The January/ February 2009 edition of Australian Family Physician, the flagship journal of The Royal Australian College of General Practitioners (RACGP), features a range of articles and research focusing on key issues in general practice today. The January/February 2009 edition includes the following articles:

HPV vaccination catch up program – Utilisation by young Australian women

Edith Weisberg, Deborah Bateson, Kirsten McCaffery, S Rachel Skinner

The human papilloma virus (HPV) vaccine provides protection against HPV types 6 and 11, and 16 and 18. The Australian Government’s offer of free vaccination to women aged 18-26 years of age through general practitioners ends 30 June 2009. This study’s objective is to determine the percentage of women attending Family Planning New South Wales (FPNSW) clinics aged 26 years or less who were aware of the free HPV vaccination program and had received a full course of the vaccine or had at least one injection. More??¦

GPs’ concerns about medicolegal issues – How it affects their practice

Louise Nash, Merrilyn Walton, Michele Daly, Maree Johnson

General practitioners’ concerns about medicolegal issues have been shown to influence the practice of medicine. This research looks at GPs’ beliefs about medicolegal issues and how medicolegal concerns affect their practice. More??¦

New action plans for the management of anaphylaxis

Andrew S Kemp, Wendy Hu

The Australasian Society for Clinical Immunology and Allergy has developed new anaphylaxis (a sudden life threatening allergic reaction) action plans intended for use across Australasia. These educational tools aim to give patients and carers easily accessible information about key steps in the emergency treatment of acute allergic reactions and anaphylaxis. This article outlines the rationale for these plans, introduces two new action plans and key practice points to consider when providing these plans. More??¦

Compounded medicines and ‘off label’ prescribing – A case for more guidance

Romano A Fois, Barry T Mewes, Andrew J McLachlan

Interest by prescribers and pharmacists in the provision of individualised pharmaceutical therapy in the form of compounded medicines (for example one-off specially prepared medicines usually prepared by a pharmacist) has grown in recent times. However, there have also been a number of case reports of patient harm associated with these medicines. This study aims to highlight areas for clinicians and pharmacists to consider when prescribing or dispensing compounded medicines, which are consistent with quality use of medicines principles. More??¦

All articles are available to read online at racgp.au/afp.

Australian Family Physician is the journal of The Royal Australian College of General Practitioners. It is a peer reviewed journal, publishing original articles and reviews dedicated to meeting the ongoing educational requirements of general practitioners. For more information including subscription to the print version, visit racgp.au/afp.

The Royal Australian College of General Practitioners (RACGP) is responsible for maintaining standards for quality clinical practice, education and training, and research in Australian general practice. The RACGP has the largest general practitioner membership of any medical organisation in Australia and represents the majority of Australia’s general practitioners.

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Research led by a scientist at Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center has opened the door for the advancement of a new category of painkillers, called TRPV1 antagonists.

These drugs block the transient receptor potential vannilloid-1 (TRPV1) channel, which is the same receptor responsible for the sensation of hotness from hot peppers. However, clinical trials have revealed that TRPV1 antagonists cause hyperthermia – a dangerous, fever-like rise in body temperature.

Research has shown that TRPV1 can be activated by several stimuli, including “pepper-like” chemicals, high temperatures and protons. The same channel is responsible for pain caused by these diverse stimuli. For a number of years scientists have focused on the development of TRPV1 antagonists, but have been stymied by the dangerous hyperthermia side effect.

The groundbreaking project to eliminate the side effect was led by Andrej A. Romanovsky, MD, PhD, at Barrow and included researchers from Amgen and Arizona State University. Their findings, published last month in the in the Journal of Neuroscience, show the side effect can be avoided.

“We think we have found a recipe for making TRPV1 antagonists that do not have this fever-like side effect,” says Dr. Romanovsky. “If an antagonist does not block activation of the TRPV1channel by protons, it does not cause hyperthermia.” This research suggests that drugs that are being developed should be designed not to block the proton activation of TRPV1.

