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Tiny safety trial prematurely touts ‘clinical benefit’ of cancer vaccine for HER2-positive cancers

New cancer vaccine shows early promise for patients with HER2-positive cancers

Our Review Summary

vaccineThis release describes a phase 1 safety trial using a modified vaccine that researchers said showed a clinical benefit in some patients diagnosed with metastatic HER2 positive cancers. None of the 11 patients in the trial had previously been treated with standard therapies. The study was presented at a recent medical conference on immunotherapy.

The release makes projections about the “promise” of the study results although phase 1 trials are fundamentally designed to assess safety and toxicity from different dosages. This trial had no control group with which to compare results. The release makes mention of these limitations but not until the very last sentence.


Why This Matters

Using immunotherapy through vaccines to combat breast cancer is an emerging area that in mice studies have shown some promising results. However, this study was a phase I clinical trial which is focused on a drug’s safety. It’s unclear what the outcomes in the human patients really mean without a comparison control group to truly understand what this vaccine could contribute in terms of treatment of metastatic cancer.


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

Not Satisfactory

The release noted that the vaccines were individually customized using each person’s immune cells. That technology does not sound cheap yet there was no discussion of cost.

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

Not Satisfactory

The release explains that six of 11 patients had a complete response, partial response, or stable disease using the experimental treatment. To the lay audience, it’s not clear what is meant by these different levels of response. Also, this is a phase 1 trial which is testing the safety of the vaccine and not focused or powered to compare benefits with current available treatments.

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


The only harm mentioned in the release was some injection site discomfort. The release also mentioned that the patients were tested to see if there was cardiotoxicity (heart dysfunction or muscle damage) and none was found.

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


The release gives a fairly detailed description of the study protocol, and dosing in particular. The release described the limitations of the current study at the very end of the release, notably that since it was a phase 1 trial it had a small sample size and there was no control group to compare the results.

Does the news release commit disease-mongering?


The release did not engage in disease mongering. It provides brief background on what HER2 cancer is and how it drives the growth of different types of cancer, including breast, ovarian, lung, colorectal, and gastroesophageal.

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


The release notes that the research was funded by the National Cancer Institute at NIH. The study abstract states the lead scientist declared no conflicts of interest.

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

Not Satisfactory

No alternatives were mentioned in the release. The only focus was on the current phase 1 clinical trial results.

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

Not Satisfactory

There was no discussion of the availability, although with it being a phase 1 clinical trial, you can assume that it is not available yet. There was no mention about scaling this work since the vaccine was produced using each individual’s immune cells to create the vaccine. It’s unclear if the trial moves forward and enrolls more subjects, how difficult (or costly) it would be to bring this method of treatment to a wider audience.

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


Although using immunotherapy to combat cancer is becoming a well known field, the approach the authors are taking with this treatment appears to be novel. The release also mentions how the vaccine was previously studied in animal models.

Total Score: 6 of 10 Satisfactory


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