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    <recommendedItem id="20100101_19_452"
                     title="Study Backs Late Cardiotoxicity of Childhood Cancer Treatment (CME/CE)"
                     score="0.014"
                     href="http://www.medpagetoday.com/HematologyOncology/OtherCancers/tb/18384?impressionId=1265817558490"
                     
      A childhood cancer survivor&apos;s risk of dying from cardiovascular causes rises with the dose of radiation his heart received during treatment, researchers in France and the U.K. affirmed.&lt;br&gt;
&lt;br&gt;Those whose hearts were exposed had a 60% higher risk of cardiovascular death than the general population, even at a dose of 1 Gy (95% CI 20% to 250%), according to Florent de Vathaire, PhD, of L&apos;Institut National de la Sant&amp;#233; et de la Recherche M&amp;#233;dicale in Paris, and colleagues.&lt;br&gt;
&lt;br&gt;The risk jumped to 12.5-fold for a cumulative radiation dose to the heart of 5 to 14.9 Gy, and to 14.9-fold for a dose of more than 15 Gy (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.01 for trend), the researchers reported online in the &lt;em&gt;Journal of Clinical Oncology&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;The notion that exposing the heart to radiation increases the risk of cardiovascular disease and death is not surprising, according to an accompanying editorial.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;However, this study examined cardiovascular mortality effects of both the dose of radiation and the dose of anthracyclines given to childhood cancer victims in the same cohort.&lt;/p&gt;
&lt;p&gt;That&apos;s something previous studies haven&apos;t done, according to editorialists Steven E. Lipshultz, MD, of the University of Miami and Holtz Children&apos;s Hospital in Miami, and M. Jacob Adams, MD, MPH, of the University of Rochester, N.Y.&lt;/p&gt;
&lt;p&gt;&quot;These are pretty profound findings,&quot; Lipshultz told &lt;em&gt;MedPage Today&lt;/em&gt;. &quot;These are the exact concerns we&apos;ve had based on careful subclinical assessments of how the heart in these survivors has been working.&quot;&lt;/p&gt;
&lt;p&gt;His group was one of the first to report that survivors of childhood cancer faced not only acute cardiotoxicity from treatment, but also late cardiac effects.&lt;/p&gt;
&lt;p&gt;As more effective treatment for childhood cancers came into play, the dramatic jump in survival rates  --  from less than 50% in the mid-1970s to 80% today  --  yielded a large enough population of survivors to make chronic issues from treatment apparent, Lipshultz noted.&lt;/p&gt;
&lt;p&gt;&quot;It appears that for some of these survivors we have substituted one fatal disease of childhood  --  cancer  --  for another fatal disease of early adult life,&quot; he said.&lt;/p&gt;
&lt;p&gt;de Vathaire&apos;s group studied a cohort of 4,122 French and British children diagnosed with childhood solid cancer between 1942 and 1986 and who survived at least five years.&lt;/p&gt;
&lt;p&gt;Over an average of 27 years of follow-up, they were at 8.3-fold higher risk of dying from any cause compared with the general populations in France and the U.K. (95% CI 7.6 to 9.0).&lt;/p&gt;
&lt;p&gt;The majority of these excess deaths occurred early after diagnosis, five to nine years afterward in this analysis  --  in which all patients survived to five years.&lt;/p&gt;
&lt;p&gt;Based on just 32 deaths from cardiovascular diseases in the cohort, the childhood cancer survivors experienced five times the cardiovascular mortality (95% CI 3.3 to 6.7) expected from the general population (1.7% cumulative at 35 years versus 0.3%).&lt;/p&gt;
&lt;p&gt;This elevation in risk was similar to that seen in large studies from the U.S. and Nordic countries, suggesting generalizability of the results, Lipshultz said.&lt;/p&gt;
&lt;p&gt;Radiation therapy also conferred a 5.0-fold elevation in risk of cardiovascular disease-related death (95% CI 1.2 to 21.4).&lt;/p&gt;
&lt;p&gt;Like radiation, a higher cumulative dose of anthracycline chemotherapy also increased risk of dying from cardiac diseases, compared with the general population (RR 4.4 for a dose over 360 mg/m&lt;sup&gt;2&lt;/sup&gt;, 95% CI 1.3 to 15.3).&lt;/p&gt;
&lt;p&gt;However, radiotherapy and chemotherapy did not appear to interact for cardiovascular mortality (&lt;em&gt;P&lt;/em&gt;=0.4).&lt;/p&gt;
&lt;p&gt;Notably, the vinca alkaloids were also significantly linked to cardiovascular disease-related death risk among childhood cancer survivors, even after adjustment for sex, treatment period, age at diagnosis, follow-up, and all other treatment modalities (RR 3.6, 95% CI 1.0 to 12.9).&lt;/p&gt;
&lt;p&gt;Currently, guidelines support regular long-term cardiovascular screening for childhood cancer survivors who received anthracycline-based chemotherapy but provide little to no direction for those treated with nonanthracycline chemotherapy or radiation, Lipshultz noted.&lt;/p&gt;
&lt;p&gt;These results suggested all three groups should be getting cardiac follow-up, he told &lt;em&gt;MedPage Today&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;However, because other research has suggested that these individual treatments affect the heart in different ways, such as diastolic rather than systolic dysfunction with radiotherapy, screening modalities may need to account for this as well, he said.&lt;/p&gt;
&lt;p&gt;The researchers cautioned that cardiovascular disease was probably under-reported as a cause of death in the cohort.&lt;/p&gt;
&lt;p&gt;&quot;Indeed, 15 of the deaths classified as results of cancer as the principal cause had cardiovascular diseases as the immediate cause,&quot; they wrote.&lt;/p&gt;
&lt;div style=&quot;float:left;border-style:solid;border-width:1px;border-color:#8dabbc;font-family:arial;font-size:12px;background-color:#DBE9F2;padding:5px;&quot;&gt;&lt;p&gt;The study was supported by the Ligue Nationale Contre le Cancer; the Programme Hospitalier de Recherche Clinique; the Agence Fran&amp;#231;aise de S&amp;#233;curit&amp;#233; Sanitaire et Produit de Sant&amp;#233;; Electricit&amp;#233; de France; the Wyeth Foundation for childhood and adolescent health; and a grant from the Foundation of France.&lt;/p&gt;&lt;p&gt;The researchers reported no conflicts of interest.&lt;/p&gt;&lt;p&gt;The editorialists reported no conflicts of interest.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_377"
                     title="Advisory Panel Rates Genomic Cancer Tests"
                     score="0.012"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/Medicare/tb/18269?impressionId=1265817558490"
                     