Even though pain is a major clinical problem and the search for new painkillers has been conducted by pharmaceutical companies and academic scientists for many years, the TRPV1 channel is one of the very few novel targets for pain identified so far. To continue developing TRPV1 antagonists, it was necessary to find a way to eliminate their hyperthermic side effect. “And, this is exactly what our study did,” Dr. Romanovsky said.

Scientists believe that this new generation of painkillers will be effective in treating pain related to a number of conditions including cancer, AIDS, migraines and diabetes.

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University of South Florida researcher Barbara Hansen, PhD, will likely never be invited to talk about weight loss on Oprah. Her message is mundanely common sense, not faddish ??” she doesn’t drop phrases like “low carb,” or “low fat,” or “geared to your body type” or “put your body into fat-burning mode.”

“The fact is that the price of leanness is eternal vigilance — losing and keeping off weight requires a lifelong effort. It amounts to maintaining a constant, realistic balance between total calories consumed and total calories expended,” said Dr. Hansen, a physiologist and psychologist specializing in obesity, diabetes and their age-related health complications.

Dr. Hansen, a professor of medicine and pediatrics, directs the USF Health’s Center for Preclinical Research, which combines obesity, diabetes and aging research, and the Diabetes Complications Prevention Center. Her latest studies with rhesus monkeys have shown that lifetime calorie restraint to prevent obesity is the most powerful way to reduce age-related health problems such as high blood pressure and high triglycerides and to prevent or delay the progression of insulin resistance toward diabetes. Monkeys whose food intake was maintained in amounts to assure a constant healthy body weight were not only healthier; on the average they lived longer than their counterparts who ate as much as they wanted.

“Our studies have unequivocally demonstrated that if you prevent excess fat deposits in the body through excess calorie restraint, you’ll improve health and postpone death,” said Dr. Hansen, who is scheduled to present the findings Feb. 17 at the American Association for the Advancement of Science Annual Meeting in St. Louis.

She is quick to point out that scientific evidence does not support assertions that the epidemic of obesity is the fault of the obese themselves or a “toxic” environment that seduces people with super-sized menus and convenience food at every corner. “There’s a tendency to enter into a ‘blame the patient’ approach of ‘you did this to yourself and you can fix it,’” Dr. Hansen said. “That’s unfair and inappropriate.”

There is still much scientists don’t know about the complex interaction of genetic and environmental factors that predispose some individuals to obesity while others seem to eat to their heart’s content without packing on pounds. Dr. Hansen considers “single cause” hypotheses such as diet composition, inactivity and obesity genes alone as too simplistic. “Obesity is a continuum that develops early or late, quickly or slowly, with a heavy dose of genetic predisposition,” she said.

Studies support the concept that each person has an age-related “set” point for weight somehow regulated by physiology and genetics. This may help explain why more than 95 percent of dieters who shed 35 extra pounds or more eventually regain the weight, Dr. Hansen said. “Basically, while your weight may fluctuate throughout life, your body’s natural tendency is to return to its individually programmed body composition.”

Dr. Hansen’s team is working to understand the underlying mechanisms of obesity that might lead to new drugs that more specifically target centers in the brain, liver and muscles that regulate weight. These would include compounds, known as mimetic agents, capable of mimicking the benefits of calorie restriction without leaving a person feeling constantly hungry. “Until we have new calorie restriction mimetic agents we need to be more accepting of obesity and its consequences,” she said.

And what about those who are not clinically obese, but nonetheless battle the bulge as they approach middle age and beyond? Dr. Hansen suggests setting realistic goals.

“I highly recommend the bathroom scale model of weight loss. If you see your weight creeping up, then cut back on your portions,” she said. “A 10-percent daily reduction in the total calories you consume may produce a small, but at least sustainable, weight loss. And, even a modest approach to calorie restraint can have positive health benefits.”

