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Recap of clinical trial on skin cancer treatment includes both strengths and weaknesses of the findings


4 Star

In clinical trial, cream reduces squamous cell carcinoma risk

Our Review Summary

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This release reports on a large multi-center clinical trial intended to gauge the preventative value of using a cream containing 5 percent fluorouacil as a means of reducing the occurrence of both squamous cell carcinoma and basal cell carcinomas. It says that the cream appears to reduce the risk of squamous cell carcinomas among the elderly veterans in the trial by 75 percent, although it has no statistically significant effect on reducing basal cell carcinomas. The release also states that the protection appears to only extend for the first year.

The release omits mention of the drug’s hefty price tag but it does clearly state both the benefits and the risks of using the medicinal cream.


Why This Matters

These skin cancers — squamous cell carcinomas and basal cell carcinomas — are among the most common forms of cancer afflicting Americans and to date, the only effective preventative has been the use of sunscreen with varying success. This trial suggest a two-to-four week-long application of this cream can reduce the risk of developing one kind of skin cancer by as much as 75 percent for one year. Given the costs of treating these cancers, both in money and resources, this finding, if borne out, is a positive step in reducing the burden that cancer places on society.


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

Not Satisfactory

The release does mention costs twice, by saying that treating these cancers surgically is more costly, and that the use of the cream “can reduce the resources needed to treat these carcinomas.”  But it doesn’t mention that the fluoroucil cream is fairly expensive. According to GoodRx, one 40g tube of 5% fluorouracil cream ranges from $73 to $136 a different pharmacy retailers. The cost may be considerably reduced by insurance plans, but the release does not address that either.

Also of note, according to results in the published study, at least 11 patients must be treated with the cream in order to possibly prevent one additional cancer, leading to a drug cost of over $14,000 to prevent that one cancer. That may exceed the cost of surgery. 

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


The release clearly states:  “After the first year, 20 of the 464 veterans in the control group developed a squamous cell carcinoma that required surgery, but only five of the 468 veterans who got 5-FU did, a statistically significant 75 percent reduction in the risk, according to the study. For the subsequent three years, there was no longer a significant difference between the two groups in the number of patients who required surgical treatment for an SCC.

There were six outcomes measured and only the difference in squamous cell carcinomas at one year was statistically significant while the other five were not. This suggests that the one statistically significant difference could have been caused by chance alone or that there truly is a difference but only in this one period of time.

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


The release describes harms in the following paragraph:

The cream does have common side effects including reddened, more sensitive and often crusty skin, effects that resolve when the application of the cream stops, Weinstock acknowledged. After the study’s first six months, 21 percent of the 5-FU group rated the side effects as “severe,” and 40 percent rated them as “moderate.”

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


The release explains that half of the participants in the study received the 5 fluorouacil cream and the other half received a cream lacking that ingredient. It mentions the total number of patients in the trial (932) and notes that it was a multi-center trial that spanned several years. It gave real numbers of resulting cancers that led to the claimed 75 percent reduction and pointed out that while the cream was effective for squamous cell carcinomas, it had no statistically significant effect on the incidence of basal cell carcinomas.

Does the news release commit disease-mongering?

Not Applicable

No indication of disease mongering here. However, the release missed an important opportunity to inform readers about the nature of these typically slow-growing cancers which rarely spread. There’s no context provided on what these cancers are or the burden they put on patients or the health care system.

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

Not Satisfactory

The release points out that the study was funded by the Veterans Administration but omits the fact that several members of the research team received support from pharmaceutical firms. However, there’s no indication that those connections played any role in the conclusions from the trial.

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


The study mentions that surgery is the normal response to these skin cancers and that Mohs surgery is the procedure of choice in many cases. It also points out that “current means for preventing new carcinomas in high-risk patients — sunscreen or oral medications” — are available.

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


The release notes that the cream, available as a generic, has been used to treat other conditions. That suggests the cream is widely available.

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


The release quotes the study author claiming this was “the first study of its type. I’m hopeful there will be other studies that show other sorts of regimens that last longer and do a better job over time as science progresses. This is an important first step.”

It also notes that further research is planned.

Total Score: 7 of 9 Satisfactory


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