• read more about SMART

    TECHNOLOGY

    SMART Cancer Center: Safer, Better, Cheaper.

    • Arc techniques minimize second cancers
    • 6 MV LINAC provides maximum sparing of critical organs
    • 3D Treatment significantly reduces costs
  • Educate yourself

    EDUCATION

    Patient Education through Physician Education.

    • Franklin County Cancer Committee
    • Franklin County Breast Care Team
    • American Cancer Society Resource Center
 

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Celebrating Survival Focusing on Quality


October 30th, 2012

Not long ago, a diagnosis of cancer was most often a death sentence. These days, most of the people diagnosed with cancer are cured. Success in the fight against cancer has been nothing short of remarkable. That very success creates our new challenge: maximizing the quality of life after treatment.

Last year, the American Cancer Society marked a milestone in the treatment of cancer. In its annual fundraising campaign, the organizers pointed out that we are now curing “2 out of 3”cases. As evidence, they published the National Cancer Institute’s survival tables, which demonstrated that the 5-year relative survival in the most recently available data was 68%.

That number is already outdated. In order to be absolutely certain that they are providing accurate analysis, the NCI report detailing 5-year survival must be based upon patients treated at least 5 years ago. In fact, the 68% survival was actually based on patients treated between 1999 and 2006. The midpoint of that time-frame is 2002, which means that the average patient in the study sample was actually treated 10 years ago.

Tremendous progress has been made in cancer care over the past 5 decades. There is no reason to believe that progress came to a halt a decade ago. It is more likely that progress has followed roughly the same trajectory in the most recent decade as it did in the previous 50 years. If we project the historical trend on the historical data (see graph), it reveals that the 5-year relative survival of a patient diagnosed with cancer in 2012 is likely to be 75% — or 3 out of 4!

As those of us who are striving to design and support the cancer center that will meet the needs of our community well into the future, we must realize that the 5-year survival rate in the year 2020 is likely to be 80% — or 4 out of 5!

In this context, it is no longer sufficient to think about cancer treatment in terms of survival alone. The old approach of “cure at all cost” must give way to a more thoughtful consideration that places a premium on the quality of survival after treatment. If 80% of the cancer patients are going to be cured, then 80% will be destined to live the rest of their normal life expectancy with the consequences and complications of the treatment.

As cancer specialists, we are not waiting for the future, we are already preparing for it. We are already making significant adjustments in our traditional approach to this disease. In breast cancer surgery for instance, these adjustments take the form of performing a less damaging form of lymph node biopsy rather than the traditional axillary dissection, because the smaller procedure provides all the benefit of the more aggressive surgery, but avoids the most serious complications, such as arm swelling and decreased range of shoulder motion.

Range of motion in the shoulder may seem a secondary consideration when dealing with something as serious as cancer, but when you consider that many of these women will be swinging a tennis racket or a golf club for decades afterward, such considerations take on a pleasant new significance.

The new generation of chemotherapy drugs is not only more effective, but far less toxic, both in the sort run and the long run. Targeted therapy based on the genetic characteristics of an individual’s cancer is in its infancy. The pipeline of new, targeted therapies is set to explode in the coming decade.

In Radiation Oncology, the most significant improvement during the last two decades has been our ability to focus the lethal effects of the radiation more precisely on the cancerous target, while sparing the surrounding, sensitive normal structures. Much of the progress in the next decade will take the form of developing even safer methods of radiation delivery to minimize the most serious long-term complications of radiation.

Today, the Cancer Care Team working in Franklin County is working diligently to integrate the newest, safest techniques into the care of each individual patient. This effort is our way of honoring those who have brought us this far.

 
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Preventing Fatal Second Malignancies from IMRT


September 7th, 2011

by: R L McLaurin Jr MD MBA

IMRT:   Intensity Modulated Radiation Therapy is a relatively recent innovation in the history of Radiation Oncology.  It employs sophisticated computer treatment planning software and hardware to focus the damaging effects of radiation on the malignant tumor while reducing the dose to nearby normal tissues.  It is a major technologic advance over the prior state-of-the-art technique of 3D Conformal Radiation Therapy (3D-CRT).

Years of accumulated data fail to show that IMRT produces any improvement in survival compared to 3D-CRT.  Nonetheless, Medicare pays approximately $45,000 per patient for IMRT vs. $12,000 for 3D-CRT.  The evidence does demonstrate that IMRT provides a small reduction in proctitis, but that advantage is more than offset by a dramatic increase in the risk of fatal second malignancies.

The Institute for Clinical and Economic Review (ICER) conducted a thorough analysis in 2007 comparing IMRT to 3D-CRT for the treatment of localized prostate cancer.  Their findings confirm that IMRT produces no survival benefit.  ICER concluded that the clinical effectiveness of IMRT is not superior to the established standard, and the comparative value of IMRT is low.

 SMART:  Stereotactic Multiple Arc Radiation Therapy is an incremental improvement over conventional 3D-CRT.  It integrates the inherent advantages of “Arc” treatment techniques.  Arc treatment delivers radiation while the radiation source is rotating around the patient.  The advantage of this technique derives from the fact that virtually all tumors have rounded surfaces.

