Richard Hyer

CHICAGO – An effort to bolster standard preoperative chemoradiotherapy with capecitabine and oxaliplatin failed to improve surgical outcomes in a four-armed, phase III clinical study of 1,608 patients with stage II and III rectal adenocarcinoma.

Results were similar whether the preoperative regimen contained capecitabine (Xeloda) or continuous venous infusion (CVI) 5-fluorouracil (5-FU); the addition of oxaliplatin (Eloxatin) increased toxicity without changing outcomes, regardless of which regimen was used.

"For the surgical outcome analysis, administration of capecitabine with preoperative radiotherapy achieved rates similar to CVI 5-FU for surgical down-staging, sphincter-saving surgery, and [pathological] complete response," said Dr. Mark S. Roh, who presenting the results of the NSABP (National Surgical Adjuvant Breast and Bowel Project) R-04 trial at the annual meeting of the American Society of Clinical Oncology.

"Addition of oxaliplatin did not improve outcomes and added significant toxicity," added Dr. Roh, chairman of surgery at M.D. Anderson Cancer Center Orlando.

The current standard of care for T3-4 rectal cancer is preoperative chemoradiotherapy with CVI 5-FU. It has a distant relapse rate of 24%-30%, and compliance is suboptimal, he said. The trial was initiated, therefore, in the hope that more effective systemic chemotherapy would improve compliance, decrease the locoregional tumor relapse rate, and increase survival.

"The thought was that giving more effective systemic therapy up front perhaps would decrease the distant relapse rate," said Dr. Roh.

Evaluation of these end points is yet to come, with the final assessments of locoregional tumor relapse and disease-free and overall survival rates to be presented in 2013.

NSABP R-04 was activated in 2004 as a two-arm noninferiority study comparing CVI 5-FU with oral capecitabine, in both cases delivered with preoperative radiotherapy. With the Food and Drug Administration’s approval of oxaliplatin, the trial was amended in 2005 to include it, and the design was changed to a 2 x 2 factorial with the oxaliplatin comparison looking for superiority. During radiation therapy, 5-FU and capecitabine were reduced from 7 to 5 days each week. The trial was closed in August 2010.

All four groups received 4,600 cGy plus 540-1,080 cGy radiation. Chemotherapy dosages were 5-FU (CVI 225 mg/m² on 5 days per week for 5-6 weeks) in group 1; the same dosage of 5-FU plus oxaliplatin (50 mg/m² once weekly for 5 weeks) in group 2; oral capecitabine (825 mg/m² twice daily on 5 days per week for 5-6 weeks) in group 3; and same dose of capecitabine plus oxaliplatin (50 mg/m² once weekly for 5 weeks) in group 4.

More than half of the patients were stage II. About two-thirds of the population were men. At randomization, sphincter-sparing surgery was the intent in about three-quarters of the cases.

The only significant difference between arms of the study was that oxaliplatin increased grade 3/4 diarrhea (15.4% vs. 6.6% without oxaliplatin; P =.0001).

Surgical down-staging rates were similar in comparisons of 5-FU vs. capecitabine (20.7% and 23%, respectively) and oxaliplatin vs. no oxaliplatin (19.2% and 23%, respectively).

Nor was there any difference in sphincter-saving surgery rates by treatment (61.7% with 5-FU and 62.5% with capecitabine; 60.4% with oxaliplatin and 63.6% without oxaliplatin).

And there was no statistically significant difference in R-04 node positivity among the various treatment groups. The rates were about 70% with no positive nodes and about 90% with 0-3 positive nodes regardless of treatment?

Surgical complication rates also did not differ significantly among the groups; the rate of any complication was 34.92% with 5-FU, 37% with 5-FU plus oxaliplatin, 36.89% with capecitabine, and 40.2% with capecitabine plus oxaliplatin.

For pathological complete response, outcomes also were similar at 22.2% with capecitabine and 18.8% with 5-FU; they were 20.9% with oxaliplatin, and 19.1% without.

Discussant Dr. Robert Glynne-Jones of the Mount Vernon Centre for Cancer Treatment in Northwood, England, praised the study and its 2 x 2 factorial design as "a very nice study, very large numbers." He said the design allowed investigators to look at individual components and "see which is doing the work." He also said that this study would not change his clinical practice.

Dr. Roh stated that he had no relevant relationships to disclose. Dr. Glynne-Jones disclosed research funding from Roche.

CHICAGO – An effort to bolster standard preoperative chemoradiotherapy with capecitabine and oxaliplatin failed to improve surgical outcomes in a four-armed, phase III clinical study of 1,608 patients with stage II and III rectal adenocarcinoma.

Results were similar whether the preoperative regimen contained capecitabine (Xeloda) or continuous venous infusion (CVI) 5-fluorouracil (5-FU); the addition of oxaliplatin (Eloxatin) increased toxicity without changing outcomes, regardless of which regimen was used.

"For the surgical outcome analysis, administration of capecitabine with preoperative radiotherapy achieved rates similar to CVI 5-FU for surgical down-staging, sphincter-saving surgery, and [pathological] complete response," said Dr. Mark S. Roh, who presenting the results of the NSABP (National Surgical Adjuvant Breast and Bowel Project) R-04 trial at the annual meeting of the American Society of Clinical Oncology.

