BBI

ATLANTA – After surgery, drug therapy and radiation, there would seem to be little room, or use, for device technologies in combating cancer, right? Wrong, as the abstracts in the "Proceedings of the American Society for Therapeutic Radiology and Oncology [ASTRO] 46th Annual Meeting" attest. While the bulk of those abstracts, a massive 2,500 in all, do focus on the use of surgical intervention, chemotherapy and radiotherapy, they also underline a growing and innovative number of medical devices and technologies arrayed against the disease, and presented during last month's annual gathering of ASTRO (Fairfax, Virginia) at the Georgia World Congress Center.

Since the introduction of irradiation technologies, the primary effort has been on ways to better target its ionizing effects – via intensity modulation and image-guided radiation therapy – so as to avoid damage to healthy tissues. Thus, a large number of the presentations at ASTRO assume the benefits of radiotherapy while exploring improved ways to image malignant tumors and better plan the therapeutic attack. In the past, these studies largely emphasized the use of X-ray, a term hardly appearing in the literature these days. Rather, there is a growing emphasis on MRI and computed tomography (CT), and the increasing presence of studies using positron emission tomography (PET), often in conjunction with MRI or CT.

A sampling of the research using PET imaging included:

A group of Australian researchers combined PET with CT imaging for planning of radiotherapy treatment of esophageal cancer, noting that while CT is accurate "for defining the radial extent of the tumor, it is far less accurate for defining the cranial and caudal extent, and its sensitivity for determining lymph node involvement is low." They conclude that use of CT alone overestimated tumor extent in some patients and that the addition of PET information to CT for radiotherapy "allows more accurate definition of the [gross tumor volume]."

A group of Canadian clinicians explored the use of "quantitatively, segmented PET images ... to identify the volume containing a tumour and its total motion." They used a "physiological torso phantom" to demonstrate that such images "can provide an accurate individualized ITV [internal target volume] for moving lung tumors." They concluded as well that "While PET may improve the localization of GTV [gross tumor volume], these results suggest that PET can define more optimal PTVs by accounting for a tumor's unique motion pattern."

German researchers used PET preceding CT in measuring lymph node tumor response in an ongoing trial and found better achievement of tumor control.

Brachytherapy is well-known for treatment of prostate cancer, but is finding expanded uses in other types of cancers, also in association with advanced imaging.

Researchers based at Washington University School of Medicine (St. Louis) used brachytherapy in the treatment of 15 patients with cancer of the cervix – using PET for treatment planning and concluding that the treatment/PET planning "was feasible and accurate relative to convention 2-D treatment planning."

High-dose-rate brachytherapy (HDRB) was used by Canadian researchers to treat 38 patients with endometrial carcinoma, with results suggesting that HDRB could be effective as a primary treatment but needs further evaluation.

Balloon/catheter combinations are finding expanded uses in treating cancerous tumors internally, a technique contrasting with external irradiation. As just two examples:

A group of U.S. university researchers evaluated the use of the GliaSite radiotherapy system (RTS) developed by Proxima Therapeutics (Alpharetta, Georgia), to treat recurrent malignant glioma of the brain. They concluded that the GlliaSite RTS "safely delivers a high dose of uniform radiation to the areas at greatest risk for recurrence while sparing the normal surrounding brain tissue" and is well tolerated. They said the results provide the basis for proceeding with a Phase III trial.

As reported earlier in October, a similar balloon/ device system, MammoSite, also made by Proxima, used in a partial-irradiation strategy for breast cancer therapy, produces results equivalent to external radiation but produces a smaller area of irritation over a shorter term than external irradiation.

Implants that work as locators to plan, carry out and evaluate tumor treatment – for instance by placement of gold coils – is finding increasing use in cancer treatment.

Researchers reported the first use in humans of the Calypso System from Calypso Medical Technologies (Seattle), consisting of implanted Beacon transponders and a non-contact magnetic array to register tumor localization in the prostate. The implants were successfully made in 15 patients and clinical evaluation of positional stability is under way.

