Varian Halcyon intensity-modulated
radiotherapy system

Radiation therapy gets more targeted and personalized

September 18, 2017
by Lisa Chamoff, Contributing Reporter
The ultimate goal of radiation therapy has always been to eradicate tumors locally while preventing damage to the surrounding tissue. New technologies aim to make treatment even more precise, while allowing clinicians to better plan treatment strategies and adapt to anatomic changes.

Many of the significant developments in the market come with software for treatment planning and management.

In May, at ESTRO in Vienna, IntraOp Medical introduced a new software package for the Mobetron 2000, its electron intraoperative radiation therapy system.

The software, called the IntraOp Prelude, includes dose and treatment planning as well as treatment management. The software can be installed on computers and tablets, whereas before the launch it was built into a special console.

“Treatment planning in intraoperative radiation therapy is up and coming and not as well established,” says Derek DeScioli, vice president of global sales for IntraOp Medical. “The question is, how do we improve efficiency? The software is about automating and simplifying.”

Treatment planning uses images captured from the patient prior to surgery, but during surgery, the body changes.

“It’s not just the radiation aspect, but because our software device is also capturing surgical factors,” DeScioli says.

While the software does not provide real-time diagnostics, DeScioli says that this is where the software for intraoperative radiotherapy is headed.

“That’s a next frontier for IORT intraoperatives, but it’s not something that exists currently,” DeScioli says.

Making it personal
Personalized medicine is also a new frontier in the radiotherapy market.

The treatment planning software and image guidance technology from Brainlab, which integrates with systems from linac manufacturers such as Varian and Elekta, create indication-specific treatments for cancer patients.

“We truly believe that the software is far more valuable when designed to meet the challenges of specific clinical maladies, instead of a one-size-fits-all approach,” says Bogdan Valcu, director of clinical research for Brainlab. “Seven years ago, we brought together world experts to discuss what would be necessary to personalize medicine for some of the most prevalent cancers. Experts from multiple disciplines provided deep insight into the struggles they had with the tools available and the silos within which they worked.

With an initial focus on its core expertise, Brainlab decided to tackle the challenges of brain metastases as the most prevalent of cranial cancers. There was really nothing on the market designed to treat multiple tumors at a time.”

To address the challenges raised by the experts, Brainlab launched a dedicated software tool that plans treatment for patients with brain metastases. The software, called Elements Multiple Brain Mets SRS, allows patients to receive focused stereotactic radiosurgery, instead of whole brain radiation therapy.

The company has also had an eye toward responsible spending and ways to address the increasing costs of cancer care. In the last few years, many new targeted and immuno-therapeutic agents have flooded the market with treatments that may run in excess of $100,000, compared to radiosurgery or surgery with costs estimated between $20,000 and $30,000, Valcu says.

“While new agents may work well for a subset of patients, the established treatments remain effective for all,” Valcu says. “Catering to the changing needs of today’s hospitals, Brainlab Elements allows centers to pick and choose the specific software tools needed to support their patient population.”

The company is also harnessing the other big health care and oncology buzzwords — machine learning and big data.

For the last two-and-a-half years, Brainlab has been the primary sponsor of the National Radiosurgery Registry, run by the American Association of Neurological Surgeons (AANS) and ASTRO, in which 30 leading U.S. institutions are collecting outcome data on patients undergoing cranial radiosurgery and surgery. The original project was expected to run for three years, and based on its initial success, has been extended by an additional three. Brainlab plans to integrate information from the registry into the company’s products over the next two years.

“The ideal treatment strategy for intracranial cancer is multidisciplinary, blending surgical and oncological expertise,” Valcu says. “Enhancing treatment planning software with ideal outcomes data will enable more physicians to offer best possible care to their patients.”

Eschewing surgery
Other companies have an eye toward avoiding surgery altogether.

In 2015, Xcision Medical Systems received FDA approval to research GammaPod, the first stereotactic body radiotherapy system (SBRT) for treating breast cancer.

SBRT is more commonly used to treat primary tumors in the prostate, lungs, spine and liver, as well as metastatic disease and recurrences where radiation was previously delivered.

Steve Rubenstein, vice president of marketing for Xcision, says the GammaPod uses an inverse dose planning system along with a dynamic dose painting technology, which consists of thousands of beam angles of radiation from three dozen sources that converge on a focal spot where the maximum dose is delivered. The patient lies on their stomach, instead of on their back, and the breast is noninvasively immobilized in a breast cup system.

