A Medical Device Daily

RaySearch Laboratories (Stockholm, Sweden) reported a long-term license and development agreement with Royal Philips Electronics (Amsterdam, the Netherlands) covering a suite of new products within the adaptive radiation therapy sector.

The agreement covers three products, the first of which will be launched during the second half of 2007.

RaySearch said that adaptive radiation therapy is considered to be the next technology shift within radiation to increase precision by taking into account changes in the patient’s anatomy during treatment, thus making it possible to deliver higher doses to the tumor and reduce side effects.

“This is one of the most important milestones in RaySearch’s history, said Johan L f, president/CEO of RaySearch. “We ... will jointly develop the next generation of treatment planning systems for adaptive radiation therapy. Given Philips leading position in the treatment planning market and that the cooperation within IMRT [Intensity Modulated Radiation Therapy] has been an important factor for RaySearch’s favorable development, we have great hopes that the joint efforts now being initiated will be just as successful.”

IMRT improves treatment quality, but to achieve an even better result, software is required to deal with problems that arise due to changes in the patient geometry over time. By taking, for example, X-rays during the course of treatment, and feeding back the information, the treatment can be corrected so that errors can be avoided or dealt with, RaySearch said, calling this approach adaptive radiation therapy.

With the agreement, three products within adaptive radiation therapy will be developed, it said: a tool for IGRT using strictly geometrical information about the patient’s anatomy; a product facilitating more advanced adaptation of the treatment and taking into account dosimetric aspects; and a product for delivering “full four-dimensional adaptive radiation therapy.”

RaySearch and Philips said they already are involved in research activities within adaptive radiation therapy, including cooperation with Princess Margaret Hospital (Toronto), that cooperation launched in 2000. The first product, RayOptimizer, was integrated in Philips’ Pinnacle treatment planning system and was introduced clinically in 2001.

Later, the supplemental products RayMachine and RayBiology were launched.

Philips claims the largest installed customer base in treatment planning technology, with about 1,500 RayOptimizer licenses sold to date.

RaySearch, a spin-off from Karolinska Institute (Stockholm), was formed in 2000. Since 2001, the company has sold its product, RayOptimizer, to more than 900 hospitals internationally through a licensing agreement with Philips, thus enabling, it says, more than 100,000 patients to receive improved radiation therapy.

Tumor radiation/surgery combo reported

Results of a long-term clinical study conducted in Salzburg, Austria, bolsters support for a change in radiation therapy for breast cancer patients, according to a report from Breast Center Salzburg , published in the International Journal of Cancer. The report says that radiation administered during surgery, directly at the site of the excised tumor (intraoperative electron radiation therapy, or IOERT), greatly reduces the incidence of same side (or ipsilateral) breast tumor recurrence.

The findings were presented by Felix Sedlmayer, MD, chairman of radiation oncology at the University of Salzberg , on Oct. 8 at a special meeting of the European Chapter of the International Society of IORT at the conference of the European Society for Therapeutic Radiation and Oncology (Brussels) in Leipzig, Germany.

The study compared 190 women who received IOERT during lumpectomy followed by whole-breast radiation, with the 188 previously treated women who received lumpectomy alone, followed by whole-breast radiation using an externally applied electron beam boost to the tumor bed.

After a median follow-up period of 51 months, no local tumor recurrence occurred in the IOERT group; after a median follow-up of 81 months, 6.4% of the control group had experienced local breast cancer recurrences.

Because it does not have to pass through healthy organs, IOERT can be delivered at higher and better doses. It may also shorten by as much as half the post-operative radiation cycle, depending on the protocol. Guided by the radiation oncologist’s clear view of the site as well as intraoperative ultrasound, IOERT also allows the electron beam to be more accurately targeted.

In addition, IOERT eliminates the traditional delay of external radiation therapy, which must be scheduled only after the surgery patient has healed. This can give cancer cells a chance to recover and spread.

A reduction or even a long delay in local tumor regrowth strongly predicts better survival rates, according to the report. Previous studies have shown that patients who develop local recurrences within two years fare much worse than those who develop such recurrences after more than five years.

A subsequent study conducted by Sedlmayer involved 541 breast cancer patients that were advised to have breast conserving therapy. As of March 2004, 541 patients received IOERT during surgery.

Ranging in ages from 23 to 89, with a median age of 50.4 years, only one patient had an in-breast recurrence after 36 months. This recurrence was due to a previously unidentified tumor and not at the original tumor site. Sedlmayer was able to achieve 100% local tumor control and an overall survival rate of 92.1% for his patients after five years.

Nearly all Austrian women live within a two-hour drive to radiation facilities, noted Dr. Felix Sedlmayer. But American hospitals are not as well equipped, or are strapped by the coverage constraints of private health insurance companies.

“Obviously, many women in the U.S. are simply forced to choose mastectomy for lack of nearby equipped radiation facilities or lack of healthcare coverage for IORT,” said Sedlmayer. “This takes an unacceptable psychological and physical toll. Given the lowered recurrence rates we are seeing, the estimated 216,000 new cases of invasive breast cancer per year in the U.S. and an estimated breast-conserving surgery rate of 70%, the U.S. alone could avoid 5,000 cases of local recurrence per year.”

IntraOp Medical (Sunnyvale, California) says it offers the first fully mobile, self-shielding intraoperative radiation therapy system, the Mobetron. The Mobetron delivers the same electron-based radiation therapy administered in dedicated, shielded operating rooms, without needing to move the patient or make structural changes to surgery suites.

“As a self-shielding, mobile device, the Mobetron represents a technology investment that comes in much lower and can be leveraged across many operating suites,” said Donald Goer, president/CEO of IntraOp.

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