A technique needing further development was presented by William Beaumont Hospital (Royal Oak, Michigan) researchers who placed surgical clips during lumpectomies to provide radiographic surrogates of the biopsy cavity, then used the clips to guide therapeutic setup. They concluded some "uncertainty" and difficulty in "visualizing the clips against ribs or other high density structures in some projections."

While increasingly significant in cardiology, the use of stem cells and other cell therapies has not been widely seen in cancer treatment. But a small number of abstracts this year suggests that more of this research type will appear at future ASTRO meetings.

Two examples:

Researchers at the University of Pittsburgh Cancer Institute (Pittsburgh) explored stem cell use to treat the injury of esophageal squamous stem cells following irradiation-induced esophagitis. After irradiation of mice for the disease, they injected them with esophageal progenitor cells isolated from donor mice. They concluded that the injections may replenish squamous stem cells lining the lumen and thus may provide a method for repairing irradiation damage in other tissues.

Researchers at three centers in Germany harvested, radiated and reseeded cervix cells as a method of "radio-protective gene therapy," saying that the results point "toward a future clinical application."

Among a wealth of other presentations at ASTRO:

Oncura (Philadelphia, Pennsylvania), an independent business of Amersham, which was acquired by General Electric (Fairfield, Connecticut) in April, unveiled long-term data demonstrating the value of prostate brachytherapy. Data describing 12-year follow-up of more than 1,500 patients was presented by Louis Potters, MD, medical director at the New York Prostate Institute (Oceanside, New York), who said the figures indicated "an excellent chance for long-term cure" via brachytherapy. "Our broader data set," Potters said, "demonstrates that 94% of our prostate cancer patients had not succumbed to their disease 12 years after being treated, and that the quality of the brachytherapy implant is a crucial factor in achieving successful outcomes."

The study demonstrated the effectiveness of brachytherapy in treating "clinically localized" prostate cancer. Potters also emphasized that when the implant is well done, the addition of hormones or external radiation offers no added benefit to the majority of patients. This study demonstrates the effectiveness of prostate brachytherapy in patients with clinically localized disease. It also shows the importance of brachytherapy implant quality, and when this is done well, the addition of other therapies, such as hormones or external radiation does not offer the majority of patients any added benefit.

Andrew Bright, Oncura's vice president of strategic marketing, said, "Data on such a significant number of patients provides valuable insight into the decision-making process all patients and their physicians must go through, allowing them to consider pre-treatment factors and the associated chances of cure."

Researchers at Fox Chase Cancer Center (Philadelphia) issued a report adding still another adverse consequence to the growing list of health problems related to being overweight. Women who are obese when diagnosed with early-stage breast cancer are at greater risk of dying of the disease than women of normal weight, according to the study presented today. This compares to previous studies that have produced contradictory results regarding the influence of obesity on surviving breast cancer.

Researchers analyzed data for 2,010 patients with stage I/II breast cancer who were treated, from 1978 to 2003, via lumpectomy, lymph node removal and radiation therapy, with or without chemotherapy. Patients were categorized into three weight groups: 452 considered of normal weight, 857 overweight, and 701 obese. Patients in the normal and overweight groups had five-year survival rates of 92% while those in the obese group had five-year survival rates of 88%. The five-year rates of distant metastasis for the groups were: 7% (normal weight), 6% (overweight) and 10% (obese).

Penny Anderson, MD, radiation oncologist at Fox Chase Cancer Center and lead study author, said that though the cancers were found at an early, more curable time, the obese women "were more likely to develop metastatic disease and subsequently die of their cancer. Because the prevalence of obesity increases with age, as does the risk for breast cancer, interventions that enhance weight control may have a substantial effect on breast cancer outcome."