“The technology has the potential to deliver a very precise treatment,” Rubenstein says.

The company is about to complete a 17-patient clinical trial on safety and feasibility sponsored by the University of Maryland School of Medicine in Baltimore, where GammaPod inventors Cedric Yu and William Regine are faculty members. Once the company receives data from the trial, it plans to submit for FDA clearance.

Other research is currently planned, including studies evaluating whether there are benefits of delivering radiation therapy before breast surgery instead of after surgery.

“Studies have shown that a preoperative approach can treat a much smaller target volume than a lumpectomy cavity, which has larger volume of tissue,” Rubenstein says. “One day we hope to … identify a subset of patients who could be spared all the challenges that come along with surgery.”

A study recently led by Dr. Elizabeth Nichols from the University of Maryland School of Medicine and published in the International Journal of Radiation Oncology, Biology, Physics found that certain patients were able to achieve a complete pathological response after preoperative partial breast treatment without surgery.

Considering quality of life
As cancer cases increase, manufacturers are looking to increase the benefits of treatment.

“We used to think of outcomes being survival,” says Chris Toth, president of global commercial and field operations for Varian Medical Systems. “We’ve expanded the definition as we expand to new treatment delivery methods. We are going to need to be considerate of not just survival, but quality of life to survival.”

Two systems Toth connects to this aim are its Halcyon image-guided volumetric intensity-modulated radiotherapy (IMRT) system, which received FDA 510(k) clearance in June, and the HyperArc high-definition radiotherapy (HDRT) system, which is 510(k) pending.

Toth says the Halcyon’s innovative beam shaping system allows clinicians to modulate the radiation beam to the tumor.

“There’s virtually no dose spillover into the spillover structures and surrounding areas of the target,” Toth says.

HyperArc is a technology tailored to treatment of individual metastases in the brain, instead of the whole brain, in an effort to maintain cognitive ability.

Varian also recently launched Rapid Plan, a module to its radiation therapy treatment planning software Eclipse. The software uses big data and mathematic modeling to improve quality, consistency and efficiency, Toth says.

“You’re getting higher quality plans faster and more consistently,” Toth says.

Software developments mean facilities can get the full life out of their systems before investing in costly new technology.

“Software innovations are allowing clinicians to get more out of their hardware acquisitions,” Toth says.

Adapting to changes
Software is a key component of treatment planning and adapting to changes in tumor size, shape and location, or subtle changes in the location of organs and other healthy tissue, due to patient weight gain or loss.

Accuray's Radixact includes a new treatment planning system using what the company calls PreciseART adaptive therapy.

"A patient undergoes radiation treatment typically over six to seven weeks," says Corey Lawson, vice president of product strategy for Accuray. “The patient can change over time. They can lose or gain weight. The tumor may start to shrink. Historically, plans created on day one were delivered over the entire course of treatment, regardless of any underlying changes. While it may have been desirable to assess and potentially modify such plans, the tools were just not available to make such a workflow practical.”

PreciseART Adaptive Therapy is a new clinical tool that monitors changes that can happen while a patient is undergoing treatment, comparing the current state to the original treatment plan, helping to ensure the clinical objectives are met over the entire course of treatment and doing so automatically. In addition to acting as an early warning system should the patient change, it can also alert clinical staff to variability in daily pretreatment patient setup.

"It lets the clinician know whether they're on track to deliver the proper dose, or if the dose they're giving is starting to veer off track, it alerts the clinician,” Lawson says. “The clinician can then decide whether replanning is necessary."

The company also made changes to the delivery side with Radixact. Using a linear accelerator with a much higher dose output, clinicians can image and deliver dose to the patient faster than before, Lawson says. Those who have already adopted this new technology have typically realized a 30 percent to 40 percent boost in patient throughput, with highly precise treatments efficiently delivered across a broad range of cases.

Dr. Malika Siker, a radiation oncologist at Froedtert & the Medical College of Wisconsin, has been treating patients using Radixact since last October.

"In general, the Radixact system delivers a seamless workflow including treatment planning and delivery process," Siker says.

