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    <recommendedItem id="20100101_19_406"
                     title="AAPM: Opioid Gains Long-Term Control of Neuropathic Cancer Pain (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/MeetingCoverage/AAPM/tb/18316?impressionId=1265777882292"
                     
      &lt;p&gt;SAN ANTONIO  --  Patients with neuropathic cancer pain obtained consistent, long-term pain control with extended-release oxymorphone (Opana), according to results of a one-year, open-label extension study.&lt;/p&gt;
&lt;p&gt;Patients reported pain in the mild range throughout most of the follow-up, and only 11% discontinued because of lack of efficacy, Errol Gould, PhD, of Endo Pharmaceuticals in Chadds Ford, Pa., reported here at the American Academy of Pain Medicine meeting. The company manufactures Opana.&lt;/p&gt;
&lt;p&gt;No unexpected adverse events occurred.&lt;/p&gt;
&lt;p&gt;&quot;Current clinical guidelines recommend opioids as second- or third-line treatment for chronic neuropathic pain,&quot; Gould said in an interview. &quot;These results suggest that oxymorphone extended release may be a viable long-term option for patients with neuropathic pain.&quot;&lt;/p&gt;
&lt;p&gt;The findings came from a one-year extension of a multicenter, open-label, noncontrolled short-term study of patients with cancer-related chronic pain.&lt;/p&gt;
&lt;p&gt;Of 44 patients who entered the extension phase, 27 had pain that was primarily neuropathic in origin. The diagnosis of neuropathic pain was based on clinician judgment, with no prespecified diagnostic criteria for guidance.&lt;/p&gt;
&lt;p&gt;Patients began treatment in the extension phase with their ending dose from the short-term study. Dose adjustments to improve pain control or tolerability were allowed throughout the 52-week extension phase.&lt;/p&gt;
&lt;p&gt;Ten of the 27 patients completed the extension study. Principal reasons for withdrawal were adverse events, patient request, loss of effectiveness, and nonadherence.&lt;/p&gt;
&lt;p&gt;The median duration from initiation of long-term maintenance to final visit was 22 weeks. Baseline pain intensity averaged 32.9 on a 100-point scale and 32.6 at final visit. Mean least pain intensity was 13.8 at baseline and 16.2 at final visit, and worst pain intensity averaged 76.3 at baseline and 66.5 at final visit.&lt;/p&gt;
&lt;p&gt;&quot;Regression analysis showed that pain intensity changed very little throughout follow-up,&quot; Gould said.&lt;/p&gt;
&lt;p&gt;The median oxymorphone dose increased from 80 mg at baseline to 160 mg at 52 weeks.&lt;/p&gt;
&lt;p&gt;Eleven (41%) patients reported at least one treatment-related adverse event. The most common events were dry mouth, constipation, and fatigue. The only serious adverse event was an episode of depressed consciousness.&lt;/p&gt;
&lt;p&gt;&quot;Patients required some gradual increases in dosage over time, but that&apos;s consistent with the nature of the disease,&quot; said Gould.&lt;/p&gt;
&lt;p&gt;Not long ago opioids were considered ineffective for neuropathic pain, he added. This study provided additional evidence in support of opioids&apos; effectiveness in controlling neuropathic pain.&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 Endo Pharmaceuticals, which manufactures Opana.&lt;/p&gt;&lt;p&gt;Gould and another co-author are employees of Endo Pharmaceuticals.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_398"
                     title="ASCO GI: Gene Test, Nodes Predict Colon CA Recurrence Risk (CME/CE)"
                     score="0.011"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASCOGI/tb/18301?impressionId=1265777882292"
                     
      &lt;p&gt;ORLANDO  --  An extended nodal examination and gene array test show promise for identifying patients at high risk of colorectal cancer recurrence in stage II disease, researchers reported at the Gastrointestinal Cancers Symposium.&lt;/p&gt;
&lt;p&gt;Across the range of recurrence scores, examination of at least 12 nodes was associated with about a 5% absolute decrease in the three-year risk of recurrence in resected stage II colon cancers, compared with the same recurrence score and examination of fewer nodes.&lt;/p&gt;
&lt;p&gt;Noting limitations of other tests and biomarkers developed to evaluate recurrence risk, the gene expression-derived recurrence score &quot;has a real chance to make its way into the clinical decision algorithm,&quot; said David Kerr, MD, of the University of Oxford in England.&lt;/p&gt;
&lt;p&gt;Both recurrence score and number of nodes examined were independent predictors of recurrence risk, but investigators found no association or interaction between the two parameters of risk assessment.&lt;/p&gt;
&lt;p&gt;&quot;The test gives us more information about individual patients about the likelihood of the cancer returning,&quot; said Kerr, who was an investigator in the study. &quot;I think the quality of the science underpinning it, the size of the sample, and the compelling statistics all combine to make this a potential winner.&quot;&lt;/p&gt;
