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    <recommendedItem id="20100101_19_440"
                     title="Soft Drinks Linked to Pancreatic Cancer Risk (CME/CE)"
                     score="0.013"
                     href="http://www.medpagetoday.com/HematologyOncology/OtherCancers/tb/18354?impressionId=1265792657718"
                     
      &lt;p&gt;Regular consumers of sugary soft drinks are at higher risk for pancreatic cancer than fruit juice drinkers or the general population, a new Singaporean study has found.&lt;/p&gt;
&lt;p&gt;Chinese men and women living in Singapore who drank two or more soft drinks per week were 87% more likely to contract pancreatic cancer after the researchers adjusted for factors such as smoking (95% CI 1.10 to 3.15), according to the report published Feb. 8 in &lt;em&gt;Cancer Epidemiology, Biomarkers &amp;amp; Prevention.&lt;/em&gt;&lt;/p&gt;
&lt;p&gt;&quot;In this large prospective cohort of Chinese men and women in Singapore, those who reported regular soft drink consumption were at increased risk of pancreatic cancer when compared with those who largely abstained,&quot; Mark Pereira, PhD, of the School of Public Health at the University of Minnesota, and colleagues wrote. &quot;There was no association between consumption of juice and risk of pancreatic cancer.&quot;&lt;/p&gt;
&lt;p&gt;While pancreatic cancer is relatively rare, it is one of the most deadly cancers, with less than 5% of patients surviving five years after diagnosis. Although rates have generally plateaued in the U.S., they continue to climb in some Asian countries, including Singapore.&lt;/p&gt;
&lt;p&gt;&quot;This increase may reflect demographic and socioeconomic shifts as well as a transition towards a more westernized lifestyle and diet,&quot; the authors wrote.&lt;/p&gt;
&lt;p&gt;Research has shown that insulin promotes pancreatic cancer cell growth, and some researchers think sugary foods could result in blood sugar and insulin fluctuations that expose the pancreas to high concentrations of insulin.&lt;/p&gt;
&lt;p&gt;While fruit juices contain sugar, soft drinks are the major sources of added sugar in the U.S. diet and major contributors to hyperglycemia and hyperinsulinemia.&lt;/p&gt;
&lt;p&gt;Pereira and colleagues followed 60,524 men and women who enrolled in the Singapore Chinese Health Study between April 1993 and December 1998 and were followed for 14 years.&lt;/p&gt;
&lt;p&gt;At enrollment, the participants completed a 146-question food frequency questionnaire, which contained three items related to soft drinks and juice. The questions asked the participants how much, if any, they drank of soft drinks such as Coca-Cola and 7-Up, orange juice, and other fruit and vegetable juices.&lt;/p&gt;
&lt;p&gt;The dietary data was later cross-referenced with records from the Singapore Cancer Registry and the Singapore Registry of Births and Deaths, to determine which of the participants had died of pancreatic cancer and whether it might be related to their soft drink or juice consumption.&lt;/p&gt;
&lt;p&gt;Overall, researchers found that 140 participants had contracted pancreatic cancer.&lt;/p&gt;
&lt;p&gt;The results were largely consistent with three of four previous U.S. studies on the links between pancreatic cancer and soft drinks. Three of the U.S. studies found an association between soft drinks and cancer.&lt;/p&gt;
&lt;p&gt;The author acknowledged that soft drink consumers are more likely than abstainers to participate in other unhealthy behaviors, including smoking and overeating, which makes it difficult to determine that soft drink consumption is an independent risk factor for pancreatic cancer.&lt;/p&gt;
&lt;p&gt;For instance, smokers in their study were at higher risk for pancreatic cancer. &quot;We could not rule out the possibility of residual confounding by factors associated with the habit of drinking soft drinks or other unascertained factors such as waist circumference,&quot; they wrote.&lt;/p&gt;
&lt;p&gt;They also noted that the study was limited in statistical power because pancreatic cancer is rare, which limited the sample size of cancer cases. &quot;Also, because we were unable to collect repeated dietary measurements in this study, we were unable to account for changes in consumption of soft drinks and juices,&quot; they wrote, &quot;especially when the diagnosis of diabetes occurred after the baseline interview.&quot;&lt;/p&gt;
