genius pill

June 04, 2007 - A drug described by some people as a "genius pill" for enhancing cognitive function provided relief to a small group of Rochester breast cancer survivors who were coping with a side effect known as "chemo-brain," according to a University of Rochester Medical Center study.

Sixty-eight women, who had completed treatment for breast cancer, participated in an eight-week clinical trial testing the effects of modafinil (Provigil). All women took the drug for the first four weeks. During the next month half of the women continued to receive the drug while the other half took an identical looking placebo pill. The women who took modafinil for all eight weeks reported major improvements in memory, concentration and learning.

"I am very enthusiastic about the potential we've demonstrated," said Sadhna Kohli, Ph.D., M.P.H., lead author of the study and a research assistant professor at the University of Rochester's James P. Wilmot Cancer Center. "This is a novel drug and after completing the trial, many of the women wanted to know how they could continue to get modafinil."

Kohli presents the research -- which is believed to be the first to examine the drug's use in breast cancer patients -- on June 3 at the American Society of Clinical Oncology meeting in Chicago. ASCO is honoring Kohli with a Merit Award.

Originally licensed to treat narcolepsy, modafinil promotes wakefulness and seems to boost brainpower without causing the jittery, restless feelings induced by amphetamines. Modafinil is part of a class of drugs called eugeroics, which stimulate the brain only when it is required. The effects of modafinil disappear in about 12 hours. For this reason, sleep-deprived college students, athletes, soldiers or others who want to gain an edge in a competitive environment sometimes seek out the drug, calling it a "genius pill."

The application for cancer care is unique and entirely appropriate, Kohli said. Although some in the scientific community doubt the existence of "chemo-brain," many cancer patients insist they are suffering from an impairment of brain function after chemotherapy and desire some form of relief. In a separate study last year, Kohli found that 82 percent of 595 cancer patients reported problems with memory and concentration. Importantly, the deficits can lead to job loss or social dysfunction.

Scientists have not yet discovered the precise cause of "chemo-brain." A separate research group at the University of Rochester is investigating the toxicity of cancer-killing drugs on healthy brain cells. In 2006 they showed that chemotherapy disrupts cell division in the hippocampus, the brain region essential for learning and memory.

Until now, cancer patients had few options. Some studies have tested Ritalin, which stimulates the central nervous system. But Ritalin has unwanted side effects like headaches, irritability and addiction, Kohli said. Since modafinil does not linger in the body, side effects are minimal, according to recent studies.

Initially, researchers looked at whether modafinil might help alleviate fatigue, another persistent side effect, given the drug's use in narcoleptic patients. Once researchers saw the drug's positive effect on fatigue, they conducted secondary analyses to assess whether modafinil could improve the breast cancer patients' memory and attention skills.

Results showed the women had a faster memory and could more accurately recognize words and pictures after four weeks on the drug. The ability to focus attention, however, did not change at first. But after taking modafinil for another four weeks, attention deficits improved and memory was even greater. Larger studies are still needed to confirm the results.

University of Rochester Medical Center

MRI detects cancers missed by mammography in breast cancer patients

June 04, 2007 - CHICAGO -- A unique examination of one treatment center's use of magnetic resonance imaging (MRI) in new breast cancer patients has found MRI to be superior to mammography in finding additional tumors in a breast in which cancer has already been diagnosed, and in detecting new tumors in a patient's supposedly healthy breast.

Two studies conducted by oncologists from Mayo Clinic (http://cancercenter.mayo.edu/) in Jacksonville, Fla., and presented June 2, at the annual meeting of the American Society of Clinical Oncology (http://www.asco.org/portal/site/ASCO) (ASCO), also revealed distinct patterns between MRI-detected ipsilateral tumors (cancer in the affected breast) and contralateral tumors (cancer in the unaffected breast) that could guide use of the screening technology, researchers say.

"These results prove that MRI can detect tumors missed by traditional exams, and can be vital in helping women choose the right course of treatment for their breast cancer," says Mayo radiation oncologist Laura Vallow, M.D. She and other radiation oncologists at the Multidisciplinary Breast Clinic (http://www.mayoclinic.org/breastcancerprogram-jax/) in Jacksonville scan both breasts of all newly diagnosed breast cancer patients with mammograms and MRI and so have been able to compare results from both screening techniques in hundreds of women.

In their study comparing MRI and mammography in detection of ipsilateral breast cancer -- the first such study of its kind in the nation --the researchers found that MRI detected tumors missed by mammography in 16 percent of 390 patients. Women with MRI-detected ipsilateral tumors tended to be younger or they had a primary breast tumor that was at least 1 centimeter in size. The primary tumors also belonged to many different breast cancer subtypes, and newly diagnosed tumors were different from the primary tumor in 29 percent of patients.

"This is an important finding because breast cancer tends to be more aggressive when diagnosed in younger women," says Dr. Vallow, the study's lead investigator. "This suggests that younger women who want breast-conserving surgery to treat newly diagnosed cancer may benefit from an MRI scan of the entire breast."

The second study, which compared MRI versus mammography in detection of contralateral breast cancer, found that MRI detected tumors missed by mammograms in 3.2 percent of 401 women. Some women participated in both studies, and in a few cases, MRI found tumors in both breasts that were not found by mammography.

