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<recommendedContent xmlns="http://api.mspoke.com">
    <recommendedItem id="20100101_19_452"
                     title="Study Backs Late Cardiotoxicity of Childhood Cancer Treatment (CME/CE)"
                     score="0.012"
                     href="http://www.medpagetoday.com/HematologyOncology/OtherCancers/tb/18384?impressionId=1265749365488"
                     
      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_307"
                     title="Good Results in Poor-Risk Rectal Cancer (CME/CE)"
                     score="0.004"
                     href="http://www.medpagetoday.com/HematologyOncology/ColonCancer/tb/18169?impressionId=1265749365488"
                     
      &lt;p&gt;Patients with high-risk rectal cancer had high response and three-year survival rates on a regimen of preoperative chemotherapy, followed by standard chemoradiation and then surgical resection, according to results of a multicenter study.&lt;/p&gt;
&lt;p&gt;Three-fourths of patients had objective responses to neoadjuvant chemotherapy, increasing to 89% after chemoradiation, researchers reported online in &lt;em&gt;The Lancet Oncology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Additionally, 97% of patients who underwent surgery had microscopically clear surgical margins. At three years, 83% of patients remained alive, including almost 70% who were progression free.&lt;/p&gt;
&lt;p&gt;&quot;Intensification of systemic therapy with neoadjuvant combination chemotherapy before standard treatment is feasible in poor-risk, potentially operable rectal cancer, with acceptable safety and promising long-term outcomes,&quot; David Cunningham, MD, of the Royal Marsden Hospital in Sutton, England, and co-authors concluded.&lt;/p&gt;
&lt;p&gt;&quot;Future development of this multidisciplinary treatment strategy in randomized trials is warranted.&quot;&lt;/p&gt;
&lt;p&gt;Although surgery remains the primary and potentially curative therapy for localized rectal cancer, local recurrence rates as high as 40% have been reported with conventional resection.&lt;/p&gt;
&lt;p&gt;The introduction of standardized surgery and total mesorectal excision reduced local recurrence rates to less than 10%, which has been associated with improved survival, the authors noted.&lt;/p&gt;
&lt;p&gt;Preoperative radiotherapy and then chemoradiation further reduced the risk of local recurrence, but did not improve overall survival compared with surgery alone.&lt;/p&gt;
&lt;p&gt;Combination chemotherapy has led to higher response rates and progression-free survival compared with monotherapy for patients with advanced rectal cancer, the authors continued. Adjuvant chemotherapy containing oxaliplatin (Eloxatin) also has improved outcomes in resected colon cancer.&lt;/p&gt;
&lt;p&gt;Given that oxaliplatin-fluoropyrimidine combinations have become a preferred standard, investigators designed a clinical trial of high-risk rectal cancer to investigate preoperative treatment with oxaliplatin and capecitabine (Xeloda).&lt;/p&gt;
&lt;p&gt;A previous report involving the first 77 patients enrolled in the trial showed substantial tumor regression, rapid improvement in symptoms, and a high rate of clear surgical margins (&lt;em&gt;J Clin Oncol&lt;/em&gt; 2006; 24: 668-74).&lt;/p&gt;
&lt;p&gt;Nine treatment-related cardiac events occurred in eight of the 77 patients, prompting a protocol amendment to exclude patients with a recent history of clinically significant cardiac problems.&lt;/p&gt;
&lt;p&gt;The updated results comprised 105 patients, and only one cardiac event occurred after the change in eligibility criteria, the authors wrote.&lt;/p&gt;
&lt;p&gt;All of the patients had MRI-defined, poor-risk but nonmetastatic rectal cancer. Patients received four cycles of neoadjuvant chemotherapy over 12 weeks, followed by chemoradiotherapy consisting of a total radiation dose of 54 Gy administered over six weeks, plus daily capecitabine.&lt;/p&gt;
&lt;p&gt;After total mesorectal excision, patients received 12 weeks of adjuvant capecitabine.&lt;/p&gt;
&lt;p&gt;The primary endpoint was pathologic complete response, and median follow-up was 55 months.&lt;/p&gt;
&lt;p&gt;Radiologically confirmed response rates were 74% after neoadjuvant chemotherapy and 89% after chemoradiation. Of 97 patients who had surgery, 93 had microscopically clear margins, and 21 of 105 patients had pathologic complete responses.&lt;/p&gt;
&lt;p&gt;Three-year progression-free and overall survival were 68% and 83%, respectively. Among patients who had surgery, three-year, relapse-free survival was 74%.&lt;/p&gt;
&lt;p&gt;&quot;Our findings show the feasibility of neoadjuvant chemotherapy with capecitabine and oxaliplatin before chemoradiotherapy and total mesorectal excision, which accord with the initial results of this study,&quot; the authors declared.&lt;/p&gt;
