells of the cervix, there are follow-up procedures that can be done to try to identify the location of those cells, after which a biopsy of the area is possible. With a breast nipple aspirate, if there are abnormal cells, the test does not target where those cells are coming from, so a biopsy may not be possible. Moreover, while the risk of abnormal cervical cells progressing to cancer is known, the risk of abnormal breast cells progressing to cancer is not.

Lerner says the test may produce results that are falsely positive or falsely negative. "False positives are possible because cells can be damaged in the aspiration process and look abnormal," he notes. "We are even more concerned about false negatives," he adds. Companies acknowledge that over 90% of their fluid samples may contain either very scant cells or no cells at all. Yet the companies call such results "diagnostically useful" and even conclude that a patient is healthy based on a cell-free sample, he says. "The test may be missing cancers and giving women dangerous false assurance," Lerner says.

Mammography Still the Best

The mammogram can be uncomfortable for the woman being screened because it compresses the breast to flatten out the breast tissue and increase the clarity of the X-ray image. Still, FDA is not alone in believing that mammography is the most effective method for screening for breast cancer. Other organizations agree, including the American Cancer Society, the American College of Radiology (the professional society of physicians who specialize in medical imaging) and the National Cancer Institute, a division of the National Institutes of Health.

The National Cancer Institute states that screening mammography can help reduce the number of deaths from breast cancer among women ages 40 to 70. The National Comprehensive Cancer Network (NCCN) 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and that it should not be used as a breast cancer screening technique.

FDA recommends that women who have received a nipple aspirate test as a form of breast cancer screening should also have a mammogram according to screening guidelines or as recommended by their doctor, and should talk to their health care professional about whether additional tests are needed.

"The bottom line is that women should not rely solely on these nipple aspirate tests for the screening or diagnosis of breast cancer, "Lerner says. "Mammography is still the gold standard."

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.