Contact: Anne DeLotto Baier
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Vicept Therapeutics, Inc. announced positive study results from a Phase II clinical trial evaluating the dose-response relationship of four concentrations of V-101 cream, a topical cream for the treatment of Type I Rosacea (Erythematotelangiectatic Rosacea). The results demonstrated a statistically significant (p=0.0006) improvement in the primary end point, which was a reduction in facial erythema, over an eight hour period in patients with erythematotelangiectatic rosacea (ETR), versus placebo. Further, V-101 demonstrated a safety profile similar to placebo cream and no evidence of “rebound” or tachyphylaxis was observed.

“These positive data showed that V-101 significantly reduced the redness associated with Type I rosacea (ETR) and demonstrated a favorable side effect profile, further confirming its potential to be the first effective topically applied therapy directed specifically toward the erythema of rosacea,” said Dr. Neal Walker, President and Chief Executive Officer of Vicept. “This is a major milestone for the Company and we are poised and committed to continue the advancement of the V-101 development program.”

Study V-101-ROSE-202 is a prospectively randomized, multi-centered, double-blinded, placebo-controlled, Phase II clinical trial designed to evaluate the dose-response relationship of four concentrations of V-101 cream vs. vehicle (placebo) for the treatment of the erythema associated with rosacea. A total of 183 patients with moderate to severe erythema participated at seven investigational centers across the United States. Patients were divided among five groups and self-administered one of four concentrations of V-101 cream or vehicle (placebo) cream once daily for 28 days. The study also demonstrated that V-101 cream was well-tolerated in these patients, a population of patients with facial skin that is highly sensitive to topical preparations. The safety profile of all the active preparations was similar to that of placebo.

About Rosacea

Rosacea is a common, chronic cutaneous disorder that affects over 15 million Americans and over 45 million people worldwide. Erythematotelenagietic rosacea (ETR), Type I, is the most commonly encountered subtype, and is most characterized by frequent episodes of transient facial erythema (flushing) and non-transient, or persistent, erythema. It may also be accompanied by facial edema, burning, or stinging, and sensitivity of the skin and intolerance to topically applied products is common. Rosacea remains a disorder of uncertain etiology and pathogenesis, though the flushing and erythema of ETR are theorized to arise from an abnormal response of the cutaneous blood vessels of the face to neurological, hormonal, thermal, topical, or other stimuli, resulting in an abnormal dilation of facial blood vessels. There is currently no approved topical therapy for the treatment of ETR (erythematotelangiectatic) rosacea.

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The U.S. Food and Drug Administration approved the Endeavor Zotarolimus-Eluting Coronary Stent for use in treating patients with narrowed coronary arteries, the blood vessels supplying the heart.

The Endeavor is the first drug-eluting stent approved since 2004 and the first since FDA convened its Circulatory System Devices Panel in 2006 to discuss evidence of the rare risk of blood clots occurring in patients who receive drug-eluting stents.

Manufactured by Medtronic, Inc., of Minneapolis, the device is a tiny metal mesh tube coated with a small amount of a new drug, zotarolimus, developed only for use on a stent. It is crimped around a balloon and delivered to the narrowed section of the coronary artery via a long thin catheter during a procedure known as an angioplasty. Once the stent is positioned, the balloon is inflated, expanding into the vessel wall where it will remain in place, acting as a mechanical scaffold to keep the artery open.

Slow release of zotarolimus over time prevents the artery from re-narrowing when new tissue begins to form. This process, known as restenosis, can eventually require a repeat angioplasty.
“The Endeavor drug-eluting stent provides cardiologists with another option for treating the one million patients who undergo an angioplasty procedure every year to open their clogged coronary arteries,” said Daniel Schultz, M.D., director of the Center for Devices and Radiological Health. “This important approval is the result of a substantial amount of clinical evidence and a careful review by both FDA and its advisory committee.”

Medtronic provided data from seven clinical trials in its marketing application. Studies showed that the Endeavor significantly reduced the number of major coronary events – heart attack, cardiac death and repeat procedures to re-open the artery – compared to a bare-metal stent (a stent without a drug coating). It also cut the restenosis rate by about half.