In a general research report, investigators from Massachusetts General Hospital (Boston), Harvard Medical School (also Boston) and the Loma Linda University School of Medicine (Loma Linda, California) reported that increasing the radiation dose delivered by highly conformal external beam radiation (EBRT) to treat early-stage prostate cancer shows an advantage in terms of increased disease-free survival rates. EBRT has been a standard method of treating prostate cancer, but radiation oncologists have been limited in terms of the dose they could deliver to the affected area for fear of inducing bladder or rectal side effects. This study – of 393 men with early-stage prostate cancer, randomized to either conventional dose or high-dose radiation therapy – showed promising disease-free results for high-dose radiation. Of those receiving the high dose, 17% showed evidence of cancer recurrence vs. 35% of recurrence in the conventional dose group. And in both groups, less than 2% experienced serious rectal and bladder side effects.

Anthony Zietman, MD, a radiation oncologist at Mass General and lead study author, said that the study "suggests that radiation oncologists can and should be more aggressive in their treatment of prostate cancer, provided they have sophisticated dose delivery techniques such as proton beam at their disposal."

GE focuses on managing motion

In therapeutic imaging, the fourth dimension is time. And time means motion. And motion is a problem. It's particularly a problem in cancer treatment in the area of the chest, which is in constant movement, even with a "breathhold" – that is, the patient attempts to stop breathing for a short time during treatment – to avoid the over-use or poorly targeted use of radiation therapy in order to catch the whole cancer. Dealing with the artifact of motion while delivering radiation in the chest area was an important issue seen among the offerings across the multiple-hanger-size expanse of the World Congress Center exhibit area during the ASTRO meeting.

Considering itself in a large lead in addressing the moving targets of tumors in the thoracic region is GE Healthcare Technologies (Waukesha, Wisconsin), which featured its Advantage 4D gating technology in conjunction with Varian Medical Systems (Palo Alto, California). "We acquire the images and deliver that information to Varian [Palo Alto, California]" for provision of treatment, according to Wendy Harris, general manager, oncology, at GE Healthcare Technologies. Display of a tumor in motion enables its irradiation, via "gating" (meaning the beam alternately turned on and off), while the patient breaths naturally, but enables both reduced irradiation and more precise targeting, Harris told The BBI Newsletter in the companies' exhibition area that was attracting goodly numbers of attendees.

Harris acknowledged a number of other companies at the show presenting systems addressing the problem of the chest in 4-D, but she said that GE Healthcare has "a good year's jump on the competition" in the area of what she termed "motion management." After receiving clearance of the Advantage 4D system in 2003, the company has sold about 25 of the systems and has a similar number on order, she said.

One of the early adopters of the Advantage 4D technology is Massachusetts General Hospital. Noah Choi, MD, a researcher in thoracic oncology and head of thoracic radiation oncology at the hospital, said that with this real-time movement imaging, via the Advantage 4D, "we have come to appreciate that our previous targeting assumptions were sometimes in error. I am currently prescribing an Advantage 4D study for all of my thoracic patients to improve my confidence in the treatment prescribed. It is my option that this powerful technology will be standard of care for thoracic radiation therapy in the future."

Advantage 4D gathers and analyzes respiration motion using data acquired by Varian's RPM Respiratory Gating System and imaging data acquired by a GE Discovery ST PET/CT scanner or LightSpeed RT wide-bore multi-slice CT scanner. The images are sorted into multiple phases of the respiratory movement and then displayed, somewhat like ultrasound, only more precisely. Besides showing tumor movement, the detail these images provide may reveal tumors that couldn't be seen before or that were previously too blurry to provide the clinician a high level of confidence, Harris said.

Carl Nuesch, MD, medical director of radiation oncology at the Texas Oncology Cancer Center (Austin, Texas), said that reparatory motion was generally "immeasurable in the past – we treated very large volumes, adding toxicity and uncertainty to the treatment. Advantage 4D gating gives us the tools to improve precision in radiotherapy. It allows for better definition of tumor volumes, giving higher doses to the target and less radiation to the organs at risk." He added that this translates to "better outcomes with fewer complications for our patients."