&lt;p&gt;Another study reported at the meeting showed few tumor-related genetic characteristics to distinguish stage II colon cancer from stage III.&lt;/p&gt;
&lt;p&gt;Both studies involved use a 12-gene assay (Oncotype DX) validated for predicting recurrence risk in stage II colon cancer. Investigators in the QUASAR validation study used data from the trial to evaluate the prognostic value of nodal assessment combined with other parameters, including the 12-gene assay.&lt;/p&gt;
&lt;p&gt;The National Comprehensive Cancer Network (NCCN) clinical guidelines for stage II colon cancer include number of nodes examined as a prognostic factor, Richard Gray, PhD, of the University of Birmingham in England, and colleagues noted in a poster presentation.&lt;/p&gt;
&lt;p&gt;Records for 657 stage II patients randomized to surgery alone showed that the median number of nodes examined was 10, including fewer than six nodes in 19% of patients and &amp;#8805;12 nodes in 37%. Risk of recurrence was more closely associated with examination of fewer than eight nodes versus more (HR 1.77, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001) than with a cutoff point of 12 nodes (HR 1.38, &lt;em&gt;P&lt;/em&gt;=0.065). &lt;/p&gt;
&lt;p&gt;More nodes were examined in later than earlier years, the investigators found.&lt;/p&gt;
&lt;p&gt;In a model that included recurrence score derived from the gene assay and the 12-node threshold recommended by NCCN, both factors proved to be independent predictors of recurrence risk (&lt;em&gt;P&lt;/em&gt;=0.01, &lt;em&gt;P&lt;/em&gt;=0.05). Similar results emerged from models that incorporated mismatch repair (or microsatellite instability) and T stage.&lt;/p&gt;
&lt;p&gt;Across the range of recurrence scores, examination of &amp;#8805;12 nodes was associated with a 3% to 7% lower risk of recurrence compared with examination of fewer nodes (about 5% overall). The investigators concluded that both parameters should be included in assessment of recurrence risk after surgery for stage II colon cancer.&lt;/p&gt;
&lt;p&gt;The second study examined the 12-gene assay&apos;s ability to distinguish stage II from stage III colon cancer. Investigators evaluated the assay, pathologic markers, and expression of 375 different genes in 634 patients with stage II disease and 844 with stage III colon cancer.&lt;/p&gt;
&lt;p&gt;The data showed minimal differences in gene expression between the two stages of colon cancer.&lt;/p&gt;
&lt;p&gt;Five of the 375 genes differed significantly in their expression in stage II versus stage III cancer (&lt;em&gt;P&lt;/em&gt;&amp;lt;0.05). Two tumor characteristics differed by stage, as stage II colon cancer was more likely to be mismatch repair-deficient (&lt;em&gt;P&lt;/em&gt;=0.04) and have mucinous histology (&lt;em&gt;P&lt;/em&gt;=0.007).&lt;/p&gt;
&lt;p&gt;The data also showed significant interaction of grade and stage (&lt;em&gt;P&lt;/em&gt;=0.005), and borderline significance for interactions of stage with T-stage, mismatch repair, and mucinous histology, reflecting prognostic value in stage II but not stage III disease.&lt;/p&gt;
&lt;p&gt;Overall, investigators in this second study found a &quot;striking similarity between stages for the recurrence score and the vast majority of genes analyzed.&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 studies were supported by Genomic Health.&lt;/p&gt;&lt;p&gt;Investigators in the studies included employees of Genomic Health.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_330"
                     title="Immune Cells Point to Skin Cancer Risk after Transplants (CME/CE)"
                     score="0.006"
                     href="http://www.medpagetoday.com/Nephrology/KidneyTransplantation/tb/18200?impressionId=1265777882292"
                     
      Monitoring two types of immune cells in kidney transplant recipients might identify patients with an increased risk of skin cancer, British investigators reported.&lt;br&gt;
&lt;br&gt;Increased levels of T-regulatory cells (Tregs) more than doubled the risk of squamous cell cancer of the skin. Decreased levels of natural killer (NK) cells were associated with more than a five-fold increased risk of skin cancer.&lt;br&gt;
&lt;br&gt;Both immune parameters had substantially greater predictive power than a history of squamous-cell skin cancer, according to an online report in the &lt;em&gt;Journal of the American Society of Nephrology&lt;/em&gt; by a team of Oxford University investigators.&lt;/p&gt;
&lt;p&gt;&quot;Squamous cell cancer of the skin affects about 30% of kidney transplant patients after 10 years of immunosuppression,&quot; Robert Carroll, MD, currently of Queen Elizabeth Hospital in Woodville, Australia, observed in a statement.&lt;/p&gt;
&lt;p&gt;&quot;A small number of patients develop multiple skin cancers per year, but there is no laboratory test to determine which transplant recipients will develop multiple skin cancers in the future.&quot;&lt;/p&gt;