Imaging studies on a subset of patients indicated that the Endeavor’s restenosis rate was higher than what is seen in currently marketed drug-eluting stents. However, the Endeavor had a similar number of coronary events when compared to one of these stents.

The number of adverse events experienced by patients implanted with the Endeavor stent was similar to those that occurred in patients implanted with bare-metal stents and existing drug-eluting stents.

Based on recent concerns over the rare but serious side effect of blood clots or stent thrombosis, FDA asked Medtronic to combine data from all Endeavor trials to determine how often this happened at various points in time following stent implantation. The stent thrombosis rate was 0.4 percent at one year and 0.5 percent at two years, a rate similar to that for bare-metal stents. To reduce such clotting risk, patients receiving the Endeavor will need to take blood-thinning medication for at least six months after implantation and should consider continuing this regimen for 12 months if they are not at an increased risk for bleeding complications.

The safety and effectiveness of the Endeavor stent in smaller diameter arteries or for longer blockages requiring more than two stents has not been studied and there has been no evaluation of the stent’s safety and effectiveness in patients who are having an acute heart attack, patients who had previous intravascular radiation treatment, or patients who have their blockage in a bypass graft, in the left main coronary artery, or in more than one vessel.

Patients who are allergic to zotarolimus or to cobalt, nickel, chromium, or molybdenum should not receive an Endeavor stent. Caution is also recommended for people who have had recent cardiac surgery and for women who are nursing or who may be pregnant.

Medtronic will continue to follow patients enrolled in six of the Endeavor trials for five years. Additionally, the company will conduct a 2,000-patient U.S. post-approval study, which will be combined with 3,300 patients from a study conducted outside the United States, to assess the long-term safety and effectiveness of the Endeavor stent and to look for rare adverse events such as stent thrombosis. Medtronic will also collect clinical data to identify the optimal duration of blood-thinning medication.

Before drug-eluting stents were available, about 15 percent to 30 percent of patients experienced restenosis within a year, requiring a repeat angioplasty. This number has dropped to 10 percent of patients since drug-eluting stents entered the U.S. market in 2003.

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Could a holiday in the sun reduce the risk of developing multiple sclerosis? In a recent review for F1000 Medicine Reports, Bridget Bagert and Dennis Bourdette highlight recent advances in potential treatments.

Multiple sclerosis (MS) results from a failure of the body to recognize itself. The immune system attacks and destroys the sheath that protects nerve fibres, as if it were a foreign body or infection. Vitamin D, which is produced in the skin in response to natural sunlight, is an immune system regulator. This might explain why MS is less common in sunnier countries.

Giving MS sufferers vitamin D pills – or encouraging them to spend more time in the sun – might be a cheap and easy treatment. Bagert and Bourdette point out that oral vitamin D therapy is now in phase II clinical trials, to see how well it works and how much would be needed.

They say “The arrival of effective oral agents will give MS patients more therapeutic options and will be a major advance in the global effort to alter the natural history of this chronic disease”.

Dennis Bourdette, Faculty Member for F1000 Medicine, is chairman of the Department of Neurology and director of the Multiple Sclerosis and Neuroimmunology Center at Oregon Health and Science University, USA.

Bridget A Bagert is a member of the Department of Neurology, Louisiana State University Health Sciences Center, USA

The full text of this article is available at f1000medicine/reports/10.3410/m1-34/.

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Do you have diabetes or do you care for someone with diabetes? Do you want to get involved in shaping your local diabetes care?

As part of the next stage of the Diabetes UK User Involvement in Local Diabetes Care project the charity is now looking for local people with diabetes wanting to get involved in the project and influence diabetes services.

North Mersey user involvement group

In the first instance, Diabetes UK is now setting up its user involvement group for the North Mersey area. People with diabetes wanting to get involved in the project can email the project manager at corinne.mccrumdiabetes or call 020 7424 1008 for more information.

