This article originally appeared in the October 2010 issue of DOTmed Business News.

The success of radiation therapy for the more than half a million patients who receive the treatment annually is governed by the ability to destroy the tumor while sparing normal tissue around it. In recent years, advances in intensity modulated radiation therapy (IMRT) and image guided radiation therapy (IGRT) have proven radiotherapy to be an indispensable, noninvasive option for cancer treatment.

But, earlier this year, safety concerns fueled by media coverage of overexposure accidents placed the industry in the national spotlight. Today, OEMs, end-users and regulators are collaborating on enhancing the safety of the treatment process, while research and innovation continue to drive the industry forward.

Market status
The global radiotherapy market experienced double-digit growth during the last few years, with the US holding a 50 percent share of the market, according to a 2010 report by Koncept Analytics, an India research firm. In the U.S., a high rate of cancer incidence paired with rapid acceptance of new treatment methods and reimbursement rates have driven the industry, according to the report.

However, 2009 proved to be a tough year for sales. But the downturn in the economy might not be bad news for all in the sector – ISOs experienced an uptick in business.

“We certainly have seen an increase in service because people are keeping their machines longer. We’ve actually had to hire new people to meet the demand,” says Steve Schwarz, CEO of Acceletronics, the world’s largest employee-owned independent radiation oncology equipment service organization.

OEMs say the U.S. market is looking up this year and there’s a lot of potential abroad, where many patients remain underserved.

“Despite the fact that radiation therapy is widely utilized in North America and in Western Europe, as a noninvasive treatment that is so effective, it could be serving a lot more patients as one of the steps toward managing their disease,” says Karla Donohoe, senior marketing director with Varian Medical Systems. “That is particularly the case in markets like India, China and a number of areas in Latin America, where there are many fewer radiotherapy treatment centers per capita than we see in North America and Western Europe.”

Although Asia is a lucrative market for radiotherapy, expanding treatment to the region is a challenging task.

“The number of linear accelerators per population is very, very low in that part of the world,” says Timothy Prosser, director, oncology business line management with Elekta. “China doesn’t have a problem with money [but with staffing] its cancer centers. It’s the only thing restraining the market right now.”

With the opportunities overseas and millions of people expected to enter the U.S. health care system, innovations in imaging capabilities, respiratory motion management tools and specialized radiotherapy devices are enhancing the efficacy of radiotherapy.

Image guidance
Image guidance capability on radiotherapy devices is one of the most prominent trends in the industry. The potential to image the site immediately prior to treatment using linear accelerators has come a long way from electronic portal imaging devices for simple plane radiographic images to cone beam CT and supplementary imaging devices, appendages mounted on the device’s gantry.

John Marquez, president of Therapy Remarketing Group, a reseller of previously owned radiation therapy equipment, says the demand for such systems is high.

“Systems with image guidance capabilities are our biggest request we get right now,” he says. “At minimum, what we’re seeing is that people want systems that are upgradeable. If they currently don’t have image guidance on them, they want something that’s going to be compatible with the minimum requirements to upgrade the unit.”

DOTmed News learned that two companies working in a strategic alliance, Acceletronics and an oncology and diagnostic imaging equipment sales firm, Radiology Oncology Systems, are introducing a new imaging device at this year’s American Society for Therapeutic Radiology and Oncology annual meeting.

“We are going to be announcing the release of the first ever FDA approved KV imaging device that can be integrated with any brand of a linear accelerator,” says John Vano, president of ROS. “What this is going to do is allow those hospitals to upgrade older linear accelerator systems to KV imaging technology without the need to replace or upgrade them with OEM options.”

The RAD II KV Imager, manufactured by Holland-based TheraView, enables clinicians to identify interfractional organ movement for the targeting and treatment of tumors. It can be configured for Varian, Siemens or Elekta linacs with or without beam stoppers.

Acceletronics’ Schwarz says the new imaging device will help clinicians meet the goals of “safety, accuracy and reproducibility” in radiotherapy.

Respiratory motion management
Technological advancements in respiratory motion management are enabling clinicians to focus on sites that have previously been hard to treat with radiotherapy. Tumors in areas such as the liver and lungs tend to shift because of breathing, making it difficult to precisely locate their position.

