“Postponing resistance” is not the same as “prolonging survival” — something this story based on a press release never tried to explain.
This was an inadequate story about a combination of experimental drugs to treat melanoma, the most dangerous form of skin cancer. It relied inappropriately on a press release, downplayed the treatment’s harms, and didn’t explain how the study’s primary outcome, progression-free survival, differs from overall survival.
If your story relies on quotes and text from a press release, how can readers be sure if it’s a thoughtful evaluation of the subject or a reposting of someone else’s ideas? Additionally, stories reporting on new drugs or combinations of drugs, particularly for serious diseases, need to be clear about the outcomes and distinguish those that matter, including risks.
Costs were not discussed. Neither of these drugs is approved for sale, so it may be hard to offer a concrete figure. But new drugs targeting melanoma via similar pathways are very expensive — in the neighborhood of $9,000/month, or $56,000 for a course of treatment. The story should have mentioned this, even if the drug combo is only available under a research protocol.
The story does not overhype the findings and uses statistics appropriately, reporting that after one year, “41 percent of patients receiving the full-dose combination treatment had no progression of their melanoma, compared with 9 percent of those receiving dabrafenib alone.”
Of course, this does not tell us whether the drug combination actually prolonged life, and the story does not explore or explain this important nuance. This is something we’ll address under the Quality of Evidence criterion below.
The story’s discussion of harms tends to downplay their importance. It quotes an expert who says there were no “untoward side effects” with the combination treatment, and it reports that skin rashes and rates of squamous cell carcinoma were “similar to that typically seen in patients taking only one of the drugs.”
That’s one take, we suppose, but the study itself reported much higher rates of drug induced fevers and chills in the combination groups, which was serious enough to require hospitalization in 19% of low-dose and 26% of high-dose combination group patients (compared with 2% of monotherapy patients). Other side effects reported more frequently in the combination groups were fatigue (in 53% of patients), nausea (44%), vomiting (40%), and diarrhea (36%). Those certainly sound like “untoward” side effects to us.
The story dutifully reports on the primary outcome of the study, progression-free survival, but doesn’t explain that this may not translate to an overall increase in survival time for patients taking the drug combination. Indeed, the percentage of patients who were alive after 1 year was not much different between the high-dose combination group and the monotherapy group (79% vs 70%). This is not to say that progression-free survival isn’t potentially a useful measure of a drug’s efficacy — it may well be — but it’s important to explain what it means and how it differs from overall survival. Here’s a useful primer on the differences from the National Cancer Institute.
The story notes that the treatment applies only to patients with a specific mutation that can be targeted by the drug.
The story informs readers that both drugs studied are being developed by GSK, which sponsored the studies. And we hear from an independent dermatologist who was not involved with the study.
Other new drugs have recently been approved for the treatment of advanced melanoma. The story did not mention these or compare results.
The story says that the drug combination is being tested in a larger phase 3 study, which is required for FDA approval. While this is true, it could also have noted that the drugs individually have already been submitted for approval as monotherapies. If they are approved, oncologists could presumably use the drugs in an off-label combination treatment similar to the one studied here.
This does appear to be a novel approach to reducing the treatment resistance seen in melanoma drugs.
Although the story features an independent take on the results, it uses a quote from a hospital press release and makes liberal use of the copy/paste functions. Example:
Press release: “In recent years, drugs that inhibit BRAF activity have rapidly halted and reversed tumor growth in about 90 percent of treated patients, but most patients’ response is temporary, with tumor growth resuming in six or seven months. Investigations into how this resistance emerges have suggested that the MAPK pathway gets turned back on through activation of MEK, another protein further down the pathway.”
Story: “Drugs that inhibit BRAF activity can rapidly stop and reverse tumor growth in about 90 percent of patients. But the response is temporary in most cases, and tumor growth resumes in six or seven months, the researchers explained. Previous research suggested that this drug resistance develops because the MAPK pathway gets turned back on through activation of MEK, another protein that is part off the MAPK pathway.”
We’re concerned that the story is regurgitating content without sufficient evaluation and analysis.