&lt;p&gt;&lt;em&gt; &lt;/em&gt;&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 by the National Cancer Institute.&lt;/p&gt;&lt;p&gt;The authors reported no financial 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"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASCOGI/tb/18122?impressionId=1265792657718"
                     
      &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_256"
                     title="ASCO GI: Targeted Regimen Active in Esophageal Cancer"
                     score="-0.001"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASCOGI/tb/18117?impressionId=1265792657718"
                     
      &lt;p&gt;Half of patients with metastatic esophageal cancer responded to a regimen of conventional chemotherapy and erlotinib (Tarceva), investigators in a small clinical trial reported here.&lt;/p&gt;
&lt;p&gt;Fifteen of 30 patients had objective responses, including one complete response, when the targeted agent was added to oxaliplatin (Eloxatin) and 5-FU (FOLFOX). The response rate exceeded prespecified efficacy criteria, which called for a 10% absolute improvement in historical response rates to oxaliplatin-based chemotherapy.&lt;/p&gt;
&lt;p&gt;&quot;We did not observe a high rate of grade 3-4 adverse events,&quot; Zev A. Wainberg, MD, of UCLA, said in an interview at the Gastrointestinal Cancers Symposium. &quot;With respect to the primary endpoint, we achieved what we set out to do, which was to achieve a response rate of 45%. We surpassed that with a 50% response rate.&quot;&lt;/p&gt;
&lt;p&gt;FOLFOX is a standard therapy for patients with metastatic gastric and esophageal cancer, but a rising incidence of adenocarcinoma of the gastroesophageal junction (GEJ) suggests a need for additional therapeutic options.&lt;/p&gt;
&lt;p&gt;Inhibitors of epidermal growth factor receptor, such as erlotinib, have demonstrated modest response rates in patients with esophageal/GEJ cancer but no evidence of activity against distal gastric cancer.&lt;/p&gt;
&lt;p&gt;Given that background, plus phase I evidence of the safety and tolerability of FOLFOX plus erlotinib, investigators designed a clinical trial to evaluate the combination in patients with untreated metastatic adenocarcinoma of the esophagus or GEJ. Patients enrolled in the phase II, single-arm study received a modified FOLFOX regimen consisting of oxaliplatin, 5-FU, and leucovorin, followed by more 5-FU. Additionally, patients received oral erlotinib daily.&lt;/p&gt;
&lt;p&gt;Treatment cycles were repeated every two weeks until disease progression, withdrawal, or unacceptable toxicity. The primary endpoint was overall response rate, with a goal of 10% improvement over a historical control rate of 34.8% with oxaliplatin-based regimens.&lt;/p&gt;
&lt;p&gt;Wainberg presented findings on 30 evaluable patients from the ongoing trial. The patients&apos; mean age was 59, all but three were men, six had unresectable cancer and the remaining 24 had metastatic disease. Four patients had prior surgery, and seven had received radiation or chemotherapy for nonmetastatic disease.&lt;/p&gt;
&lt;p&gt;In addition to the 50% overall response rate, 12 additional patients had stable disease, resulting in an overall disease control rate of 90%. The median progression-free survival was 5.1 months, and median overall survival was 11 months. Median follow-up duration was 7.5 months.&lt;/p&gt;
&lt;p&gt;The most common adverse events were diarrhea/dehydration (24%), hypokalemia (15%), neutropenia (9%), and elevated liver enzymes (9%). Wainberg said 86.5% of adverse events were grade 1-2. One patient died following gastrointestinal perforation, and 13 patients required interruptions or modifications in erlotinib dosing.&lt;/p&gt;
&lt;p&gt;&quot;To our knowledge, this is the first trial to selectively examine the addition of a targeted agent to chemotherapy in a clinically defined subset of upper GI cancers,&quot; Wainberg and colleagues concluded in a poster presentation.&lt;/p&gt;
&lt;p&gt;&quot;Based on these results, FOLFOX plus or minus erlotinib should be considered for further development,&quot; they 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;No funding source was reported for the study.&lt;/p&gt;&lt;p&gt;The authors had no disclosures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_257"
                     title="ASCO GI: Targeted Agent Slows Neuroendocrine Tumors"