“We see lung cancer as a huge opportunity for treating more patients and actually saving more lives. There is a fairly low cure rate right now with lung cancer,” says Varian’s Donohoe. “There is also a strong differentiation between ‘operable’ and ‘inoperable’ patients and how they are typically treated. A lot of recent scientific research into the impact of radiosurgery and radiotherapy on lung cancer patients has been extremely promising.”

In April, Varian introduced TrueBeam, its latest system designed for all forms of external beam radiotherapy, including IGRT, IMRT, stereotactic body radiotherapy, radiosurgery and RapidArc radiotherapy.

TrueBeam comes standard with Gated RapidArc technology, a feature that monitors patient breathing and compensates for movement. The technology works by “gating” the beam, or turning it on and off, in response to tumor motion. Varian’s Donohoe says the technology ensures a higher level of dose conformity.

Elekta introduced its innovation for respiratory motion management earlier this year. Designed to reduce treatment margins, the XVI Symmetry product is enabled by 4-D guidance and eliminates the need for external markers. The feature works by capturing images of the patient’s breathing phase and then calculating 4-D imaging data. The information is used to visualize the tumor position in each phase of the respiratory cycle and acquire an average position for the tumor for each treatment.

OEMs say they plan to advance motion management technologies and are excited about the developments in the realm of lung stereotactic surgery.

“We actually have a chance in radiation therapy to be the primary treatment modality for lung lesions over surgery,” says Elekta’s Prosser. “If they’re small enough and caught early enough, it might be a noninvasive alternative to surgery.”

Linear accelerators continue to expand their capabilities and offer flexibility in the treatment of all tumor sites. In addition, several specialized radiotherapy devices – such as the Gamma Knife, the CyberKnife and TomoTherapy – are making headway through research and technological advancements.
Gamma Knife
A few years ago, the Gamma Knife Center at the Upstate University Hospital in Syracuse, N.Y., was gearing up to upgrade the Cobalt generated gamma radiation sources on its Gamma Knife unit. The scheduled replacement coincided with Elekta’s introduction of the new Leksell Gamma Knife Perfexion, a stereotactic radiosurgery system, which the facility decided to purchase.

Dr. Walter Hall, professor of neurosurgery with the hospital, says the Gamma Knife Perfexion is superior to the previous system because of its ability to treat lesions in the cervical spine and an automatic targeting system. If the treatment field is delivered using multiple spheres of radiation, the clinician doesn’t have to readjust the system for each sphere.

“It will automatically move from one sphere of treatment to another. It significantly shortens the duration for the treatment in terms of how long patients are actually in the machine,” says Hall.

A Gamma Knife system uses multiple radiation beams that converge in three dimensions and focus on the tumor. Industry experts say the major advantage of this device is its ability to localize the target. In a treatment using the Gamma Knife, a head frame is secured on the patient by a neurosurgeon and the patient undergoes an imaging scan to visualize the tumor. The head frame then stays on during the treatment process.

Hall says he prefers the Gamma Knife Perfexion system because of its accuracy and speed of treatment.

“It’s a single-shot treatment and you’re getting a patient totally treated within three hours from start to finish. Many lesions that I would normally operate on could all be treated with the Gamma Knife,” he says. “There’s no hospitalization, there’s no length of stay, it’s less expensive than conventional surgery and the patient outcomes are just as good as with surgery for some lesions. I think the patient satisfaction level is astronomical.”

For Elekta’s neuroscience business, 2009 was a record year. The company’s factory is currently building its hundredth unit, wrote Per Nylund, senior marketing director, business line management, Leksell Gamma Knife, in remarks e-mailed to DOTmed News.

“Approximately 60,000 procedures are carried out every year and more than a half million treatments have been conducted to date,” said Nylund.
Within the last year, Elekta introduced two innovations to enhance its system. WarpSpeed is a new tool for treatment planning with the Perfexion system. It provides clinicians with real-time dose planning, enabling them to formulate better treatment plans faster, said Nylund. WarpSpeed allows for the optimization of dose distribution through modification and addition or removal of isocenters in any image with instant feedback.

Another innovation is the Extend system for the Perfexion unit, a program for fractionated treatments. The feature extends the capabilities of the Gamma Knife to treatment of large tumors or lesions close to critical structures located in the brain, skull base and other regions of the head and neck.