      &lt;p&gt;Some genomic tests aimed at identifying patients most likely to respond to cancer drugs won a thumbs-up from a Medicare advisory panel, but others didn&apos;t make the grade.&lt;/p&gt;
&lt;p&gt;As part of a national coverage determination under way at the Centers for Medicare and Medicaid Services, members of the Medicare Evidence Development &amp;amp; Coverage Advisory Committee (MEDCAC) last week rated the clinical value of several pharmacogenomic cancer tests now available.&lt;/p&gt;
&lt;p&gt;The tests would be used to select patients for treatment with drugs including tamoxifen, irinotecan (Camptosar), trastuzumab (Herceptin), and imatinib (Gleevec).&lt;/p&gt;
&lt;p&gt;CMS has not previously decided whether such tests should be reimbursed by Medicare, although testing is already routine for some of these treatments.&lt;/p&gt;
&lt;p&gt;The FDA-approved labeling for trastuzumab requires such testing. Imatinib&apos;s approvals include chronic myeloid leukemia featuring the BCR-ABL &quot;Philadelphia chromosome&quot; mutation, although the label doesn&apos;t explicitly mention testing.&lt;/p&gt;
&lt;p&gt;&quot;CMS is aware that the body of evidence on the role of pharmacogenomic testing in cancer continues to evolve,&quot; according to the agency&apos;s notice of the meeting.&lt;/p&gt;
&lt;p&gt;&quot;Recognizing the rapid accumulation of such evidence, CMS seeks guidance from the panel to inform future coverage determinations. We want to ensure that Medicare beneficiaries have access to any demonstrated improved health outcomes of pharmacogenomic testing, and are protected from inaccurate or inappropriate pharmacogenomic testing that could compromise therapy or increase the risks of adverse events during therapy.&quot;&lt;/p&gt;
&lt;p&gt;MEDCAC panelists were asked to rate their confidence in the clinical utility of five tests and in the scientific evidence available for review.&lt;/p&gt;
&lt;p&gt;The five tests cover: &lt;ul&gt; &lt;li&gt;Polymorphisms in the CYP2D6 drug-metabolizing enzyme for breast cancer patients who are candidates for tamoxifen&lt;/li&gt; &lt;li&gt;Polymorphisms in the UGT1A1 gene for colon cancer patients considered for irinotecan treatment&lt;/li&gt; &lt;li&gt;Presence of HER/neu epidermal growth factor receptor expression in patients with breast cancer, indicating suitability for trastuzumab&lt;/li&gt; &lt;li&gt;Presence of the BCR-ABL mutation in patients with chronic myeloid leukemia who would be candidates for imatinib&lt;/li&gt; &lt;li&gt;Mutations in the K-ras gene for metastatic colorectal cancer patients eligible for cetuximab (Erbitux) or panitumumab (Vectibix)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The 15 panel members assigned values of one to five, reflecting low to high confidence, to each test. A score of two reflected medium-low confidence, while a four meant medium-high confidence.&lt;/p&gt;
&lt;p&gt;Most of the panelists agreed that the evidence underlying the tests for CYP2D6 and UGT1A1 polymorphisms was still too scant for an assessment of their clinical value. Mean scores for these tests were 2.07 and 1.83, respectively, with nearly all votes either a one or two.&lt;/p&gt;
&lt;p&gt;But MEDCAC members were more confident that the usefulness of the other three tests for diagnostic and monitoring purposes could be evaluated. Mean scores for those tests were all well above four.&lt;/p&gt;
&lt;p&gt;For the HER/neu, BCR-ABL, and K-ras tests, since members believed the evidence was adequate for assessment, MEDCAC also voted on whether their use actually would improve health outcomes in cancer patients.&lt;/p&gt;
&lt;p&gt;A third ranking provided the committee&apos;s views on whether the conclusions could be generalized to the Medicare population and patients in the community.&lt;/p&gt;
&lt;p&gt;Mean scores for those rankings were all also above four, indicating the panel&apos;s support for these tests as clinically beneficial.&lt;/p&gt;
&lt;p&gt;On the other hand, when asked whether there was enough evidence to assess the utility of the BCR-ABL test in detecting treatment failure, panelists didn&apos;t think so. Most of those votes were twos, and the mean was 2.47.&lt;/p&gt;
&lt;p&gt;CMS has not given a time line for deciding whether to approve Medicare coverage for the tests.&lt;/p&gt;

    </recommendedItem>
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                     title="ASCO: Cetuximab Adds to First-Line Chemotherapy Benefit for Metastatic Colorectal Cancer"
                     score="-0.005"
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