In a small study of 80 patients with human papillomavirus (HPV)-positive cancers of the tonsils and throat, researchers found they could reduce side effects of radiation by reducing the radiation dose. These patients often suffer from lifelong swallowing and eating issues following radiotherapy. The short release did not provide much context. We weren’t provided any numbers for the rate of “cure” in standard doses versus the lower doses under study.
The repeated use of the word “cure” in the text seems unjustified since these types of cancers do recur. The word may mean different things to doctors and patients and we discourage its use in medical communications. See our toolkit piece on 7 Words (and more) You Shouldn’t Use in Medical News.
There has been an increase in HPV-associated cancers of the head and neck. The Centers for Disease Control and Prevention estimates there are about 16,000 new cases diagnosed per year in the United States. Reducing treatment side effects is important for patients and families. But we don’t find this release gives us enough information to judge whether the reduced radiation therapy doses are just as effective as higher doses.
The release does not mention costs. We would have liked some context. What kind of rehabilitation costs are associated with the severe lifelong swallowing side effects that are mitigated by the reduction in dose discussed in the study?
The release did include some quantification of benefits, but we would have liked a bit more. Here is what was provided:
“The study…showed that patients treated with reduced radiation had less difficulty swallowing solids (40 percent versus 89 percent of patients treated with standard doses of radiation) or impaired nutrition (10 percent versus 44 percent of patients treated with regular doses of radiation.”
The release would have been improved with a discussion of how “less difficulty” and “impaired nutrition” were measured.
The published paper makes it clear that the swallowing difficulties and nutritional impairment were self-reported using a questionaire of some kind. This also would have been useful information to include in the release.
The release does not quantify whether there is any reduction in progression-free survival or “cure” rate with reduced radiation. The release also does not quantify what is meant by the words “reduced radiation.” Is it half of normal doses, or reduced frequency but the same dose?
There may be potential harms in reducing a therapy aimed at a cure, but the release does not address this except in vague terms:
“We found there are some patients have very high cure rates with reduced doses of radiation,” said Barbara Burtness, MD, Professor of Medicine (Medical Oncology), Yale Cancer Center, Disease Research Team Leader for the Head and Neck Cancers Program at Smilow Cancer Hospital, and the chair of the ECOG-ACRIN head and neck committee. “Radiation dose reduction resulted in significantly improved swallowing and nutritional status,” she said.
The release provides some information about the study and how it was conducted. And it does note that “patients who had a history of smoking less than 10 packs of cigarettes a year had a very high disease control compared with heavy smokers.” But it does not mention that this is a stage 2 study and that the number of patients (80) is very small as medical trials go. The published study notes that “This finding provides justification for further study of radiation deintensification but requires validation in a larger comparative trial.” That limitation should have been included in the release.
There was no disease mongering.
The release failed to mention any funding source or the presence or absence of a conflict for researchers.
The published study notes that the research was supported by US Public Health Service grants, the National Cancer Institute, National Institutes of Health, and the US Department of Health and Human Services. An author quoted in the release disclosed consulting and other financial relationships with seven pharmaceutical companies but no radiation device manufacturers.
The release summarizes a study that compares low dose and high dose radiation, and notes that chemotherapy was also part of the treatment regimen for the patients. It states that all of the patient volunteers were candidates for surgery, which is another alternative or adjunct therapy for these types of cancers.
The issue of availability of reduced dosages doesn’t apply here.
The release makes no claim of novelty other than it is a “new clinical trial.” It might be assumed that low dose radiation is novel because it is not standard for these types of cancers but there is no way to know this from either the release or the published study. A brief online search revealed that a partnering institution issued a related news release on low dose radiation research in HPV-positive head and neck cancers in 2014.
The release doesn’t rely on sensational language but the frequent use of the term “cure” seems misleading, especially when we aren’t provided specifics on the treatment outcomes. These cancers can certainly recur after treatment, so how did the researchers establish whether patients were cured or not?