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A test that identifies women with breast cancer who can “skip chemo”? AP thoroughly analyzes the claim

Rating

5 Star

Some with early-stage breast cancer can skip chemo, study says

Our Review Summary

DNA sequencestudy in the New England Journal of Medicine (NEJM) looked into the most common type of breast cancer – early stage, without spread to lymph nodes and hormone positive, meaning the tumor’s growth is promoted by estrogen and/or progesterone. According to the Associated Press article on the study, more than 100,000 women in the US are diagnosed with this type.

Doctors usually remove the tumor via surgery and prescribe hormone-blocking drugs, but they are unsure whether chemotherapy can offer additional benefits for some women. In this NEJM study, patients with this common breast cancer took a gene test to see whether their tumors would respond well to hormone-blocking drugs alone. Those labeled “low risk” based on this gene test skipped chemo and saw they had a very low rate of cancer recurrence within five years.

The Associated Press article touches upon all the main points – costs of the gene test, study design and benefits, context – and we applaud how thoroughly the story addresses some of our criteria, especially on a tight deadline. Our main suggestion is to look for and report on conflicts of interest, especially if they concern the first author and are relevant to the study.

 

Why This Matters

In the US, breast cancer is the second most common cancer in women after skin cancer, with about 230,000 new cases diagnosed in women each year, according to the National Cancer Institute. Cancer treatments usually involve chemotherapy, which results in a long list of possible side effects and complications. In most cases, more than one drug is used, and patients could take these medications for years at a time. Not only that, cancer treatment drugs can be expensive. A typical weekly course of cancer drug Paclitaxel costs about $13,000, whereas the biweekly regimen is $23,000 to $40,000, according to one oncologist from Ohio’s Cleveland Clinic (login may be required).

Any research that shows the benefits of forgoing chemotherapy could help patients avoid toxic side effects and complications and help curb the US’s epidemic of  “over care” and spiraling health care costs.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story states the Oncotype gene test costs $4,175 and adds that many insurers, as well as Medicare, cover it.

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

Satisfactory

In the low risk population, women who had foregone chemotherapy had less than a 1 percent chance of cancer occurrence at another faraway spot, the story says. It also mentions that 16 percent of the 10,253 study participants were classified as low risk.

Later down in the article, it lists more study findings: “After five years, about 99 percent had not relapsed, and 98 percent were alive. About 94 percent were free of any invasive cancer, including new cancers at other sites or in the opposite breast.”

The only feedback we have is that the story could have been a bit clearer in pointing out that all of these figures pertained to the low-risk group.

But the quantifying of benefits was good enough to merit a Satisfactory rating here.

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

Satisfactory

We give the story the benefit of the doubt here. It mentions that adding chemo exposes patients “to side effects and other health risks,” but it doesn’t detail what those effects are. Two other people mentioned in the story refer to “complications” and chemo being “not pretty,” but the story does not elaborate on these comments. The National Cancer Institute lists a slew of side effects from undergoing cancer treatment, such as bleeding, fertility problems and hair loss.

On the flip side, researchers mentioned it’s possible that patients in the low risk group could experience relapses in the future, and it’s unclear if early administration of chemo would have helped in these cases. We address this point in the “Quality of Evidence” section, since researchers addressed this as a study limitation in their paper.

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

Satisfactory

No limitations of the study are raised or addressed in the Associated Press article, and it also does not provide any critical perspectives on the research. We always encourage stories to take a questioning, skeptical stance toward new research, but we’re not sure how easy it would be to find someone to offer a hard-nosed assessment of this study, especially on a tight deadline. The findings look solid.

One study limitation that the researchers acknowledged was that they expect more relapses with longer follow-up times (i.e. more than 5 years), and they’re not sure if administering chemotherapy for this low risk group could have prevented recurrences further down the line. Then again, the study also notes in the discussion section that chemotherapy primarily impacts recurrences within 5 years.

A breast cancer specialist says, “There is no chance that for these patients, that chemotherapy would have any benefit,” and we wonder if the story should have pushed back against this a bit — especially since the study is ongoing and only completed a 5-year follow-up for the low risk population. But overall we think the coverage was Satisfactory.

Does the story commit disease-mongering?

Satisfactory

There is no disease mongering in this article.

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

Not Satisfactory

The Associated Press interviews five experts for the article – one is the study’s lead author and the rest are independent sources. This is a strong point in the story.

But while the story also mentions the funding source (National Cancer Institute), there was a relevant conflict of interest that was overlooked here. Dr. Joseph Sparano, the study’s lead author, reported a patent “related to tests to predict responsiveness of cancer patients to chemotherapy treatment options” in his NEJM disclosure forms (p.79-80). Since we feel this is significant enough conflict of interest that should have been touched upon in the story, we give it a Not Satisfactory rating here.

Does the story compare the new approach with existing alternatives?

Satisfactory

The story describes the usual course of treatment, which is surgery followed by years of a hormone-blocking drug, as well as chemotherapy.

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

Satisfactory

The Associated Press report talks about costs of the Oncotype DX gene test by California company Genomic Health and adds that other tests are also on the market.

Does the story establish the true novelty of the approach?

Satisfactory

The Associated Press article does a good job providing some context to the NEJM study and states that past studies have looked into how women with varying levels of risk have fared. This is the first study to assign women treatments based on their scores and to track recurrence rates, the story says.

The initial studies that led to widespread use of the test were (very large) retrospective validation studies. This is the first prospective study of its kind.

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

Satisfactory

The Associated Press article does not seem to be based on any news releases we found online. In addition, the story demonstrates original reporting with its four independent sources and comment from the lead author.

Total Score: 9 of 10 Satisfactory

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