Partial-breast irradiation nears longer-term test

What does it take – and how long does it take – for a new technology to nail down a "standard of care" status? A few rounds of poster and clinical trial presentations at prestigious conferences and several years of solid, long-term data are best, according to Martin Keish, MD, of the Mount Sinai Comprehensive Cancer Center (Miami Beach, Florida), and a poster presenter for Proxima Therapeutics (Alpharetta, Georgia) at the ASTRO meeting.

Keish, a technical consultant for Proxima, delivered a poster presentation on the three-year results of the company's MammoSite system for partial breast irradiation in a Phase II study. While those results are positive, and robustly so, it may take up to another 10 years for the MammoSite system to reach the standard of care designation for a population of women that could well total up to 1 million over that period, Keish told BBI, amid the hustle and bustle of the sprawling exhibition floor.

Keish reported just seven studies on the MammoSite last year at ASTRO, growing to 20 this year, primarily by independent investigators; a large 1,700-patient registry now under way; and a Phase III study of about 110,000 patients to be launched later this year. The current Phase II and registry studies are single-arm, while the Phase III study will compare partial-breast irradiation to whole-breast irradiation.

Keish unveiled results of a three-year follow-up of partial-breast irradiation of 43 patients. In summary: none of the women showed local recurrences of the breast cancer, they had minimal toxicity, and 85% reported "good/excellent" cosmetic results. Patient satisfaction was "good/excellent" in all but one patient.

The MammoSite system involves placement of a balloon in the space where a breast tumor has been excised, with an attached silicone catheter enabling, shortly after the surgery, the introduction of a saline solution and then irradiation. The radiation is applied for about five minutes, twice a day over five treatment days, with the balloon/catheter device then withdrawn. The system received FDA approval in May 2002 and is CE-marked.

The main side effect of irritation is generally the same as in whole-breast irradiation, Keish said, but "smaller in volume," he said, given the much reduced area of tissue irradiated and the shorter treatment time – one week vs. 6 1/2 weeks for whole breast irradiation. The Phase III study will provide even greater support for the technique since it will follow patients over an eight-year period. It will likely require several months more of data analysis, he noted. This long-term experience should convince this sector of the technique's strengths and overcome its key barriers, he said, the main two being short-term data, comparatively speaking, compiled thus far, and "an unwillingness to change," mainly the move from the non-invasive irradiation approach to one requiring surgery.

Personally, Keish is convinced of the MammoSite system's ability to produce results at least as good as whole breast irradiation, with perhaps greater patient satisfaction, but he said he doesn't push the approach on his patients. He said, though, that after he provides the options, patients usually choose the partial-breast approach. The best thing about the partial-breast irradiation technique, he emphasized, is that it doesn't close off other future treatment options. "If I'm wrong [about MammoSite treatment], it's just a local failure," he said, and it leaves open further treatment approaches such as additional radiation, more surgery or mastectomy.

He noted also that that the Centers for Medicare & Medicaid Services (Baltimore) has approved specific codes for the MammoSite procedure – beyond the current coding for a general brachytherapy approach it now has – going into effect in January. Bottom line, he said, the partial-breast irradiation method "can no longer be ignored."

Separately, Proxima described what it called "encouraging results" of a post-market study on its GliaSite radiation therapy system as first-line treatment for single resected brain metastasis, a problem diagnosed in more 150,000 people yearly. Multi-center study data were presented in a poster titled, "Interim Results of a Phase II Study of Resection and GliaSite Brachytherapy for a Single Brain Metastasis," by Lisa Rogers, MD, of Henry Ford Hospital (Detroit).

"In order to reduce the potential immediate and delayed complications of whole brain radiation, our study looked at localized radiation therapy following surgery as a primary treatment method for treating a single brain metastasis," she said. "We are pleased with the local control and survival results of the study that were achieved while being able to preserve quality of life and reserve the option of whole brain radiation for the future," said Rogers, study co-author.

