By Larry Greenemeier Scientific American

Targeted beams of high-intensity radiation can shrink early-stage tumors with limited collateral damage to surrounding healthy tissue. The addition of robotics and image guidance systems in recent years has made these stereotactic, or directed beam, radiosurgery systems an even more versatile weapon against cancer, attacking not only brain tumors (for which they were originally designed) but also other diseases virtually anywhere in the body.

Researchers have begun pushing the technology to the next step by increasing beam accuracy so that physicians can safely administer higher doses of radiation to cancerous cells, making radiosurgery a viable alternative to conventional surgery in more cases. Such accuracy would prohibit radiation overdose, which has serious consequences—an errant high-power beam passing through healthy tissue and organs could cause severe damage, and even cause a fatal shut down, as a January article in The New York Times illustrated.

Surgery alternative

A prime target is lung cancer, where the standard treatment is surgery to remove diseased tissue, says Eric Lindquist, a senior vice president and chief marketing officer for Accuray, Inc., a Sunnyvale, Calif., company that makes the CyberKnife Robotic Radiosurgery platform. “But it’s highly invasive, meaning the patient will have scars, a long healing time and blood loss,” he adds.

Lindquist believes that early-stage non–small cell lung cancer patients treated with targeted, high-dose radiation delivered in three or four treatments can have the same, if not better, chance of survival as patients undergoing surgery. To prove this, Accuray has partnered with The University of Texas M. D. Anderson Cancer Center in Houston on a clinical study to compare survival rates between traditional surgery and CyberKnife three years after treatment. Accuray and M. D. Anderson hope to have their study, which began in 2007 and may include more than 1,000 patients, wrapped up by the end of 2013.

New targets

Accuray is also exploring other applications for CyberKnife, including the treatment of atrial fibrillation (irregular heartbeat), Parkinson’s disease, epilepsy and psychiatric disorders (pdf). Doctors have been using CyberKnife for the past decade to treat trigeminal neuralgia, a chronic pain condition arising from the trigeminal nerve, which relays facial sensation. In February doctors at the Memorial Cancer Institute in Pembroke Pines, Fla., used CyberKnife to successfully treat a woman suffering from this malady by focusing radiation on the culprit—a nerve connected to her brain stem that doctors believe was unprotected and highly irritable.

How it works

Radiosurgery (and radiation therapy, which relies on lower doses of radiation spread out over a longer period of time) uses a beam of energetic particles to ionize the atoms that make up the DNA chain. A treated cell becomes unable to reproduce and loses its structural integrity. Because the technology does not discriminate between healthy and cancerous cells, Accuray developed a tracking system to help CyberKnife maintain accurate targeting of soft-tissue tumors that shift position during respiration, says Brian Collins, an attending radiation oncologist and assistant professor in Georgetown University Hospital’s Department of Radiation Medicine.

As a result, CyberKnife’s linear particle accelerator can produce a radiation beam that moves in rhythm with a patient’s breathing, targeting the correct spot at all times. Anesthesia is not typically needed for a CyberKnife procedures, and the treatment itself is painless, Collins says, adding, “The number one thing I hear from patients afterward is, ‘Are you sure I got treated?’” Collins and his colleagues tend to administer CyberKnife radiotherapy treatments for 30 to 40 minutes at a time over one to five treatment sessions, typically during a single week.

3 types of radiosurgery

CyberKnife employs one of the three basic types of stereotactic radiosurgery technologies. To generate a radiation beam, CyberKnife (and Varian Medical Systems’s Novalis Tx) use a linear accelerator that can be moved to treat tumors in both the head and the body. Indeed, Georgetown physicians found that CyberKnife could not only treat brain tumors but also prostate, neck and other cancers, Collins says.

A second type of stereotactic radiosurgery is Elekta, AB’s Leksell Gamma Knife, a pioneering technology in the radiosurgery field. It uses a fixed beam generated by a cobalt 60 synthetic radioactive isotope. When Gamma Knife was developed in the late 1960s, it offered an alternative to conventional radiation therapy, which bathes portions of the body in lower-dose radiation for longer periods of time in an effort to kill cancer cells while limiting damage to surrounding healthy tissue. Unlike CyberKnife, Gamma Knife’s beam cannot move during treatment, making the technology suitable for treating tumors in the brain but not other areas of the body that move due to respiration.

The third form of radiosurgery relies on a beam of protons to irradiate tumors. This proton (particle) beam technique has not found wide deployment in the U.S., in part because the equipment can cost in excess of $100 million, but also because little research exists on the technology’s efficacy and safety.

Despite costing 10 times as much, proton therapy has emerged as a challenge to CyberKnife, because it uses a different type of radiation at a lower dosage, Collins says. Protons, he adds, also do not work well with a moving target. “If you could make a proton system that’s as accurate as a CyberKnife, it would be fantastic,” he says.

