September 10, 2016
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Proton beam therapy at ‘tipping point’ due to inconsistent reimbursement, lack of comparative data

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The FDA approved the first generation of proton beam therapy nearly 30 years ago.

Despite tremendous enthusiasm about the modality’s potential, concerns about high costs — as well as the lack of comparative data — have prevented it from solidifying its place in the radiation therapy armamentarium.

“Proton therapy is a very attractive treatment for cancer, based on a legacy of sound theory and on decades of clinical experience,” Anthony L. Zietman, MD, director of the genitourinary service at Massachusetts General Hospital Cancer Center and residency director for the Harvard Radiation Oncology Program, wrote in an editorial published in May in International Journal of Radiation Oncology*Biology*Physics. “Until recently, however, it has been regarded as exotic, expensive and irrelevant to the majority of [patients with cancer] and practitioners.”

Evidence clearly demonstrates proton therapy is effective and safe for children with cancer, but comparative data in other settings are needed, according to Anthony L. Zietman, MD.
Evidence clearly demonstrates proton therapy is effective and safe for children with cancer, but comparative data in other settings are needed, according to Anthony L. Zietman, MD. “There are not that many pediatric cancers, so there needs to be newer and more appropriate indications for the therapy to endure,” he said.

Photo courtesy of Massachusetts General Hospital Cancer Center.

The “tipping point” has arrived, Zietman said.

Costs of proton therapy have decreased considerably in the past decade, and researchers have intensified their efforts to validate the approach’s efficacy and safety compared with other radiation delivery methods.

If these investigations succeed, proton therapy may finally become mainstream for cancer treatment. If results are not stellar, it may never extend beyond a specialty niche in oncology care.

Further, if insurers opt not to pay for proton therapy, or if they only cover its use for select patients, about half of the nearly two dozen proton therapy centers operating in the United States could close, Zietman said.

“We have finally hit a crossroad,” Zietman told HemOnc Today. “Over the next few years, we will be able to determine if this will move forward.”

HemOnc Today spoke with radiation oncologists about the state of proton beam therapy, the general consensus in the clinical and research communities about its potential, and what the future likely holds for the field.

‘Cutting-edge techniques’

Proton beam therapy is a form of precise radiation treatment designed to destroy cancer cells while minimizing damage to surrounding healthy tissue.

A 220-ton cyclotron or synchrotron uses high-powered magnets to strip protons from hydrogen atoms in water and accelerate them. The high-speed protons are directed into an airless tube — known as a beamline — that is about the length of a football field, and then into devices that deliver the desired radiation dose to a tumor.

Proton beam therapy debuted on an experimental basis at Berkeley Radiation Laboratory in 1954. The FDA approved its use in 1988.

Only four proton beam therapy centers operated in the United States in 2004. Today, 23 centers are operational and another 13 are forthcoming.

Decreasing costs have contributed to the rapid growth.

The University of Pennsylvania spent $144 million to open its center in 2010, and Hampton University Proton Therapy Institute in Virginia — which opened later that year — cost $225 million. This year, however, University Hospitals in Cleveland opened a “compact,” single-room proton therapy center that cost $30 million.

“It used to be that proton beam therapy facilities came with an elite treatment machine, and you had to buy them in groups of three or four to treat hundreds of patients,” Zietman said. “Now, these single-room facilities have one machine that costs $30 million. Many hospitals can buy a proton beam machine and not go into debt.”

The technology also has evolved.

Many newer centers — such as Roberts Proton Therapy Center at Penn Medicine, and the Maryland Proton Treatment Center, a 110,000-square-foot outpatient facility that opened this year — offer pencil beam scanning.

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The delivery technique uses an electronic scanning system in which a narrow beam moves across each layer of a tumor to “paint” it with radiation. It is increasingly used for complex cases in which tumors are close to critical organs, such as the heart or lungs.

The Maryland Proton Center has treated more than 60 patients, according to William F. Regine, MD, the center’s executive director, as well as chair of and professor in radiation oncology at University of Maryland School of Medicine. Several have had tumors in the brain, spine or base of the skull, all of which require extreme precision.