GliaSite was FDA-cleared in 2001 for delivering radiation directly to the site of a tumor from within the tumor cavity, specifically for treating newly diagnosed, metastatic and recurrent brain tumors. The study looked specifically at GliaSite as an initial treatment, following the surgical removal of the tumor, for patients with metastatic brain tumors.

A little gold, several phantoms

Sprinkled amidst the huge haystack of video display screens and instrumentation setups on the ASTRO exhibit floor were less-huge exhibits providing the smaller, more intriguing technologies. That is exactly what we found in our conversations with RadioMed (Tyngsboro, Massachusetts), a maker of tiny gold helical coils, and The Phantom Laboratory (Salem, New York), a manufacturer of, well, phantoms.

RadioMed's primary product is the VisiCoil, a line of tiny flexible helical coils that are implanted in cancerous tumors to aid in guiding radiotherapy. Coming in 18 different sizes ranging from 1 cm to 6 cm and diameters from 35 mm to 75 mm, VisiCoils are implanted into the tumor with a needle-like delivery device and remain permanently in the tissue, Bruce Taylor, national sales manager for RadioMed, told BBI. These tiny coils act as "linear tissue markers," Taylor said, with each of them providing "two finite points at each end of the coil" to enable continuous tracking and monitoring of a tumor before treatment, during the progress of treatment and any subsequent changes or additional treatments, a critical problem since soft tissue is so difficult to image distinctly.

The coils are made of "99.9% pure gold, and there are no issues in putting these in the body," Taylor noted. The VisiCoils stay fixed in one position in the tissue but, because they are flexible, they move with the natural changes in shape and movement of the soft tissue under treatment, he noted, thereby making more objective the tracking of those changes, as opposed to the general subjectivity of clinician judgment concerning the position, shape and margins of a tumor.

Too often, Taylor said, clinicians must rely on "a single point of information" concerning tumor shape and position, with different clinicians frequently making different judgments as to the direction and intensity of radiation needed. With VisiCoils, usually from two to five of the devices are implanted, depending on the type of tumor, the particular treatment to be used and the specific judgment of the physician. They can then be imaged with a range of modalities, from basic X-ray to ultrasound, fluoroscopy or MRI.

VisiCoils have been FDA-approved for implantation into any soft body tissue, but the company has thus far marketed them primarily for targeting irradiation in prostate cancer. With the development of risk/ benefit analyses in other sectors, Taylor said, the coils will next be marketed for several other tumors, of the liver, lung, breast and so forth.

In a nearby area of the exhibit hall, we found a display of mannequin-like figures, synthetic human body parts and non-anatomic instrumentation systems, highlighting the product line of The Phantom Laboratory. President Joshua Levy explained that phantoms are "test objects either anthropomorphically or theoretically replacing a human patient." The "littleness" of The Phantom Laboratory is in its staff – just 10 in all, Levy noted – but it has a large and important mission.

While phantoms are used in a wide array of applications, and find these applications in a variety of overlapping niche markets, he said, the company's presence at ASTRO was to highlight the use of its products for the testing and quality control of radiological systems. As one example, the RSVP phantom is a clear-plastic hollow-head form used to provide stereotactic localization and dose verification for radiosurgery machines. When filled with water, it is used to simulate and reproduce the radiation absorption and scatter within the soft tissue of the head, while the outer shell can accommodate the anchoring screws used for positioning of the head frame required for these treatments.

Then there are the RANDO Phantoms, perhaps best described as high-tech mannequins – coming not unexpectedly in two genders, though minus hands and legs – used for detailed mapping of dose distribution in the body. Inside these phantoms are simulated human skeleton models cast inside soft tissue-simulating materials. These soft tissue materials are made of a urethane formulation with an atomic number and mass density that simulates muscle tissue and randomly distributed fat. And the head, neck and bronchi areas of the RANDOs incorporate duplications of natural open spaces in these areas. The figures are sliced at 2.5 cm intervals for the insertion of film, and an external grid pattern can be used to guide the drilling of holes for the insertion of dosimeters to record the distribution and extent of radiation dosages.

