<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_3243"
                     title="Similar Survival with Two Ovarian Cancer Strategies (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/HematologyOncology/OvarianCancer/tb/22002?impressionId=1283457949604"
                     
      Patients with bulky, advanced ovarian cancer survived just as long whether treated with neoadjuvant chemotherapy and surgery or with primary surgery followed by adjuvant chemotherapy, investigators in a multinational trial reported.&lt;br&gt;
&lt;br&gt;Both treatment strategies led to a median overall survival of about 30 months and median progression-free survival of 12 months, according to an article in the Sept. 2 issue of the &lt;em&gt;New England Journal of Medicine&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;Intention-to-treat analysis resulted in a hazard ratio for death of 0.98 for neoadjuvant chemotherapy versus primary surgery&lt;em&gt;&lt;/em&gt;.&lt;br&gt;
&lt;br&gt;&quot;Neoadjuvant chemotherapy followed by interval debulking surgery was not inferior to primary debulking surgery followed by chemotherapy as a treatment option for patients with bulky stage IIIC or IV ovarian carcinoma in this study,&quot; Ignace Vergote, MD, of University Hospitals in Leuven, Belgium, and co-authors wrote in conclusion.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&quot;Complete resection of all macroscopic disease, whether performed as primary treatment or after neoadjuvant chemotherapy, remains the objective whenever cytoreductive surgery is performed.&quot;&lt;/p&gt;
&lt;p&gt;The results warrant a cautious interpretation, according to a gynecologic oncologist familiar with the study. Robert Coleman, MD, of MD Anderson Cancer Center in Houston, noted that the study involved patients with specific tumor characteristics that might not be generalizable to other patient populations.&lt;/p&gt;
&lt;p&gt;Moreover, the 30-month median survival is well below what most patients with advanced ovarian cancer might expect with surgery and chemotherapy, Coleman added.&lt;/p&gt;
&lt;p&gt;Primary debulking surgery followed by chemotherapy has formed the basis of treatment for extensive advanced ovarian cancer. Investigators in several prospective studies have evaluated outcomes with neoadjuvant chemotherapy before cytoreductive surgery as an alternative to primary surgery. One meta-analysis of such trials showed worse outcomes with neoadjuvant chemotherapy compared with primary surgery (&lt;em&gt;Gynecol Oncol&lt;/em&gt; 2006; 103: 1070-1076).&lt;/p&gt;
&lt;p&gt;Considering the issue of optimal therapy unresolved, Vergote and colleagues at 59 centers conducted a randomized trial comparing primary surgery followed by platinum-based chemotherapy versus neoadjuvant platinum-based therapy followed by cytoreductive surgery and additional chemotherapy.&lt;/p&gt;
&lt;p&gt;Eligible patients had stage IIIC or IV epithelial ovarian, primary peritoneal, or fallopian-tube carcinoma. Investigators enrolled 718 patients, 670 of whom were randomized and included in the intention-to-treat analysis. The primary endpoint was overall survival, and the trial was statistically powered to evaluate the noninferiority of neoadjuvant chemotherapy versus primary surgery.&lt;/p&gt;
&lt;p&gt;After a median follow-up of 4.7 years, patients treated with neoadjuvant chemotherapy had a median overall survival of 30 months versus 29 months for the primary-surgery cohort. The hazard ratio for the noninferiority of neoadjuvant chemotherapy versus primary surgery proved to be statistically significant (&lt;em&gt;P&lt;/em&gt;=0.01).&lt;/p&gt;
&lt;p&gt;Subgroup analysis failed to identify any patient or tumor characteristics associated with better outcomes with one treatment strategy or the other.&lt;/p&gt;
&lt;p&gt;In both treatment groups, the success of cytoreductive surgery was the strongest predictor of survival.&lt;/p&gt;
&lt;p&gt;In the primary surgery group, median overall survival declined from 45 to 32 to 26 months, respectively, for patients who had no residual tumor, residual tumors 1 to 10 mm, and residual tumors &amp;gt;10 mm. Corresponding survival figures in the neoadjuvant therapy group were 38, 27, and 25 months.&lt;/p&gt;
&lt;p&gt;&quot;Given our findings and the results of other studies, a potential approach for debulking surgery could be the elimination of all macroscopic residual disease, rather than the elimination of lesions larger than 1 cm in diameter,&quot; the authors wrote in the discussion of their findings.&lt;/p&gt;
&lt;p&gt;&quot;A potential drawback of neoadjuvant chemotherapy followed by debulking surgery is that the occurrence of fibrosis after chemotherapy may make complete resection of macroscopic disease more difficult.&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;Vergote and the co-authors reported that they 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_3195"
                     title="ESC: Hot Line Actually Only Lukewarm"
                     score="0.011"
                     href="http://www.medpagetoday.com/MeetingCoverage/ESCCongress/tb/21936?impressionId=1283457949604"
                     