                     score="-0.001"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASCOGI/tb/18116?impressionId=1265792657718"
                     
      &lt;p&gt;ORLANDO  --  Patients with progressive pancreatic neuroendocrine tumors lived twice as long without progression when treated with sunitinib (Sutent) compared with placebo, data from a French clinical trial showed.&lt;/p&gt;
&lt;p&gt;Median overall survival had not been reached in the sunitinib arm, but sunitinib treatment was associated with a 60% reduction in hazard ratio compared with placebo. More than 90% of patients in the sunitinib group remained alive at six months, Eric Raymond, MD, reported here at the Gastrointestinal Cancers Symposium.&lt;/p&gt;
&lt;p&gt;&quot;Sunitinib continuous daily dosing resulted in clinically significant improvement in the median progression-free survival (PFS), improvement in overall survival, and a clinically significant increase in overall response rate versus placebo,&quot; said Raymond, of Hopital Beaujon in Clichy, France.&lt;/p&gt;
&lt;p&gt;Most of the survival benefit owed to disease stabilization, as fewer than 10% of patients had objective responses.&lt;/p&gt;
&lt;p&gt;The finding suggests that sunitinib might facilitate use of second- and third-line therapies that could build on the delayed progression and extended survival, he added.&lt;/p&gt;
&lt;p&gt;Moreover, these findings appear to confirm results of phase I-II studies that showed sunitinib activity in pancreatic neuroendocrine tumors. In an open-label phase II study, for example, treatment with sunitinib led to partial responses in 16.7% of patients and stable disease &amp;#8805;6 months in 56.1%, and median time to progression of 7.7 months in 66 patients, Raymond said.&lt;/p&gt;
&lt;p&gt;Those favorable early benefits led to this multicenter phase III trial involving 170 patients, who received sunitinib 37.5 mg/d or placebo. Treatment continued until progression, death, withdrawal, and development of unacceptable toxicity. All patients also received best supportive care.&lt;/p&gt;
&lt;p&gt;The primary endpoint was progression-free survival. Secondary endpoints included overall survival, overall response rate, time to response, duration of response, safety, and patient-reported outcomes.&lt;/p&gt;
&lt;p&gt;The patients&apos; median age was 56, and 48% were men. All but one patient had ECOG 0-1 performance status. About half of the tumors were non-functioning. Among functioning tumors, gastrinomas accounted for 11%, other/multiple neuropeptide for about 8%, and unspecified for 22%.&lt;/p&gt;
&lt;p&gt;The median progression-free survival was 11.4 months in the sunitinib group and 5.5 months with placebo (HR 0.418, &lt;em&gt;P&lt;/em&gt;=0.0001). Patients treated with sunitinib had a 71.3% probability of being alive and free of disease at six months compared with 43.2% of the placebo group.&lt;/p&gt;
&lt;p&gt;Overall survival had not been reached after a median follow-up of 10 to 11 months. The probability of being alive at six months was 92.6% in the sunitinib arm and 85.2% in the placebo group. Kaplan-Meier analysis revealed a significant advantage in favor of the sunitinib arm (HR 0.409, &lt;em&gt;P&lt;/em&gt;=0.0204).&lt;/p&gt;
&lt;p&gt;Sunitinib was associated with an overall response rate of 9.3%, consisting of two complete responses and six partial responses. Additionally, 62.8% of patients in the sunitinib group had stable disease. The median response duration was 8.1 months. No objective responses occurred in the placebo group, but 60% had stable disease.&lt;/p&gt;
&lt;p&gt;Adverse events occurred more often in the sunitinib group, but grade 3+ events were uncommon in both groups.&lt;/p&gt;
&lt;p&gt;Although no unexpected adverse events were observed, Raymond said patients should be advised of the potential for graying of the hair, which occurred in almost 30% of sunitinib-treated patients.&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 Pfizer.&lt;/p&gt;&lt;p&gt;One or more investigators disclosed relationships with Pfizer.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
    <recommendedItem id="20100101_19_254"
                     title="ASCO GI: Survival Benefit with No New QoL Costs in Gastric Cancer"
                     score="-0.002"
                     href="http://www.medpagetoday.com/MeetingCoverage/ASCOGI/tb/18115?impressionId=1265792657718"
                     
