Keeping you up to date on recent developments in oncology

Manufacturers of high-end CT equipment take note: NCI is a fan . . . The National Cancer Institute, part of the U.S.'s National Institutes of Health, is not charged with taking a stand on which imaging modality is better than which, but a recent statement by NCI seems to suggest that spiral CT imaging produces better results than conventional chest X-rays where lung cancer screening is concerned. According to a Nov. 4 NCI statement, the National Lung Screening Trial, described by NCI as "a randomized national trial involving more than 53,000 current and former heavy smokers ages 55 to 74," turned out data showing that those in the group who were screened with low-dose spiral CT had 20% fewer deaths than those who were screened with conventional X-ray technology. The National Lung Screening Trial (NLST), which randomized the 53,000 to spiral CT and standard X-rays, was sponsored by NCI and conducted by a branch of the American College of Radiology (ACR; Reston, Virginia), the ACR Imaging Network (ACRIN). Harold Varmus, MD, director of NCI, said in the statement that lung cancer "is the leading cause of cancer mortality" in the U.S "and throughout the world, so a validated approach that can reduce lung cancer mortality by even 20% has the potential to spare very significant numbers of people from the ravages of this disease." He described the study as a "large and well-designed study used rigorous scientific methods to test ways to prevent death from lung cancer by screening patients at especially high risk." Interestingly enough, the trial also brought out a 7% lower rate in all-cause mortality for spiral CT, but the NCI statement acknowledges that the study was not powered for this comparison, and states that further analysis "will be required to understand this aspect of the findings more fully." The trial commenced in August 2002 and followed the enrollees for five years. The study's data safety monitoring board (DSMB) met for the last time in October and determined that the study should be halted because of the difference in mortality between the two arms, which came to 354 deaths in the spiral CT arm versus 442 in the standard X-ray arm. For those who have questions about the prospects for coverage, the NCI statement notes that the current Medicare reimbursement rate for a non-contrast helical diagnostic CT of the lung is roughly $300, "but varies by geographic location," although critics of the news warned against another medical stampede. A paper describing the design and the protocol of the trial was published earlier this month in a paper titled "The National Lung Screening Trial: Overview and Study Design," which appeared in the journal Radiology. The paper is available to all viewers at www.radiology.rsna.org.

Mayo's Sunshine State clinic joins in the MRI-guided laser ablation assault on tumors of the kidneys and liver . . . The war on cancer has produced some interesting battles between human ingenuity and genetic deviation, but the Mayo Clinic in Jacksonville, Florida, has joined its older sibling in Rochester, Minnesota, in using MRI-guided laser ablation to deal with tumors of the kidney and liver. According to an Oct. 14 statement at the Mayo website, physicians at the Jacksonville Mayo have treated five patients with liver and kidney tumors "successfully," a term they define as "meaning no visible tumors remained after the procedure." The Mayo statement notes that while this approach is still in the development stage, the physicians see the treatment as having something to offer patients with both primary and secondary tumors so long as "there are only a few in an organ and they are each less than five centimeters" – or two inches – in diameter. One group of patients who might not be eligible for the procedure are those with pacemakers or certain metallic implants given that the procedure is conducted inside an MRI unit. Eric Walser, MD, an interventional radiologist who pioneered the technique at Mayo Florida said in the statement that laser ablation "offers us a way to precisely target and kill tumors without harming the rest of an organ," and that he and other physicians "believe there are a lot of potential uses of this technique." The Mayo statement points out that laser ablation is ordinarily applied to tumors of the brain and spine in addition to its use in zapping prostate tumors, and although the technology has won FDA's seal of approval for any soft-tissue tumor, "only a few centers have adapted the technique to tumors outside of the brain." Walser is said to have been working with the methods and technology since June after picking up the needed skills in Italy, where Mayo said "its use is more common." Mayo added that Walser adapted the technique in some unspecified fashion and is using it to treat patients with liver cancer while they wait for a transplant organ to become available. This approach is not seen as a cure for many of these patients at present, but lives are extended and a few patients do find themselves with a viable transplant thanks to the extension of their lives. "We treated the tumors to keep them at bay because we could not use chemotherapy in these patients, who are quite ill and are waiting for a new liver," Walser said. The MRI unit tracks the temperature inside the tumors as they are heated by a non-metallic needle that is inserted into the tumor, which has been heated with laser energy. Small tumors might need only one needle whereas the larger tumors may require the insertion of several, but the patient in any event is anesthetized due to problems that would arise from patient movement. Walser said in the Mayo statement that laser ablation is far more precise than cryotherapy or radio frequency ablation, and post-treatment side effects include some local pain and a few symptoms resembling a flu that are triggered by the body's reaction to the destroyed tissue. These side effects, Mayo said, typically subside in three days to a week.

UNM Cancer Center, Sandia, partner up for $4 million in cancer research work . . . If research in the U.S. does not result in a few serious cures – or at least therapies – for various forms of cancer, it won't be because the American taxpayer hasn't ponied up. According to an Oct. 10 statement by the U.S. government's Sandia National Labs, the National Cancer Institute at the National Institutes of Health has awarded Sandia and the University of New Mexico Cancer Center (Albuquerque, New Mexico) roughly $4 million to take on a couple of major projects toward cures for cancer. The $4 million is split between two grants, one of which is for the sum of $1.95 million grant that will fund the creation of a joint Cancer Nanotechnology Platform Partnership, with the balance of $1.8 million set aside for a new Cancer Nanotechnology Training Center that the statement says will be used to "train a new generation of multidisciplinary scientists." The state of New Mexico is also chipping in, the statement notes, providing an additional $2 million to build a lab that will be set up to investigate and develop nanoscale biomaterials and related nanomedical inventions. Sandia's statement indicates that the awards make up a second phase of NCI's Alliance for Nanotechnology in Cancer Program, which calls for an investment of more than $30 million per year for each of the next five years to establish centers of excellence in nanotechnology and cancer. The statement also says that since its inception in 2004, the alliance's support of research "has led to the discovery of many novel technologies, some of which are currently undergoing commercialization and clinical trials."

CMS to hear arguments for Provenge . . . Coverage of cancer treatments almost always carries a hefty price tag, and the Centers for Medicare & Medicaid Services is going over such matters this week in a hearing of the Medicare Coverage and Evidence Development Advisory Committee at the agency's headquarters in Baltimore. The topic of discussion will be whether administration of Provenge (sipuleucel), made by Dendreon (Seattle) meets the agency's standard of "reasonable and necessary" for the treatment of prostate cancer. The drug earned an FDA biologics license application earlier this year and the drug's supporters will point out that Provenge provided patients with refractory, metastatic prostate cancer with about four additional months of life over placebo, according to an April 26 FDA document. On the other hand, such matters tend to be calculated by the metric of the dollar cost per quality-adjusted life year, and Provenge is widely described as costing about $93,000 for a full three courses of treatment. The patient population, however, is a desperate one and desperate conditions tend to drive outcomes at both CMS and FDA.

– Compiled by Mark McCarty, MDD Washington Editor

mark.mccarty@ahcmedia.com

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