      &lt;p&gt;STOCKHOLM  --  Intracoronary bone marrow cell transplantation extended survival in patients with chronic heart failure due to ischemic cardiomyopathy  --  that was the good news. The bad news was that the finding was not &quot;new&quot; at all  --  it had already been published.&lt;/p&gt;
&lt;p&gt;Late today the European Society of Cardiology said it would sanction the researcher who reported the stem cell study by barring him from presenting research at ESC congresses for two years.&lt;/p&gt;
&lt;p&gt;The ESC guidelines for Hot Line trials specifically state that the information submitted should be new, unpublished data. Yet, the STAR trial was accepted for presentation as a Hot Line trial at the ESC annual meeting here.&lt;/p&gt;
&lt;p&gt;When asked by &lt;em&gt;MedPage Today&lt;/em&gt; to point out the &quot;news&quot; in the Hot Line presentation, STAR lead investigator Bodo-Eckehard Strauer, MD, of the Heinrich Heine University of D&amp;#252;sseldorf, Germany, said the news was that bone marrow cell therapy significantly improved survival in patients with chronic cardiomyopathy, which he illustrated with a slide showing a Kaplan-Meier curve  --  the same graph that was published in the July issue of the &lt;em&gt;European Journal of Heart Failure.&lt;/em&gt; Moreover, every data slide in Strauer&apos;s presentation matched the tables in the published paper.&lt;/p&gt;
&lt;p&gt;Late today, the ESC acknowledged the breach of congress rules in a statement saying that it &quot;acknowledges that significant information pertaining to the results of the STAR Heart Study, presented today at ESC Congress 2010 as novel had already been published prior to [the] ESC Congress.&quot;&lt;/p&gt;
&lt;p&gt;The presentation therefore, &quot;clearly breaks ESC rules for Hot Line Sessions, which state that information must be first presented at ESC Congresses in order to qualify for presentation in a Hot Line session.&quot;&lt;/p&gt;
&lt;p&gt;The ESC said it was not informed of the publication before the meeting. As a result of the violation, the ESC said it would &quot;not accept abstracts from this investigator for a period of two years.&quot;&lt;/p&gt;
&lt;p&gt;According to information in the journal, Strauer and colleagues submitted their paper in February, revised it in April, and the journal accepted it in late April.&lt;/p&gt;
&lt;p&gt;It should be noted that the &lt;em&gt;European Journal of Heart Failure &lt;/em&gt;is a journal of the ESC.&lt;/p&gt;
&lt;p&gt;Immediately after the press briefing &lt;em&gt;MedPage Today&lt;/em&gt; asked Fausto Pinto, MD, PhD, the ESC program chair, and ESC President Roberto Ferrari, MD, why they had accepted the STAR paper as a Hot Line presentation. They said &quot;we thought there were new data.&quot;&lt;/p&gt;
&lt;p&gt;Ferrari then added, &quot;We were snookered.&quot;&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_3133"
                     title="Antiviral Tx in Early Pregnancy Safe for Baby (CME/CE)"
                     score="0.01"
                     href="http://www.medpagetoday.com/OBGYN/Pregnancy/tb/21855?impressionId=1283457949604"
                     
