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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=1265755428930"
                     
      &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_298"
                     title="FDA Updates Myeloma Drug Label for New Risks"
                     score="0.004"
                     href="http://www.medpagetoday.com/ProductAlert/DevicesandVaccines/tb/18158?impressionId=1265755428930"
                     
      &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_19_4028"
                     title="ASH: IV Iron Fails Test in Cancer-Related Anemia (CME/CE)"
                     score="-0.005"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASHHematology/tb/17441?impressionId=1265755428930"
                     
      &lt;p&gt;NEW ORLEANS  --  In a finding that ran counter to prior research, intravenous iron supplementation failed to boost the benefits of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia, according to data from the largest study of its kind.&lt;/p&gt;
&lt;p&gt;Compared with oral supplementation and placebo, IV iron had no differential impact on hemoglobin levels, blood transfusions, ESA usage, or patient quality of life, researchers reported here. Patients who received IV iron also had more grade 3 adverse events.&lt;/p&gt;
&lt;p&gt;&quot;At least in our hands, parenteral ferrous gluconate didn&apos;t provide any additional benefits beyond the ESA,&quot; David Steensma, MD, of the Mayo Clinic in Rochester, Minn., said at the American Society of Hematology meeting.&lt;/p&gt;
&lt;p&gt;&quot;We didn&apos;t see any of the previously described benefits of IV iron compared to oral iron, and there were some increases in adverse events, although these were fairly small.&quot;&lt;/p&gt;
&lt;p&gt;The findings buck what had been a model of consistency in studies of the IV iron supplementation.&lt;/p&gt;
&lt;p&gt;&quot;I think that we can say, yes, there are seven positive studies, but now there is one negative study, and one needs to think about these things when discussing intravenous iron supplementation in patients who are getting ESA therapy,&quot; Steensma added.&lt;/p&gt;
&lt;p&gt;About 75% of cancer patients treated with cytotoxic chemotherapy become anemic at some point in the process. ESAs are indicated for treatment of chemotherapy-associated anemia and can spare some patients from blood transfusions by keeping hemoglobin at acceptable levels.&lt;/p&gt;
&lt;p&gt;However, 30% to 60% of patients do not respond to ESA treatment. This has been attributed to a functional iron deficiency that arises from tumor induction of inflammatory cytokines and hepcidin, and inactivation of ferroportin.&lt;/p&gt;
&lt;p&gt;&quot;No matter how much erythropoietin one is clogging the bone marrow with, there is just not iron available, despite total body excess of iron,&quot; said Steensma.&lt;/p&gt;
&lt;p&gt;At least five published studies and two more reported as abstracts have suggested that parenteral iron supplementation can overcome functional iron deficiency, leading to improved hemoglobin levels, reduced transfusion need, improved quality of life, and reduced ESA usage to treat chemotherapy-induced anemia.&lt;/p&gt;
&lt;p&gt;Building on the previous favorable findings, investigators conducted a randomized clinical trial involving patients treated with cytotoxic chemotherapy for nonmyeloid malignancies.&lt;/p&gt;
&lt;p&gt;Eligible patients had a hemoglobin level &amp;lt;11 g/dL at enrollment, ferritin level &amp;gt;20 &amp;#181;g/L, transferrin saturation &amp;lt;60%, and Zubrod performance score &amp;#8804;2.&lt;/p&gt;
&lt;p&gt;The trial protocol excluded patients with nutritional anemia, myelodysplastic syndrome, recent surgery or transfusion, treatment with an ESA within three months before enrollment, thrombosis within the previous year, or genetic hemochromatosis.&lt;/p&gt;
&lt;p&gt;All patients received the ESA darbepoetin alfa (Aranesp) at a dose of 500 &amp;#181;g every three weeks until their hemoglobin level exceeded 11 g/d, followed by maintenance therapy of 300 &amp;#181;g/L.&lt;/p&gt;
&lt;p&gt;Investigators randomized 500 patients to one of the following: IV ferric gluconate at a dose of 187.5 mg every three weeks, oral ferrous sulfate at a dose of 325 mg/d, or oral placebo.&lt;/p&gt;
&lt;p&gt;Treatment continued for 16 weeks. CBC was monitored weekly and iron parameters at baseline and weeks seven and 16.&lt;/p&gt;
&lt;p&gt;Hemoglobin levels were similar in the three groups at baseline and increased to a similar extent in all three groups over the 16 weeks of the study.&lt;/p&gt;
&lt;p&gt;Serum ferritin level averaged about 500 &amp;#181;g/L at baseline and increased to a mean of 726 &amp;#181;g at 16 weeks in the IV iron group, compared with 426 &amp;#181;g with oral iron and 372 &amp;#181;g with placebo.&lt;/p&gt;
&lt;p&gt;All principal outcomes were similar in the three treatment groups.&lt;/p&gt;
&lt;p&gt;Between 65% and 70% of patients had a hemoglobin response, defined as &amp;gt;2.0 g/dL increase in serum hemoglobin or an increase to a level &amp;gt;12 g/dL.&lt;/p&gt;
&lt;p&gt;The mean serum hemoglobin level increased by 2.3 to 2.7 g/dL in the three groups.&lt;/p&gt;
&lt;p&gt;Between 13% and 14% of patients required blood transfusions. The median total darbepoetin dose was 1512.5 to 1625 &amp;#181;g in all three groups, and quality-of-life scores improved by 14% to 21%.&lt;/p&gt;
&lt;p&gt;Adverse events were generally mild and transient. However, the proportion of patients with grade 3 events was slightly (but significantly) greater in patients who received IV iron (55% versus 45% with oral iron and 47% in the placebo group, &lt;em&gt;P&lt;/em&gt;=0.03).&lt;/p&gt;
&lt;p&gt;&quot;I am at a bit of a loss to explain these results,&quot; said Steensma. &quot;This is the largest study to date and had characteristics similar to many of the previously reported studies. Perhaps the way that ferric gluconate was administered was somehow inadequate, although it&apos;s very similar to a European study that was published last year.&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 study was funded in part by Amgen.&lt;/p&gt;&lt;p&gt;Steensma and co-investigators had no relevant disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_1_167"
                     title="Off-Label Use of Hemophilia Drug May Be Risky"
                     score="-0.007"
                     href="