This is a news release about a study carried out in the Netherlands that looked at 3-year data from more than 600 patients with superficial basal cell carcinoma (BCC) who were treated topically with non-surgical, noninvasive therapies. The study compares two different forms of topical treatment with photo-dynamic therapy (which employs a photosensitizing agent along with a particular type of light). The study found that after 1-3 years of follow-up, the ointments — imiquimod and fluorouracil — compared favorably with photo-dynamic therapy.
The release does a nice, pithy job of summarizing the issues being addressed as well as the advances in knowledge that resulted. It includes lots of numbers — totals and percentages, which we applaud. It notes high in the release that the work is a randomized, controlled clinical trial, which we also applaud. But we think it might have been more complete had it noted that surgery is the most common treatment for skin cancers and is an option for the superficial ones studied here, and if the authors declared no conflicts of interest, especially since the authors talk about potential drawbacks of a cheaper treatment.
BCC is the most common form of skin cancer and most of its harm is from local spread. Basal cell carcinomas rarely kill but surgical treatment can be painful and, in certain areas of the face, may be disfiguring. If superficial basal cell carcinomas can be treated topically without sacrificing efficacy, that would be useful information for patients and their doctors to know. And the need to know appears to be growing. Although data are not strong, some studies indicate that between the 1960s and the 1980s the prevalence of non-melanoma skin cancers more than doubled.
Although 58%-80% of the patients in this study were cured, many (20-40%) were not and that implies additional treatment was necessary. For some individuals, getting it solved the first time may be more important than the cosmetic effect. There may also be some individuals who may find it difficult to apply the topical treatment for the time needed and that there are differences in costs among not only these topical treatments but also compared to surgery.
The news release notes that “Fluorouracil has the advantage of being less expensive than imiquimod,” a statement for which we rank this satisfactory. But it would have been more complete if we had been told how much cheaper, and how the topical treatments compare with the cost of surgical removal or photo-dynamic therapy.
The news release gives us lots of data — a total of 601 patients with a superficial BCC participated in this study: 202 patients were treated with methylaminolevulinate photodynamic therapy (MAL-PDT), 198 with imiquimod cream, and 201 with fluorouracil cream.
And then it gives us the results: “Around 80% of patients with superficial BCC were tumor free after imiquimod treatment after three years. The clearance rate was 68% for patients treated with fluorouracil and 58% for individuals receiving PDT.”
The news release does note that, between 1- and 3-year follow-up, “more recurrences were diagnosed in the fluorouracil group compared with the imiquimod group.” It would have helped to know how many more recurrences.
The study, a follow-up, was described as a randomized, controlled clinical trial. However, we rate this unsatisfactory for some omissions. We’d like to have seen some mention of follow-up rates (the number of patient volunteers that completed the trial) — even as simple as follow-up was good and there were no differences among the three groups. It also would have been nice to know who assessed the outcome. Ideally, it would be someone blinded to which treatment was received.
The news release tells us that “more than 80% of all skin cancers are BCC, arising from the basal cells (i.e., small, round cells found in the lower layer of the epidermis),” that more than 2 million cases occur each year in the United States, and that outcomes are excellent. It also tells us that a person’s lifetime risk of developing a BCC before age 85 is one in five.
It would have been more complete had it said where it got those figures.
The release doesn’t mention funding sources.
The study notes that several topical agents are available in addition to surgery. It might also have mentioned that surgery can be done as a one time thing and probably has better outcomes.
The news release implies that each of these are available treatments and the goal is to compare existing treatments.
The release states that this is the first study to look at long-term outcomes from use of ointments for superficial skin cancers.
No unsupported claims were made.