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    <recommendedItem id="20100101_19_452"
                     title="Study Backs Late Cardiotoxicity of Childhood Cancer Treatment (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/HematologyOncology/OtherCancers/tb/18384?impressionId=1265776365236"
                     
      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="0.01"
                     href="http://www.medpagetoday.com/PublicHealthPolicy/Medicare/tb/18269?impressionId=1265776365236"
                     
      &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>
    <recommendedItem id="20100101_19_299"
                     title="Teen Pregnancies, Births, and Abortions Increase"
                     score="0.003"
                     href="http://www.medpagetoday.com/OBGYN/Pregnancy/tb/18162?impressionId=1265776365236"
                     
      &lt;p&gt;After a decade of decline, the rate of teenage pregnancies increased by 3% in 2006 as 750,000 women younger than 20 became pregnant, according to a report released by the Guttmacher Institute.&lt;/p&gt;
&lt;p&gt;And as pregnancies increased, so did births  --  41.9 births per 1,000 U.S. teenage girls, which was 4% higher than in 2005  --  and abortions, which increased by 1% from 2005 to 2006.&lt;/p&gt;
&lt;p&gt;In a prepared statement, Planned Parenthood blamed abstinence-only sex education programs for the uptick.&lt;/p&gt;
&lt;p&gt;&quot;It is a tragedy that after a decade of progress in reducing the rate of teenage pregnancy we are witnessing a substantial increase in the number of teens who are getting pregnant,&quot; Planned Parenthood said.&lt;/p&gt;
&lt;p&gt;In a statement released last May in conjunction with the &quot;National Day to Prevent Teen Pregnancy&quot; the American College of Obstetricians and Gynecologists (ACOG), agreed that comprehensive sex education was likely to be more effective than abstinence-only programs.&lt;/p&gt;
&lt;p&gt;&quot;Abstinence works for some teens, but the idea that most teens will wait to have sex indefinitely is rigid and impractical,&quot; said Richard S. Guido, MD, chair of the ACOG&apos;s Committee on Adolescent Health Care.&lt;/p&gt;
&lt;p&gt;But the Guttmacher report suggested that the reasons for increase may be more complex, including &quot;shifts in the racial and ethnic composition of the population, increases in poverty, the growth of abstinence-only sex education programs at the expense of comprehensive programs, and changes in public perception and attitudes toward both teenage and unintended pregnancy.&quot;&lt;/p&gt;
&lt;p&gt;Among black teenagers the pregnancy rate was 126.3 per 1,000 versus 44 per 1,000 non-Hispanic white teenagers.&lt;/p&gt;
&lt;p&gt;A breakdown by state revealed that New Mexico had the highest teenage pregnancy rate, followed by Nevada, Arizona, Texas, and Mississippi.&lt;/p&gt;
&lt;p&gt;Conversely, the lowest teenage pregnancy rate was in New Hampshire  --  33 pregnancies per 1,000  --  followed by Vermont, Maine, Minnesota, and North Dakota.&lt;/p&gt;
&lt;p&gt;Texas had the highest rate of births to teenage mothers  --  62 per 1,000  --  and New York had the highest rate of abortions among teenagers, 41 per 1,000.&lt;/p&gt;
&lt;p&gt;The report was based on data from the National Center for Health Statistics of the U.S. Department of Health and Human Services (number of births), the Guttmacher Institute (total number of abortions), the U.S. Centers for Disease Control and Prevention (age and race/ethnicity distribution of women obtaining abortions), and the Population Estimates Program of the U.S. Bureau of the Census in collaboration with NCHS (population estimates).&lt;/p&gt;
&lt;p&gt;Among other findings in the report: &lt;ul&gt; &lt;li&gt;The pregnancy rate was 71.5 pregnancies per 1,000 girls ages 15-19 and pregnancies occurred among 7% of females in this age group.&lt;/li&gt; &lt;li&gt;Although teenage abortions increased by 1% from 2005 to 2006, the overall teenage abortion rate declined by about a third over the two decades from 1986 to 2006.&lt;/li&gt; &lt;li&gt;The increase in teen pregnancies and births to teenage mothers was observed across all racial and ethnic groups.&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The authors said that additional research was needed to determine if the disparities in rates by both race and region carry over to adult women.&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 report was prepared by Kathryn Kost, Stanley Henshaw, and Liz Carlin of the Guttmacher Institute.&lt;/p&gt;&lt;p&gt;Lawrence Finer, Rebecca Wind, Susheela Singh, and Laura Lindberg provided comments on early drafts.&lt;/p&gt;&lt;p&gt;The report was funded by grants from the Brush Foundation, The California Wellness Foundation (TCWF) and the Annie E. Casey Foundation. The Guttmacher Institute also gratefully acknowledges the general support it receives from individuals and foundations, including major grants from The William and Flora Hewlett Foundation, The David and Lucile Packard Foundation, and the Ford Foundation, which undergirds all of the Institute&apos;s work.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_214"
                     title="Analysis Affirms Cervical Cancer Standard (CME/CE)"
                     score="-0.003"
                     href="http://www.medpagetoday.com/Oncology/OtherCancers/tb/18060?impressionId=1265776365236"
                     
