<?xml version="1.0" encoding="utf-8"?>
<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_429"
                     title="Low-Dose Radiation in Breast Cancer Gets Support (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/HematologyOncology/BreastCancer/tb/18339?impressionId=1265755467074"
                     
      &lt;p&gt;About 40% of women in two large breast cancer radiotherapy trials reported being concerned about some aspect of body image over the five years following therapy, researchers said.&lt;/p&gt;
&lt;p&gt;But there was little difference between those in the standard therapy arms and those getting so-called hypofractionated regimens, according to Penelope Hopwood, MD, of the Institute of Cancer Research in Sutton, England, and colleagues.&lt;/p&gt;
&lt;p&gt;The finding is evidence that a lower overall radiation dose given in fewer but larger fractions does not increase adverse effects or worsen body image for most women, Hopwood and colleagues said online in &lt;em&gt;The Lancet Oncology&lt;/em&gt;&lt;em&gt;&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;The researchers used data from quality-of-life substudies from the two randomized Standardisation of Breast Radiotherapy (START) trials, conducted concurrently in the U.K.&lt;/p&gt;
&lt;p&gt;The Start A trial compared a standard regimen  --  50 gray (Gy) delivered in five 2.0-Gy fractions weekly over five weeks  --  with two hypofractionated regimens.&lt;/p&gt;
&lt;p&gt;In the first test regimen, women were treated with 41.6 Gy in 13 fractions of 3.2 each over five weeks, with three fractions in one week and two the next. The other regimen followed the same schedule, but delivered 39 Gy in 13 fractions of 3.0 each.&lt;/p&gt;
&lt;p&gt;The Start B study was a noninferiority trial comparing the standard regimen with one that delivered 40 Gy in 15 fractions of 2.67 each over three weeks. In contrast to Start A, both regimens had five fractions per week.&lt;/p&gt;
&lt;p&gt;As part of the studies, the researchers enrolled 2,208 participants in a quality-of-life analysis that looked at adverse events and changes in body image over a five-year follow-up period.&lt;/p&gt;
&lt;p&gt;They found: &lt;ul&gt; &lt;li&gt;The most frequently reported adverse effects in women with breast-conserving surgery were breast hardness and overall change in breast appearance after radiotherapy  --  about 41% and 39%, respectively, at five years. &lt;/li&gt; &lt;li&gt;In all radiotherapy regimens, breast symptoms fell significantly (at &lt;em&gt;P&lt;/em&gt;&amp;lt;0.0001) from baseline to 60 months, but there was no significant difference between regimens in either trial.&lt;/li&gt; &lt;li&gt;Compared with the standard regimen, adverse effects of radiotherapy tended to be lower for the 39 Gy regimen in trial A and the 40 Gy regimen in trial B, but rates were similar between the control regimen and the 41.6-Gy regimen in trial A. &lt;/li&gt; &lt;li&gt;The only significant difference from the 50-Gy regimen, however, was adverse change in skin appearance, which was lower for patients who received 39 Gy or 40 Gy. The hazard ratios were 0.63 and 0.76, respectively.&lt;/li&gt; &lt;li&gt;There was no significant difference in change in skin appearance between patients who got 41.6 Gy or 50 Gy in trial A. (The hazard ratio was 0.83, but the 95% confidence interval crossed unity.)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Overall, the findings &quot;strengthen evidence in favor of hypofractionated regimens, with a potential for fewer adverse effects on the normal breast tissues,&quot; the researchers concluded.&lt;/p&gt;
&lt;p&gt;The study&apos;s findings &quot;provide a strong foundation&quot; for more research into how patients experience radiotherapy, according to Julie Schnur, PhD, of Mount Sinai School of Medicine in New York City.&lt;/p&gt;
&lt;p&gt;Among areas that might be examined, she wrote in an accompanying editorial, are: &lt;ul&gt; &lt;li&gt;The acute treatment period, which &quot;presents unique challenges to women&quot;&lt;/li&gt; &lt;li&gt;How women view the treated breast specifically, rather than the body overall&lt;/li&gt; &lt;li&gt;The use of behavioral medicine approaches to enhance body image&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;Schnur said the researchers showed &quot;a consideration of the patient&apos;s point of view that is too often absent.&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 had support from Cancer Research UK, the U.K. Medical Research Council, and the U.K. Department of Health.&lt;/p&gt;&lt;p&gt;The authors declared 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_259"
                     title="ASCO GI: Gene Therapy Shows Promise in Esophageal Cancer (CME/CE)"
