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Opdivo for head and neck cancers: 2-month survival benefit called ‘game-changing’ in PR release

'Game-changing' immunotherapy doubles head and neck cancer survival

Our Review Summary

IVThis news release focuses on a study published in NEJM that evaluated the use of the immunotherapy drug nivolumab (marketed as Opdivo) to treat patients with head and neck cancers whose cancer has progressed despite receiving conventional chemotherapy. Patients receiving nivolumab tended to live slightly longer than patients who received only conventional chemotherapy. In addition, patients receiving conventional chemotherapy reported a more significant adverse impact on their quality of life than patients receiving nivolumab. The release does not address cost or offer insight into potential side effects of nivolumab. Perhaps most importantly, the release using sweeping language, such as “game changer,” to describe nivolumab. That sort of vague, and potentially misleading, language has little place in a news release like this one.

[Editor’s note: Some of the concerns with the release are recurring ones we’ve seen in both news releases and news articles on immunotherapy drugs. They are discussed in more detail in our tips for writing accurately about cancer immunotherapy drugs.]

 

Why This Matters

According to the National Cancer Institute, approximately 52,000 people in the U.S. are diagnosed with head and neck cancer each year (though — worth noting — that estimate was made for 2012 in particular). Mortality varies widely, depending on the specific type of cancer and a patient’s background, but this is clearly a life-threatening disease. In addition to the impact of head and neck cancers on patients and their families, there is an economic cost as well: treatment of head and neck cancer-related costs can be upwards of $3.5 billion per year. All of this means that advances in treatment for patients with head and neck cancer — particularly for patients in whom conventional chemotherapy isn’t working — are important and worth highlighting. However, it’s important to offer detailed information, such as what side effects a new treatment may cause. Patients, their families, and their healthcare providers, should have a clear understanding of the potential risks and benefits associated with each treatment option. This release falls short in that department. It also builds up unrealistic expectations, using the term “game-changing” in the headline, and “game changer” in the opening paragraph. The study this release is focused on didn’t lead to remission for patients. Nor did it suspend the progression of cancer indefinitely. Based on this study, nivolumab bought some patients a little extra time. That’s not insignificant, and stating the facts should have been enough — the release didn’t need to oversell it.

Criteria

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

Not Satisfactory

The release doesn’t address costs at all. This may be because the study was done in the U.K., where public health care mitigates the cost for patients. However, it is definitely an issue for patients in the U.S. In an NEJM piece published last year, one doctor stated that, when used for treating metastatic renal-cell cancer, nivolumab costs, “by my estimate, around $65,000 for Medicare beneficiaries and up to twice that for commercially insured patients.” Other estimates are that nivolumab treatment — again, for cancers other than head and neck cancer — could cost more than $100,000 per patient. That is a huge factor in making treatment decisions, and needs to be addressed.

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

Satisfactory

There are two way of considering benefits in relation to this study: survival time and quality of life. The release addresses both of these. For example, the release notes that median survival time for patients receiving nivolumab was 7.5 months, as compared to 5.1 months for patients receiving conventional chemotherapy. The release also notes that fewer patients in the nivolumab group (13 percent) experienced “serious side-effects” than in the chemotherapy group (35 percent).

The release states: “More than double the number of patients taking nivolumab were alive after one year as those treated with chemotherapy.”  However, according to a table published as part of the study, the actual numbers of patients at that point had dwindled to 24 on the drug and five on conventional treatment, from the original group of 361 patients. Three months later this was down to five on the drug and one on conventional treatment, and 3 months after that (18 months into the trial), all patients had died. (as per Fig 1)

It’s worth noting that the group receiving nivolumab was significantly younger than the control group; the majority were under age 65. Drug companies do many things to bias their studies in subtle ways–might having relatively younger, healthier people in their drug group be one?

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

Not Satisfactory

As noted above, the release does address side effects, stating: “fewer patients experienced serious side-effects from taking nivolumab than with conventional treatment – only 13 per cent compared with 35 per cent of patients who received chemotherapy.” However, it doesn’t explain what those “serious side-effects” might be. According to the website for one nivolumab drug, these side effects may include inflammation of the brain or nerve problems that lead to paralysis. Patients, families, and healthcare providers make decisions based on quality of life as well as length of life, and information like this is essential for anyone wanting to make informed decisions about treatment options. It’s not enough to refer to “serious side-effects,” you need to explain what those side effects may include. Vague language does a disservice to the reader.

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

Satisfactory

The release does an adequate job of describing the study design; however, the introduction of another disease — human papillomavirus (HPV) — added some unnecessary confusion. It stated:

“The survival benefit was more pronounced in patients whose tumours had tested positive for human papillomavirus (HPV). These patients survived an average of 9.1 months with nivolumab and 4.4 months with chemotherapy.

HPV-negative patients survived an average of 7.5 months with nivolumab and 5.8 with chemotherapy.”

The release is noting a survival benefit in both HPV positive and in HPV negative patients. Biomarkers on tumors can be very helpful in directing which drugs a tumor may respond to, but that didn’t seem to be the case here in any definitive way.

We’re not sure what to make of this post hoc exploratory analysis of HPV. This seems on the surface to be a subtle way to bias a cancer study.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering here.

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

Not Satisfactory

The release makes clear that the study was funded by Bristol Myers Squibb. That’s good. The release does not, however, tell readers that some of the study authors received personal fees from Bristol Myers Squibb, in addition to the grant funding. That information can be found in conflict-of-interest disclosure documents on NEJM‘s site.

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

Satisfactory

The study at issue was for patients who were seeing cancer progression despite the use of conventional chemotherapy treatments. In other words, as the release makes clear, the alternatives had been tried already.

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

Satisfactory

The release makes clear that nivolumab is not yet approved for use in head and neck cancer patients in Europe (including the U.K.).

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

Satisfactory

The release addresses this explicitly: “Nivolumab became the first treatment to extend survival in a phase III clinical trial for patients with head and neck cancer in whom chemotherapy had failed.”

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

Not Satisfactory

This is a weak point for the release. Vaguely exciting terms, such as “game changer,” have no place in a news release that is discussing the lives of human beings. “Game changer” is a term that has no objective definition. One person may think that the possibility of extending life by two months is a “game changer.” Another person may see the term “game changer” and think that it must mean they’ve found a new way to put head and neck cancer into remission. This could lead to disappointment when the findings are explained in detail.

The release states that the drug “greatly improves survival” — and perhaps within the oncology community this may be appreciated as an improvement for this type of refractory cancer. But in patient terms we are talking months of survival. All of the study participants had died by 18 months.

Total Score: 6 of 10 Satisfactory

Comments (1)

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Malini Guha

October 18, 2016 at 4:53 pm

Although I don’t disagree with your overall analysis of the new release, I am confused by one point you make about the NEJM overall survival data. You write: “The release states: However, according to a table published as part of the study, the actual numbers of patients at that point [one year] had dwindled to 24 on the drug and five on conventional treatment, from the original group of 361 patients. Three months later this was down to five on the drug and one on conventional treatment, and 3 months after that (18 months into the trial), all patients had died. (as per Fig 1). But neither surival curve falls to 0. Perhaps the number at risk falls to 0 because of data censoring, not because all patients had died? The text also states: “At the time of analysis, 41 of 236 patients (17.4%) were still receiving
nivolumab and 3 of 111 (2.7%) were still receiving
standard therapy.”