      &lt;p&gt;Chemoradiotherapy for unresected cervical cancer significantly improves survival, regardless of the type of chemotherapy used, a systematic review of individual patient data suggests.&lt;/p&gt;
&lt;p&gt;As compared with radiotherapy alone, chemotherapy given with the radiation improved five-year survival by almost 20%, and patients benefited whether they received platinum- or nonplatinum-based chemotherapy, British investigators reported in the first 2010 issue of the &lt;em&gt;Cochrane Database of Systematic Reviews.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;A course of chemotherapy after completion of chemoradiotherapy resulted in a trend toward further improvement in survival, a finding that requires validation, Claire L. Vale, PhD, of the Medical Research Council Clinical Trials Unit in London, and colleagues reported.&lt;/p&gt;
&lt;p&gt;&quot;This meta-analysis provides an unconfounded estimate of the effect of chemoradiotherapy compared with radiotherapy,&quot; the authors wrote. &quot;Adding chemotherapy to radiotherapy offers a modest, but significant additional benefit on all outcomes and for all stages of disease. There is also the potential to use both platinum and nonplatinum regimens.&quot;&lt;/p&gt;
&lt;p&gt;Since 1999, chemoradiotherapy has been standard of care for women with cervical cancer. The standard was widely adopted after favorable reports from five clinical trials, followed by a &lt;a href=&quot;http://www.nih.gov/news/pr/feb99/nci-22.htm&quot; mce_href=&quot;http://www.nih.gov/news/pr/feb99/nci-22.htm&quot; target=&quot;_blank&quot;&gt;clinical alert from the National Cancer Institute&lt;/a&gt;, recommending that &quot;concomitant chemotherapy should be considered instead of radiotherapy alone in women with cervical cancer.&quot;&lt;/p&gt;
&lt;p&gt;However, interpretation of the benefits was complicated by differences in control-arm therapies, heterogeneity in trial results, and inconsistency in outcome definitions.&lt;/p&gt;
&lt;p&gt;&quot;[We] concluded that an individual patient data meta-analysis would be required to obtain time-to-event analyses of local and distant recurrence, more reliable estimates of effect in patient subgroups, and a better attribution of relative toxicities,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;Use of individual patient data allowed more precise evaluation of differences in treatment effects by trial or patient characteristics, they continued. Moreover, they sought updated follow-up for each patient in each trial, which permitted assessment of outcomes over the long term.&lt;/p&gt;
&lt;p&gt;The review was limited to randomized comparisons of concomitant chemoradiotherapy versus radiotherapy alone for patients with locally advanced, previously untreated cervical cancer. The investigators reviewed published and unpublished studies. The primary outcome was overall survival from the time of randomization.&lt;/p&gt;
&lt;p&gt;The primary analysis comprised 15 clinical trials, 3,452 patients, and 1,138 deaths. Eleven trials used platinum-based chemotherapy, three used nonplatinum regimens (5FU, mitomycin, or the combination), and one trial randomized patients to chemoradiotherapy with either 5FU or cisplatin.&lt;/p&gt;
&lt;p&gt;In 13 trials that compared chemoradiotherapy with the same radiotherapy regimen, the addition of chemotherapy led to an absolute improvement in five-year survival of 6% (66% versus 60%), which translated into a 19% reduction in the hazard ratio (HR 0.81, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001).&lt;/p&gt;
&lt;p&gt;The two remaining trials compared chemoradiotherapy followed by more chemotherapy versus radiotherapy alone. Those two trials demonstrated a 54% reduction in the mortality hazard (HR 0.46, 95% CI 0.32 to 0.66, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001) and an absolute survival benefit of 19% at five years (79% versus 60%).&lt;/p&gt;
&lt;p&gt;Patients treated with platinum-based chemotherapy had a 17% reduction in the mortality hazard (&lt;em&gt;P&lt;/em&gt;=0.017), and nonplatinum chemotherapy resulted in a 23% reduction in the hazard (&lt;em&gt;P&lt;/em&gt;=0.009).&lt;/p&gt;
&lt;p&gt;Chemoradiotherapy also reduced the incidence of local and distant recurrence and progression and improved disease-free survival.&lt;/p&gt;
&lt;p&gt;A trend toward improved survival by tumor stage was observed, but the results were not uniform across patient subgroups.&lt;/p&gt;
&lt;p&gt;The dose of radiotherapy or chemotherapy did not affect the magnitude of the benefit.&lt;/p&gt;
&lt;p&gt;Hematologic and gastrointestinal toxicity occurred more often with chemoradiotherapy, but data were insufficient to permit analysis of long-term toxicity.&lt;/p&gt;
&lt;p&gt;&quot;These results endorse the recommendations of the NCI alert, but also demonstrate their applicability to all women and a benefit of nonplatinum based chemoradiotherapy,&quot; the authors wrote in conclusion.&lt;/p&gt;
&lt;p&gt;&quot;Furthermore,&quot; they wrote, &quot;although these results suggest an additional benefit from adjuvant chemotherapy this requires testing in randomized clinical trials.&quot;&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 authors had no disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_1_67"
                     title="Infant Botulism Drug Safe And Effective"
                     score="-0.005"
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