	Join us for a Webinar on July 22, 2010 Please join us Thursday, July 22, 2010 from 1:00 - 2:00 PM (PDT) Dr. Anand Mahadevan, faculty Radiation Oncologist at Beth Israel Deaconess Medical and Chair of the CKS PDC GI Anatomical Subcommittee will discuss a protocol concept for pancreatic cancer.  Topics of discussion will include: 1)  Treatment options for Locally Advanced pancreas cancer 2)  Current Status of SBRT for Locally advanced pancreas cancer 3)  Time for new directions 4)  Proposal for a Randomized Study 5)  Role for SBRT in Resected Pancreas Cancer Title: Interested in a Pancreatic Protocol Concept? Date: Thursday, July 22, 2010 Time: 1:00 PM - 2:00 PM PDT After registering you will receive a confirmation email containing information about joining the Webinar. System Requirements PC-based attendees Required: Windows® 7, Vista, XP, 2003 Server or 2000 Macintosh®-based attendees Required: Mac OS® X 10.4.11 (Tiger®) or newer Sign-up now at: https://www2.gotomeeting.com/register/509781554

]]> http://corporateblog.morsecyberknife.com/?feed=rss2&p=323 http://corporateblog.morsecyberknife.com/?p=313 http://corporateblog.morsecyberknife.com/?p=313#comments Wed, 19 May 2010 15:30:16 +0000 admin http://corporateblog.morsecyberknife.com/?p=313

There was much interest in this meeting, which was attended by many representatives of the radiation therapy community.  Among those testifying was Chrissie Kotwica RN, our nurse liason, and Dr. Jim Hevezi, Chief of Physics at the CKC Miami was one of the panel members, as he is one of the approximately 98  MedCAC members!   It was anticipated that some specific action, possibly negative, would be taken regarding Cyberknife.  The common perception in the general medical community, and perpetuated by organized radiation oncology, has been that while there’s  good evidence for RT for prostate treatment, the data on CK is not yet mature enough or large enough.

In actuality, the committee reached a much different conclusion.   In fact, the major conclusion was that none of the radiation therapy treatments currently being used is supported by sufficient data to clearly indicate effectiveness versus watchful waiting, let alone superiority to other treatments. However, it was also clear that no other modality, surgical, RT, etc.,  had data sufficient to satisfy the current “evidence based” requirements.  In this light, CK was no better or worse than any of the other treatments.  The panels recommendation was that at this time there would be no change in coverage, and no National Coverage Determination (”NCD”), with coverage decisions to be left to the local intermediaries.

Significantly then, while we did not get a determination mandating coverage, there is no change in current coverage, nor an NCD.  However, Cyberknife/SBRT now seems to be accepted along with other radiation therapy modalities, none of which seem to have much more data than to support their use than Cyberknife/SBRT.

In this landscape, Cyberknife is the only modality to be ready with a registry to track it’s use and efficacy, a significant situation since there is a dirth of randomized clinical trials for any other treatments, and the conduct of randomized trials in prostate cancer is, at the most optimistic, highly impractical, highly unlikely.   In my opinion, given the importance of this disease and long experience with various time, dose and fractionation schedules which have been used, there is a real question regarding whether it is even  ethical to require of patients and physicians to enter randomized clinical trials for this disease.

I think it’s important to note, that given the likelihood that Cyberknife/SBRT is at least equally as efficacious as other forms of radiation therapy for prostate cancer, it offers the potential for shorter treatment times, less costly treatment in terms of direct cost of treatment and lost patient time, and less toxicity.  This possibility of marked improvement in time, cost and toxicity should be emphasized as a strong reason for resources to be committed to clarify the role of Cyberknife and SBRT for prostate cancer. This would include supporting a registry.  As you know, there is a Florida registry, in which CKC Miami and CKC PB will be participating, funded by the participating facilities. This is the first of it’s kind, of which I’m aware, certainly with prostate cancer, and likely with most other sites, as well.

So I think the result of this meeting was actually quite favorable for Cyberknife treatment of prostate cancer.  It has finally been recognized as on par with other existing modalities, in particular other radiation therapy treatments, and the potential advantages were clarified.  We are therefore, eager to continue supporting additional treatment at our sites, and will be contacting our radiation oncologists and urologists to see where we can assist them in caring for their patients with prostate cancer.  Please, as ever feel free to contact me should you have any questions regarding treatment for prostate cancer.

James G Schwade MD FACR FACRO FASTRO

Executive Director,
Cyberknife Centers of Miami & Palm Beach

Clinical Prof. of Radiation Oncology &
Former Chairman,
Dept. of Rad. Onc., UM Miller Sch. of Med.

