Oncologists question safety of new “NanoKnife” cancer treatment

A new apparatus known as NanoKnife has gotten the attention of some cancer doctors, who worry that the device has not been tested thoroughly for safety and effectiveness in humans. NanoKnife is currently used in just over ten hospitals here in the United States, and each NanoKnife machine costs as much as $300,000.

Some hospitals, including the University of Miami Sylvester Comprehensive Cancer Center, are heavily promoting NanoKnife, despite the fact that it has been tested on a very small number of human patients. It has been tested on animals, according to AngioDynamics Inc., NanoKnife manufacturer. The Queensbury, New York-based company admits that it has not conducted “randomized, controlled clinical trials, the so-called gold standard studies,” but calls NanoKnife “a very promising technology for treating cancer.”

Other hospitals using NanoKnife include Baptist Health Medical Center in Arkansas and Shands Hospital in Florida. The University of Miami NanoKnife ad claims that the device offers “real hope” to people who know cancer, especially lung, liver and kidney cancer, and they promise that patients will experience “almost no side effects.” Reported side effects include rapid heartbeat [due to electric volts] and serious Hemothorax, or a build-up of blood between the lungs and the chest wall. Only one case of Hemothorax was reported to the FDA in July of this year, and the patient was hospitalized for over two weeks. Oncologists say that the NanoKnife “probably” caused a puncture wound during the procedure, but that this type of incident is common in therapies similar to NanoKnife.

So, what’s the problem? Many researchers are concerned that hospitals and cancer treatment centers are putting the cart before the horse. The NanoKnife has treated only 300 cancer patients worldwide, according to AngioDynamics, Inc. Chief Executive Jan Keltjens. It has been used in only five non-U.S. hospitals, but doctors who have used it say it has saved the lives of their patients, including some with incurable prostate cancer. While this is good news, Keltjens says that he does not have anything to do with the promotional efforts of hospitals like the University of Miami, saying that the hospital’s ads “are not something we are happy about,” and declining to comment on the company’s PR efforts in general.

Complications related to NanoKnife treatment have only been reported in a small number of human patients, but doctors still worry that it just hasn’t been tested enough yet, and should undergo more thorough safety testing before it is used in cancer centers to treat people who know cancer.

Riad Salem is one of those physicians who is concerned about NanoKnife. As the Chief of Interventional Oncology at Northwestern Memorial Hospital in Chicago, Illinois, Dr. Salem believes that NanoKnife “is being widely adopted prior to having gone through the necessary rigors” of highly controlled studies. He calls concerns about the treatment a “growing concern” in his field.

The NanoKnife zaps cancer tumors with electricity in an effort to kill them off. It looks a bit like a cutting-edge kitchen appliance, with two thin, long needles. The “electrode needles” are attached to an apparatus the size of a mini-fridge. The needles are inserted into the patient’s tumor, and electricity flows from one needle to the other, which create tiny holes within the cancer cells that then go to work destroying the malignancy.

NanoKnife has escaped the strict regulations of the Food and Drug Administration, which often studies and must approve cancer treatment devices.  The FDA will approve certain technologies for use if they are similar to other devices already available. Many people call this an unsafe “shortcut” that allows potentially unsafe devices to slip through the cracks. However, AdvaMed, a medical device industry group, asserts that devices that are approved through “FDA shortcuts” actually have a very good safety record. The NanoKnife was actually approved almost two years ago, after the FDA learned that it works like existing devices that have long been used during heart surgery. Instead of being used to treat patients with heart conditions, NanoKnife is being used to attack cancer cells, especially in tumors that are situated near vulnerable tissues, such as arteries or airways.

Oncologists at hospitals which use NanoKnife are said to receive some reimbursement for patients who undergo NanoKnife therapy, but some private health insurance companies are refusing to cover the treatment due to a lack of evidence that it is both effective and safe. Medicare will not cover use of NanoKnife.

The inventor of NanoKnife sticks by his creation, despite concerns from doctors and cancer scientists. Retired radiologist Gary Onik, inventor of NanoKnife, says that results of NanoKnife treatment are “phenomenal.” He personally treated thirty patients, and reports that all but two remain cancer free two years post-treatment. Some doctors across the world have spoken up in defense of NanoKnife at at various medical conferences, saying that it has permitted them to access and treat tumors in precarious places, which were previously unreachable with other therapies.

Regardless of how impressive NanoKnife appears to be, it seems as though further testing is absolutely necessary.


The Wall Street Journal Health

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