There has never been a square tumor, or a hexagonal one or an octagonal one.  The common 4 or 6 or 8-field plans using a finite number of static portals cannot provide as good a fit to the tumor, because the Arc technique enables us to “bend” the isodose curves to conform more precisely to the target contour.  Simple geometry dictates that the greatest area that can be contained in a given perimeter is a circle.  All of the “extra” area contained in other shapes exposes additional normal tissue to unnecessary radiation.

SMART exclusively employs 6 MV beams, partly because of the risks inherent in high-energy beams.  High-energy beams produce increased radiation scatter and neutron contamination.  These problems are exacerbated by IMRT, and are the root cause of the enhanced risk of fatal second malignancies.

Research has also shown that 6 MV beams produce the optimal treatment plans.  A recent study exploring the effect of beam energy on treatment plan quality in the modern era of sophisticated treatment planning demonstrates that, “for plans with comparable target coverage, critical structure sparing is best achieved with 6 MV beams.”

Prostate Cancer: Not all malignancies are created equal.  Cancer is a disease characterized by a wide spectrum of virulence, and the control rates differ dramatically among malignancies originating from different organ sites.  The National Cancer Institute regularly assembles 5-year relative survival tables, which tabulate the actual survival of patients diagnosed with cancers from various sites, and compares them to the expected actuarial survival of an age-matched cohort of patients who have never had cancer.  These tables demonstrate that the control rate for lung cancer remains dismal at 14%, while the overall 5-year relative survival rate for prostate cancer is 100%. 

 The 100% 5-year relative survival for patients diagnosed with prostate cancer is partly due to improved early detection.  Since the widespread use of the PSA test, there has been a profound “stage shift,” such that the vast majority of prostate cancer cases diagnosed in America today are found in the earliest stage, when the disease is still confined within the prostate gland.  Treatment of organ-confined prostate cancer, whether by surgery or radiation, is highly successful.  For patients diagnosed with localized prostate cancer, cures are the rule rather than the exception.

In order to be absolutely certain that the 5-year relative survival rates are reliable, the National Cancer Institute analyzes only results of patients who have been followed for at least 5 years.  Therefore, the survival tables published in 2007, which demonstrate the 100% 5-yr relative survival rate, reflect the results for patients treated before 2002.  The timeframe is important because 2002 was the year that Medicare began to reimburse for IMRT, which marked only the beginning of the widespread adoption of IMRT.  The excellent survival rates were established prior to the generally availability of IMRT.

Destructive Technology: Despite the paucity of data to support the use of the newer, more expensive modality, the extremely high level of reimbursement has driven virtually every Cancer Center in the State of North Carolina to undertake a wholesale conversion to IMRT.  It has been marketed very aggressively by those who have paid to obtain the technology, some claiming that IMRT must be considered the sole standard of care.

Most troubling about these claims is that they intentionally ignore the fact that IMRT produces a dramatic increase in the risk of fatal second malignancies.  Kry and Followill, radiation physicists from M D Anderson Cancer Center, demonstrated that the risk of fatal second malignancies from IMRT is in the range of 3–5% (see table above).

Followill earlier demonstrated an expected rate of 0.3% for conventional radiation treatment using 6 MV beams.  Thus, IMRT produces a 10 to 17 fold increase in the rate of fatal second malignancies compared to treatment strategies based on conventional radiation with 6 MV beams.

Put another way, the use of IMRT to treat a prostate cancer patient introduces approximately 3-5% risk of additional deaths from second cancers caused solely by the choice of treatment modality.

Since IMRT provides no survival benefit, the added risk of fatal second malignancies would actually decrease the likelihood of survival.  The decreased survival is not yet evident because there is a long lag time from the exposure to high levels of radiation and the subsequent manifestation of second fatal malignancies.  The risk estimates are based upon rigorous scientific measurements, and calculated from well-established coefficients provided by the Nuclear Regulatory Commission (NRC).  These coefficients are derived from data on previous radiation exposure events such as Hiroshima.

Why would anyone pay 4 times as much for the privilege of being exposed to such risk?

Franklin County Cancer Center is the only radiation treatment facility in this part of the state that has not succumbed to the temptation to over-charge patients by using IMRT.  My refusal to install the IMRT technology was made purely on principle.  The “McLaurin Arch” has been commercially available since the mid-1990’s and has been marketed as “IMRT-enabling technology.”  It is among the tools other Cancer Centers around the country, and around the world, use to make IMRT possible.

I could have easily installed the remaining IMRT hardware and software, and would have recaptured my costs in the treatment of the first few prostate cancer patients.  I have chosen not to do so because of ethical reservations regarding both the costs and the risks of the technology.

The recent universal conversion to IMRT by all the other Cancer Centers in the region means that every patient with early stage prostate cancer who get sent out of Franklin County for radiation treatment is now getting charged approximately 4 times as much – to achieve the same short-term results – while exposing him to an unacceptable level of potentially fatal long-term consequences.

