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Release oversells evidence when claiming new standard of care for advanced breast cancer

International trial changing standard of care for advanced breast cancer

Our Review Summary

breast cancerA study presented at the American Society of Clinical Oncology (ASCO) scientific conference that supposedly will “change the standard of care” for patients with advanced breast cancer should have more evidence backing up the claim. This news release gives short shrift to salient details, including costs, risks, the quality of the evidence, and proof of the novelty of this surgery-first approach.

The release doesn’t  acknowledge that the study found no difference between groups for the primary outcome (survival at 36 months). A statistical difference was found when the study was extended to 40 months but on a smaller subset of the original full sample group. The release makes the results sound like a success by focusing on subgroups of patients, but those results should be interpreted very carefully.

 

Why This Matters

Although the news release was able to discuss in simple terms some of the results of the study, there is concern when broad statements such as claims of a change in practice will occur based on the results of one study.

There were also some study limitations that were not addressed in the news release. The original study was powered to detect differences in survival between the two groups at 36 months, but the study failed to find a difference. It was only with subgroup analyses and a longer follow-up time did the researchers find significant differences between the groups. The concern is that the study may not have been adequately powered for these subgroup analyses and therefore, the results may not be accurate.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

There was no discussion of costs in the release. This would be an easy addition, given how common these types of surgeries are.

Does the news release adequately quantify the benefits of the treatment/test/product/procedure?

Satisfactory

The release does quantify the benefits, but we have concerns with how the release states: “At about 40 months after diagnosis, the women who received the surgery plus standard therapy lived an average of nine months longer than their counterparts…” This is a difficult sentence to follow since 40 months was the median survival (with a range of 20-51 months). The sentence might be interpreted by some readers that most women lived to at least 40 months, which was not the case.

Does the news release adequately explain/quantify the harms of the intervention?

Not Satisfactory

There is no mention in the release of the risks associated with surgery. It’s unclear from the abstract whether the study captured the risks involved in the surgeries.

Does the news release seem to grasp the quality of the evidence?

Not Satisfactory

We understand that findings such as these are often presented at academic conferences. But there is a difference between findings going out unchallenged at an academic conference and findings having to go through the rigors of peer review for publication in an academic journal. In this case, these findings are just being announced at a conference (not published in a journal), and by not making that distinction, the release presents the findings as more rock solid than they actually are, even adding in a little “best of” moniker to make them more believable. It says:

“The results of the phase III randomized, controlled trial will be presented Saturday at the American Society of Clinical Oncology (ASCO) annual meeting in Chicago. The study was selected for the society’s “Best of ASCO,” an effort to condense the research “most relevant and significant to oncology” into a two-day program to increase global access to cutting-edge science.”

The release only includes the study’s positive results based on a subgroup analyses, not the limitations of the research. The main study purpose — to detect differences in survival between the two groups at 36 months — revealed there was not a significant difference. A difference was found when the study was extended to 40 months and a smaller selection of study participants were analyzed. But this isn’t mentioned.

The study is also being conducted in Turkey and other studies have shown some differences in breast cancer incidence in Turkey compared with Western countries. The differences in incidence could be a result of differences in risk factors, age at diagnosis, and screening — all of which could also affect treatment outcomes.

Does the news release commit disease-mongering?

Satisfactory

There is no disease mongering in this release.

Does the news release identify funding sources & disclose conflicts of interest?

Satisfactory

The release mentions who did the study and how it was funded.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release does not adequately compare surgery with alternatives, although it does mention them:

“Half the women received standard therapy, which avoids surgery and consists of a combination of chemotherapy, hormonal therapy and targeted therapy,”

How did surgery compare? We aren’t told. notes that “At about 40 months after diagnosis, the women who received the surgery plus standard therapy lived an average of nine months longer than their counterparts who received standard therapy alone.”

[Editors note: This rating has been revised to reflect that this criteria is satisfactorily addressed in the news release.]

Does the news release establish the availability of the treatment/test/product/procedure?

Not Applicable

It should be clear to any audience that these types of basic surgeries are available, and so we are giving this criteria a pass.

Does the news release establish the true novelty of the approach?

Not Satisfactory

The release presents these findings as a novel breakthrough for surgery for breast cancer. It says:

“Our findings will change the standard of care for women newly diagnosed with stage IV breast cancer,” said principal investigator Atilla Soran, M.D., M.P.H., clinical professor of surgery, University of Pittsburgh School of Medicine, and breast surgical oncologist with UPMC CancerCenter. “We’ve shown that surgery to remove the primary tumor–either through lumpectomy or mastectomy–followed by standard therapy, is beneficial over no surgery.”

It’s pretty apparent what they’re claiming is novel here — surgery for metastatic stage IV cancer is beneficial. But the problem is that’s not a novel finding. This is a longstanding question and one which was discussed in a previous story review.

What’s different about this study and why is it practice-changing when other research has reported similar findings? The release doesn’t say.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Not Satisfactory

The headline and quote in the text about “changing the standard of care” for breast cancer treatment was unjustifiable given the size of the trial and the fact that the findings have yet to undergo peer review.

Total Score: 4 of 9 Satisfactory

Comments (2)

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Marc Beishon

June 8, 2016 at 5:01 pm

“How did surgery compare? We aren’t told.”

Unless I’m missing something the whole point of the study is to compare surgery on the primary tumour with not doing such surgery… The current international guidelines say that removing the primary tumour in patients with de novo metastatic breast cancer has not been associated with prolonged survival, with the possible exception of patients with bone only disease, but there are ongoing prospective trials, of which presumably this is one, in what is a controversial (in oncology terms) area. I agree that this release more than oversells this study – this question is not likely to be answered by anything other than a systematic review of high quality prospective studies that add solid evidence to patient selection.

However, it can be considered in selected patients, particularly to improve quality of life, always depending on patients preferences.

Reply

    Kathlyn Stone

    June 9, 2016 at 2:14 pm

    Marc:
    Many thanks for the observation. The rating dealing with comparing this approach to existing therapies has been changed to reflect that it is satisfactorily addressed.
    Kathlyn Stone
    Associate editor

    Reply