“These cutting-edge techniques offer a powerful tool to fight cancer — one that can work extremely well in the right patients,” Regine told HemOnc Today.

Pediatric cancers

Dosimetric studies have suggested proton therapy reduces the radiation dose to healthy tissue by 50% or more, making it a potentially important modality for pediatric patients.

The Children’s Oncology Group protocol for high-risk pediatric Hodgkin lymphoma allows for the use of proton therapy partly due to the expectation that it may result in fewer long-term adverse effects. However, data on the modality’s use in this setting had been limited.

Wray and colleagues evaluated outcomes of 22 pediatric patients (age range, 6 to 18 years) with Hodgkin lymphoma who underwent chemotherapy followed by proton therapy between 2010 and 2014 at University of Florida. Eleven patients had high-risk disease and four had relapsed.

Results, published in May in Pediatric Blood & Cancer, showed 94% of patients achieved 3-year OS and 86% achieved 3-year PFS. This represented short-term disease control comparable to that reported in large multi-institutional clinical trials.

Three patients with high-risk disease experienced recurrence within 5 months of proton therapy completion. However, no grade 3 or higher acute or late complications occurred.

Torunn I. Yock, MD, MCH, director of pediatric radiation oncology at Massachusetts General Hospital and director of pediatric radiation oncology at the Francis H. Burr Proton Therapy Center, and colleagues conducted a phase 2 single-arm study that included 59 patients aged 3 to 21 years who underwent proton therapy for medulloblastoma. The majority (n = 39) had standard-risk disease.

All patients underwent craniospinal irradiation with 18 Gy to 36 Gy radiobiological equivalents (RBE) delivered at 1.8 GyRBE per fraction, followed by a boost radiation dose.

Cumulative incidence of all late effects at 3 years and 5 years served as the primary outcome measures.

Results, published in March in The Lancet Oncology, showed cumulative incidence of grade 3 to grade 4 hearing loss was 12% (95% CI, 4-25) at 3 years and 16% (95% CI, 6-29) at 5 years. Cumulative incidence of neuroendocrine deficit was 55% (95% CI, 41-67) at 5 years.

After median follow-up of 5.2 years, full-scale intelligence quotient declined by 1.5 points (95% CI, 0.9-2.1) per year. Researchers reported no significant change in perceptual reasoning index or working memory. No pulmonary, cardiac or gastrointestinal late toxic effects occurred.

Five-year PFS was 80% (95% CI, 67-88) and 5-year OS of 83% (95% CI, 70-90).

The researchers concluded proton radiotherapy was associated with acceptable and even favorable toxicity and survival outcomes compared with conventional radiotherapy.

“When we embarked on this study, there was a lack of good data. It was very sparse,” Yock told HemOnc Today. “We knew that if we were going to truly move the proton therapy field forward, we would have to collect data in an organized and meticulous way. These data are prospectively collected in a sequential way, and there is absolutely no hint at inferiority of proton therapy. In fact, the trend is very reassuring that it is at least equivalent to photon therapy for disease control and very suggestive that the modality is associated with fewer toxicities.”

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Available evidence suggests proton therapy is the best type of radiation therapy for pediatric patients.

“Children are incredibly sensitive to radiation and they develop cancers from radiation treatment,” Zietman said. “There is no question about the safety and efficacy [of proton therapy] in children ... but there are not that many pediatric cancers, so there needs to be newer and more appropriate indications for the therapy to endure.”

Emerging data

Other studies have suggested proton therapy may be a viable treatment modality for several cancer types, including spine or skull-base tumors, sarcoma, and breast, gastrointestinal, gynecologic, head and neck, lung and prostate cancers.

However, questions remain due to the lack of randomized trials.

“There are emerging data — I cannot yet say they are compelling — for liver, pancreas and lung cancers, and perhaps even for some lymphomas,” Zietman said. “There is a race to develop the data, but the data that are being developed are not necessarily comparative. The outcomes are good, but we are still unsure if proton therapy is better than other therapies for certain cancer types.”