                     score="0.001"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASCOGI/tb/18122?impressionId=1265755467074"
                     
      &lt;p&gt;ORLANDO  --  Injecting the gene encoding for tumor necrosis factor-alpha (TNF-alpha) directly into tumors led to pathologic complete responses in a third of patients and a median survival of four years in a small study of patients with locally advanced esophageal cancer.&lt;/p&gt;
&lt;p&gt;The gene-therapy strategy led to nodal conversion and downstaging in a majority of patients, most of whom underwent surgical resection following chemoradiation and the intratumoral injections of TNF.&lt;/p&gt;
&lt;p&gt;Patients who received the three lowest doses of TNF in the dose-finding study had a five-year median survival of 56%.&lt;/p&gt;
&lt;p&gt;&quot;This represents an encouraging increase in survival relative to historical controls,&quot; Kenneth J. Chang, MD, of the University of California Irvine, reported here at the Gastrointestinal Cancers Symposium. &quot;These results warrant further evaluation.&quot;&lt;/p&gt;
&lt;p&gt;However, another investigator in the multicenter study cautioned that the trial was stopped because of treatment-related deaths that have not been fully explained, and that the regimen is complicated and time-consuming.&lt;/p&gt;
&lt;p&gt;The primary objective of the study was to assess the safety, feasibility, and tolerability of weekly intratumoral injections of TNFerade, a second-generation replication-deficient adenovector, carrying the transgene encoding human TNF-alpha, regulated by the radiation-inducible promotor Egr-1.&lt;/p&gt;
&lt;p&gt;Upon its release inside a tumor, the gene therapy stimulates TNF production to help destroy the tumor. The therapy was developed for use with radiation and conventional chemotherapy.&lt;/p&gt;
&lt;p&gt;The gene therapy has received FDA fast-track status for evaluation as treatment for pancreatic cancer.&lt;/p&gt;
&lt;p&gt;Chang reported results from a dose-finding study involving 24 patients with locally advanced esophageal cancer. All were surgical candidates before enrollment. Each patient received five weekly injections of TNF concurrent with 5-FU, cisplatin, and external-beam radiation therapy. The TNF doses evaluated ranged from 4 x 10&lt;sup&gt;8&lt;/sup&gt; to 4 x 10&lt;sup&gt;11&lt;/sup&gt; PU.&lt;/p&gt;
&lt;p&gt;Staging results showed that all but one of the patients had T3 disease, and 18 had nodal involvement (N1).&lt;/p&gt;
&lt;p&gt;The preoperative therapy was administered over 5.5 weeks. Following a recovery period of five to 11 weeks, patients were to undergo surgical resection, which ultimately was performed in 19 of the 24 study participants.&lt;/p&gt;
&lt;p&gt;Of the 19 patients who underwent resection, six (32%) had pathologic complete responses. Chang reported that nine of 16 evaluable patients converted from N1 to N0 status following preoperative therapy, and 11 of 20 were downstaged from T3 to T2-T0.&lt;/p&gt;
&lt;p&gt;Median overall survival for the patients was 47.7 months. The 56% five-year survival applied to patients in the first three dosing levels. Patients who received the highest dose have not been followed long enough to determine five-year survival.&lt;/p&gt;
&lt;p&gt;During the discussion that followed the presentation, Jaffer Ajani, MD, of M.D. Anderson Cancer Center in Houston, cited concerns about the treatment-related deaths and complexity of the regimen.&lt;/p&gt;
&lt;p&gt;&quot;This is a very big production; it&apos;s not simple to do,&quot; said Ajani. &quot;You have to have a gastroenterologist available to inject every week.&quot;&lt;/p&gt;
&lt;p&gt;&quot;Your numbers are very small, and the pathological CR rate is no different than any other reported in even larger trials,&quot; he added. &quot;And then the subgroups with survival, I&apos;m not sure how meaningful that is because your numbers are so small.&quot;&lt;/p&gt;
&lt;p&gt;Responding to the concern about treatment-related deaths, Chang said none of the deaths was related to the TNF injections.&lt;/p&gt;
&lt;p&gt;With regard to the survival data, he acknowledged the small size of the study and said, &quot;It is what it is.&quot;&lt;/p&gt;
&lt;p&gt;&quot;It appears, as an adjunct, to be safe, and given the preliminary data, I think it is encouraging enough to go on to a larger trial,&quot; said Chang. &quot;That is basically what we are saying. We have something interesting that warrants further study.&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 supported by GenVec.&lt;/p&gt;&lt;p&gt;One or more investigators disclosed relationships with GenVec.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_230"
                     title="Radiation Benefit of Digital Mammogram Not Clear (CME/CE)"
