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It’s misleading to call results from phase 1 trials with 6 and 13 patients a ‘cancer breakthrough’


4 Star



Our Review Summary

harms of cancer immunotherapyUngrounded speculation or reasonable caution? Both are present in this Newsweek story on two very early trials of immunotherapy drugs being developed to protect against melanoma. While the headline calls the research “a cancer breakthrough,” quotes from researchers bring some much-need focus on the studies’ limitations.

These are — after all — phase 1 safety trials with just six volunteers in one and 13 in the other. Far too small a group to make any claims about successful results. The article does tell readers what questions remain about the vaccines (such as do they extend life and how effective are they compared with other treatments), and the type of research studies that are needed to answer these questions. However, noticeably absent from the story is a discussion about the exorbitant price tag associated with immunotherapy.

We’re seeing a lot of health news and PR releases devoted to immunotherapy trials so we’ve put together some tips for covering news on cancer immunotherapy drugs.


Why This Matters

Results from small, preliminary studies like these involving six and 13 volunteers should be viewed cautiously.

Information about the effectiveness of a treatment is of limited consequence if patients cannot afford the treatment. There needs to be a discussion of cost so patients can determine whether such treatment is even possible for them.


Does the story adequately discuss the costs of the intervention?

Not Satisfactory

This story doesn’t discuss how much the vaccines cost. Therefore, readers can’t compare the affordability of these vaccines to existing treatment options.

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


The story says that four of the six patients had no cancer recurrence after 25 months in the first study, and in the second study, eight of the 13 patients remained tumor free after 23 months.

But the studies cited are both phase I clinical trials designed to address safety, not efficacy. Any claims regarding the latter, especially given the limited number of subjects, would be highly speculative. Therefore, the headline is misleading. As noted in the final sentence of the article:

“… The next step will be to test these personalized vaccines in larger clinical trials to see if they are better than existing treatments, if they improve survival, and what their long-term side effects could be.”

Does the story adequately explain/quantify the harms of the intervention?


We give the story credit for making an important point that waiting for the vaccine to be made might be detrimental to patients with advanced cancer. It says, “As the vaccine therapies are designed and generated specifically for each individual there is a lag time from enrollment to commencement of treatment—approximately four months—which may be too long from some patients with advanced cancer.”

The story also notes that “Both vaccines were deemed safe” but it doesn’t discuss any side effects that may have shown up in the trials. What happened to the five patients who were not tumor free at 25 months?

The story does mention that more research is needed to identify potential harms.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

The story mentions the types of studies that were conducted and the size of the trials. Both of these factors impact the claims that can be made from the research. And that’s important because the claims made seem out-sized compared to the very preliminary nature of the research. Phase I clinical trials are used to look at safety and side effects, not to make conclusions about the future success of personalized medicine.

To its credit, the article includes a very important quote from one of the study authors that clarifies that no conclusions should be drawn from these preliminary studies:

“It is still unknown whether these vaccines will extend the survival of cancer patients, or whether they are more effective than other recently developed immunotherapies. Additional clinical trials will be required to determine the utility of these individualised neoepitope vaccines.”

Does the story commit disease-mongering?


There is no evidence of disease mongering in this story.

Does the story use independent sources and identify conflicts of interest?


The story incorporates insights from a few independent sources. This gives readers additional information about how the findings should be interpreted. However, no information is provided about potential conflicts of interest.

Does the story compare the new approach with existing alternatives?

Not Satisfactory


The story doesn’t mention any other treatment options for melanoma by name but states that additional research is needed to determine the effectiveness of these vaccines in comparison to existing options.

The story could have been improved by including information about the prevalence of cancer recurrence among cancer patients using existing treatment options such as surgery and chemotherapy.

One of the trials described was conducted in people who had had surgery and no other treatment options. It would have been helpful to include the length of time to tumor recurrence in people who had not received any other interventions.

Does the story establish the availability of the treatment/test/product/procedure?


Although not explicitly stated, most readers will understand that the vaccines are not currently available and have to undergo a lot more testing before they are available — if ever.

Does the story establish the true novelty of the approach?


The article discusses what is and isn’t new about the research in this section: “Cancer vaccines that are personalized to the patient—designed to help the immune system identify tumors as foreign bodies and destroy them—have been considered as a potential treatment for a number of years. But working out the unique mutations of each person’s cancer, a time-consuming and complicated process, must first be identified before a vaccine can be developed for them.”

Does the story appear to rely solely or largely on a news release?


The story includes independent sources and does not appear to be reliant on a news release.

Total Score: 7 of 10 Satisfactory


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