Behera and colleagues used the National Cancer Data Base to assess 140,383 patients (median age, 68 years; 57% men; 59% white) with stage I to stage IV non–small cell lung cancer who underwent proton radiotherapy or conventional photon-based therapy between 2001 and 2012. The majority (59%) had stage II or stage III disease. Fewer than 1% (n = 348) of patients underwent proton therapy.

Results, presented in June at the ASCO Annual Meeting, showed risk for death was greater with photon therapy (HR = 1.46; P < .001). Among patients with stage II or stage III disease, proton therapy appeared associated with a higher 5-year OS rate (22.3% vs. 15%; P = .01). Patients who underwent proton therapy also achieved longer median OS (19 months vs. 11 months).

“Does this mean that protons are more effective than photons for treating NSCLC? Unfortunately, this study cannot answer that question adequately,” Nathan A. Pennell, MD, PhD, medical oncologist at Cleveland Clinic’s Taussig Cancer Institute, told HemOnc Today after the results were presented. “The National Cancer Data Base is a powerful tool for retrospective analyses, with outcomes data available from 70% of patients treated in the United States, but its power is derived from the sheer numbers of patients available for analysis. It is much less useful when numbers are small.”

Nathan A. Pennell, MD, PhD
Nathan A. Pennell

Patients treated with proton therapy were more likely to have higher income and education levels and undergo treatment at academic centers.

“Essentially, this study compared those patients — treated in one of only 23 proton centers in the United States — with the rest of the country and, as such, the conclusions really are not interpretable,” Pennell said. “Given the relatively small numbers and favorable prognostic characteristics of proton-treated patients with NSCLC, this simply is not a question that can be answered retrospectively. The good news is that there are prospective, randomized trials that should provide better answers to this question.”

One of them, a randomized phase 2 trial by Liao and colleagues presented at ASCO, showed no significant difference with regard to survival, local control or toxicity between chemoradiation with protons or intensity-modulated radiation therapy for patients with stage III NSCLC.

The ongoing randomized phase 3 Radiation Therapy Oncology Group 1308 trial will make the same comparison among patients with inoperable stage II or stage III NSCLC.

“[This trial] should be strongly supported if we hope to ever put this issue to rest,” Pennell said.

The value of proton therapy for prostate cancer also has been controversial.

Hoppe and colleagues compared prospectively collected quality-of-life data from 1,447 men with prostate cancer. The majority of men (n = 1,243) underwent proton therapy administered at doses of 76 Gy to 82 Gy. The other 204 men underwent IMRT in doses from 75.6 Gy to 79.4 Gy.

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An analysis of patient-reported data collected the first 2 years after treatment, published in Cancer, showed no significant differences between cohorts in summary score changes in bowel, urinary incontinence, urinary irritative/obstructive and sexual domains. However, men who underwent IMRT reported more moderate or major problems with rectal urgency (P = .02) and frequent bowel movements (P = .05).

An evaluation of proton therapy in women with breast cancer undergoing radiation — particularly to the left side of the breast — is warranted, according to Mark McDonald, MD, radiation oncologist at Winship Cancer Institute of Emory University.

“These patients have an increased risk for cardiac events many years down the road related to even low doses of radiation to the heart,” McDonald told HemOnc Today. “The benefit of radiation exceeds these risks and we still recommend radiation because of the benefits, but it does not mean we should not minimize these risks by improving our radiation dose distribution with proton therapy. Although this is a benefit that is not immediately apparent, it is still a significant benefit for the future of our patients and for future costs.”

Barriers to trials

Despite the need for more data, barriers to comparative clinical trials remain, James D. Cox, MD, professor and former head of the division of radiation oncology at The University of Texas MD Anderson Cancer Center, wrote in an editorial published this spring in International Journal of Radiation Oncology*Biology*Physics.

For example, a key advantage of proton therapy is the avoidance of toxicity; however, radiation-induced toxic effects may not be evident for many years. The cost of proton therapy — and inconsistent reimbursement from third-party carriers — also is a factor.

“Unbiased studies, especially comparative clinical trials, rely on equal access to the arms of the study,” Cox wrote. “Financial considerations are important if unbiased studies are to be completed. Coverage of treatments by third parties is usually necessary. If patients have Medicare, they will usually be covered by this mechanism, although the payments for their treatments will be lower than costs. However, relying on Medicare coverage to enroll patients with common forms of cancer would result in age bias.”

