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AMA touts organ preservation outcome in study “not powered to assess organ preservation”


2 Star

Combination Chemo-Radiation Therapy May Help Preserve Larynx for Patients with Laryngeal Cancer

Our Review Summary

Illustration: National Cancer Institute

Illustration: National Cancer Institute

The release focuses on a recent article published in JAMA Otolaryngology – Head & Neck Surgery about a treatment for cancer of the larnyx. The paper reports that use of the drug cetuximab in conjunction with radiation therapy results in modestly-improved survival rates for patients with cancer of the larynx or hypopharynx who have not had their larynx surgically removed. The release does a good job of explaining the nature of the research involved, namely that these findings stem from a retrospective analysis of a relatively small subgroup who participated in a larger study. The release also stresses that the use of cetuximab in conjunction with radiation therapy for requires further evaluation. That is all to the good. However, while the release provides specific numbers in regard to potential benefits, it never makes clear that these numbers, in this study design, are statistically nonsignificant. In other words, statistically speaking, there is no advantage. In addition, the release does not do enough to address issues related to cost and potential harms — nor does it place the work in context with previous research on the use of cetuximab and radiation therapy in treating head and neck cancers.


Why This Matters

Cancer of the larynx is relatively uncommon, with 13,430 new cases anticipated in the U.S. in 2016, according to the National Cancer Institute. However, the 5-year survival rate is highly variable: patients who catch the cancer while it is still localized have a 76.3 percent chance of surviving for five years; that survival rate drops to 35.1 percent if the cancer has metastasized. And 19 percent of laryngeal cancer patients are diagnosed only after the cancer has metastasized. What’s more, surgical treatment of laryngeal cancers can mean removal of the larynx — meaning a patient often loses the ability to speak. That can have a significant impact on a patient’s quality of life. New research that can improve survival rates for patients, while preserving the larynx, is certainly worth of discussion. However, as with all potential clinical treatments, the potential benefits need to be discussed alongside related costs and potential risks. Without that context, healthcare providers, patients, and their loved ones are not able to make informed decisions. In addition, the release doesn’t acknowledge the body of work that already exists on using cetuximab in conjunction with radiation to treat head and neck cancers. That makes it harder for readers to determine what is truly new about this research news.


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

Not Satisfactory

The release doesn’t discuss costs at all. Given that the relevant study compared radiation therapy to the use of radiation therapy in conjunction with cetuximab, that’s particularly problematic. Cetuximab is already on the market (under the trade name Erbitux) for use in treating various cancers. The drug has been the subject of public debate regarding its cost relative to its therapeutic value (e.g., see these articles in the Wall Street Journal and USA Today). Regardless of where one stands on that debate, treatment with cetuximab can cost tens of thousands of dollars, which is worth mentioning. And the likelihood that the combo therapy won’t be covered by insurance (given its nonsignificant results) should have been discussed.

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

Not Satisfactory

The release addresses three benefits, and provides numbers for all three. That’s good. However, the release doesn’t tell readers that these numbers, given the size and nature of the study, are not statistically significant. There appears to be no advantage in taking a drug that is both costly and can cause significant adverse side effects.

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

Not Satisfactory

This comes back to cetuximab. As noted above, cetuximab is already sold under the trade name Erbitux. And Erbitux’s own website notes that it can cause significant adverse health effects, including heart attacks and allergic reactions that resulted in death. We don’t expect a news release to include a thorough recounting of every possible adverse health effect associated with a treatment, but we do expect there to be at least an acknowledgment of known health risks — and especially so when the relevant risks are so severe.

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


This is a close one. In many ways, the release does an exemplary job of characterizing the research: it clearly notes that this was a “secondary subgroup analysis” and tells readers the number of patients involved (160 patients: 90 got CRT, 78 got only radiation therapy). The release also explicitly states that “These results need to be interpreted in the context of a retrospective subset analysis with limited sample size.” Kudos to them for writing that. The release also states that “This treatment approach warrants further evaluation in larger populations to fully assess the potential value of cetuximab or other molecular targeting agents to augment laryngeal preservation rates.” That sentence makes clear that more work is needed, in a bigger study, to address a very specific benefit. So, kudos again. However, there are three things the release doesn’t tell us. First, we aren’t told that the differences between the compared therapies were statistically insignificant. Secondly, the reader has no way of knowing what stage of cancer the patients had. Did all the patients have localized cancers? Did they all have metastasized cancers? Was it a mix? And, if it was a mix, how were patients with different stages of cancer divided between the CRT and radiation therapy groups? This can make a huge difference in how to interpret the results. Thirdly, while the release notes that this research evaluated only a subgroup of a larger study, it doesn’t tell us much about the larger study. What was the larger study designed to evaluate? That would be good to know.

Does the news release commit disease-mongering?


No disease mongering here. The release might have mentioned that layyngeal cancer is partly preventable with the human papillomavirus (HPV) vaccine.

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

Not Satisfactory

The release tells readers that the work was funded by Eli Lilly and Company, but refers readers to the journal article for information about financial disclosures, potential conflicts of interest, etc. This is not okay, for two reasons. First, while the release mentions Eli Lilly’s funding, it doesn’t make clear Lilly’s financial ties to cetuximab. Lilly manufactures cetuximab and receives royalties on Erbitux worldwide (though it is marketed by different companies, depending on where it is being sold). In short, Lilly has a vested interest in seeing an increase in cetuximab use (the drug reportedly brought in $723 million in 2014 — in North America alone). Second, many readers, possibly most readers, may not have access to the journal article. And if an institution knows that information is worth mentioning to readers (such as whether researchers had conflicts of interest), then an institution should not make readers put in extra legwork to find that information. And there is certainly relevant information to share here. The lead author reported working as a consultant for Lilly. Two co-authors are Lilly employees. A third co-author is a former Lilly employee and owns Lilly stock. And a fourth co-author works for Merck KGaA, which markets cetuximab outside of North America. In other words, five of the nine authors have clear conflicts of interest that are not disclosed in the release.

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

Not Satisfactory

The focus here is on laryngeal cancer treatments that don’t require surgical intervention, so we can leave surgical interventions out of the picture. However, there are a range of other chemotherapy treatments that can be used in conjunction with radiation therapy, such as cisplatin. The release doesn’t mention these “chemoradiation” options, much less offer any sort of comparison.

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

Not Satisfactory

This release notes that more research, on a larger scale, needs to be done to “assess the potential value” of interventions like CRT in treating cancer while preserving the larynx. However, the release would have been much better if it had clearly noted that cetuximab is not currently eligible for insurance coverage for this particular condition and a result will not be available to many patients.

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

Not Satisfactory

Earlier studies have looked at the use of cetuximab and radiation therapy in treating head and neck cancers. For example, “Concurrent cisplatin and radiation versus cetuximab and radiation for locally advanced head-and-neck cancer” was published in 2011. And “Cetuximab prolongs survival in patients with locoregionally advanced squamous cell carcinoma of head and neck: A phase III study of high dose radiation therapy with or without cetuximab” came out in 2004. Granted, these are not necessarily addressing the same thing as “laryngeal preservation” in patients with larynx or hypopharynx cancers — but it’s certainly worth mentioning. Readers could easily infer from the release that using cetuximab and radiation therapy in conjunction to treat throat cancers is relatively new — and it’s not.

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


The release uses fairly cautious language throughout. However, two statements that contradict each other earned this an unsatisfactory:

“The higher rate of laryngeal preservation that was achieved with the use of CRT compared with radiotherapy alone was encouraging,”

“This study was not powered to assess organ preservation.”

Total Score: 3 of 10 Satisfactory


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