This story summarizes the results of two studies involving drugs for the treatment of prostate cancer. The main takeaway from the story is that in certain men with high-risk cancers who’ve already had their prostates removed, the drugs extended the amount of time before these men’s cancer spread beyond the prostate. The story helpfully quantifies the amount of time the drugs bought these men in absolute terms.
But the story missed some important context. For example, the story is totally silent on the issue of adverse effects and how many patients suffered them. And it doesn’t caution that the outcome reported in the study — “metastasis-free survival” — may not translate to a corresponding increase in patients’ overall length of life.
Disease-mongering was also a concern. The story features statistics about the huge numbers of prostate cancers diagnosed each year, but it doesn’t acknowledge that most of these cancers will never progress to cause problems for the patient. Moreover, it erroneously suggests that prostate removal is the “typical” approach to the treatment of early prostate cancer, when no treatment at all is the approach favored by about half of all men who receive such a diagnosis.
An independent source would probably have helped bring some balance to the coverage, but the only experts quoted had a vested interest in the research.
Despite having their prostates removed, men with aggressive forms of prostate cancer face a higher risk of having that cancer spread beyond the prostate. There is currently little that such men can do following initial treatment except watch and wait, but these preliminary results suggest that certain drugs may delay the spread of these cancers. Until the results are published and scrutinized by other researchers, however, it’s best to reserve judgment and view the claims of vested interests skeptically.
The story pegs the cost of Xtandi, one of the two drugs studied, at more than $10,000 for a 30-day supply, That’s useful information. However, it doesn’t address the likely cost of the second drug, apalutamide which hasn’t yet been approved. A ballpark estimate of that figure probably could have been provided, but since the story at least gave an effort to address cost, we’ll give the benefit of the doubt and rate this satisfactory.
The story describes the benefit high up in the story as follows:
apalutamide and Pfizer’s prostate cancer drug Xtandi delayed the worsening of the most common tumor by more than 70 percent compared with a placebo in two separate studies.
It does a good job clarifying what this relative reduction means further down in the story with this description using absolute terms:
Men treated with J&J’s apalutamide went for 40 months, or 3.3 years, before the cancer metastasized, compared with 16 months in the placebo group.
That’s good enough for a satisfactory grade, but we wish the story had also clarified that improvement on this outcome — called “metastasis-free survival” — does not necessarily mean that these men will live longer overall. We’ll address that issue below under the evidence criterion.
The story doesn’t address harms. The adverse effects of Xtandi should be easy to describe since the drug is already on the market. Another write-up of these studies reported that adverse events with apalutamide led to discontinuation of the drug in 10.7% of patients compared with 6.3% in the control arm. The fact that one in 10 patients had to stop treatment because of side effects is noteworthy.
The story makes it reasonably clear that these were high-quality studies pitting the two drugs against a placebo in large groups of patients. But it should have warned that the results come from a conference presentation that likely received only limited peer review. Key details won’t be reported until the studies are published in a journal.
More importantly, the story doesn’t caution that improvement on the outcome reported — metastasis-free survival, or survival without the cancer spreading beyond the prostate — does not necessarily guarantee that men treated with these drugs will live any longer. And that’s important information to provide. Although it may give peace of mind and improved quality of life for men to know that their cancer is not progressing, it’s also possible that adverse effects and the financial toxicity of additional drug treatment will cancel out such benefits. An improvement in overall survival is a much more definitive sign that the drug is truly helping patients.
Lastly, since the story is reporting on a study that tested a hypothesis about earlier treatment for more aggressive cancers, it would be helpful to know how the study picked the patients whose cancers would be most likely to grow. Was prostate-specific antigen (PSA) testing used to determine this, and how high does PSA have to rise before starting the medication? Patient selection always key with any therapy.
The story falls short on this criterion in several areas, first when it erroneously claims, “Right now patients with early disease typically undergo surgery, radiation and, if needed, treatment to deprive the tumor of testosterone that fuels its growth.”
In fact, as this New York Times story from 2016 points out, about half of men are choosing no treatment at all for early prostate cancer — reflecting increased recognition that most prostate cancers are very slow-growing and do not require immediate treatment.
The story seems to be talking about the specific group of men in this study with higher-risk cancers, but the broad use of the term “early disease” will be confusing at best for readers.
Another problem is the story’s misleading use of statistics: “More than 164,000 men in the U.S. will be diagnosed with prostate cancer in 2018 and almost 30,000 will die from it.”
While the numbers may be accurate, the story doesn’t acknowledge that the vast majority of prostate cancers are slow-growing and will never progress to cause problems, which is why 97% of men with prostate cancer will not die from the disease.
Lastly, the story is likely to confuse readers when it refers to “watchful waiting,” which is the term often applied to men with slow-growing cancers who opt for no immediate treatment. In this case, the story is applying the term to a much smaller group of men with high-risk cancers who’ve already had their prostates removed and are hoping to delay recurrence and spread of the cancer.
While that may also be a form of “watchful waiting,” it’s not the usage readers are accustomed to and this should have been clarified.
The story quotes an oncologist who reviewed the study abstract for the conference, but neglects to disclose that this source is on the payroll of many drug companies including Pfizer, which makes one of the drugs covered in the story. (See here for his disclosures.) Other sources include the primary investigator on one of the studies and a Pfizer executive, who predictably calls the results “a catalyst for change.” An independent analysis would have greatly strengthened the piece.
The story notes that watchful waiting is the only other option for men with high-risk cancers who’ve already had their prostates removed.
The story notes that one of the drugs — Xtandi — is already approved for metastatic cancer and that the second drug — apalutamide — is experimental.
The story establishes novelty with this statement: “there is no approved follow-on therapy for those with worrisome blood test results who don’t yet have visible evidence that the prostate cancer has metastasized.”
The story goes beyond any news release and features original reporting.