      &lt;p&gt;ORLANDO  --  Patients with advanced HER2-positive gastric cancer live longer, with no decline in quality of life, when trastuzumab (Herceptin) is added to chemotherapy, researchers reported here.&lt;/p&gt;
&lt;p&gt;Symptoms improved when the monoclonal antibody was added to therapy, and pain scores and use of analgesics did not differ between patients who received chemotherapy with or without trastuzumab.&lt;/p&gt;
&lt;p&gt;&quot;Trastuzumab plus chemotherapy improves overall survival and progression-free survival versus chemotherapy alone, without compromising quality of life,&quot; Taroh Satoh, MD, of Kinki University in Osaka, Japan, told attendees at the Gastrointestinal Cancers Symposium.&lt;/p&gt;
&lt;p&gt;&quot;Because the regimen is associated with prolonged progression-free survival (PFS), more patients in the trastuzumab-chemotherapy arm could benefit from improved quality of life compared to chemotherapy alone,&quot; he added.&lt;/p&gt;
&lt;p&gt;After Satoh&apos;s presentation, an invited discussant said the trastuzumab-chemotherapy regimen should be considered standard of care for patients with HER2-positive gastric cancer.&lt;/p&gt;
&lt;p&gt;The findings came from a secondary analysis of a phase III, randomized global clinical trial evaluating the safety and efficacy of trastuzumab in patients with advanced HER2-positive cancer of the stomach or gastroesophageal junction.&lt;/p&gt;
&lt;p&gt;As previously reported, the primary outcome of the study was overall survival, which improved from 11.1 months with chemotherapy to 13.8 months (&lt;em&gt;P&lt;/em&gt;=0.0046) when trastuzumab was added to chemotherapy (ASCO 2009. Abstract 4509). PFS also favored the trastuzumab arm (6.7 months versus 5.5 months, &lt;em&gt;P&lt;/em&gt;=0.0012).&lt;/p&gt;
&lt;p&gt;An exploratory analysis of patients with more intense overexpression of HER2 showed an even greater survival benefit in favor of the trastuzumab arm (16.0 months versus 11.8 months, HR 0.65, 95% CI 0.51-0.83).&lt;/p&gt;
&lt;p&gt;The study involved 584 patients, who were randomized to capecitabine (Xeloda) plus 5-FU with or without trastuzumab. Quality of life was a prespecified secondary endpoint.&lt;/p&gt;
&lt;p&gt;Satoh said quality of life, pain, and analgesic use were evaluated at baseline and then every three weeks until disease progression.&lt;/p&gt;
&lt;p&gt;Investigators used a standardized questionnaire to evaluate patients&apos; global health status, functional status, and symptoms. A questionnaire specific to gastric cancer was used to assess disease- and treatment-related symptoms, side effects, dysphagia, nutrition, and emotional status.&lt;/p&gt;
&lt;p&gt;Patients rated pain intensity by means of a visual analog scale.&lt;/p&gt;
&lt;p&gt;Compliance with both regimens remained at 95% or higher throughout most of the trial for patients who continued treatment. Global health and physical functioning scores improved in both groups, and symptom scores decreased, including nausea and vomiting, and did not differ between groups, said Satoh.&lt;/p&gt;
&lt;p&gt;Dysphagia also improved over time in both groups. Pain intensity varied somewhat but generally declined in both groups, and the magnitude of improvement was similar in both groups.&lt;/p&gt;
&lt;p&gt;The vast majority of patients maintained or decreased analgesic use over the course of the study. Satoh said 20% of the trastuzumab group and 17% of the chemotherapy arm required dose increases or the addition of a new medication.&lt;/p&gt;
&lt;p&gt;The similarity of quality-of-life outcomes reinforced most gastric cancer specialists&apos; view that trastuzumab provides a survival benefit without a negative impact on quality of life, David Cunningham, MD, of the Royal Marsden Hospital in London, said in a discussion of the study.&lt;/p&gt;
&lt;p&gt;&quot;For patients with advanced gastroesophageal cancer who are HER2-positive the combination of trastuzumab, cisplatin and a fluoropyramidine should become the new standard treatment,&quot; Cunningham said. &quot;For HER2-negative patients, we continue to search for improvement in outcome. Doublet or triplet chemotherapy would appear to be acceptable treatment options for these patients.&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;One or more investigators disclosed relationships with Roche.&lt;/p&gt;&lt;p&gt;Cunningham reported no disclossures.&lt;/p&gt;&lt;/div&gt;&lt;div style=&quot;clear:both;&quot;&gt;&lt;/div&gt;
    </recommendedItem>
</recommendedContent>