&lt;p&gt;&quot;If a test can confirm high risk of skin cancer development, this may help clinicians to tailor immunosuppressive regimens for individual patients,&quot; he added.&lt;/p&gt;
&lt;p&gt;Long-term immunosuppression, such as that required for transplant recipients, confers an increased risk of squamous-cell skin cancer.&lt;/p&gt;
&lt;p&gt;Estimates of the magnitude have ranged as high as 200 times greater than the general population, the authors wrote. Additionally, 3% of organ transplant recipients require extensive plastic surgery each year as a result of skin cancer lesions.&lt;/p&gt;
&lt;p&gt;Age at transplantation and the immunosuppression dosage are the principal determinants of skin-cancer risk, and the dosage of immunosuppression also influences the risk of metastasis from squamous-cell cancer of the skin.&lt;/p&gt;
&lt;p&gt;In the general population, cancer has been associated with increased levels of Tregs, including CDR&lt;sup&gt;+&lt;/sup&gt;CD25&lt;sup&gt;high&lt;/sup&gt;FOXP3&lt;sup&gt;+&lt;/sup&gt; and CD8&lt;sup&gt;+&lt;/sup&gt;CD28&lt;sup&gt;-&lt;/sup&gt; cells. The same types of cells could play a role in the risk of skin cancer among organ transplant recipients, the authors wrote.&lt;/p&gt;
&lt;p&gt;Within the tumor microenvironment, Tregs may impair the antitumor activity of CD8&lt;sup&gt;+&lt;/sup&gt; and NK cell. However, in organ transplant recipients, Tregs help control or prevent rejections and may help improve long-term outcomes.&lt;/p&gt;
&lt;p&gt;Different immunosuppressive drugs affect Tregs differently, the authors continued. Sirolimus (Rapamune), for example, increases the number of FOXP3&lt;sup&gt;+&lt;/sup&gt; cells, whereas cyclosporine decreases Treg numbers.&lt;/p&gt;
&lt;p&gt;&quot;Tregs have not been assessed in relation to cancer after transplantation,&quot; the authors wrote. &quot;We therefore investigated the hypothesis that squamous-cell cancer in kidney transplant recipients would be associated with an increased number of Tregs.&quot;&lt;/p&gt;
&lt;p&gt;To examine the hypothesis, investigators phenotyped peripheral blood from 65 kidney transplant recipients with squamous skin cancer and 51 recipients without skin cancer, matched for age, sex, and duration of immunosuppression.&lt;/p&gt;
&lt;p&gt;They also quantified lymphocyte populations in skin cancer lesions from a subset of 25 patients and matched them with 25 other nontransplant patients with squamous cell cancer of the skin.&lt;/p&gt;
&lt;p&gt;The kidney transplant recipients had a median follow-up of 340 days. The investigators found that a concentration of &amp;gt;35 peripheral FOXP3&lt;sup&gt;+&lt;/sup&gt;CD4&lt;sup&gt;+&lt;/sup&gt;CD127&lt;sup&gt;low&lt;/sup&gt; regulatory T cells/&amp;#181;L was associated with a hazard ratio for squamous cell skin cancer of 2.48 (95% CI 1.04 to 5.98).&lt;/p&gt;
&lt;p&gt;An NK cell count &amp;lt;100 cells/&amp;#181;L was associated with a skin cancer hazard ratio of 5.6 (95% CI 1.31 to 24). A history of squamous cell cancer of the skin increased the risk of skin cancer recurrence by a third (HR 1.33, 95% CI 1.15 to 1.53).&lt;/p&gt;
&lt;p&gt;&quot;If similar immune phenotypes are predictive in other kidney transplant recipient populations, then immune phenotype method has the potential to inform immunosuppressive regimen manipulation in kidney transplant recipients at high risk for developing multiple squamous cell cancers,&quot; the authors concluded.&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 relevant disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_298"
                     title="FDA Updates Myeloma Drug Label for New Risks"
                     score="0.004"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18158?impressionId=1265777882292"
                     
      &lt;p&gt;WASHINGTON  --  The FDA has revised dosage and safety information for bortezomib (Velcade), the myeloma and mantle cell lymphoma drug, to reflect an increased toxicity risk.&lt;/p&gt;
&lt;p&gt;The new labeling includes a warning for patients with moderate-to-severe hepatic impairment and now recommends at-risk patients start at a lower dosage of 0.7 mg for the first cycle of treatment and escalate to 1.0 mg, or reduce further to 0.5 mg, in subsequent cycles.&lt;/p&gt;
&lt;p&gt;The label has also been updated to include clinical study data showing a higher median survival rate in patients using a combination of bortezomib, melphalan, and prednisone versus a regiment of just melphalan and prednisone (&lt;em&gt;P&lt;/em&gt;=0.00084).&lt;/p&gt;
&lt;p&gt;The drug is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. The FDA also warns that women should avoid becoming pregnant while undergoing treatment with bortezomib.&lt;/p&gt;
&lt;p&gt;The drug is manufactured by Millennium: The Takeda Oncology Company of Cambridge, Mass.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20090101_2_635"
                     title="Hemoglobin Variability Predicts Mortality in Dialysis Patients"
                     score="-0.007"
                     href="