                     score="-0.002"
                     href="http://www.medpagetoday.com/HematologyOncology/BreastCancer/tb/18087?impressionId=1265755467074"
                     
      &lt;p&gt;Digital mammography exposes women to a lower radiation dose than standard film mammography, but digital imaging is likely to require more than four normal views in about 20% of women screened, according to a subset analysis of data from a study of almost 50,000 women.&lt;/p&gt;
&lt;p&gt;The mean glandular dose per view was 2.37 mGy for film mammography versus 1.86 mGy for full-field digital mammography, a difference of 22%, R. Edward Hendrick, PhD, of the University of Colorado-Denver, and colleagues reported in the February issue of the &lt;em&gt;American Journal of Roentgenology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;But only 12% of women screened with traditional mammography required more than four normal views compared with 21% of the women imaged with digital systems.&lt;/p&gt;
&lt;p&gt;When the need for additional views was factored in, they wrote, the difference in radiation exposure between the two modalities dropped to 17%, 4.14 mGy for digital versus 4.98 mGy for standard mammography.&lt;/p&gt;
&lt;p&gt;Furthermore, these differences were not standard  --  there was a wide variation across manufacturers. For example, the average mean glandular dose per view was 3.77 for Fischer digital versus 5.03 for Hologic Selenia, which was also the only manufacturer in which the digital dose was higher than the standard film dose.&lt;/p&gt;
&lt;p&gt;Doses were compared on a manufacturer basis  --  film mammography versus digital: &lt;ul&gt; &lt;li&gt;5.36 mGy for Fischer standard film versus 3.77 mGy for Fischer digital&lt;/li&gt; &lt;li&gt;4.02 mGy for Fugifilm standard film versus 4.45 mGy for Fugifilm digital&lt;/li&gt; &lt;li&gt;5.03 mGy for GE standard film versus 4.02 mGy for GE digital&lt;/li&gt; &lt;li&gt;5.01 mGy for Hologic CCD standard film versus 4.60 for Hologic CCD digital&lt;/li&gt; &lt;li&gt;4.24 mGy for Hologic Selenia versus 5.03 for Hologic Selenia digital &lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The analysis of parameters and radiation dose was culled from data collected by the American College of Radiology Imaging Network Digital Mammographic Imaging Screening (DMIST) trials, which enrolled 49,528 women from October 2001 through October 2003.&lt;/p&gt;
&lt;p&gt;The primary goal of DMIST was to compare the accuracy of the two technologies. The results, reported in 2005, found that digital mammography was superior for younger women and for women with dense breasts, but when results from all 50,000 women were considered there was no significant difference.&lt;/p&gt;
&lt;p&gt;This latest study was based on technical data compiled on 5,102 women of which 4,366 cases yielded &quot;clean&quot; data that were included in the analysis.&lt;/p&gt;
&lt;p&gt;The researchers did find a significant difference in the pressure each modality exerted on the breast. &quot;Mean compression force was 10.7 dN for screen-film mammography and 10.1 dN for full-field digital mammography (5.5% difference, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.001),&quot; they wrote.&lt;/p&gt;
&lt;p&gt;There was also a 1.7% statistically significant difference in mean compressed breast thickness  --  5.3 cm for screen-film mammography versus 5.4 cm for digital.&lt;/p&gt;
&lt;p&gt;But the difference in breast compression, while statistically significant, was &quot;likely clinically insignificant,&quot; Hendrick and colleagues concluded.&lt;/p&gt;
&lt;p&gt;The authors noted that the study was limited by the advances in imaging technology  --  since the study was conducted, film manufacturers have introduced &quot;new screen-film combinations, such as double-sided screens and double-emulsion films that were not available during DMIST.&quot;&lt;/p&gt;
&lt;p&gt;For that reason, &quot;breast dose along with image quality and other parameters should be carefully compared between existing screen-film mammography and any new [digital] system being considered for integration into a breast imaging practice.&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 DMIST trial was supported by the National Cancer Institute and by the Lynn Safe Breast Cancer Research Foundation.&lt;/p&gt;&lt;p&gt;Hendrick disclosed that he is a consultant to GE Healthcare on digital breast tomosynthesis and other breast imaging projects not related to DMIST.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20090101_1_666"
                     title="ASTRO: Post-Lumpectomy Radiation Remains Best for Best-Case Breast Cancer"
                     score="-0.005"
                     href="