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Needed context absent from release on “less toxic way to treat brain tumors”

International Study Finds Effective, Less Toxic Way to Treat Brain Tumors

Newswise — CHARLOTTE, N.C., July 26, 2016 /PRNewswire-USNewswire/ — Physicians from Carolinas HealthCare System’s Neurosciences Institute and Levine Cancer Institute are among the authors of a study that was accepted for publication by the Journal of the American Medical Association (JAMA). The study, released on July 26, 2016, shows that patients with the most common form of brain tumor can be treated in an effective and substantially less toxic way by omitting a widely used portion of radiation therapy. These results will allow tens of thousands of patients with brain tumors to experience a better quality of life while maintaining the same length of life.
Anthony L. Asher, MD, FACS, medical director at Carolinas HealthCare System’s Neurosciences Institute and the senior author on the report, and as well as Stuart H. Burri, MD, chairman, department of radiation oncology at Levine Cancer Institute, began their research on this subject over 10 years ago in Charlotte, North Carolina. Along with Dr. Paul Brown at Mayo Clinic, they spearheaded an international, multi-institutional, randomized trial that will ultimately improve the standard of care for patients with a specific type of brain tumor, brain metastases, by reducing the toxicity of their treatment without reducing the effectiveness.

Typical therapies for these types of brain tumors include surgery, whole brain radiation therapy and focused radiation, also known as stereotactic radiosurgery. “We discovered that whole brain radiation added to focused radiation in the treatment of brain metastases – in other words, cancer that travels to the brain- reduces the number of new brain tumors over time; however, patients receiving the whole brain radiation had significantly more difficulties with memory and complex thinking than patients who only had the focused radiation,” says Dr. Asher.

“Whole brain radiation patients also reported worse quality of life compared with patients who only received the focused radiation,” adds Dr. Burri. “Interestingly, the data showed that the addition of whole brain radiation produced no improvement in survival.”

According to the American Cancer Society, in 2016, there will be approximately 1.7 million new cancer cases diagnosed in the United States. Almost one in four of those patients (about 400,000) will experience spread of their cancers to the brain. In contrast, 300,000 and 240,000 patients will be newly diagnosed with breast and primary lung cancers, respectively, each year. “Brain metastases are not only extremely common, they are also a major source of disability in society,” says Dr. Asher. Because of their location, these tumors often produce severe neurological symptoms, such as headaches, weakness or problems with speech and information processing, thereby compromising both daily function and quality of life in cancer patients.

According to Dr. Asher, there are two primary objectives in cancer care:

To improve survival
To maintain or improve quality of life for patients
“The first and highest rule of medical care is ‘do no harm,'” says Dr. Asher. “Consistent with that obligation, when it isn’t possible to extend survival with various therapies, it’s absolutely essential that we work to reduce or eliminate any possibility that quality of life will be compromised by treatments. Another way to state that principle for cancer care, is that when two cancer therapies produce similar survival, it’s important to understand which therapy offers patients a better quality of life.”

In this study, although whole brain radiation decreased the number of new brain tumors over time, its addition to focused radiation interestingly did not result in a survival benefit over focused radiation alone. Furthermore, whole brain therapy was associated with considerably worse quality of life.

“In the past, clinicians who treated patients with brain tumors seldom used sophisticated techniques like neurocognitive tests to evaluate patients’ daily function in response to various therapies,” said Dr. Burri. “Without those tests, we might have incorrectly concluded that whole brain radiation was a better option for patients because it made their scans look better, at least in the short term. However, the data from our study shows that clinicians can no longer simply rely on the results of traditional lab tests or scans to assess the value of care; we have to understand the total impact of cancer therapies on our patients.”

Drs. Asher and Burri emphasize that the real importance of this study is its potential to make us think differently about what really matters in cancer therapy.

The trial authors concluded that the benefit of adding whole brain radiation was outweighed by its risks in patients with one to three newly diagnosed brain metastases. This is a very relevant finding, as over 200,000 patients still receive whole brain radiation in the United States each year, and the majority of patients with brain metastases have a limited number (typically three or less) of brain lesions. Drs. Asher and Burri, along with their co-investigators, now recommend that patients with one to three brain metastases should no longer receive routine whole brain radiation therapy, and should be treated with focused therapy alone to better preserve cognitive function and quality of life.

“Having the research published in JAMA is validation of more than a decade of work,” says Dr. Burri. ” It is deeply satisfying to have developed an important scientific project, work in close collaboration with other investigators to obtain support from the National Cancer Institute, then carry the to carry the trial to completion with publication of impactful results in one of the leading medical journals in the world.”

Drs. Asher and Burri are now working on a new method of focused therapy for tumors that have spread to the brain that combines radiation and surgery. The technique was pioneered at Levine Cancer Institute and they are looking to expand and further validate the approach with the National Cancer Institute.

About Carolinas HealthCare System
Carolinas HealthCare System (carolinashealthcare.org), one of the nation’s leading and most innovative healthcare organizations, provides a full spectrum of healthcare and wellness programs throughout North and South Carolina. Its diverse network of care locations includes academic medical centers, hospitals, freestanding emergency departments, physician practices, surgical and rehabilitation centers, home health agencies, nursing homes and behavioral health centers, as well as hospice and palliative care services. Carolinas HealthCare System works to enhance the overall health and wellbeing of its communities through high quality patient care, education and research programs, and numerous collaborative partnerships and initiatives.