Other products from the company are either individual, "sectional" body parts, primarily extremities, or non-anatomical devices offering the "theoretical" simulation approach. Catphan Phantoms, for instance, are cylindrical modules used to validate and evaluate the performance of axial and spiral CT. scanners.

But quality control is just one use of these devices, Levy emphasized. Besides offering its phantoms on an OEM basis, the company is equally focused on developing devices to address a broad variety of development and research issues. "There are tons of little questions out there" Levy said, with The Phantom Laboratory able to provide the necessary custom work to make the systems helping to offer the answers. The ability to exactly quantify the effect of radiation, provide quality control of radiation systems and enable critical research in these areas are all important benefits of The Phantom Laboratory's devices, Levy told BBI.

Oncologists in particular, he said, depend on medical physicists to assure that their equipment is up to standard in terms of gathering images, developing treatment plans and then carrying out treatments. "They work together to get maximum benefit out of their systems," he said. And the company's phantoms "tell you what the dosage is, especially important in trying to avoid excess dosages." Most importantly, "The phantom is consistent, always the same," thus providing a continuous, quality-based record of dose verification crucial to the radiotherapy industry.

Symposium eyes uses of On-Board imager

Cancer treatment specialists reported at the ASTRO meeting that a new imaging technology for tracking tumor motion has the potential to improve outcomes and lower complications for many patients. A group of clinicians, who recently became the first in the world to use the new On-Board imager device from Varian Medical Systems to treat cancer patients, offered their observations at a "Dynamic Targeting IGRT" symposium. The presentations were sponsored by Varian in connection with the ASTRO meeting. Addressing an audience of about 800 radiation therapy professionals, the presenters – Ingemar Naslund, MD, PhD, of the Karolinska University Hospital (Stockholm, Sweden); Yoshiya Yamada, MD, of Memorial Sloan-Kettering Cancer Center (New York); and Ian Crocker, MD, and Timothy Fox, PhD, of Emory University Hospital (Atlanta) – offered details of their early clinical experience with this new technology for image-guided radiation therapy (IGRT), and views on Varian's cone-beam CT technology option, which is pending FDA 510(k) clearance.

Naslund reported on his institution's use of the On-Board imager device to decrease the margin of normal tissue surrounding a tumor that is traditionally irradiated during radiotherapy in order to compensate for tumor position uncertainties. He and his clinical colleagues have used the On-Board imager to visualize the tumor area on a daily basis, reducing the dose going to normal tissues, while actually increasing the dose to the tumor. "Karolinska was the first clinic in the world to use a Varian On-Board imager, and it has become a vital tool – one that will be instrumental in future developments in radiotherapy," Naslund said.

In addition, Naslund described two new devices he and his colleagues have developed for use with the On-Board Imager. "One is a new marker for placement in the tumor," he said, that will enable his clinic to take advantage of a "marker matching" feature of the Varian device. The second is a special tilting tabletop that enables him to position patients both vertically (standing) and horizontally for extracranial stereotactic treatments. "The next step will be developing our ability to check the tumor position in three dimensions using the On-Board Imager for cone-beam CT scanning," Naslund added.

Yamada's presentation covered protocols being developed at Memorial Sloan-Kettering for using the On-Board Imager to position patients for IMRT treatments. In addition, he talked about his research exploring ways of using the On-Board imager to generate cone-beam CT, or 3-D, images of a tumor site, just prior to treatment. "Varian has an excellent tool for generating cone-beam CT images," he said. "This can potentially be a valuable complement to automated radiographic and fluoroscopic IGRT. At Memorial Sloan-Kettering, we are researching how and when the use of cone-beam CT imaging can make a difference for patients, and looking particularly at stereotactic or hypofractionated approaches to treating tumors that are very close to dose-sensitive structures – for example, paraspinal tumors or prostate cancer."