In addition, institutional review boards often are comprised of individuals who have limited knowledge of radiation therapy, and “it seems inconceivable to them that an approach such as IMRT or proton therapy might be introduced with the specific goal of reducing toxicity,” Cox wrote.

“The barriers to prospective comparative trials with proton therapy are sufficiently formidable that whether such trials can be accomplished at all is unclear,” Cox wrote. “Even if comparative trials are completed, they are likely to be flawed in some way.

“Until such time that proton therapy has the wide distribution and third-party acceptance of photon therapies, comparative trials will be delayed for years,” he added. “Each of the barriers enumerated here must be acknowledged and efforts made to overcome them. It is fanciful to think this will happen any time soon.”

Variable reimbursement

Minesh Mehta, MD
Minesh P. Mehta

Consistent reimbursement from payers is another hurdle that must be overcome.

“When the FDA approved proton therapy, it approved it in the context of a therapy that can be substituted for radiation therapy, and the implication is that it could be used for almost any condition where the treating physician deems there to be a specific advantage with the use of protons, not just conditions for which randomized trials have been conducted,” Minesh Mehta, MD, deputy director and chief of radiation oncology at Miami Cancer Institute, told HemOnc Today. “Most patients who have Medicare are generally covered; however, many private insurers restrict the diagnoses that they will cover proton therapy for, so coverage is not uniform. Some insurance companies will cover children and certain brain tumors, some will cover prostate cancer, and others will cover breast or lung cancers.”

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This leads to considerable hurdles for physicians, Yock said.

“I have had to call insurance companies and write letters of medical necessity before patients are approved,” Yock said. “In some cases, I have had to conduct a peer-to-peer review of the case. There are a certain number of hoops to jump through.”

Payers are motivated to contain costs, protect profit margins and keep private insurance affordable, McDonald said.

“There are upfront costs and, if we are successful, they can pay enormous dividends for future patient care,” McDonald said. “There are different motivations in coverage policies for proton therapy and we would like to see an approach that offers coverage for evidence development. It is important that we innovate in radiation oncology to improve patient care.”

However, long-term benefits must be considered, proponents said.

“The evidence shows that these costs are balanced by lower lifetime costs for patients who undergo proton therapy,” Regine said. “There are fewer complications and less need for subsequent treatments.”

Mehta agreed.

“Concerns about high costs for cancer treatment or therapy for any other disease are extremely relevant,” Mehta said. “A therapy that works but is not affordable is not good for anybody. However, one must look at the big picture with proton therapy. It is a matter of upfront costs vs. lifetime costs.”

If a child with cancer requires radiation, treatment with conventional photons costs less than proton beam therapy. However, proton beam therapy is less likely to cause long-term — and chronic — treatment-related side effects.

“If you add the cost of survivorship, it significantly favors protons in many cases,” Mehta said.

Verma and colleagues conducted a systematic review of studies that assessed proton radiotherapy’s cost-effectiveness. Their analysis included 18 original investigations from 2000 through 2015.

Results, published in May in Cancer, showed proton beam therapy was a cost-effective option for pediatric brain tumors, patients with left-sided breast cancers at high risk for cardiac toxicity, individuals with locoregionally advanced NSCLC; patients with head and neck cancers at higher risk for acute mucosal toxicities; and patients with uveal melanoma. Researchers reported “suboptimal” cost-effectiveness of proton beam therapy for prostate cancer and early-stage NSCLC.

“Careful patient selection is absolutely critical to assess cost-effectiveness,” Verma and colleagues wrote.

However, the researchers also cited “greatly limited amounts of data” and noted more clinical trial evidence, coupled with technological improvements, could lead to rapid changes in cost-effectiveness classifications.

“There are not infinite health care dollars anymore, and many providers are refusing to pay,” Zietman said. “An individual battle is required for each individual patient. We have two choices: Generate the evidence to move forward and justify its use, or not generate the evidence and simply not be reimbursed — in which case, many of the current proton beam therapy facilities may close.”

