“It’s safe, quick, and the effect is durable – from one treatment.” We challenge the news release’s ability to make this claim after a look at just two patients.
While immunotherapy has taken the cancer treatment world by storm, the use of “immune checkpoint inhibitors” can produce debilitating side effects. In about 40% of patients, one of those side effects is severe inflammation of the colon, a problem that brings treatment to a halt until the colon clears up. In this preliminary, “proof-of-concept” study, a team of MD Anderson Cancer Center researchers found that fecal transplants returned the colons of two afflicted cancer patients to a healthy state. While such results suggest that clinical trials will be a welcome next step, they don’t give oncologists or public information officers carte blanche to tout the effectiveness of the strategy. Nature Medicine thought the small study deserved a spot in its “Brief Communication” section, but communication professionals at the cancer center should have taken a pass on this one and waited until more robust evidence becomes available.
If this intervention ends up being fully evaluated and proven successful, treating colitis related complications could possibly be done without using corticosteroid therapy (which has its own complications at high doses and over long periods of time.
But until then, keep in mind that the sometimes severe side effects of immunotherapy have patients casting about on the internet for solutions. You can learn how to perform your own DIY fecal transplant thanks to YouTube—minus the careful screening procedures, of course—so recommending a procedure such as this must be the result of careful clinical exploration.
Although the use of fecal transplants to soothe severe colitis in cancer patients (caused, in this case, by immunotherapy) has yet to be tested clinically, the treatment itself is increasingly popular for other gastrointestinal issues and typically costs in the $1000 to $2000 range. Alas, we learn nothing about that cost in this release.
The release clearly states the outcomes of fecal transplants in the two patients that constitute the study.
Risks of these transplants are not mentioned. Fecal material produced without careful screening could introduce microbes, including those linked to MS and Parkinson’s.
Formally evaluating this intervention is important and making claims of “safety” and “durability” is not technically accurate for a proof-of-concept study. Larger phase I trials are needed to evaluate safety.
To its credit, the news release notes that “the very small cohort” limits the quality of the evidence. But on the other hand, a study involving just two patients raises the question of why anyone would publicize this study via a news release in the first place.
The release doesn’t disease-monger. Inflammation of the colon is the second most common side effect of employing immune checkpoint inhibitors, according to the release. That makes finding a way to minimize this side effect important.
The release does identify funding sources, but it does not illuminate possible conflicts of interest. Admittedly, this would be hard to do given the large number of coauthors. But a section on “competing interests” in the Nature Medicine article that jump-started this release does indicate that some of the coauthors have a commercial interest in the success of microbiome treatment applications.
The text explains that traditional treatment of severe gastrointestinal symptoms involves steroids and drugs that may suppress the efficacy of immunotherapy and suppress an individual’s immune system, while generating their own unpleasant side effects.
Determining this will be confusing to someone reading this release. Fecal transplant procedures are in use to treat a variety of gastrointestinal issues, so this would suggest that the procedure is available. But its employment to subdue inflammation caused by immunotherapy treatment is just being explored and has not even been subjected to clinical testing yet. So whether the procedure would be available to cancer patients receiving immunotherapy is an open question.
The text maintains that this study represents “the first time” that fecal transplants have been used to treat individuals with immunotherapy-induced colitis.
Although the text identifies the sample of only two patients as a design limitation, the first author of the study projects confidence that the procedure is “safe, quick, and the effect is durable” and recommends that others consider the procedure “as a first-line therapy for ICI-associated colitis.” Without appropriate clinical trials on a larger population, such confidence may not be warranted.
Systematic, Criteria-Driven
Monday at #ADA2021, an infectious disease epidemiologist, a journalist, and a researcher shared perspectives on communication of risk in the era of COVID-19: http://ow.ly/ROfR30rMeE7 @AstleyCM @garyschwitzer @berthahidalgo @ADA_DiabetesPro
Shoutouts to @susan_bewley @drkevinknopf @MichaelBaum11 in this call for more than fawning coverage from press releases for these kinds of stories.
Also, linked history inside goes back 5 years just on Grail apparently trying to become Holy Grail. https://twitter.com/garyschwitzer/status/1408849696416841731
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