This story is one of two we reviewed about studies of drugs that activate the immune system to fight lung cancer. The studies involving Keytruda, Yervoy and Opdivo — known as checkpoint inhibitors — were presented at the American Association for Cancer Research meeting. We also reviewed the Washington Post’s coverage.
While this story didn’t rely on a news release, it fell short almost everywhere else. Most significantly, it didn’t help readers understand that one of the studies is expected to result in immediate changes to how one common type of lung cancer is treated. It also didn’t give data that would illustrate the scope of the benefits of these drug, study limitations, side effects or costs.
More people die from lung cancer than any other cancer, according to the CDC. Treatment advances are big news that will affect hundreds of thousands of people and their families. But giving immunotherapy drugs such as Keytruda to the hundreds of thousand of U.S. patients who might benefit will cost billions of dollars a year. It’s critical for news stories to give a clear picture of the proven benefits, limitations of the evidence, potential side effects, and costs.
The $150,000-plus annual cost of these drugs isn’t mentioned.
The story doesn’t give absolute data for two of the three studies it mentions.
It says the two-drug combination of Opdivo and Yervoy found that after nearly a year, the lung cancer in people taking the immotherapy was “42% less likely to have progressed than among people getting chemotherapy,” and patients taking Keytruda with chemotherapy were “51% less likely to die after 10.5 months” than people getting just chemotherapy.
Absolute numbers would have given a clearer picture of what portions of patients saw a benefit. For example, in the Keytruda study, 69% of patients originally assigned to Keytruda were alive at the end of the study period versus 49% of those who received chemotherapy alone.
For the third study, the story says taking Opdivo before surgery “shrunk those tumors drastically and lowered the chances for relapse” and “in about half of the people treated … the growths showed significant destruction by immune cells in the blood and certain targets on the tumor cells.”
Here the coverage could have been improved with a quantitative description of what’s meant by terms such as “significant destruction.” Also, this third study was very small and experimental, which we’ll discuss under evidence quality below.
No side effects are mentioned, and this is a major oversight of the story.
For example, it could have mentioned that in the Keytruda study of patients with a common type of advanced disease, called non-squamous non-small-cell lung cancer, those in the immunotherapy group experienced more of certain adverse events, such as kidney problems, and were more likely to drop out of treatment due to side effects that those receiving chemotherapy alone.
Not to mention that in general, immunotherapy can lead to many inflammatory conditions that can occur throughout the body as a result of treatment, such as colitis.
The story starts out strong on this point, by discussing the study design and number of patients in the first trial it discusses, known as CheckMate-227; however, it never provided limitations to the data.
But less information is given about the second study–how many people? Was it randomized and controlled? What were the limitations?
But, the biggest issue is with the third study, in which a handful of patients received an immunotherapy before lung cancer tumor removal. It is a pilot study, so the story should have better conveyed the results as preliminary for patients. It did refer to it as a “small” study, but didn’t explain why that matters.
The story does not engage in disease-mongering, but it also doesn’t say how many people get lung cancer and might benefit from these drugs.
The story would have benefited from at least one independent expert.
All of the experts quoted were authors in the studies being reported. Also, all of the sourced reported conflicts of interest from either funding from a drugmaker or a pending patent that weren’t mentioned in the story.
The story mentions chemotherapy, which it says “therapy typically leads to only a 5% improvement in people’s chances of living five years — but an up to 70% chance of being exposed to serious toxicities.” (But, note that the story never provided information on immunotherapy’s serious toxicities.)
The story says Keytruda is “already approved for treating about 25% to 30% of people with advanced (non-small cell lung cancer) who have a certain genetic profile that makes their cancer vulnerable to the drug.”
More generally it says that “a series of checkpoint inhibitor drugs was first approved in 2011 initially for treating melanoma.”
The story could have clarified whether additional FDA approvals are needed to expand uses of these drugs.
The story states that these studies amount to “some of the most encouraging results yet for treating lung cancer with the latest immune-based treatments, most of which have been approved to treat other types of tumors.”
It also states that researchers have “found innovative ways to weaken lung tumors to improve people’s chances of surviving the disease.”
While there is some truth to these statements, the story is misleading because it puts all of the trials on equal footing. In fact, only one is expected to have an immediate impact on patients by changing the way certain types of lung cancer are treated. That wasn’t clear.
The story doesn’t appear to rely on a news release.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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