Looking ahead

Despite concerns about reimbursement, payers behavior “is both predictable and rational,” Peter A.S. Johnstone, MD, FACR, clinical director and vice chair of radiation oncology at Moffitt Cancer Center, and John Kerstiens, MBA, CPA, director of operations for radiation oncology at Miami Cancer Institute at Baptist Health South Florida, wrote in an editorial published in International Journal of Radiation Oncology*Biology*Physics.

Payers want to reduce the cost of their clients’ procedures — through limitation of access or price negotiations — to ensure their profit, Johnstone and Kerstiens wrote.

Patients treated at Maryland Proton Center and Mayo Clinic’s proton center in Minnesota are offered proton therapy at the same cost as IMRT. CMS, meanwhile, reduced complex proton reimbursement rates by 12% between fiscal 2014 and fiscal 2015.

“Such examples reveal the ultimate truth of proton therapy: Although the treatment is based on the laws of physics, we ignore the laws of economics at our own peril,” Johnstone and Kerstiens wrote. “As new centers proliferate, the supply of proton therapy will outpace the demand of patients with insurance or cash to pay for the procedure.”

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Johnstone and Kerstiens estimated that, under current reimbursement models, a population must exceed 1 million to ensure treatment capacity for a one-room proton therapy center.

“As with all bubbles, the proton therapy bubble will burst. The mechanism of the bursting will be reimbursement,” they wrote. “Lower reimbursements forced on the market will drive for-profit centers, debt-laden centers and poorly located centers from the field. Only those centers with the backing of large, financially healthy systems will survive under this model. Future expansion of proton therapy will look very different from the frenzy we have seen over the past decade. Lower reimbursements, restricted coverage policies, and emphasis on pediatrics will set proton therapy up as a loss leader for major cancer centers.”

Zietman expressed more optimism.

“I do think the field is going to move forward because the price will come down,” he said. “There are also technological advances that may bring the price down even lower. The second thing is that there is quite a lot of advocacy behind proton beam therapy that will stop CMS saying they will not reimburse for it. Advocacy will stay alive on Capitol Hill long enough to develop new research.”

Mehta agreed proton therapy is here to stay.

“New technology is making us realize the magnitude of impact that proton therapy can have on many patients with cancer,” Mehta said. “Over time, the proportion of patients with cancer who are treated with proton therapy will simply continue to increase. We will see growth in the industry through improved technology and minimization, smaller footprints, and potential reduction in costs as the footprint downsizes and availability goes up.”

Additional scientific evidence also is essential, Regine said.

“We have some data already, but we need more — and it is coming,” Regine said.

Research from Mark V. Mishra, MD, assistant professor of radiation oncology at University of Maryland School of Medicine, showed there are 111 active trials with nearly 30,000 patients worldwide designed to evaluate proton therapy.

“There are also at least seven randomized studies evaluating the approach,” Regine said. “In total, these trials will tell us which patients, and which cancers, can benefit most from proton therapy.”

As research intensifies to identify drugs that can better target cancers and cause fewer adverse effects, a similar effort is required in the field of radiation therapy, McDonald said.

“When we look at what we can do with conventional photon therapy, we are at — or very near — a plateau with regard to what we can do to further improve the therapeutic ratio,” McDonald said. “We made a lot of strides during the past 10 years in image-guided therapy, but further improvement will be limited by simple physics of X-ray beams.

“Moving to proton beam therapy opens up new possibilities,” he added “There are differences in the physical properties of proton therapy that we can exploit for better dose distribution. Radiation therapy is going to be marginalized in future treatment strategies that require us to improve or maintain our effectiveness, but decrease toxicities. Proton therapy is a tremendous way for us to do this.” – by Jennifer Southall

References:

Behra M, et al. Abstract 8501. Presented at: ASCO Annual Meeting; June 3-7, 2016; Chicago.

Hoppe BS, et al. Cancer. 2014;doi:10.1002/cncr.28536.

Johnstone PA and Kerstiens J. Int J Radiat Oncol Biol Phys. 2016;doi:10.1016.j.ijrobp.2015.09.037.

