No cost information. No benefit quantification. No risk mention. No comparison to alternatives. There were too many things missing from this release on the safety and efficacy of stereotactic body radiation in elderly patients with lung cancer to allow a reporter or patient to judge whether this was really an interesting scientific finding.
Lung cancer is a life-threatening disease at any age and news about treatments are of interest to a wide audience. This release describes results from an observational study of patients treated for early stage lung cancer with stereotactic body radiation treatment (SBRT) between 2004 and 2014. The release notes that the study looked at treatment outcomes broken down by age and suggests that treatment benefits were similar, but the release didn’t describe any harms from SBRT treatment and whether they varied by patient age.
In order to justify a claim that SBRT should be used in people over 80 years old researchers would need comparative data showing that SBRT outcomes in this elderly population are superior to other forms of radiation and other treatments. That comparison was not a part of this study.
There are no costs mentioned in the release. There have been a number of studies on the cost-effectiveness of different radiation therapies, including SBRT.
No where in the release does it back up the claims made in the headline and the lead that SBRT that the research supports use of SBRT on those 80 and older. Where are the data to support this? The release says:
Study results show no significant differences among the three age groups with respect to 2-year local recurrence, regional recurrence, distant metastases or the incidence of grade 3 or higher toxicity. Cause-specific survival was similar among all three age groups (90.3 to 90.6 percent). Two-year overall survival was lower in older patients, which is likely related to other medical issues.
So we are apparently to take this to mean that because cancer recurrence in older patients was no different than in younger patients that the treatment was successful? We need numbers to back up these claims.
We’d also like the release to be transparent about the fact that the treatment was not compared with any others.
There is no mention of harms in the release. The study alludes to harms in a quote, saying:
“Older patients are often not considered for radiation therapy due to concerns about their ability to tolerate treatment.”
Ok. So this starts getting at the fact that the treatment itself is harmful. Why not go further and explain to readers and journalists what the risks are from the treatment and how the risks played out with this study?
Known harms from this treatment include fatigue lasting 4-6 weeks, neuropathic pain, rib fractures and other risks.
The release does a reasonable job explaining the size of the study and that it is on the verge of being published. But the release should have made it clear that similar results in patients undergoing SBRT at different ages does not translate into a claim that this therapy is equal or superior to other options available to elderly patients.
There is no disease mongering in the release. But we also don’t know the natural history of early stage lung cancer in this population. Does treatment really extend the quantity or quality of life? We expect it does, but nothing presented here supports SBRT compared to no treatment or other active treatments.
The release makes it clear that the findings were produced with funding from Elekta. However, it does not make it clear that Elekta is a large medical technology company that manufactures SBRT and other equipment used in radiation oncology.
The release makes no meaningful comparison to alternatives. The closest the release comes to mentioning any alternative is in a quote by the lead author, “The results of our study clearly support the use of SBRT for elderly patients, especially those who may not be able to tolerate longer courses of radiotherapy or more invasive treatment options.” However, this is not sufficient to give them credit here.
It is clear from the release that the treatment is available at the five sites that participated in the observational study, but whether it is available outside of major academic cancer treatment centers isn’t spelled out.
The release states that “new data” shows SBRT is a safe treatment option for elderly patients and the study is the “largest of its type.” While the study may provide some new information on the use of SBRT in elderly patients the release didn’t provide any context on any other studies on SBRT in the elderly, didn’t provide information on harms nor did the release back up claims about safety.
The release doesn’t rely on sensational language. But given the lack of data to back up the claims in the headline and lead of the release, we have to say that the claims being made in the release are unjustified.
A more appropriate headline, supported by the study data, would be:
“New Data From the Elekta Lung Research Group Show Stereotactic Body Radiation Therapy Provides Similar Results in Elderly Compared with Younger Patients With Early-stage Lung Cancer”
as opposed to
“New Data From the Elekta Lung Research Group Support the use of Stereotactic Body Radiation Therapy in Elderly Patients With Early-stage Lung Cancer.”
One could argue that this is a fairly subtle difference, but it is a large one. Even if the release provided additional data that showed SBRT compared favorably to other treatments, it would still have needed to compare outcomes of those over age 70 treated with SBRT and other treatments to make this claim.