This was an interesting story about an early trial to treat glioblastoma. It reported on partial results of a study. But it let the principal investigator get away with declining to reveal all of the survival data because he wanted to wait until he presented the data at a cancer meeting. Even when he presents the data at that meeting, it will not have been peer-reviewed and it would be difficult for others to comment in-depth about the results. This is one of the weaknesses of stories that try to get a jump on reporting research results. Indeed, the story contained only the perspectives of two clinicians involved in the study. No independent perspective was included. We commend the story for at least referring to the potential bias of one of the sources.
The story did not really provide a clear picture about the usual course of the disease. It also did not adequately detail what lies behind the end point of time to cancer recurrence. In addition, although the story mentioned that the people who received the experimental approach were ‘cherry-picked’, it failed to point out that one can’t conclude that the approach had an effect because the outcomes for those in the study were compared to historical controls which would have included a broader range of disease than those in the ‘cherry-picked’ group. The optimism, therefore, may be misplaced.
The grateful patient’s perspective may not be representative and her health status at this time cannot be clearly linked to the experimental approach.
The story did not provide adequate information about risks and benefits. Cost information was also lacking.
And while it was timely to mention Senator Kennedy’s recent diagnosis, the story exhibited one of the flaws in reporting on the illness of well-known people when you don’t have first-hand knowledge of the situation. The story said that “Kennedy’s tumor is thought to be inoperable.” Perhaps so. But today Kennedy had surgery, which may be followed by radiation and chemotherapy.
There was no mention of costs associated with the two additions to current glioblastoma treatment strategies. How much does Temodar cost? How much does Avastin cost? Would insurance cover it? And why didn’t the story at least include a projection of how much the vaccine would cost? These are increasingly important issues in cancer treatment.
The impact of the treatment on time to cancer recurrence was provided in the story. The story included a hint that the study may also demonstrate an increase of survival time. However since the information about survival time was not available at the time the story was published, it is not fair to make this suggestion. Inclusion by the clinician involved in the story that "It appears very promising for a cancer where there’s been little hope." may suggest more benefit than may be attained with this treatment.
There was no mention of whether the vaccine had any effects other than appearing to lengthen the time needed to observe cancer recurrence.
It is important to focus on the type of study this was: a trial of two different durations of the vaccine drugs, not a trial of the vaccine versus no vaccine. The lead paragraph states that the finding was that the combination of chemotherapy plus a new vaccine prolonged survival. This is misleading because there is no arm of the study without the vaccine. The prolongation is compared to historical controls, and this is not a robust comparison. The study participants were, as the story commendably explains, "cherry-picked" for the study and may not be comparable to the historical controls.
Further, there was some information provided about the results of the trial (i.e. time to tumor recurrence) and that the trial itself was a pilot study and the results would need to be replicated. That said, the story mentioned the data about time to recurrence in the same paragraph as it discussed time to patient death (data not available at the time the story was written). It is likely that readers will fail to appreciate the difference between these two end points (time to cancer recurrence and time to death); the story should have provided some insight for readers about how meaningful the end point of time to recurrence really was (the sample size may have been too small for a difference of 2.6 months to be statistically different). Was it statistically different and/or clinically significant?
The story quoted two clinicians involved in the current study. While it was refreshing to include the comment from the first author of the study that though enthusiastic about the results, he was "biased", the story would have been much better if it had included comments from experts in the field who were not involved in the study.
Inclusion of the interview comments from one of the patients who has received the experimental treatment is potentially misleading for readers because there was no framework for understanding the disease. While she is still alive and doing well 2 years after receiving the treatment, it is premature to conclude that this treatment is the reason for her current state of health.
This was a story about additional treatments that might be used in conjunction with currently utilized therapy. It was clear that surgery, radiation and standard chemotherapy are used.
The story explained that the treatment described was available only as part of a clinical trial.
While this was accurately reported, the story should have mentioned whether or not patient recruitment for the trial was ongoing and if so, it could have included a link to http://clinicaltrials.gov/.
The story was clear that combining a vaccine with conventional chemotherapy for the treatment of this tumor was novel.
A story about a clinical trial should include a link to a source of information about clinical trials as a service to readers.
We can’t be sure if the story relied solely or largely on a news release. We do know that it only quoted two researchers who were involved in the current study.
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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