"Addition of oxaliplatin did not improve outcomes and added significant toxicity," added Dr. Roh, chairman of surgery at M.D. Anderson Cancer Center Orlando.

The current standard of care for T3-4 rectal cancer is preoperative chemoradiotherapy with CVI 5-FU. It has a distant relapse rate of 24%-30%, and compliance is suboptimal, he said. The trial was initiated, therefore, in the hope that more effective systemic chemotherapy would improve compliance, decrease the locoregional tumor relapse rate, and increase survival.

"The thought was that giving more effective systemic therapy up front perhaps would decrease the distant relapse rate," said Dr. Roh.

Evaluation of these end points is yet to come, with the final assessments of locoregional tumor relapse and disease-free and overall survival rates to be presented in 2013.

NSABP R-04 was activated in 2004 as a two-arm noninferiority study comparing CVI 5-FU with oral capecitabine, in both cases delivered with preoperative radiotherapy. With the Food and Drug Administration’s approval of oxaliplatin, the trial was amended in 2005 to include it, and the design was changed to a 2 x 2 factorial with the oxaliplatin comparison looking for superiority. During radiation therapy, 5-FU and capecitabine were reduced from 7 to 5 days each week. The trial was closed in August 2010.

All four groups received 4,600 cGy plus 540-1,080 cGy radiation. Chemotherapy dosages were 5-FU (CVI 225 mg/m² on 5 days per week for 5-6 weeks) in group 1; the same dosage of 5-FU plus oxaliplatin (50 mg/m² once weekly for 5 weeks) in group 2; oral capecitabine (825 mg/m² twice daily on 5 days per week for 5-6 weeks) in group 3; and same dose of capecitabine plus oxaliplatin (50 mg/m² once weekly for 5 weeks) in group 4.

More than half of the patients were stage II. About two-thirds of the population were men. At randomization, sphincter-sparing surgery was the intent in about three-quarters of the cases.

The only significant difference between arms of the study was that oxaliplatin increased grade 3/4 diarrhea (15.4% vs. 6.6% without oxaliplatin; P =.0001).

Surgical down-staging rates were similar in comparisons of 5-FU vs. capecitabine (20.7% and 23%, respectively) and oxaliplatin vs. no oxaliplatin (19.2% and 23%, respectively).

Nor was there any difference in sphincter-saving surgery rates by treatment (61.7% with 5-FU and 62.5% with capecitabine; 60.4% with oxaliplatin and 63.6% without oxaliplatin).

And there was no statistically significant difference in R-04 node positivity among the various treatment groups. The rates were about 70% with no positive nodes and about 90% with 0-3 positive nodes regardless of treatment?

Surgical complication rates also did not differ significantly among the groups; the rate of any complication was 34.92% with 5-FU, 37% with 5-FU plus oxaliplatin, 36.89% with capecitabine, and 40.2% with capecitabine plus oxaliplatin.

For pathological complete response, outcomes also were similar at 22.2% with capecitabine and 18.8% with 5-FU; they were 20.9% with oxaliplatin, and 19.1% without.

Discussant Dr. Robert Glynne-Jones of the Mount Vernon Centre for Cancer Treatment in Northwood, England, praised the study and its 2 x 2 factorial design as "a very nice study, very large numbers." He said the design allowed investigators to look at individual components and "see which is doing the work." He also said that this study would not change his clinical practice.

Dr. Roh stated that he had no relevant relationships to disclose. Dr. Glynne-Jones disclosed research funding from Roche.

CHICAGO – An effort to bolster standard preoperative chemoradiotherapy with capecitabine and oxaliplatin failed to improve surgical outcomes in a four-armed, phase III clinical study of 1,608 patients with stage II and III rectal adenocarcinoma.

Results were similar whether the preoperative regimen contained capecitabine (Xeloda) or continuous venous infusion (CVI) 5-fluorouracil (5-FU); the addition of oxaliplatin (Eloxatin) increased toxicity without changing outcomes, regardless of which regimen was used.

"For the surgical outcome analysis, administration of capecitabine with preoperative radiotherapy achieved rates similar to CVI 5-FU for surgical down-staging, sphincter-saving surgery, and [pathological] complete response," said Dr. Mark S. Roh, who presenting the results of the NSABP (National Surgical Adjuvant Breast and Bowel Project) R-04 trial at the annual meeting of the American Society of Clinical Oncology.

"Addition of oxaliplatin did not improve outcomes and added significant toxicity," added Dr. Roh, chairman of surgery at M.D. Anderson Cancer Center Orlando.

The current standard of care for T3-4 rectal cancer is preoperative chemoradiotherapy with CVI 5-FU. It has a distant relapse rate of 24%-30%, and compliance is suboptimal, he said. The trial was initiated, therefore, in the hope that more effective systemic chemotherapy would improve compliance, decrease the locoregional tumor relapse rate, and increase survival.

"The thought was that giving more effective systemic therapy up front perhaps would decrease the distant relapse rate," said Dr. Roh.

