"Simply cruel": Patient advocates condemn hype in breast cancer immunotherapy

"Increases life expectancy," Newsweek announced.

"Helped slow down an aggressive type of breast cancer," Reuters reported.

"Says to change the standard of care," the New York Times exclaims.

Judging by the news reported last week, women with metastatic triple negative breast cancer had reasons to rejoice in the results of a clinical trial of a drug of any kind. immunotherapy called atezolizumab, marketed under the name of Tecentriq.

The trial was promoted by a press release stating that this was the "first success of immunotherapy" in patients with triple-negative breast cancer, for whom there was no evidence effective treatment options.

But unlike the impression left by the press release and many reports, the results of this study have not been so spectacular. The drug actually do not prolong life.

The median overall survival was 21.3 months for patients taking both the immunotherapy drug and the chemotherapy, compared to 17.6 months for those taking a placebo plus chemotherapy. This difference was not statistically significant.

So where does the hype come from?

The immunotherapy medication actually improved a surrogate marker called progression-free survival, which meant that tumors took longer to develop in women who received the drug. It also appeared to prolong the life of a subgroup of patients with high levels of a protein called PD-L1, although there are too few women enrolled in the study to firmly conclude that there is had a profit.

Both results are accompanied by red flags. As we have written, surrogate markers and subgroup outcomes have limitations that patients need to know. Unfortunately, much of the media coverage we encountered did not bring these caveats.

What are the disadvantages of optimistic coverage?

However, it is possible that this medicine could help some people. So what is the harm in a small positive rotation?

We contacted a number of breast cancer advocates who highlighted what they saw as the dangers of sensational reporting on clinical trials.

Most of the exaggerated claims about Tecentriq – associated with a noticeable minimization of severe damage – have probably created false expectations in patients with triple-negative breast cancer. Some expressed anger about the cover.

"Living with a terminal illness is an emotion roller Coaster to begin. I think it's shameful to peddle hope with such a broad brush stroke when it's actually a thin pen tip, at least for the moment, "said AnneMarie Ciccarella, a patient lawyer who writes on the blog ChemoBrainFog.

Suzanne Hicks, an active member of the National Breast Cancer Coalition, said treating total value was "just cruel" for patients who "are often willing to do anything to survive."

The stories of hope tend to be shared by friends, family and other patients. Ciccarella noted that the press release had been published in a Facebook support group. In response, a member of the group shared a column from Forbes that was among the few pieces expressing strong warnings about the study..

"I can not help but wonder how many well-intentioned friends have been called to make sure these patients are" aware "of this new" breakthrough, "Ciccarella said.

"It's shameful to peddle hope"

Some stories echoed the hopeful story of the press release, which focused on the potential benefits for survival in the subgroup of PD-L1 patients. This advantage has yet to be confirmed by a later, broader study – a point that has been overlooked in some stories.

CBS News has gone further than other media by focusing on a single patient who has had an atypically positive outcome. As stated in our tips for writing about immunotherapy, it is important that reporters look for multiple patients and / or ask detailed questions about patients who have responded in unusual ways.

Readers may not be able to distinguish between all patients in the study and those in the subgroup.

"The thing with hope is this: we never want it to be taken away from us," said Ciccarella. "There are almost always successes, mostly outliers, or in this case, it seems like a certain subset of patients might react."

Deanna Attai, MD, a breast surgeon at the David Geffen School of Medicine at the University of California at Los Angeles, acquiesced. "Early studies showing" promising "results do not guarantee that all subsequent patients will have the same good results, and that the results will be [long-lasting]. So there is a potential for false hope among a population of desperate patients, rightly so, because they have no other choice, "Attai said.

Patients with positive spin pressure

A positive reaction could encourage patients to seek expensive treatments that would not be useful to them and could hurt them, although Mr. Attai said they would not necessarily get these treatments.

Still, there could be an emotional toll.

"One of the problems faced in people with metastatic cancer is the need to continue treatment and to try different types of treatment, even if it will not prolong the life of their patient or will improve their quality of life, "said Mandy, a breast cancer survivor and epidemiologist. Stahre, PhD.

She said that patients who read such coverage "may feel that they are being treated unfairly, and only if their doctor prescribes immunotherapy do they get better". The financial and emotional costs for people who want to find a "cure" are inflated by this type of information coverage.

Patients also want a quality of life

Several lawyers have protested against minimizing the toxic side effects of immunotherapy, which can hasten death.

For example, Newsweek waited for the last paragraph to mention that 103 patients had serious side effects due to immunotherapy and that six had fatal reactions. This was compared to three deaths in the group who did not receive the drug.

According to the study, three of the deaths in the immunotherapy group were attributed to treatments, compared to one of the deaths in the placebo group.

"It struck me between my eyes and frankly, it's irresponsible to put this in the very last paragraph when most people will probably not have gone so far," said Ciccarella.

In addition, patients in the immunotherapy group were almost twice as likely to drop out.

Hicks said that these perverse effects should have been reinforced: "Survivors do not want just a few weeks, especially if these weeks are difficult and end of life. They also want a quality of life.

Christine Norton, President and Co-Founder of the Minnesota Breast Cancer Coalition, said data on serious harm and quality of life are among the top priorities for reporting on the treatment of diseases in Canada. last phase. (See box.)

"I think most patients with a terminal illness, regardless of their type, want the media to clearly report two things: any improvement in overall survival with treatment and the quality of life of that disease. treatment. This treatment failed in both cases for most participants, "said Norton.

"It's not a game."

Eric Topol, MD, executive vice president and professor of molecular medicine at Scripps Research, said the reports are "emblematic of so many other covers" conveying excessive demands for new drugs.

"I'm still a little nauseous when I read the word" game changer "because it's not a game," said Topol, referring to a commentary by a researcher in the Times.

On the basis of coverage, he said: "The public may have a false impression that there is a cure."

Tecentriq joins a long list of cancer drugs over $ 100,000 a year that it has not been proven that they prolong survival, but that have harmful side effects and which usually get worse. 39 FDA approval because of their ability to move a needle on an unproven substitution criterion or in a subgroup of patients.

Trials like this one, which measure several criteria for effect, increase the chances that a drug will produce an effect suggesting a benefit, said Topol, who criticized Twitter for publishing the data for the year. ;study.

Too often, press coverage exhausts positive nuggets while correcting negative conclusions that could have a greater impact on patients.

"What should have been revealed to the public by these articles is that there has been no improvement in survival," Topol said, noting that the Associated Press was among the few media outlets that clearly referred to this point in the fifth paragraph. The AP also raised the issue of side effects in advance.

"We all want to see progress" in the treatment of triple negative metastatic breast cancer, said Topol. "But there is no reason to exaggerate what the data shows."