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Harms, costs and clear benefits omitted from release on anal cancer drug trial

First-ever nivolumab study to treat aggressive anal cancer appears promising

Our Review Summary

intravenousAs the nation’s largest cancer center, MD Anderson made a splash in 2012 with its ambitious announcement of a multi-billion dollar Moon Shots Program, which it called an unprecedented effort to rapidly convert scientific discoveries into life-saving advances. This news release, about a phase II clinical trial of the immunotherapy drug nivolumab (marketed as Opdivo) for one type of anal cancer, is decidedly more down to earth. The news release refrains from hype but still falls short of the mark when it comes to describing costs, potential harms, and comparisons with existing treatments. While calling results “encouraging,” the news release would be more helpful if it provided a meaningful assessment of whether this therapy might advance the Moon Shot’s directive of saving lives.


Why This Matters

Anal cancer is relatively rare. The American Cancer Society projects 8,080 new cases and 1,080 deaths in 2016. The number of new anal cancer cases has been rising. It is found mainly in older adults, with an average age in the early 60s. The risk of being diagnosed with anal cancer during one’s lifetime is about 1 in 500, with women at slightly higher risk. Squamous cell carcinoma of the anal canal (SCCA) is the most common form of anal cancer and is linked to infection by the human papilloma virus (HPV), the same virus that causes cervical cancer. The chemotherapy and radiation protocols that have been used to treat anal cancer have remained little changed since the 1970s, and there is no FDA-approved chemotherapy drug specific to anal cancer, according to the HPV and Anal Cancer Foundation. In recent years, a new class of drugs called immunotherapy drugs that unleash the body’s own immune system to attack cancer have offered a potential alternative to traditional treatments for several types of cancer.


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

Not Satisfactory

There is no discussion of the sky-high cost of nivolumab, the drug tested in this study. It’s disappointing because it’s at least the second time MD Anderson has failed to mention the cost of this drug in a news release. In a separate review last fall, calculated the monthly cost of nivolumab to be in the vicinity of $12,600, excluding administration. Nor does this review address whether a patient’s health insurance is likely to cover the cost.

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


The patients’ response was modest and the news release reflects that. The release quotes a researcher saying, “This study demonstrated responses in five of 18 patients treated at MD Anderson, and many of the patients had significant reductions in their tumor size.” It also gives details of some of those treatment responses.

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

Not Satisfactory

This news release makes no mention of potential harms. According to the website, more than 30 percent of patients on nivolumab may experience fatigue, low white blood cells, low sodium, shortness of breath, musculoskeletal pain, decreased appetite and cough.

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

Not Satisfactory

The news release falls short here because it fails to explain how a reduction in tumor size or other responses to treatment might translate into what matters to patients: quality of life and survival rates. The news release does note  that “final clinical results” will be reported at the American Society of Clinical Oncology’s 2016 annual meeting in Chicago, but would have been more helpful if it mentioned when that will occur and what additional data will be released.

Does the news release commit disease-mongering?


No disease mongering here. In fact, the news release mentions right off the bat that this form of cancer is “rare.” The news release also highlights the fact that squamous cell cancer (SCCA) is “on the increase,” but it would have been helpful to provide details that might help readers understand why cases are increasing and at what rate.

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

Not Satisfactory

The news release could have been transparent about financial backing. Funding sources are listed, but there is no mention of whether individual researchers have potential conflicts of interest. In our review of MD Anderson’s kidney cancer news release last fall, we noted that one of the researchers involved in that study is a paid consultant to the maker of nivolumab, Bristol-Myers Squibb. That researcher, Padmanee Sharma, M.D., is also part of the anal cancer study team. Neither news release noted her financial tie, and the reader is left to wonder whether any of the researchers have vested interests in the study outcome.

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

Not Satisfactory

Immunotherapy may offer a less toxic alternative to traditional chemotherapy, but there is no mention of that here. In fact, there is no attempt to describe the relative advantages and disadvantages of nivolmab versus the traditional treatment protocol. The release also neglects to mention that human papillomavirus (HPV) vaccine has been proven to prevent anal precancerous lesions and has the potential to make this tumor even more rare.

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


The news release squeaks through here, describing nivolumab as “one of the drugs represented among the growing arsenal of immnotherapy therapies.” This might imply to the reader that the drug is already available to treat other conditions. However, it does not state specifically whether the drug has FDA approval for anal cancer or any other application.

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


There is no question of the newness of immunotherapy drugs for treating cancer. The news release heralds this as the “first-ever” study of nivolumab on aggressive anal cancer. Still, the news release could clarify whether this is the first trial of any immunotherapy drug for anal cancer and if so how this study contributes to body of evidence of the potential for immunotherapy drugs to improve treatment options for patients.

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


No outright sensational language, but the news release failed to explain its use of the word “encouraging” to describe study findings. There is no quote from a researcher to back up that adjective. The study abstract only mentions “potential correlations” between immunological biomarkers and clinical outcomes to nivolumab.

Total Score: 5 of 10 Satisfactory

Comments (1)

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Susan Briggs

April 28, 2016 at 4:29 pm

Being an anal cancer survivor who had the standard chemo/ radiation protocol, which proved to eradicate my SCCA but leave me with pelvic radiation disease, I question several things in this report. First, the suggestion that most anal cancer patients are in their 60’s is incorrect. Most of us are in our early 50’s and many of us are in our 40’s. Secondly, this article fails to mention what happens if immunotherapy with this drug fails. Is there then the option for chemo/radiation therapy or is the patients only option a colostomy? The real downfall of what is presented is that the side effects are not clearly stated, addressed or have treatments. This is just as damaging as the side effects from chemo/radiation, for which there is no studies, treatments or cure. In fact for the most part the US medical doctors walk away from the patient once treatment is complete, totally ignoring pelvic radiation disease as anything they can manage. Let’s solve the side effect issue before “trying” something that may or may not work. Chem/radiation at least is proven to be 85-95% effective.