If the patient happens to be an employee of Franklin County, though the individual risks paying the ultimate price, it is the county taxpayer who pays the extra cost, both for the current treatment and the cost of the later consequences.

Conclusion:  The exorbitant financial costs and the extremely high risk of fatal second malignancies associated with IMRT far outweigh the modest reduction in proctitis it provides.  The increased risk of fatal second malignancies from IMRT may be as high as 5%.  The best way to prevent unnecessary deaths from IMRT is avoid its use in the first place.

 
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A Dangerous Game with Potentially Disastrous Consequences for Franklin County


August 3rd, 2011

First and foremost, let me take this opportunity to personally thank Senator Doug Berger for his unwavering support of the Franklin County Cancer Center.  Throughout his entire career, he has been an ardent supporter of improved access to quality healthcare, particularly for the medically underserved.  His staunch support of our Cancer Center is completely consistent with his ethical commitment to the best interest of all the people of his district and the entire state.

Approximately one year ago, Greg Beier, head of hospitals for Novant, and a recognized expert on access to advanced medical technology, when asked whether Franklin County could qualify for a Linear Accelerator (LINAC) under the new law, replied, “Never.”

Senator Berger and his staff, around the same time, went to the trouble to research this exact issue before the Senator attended a meeting of the Franklin County Medical Society.  In fact, it was Senator Berger who personally communicated to all present at that meeting, that if the LINAC housed within the Franklin County Cancer Center were to be shut down, that the probability that another LINAC would be permitted to replace it was “Zero.”

Despite being informed of the consequences of trying to shut down the LINAC, certain parties intentionally ignored the best interests of the entire population of Franklin County, and tried to shut down the Cancer Center for their own personal gain. Whoever is behind the effort to shut down our Cancer Center may claim they were simply seeking clarification of the legal status of the center.  That claim is disingenuous at best.  They are playing a very dangerous game, the most likely outcome of which would be that Franklin County would lose its Cancer Center forever.

Dr. McLaurin incurred more than $35,000 in legal expenses to accurately demonstrate to the CON Section the facts surrounding the establishment of this extremely complicated enterprise.  He was able to prove that the Cancer Center is now, and always has been, in complete compliance with the law.  The attorney for the NC Department of Justice, who handled the case for the state, said that “someone was putting intense pressure on the CON Section to shut down your LINAC.”  She further stated that, if we were unable to adequately defend against the challenge, the DOJ was prepared to issue a “cease and desist” order, shutting down the center immediately.  If Dr. McLaurin did not have the resources necessary to hire CON attorneys to provide a reply to the CON Section, the center would be closed today.

The parties who put pressure on the CON Section to shut down the Cancer Center paid nothing to initiate the challenge, and continue to try to hide their identities.  They are very familiar with the CON process, and are fully aware that the sheer financial burden imposed by $400 per hour lawyers is often sufficient to thwart otherwise legitimate projects.  They may have insinuated that they could always build a newer and better center at some time in the future after the existing Cancer Center was forced to close, but that is extremely unlikely.

First of all, the legal avenue by which Dr. McLaurin established the cancer center by making it operational under a certain monetary threshold no longer exists. That pathway was eliminated by a change in the law on August 26, 2005. Now all new linear accelerators (LINAC’s) require a CON before they can even be purchased. This fact is confirmed in detail in the recent determination of “no review” provided by the CON Section for the existing LINAC, which details the impact of the change in the law in 2005.

Secondly, it is very unlikely that anyone could obtain a CON for a LINAC in Franklin County, because the population and demographics simply don’t support it. Furthermore, CON’s for LINAC’s are highly prized by all cancer care providers, and the competition for them is fierce.  The last time the Division of Facility Services determined that the need for one more LINAC existed in the service area which encompasses Franklin and Wake counties; there were 5 applications for that CON, all of them in Raleigh.

Finally, the acquisition of a very expensive new LINAC is simply not a viable business venture in Franklin County. It is no secret that Franklin County is not the richest county in the state.  Because of the high percentage of elderly, uninsured and underinsured patients in the county, the “payer mix” is unfavorable for reimbursement.  In order to support the acquisition of very expensive medical equipment (UNC-CH recently submitted a CON application for a LINAC costing $9.8 million) there must be adequate reimbursement to service the debt, afford the sky-high service contract to keep the equipment running, and pay the highly-trained personnel to run it.

It is likely that the people behind the legal challenge understand all of this.  So it is implausible that they would be unaware of the potential consequences of their actions.  It is also unlikely that their efforts to shut down the Cancer Center will end even after the CON decision has been rendered. If Dr. McLaurin had not prevailed in defending the Franklin County Cancer Center’s right to operate, or if he is unable to overcome their continuing efforts to undermine his center, it is almost inevitable that Franklin County will be deprived of this very valuable, life-saving service forever!

One must ask, is this the kind of reputation Franklin County wants to have when it comes to recruiting new businesses or services to this community?