North Mersey Diabetes Network is one of the three chosen partners for this user involvement project. The network consists of Liverpool PCT, NHS Sefton and NHS Knowsley. The network has approximately 41,000 people registered with diabetes.

Lincolnshire user involvement group

Diabetes UK will also shortly call for people to get involved in its Lincolnshire group. NHS Lincolnshire is one of the two other chosen partners for the project.

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“We looked at other processors, but having memory and I/O, and a dedicated C compiler with examples made Rabbit the right choice” – Martin Brown, Best Medical Canada

One of the most effective methods to combat cancer and tumors is radiation therapy. Along with the benefits there also exists a significant level of risk, since too much radioactive exposure can cause new formations of cancer or even lead to death. In order to protect from over-exposure, a subspecialty called dosimetry calculates the radiation level of in a mass or tissue. Measurements are made with a device called MOSFET (Metal Oxide Field Effect Transistor) dosimeter. Dosimeters have become widely popular for clinical use, especially with radiotherapy. With the help of the RCM3100 RabbitCore, Best Medical Canada is taking dosimetry to a whole new level.

Martin Brown, an Engineering Technologist at Best Medical Canada brings insight into the innovations and improvements of dosimeter technology. Traditional MOSFET dosimeter verification systems have typically consisted of large machines with numerous wires and power supplies, all of which are connected to the wall. Brown explained that Best Medical Canada identified a market in which the mobileMOSFET would be ideal, focusing on portability and ease of use.

“We felt that the market would benefit from a smaller battery powered wireless product with minimal size and cables,” stated Brown.

The mobileMOSFET is a wireless dose verification system, which is a portable, easy-to-use, and seamlessly integrated system. The system minimizes QA time, making the device ideal for a busy radiotherapy center. Best Medical Canada’s mobileMOSFET system is entirely software driven, allowing for remote control of multiple systems from one PC. The system consists of Remote Monitoring Dose Verification Software, a wall-mounted Bluetooth® Wireless Transceiver, and a small Reader Module that acts as a channel between the MOSFET and software.

MOSFET dosimeters placed on the patient connect to a reader module that transmits data to a PC via a Bluetooth transceiver. As a patient is irradiated, the MOSFET sensors measure the level of exposure and the reader module captures the readings. The reader module, which contains the RCM3100, processes the information and sends the information to a PC via Bluetooth.

Multiple wireless readers allow multiple patients to be monitored from one PC. The verification system allows health professionals to treat more patients with better accuracy, using real-time data. More traditional dosimeter systems require a level of maintenance due to the extra cabling that must be connected and reconnected as well as the reduction of mobility in the treatment room.

In the heart of the mobileMOSFET reader module resides an RCM3100 RabbitCore® module, the main processing unit in the reader module. When the PC requests information from the sensors, the RCM3100 monitors the request, turning on power supplies and appropriate analog switches for configuration. The I/O pins check whether any sensors are connected. The RCM3100 processes the gathered information from the dosimeters and sends the data back to the main PC. Brown pointed out medical equipment must meet certain criteria.

“All of our medical products need to be rigorously tested to comply with European CE regulations. A large concern to our design engineers was the EMI emissions and susceptibility tests,” Brown said.

He further explained that for a time the weakest link in the system was the microprocessor, though after seeing a Rabbit advertisement in a magazine, they felt it was worth a try.

“Sample code to reduce time-to-market and great EMI performance was very beneficial,” said Brown.

Not only did Dynamic C® and the sample programs help Best Medical Canada to bring mobileMOSFET to market quickly, but the microprocessor’s low EMI also fit their strict requirements.

“The ability to step through the software in a core module while it is actively installed in a target board has helped a great deal in developing code,” stated Brown. “We looked at other processors, but having memory and I/O, and a dedicated C compiler with examples made Rabbit the right choice.”

Rabbit once again provided a product that truly meets the needs of the customer. The RCM3100 allowed Best Medical Canada to bring dosimetry to the next level, helping medical professionals provide patients with the highest quality of care.