Ongoing research and the collaboration between the OEM and leading facilities promises to continue expanding the clinical reach of the Gamma Knife. The National Institutes of Health is currently sponsoring a U.S. study that’s investigating the use of radiosurgery for the treatment of epilepsy.

“Researchers are looking at patients who have seizures related to mesial temporal sclerosis and they’re hoping that if they give enough radiation to that portion of the temporal lobe that has the sclerosis, they’ll prevent epilepsy,” says Hall.

The focus on research was evident at this year’s International Leksell Gamma Knife Society meeting held in May. A record 332 posters and oral presentations were submitted for the meeting, the most ever in the society’s 21-year history, said Nylund.

“A continuous growth of tumor radiosurgery fueled by Perfexion’s ability to treat multiple lesions and multiple fractions is expected,” he said. “Another growing field is in functional neurosurgery, which also includes the use of Gamma Knife radiosurgery for Parkinson’s disease and trigeminal neuralgia.”

CyberKnife
Accuray’s CyberKnife is another specialty radiation delivery device. Unlike the Gamma Knife, it’s a frameless robotic radiosurgery system that is not limited to intracranial sites and can treat tumors throughout the body. The CyberKnife uses a compact linear accelerator on the end of a robot arm that delivers the treatment, explains Dr. Omar Dawood, VP of clinical development with Accuray. The mobility of the robotic arm enables the delivery of radiation from a wide variety of angles, thus providing precise sculpting of the dose delivery to the target.

“We have treated just about 90,000 tumors now with the CyberKnife all over the body,” says Dawood. “A little more than half, about 55 percent of all the patients treated are extracranial right now.”

Accuray pioneered the first technology to continuously synchronize beam delivery to the motion of the tumor when it introduced the Synchrony Respiratory Tracking System. The system enables clinicians to reduce wide treatment margins in the planning to compensate for the moving target.

More recently, the company released the XSight Lung System, which works with the Synchrony system. Originally, Synchrony used implanted markers in the tumor but XSight Lung allows the system to lock onto the tumor itself.

“It does that by essentially using an algorithm that enhances the images that are taken during treatment,” says Dawood. “It’s revolutionary because now you’re actually tracking.”

Like the lung, the liver is another organ that moves frequently and therefore requires correction for respiratory motion. Within a month, Accuray anticipates the launch of two multi-center, international studies looking at the treatment of liver sites.

The treatment of prostate tumors is another exciting area of development. For years, prostate has been treated with long courses of radiation with small fraction doses, explains Dawood. Researchers are now examining the benefits of delivering high doses of radiation in shorter periods of time to the prostate and evaluating the method’s efficacy of reducing some of the treatment side effects, such as erectile dysfunction.

In a 2009 study published in Technology in Cancer Research and Treatment, researchers looked at the use of the CyberKnife as an emerging treatment approach for localized prostate cancer. They treated 112 patients with the system and found that more than 82 percent of men maintained sexual function two years after treatment.

Research on this CyberKnife capability is continuing at two multi-center clinical studies. A study looking at the homogenous dose distribution is taking place in 23 centers nationwide. Another study is examining the production of dose distributions comparable to those created by high dose rate brachytherapy treatment. HDR brachytherapy has excellent outcomes but also has its set of drawbacks: it’s catheter-based and invasive.

“A huge portion of the community believes in HDR brachytherapy, but doesn’t believe in its invasiveness for patients or the difficulty in performing it because it’s not easy to put in those catheters reproducibly,” says Dawood.

The 10-center study will examine the efficacy of this treatment using the CyberKnife and without catheters. Abstracts from both studies will be a part of the poster presentations at the ASTRO annual meeting later this month.

TomoTherapy
The TomoTherapy Hi-Art treatment system is an IMRT device known for its complete integration of the treatment process.

“TomoTherapy delivers radiation using a slit beam in a helical fashion, much like a CT unit gathers imaging information,” says Dr. Jay Burmeister, chief of physics with the Karmanos Cancer Center in Detroit, Mich. “It also images the patient using the treatment beam. It’s really an integrated imaging and treatment platform.”

