This release about the addition of an immunotherapy drug (atezolizumab, brand name Tecentriq) to chemotherapy for patients with advanced squamous non-small-cell lung cancer is an exercise in highlighting the most favorable interpretation of trial results that overall showed no survival difference, while burdening patients with higher rates of severe or life-threatening side effects.
The release and an abstract presented at the American Society of Clinical Oncology (ASCO) Annual Meeting put the spotlight on a 29% “reduced risk of disease worsening or death”… while acknowledging only in the final sentence that there was no evidence of improved overall survival. What’s more, while the release refers to “disease worsening,” what the trial actually measured was “investigator (INV) assessed PFS”, that is, progression-free survival as determined by the researchers, which is not the same as “disease worsening” as reported by patients. Because the release was distributed in the same document with the research abstract, we gave it credit for including information (notably extensive disclosures, along with detailed results) that were not included in the body of the release itself.
See our recent blog piece on how news release framing helped shape coverage of another cancer trial at this scientific meeting.
Patients care about how long they live and how they feel during the time they have. The primary outcome of this trial was a measure of cancer progression that may not relate to survival or quality of life. Indeed, the patients given immunotherapy in addition to chemotherapy reported higher rates of severe or life-threatening side effects (including double the rate of “serious” treatment-related adverse events). So rather than the sunny headline and lead about benefits to patients, a summary of this trial could be that while researchers saw slightly slower cancer growth, patients receiving immunotherapy on average felt worse, while not living any longer.
The release does not mention cost, which is an important point in this case, because each treatment with atezolizumab (Tecentriq) can cost more than $8000. These patients were treated every three weeks, which would produce bills upwards of $12,000 per month.
Although the release and accompanying research abstract include specific results, the release spins them by proclaiming benefits in the headline and lead paragraph, while burying the caveats that there’s no evidence patients lived any longer and that those who received immunotherapy suffered more severe or life-threatening side effects. The release highlighted a higher rate of progression-free survival, but that term can be confusing, because it doesn’t necessarily mean patients lived any longer, just that more time passed (in this case a median of about three weeks) before their cancers showed signs of progression. Neither the release nor the abstract discussed the quality of life of the patients in the study groups.
Here again, the release and abstract include specific rates of treatment-related adverse events, but only buried deep in the text and without important context or explanation. It is not enough to glibly pass off higher rates of serious side effects as “manageable” and “consistent with known safety risks.” The release states that there were grade 3-4 adverse events in 68% of the patients receiving atezolizumab in addition to chemotherapy, compared to 57% of the patients receiving chemotherapy alone. But there is no explanation of what these numbers mean. Grade 3 usually means severe and a grade 4 adverse event is typically life-threatening. There is also no mention in the release itself of the finding that 20.4% of the immunotherapy patients suffered “serious” treatment-related adverse events, compared to 10.5% of those who received only chemotherapy.
Although the release describes key features of the trial, it does not point out that the primary outcome (cancer progression as assessed by the researchers) is a test result that may not correspond to how patients feel and which may not predict improved survival.
In addition, while the release says the trial was a randomized controlled trial, it does not say if it was blinded or double-blinded. The quality of the study is not really assessed.
The release explains that squamous non-small cell lung cancer accounts for 25-30% of all non-small cell lung cancers and accurately portrays the poor prognosis of this cancer.
The release notes that the trial received funding from F. Hoffmann-La Roche. We will give the package of release and abstract a satisfactory rating because the abstract includes a long list of ties between the researchers and industry. The disclosure statement is almost as long as the description of the trial and its results.
This trial is a direct comparison with existing treatment.
As it turns out, a similar trial involving squamous cell lung cancer patients, also presented at ASCO, that used a different immunotherapy drug, did report improved overall survival, but those results were not public when this release was written.
The release refers to the brand name of the immunotherapy drug, which would be enough to alert most journalists covering the ASCO meeting that that this drug is approved for other uses.
However, given the cost and marginal benefit, many insurers will not pay for it which would make it prohibitive for most.
The release characterizes this trial as one example of a broader effort to explore the addition of immunotherapy to chemotherapy when treating people with lung cancer. It is perhaps prophetic that the release more often refers to immunotherapy in general, rather than the specific drug used in this trial, since the makers of another immunotherapy drug announced at the ASCO meeting that their product improved the overall survival of similar patients, something the drug used in this trial has not demonstrated.
The release could be rated as satisfactory on the criterion, if readers assume that the claims of “rapid change in clinical practice” refer only to immunotherapy in general, not to the drug tested in this trial. Since this drug has not shown longer overall survival, it is likely that any changes in prescribing will favor a competing drug that has now demonstrated longer survival results.
Systematic, Criteria-Driven
With the discontinuation of @HealthNewsRevu, there's a genuine concern that well-written and researched "reality checks" in healthcare are not economically interesting. This should be disconcerting to anyone, and yet I'm only seeing more and more piling into "promising findings"
Thanks for ALL you do and have done, Gary. https://t.co/93K4hzQXZj
Thanks for sharing this with all of us today, @garyschwitzer @HealthNewsRevu
A nice gift.
#healthcare #healthcarenews #journalism #reporting #factsmatter #truthmatters https://t.co/hNHdZDl2rc
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