text_1: FDA Clears P-Cure Upright Imaging Solution  for Proton Therapy Enhancement
text_2: P-Cure Ltd. device We’re fully prepared to believe that there are ways to more accurately administer proton beam therapy with fewer side effects and lower costs. This release makes just those claims and yet provides nothing to back the claims up. There is no quantification of benefits. No true exploration of risks. No explanation of the quality of the evidence. And no true comparison of alternatives. The release muddies the water on what kind of nod it got from the US’s regulatory agency. The company received FDA “clearance” to market the device but not an “approval.” (See the discussion under the Quality of Evidence criteria.) Proton beam therapy represents an alternative form of radiotherapy compared to conventional x-rays. Interest in this form of therapy has grown based upon its ability to deliver higher doses of radiation to a smaller field. This may improve the benefit and reduce the harm for patients with cancer who need radiotherapy. Although not a focus in this release, the proven outcomes of proton vs. conventional radiotherapy in terms of benefits (increased survival) and harms (less damage to surrounding normal tissue) are less clear than the proponents of proton therapy would like to admit. For many cancers, conventional therapy may be adequate. Here the question is whether the delivery of proton beam therapy to patients who are getting it can be enhanced by delivering the treatment to the patient in a seated compared to a flat position. One can imagine for some patients that may lead to a more comfortable treatment, but it isn’t clear how many would derive a measurable benefit. The release focuses on decreases in the discomfort of treatment and implies that some who may not otherwise tolerate this therapy could now have it. All interesting, but no information is provided to support the release’s claims. Finally, the release focuses on the potential benefits to the proton beam center in terms of its costs — but patients will have other questions about cost such as whether the device is more expensive than what the center is currently using. If so, those costs may be passed on to insurers and thus patients based upon the specifics of their policy. As such, it isn’t clear whether the “clinical breakthrough” or “paradigm shift” will be apparent to the average patient undergoing this form of cancer treatment.