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Roche announced today that the European Commission has approved MabThera (rituximab) for first line use in treatment of indolent non-Hodgkin’s lymphoma (NHL) in combination with conventional chemotherapy.

The European Commission’s decision was based on phase III study results which showed MabThera in combination with CVP (cyclophosphamide, vincristine and prednisolone) chemotherapy to be significantly superior to CVP chemotherapy alone:

– Time to treatment failure was significantly prolonged by more than 1? years: 26 months versus 7 months

– Freedom from disease progression was nearly doubled: 27 months versus 15 months

– More patients responded to the combination treatment: overall response rate was 81% versus 57 %, and complete response rate quadrupled to 41% from 10%

“This approval is excellent news for the many indolent NHL patients suffering from this potentially fatal disease,” said William M. Burns, Head of Roche’s Pharmaceuticals division. “MabThera in combination with chemotherapy is a vital treatment option, and making it available to patients across Europe underlines its position as the standard of care in indolent NHL.”

MabThera monotherapy was approved for the treatment of relapsed or refractory indolent NHL in June 1998 and in combination with CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) chemotherapy for treatment of aggressive NHL in March 2002. Non-Hodgkin’s lymphoma affects 1.5 million people worldwide. Indolent NHL, representing about 45% of NHL patients, is a slow developing but serious cancer of the lymphatic system, and patients are prone to relapse after treatment.

“This approval for MabThera marks a major advance in the treatment of indolent NHL,” said Kapil Dhingra, Vice President Roche Oncology. “By every criterion of effectiveness, whether time to progression, disease-free survival or duration of response, patients who received MabThera in addition to chemotherapy had a superior outcome as compared to those receiving conventional chemotherapy only. This is the first time that the addition of a well tolerated biologic agent to chemotherapy has led to such a significant clinical benefit in this condition.”

About the study

The filing for approval of MabThera in indolent NHL was based on final results from the multi-centre, phase III randomised study, which involved 321 patients from 11 countries and compared a treatment regimen of MabThera plus CVP chemotherapy with CVP chemotherapy alone. Patients were previously untreated and were diagnosed with advanced stage, indolent (follicular) NHL. Of the 321 patients involved, 159 were randomised into the CVP chemotherapy group and 162 into the MabThera plus CVP chemotherapy treatment group.

About MabThera

MabThera is a therapeutic antibody that binds to a particular protein – the CD20 antigen – on the surface of normal and malignant B-cells. It then recruits the body’s natural defence to attack and kill the marked B-cells. Stem cells (B-cell progenitors) in bone marrow lack the CD20 antigen, allowing healthy B-cells to regenerate after treatment and return to normal levels within several months. MabThera is known as Rituxan in the United States, Japan and Canada. More than 300,000 patients have been treated with MabThera worldwide to date. Genentech and BiogenIdec co-market MabThera in the United States, and Roche markets MabThera in the rest of the world, except Japan, where MabThera is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.

Roche in Oncology

Within the last five years the Roche Group including its partners Genentech in the US and Chugai in Japan has become the world’s leading provider of anti-cancer treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented four marketed products with survival benefit in different major tumor indications: Xeloda and Herceptin in advanced stage breast cancer, MabThera in non-Hodgkin’s lymphoma, and Avastin in colorectal carcinoma. In the United States Herceptin, MabThera and Avastin are marketed either by Genentech alone or together with Biogen Idec Inc. Outside of the United States, Roche and its Japanese partner Chugai are responsible for the marketing of these drugs.

The Roche oncology portfolio also includes NeoRecormon (anaemia in various cancer settings), Bondronat (prevention of skeletal events in breast cancer and bone metastases patients, hypercalcemia of malignancy), Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and Roferon-A (hairy cell and chronic myeloid leukaemia, Kaposi’s sarcoma, malignant melanoma, renal cell carcinoma). CERA is the most recent demonstration of the commitment to anaemia management. The Roche Group’s cancer medicines generated sales of more than 6 billion Swiss francs in 2003.