Siker notes that when she encounters patients with a complicated geometry, she prefers to use the Radixact system. For example, she recently treated a prostate cancer patient who had undergone a bilateral hip replacement successfully with the Radixact system. While it is very difficult to visualize the prostate with most daily imaging systems, as the metal implants create artifacts, the high-dose MVCT image guidance on the Radixact helps overcome this obstacle.

Siker says the future of radiation therapy advancement will come with online adaptive treatment and personalized treatment plans.

"Being able to use daily imaging and adapt the plan on a daily basis is going to become exceedingly important," Siker says.

While online adaptation doesn't happen in the clinic, the Radixact system does make offline adaptations easier and more practical, Siker says.

"Currently, we are not able to adapt to changes in real time in the clinic," Siker says. "It takes time for planning in-between fractions. We know that's a priority for Accuray.

"Adaptive planning is certainly the future, but in some ways, the future is now. We've had many patients where anatomy has changed drastically during treatment - weight loss, tumors shrink. With Radixact, and with daily IGRT and adaptive models, it makes delivery of offline adaptive treatment possible."

Elekta also sees adapting to changes in real time as the future for radiotherapy. In April, Elekta introduced technology that enables real-time imaging during radiotherapy with its MR-linac, the Elekta Unity, which integrates a 1.5-Tesla MR scanner with a linear accelerator. The technology allows clinicians to visualize the size, shape and location of tumors and nearby healthy tissue during treatment and adapt it accordingly.

“The use of advanced image guidance applications can radically improve the accuracy of radiation dosing, allowing radiation therapy to be used safely and effectively in more patients and in new cancer indications,” says Peter Gaccione, executive vice president for Elekta’s North America region.

In May, Elekta announced that the University Medical Center Utrecht had treated the first patient as part of a clinical study.

A similar product from ViewRay, called the MRIdian Linac, was approved by the FDA in February and installed at the Henry Ford Cancer Institute in Michigan.

Elekta will also launch its MOSAIQ Oncology Analytics software solution at the American Society for Radiation Oncology (ASTRO) 2017 annual meeting this month in San Diego.

The software, which Gaccione calls a “game-changing solution” for managing cancer treatment, provides automated processes and analytics to help clinicians make decisions that can improve clinical outcomes and financial performance and increase productivity.

“Workflows in radiation therapy are continuously improving, resulting in better integration and optimization with treatment systems,” Gaccione says. “This enables higher efficiency and quality of care. With advanced software systems, such as Elekta's MOSAIQ Oncology Analytics, other areas of the cancer management ecosystem can be integrated with radiation therapy, resulting in improved workflow and efficiency.”

Shrinking systems
Radiotherapy systems for certain cancers are also getting smaller.

Xstrahl recently submitted for FDA 510(k) clearance for an 80-kV continuous wave X-ray system for treating skin cancer. The low-cost system is mobile and doesn’t need as much radiation shielding as larger systems.

The smallest system the company sells is a 100-kV system, which starts at 10 kV. It also markets 150-kV and 200-kV systems that both start at 20 kV, and a 300-kV system that starts at 40 kV. All vary in how deep the radiation beam can penetrate the skin.

In the U.S., the 100-kV and 150-kV systems are the most common, while 200-kV systems are more common throughout the rest of the world.

“Most patients coming in will not need treatment to go that deep,” says Adrian Treverton, chief operating officer of Xstrahl, Inc. “In the U.S., there’s more awareness of skin cancer and people tend to be diagnosed by their dermatologists a lot earlier.”

The company has been continuously improving the user interface and software of its systems, adding patient imagery to view the treatment area and changing the database, and it has introduced a dose planning system that is currently available in Europe and Canada.

A 10-year life span is fairly standard for most systems, Treverton says, and software is designed to improve workflow as facilities work to keep their investments up to date.

“Now, we’re looking at a better way for the physicists and the radiation technologists to interact with the machine,” Treverton says.

Starting with alpha
Alpha particle radiation therapy, which uses alpha particle emitters instead of beta emitters for more targeted cancer treatment, has been gaining ground since the FDA approved the first such cancer treatment drug in May 2013. The idea is that alpha particles travel a shorter distance and cause less damage to surrounding healthy tissue.

Professionals working in the industry say it’s still too early to tell where the technology is headed.

“We’ve certainly been watching it,” says Toth of Varian.