&lt;p&gt;&quot;High radiological response rates to preoperative treatment were recorded, and the number of pathological complete responses surpassed the prespecified number needed to meet the primary objective of this trial.&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 England&apos;s National Health Service and sanofi-aventis.&lt;/p&gt;&lt;p&gt;Cunningham and co-author Niall Tebbutt disclosed relationships with Roche and sanofi-aventis.&lt;/p&gt;&lt;p&gt;Co-author Ian Chau disclosed relationships with Roche and sanofi-aventis.&lt;/p&gt;&lt;p&gt;Co-author Yu Jo Chua disclosed relationships with Roche and sanofi-aventis.&lt;/p&gt;&lt;p&gt;Co-author Gina Brown disclosed a relationship with sanofi-aventis.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_262"
                     title="Unequal Outcomes Despite Equal Treatment (CME/CE)"
                     score="0.001"
                     href="http://www.medpagetoday.com/HematologyOncology/OtherCancers/tb/18110?impressionId=1265749365488"
                     
      &lt;p&gt;Race and income determined the likelihood of surviving liver cancer even when patients&apos; treatment appeared the same, researchers said.&lt;/p&gt;
&lt;p&gt;Data from the CDC&apos;s Surveillance, Epidemiology, and End Results (SEER) database for nearly 15,000 patients diagnosed with hepatocellular carcinoma from 1973 to 2004 found that blacks had a 15% higher death rate than whites (95% CI 9% to 22%), according to Joseph Kim, MD, of City of Hope in Duarte, Calif., and colleagues.&lt;/p&gt;
&lt;p&gt;Unadjusted five-year survival rates were about 6% for blacks, compared with about 9% for whites with liver cancer, the researchers reported online in &lt;em&gt;Cancer&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;Moreover, middle and high income levels were associated with better survival than low income (hazard ratio for death 0.89 and 0.95, respectively, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.03 for both versus low income), the researchers wrote.&lt;/p&gt;
&lt;p&gt;The results reflected adjustments for types of treatments administered, such as tumor ablation or resection or liver transplantation, for tumor grade at diagnosis, and for other factors.&lt;/p&gt;
&lt;p&gt;&quot;Our study demonstrates that black patients and lower income patients continue to have the worst survival,&quot; Kim and colleagues wrote.&lt;/p&gt;
&lt;p&gt;The findings conflict with other studies suggesting that race was not a predictor of liver-cancer survival when treatment types were taken into account.&lt;/p&gt;
&lt;p&gt;That earlier research concluded that blacks with liver cancer were less likely to undergo surgery for localized disease, and that this difference in treatment fully accounted for racial differences in survival.&lt;/p&gt;
&lt;p&gt;So Kim and colleagues also took a closer look at treatment of patients in the SEER database with localized liver tumors diagnosed since 1998.&lt;/p&gt;
&lt;p&gt;Such patients would have been most appropriate for surgery, the researchers indicated. They found that, in line with the earlier studies, blacks had the lowest rates of surgery and transplantation (31% versus 38% for whites, &lt;em&gt;P&lt;/em&gt; not reported).&lt;/p&gt;
&lt;p&gt;But among those patients receiving orthotopic liver transplant, data from the United Network for Organ Sharing (UNOS) showed that blacks had lower rates of graft survival and overall survival compared with whites and other racial-ethnic groups.&lt;/p&gt;
&lt;p&gt;(Throughout the study, Asians tended to have the best outcomes after adjusting for other factors, and Hispanics generally had similar outcomes to whites.)&lt;/p&gt;
&lt;p&gt;The hazard ratio for graft loss among blacks versus whites was 1.63 (95% CI 1.29 to 2.04) and for overall survival it was 1.66 (95% CI 1.29 to 2.12).&lt;/p&gt;
&lt;p&gt;&quot;Therefore, our study demonstrates that survival disparities by race and ethnicity cannot be explained by access issues alone, and other factors need to be considered,&quot; according to Kim and colleagues.&lt;/p&gt;
&lt;p&gt;On the other hand, they acknowledged that there could have been differences in treatment not captured in the SEER and UNOS data.&lt;/p&gt;
&lt;p&gt;Comorbidities and hepatitis C virus-related cirrhosis were also not evaluable, making it possible that black patients were generally sicker and therefore less likely to survive.&lt;/p&gt;
&lt;p&gt;In other findings from the SEER data, Kim and colleagues noted that survival rates had increased markedly over time, and in racial-ethnic and income subgroups.&lt;/p&gt;
&lt;p&gt;Relative to patients diagnosed in the 1970s, those diagnosed from 2000 to 2004 were four times as likely to survive (HR 0.25, 95% CI 0.22 to 0.28). Five-year unadjusted survival rates increased from about 2% to 15% during this span.&lt;/p&gt;