Adjunct Prof. of Biomedical Engineering

Dept. of Biomedical Engineering, FIU

305-812-2722 (c)
305-279-2900 (o)
305-279-1415 (f)

drschwade@aol.com

www.morsecyberknife.com
www.cyberknifemiami.com
www.cyberknifepalmbeach.com
www.canceranswers123.com
www.ca123.com

• American Cancer Society
• Cancer Aliance of Help and Hope
• Connor Morgan Children’s Cancer Foundation
• Holistic Healing Wellness Center
• South Florida Cancer Association
• St. Mary’s Medical Center
• Susan G. Komen For the Cure
• Woman2Woman Breast Cancer Foundation

WASHINGTON (Reuters) – At a time of growing debate over prostate cancer treatments, U.S. Medicare officials will take a closer look at radiation therapy and its ability to reduce deaths and side effects in men. The Center for Medicare and Medicaid Services (CMS) has asked a panel of outside experts meeting on Wednesday to say how confident they are that various types of radiation treatment can improve patient outcomes. Researchers have found that many prostate cancers are so slow-growing that most men will die from other causes, sparking debate over whether diagnosis is too frequent and whether treatments, which also include surgery, are excessive. While the meeting will not directly address the agency’s reimbursement rates, CMS is seeking advice that could later be used to determine its payment policies. It oversees 45 million elderly and disabled covered by the Medicare health insurance program, about 40 percent of them men. Any changes in how the agency — the nation’s largest healthcare payer — covers radiation treatments could affect the use of therapies by companies such as Accuray Inc, Siemens AG, TomoTherapy, and Varian Medical Systems. The experts will discuss the effectiveness of Accuray’s CyberKnife robotic radiosurgery system and other radiation treatments such as external beam radiation and implantable radiation “seeds”. The immediate impact on stocks is likely to be neutral, said Josh Jennings, a medical device equities analyst at Jefferies & Co. But “if they feel that radiation therapy is being overutilized, there could be a chance for some negative recommendation” that could later cause some waves, he said. Much debate surrounds how to treat prostate cancer in the medical community, with surgeons, cancer radiologists and urologists taking different approaches.

“The problem is trying to find … the prostate cancers that need to be treated and which ones don’t, and that’s not perfectly clear today,” Dr. Theodore DeWeese, a radiation oncologist at Johns Hopkins Kimmel Cancer Center in Baltimore. CMS has said looking at all the various treatments would be too big a task for one day. “The scope of this (meeting) is limited to radiotherapy for the treatment of localized prostate cancer with comparisons to watchful waiting,”  it said in announcing the panel.

CYBERKNIFE

Medicare already pays for prostate cancer treatments. But for officials at Accuray, the potential for payment changes is a top concern.With no formal Medicare rule requiring national coverage of its CyberKnife treatment, coverage varies by region. Two areas — the Northwest and parts of the West — have opted against payment. Quentin Helm, Accuray’s vice president for patient access, said he hoped CMS would keep the status quo but was concerned a future decision could rule against payment nationwide.

“When there’s doubt about what Medicare’s going to do, that can be a deterrent to private insurers” that already offer a “mixed bag” when it comes to reimbursement, Helm said.Prostate cancer affects mostly older men — and Medicare covers those aged 65 and older — but private payers often look to CMS in making their own payment policies.Unlike the use of CyberKnife with other cancers, “with prostate it’s kind of spotty,” Helm said, referring to private payer coverage. John’s Hopkins’ DeWeese said there is a lack of consensus about focused radiation products. “As of today, there’s very little data to support that approach in terms of its likelihood of a cure,” he said. “It might be equally effective, but it’s certainly not proven.” But Dr. Sean Collins, a radiation oncologist at Georgetown University Hospital in Washington who uses the CyberKnife, said it seems CMS is “trying to hold (CyberKnife) to a higher level of standards.” Collins, who will speak on Accuray’s behalf on Wednesday but is not a paid consultant, said CyberKnife has the same side effect risks as other types of radiation but requires just a few visits rather than two months of daily doses. “I think CyberKnife is a reasonable treatment option,” he said.

Article from Yahoo Daily News, http://news.yahoo.com/s/nm/20100418/hl_nm/us_medicare_prostate_preview

The ASTRO Emerging Technology Committee last week released it’s report on Stereotactic Body Radiotherapy (SBRT, as you know, is the term of art for extracranial radiosurgery) for Lung Cancer.  It is exciting to see that they have concluded that SBRT is an acceptable treatment option for non-operable Stage I-II NSCLC!   However, they stopped short of accepting it as an option for operable patients, at this time, citing the need for more follow-up.  They do encourage  “structured investigative protocols” ( a pretty broad term) as a way of treating Stage I operable NSCLC in order to get more data.   These conclusions are consistent with our own experience and we’re very encouraged that this treatment is rapidly gaining acceptability.   The exact wording of the summary was:

” In the medically inoperable setting, we conclude that SBRT is an accepted treatment option for Stage I-II NSCLC. In the operable setting, we conclude more study and longer follow-up is necessary to ensure that results are equivalent to those of surgery. Ideally, medically operable patients with Stage I lung cancer would likely receive SBRT on a structured investigative protocol.”

While the report is lengthy, it can be read HERE

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