TomoTherapy uses software for treatment planning, quality assurance, patient set-up and treatment delivery, storing all patient and plan information in one place.

“We have a centralized secure database, a single point of storage and unmatched computing power, which enables rapid creation of very sophisticated treatment plans,” says Dr. Fred Roberston, the company’s president and CEO. “Our system has a built-in machine and patient specific quality assurance.”

Robertson says customers are using the system for applications of stereotactic radiosurgery, stereotactic radiation therapy and stereotactic body radiation therapy. TomoTherapy has a patented binary multi-leaf collimator, ensuring dose conformity and homogeneity.

“There’s a lot of evidence in the medical literature that this design reduces toxicity and side effects and enables radiotherapy with a radiobiologic advantage, which we believe ultimately translates to improved quality of life for our patients and for cancer survivors,” says Robertson.

With TomoTherapy, patients can be imaged daily, enabling clinicians to offer adaptive therapy, says Robertson. Clinicians can make adjustments based on changes in the anatomy and have a more comprehensive picture of the dose the tumor already received.

TomoTherapy is also advantageous for hypofractionation, or delivering short courses of high dose radiation, a growing industry trend.

“Daily 3-D image guidance is critically important with hypofractionated dosing because when you’re using larger fractions, they have to be delivered correctly and with extreme precision,” says Robertson. “Many physicians would agree that hypofractionated radiation therapy is really only possible with very high quality 3-D volumetric image guided capabilities.”

Advances in image guidance technology for radiotherapy are moving the industry toward personalized patient care and have “really opened up the possibility of being able to personalize the prescription to most effectively treat each patient’s tumor,” says Robertson.

Enhancing the process
The complexity of the radiotherapy equipment and the overall treatment process is a challenge end-users and OEMs face today.

“If you go to a typical console of a radiotherapy device these days, it can be overwhelming just walking up and seeing numerous monitors and all of the bells and whistles you see there,” says Karmanos’ Burmeister. “It’s difficult for the therapists who operate these machines to pay attention to the patient and to everything that’s going on with the machine. These machines are doing very complicated things in terms of imaging and delivery with respect to what they used to do.”

OEMs are responding to the challenges faced by clinicians with features that help simplify and organize the intricate information.

Elekta offers Synergistiq, a clinical workflow management tool. It integrates the patient’s electronic medical record, imaging data and the control of the linear accelerator in a unified user interface.

With the help of customer input, Varian’s new TrueBeam system was redesigned from the ground up to offer clinicians an integrated interface and an adjustable level of automation control.

“From a control system perspective, we’ve got a design where absolutely every element of this machine is completely integrated and synchronized, facilitating automation and a streamlined clinical flow,” says Varian’s Donohoe. “This level of tight integration offers us a platform not just for today’s clinical techniques but also for future innovations.”

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DOTmed Registered Linear Accelerator Equipment Sales & Service Companies
Names in boldface are Premium Listings.

Domestic
Jose Rodriguez, OncoAmerica Cancer Care Centers, AL
John Vano, Radiation Oncology Systems, CA
John Marquez, Therapy Remarketing Group, CA
DOTmed certified
Varian Medical Systems, CA
Omar Dawood, Accuray, Inc., CA
Simon Bhangal, LinaTech, CA
Stewart Farber, Farber Medical Solutions, LLC, CT
Robert Maziuk, VJ Technologies, Inc., CT
Rich Ellis, Technical Options of Georgia, GA
Timothy Prosser, Elekta, GA
Nader Alfaqeeh, Orbit Medical Technologies, Inc., IL
DOTmed certified
Chaz Beadling, American X Ray Equipment Sales & Service, MD
Jay Burmeister, Karmanos Cancer Center - Wayne State University, MI
Kenneth Wolff, RS&A, Inc., NC
Marilyn Jaccard, Diagnostic Imaging Sales, NJ
DM100
Tony Richardson, Oncology Services International, NY
Larry Day, Acceletronics, Inc., PA
Bill LeCompte, Systemic Energy, LP, TX
Robert Dyer, Dyer Technical Service (DTS), TX
Frederick Robertson, TomoTherapy, Inc., WI

International
Javier Espinos, Ingenieros en Radioterapia, Mexico

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