Patients with MRI-detected tumors were more likely to be postmenopausal, and to have a common type of tumor, one classified as estrogen receptor (ER)-positive, says the contralateral breast study's lead investigator, oncology resident Johnny Bernard Jr., M.D., who works with Dr. Vallow. This result mirrors findings of a 969-patient study reported in April 2007 in the New England Journal of Medicine (http://content.nejm.org/) (NEJM) which concluded that MRI detected contralateral breast tumors in 3.1 percent of patients that had been missed by mammography. Data on 65 Mayo patients were part of the NEJM study.

Detecting contralateral breast cancer before a newly diagnosed patient is treated is important, says Dr. Bernard. "Patients can have treatment for both breast cancers simultaneously rather than the physical and psychological trauma of having a contralateral cancer detected years later," he says. "Furthermore, treatment recommendations by the physician may be affected by the finding of a contralateral cancer, as well as patient preferences for one treatment versus another, such as for mastectomy versus breast-conserving surgery.

"Patients with a diagnosis of breast cancer are considered high risk and therefore we contend that these patients should have a screening MRI to further evaluate the extent of ipsilateral disease and also to evaluate the contralateral breast," says Dr. Bernard.

"The combined results of these studies validate what we have already seen in our clinic, and that is that MRI breast cancer screening is quickly becoming an indispensable tool," says Dr. Vallow. "Studies like these are needed to pave the way toward greater use of MRI breast cancer screening in newly diagnosed patients."

However, Dr. Vallow acknowledges that MRI scans need to be "faster, cheaper, more accessible, and uniform across institutions," before it can be widely used, and cautions that cancer centers that use MRI also need to be able to perform MRI-guided biopsy of the suspected tumor, if necessary. "There is huge variation in how clinics conduct breast MRI screenings, because there is no quality control at the moment," she says. "Patients at centers that don't offer MRI-guided biopsy can end up having mastectomies because physicians there have no way to investigate the findings seen on the scan."

New guidelines, issued in April by the American Cancer Society (http://www.cancer.org/docroot/home/index.asp), recommend that women who are at high risk of developing breast cancer receive both annual MRI and mammography scans starting at age 30.

Remotely Activated Nanoparticles Destroy Cancer

Targeted nanotech-based treatments will enter clinical trials in 2007.
By Kevin Bullis
The first in a new generation of nanotechnology-based cancer treatments will likely begin clinical trials in 2007, and if the promise of animal trials carries through to human trials, these treatments will transform cancer therapy. By replacing surgery and conventional chemotherapy with noninvasive treatments targeted at cancerous tumors, this nanotech approach could reduce or eliminate side effects by avoiding damage to healthy tissue. It could also make it possible to destroy tumors that are inoperable or won't respond to current treatment.

One of these new approaches places gold-coated nanoparticles, called nanoshells, inside tumors and then heats them with infrared light until the cancer cells die. Because the nanoparticles also scatter light, they could be used to image tumors as well. Mauro Ferrari, a leader in the field of nanomedicine and professor of bioengineering at the University of Texas Health Science Center, says this is "very exciting" technology.
"With chemotherapy," Ferrari says, "we carpet bomb the patient, hoping to hit the lesions, the little foci of disease. To be able to shine the light only where you want this thing to heat up is a great advantage."
Although several groups are now working on similar localized treatments, Naomi Halas and Jennifer West have led the way in this area, and their work is the farthest along. (See "Nano Weapons Join the Fight Against Cancer.") Nearly ten years ago, Halas, professor of chemistry and electrical and computer engineering at Rice University, developed a precise and reliable method for making nanoshells, which can be hollow spheres of gold or, in the case of the cancer treatment, gold-coated glass spheres. These spheres are small enough (about 100 nanometers in diameter) to slip through gaps in blood vessels that feed tumors. So as they circulate in the bloodstream, they gradually accumulate at tumor sites.
Halas tuned the nanoparticles to absorb specific wavelengths of light by changing the thickness of the glass and gold. For the cancer treatment, she selected infrared wavelengths that pass easily through biological tissues without causing damage. To destroy a nanoshell-infiltrated tumor, the tumor is illuminated with a laser, either through the skin or via an optical fiber for areas such as the lungs.
"We shine light through the skin, and in just a few minutes, the tumor is heated up," Halas says. "In the studies that were initially reported--and this has been repeated now more than 20 times in at least three different animal models--we have seen essentially 100 percent tumor remission." The tests also suggest the nanoshells are nontoxic. Halas says they are eliminated from the body through the liver over several weeks. The technology was developed at Rice in collaboration with Jennifer West, a professor of bioengineering. It has been licensed by Nanospectra Biosciences, a startup based in Houston, TX, that is beginning the process of getting FDA approval for clinical trials for treating head and neck cancer. In the future, the technology could be used for a wide variety of cancers.
"There is a potential for this to bring a profound change in cancer treatment," Halas says. "For the case of someone discovering a lump in their breast, this would mean that a very simple procedure could be performed that would induce remission." She says that "for many, many cases of cancer, rather than the lengthy chemotherapy or radiation therapy," an individual would have "one simple treatment and very little side effects."
Halas anticipates that approval for the method will come quickly, in part because the nanotechnology is not a drug but a device, for which the approval process is simpler. Also, she expects it will perform the same in humans as in animal models, "because heat and light work in exactly the same way whether you're in a pig, a dog, [or] a human being."
Since their initial experiments, the researchers have been further developing the technology. They've demonstrated the ability to coat the nanoshells with antibodies that latch on to breast-cancer cells, further improving the selectivity of the treatment. They've also attached molecules that make the nanoshells into pH sensors that would be useful for both imaging tumors and as an "optical biopsy" for identifying cancers, Halas says.

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