Liao Z, et al. Abstract 8500. Presented at: ASCO Annual Meeting; June 3-7, 2016; Chicago.

Plastaras JP, et al. Semin Oncol. 2014;doi:10.1053/j.seminoncol.2014.10.001.

Verma V, et al. Cancer. 2016;doi:10.1002/cncr.29882.

Wray J, et al. Pediatr Blood Cancer. 2016;doi:10.1022/pbc.26044.

Yock TI, et al. Lancet Oncol. 2016;doi:10.1016/S1470-2045(15)00167-9.

Zietman AL. Int J Radiat Oncol Biol Phys. 2016;doi:10.1016/j.ijrobp.2016.02.056.

For more information:

Mark McDonald, MD, can be reached at mark.mcdonald@emory.edu.

Minesh P. Mehta, MD, can be reached at mineshpmehta@gmail.com.

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Nathan A. Pennell, MD, PhD, can be reached at penneln@ccf.org.

William F. Regine, MD, can be reached at wregine@umm.edu.

Torrun I. Yock, MD, can be reached at tyock@mgh.harvard.edu.

Anthony L. Zietman, MD, can be reached at azietman@partners.org.

Disclosure: McDonald, Mehta, Pennell, Regine, Yock and Zietman report no relevant financial disclosures.

POINTCOUNTER

Should proton beam therapy be standard for pediatric medulloblastoma?

POINT

Yes.

Five-year survival is around 80% for patients with standard-risk medulloblastoma and 60% for those with high-risk disease. These excellent results have been obtained by the improvement of surgery and postoperative intensive care; accuracy of simulation and dosimetry; better knowledge of dose distribution; quality control of radiotherapy delivery; and perhaps — at least for high-risk patients — a benefit of adding chemotherapy.

Christian Carrie, MD
Christian Carrie

Future improvements in survival are expected. They probably will come from new drugs and immunomodulation, but probably not from radiotherapy dose escalation or dose delivery.

It could be considered anachronic to think that proton therapy could be — or is right now — the standard of care for this disease. Clearly, the dose distribution with proton therapy is superior, but it is unlikely that this better dose distribution will improve survival.

The biological effect of proton therapy is not superior compared with photon therapy. So why must proton therapy be the standard if the standard of radiation therapy for medulloblastoma is still craniospinal irradiation? Because of late effects from treatment.

The modeling radiation dosimetry to predict cognitive outcome in pediatrics, published by Hall and colleagues in 2006, stated that preradiation IQ is 93 and the loss is 0.14 per month for the base model. For each increase of 1 Gy, IQ decreased by 0.0098 given identical age, but the decline will be increased by 0.028 per month for a child aged younger than 1 year. For a 5-year-old child, changes in IQ will be –3.9 IQ per year after 36 Gy of craniospinal irradiation and a 55 Gy boost on posterior fossa.

Due to the higher conformation of the boost, proton therapy reduces the mean dose on the supratentorial of 20 Gy — the contribution of the dose to the temporal lobe — and reduces potential changes in IQ. As far as the standard of treatment, craniospinal irradiation, proton therapy will provide a fantastic benefit on the delivered dose to the thyroid, heart, intestinal track and lung.

We can effectively discuss the potential benefit of intensity-modulated radiation therapy or helical radiotherapy for craniospinal irradiation. However, it is not certain that the dosimetry signatures would be translated into probabilities of reductions of late effects, and that 10 Gy vs. 15 Gy or 20 Gy on the thyroid or the heart would have a clinical impact. For proton therapy, the difference is near 0 vs. 20 Gy.

In 2014, Stoker and colleagues published an important work that showed proton therapy could reduce incidence of second cancers and cardiac mortality by sixfold and reduce mortality by threefold. So, yes, I definitely believe proton therapy must be considered standard treatment for pediatric medulloblastoma.

References:

Hall EJ, et al. Int J Radiat Oncol Biol Phys. 2006;65:1-7.

Stoker JB, et al. Int J Radiat Oncol Biol Phys. 2014;doi:10.1016/j.ijrobp.2014.07.003.

