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Lack of supporting data is more than a small problem for the NanoKnife

News Release Source Cannot Be Ascertained -- See Editor's Note Below

New Data Shows Irreversible Electroporation Nearly Doubles Overall Survival of Patients with Locally Advanced Pancreatic Cancer When Added to Standard Therapy

Our Review Summary

nanoknife2A futuristic-sounding medical treatment is paired with a bold claim of survival benefit in this news release. But the release is missing basic information to back up the headline’s claims and put the treatment’s efficacy into perspective. And an important conflict of interest is not disclosed. Such omissions could help instill false hope in sufferers of pancreatic cancer and their families.

[Editor’s note: At the top of this review, we’ve left blank the area where we’d normally put the logo for the organization that issued this new release. This reflects our uncertainty as to who should be considered the source of this news. As we’ve discussed in a blog post, the release is worded to suggest that it originated with the University of Louisville, and it includes a University of Louisville media contact. However, that contact has told us, via email and a comment on this review, that the release originated with MCS Healthcare Public Relations, which was working with a member of the University of Louisville faculty. That faculty member, in turn, suggested to us that the release was in fact cleared and sanctioned by the University. The University of Louisville media contact has refused to provide any further clarification. We’re unsure whom to believe, so we’ve deliberately left blank the area where we’d normally indicate the news release source. The fact that we can’t even tell where this news came from should raise questions about the process that produced it.]

 

Why This Matters

Pancreatic cancer is one of the most aggressive forms of cancer, killing nearly three-quarters of victims within a year of diagnosis and about 94 percent within five years. One reason, according to the CDC, is that nearly 80 percent of patients are diagnosed too late for surgery (which can extend median survival by about 10 months). Thus any treatment shown to be effective in treating the disease–especially a minimally invasive, non-surgical method–could possibly reduce patients’ suffering and provide them significantly more quality time with their loved ones.

Criteria

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

Not Satisfactory

Costs aren’t discussed, but secondary sources suggest each NanoKnife machine (which can be used over and over again) costs between $200,000$300,000. The one-use needles, which are used to zap or ablate cancerous pancreatic tissue, cost about $2,000 each–but it’s not said how many sessions are required. Nor is the cost of doctors, hospital stay, etc. discussed. Plus, it’s unknown if insurance will cover this.

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

Not Satisfactory

The release clearly states that nearly three-quarters of pancreatic cancer patients die within a year of diagnosis and 94 percent die within 5 years. It then goes on to say the NanoKnife IRE treatment doubles overall survival to 24 months. But the release never provides the absolute numbers from either the treatment or control group to substantiate this. The percentage of patients alive at 24 months may be higher in one group or the other, but the data are not there to tell. In addition, the release states that existing treatment “will only stabilize the disease and not destroy the tumor,” whereas the new treatment “overcomes rapid growth of the tumor by killing all malignant cells at once so they cannot continue to grow and spread.” But it’s not clear that the new treatment does, in fact, do more than “stabilize the disease” or that the cancer won’t “grow and spread” with the new treatment, since a chart in the abstract suggests that the disease unfortunately remains uniformly fatal even with the new treatment.

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

Not Satisfactory

Harms are alluded to, e.g. “[19] percent sustained complications with a median grade of 2 (range 1-3),” but they’re not discussed or explained in sufficient detail. What’s a “median grade 2” complication? It would have helped this release to cite, for example, the American Cancer Society on the side effects of ablative therapies for pancreatic cancer. Generally, according the ACS, those harms can “include abdominal pain, fever, nausea, infection, and blood clots in nearby blood vessels” with a potential for serious complications.

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

Not Satisfactory

We’re told the study results were “compared to standard of care data for Stage III [locally advanced pancreatic cancer],” but the release doesn’t provide any numbers or context with the control group. There are many factors that can affect cancer survival, and so it’s important to know how these control group patients were selected and whether their disease and treatment were truly comparable to those who received electroporation. But details on that issue are missing. It’s also worth noting that, while a median survival of nearly 2 years sounds promising, there’s a chance this claim might be overstated. Four known variations in pancreatic cancer tissue were recently and significantly shown to predict a pancreatic cancer patient’s survival. Those with three or four of the variations showed a median survival of about 9 months; those with only 1-2 survived about 23 months. Although it’s unlikely most of the 200 patients in the study presented by this release fell into the latter category, it’s just one example of how the benefits aren’t put into context and adequately explained.

Does the news release commit disease-mongering?

Satisfactory

There’s no exaggeration of pancreatic cancer here. Pancreatic cancer is uniformly fatal with or without this new treatment. At great expense it appears survival might be extended (it is not clear for how long) . Adding the number of people who are diagnosed and/or die from the disease every year in the U.S.–about 49,000 and 40,000, respectively–would have made this release stronger.

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

Not Satisfactory

We aren’t told what the funding sources are, nor whether there’s any conflict of interest. This information is also missing from the abstract itself. But by digging just a little bit, we learned that the lead author of the study and the primary source for this release (Dr. Martin) is a paid consultant to Angiodynamics (scroll to the bottom for disclosure info), which makes the NanoKnife system. This is critical information to disclose with these results.

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

Satisfactory

A quote from the lead author mentions the alternatives for pancreatic cancer patients, “whose only treatment options until now were chemotherapy or a combination of chemo-radiation therapy” and that–with the NanoKnife IRE treatment’–“these patients now have a surgical treatment option to augment their treatment plan.”

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

Not Satisfactory

We’re told the NanoKnife system “is approved by the U.S. Food and Drug Administration for the surgical ablation of soft tissue” and that it “is not approved for use in specific cancers.” So does that mean a pancreatic cancer patient could ask for this treatment? It’s unclear. It’s also unclear if insurance will pay for it.

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

Satisfactory

Ablative therapy is not new to pancreatic cancer treatment, but if true, extending 1-year survival to nearly 2 years could be a large and significant improvement.

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

Satisfactory

The release asserts the NanoKnife IRE treatment can double the survival for pancreatic cancer patients, but it doesn’t lay out potential caveats, nor how this only applies to the 1-year survival category (and not the 5-year survival category). However, since we’ve already dinged them for that deficiency, and there are no other examples of hyperbole, we’ll call this Satisfactory.

Total Score: 4 of 10 Satisfactory

Comments (3)

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Jill Scoggins

April 30, 2015 at 1:06 pm

Please remove the University of Louisville logo and name from this post. We are not the source of this news. Our researcher is quoted in the news release but the source of the news is the agency working with the company being cited. Jill Scoggins, Associate Director of Communications, University of Louisville Health Sciences Center

Reply

    Kevin Lomangino

    April 30, 2015 at 2:48 pm

    Readers: We have contacted Ms. Scoggins and are awaiting a reply so that we can confirm the source of this news release. The source of the news release is listed as “University of Louisville” on PR Newswire. We will update the post when more information is available.

    – Kevin Lomangino, Managing Editor

    Reply

      Kevin Lomangino

      May 20, 2015 at 10:02 pm

      Although we’ve failed to receive any further clarification from Ms. Scoggins, we’ve removed the University of Louisville logo from this news release review. See the editor’s note in the Review Summary for explanation.

      — Kevin Lomangino, Managing Editor