&lt;p&gt;&quot;All racial/ethnic and income groups . . . have benefited to some degree from advances in screening, diagnosis, and treatment,&quot; the researchers wrote.&lt;/p&gt;
&lt;p&gt;Survival rates in women have been somewhat better than in men (HR for death 0.92, 95% CI 0.86 to 0.96).&lt;/p&gt;
&lt;p&gt;Patients undergoing resection or transplantation also fared much better than those not having surgery of any kind, (HR for death 0.27, 95% CI 0.25 to 0.28). Tumor ablation or destruction was also highly beneficial (HR 0.40, 95% CI 0.36 to 0.44 relative to no surgery).&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;No external funding for the analysis was reported.&lt;/p&gt;&lt;p&gt;No potential conflicts of interest were reported.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_242"
                     title="Ultrasound Aids Early Ovarian Cancer Detection (CME/CE)"
                     score="-0.001"
                     href="http://www.medpagetoday.com/Radiology/DiagnosticRadiology/tb/18096?impressionId=1265749365488"
                     
      &lt;p&gt;Serum biomarkers identified through proteomic analysis, coupled with contrast-enhanced ultrasound, ultimately may provide a means for early diagnosis of ovarian cancer, researchers say.&lt;/p&gt;
&lt;p&gt;&quot;Exciting preliminary data have shown that specific combinations of peptides from molecules, such as &lt;em&gt;BRCA2&lt;/em&gt;, exist in the serum of epithelial ovarian cancer patients,&quot; Sonia Dutta, MD, of Mount Sinai School of Medicine in New York, and colleagues reported in the February&lt;em&gt; American Journal of Roentgenology&lt;/em&gt;.&lt;/p&gt;
&lt;p&gt;This discovery suggests that &quot;highly discriminatory proteins&quot; may serve as biomarkers for early epithelial cell ovarian cancer, although the findings must be further validated, the authors wrote.&lt;/p&gt;
&lt;p&gt;Despite advances in surgery and chemotherapy, survival from advanced stage ovarian cancer is only 30%, and the authors cite a &quot;dire need&quot; for a validated screening method to detect the disease early.&lt;/p&gt;
&lt;p&gt;Unsuccessful efforts find a biomarker for this deadly malignancy have focused primarily on a single cancer-specific marker, which the authors concede is a &quot;mission impossible.&quot;&lt;/p&gt;
&lt;p&gt;Impediments to the identification of cancer-specific markers include the molecular heterogeneity that characterizes different tumors, the sharing of pathophysiologic events among cancer and other diseases, and low marker production and concentration.&lt;/p&gt;
&lt;p&gt;To overcome these difficulties, a new approach known as proteomics is being used to analyze the entire protein complement of a cell.&lt;/p&gt;
&lt;p&gt;The rationale for this analytical technique lies in a significantly greater understanding of the tumor microenvironment. It is now known that tumor cells participate in complex interactions with surrounding structures and other cell populations.&lt;/p&gt;
&lt;p&gt;&quot;This biochemical cross-talk is hypothesized to generate a cascade of specific and sensitive biomarkers elaborated directly from the tumor cell population, indirectly from the interacting non-tumor cells or extracellular molecules, or a specific product of the microecology,&quot; they explained.&lt;/p&gt;
&lt;p&gt;In fact, the most specific cancer markers may turn out to be molecules that normally are not malignant but that have been modified by that tumor microenvironment  --  clipped, cleaved, phosphorylated, or glycosylated  --  and carry a detailed picture of the local pathophysiology.&lt;/p&gt;
&lt;p&gt;Previous techniques used in the hunt for markers, such as two-dimensional gel electrophoresis, were unable to detect these altered or clipped molecules, which occupy the low molecular weight range of the proteome.&lt;/p&gt;
&lt;p&gt;Mass spectrometry, which is most sensitive in the low molecular weight range, is now a tool used to explore these modified protein molecules and has already revealed a vast number of previously unknown biomarkers.&lt;/p&gt;
&lt;p&gt;The next steps, the researchers explained, will be to develop capture reagents that can measure the markers and, using reverse-phase protein array, to further characterize proteins of interest.&lt;/p&gt;
&lt;p&gt;But any diagnostic information gained through proteomic analysis must be verified by some imaging technique. Conventional ultrasound has proven inadequate, but pulse-inversion harmonic ultrasound currently appears to differentiate malignant from benign lesions.&lt;/p&gt;
