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Baylor should put the brakes on claims based on a tiny study of breast cancer and extrapolated benefits

A new HER2 mutation, a clinical trial and a promising diagnostic tool for metastatic breast cancer

Our Review Summary

This news release describes the effects a new drug, neratinib, had on a very small subset of patients with metastatic HER2+ positive breast cancers. Neratinib (marketed as Nerlynx) very recently received FDA approval as an add-on treatment for early stage HER2+ positive cancer, but this information was left out of the release. In fact, the release refers to neratinib as an “experimental” drug. It was also confusing as to what was being highlighted in the release. The first part describes the results of a 16-patient clinical trial for which only five patients showed a “meaningful clinical response” (no details were given on what that meant), but the second part of the release describes a new screening tool used to recruit subjects into the clinical trial. It was concerning that the release didn’t talk about the limitations of the clinical trial results, disclose the lead authors’ numerous financial ties with the drug maker, discuss costs associated with the drug, or describe any side effects. In the end, despite its optimistic tone and claim of novelty, the release doesn’t provide much information on progress towards treating this type of cancer.


Why This Matters

Metastatic breast cancer patients have limited treatment options. Touting such limited effects of a drug in a small phase 2 trial does little to help inform patients seeking better treatments.


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

Not Satisfactory

There was no mention of cost in this release. Neratinib (marketed as Nerlynx) was approved July 17, 2017 for the treatment of early-stage HER2+ breast cancer so cost estimates should be available.

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

Not Satisfactory

The release mentioned that about five patients in the trial had a “meaningful clinical response showing significant disease stabilization or regression,” but did not provide any details as to what that means in patients with metastatic disease.

The release irresponsibly speculates, based on extrapolated (not actual) data about how many people with metastatic breast cancer with the “new mutation” could benefit from the drug.

“The number of patients who could potentially benefit from this new treatment approach is estimated to be in the thousands. The researchers estimate that as many as 200,000 patients are likely to be living with metastatic breast cancer today in the United States. Based on the estimate that the new mutation is present in 2 to 3 percent of cases, the researchers calculated that approximately 4,000 to 6,000 patients with metastatic breast cancer carry a HER2 mutation and are therefore potential candidates for neratinib treatment.”

Remember, these estimates in the thousands are based on a study of just 16 people.

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

Not Satisfactory

No side effects of the drug were mentioned. It was also glossed over that most of the patients in the trial did not seem to have any response to neratinib. The release’s only reference to harms was that “Neratinib was well tolerated by most patients.” Other research (including the peer-reviewed paper this release is based on) has shown diarrhea to be a significant side effect of neratinib.

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

Not Satisfactory

This was a small phase 2 clinical trial of 16 women with HER2+ metastatic breast cancer — only five of whom had some “response” to the drug. The small size and modest result are limitations that should have been noted in the release.

Does the news release commit disease-mongering?


The release did not appear to commit disease mongering.

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

Not Satisfactory

The release didn’t name funders or discuss any potential conflicts of interest, instead referring readers to the full study, for which a journal subscription is required. The published study on which the release is based does list the full funding sources and the study authors’ conflicts of interest. Puma Biotechnology Inc, the maker of neratinib, was one of the study funders. This should have been disclosed in the release. All three corresponding authors of the study have multiple financial ties with Puma Biotechnology and other pharmas. This, too, should have been noted in the release.

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

Not Satisfactory

No alternatives were compared in this study although the study authors mentioned that this drug was aimed at those women who did not respond to conventional therapies to treat HER2+ cancers.

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

Not Satisfactory

The release didn’t make it clear that more research is needed following the phase 2 trial. The release could have mentioned that neratinib has already been approved by the FDA for women with early-stage HER2+ breast cancers as a follow-on therapy.

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

Not Satisfactory

The release made it seem that neratinib was an experimental drug that could be used for women with a particular gene mutation related to HER2+ metastatic breast cancer. It wasn’t made clear that neratinib is already used to treat early-stage HER2+ breast cancer.

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

Not Satisfactory

No sensational language here. But with only five patients (out of 16) showing a response to neratinib, the release seems to inflate the study results.

Total Score: 1 of 10 Satisfactory

Comments (1)

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Sherry Bucher

September 7, 2018 at 2:16 pm

Thx for the info. My oncologist has been wanting me to take this chemo pill and I have not been that excited about it. Now I know I’m not taking