Christian Carrie, MD, is head of radiation oncology at Leon-Berard Cancer Multidisciplinary Center in Lyon, France. He can be reached at christian.carrie@lyon.unicancer.fr. Disclosure: Carrie reports no relevant financial disclosures.

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COUNTER

No.

The evolution of our understanding of the molecular biology of medulloblastoma, and the classification of the disease into subtypes based on this molecular biology, is a paradigm shift. An understanding of the roles of individual oncogenes and tumor suppressor genes in the pathogenesis of the tumor provides hope for the identification of new druggable therapeutic targets.

Edward C. Halperin, MD, MA
Edward C. Halperin

Improvements in survival can be traced to improved diagnostic and surgical techniques, better diagnostic imaging, standardized staging, treatment algorithms driven by meticulously done clinical trials, improved radiotherapy techniques that avoid marginal misses of the treatment volume, and the appropriate use of chemotherapy.

Long-term survival and minimization of treatment-related morbidity are positively affected by improved radiotherapy technique, as well as use of as low a dose of radiation and chemotherapy as possible to minimize deaths and adverse late effects from injury to normal tissue. It is in reference to this last point that proton treatment shows promise, although not all agree that it does.

Cancer in children and adolescents accounts for 1.4% of all cancers worldwide but 4.8% of cancers in Africa, primarily because of differences in age composition of the population and life expectancy. Low- and- middle-income countries account for 94% percent of deaths from cancer in people aged up to 14 years. Simply stated, the vast majority of the world’s pediatric cancer burden and childhood cancer deaths occur in the economically less developed world.

There are several times as many linear accelerators in Durham County, North Carolina — with a population of 288,000 — than in the nation of Ethiopia, home to 94.1 million people. The manufacturers of radiation therapy equipment need to spend more time developing, marketing and installing low-cost radiation therapy equipment to provide basic cancer services to the world’s population and less time promoting a radiotherapy nuclear arms race in which the less economically developed world is chasing after the acquisition of a proton machine as a perverse form of national pride.

The best technical innovation we can strive for in radiation oncology is a reliable, low-cost radiotherapy unit for the less economically developed world. We would be better off if we spent more time talking about and solving the problem of the complete absence of any radiation therapy service for most of the world’s population than providing duplicative proton machines for high-income countries.

No one would be better pleased than me if the argument I have articulated in the previous paragraph were to be rendered moot by proton therapy being reimbursed at the same rate as photon therapy. The profit motive should be taken out of the equation. I look forward to the manufacturers of proton machines slashing their profit margins and providing their equipment at a cost that fits with the availability of scarce financial resources, hospitals and clinics not receiving multiples of the price of photon therapy for proton therapy, and doctors having no personal financial benefit from employing proton therapy.

For those who complain that my ideas amount to interfering with the free marketplace of the capitalist system, grow up. Americans already interfere with the free marketplace in the pricing systems for tobacco, milk, racehorses, corn, weapons, soft drinks and vaccines. I am always amused by the wealthy insisting upon capitalism for the poor and socialism for the rich.

Asserting that protons are the worldwide standard of care for pediatric medulloblastoma, in a world where most children with cancer have no access to radiotherapy services, is patently absurd and a form of cultural imperialism. One might as well assert that — because a $100,000 Land Rover sport utility vehicle gives a comfortable ride and provides safety to passenger and driver in a wealthy area of Manhattan — it is the worldwide standard for family transportation.

References:

Borowska A and Jozwiak J. Arch Med Sci. 2016;doi:10.5114/aoms.2016.59939.

Coluccia D, et al. Curr Neurol Neurosci Rep. 2016;doi:10.1007/s11910-016-0644-7.

Leroy R, et al. Int J Radiat Oncol Biol Phys. 2016;doi:10.1016/j.ijrobp.2015.10.025.

Halperin EC. Lancet Oncol. 2013;doi:10.1016/S1470-2045(13)70529-1.

Magrath J, et al. Lancet Oncol. 2013;doi:10.1016/S1470-2045(13)70008-1.

Edward C. Halperin, MD, MA, is chancellor and CEO at New York Medical College in Valhalla, New York. He can be reached at edward_halperin@nymc.edu. Disclosure: Halperin reports no relevant financial disclosures.