Yamada said he believes that image-guided therapy has the potential to revolutionize how radiation therapy is conceptualized and delivered. "Currently, image-guided radiotherapy of paraspinal lesions has changed the pattern of practice within the spine tumor group at MSKCC. We plan to implement on-board imaging based protocols across a wide spectrum of disease sites," he said.

Fox and Crocker discussed the problem of tumor motion over a four- to six-week course of daily radiation therapy treatments. Tumors move around within the body by as much as a few centimeters each day due to normal physiological processes and tiny differences in how patients are set up for treatment. They talked about using the On-Board imager to automatically correct for this "inter-fraction motion" between daily treatments, increasing their targeting precision. "We are using the On-Board Imager system to position more than 20 patients each day," Fox reported. "The process adds an average of four or five minutes to each treatment session."

The Emory team reported that, using the On-Board Imager, they find they need to make millimeter shifts in patients' positions nearly every day. In addition, during the last week of September, Crocker and Fox became the first clinicians in the world to treat patients using Varian's new Trilogy linear accelerator, which is outfitted with an On-Board imager device. In the week prior to the ASTRO meeting, they used the Trilogy machine to deliver stereotactic radiosurgery to a handful of patients with brain lesions. "The Trilogy system is calibrated to give us a very tight isocenter, precise enough for both intracranial and extracranial radiosurgery," Crocker said. "When we combine that precision with image-guided tumor localization using the On-Board Imager, we have a very effective technology for treating cancer with stereotactic radiosurgery." The use of the Trilogy system will soon broaden at Emory. "Moving toward frameless radiosurgery for intracranial tumors is the next step at Emory," said Crocker. "We also plan on doing frameless radiosurgery for tumors in other parts of the body by the end of the year."

Varian also introduced the Clinac iX linear accelerator, calling it the "most ergonomic and customizable technology platform for treating cancer with image-guided radiotherapies [IGRTs]." Designed to help clinics maximize their technology investment, each Clinac iX is easily installed, customized, configured and upgraded to support every type of radiotherapy treatment process, the company said, from conventional 2-D and 3-D treatments to the sophisticated intensity-modulated radiation therapy (IMRT) and IGRT. "The Clinac iX is an ideal platform for Dynamic Targeting IGRT and beyond," said Richard Stark, director of Varian's delivery systems product line. "Like its predecessor, the Clinac EX, it is designed to enable therapists to deliver the most sophisticated, complex treatments within a normal treatment appointment timeframe."

Varian also reported the addition of new clinical management tools to its VARiS Vision radiation oncology management software, which providing an electronic health record. New Clinical Assessment and Dynamic Documents modules accelerate the adoption of a paperless, and filmless, environment and streamlining the clinical processes for cancer treatment. VARiS Vision now also incorporates an enhanced user interface, making personalized displays available at any workstation within a clinic when a particular user logs on. The VARiS Vision system incorporates DICOM and HL7 standards so that radiation oncology department personnel can share images and patient information with other hospital departments.

Other company news

Elekta (Stockholm, Sweden), a developer of neurosurgery and radiation oncology solutions unveiled several new initiatives at the meeting, plus 15 presentations and 16 posters featuring the company's 4D Adaptive image-guided radiation therapy solution. The company also was showing its next generation of stereotactic radiation therapy, Elekta Synergy S, as works in progress. With Elekta Synergy and Elekta Synergy S, clinicians can visualize the target at the time and point of treatment, thus sparing healthy tissue while using a higher dose. On the stereotactic radiosurgery front, Elekta was highlighting Leksell Gamma Knife 4C, the fourth generation of what it termed "the most successful radiosurgery weapon in the fight against brain disorders."

Calypso Medical (Seattle) unveiled an agreement with Impac Medical Systems (Mountain View, California) for Impac to integrate target localization data generated from the Calypso 4D localization system into its electronic medical record (EMR), which improves treatment setup, verification and recording on more than 2,400 linear accelerators worldwide. Calypso 4D localization was designed to provide an objective and continuous method to setup treatment and monitor the patient during radiation delivery without adding ionizing radiation, the company said.