(R) Anthony L. Asher, MD, FACS, medical director at Carolinas HealthCare System’s Neurosciences Institute and the senior author on the report, and (L) Stuart H. Burri, MD, chairman, department of radiation oncology at Levine Cancer Institute, spearheaded an international, multi-institutional, randomized trial that will ultimately improve the standard of care for patients with a specific type of brain tumor, brain metastases, by reducing the toxicity of their treatment without reducing the effectiveness.
Video – http://origin-qps.onstreammedia.com/origin/multivu_archive/PRNA/ENR/CarolinasHealthCareSystem.mp4
Photo – http://photos.prnewswire.com/prnh/20160726/392955

CONTACT: Claire Simmons, (704) 612-3055, claire.simmons@carolinashealthcare.org

International Study Finds Effective, Less Toxic Way to Treat Brain Tumors

Our Review Summary

MRI Scan Of The BrainA comparison of radiation treatments for some patients with metastatic brain tumors produced useful evidence that adding whole brain radiation to radiation focused on just the tumors was associated with more cognitive declines and lower quality of life, without adding to survival. That’s a noteworthy finding, but the news release obscures the advance in clinical evidence behind a flurry of superlatives, while leaving out important context. One bright spot is that the release highlights the finding that the patients given both whole brain and focused radiation had cleaner brain scans, but then did not live any longer. That’s an important reminder that disease progression tests do not necessarily point to better outcomes.

The study results, as the release notes, could help spare many patients from over-treatment. But rather than promising a “better quality of life,” the release would have done better to stick to a more sober portrayal, that the study supports recommendations updated in recent years against using whole brain radiation in these patients.

 

Why This Matters

When cancer that started in the lungs or other organs spreads to a patient’s brain, the outlook for a long survival dims. As the researchers quoted in the release note, for these patients the effects of treatments on the quality of life take center stage.

It’s a positive sign that more cancer researchers are studying a treatment’s outcomes on quality of life in addition to measuring tumor response. But it is important to maintain a sober tone about the likely scenarios, and resist implying that making the “right” choice of treatment will produce a substantially better quality of life, when the realistic goal is minimizing the rate of decline.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

Since both the focused radiation and whole brain radiation are common treatments for brain tumors, an estimate of typical costs should have been included in the release.

There is likely to be a range of costs because of issues with the specific tumor target. However, the release could have made note of that.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

The release is far more emphatic than the study. The release says focused radiation treatment alone proved to be “substantially less toxic” than a combination of focused and whole brain radiation treatment for these brain tumor patients. By contrast, the study referred to “less cognitive deterioration” and lower rates of decline in the quality of life. However, the lack of detail about benefits in the release is largely due to the lack of detail in the study itself, which reported only on a combined measure of cognitive function and did not spell out specific benefits. The same can be said of the discussion of survival rates, because the study itself said only that there was no significant difference between the treatment groups. The release should have included a vital point: that few patients in either group lived more than a few months. Indeed, 20 percent had died before the first evaluation just three months after treatment.

On the other hand, the release does a great service by highlighting the finding that although patients who received whole brain radiation in addition to focused radiation had better brain scan results, they did not live any longer than those whole were given only focused radiation treatment. The finding is yet another example of the danger of putting too much stock in measures of disease progression or other tests that logically seem to be related to important health outcomes, but often fall short.

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The main point of the release, emphasized in several statements, is that whole brain radiation is more toxic to the brain than focused (or stereotactic radiation) without improving survival outcomes. So, while one might expect that the more targeted approach might cause harm by “missing” some of the cancer, the story does a good job of pointing out the LACK of additional harm by targeting the tumor rather than irradiating the entire brain.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

The release does not describe the trial, either the features that make it noteworthy or its limitations.

Does the news release commit disease-mongering?

Satisfactory

This ruling is a close call. Although the claim in the release that the study results could apply to tens of thousands of patients with brain tumors may be a reasonable estimate, it fails to put that number in context. The study included only a select group of patients with three or fewer metastases in their brains. By failing to mention either that one out of five patients in the trial died before the first post-treatment evaluation or that many patients with brain tumors don’t match the description of those in the trial, readers are given an inflated sense of the relevance of these findings.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The funding source is not identified in the release. The release also makes no mention of conflicts of interest, but the journal article disclosure section notes only that one of the authors (not mentioned in the release) receives some industry funding.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release is clear that the point of the study was a direct comparison of two commonly-used treatments. The release also points out that surgery is a treatment option for these patients.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

It is clear that the treatments are currently in general use.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The release fails to tell readers that whole brain radiation for these patients is, as an accompanying editorial comment notes, “falling out of favor.” The editorial goes on to note that, “In 2014, the American Society of Radiation Oncology… indicated that WBRT [whole brain radiation treatment] should not routinely be added to SRS [stereotactic radiosurgery or focused radiation] for patients with a limited number of brain metastases.” So this research, informative to clinicians as it may be, is unlikely to change the underlying trend away from using whole brain radiation in the treatment of these patients.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release doesn’t go overboard with sensational language. But as mentioned above, phrases such as “substantially less toxic” and “better quality of life” without quantification, along with tangential promotion of related research by the institution’s researchers, tilt the release toward marketing.

Total Score: 5 of 10 Satisfactory

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