&lt;p&gt;For example, although the time to peak enhancement with contrast-enhanced ultrasound is similar in benign and malignant masses, a small study found that malignant lesions have: &lt;ul&gt; &lt;li&gt;Greater peak enhancement (23.3 versus 12.3 dB, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Longer half wash-out time (139.9 versus 46.3 seconds, &lt;em&gt;P&lt;/em&gt;&amp;lt;0.01)&lt;/li&gt; &lt;li&gt;Greater area under the enhancement curve (2,012.9 versus 523.9 seconds, &lt;em&gt;P&lt;/em&gt;=0.07)&lt;/li&gt; &lt;/ul&gt;&lt;/p&gt;
&lt;p&gt;The authors noted that these enhancement kinetics data were from just 17 patients and are therefore limited, but stated that the technique &quot;shows great promise.&quot;&lt;/p&gt;
&lt;p&gt;In addition, the diagnostic capacity of ultrasound can be further increased by the use of intravenous contrast agents, which may help visualize the early microvascular changes typical of malignancy.&lt;/p&gt;
&lt;p&gt;The researchers predicted that, by using a combination of clinically relevant biomarkers identified through proteomic analyses plus contrast-enhanced ultrasound, &quot;we will likely be able to shift from an era of diagnosing advanced-stage ovarian cancer to that of early-stage disease and, most important, save the lives of many women.&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;No disclosures were provided.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_223"
                     title="ASCO GI: Regimen Benefits Colon Cancer Patients of All Ages"
                     score="-0.003"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASCOGI/tb/18076?impressionId=1265749365488"
                     
      ORLANDO -- Patients with early-stage colorectal cancer benefit from adjuvant chemotherapy with capecitabine (Xeloda) and oxaliplatin (Eloxatin) regardless of age, according to a new analysis of data from a large multicenter clinical trial.&lt;br&gt;
&lt;br&gt;Disease-free survival (DFS) at three years increased from 60% with a control regimen to 66% with the capecitabine/oxaliplatin (XELOX) regimen among patients 70 or older.&lt;br&gt;
&lt;br&gt;Younger patients had a 3% absolute improvement in three-year DFS when treated with the regimen (72% versus 69% for the control group).&lt;br&gt;
&lt;br&gt;Similar results emerged from an analysis that used 65 as the age cutpoint, according to a presentation at a press briefing prior to the 2010 Gastrointestinal Cancers Symposium.&lt;p&gt;&lt;/p&gt;
&lt;p&gt;&quot;XELOX is a new standard of care for patients with early colon cancer, regardless of age,&quot; said Daniel G. Haller, MD, of the University of Pennsylvania. &quot;Patients receiving XELOX immediately after surgery live disease-free for longer, and there is a trend towards superior overall survival with XELOX.&quot;&lt;/p&gt;
&lt;p&gt;The results contradict those of other recent studies that showed no survival benefit with the XELOX regimen in older patients. The reasons for the contradictory findings have yet to be determined, said Haller.&lt;/p&gt;
&lt;p&gt;The findings came from a subgroup analysis of the NO16968 trial. It compared XELOX with bolus intravenous 5-FU/leucovorin, which was the standard of care for stage III colon cancer when the trial began.&lt;/p&gt;
&lt;p&gt;The analysis was performed after two studies reported last year showed that the survival benefit of the regimen was limited to younger patients (&lt;em&gt;ASCO&lt;/em&gt; 2009. Abstract 4010, &lt;em&gt;J Clin Oncol&lt;/em&gt; 2009; 27: 3109-116).&lt;/p&gt;
&lt;p&gt;NO16968 involved a total 1,886 patients, including 409 patients who were ages 70 or older. Study participants were randomized to XELOX or the control regimen, and the primary endpoint was DFS.&lt;/p&gt;
&lt;p&gt;After a median follow-up of 57 months, the three-year DFS in patients younger than 70 was 72% with XELOX and 69% with the control regimen, representing a 21% reduction in the hazard ratio (95% CI 0.66 to 0.94).&lt;/p&gt;
&lt;p&gt;Among older patients, the 6% absolute difference in DFS favoring XELOX constituted a 13% reduction in the hazard ratio (95% CI 0.63 to 1.18).&lt;/p&gt;
&lt;p&gt;When the definition of &quot;older&quot; patients was 65 and older, XELOX still resulted in a 6% absolute difference in DFS compared with the control regimen (68% versus 62%, HR 0.81, 95% CI 0.64 to 1.03). Among patients younger than 65, XELOX led to a three-year DFS of 72% versus 69% with 5FU and leucovorin (HR 0.80, 95% CI 0.65 to 0.98).&lt;/p&gt;
&lt;p&gt;In response to a question, Haller acknowledged that the DFS difference in older patients did not achieve statistical significance, but he said the principal objective of the study was to examine the data for evidence of trends.&lt;/p&gt;
&lt;p&gt;Overall survival data were not sufficiently mature to perform definitive analyses. However, Haller said the data demonstrated trends in favor of XELOX for all age groups evaluated.&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;Haller disclosed relationships with sanofi-aventis and Hoffmann-La Roche.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>