In a recent phase III study Tarceva met its primary endpoint of improving overall survival in patients with non-small cell lung cancer. Tarceva is being developed by Roche, Genentech and OSI Pharmaceuticals. Chugai is pursuing its development and regulatory approval for the Japanese market.

Roche is developing new tests, which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumor markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.

Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).

About Roche

Headquartered in Basel, Switzerland, Roche is one of the world’s leading innovation-driven healthcare groups. Its core businesses are pharmaceuticals and diagnostics. Roche is number one in the global diagnostics market, the leading supplier of pharmaceuticals for cancer and a leader in virology and transplantation. As a supplier of products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche employs roughly 65,000 people in 150 countries. The Group has alliances and R&D agreements with numerous partners, including majority ownership interests in Genentech and Chugai.

All trademarks used or mentioned in this release are legally protected.

Further information:
Cancer: health-kiosk.ch
World wide association of lymphoma groups: lymphomacoalition/home.htm

For free B-roll/video content about the study that led to the European Commission’s approval: thenewsmarket

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The University of Illinois at Chicago has enrolled the first patient in the United States in a study of a new treatment for the most common and aggressive type of brain tumor.

The international, multi-center trial will compare the best standard treatments — surgical removal of the tumor, radiotherapy or chemotherapy — to that treatment combined with a new, noninvasive therapy that provides alternating electrical fields directly to the surface of the head.

“This therapy is a totally novel approach that is, in concept, relatively simple,” said Dr. Herbert Engelhard, associate professor of neurosurgery and site investigator for the trial at UIC.

Following a baseline MRI to determine the location of the tumor, several electrodes are placed on the patient’s shaved head. The electrodes are connected to a medical device with alternating electric fields powered by a portable battery. The patient remains on the portable device for 22 hours a day, indefinitely, while continuing his or her daily activities at home.

“Research has shown that these electrical fields rupture the cancer cells as they divide,” Engelhard said.

While likely not a cure for the deadly tumor, called glioblastoma multiforme, the therapy, Engelhard says, may extend life for some people. In an earlier small-scale study, the therapy more than doubled survival for glioblastoma patients.

Glioblastoma multiforme is the most deadly of all intracranial tumors. Standard therapy does not provide a cure and often results in side effects that compromise a patient’s quality of life. Despite attempts to improve outcome, the current three-year survival is only 6 percent.

“Patients with recurrent glioblastoma whose tumor progresses despite radiation treatment and chemotherapy do not have many options,” Engelhard said. “Therefore, it’s critical that we consider new therapies for the treatment of this disease.”

Fifty-one-year-old Daniel Torres of Chicago is a pioneer, according to Engelhard. Torres is the first person in the United States randomized to receive the novel therapy.

On Nov. 15 Torres had 36 electrodes placed on his head to emit very low intensity, intermediate frequency electric fields called tumor-treating fields. He was kept in the hospital overnight for observation and discharged the next day.

Torres, a father of four, ages 6 to 16, says the therapy may offer him a second chance at life. He has had three surgeries, chemotherapy, radiation and radiotherapy since he was first diagnosed with glioblastoma multiforme nearly three years ago.

He says he is hopeful for himself, but also for future patients who may benefit from the study.

The trial will enroll 236 patients at 10 U.S. centers and seven in Europe. Half the patients will receive continuous therapy with the NovoTTF-100A in addition to standard treatment and will be evaluated every four weeks; the other half will receive the standard treatment alone. All patients in the study will be evaluated for disease progression.

Funding for the study is provided by NovoCure, Ltd.

The principal investigator of the multi-center trial in the United States is Dr. Philip Gutin at Memorial Sloan Kettering Cancer Center in New York. The principal investigator in Europe is Dr. Roger Stupp at the University of Lausanne in Switzerland.

University of Illinois at Chicago
601 S. Morgan St. MC 288
Chicago, IL 60607-7113
United States
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