      Antiviral herpes treatment during the critical period of early pregnancy doesn&apos;t appear to impair infant organ formation, researchers affirmed.&lt;br&gt;
&lt;br&gt;Major birth defects were no more common among infants exposed during the first trimester than among the unexposed, Bj&amp;#246;rn Pasternak, MD, PhD, and Anders Hviid, MSc, DrMedSci, both of the Statens Serum Institut in Copenhagen, found.&lt;br&gt;
&lt;br&gt;In their population-based cohort study, the major birth defect rate was 2.2% for acyclovir (Zovirax), valacyclovir (Valtrex), and famciclovir (Famvir) exposures combined versus 2.4% without exposure, they reported in the Aug. 25 issue of the &lt;em&gt;Journal of the American Medical Association&lt;/em&gt;.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;The results looked reassuring for the individual drugs as well, although the data was too limited to draw conclusions of safety for famciclovir and valacyclovir, the investigators noted.&lt;/p&gt;
&lt;p&gt;&quot;Acyclovir is the most extensively documented antiviral and should therefore be the drug of choice in early pregnancy,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;For acyclovir, the study offered &quot;fairly strong reassurance&quot; to reinforce the general lack of teratogenicity seen in prior small, underpowered studies, agreed James L. Mills, MD, MS, and Tonia C. Carter, PhD, both of the National Institute of Child Health and Human Development in Bethesda, Md., in an accompanying editorial.&lt;/p&gt;
&lt;p&gt;But even the large Danish cohort couldn&apos;t sort out whether any of the antivirals increased specific types of defects, the editorialists warned.&lt;/p&gt;
&lt;p&gt;&quot;This is a critical limitation because no teratogen produces an increase in all malformations,&quot; they wrote. &quot;Instead, each produces a characteristic pattern of malformations, almost a distinctive signature.&quot;&lt;/p&gt;
&lt;p&gt;The researchers explained that the number of exposed cases in each of the 13 malformation subgroups was small, although their exploratory analyses suggested no associations with antiviral drug exposure.&lt;/p&gt;
&lt;p&gt;The study included data on 837,795 infants born in Denmark from 1996 through September 2008 who were not diagnosed with other clear risk factors or causes of malformation  --  chromosomal aberrations, genetic syndromes, birth defect syndromes with known causes, or congenital viral infections.&lt;/p&gt;
&lt;p&gt;Antiviral drugs were dispensed to the mother in the first trimester of pregnancy for 1,804 of these infants, based on data from the universal healthcare registries available.&lt;/p&gt;
&lt;p&gt;This included 1,561 acyclovir exposures with 32 diagnosed major birth defects among them (2.0%) for an adjusted prevalence odds ratio of 0.82 (95% confidence interval 0.57 to 1.17) compared with nonexposed infants.&lt;/p&gt;
&lt;p&gt;Birth defects occurred in seven of 229 valacyclovir-exposed infants (3.1%, adjusted prevalence odds ratio 1.21, 95% CI 0.56 to 2.62) and one of just 26 famciclovir-exposed babies (3.8%), which Mills and Carter called too few for solid conclusions on both counts.&lt;/p&gt;
&lt;p&gt;A sensitivity analysis that looked only at antiviral prescriptions filled during the peak time of teratogenic susceptibility from two to four weeks after conception when organ formation is underway also showed no excess risk of major birth defects (adjusted prevalence odds ratio 0.58, 95% CI 0.35 to 0.98).&lt;/p&gt;
&lt;p&gt;The researchers acknowledged that the birth defect registry had complete coverage for only one year of follow-up whereas defects diagnosed later would have been missed. Nor did the study include planned or spontaneous abortions.&lt;/p&gt;
&lt;p&gt;The study was also limited by use of filled prescriptions as a measure of exposure since women may not have actually taken the pills, which would have biased the results toward the null, the researchers added.&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 grants from the Danish Medical Research Council and the Lundbeck Foundation. Pasternak and Hviid reported having no conflicts of interest to declare.&lt;/p&gt;&lt;p&gt;The editorial was supported by the Intramural Research Program of the National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development. The editorialists reported having no conflicts of interest to declare.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_3120"
                     title="ACOG Endorses Guidelines on HPV Vaccination"
                     score="0.009"
                     href="http://www.medpagetoday.com/InfectiousDisease/Vaccines/tb/21834?impressionId=1283457949604"
                     
      &lt;p&gt;The American College of Obstetricians and Gynecologists is adding its weight to recommendations that 11- and 12-year-old girls be vaccinated against human papillomavirus (HPV) and that &quot;catch-up&quot; shots are a good idea for unvaccinated teens and young women up to age 26.&lt;/p&gt;
&lt;p&gt;In a new statement, ACOG&apos;s Committee on Adolescent Health Care also stressed that Pap smears are still necessary for women starting at 21, even if they&apos;ve been vaccinated against HPV. Current vaccines do not protect against all viral strains, and vaccination does not clear preexisting infections.&lt;/p&gt;
&lt;p&gt;Two HPV vaccines are now available: a bivalent product (Cervarix) that protects against genotypes 16 and 18; and a quadrivalent product (Gardasil) that protects against the same two strains plus genotypes 6 and 11.&lt;/p&gt;
&lt;p&gt;The new statement, published online in &lt;em&gt;Obstetrics &amp;amp; Gynecology&lt;/em&gt;, updates one issued in 2006 when the quadrivalent product was approved. The bivalent vaccine was approved last October.&lt;/p&gt;
&lt;p&gt;The federal Advisory Committee on Immunization Practices has recommended that girls first receive HPV immunization at age 11 or 12, before becoming sexually active, and the ACOG committee said that was appropriate in most cases.&lt;/p&gt;
&lt;p&gt;&quot;Depending on the circumstances, the vaccine can be given to individuals as young as age 9 years,&quot; the committee indicated.&lt;/p&gt;
&lt;p&gt;Vaccination before the start of sexual activity ensures maximal effectiveness, but ACIP has recommended catch-up vaccination for sexually active young women who have not received either product.&lt;/p&gt;
&lt;p&gt;The ACOG committee endorsed the recommendation, noting that the vaccines may even be given to young women with a history of possible HPV infection as indicated by previous cervical intraepithelial neoplasia or genital warts.&lt;/p&gt;
&lt;p&gt;Unvaccinated sexually active women &quot;should be counseled that the vaccine may be less effective in individuals who have been exposed to HPV,&quot; according to the ACOG statement. However, HPV testing is not necessary or recommended before giving the vaccine, because a positive result would not be a contraindication.&lt;/p&gt;
&lt;p&gt;&quot;If the patient is tested and the results are positive, vaccination is still recommended because the chance that all vaccine preventable types are present is low,&quot; the committee explained.&lt;/p&gt;
&lt;p&gt;It also advised that vaccination is not recommended for women who are pregnant or trying to get pregnant, but that women who are breastfeeding may safely receive the vaccines without endangering their babies.&lt;/p&gt;
&lt;p&gt;To be safe, sexually active women starting the three-dose vaccination series should use contraception until it is completed.&lt;/p&gt;
&lt;p&gt;If pregnancy occurs while the series is underway, dosing should be delayed until the pregnancy ends, and the pregnancy and its outcome should be reported to the vaccine manufacturer&apos;s registry.&lt;/p&gt;