"By introducing the technology to Impac's large installed base along with new accelerator installations, the potential exists to accelerate the adoption of adaptive therapy," said Joseph Jachinowski, Impac president and CEO. "Working together with the leaders in the field of radiation therapy we can provide the missing link to advance radiation treatment options," said Eric Meier, Calypso president and CEO. "Our open-system architecture design enables the integration of localization and tracking information throughout the care pathway from simulation through treatment delivery."

Calypso also reported a similar collaboration with Philips Medical Systems (Andover, Massachusetts) enabling the development of products "with the potential to deliver both adaptive and image-guided radiation therapy," it said. Via the collaboration, Philips said it would provide enhancements to its treatment planning systems with target localization data from the Calypso 4D localization system.

Siemens Medical Solutions (Malvern, Pennsylvania) showcased its new Somatom Sensation Open computed tomography (CT) system. The company said this device is "the optimal solution for efficient CT-based radiation therapy planning and for other CT applications where patient accessibility and advanced CT performance are required." The Somatom is designed to deliver diagnostic support for radiation therapy planning, CT-based trauma examinations, interventional procedures and imaging of bariatric patients. Based on the company's latest CT technology, the Sensation Open is the first open 20-slice CT system with 0.5-second gantry rotation speed and incorporating the compact Straton X-ray tube, providing better image quality and increased examination speed. First installations were successfully completed in early summer, 2004, Siemens said. The Somatom, introduced at the Radiological Society of North America annual meeting last year in Chicago, was FDA-cleared in April and will be available this month, Siemens said.

Siemens Medical Solutions' Oncology Care Systems division was showing its Artiste technology, using the company's In-Line Technology, calling it "the first integrated solution for Dose-Guided Radiation Therapy [DGRT]." Siemens said that DGRT advances radiation treatment capabilities "beyond Image-Guided Radiation Therapy. Where current IGRT solutions concentrate on accurate treatment delivery based upon tumor position, DGRT introduces the consideration of anatomy and dosimetric changes into the treatment protocol. DGRT relies upon information about the tumor shape and treatment does in order to adapt the treatment."

The system provides both kilovoltage and megavoltage imaging capabilities by providing a separate radiation source and imaging panel for each energy range, according to Siemens. "Each energy range is then used to provide the images necessary for DGRT, and can become the basis of distinct treatment and imaging capabilities." The arrangement of the sources and imaging panels are 180 degrees [in-line] from one another," allowing Artiste to provide "the only solution able to image both the patient and the treatment at the same time." The system is not yet 510(k)-cleared.

The results of the largest and most comprehensive study ever undertaken of permanent prostate brachytherapy, or "seed therapy," found overall survival rates for patients were equal to or better than surgery. The study, "Twelve-Year Outcomes Following Permanent Prostate Brachytherapy In Patients With Clinically Localized Prostate Cancer," was conducted by Louis Potters, MD, medical director of the New York Prostate Institute (Oceanside, New York).

Researchers followed 1,449 patients treated with permanent prostate brachytherapy between 1992 and 2000. The long-term research results showed a biochemical, recurrence-free survival rate of 81%, which is equal to or better than comparable rates found in studies of other forms of treatment for men with clinically localized prostate cancer.

As part of the study, 1,129 of the patients were treated using palladium-103 (Pd-103) seeds produced by Theragenics (Buford, Georgia), the maker of TheraSeed, the premier palladium-103 cancer treatment device. "This study should end any doubt about the efficacy of brachytherapy while providing substantial evidence – and assurance to doctors about the long-term effectiveness of using palladium-103 (Pd-103) to treat their patients with prostate cancer," said Christine Jacobs, chairman, CEO and president of Theragenics.

"The size and length of this study provide further evidence that permanent prostate cancer brachytherapy is as effective as surgery for men with localized prostate cancer," Potters said. "The quality of the seed implant used in brachytherapy cannot be understated. It is crucial that patients understand their physicians' outcomes with all types of seeds when considering brachytherapy."