    </recommendedItem>
    <recommendedItem id="20100101_19_3119"
                     title="Give Antibiotics Before C-Section, Group Urges"
                     score="0.007"
                     href="http://www.medpagetoday.com/OBGYN/Pregnancy/tb/21832?impressionId=1283457949604"
                     
      &lt;p&gt;Women scheduled for cesarean section should be started on antibiotics an hour before delivery, according to new recommendations from the American College of Obstetricians and Gynecologists (ACOG).&lt;/p&gt;
&lt;p&gt;The only exceptions would be patients already on appropriate antibiotics  --  to combat chorioamnionitis, for instance  --  and emergency cases, which should get antibiotics as soon as possible, according to an ACOG committee opinion statement.&lt;/p&gt;
&lt;p&gt;Although antimicrobial prophylaxis to reduce postoperative maternal infections is already common practice for C-sections, clinicians need to stop waiting until after clamping the umbilical cord to administer them, according to the statement.&lt;/p&gt;
&lt;p&gt;Preoperative administration is more effective, the writing committee explained in the September issue of &lt;em&gt;Obstetrics &amp;amp; Gynecology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Compared with administration of antibiotics after umbilical cord clamping, the statement cited studies showing: &lt;ul&gt; &lt;li&gt;Fewer wound infections (0.6% when given two hours before skin incision versus 1.4% within three hours after incision)&lt;/li&gt; &lt;li&gt;Significantly lower endometriosis rates (1% when given 15 to 60 minutes before C-section versus 5% after clamping in one trial and 7.8% when given at incision versus 14.8% after clamping in another)&lt;/li&gt; &lt;li&gt;Significantly lower total postoperative infection rates (4.5% when given 15 to 60 minutes before C-section versus 11.5% after clamping)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Although an additional small randomized trial showed no significant maternal benefit from preoperative antibiotics, it showed no harm.&lt;/p&gt;
&lt;p&gt;Concerns that exposure could have a negative impact on the baby by masking positive bacterial culture results or leading to antibiotic resistant infections are unfounded, the committee concluded.&lt;/p&gt;
&lt;p&gt;Randomized trials have shown no difference in rates of neonatal sepsis overall or from resistant organisms or in rate of admission to a neonatal intensive care unit, although all were underpowered to analyze these secondary outcome measures.&lt;/p&gt;
&lt;p&gt;The recommendation for starting prophylaxis within 60 minutes of the start of cesarean delivery should allow a sufficient serum level to be established by the time of skin incision, the statement noted.&lt;/p&gt;
&lt;p&gt;Therapeutic levels need to be maintained throughout the operation, so the same dose should be readministered at intervals one or two times the drug&apos;s half-life, according to the new recommendation.&lt;/p&gt;
&lt;p&gt;First-generation cephalosporins and other narrow-spectrum antibiotics effective against gram-positive and gram-negative bacteria as well as against some anaerobic bacteria are the typical prophylactic choice in the cesarean setting.&lt;/p&gt;
&lt;p&gt;Clindamycin (Cleocin) with gentamicin (Garamycin) would be a reasonable alternative for women with a significant allergy to beta-lactam antibiotics, according to the ACOG statement.&lt;/p&gt;

    </recommendedItem>
</recommendedContent>