Evaluation of these end points is yet to come, with the final assessments of locoregional tumor relapse and disease-free and overall survival rates to be presented in 2013.

NSABP R-04 was activated in 2004 as a two-arm noninferiority study comparing CVI 5-FU with oral capecitabine, in both cases delivered with preoperative radiotherapy. With the Food and Drug Administration’s approval of oxaliplatin, the trial was amended in 2005 to include it, and the design was changed to a 2 x 2 factorial with the oxaliplatin comparison looking for superiority. During radiation therapy, 5-FU and capecitabine were reduced from 7 to 5 days each week. The trial was closed in August 2010.

All four groups received 4,600 cGy plus 540-1,080 cGy radiation. Chemotherapy dosages were 5-FU (CVI 225 mg/m² on 5 days per week for 5-6 weeks) in group 1; the same dosage of 5-FU plus oxaliplatin (50 mg/m² once weekly for 5 weeks) in group 2; oral capecitabine (825 mg/m² twice daily on 5 days per week for 5-6 weeks) in group 3; and same dose of capecitabine plus oxaliplatin (50 mg/m² once weekly for 5 weeks) in group 4.

More than half of the patients were stage II. About two-thirds of the population were men. At randomization, sphincter-sparing surgery was the intent in about three-quarters of the cases.

The only significant difference between arms of the study was that oxaliplatin increased grade 3/4 diarrhea (15.4% vs. 6.6% without oxaliplatin; P =.0001).

Surgical down-staging rates were similar in comparisons of 5-FU vs. capecitabine (20.7% and 23%, respectively) and oxaliplatin vs. no oxaliplatin (19.2% and 23%, respectively).

Nor was there any difference in sphincter-saving surgery rates by treatment (61.7% with 5-FU and 62.5% with capecitabine; 60.4% with oxaliplatin and 63.6% without oxaliplatin).

And there was no statistically significant difference in R-04 node positivity among the various treatment groups. The rates were about 70% with no positive nodes and about 90% with 0-3 positive nodes regardless of treatment?

Surgical complication rates also did not differ significantly among the groups; the rate of any complication was 34.92% with 5-FU, 37% with 5-FU plus oxaliplatin, 36.89% with capecitabine, and 40.2% with capecitabine plus oxaliplatin.

For pathological complete response, outcomes also were similar at 22.2% with capecitabine and 18.8% with 5-FU; they were 20.9% with oxaliplatin, and 19.1% without.

Discussant Dr. Robert Glynne-Jones of the Mount Vernon Centre for Cancer Treatment in Northwood, England, praised the study and its 2 x 2 factorial design as "a very nice study, very large numbers." He said the design allowed investigators to look at individual components and "see which is doing the work." He also said that this study would not change his clinical practice.

Dr. Roh stated that he had no relevant relationships to disclose. Dr. Glynne-Jones disclosed research funding from Roche.

CHICAGO – Serum hepcidin levels may help predict which cancer patients would benefit from the combination of erythropoiesis-stimulating agents and supplemental iron in the treatment of chemotherapy-associated anemia, new data suggest.

Investigators found a positive association between serum hepcidin levels and clinical response to the combination of darbepoetin alfa (Aranesp) and intravenous iron in a planned analysis of 489 patients in a randomized, phase III trial. The original study did not find a benefit from the combination, but the new analysis showed it was effective with higher doses of intravenous iron in people who had lower levels of hepcidin.

Overall, the analysis showed that patients who received four or five 187.5-mg doses of intravenous iron were the most likely to achieve a hemoglobin response (80%, vs. 65% for placebo, 67% for oral iron, and 56% for fewer than four doses of IV iron – all given in addition to darbepoetin). They also had the least need of red blood cell transfusions (9% vs. 13%-17% in the other groups).

The highest hemoglobin response rates in the study (92%-95%) occurred in 47 patients who had serum hepcidin levels below 64.3 ng/mL and received four to five doses of IV iron – and these patients required no red blood cell transfusions, Dr. David P. Steensma of Dana-Farber Cancer Institute, Boston, and his coauthors reported in a poster at the annual meeting of the American Society of Clinical Oncology.

"We found, interestingly, that patients who have lower hepcidin levels were much more likely to have positive response to the IV iron plus darbepoetin combination," Dr. Steensma said in an interview.

Hepcidin, a peptide made by hepatocytes, is a critical regulator of systemic iron homeostasis, and low serum hepcidin concentrations may predict iron deficiency, according to the poster.

This planned analysis followed a Mayo Clinic Cancer Research Consortium study which compared darbepoetin with darbepoetin plus oral iron and darbepoetin plus IV iron (ferrous sulfate) in two doses. The investigators reported that supplemental IV iron provided no additional benefit compared with oral placebo or oral iron in the trial (J. Clin. Oncol. 2011;29:97-105).

Serum hepcidin concentration was measured from samples taken before treatment from 405 (83%) of the 489 eligible patients. Stratification by tertiles showed the lowest tertile had up to 20.2 ng/mL, the middle greater than 20.ng/mL to 64.3 ng/mL, and the highest greater than 64.3 ng/mL.

"The conclusions from this evaluation were that lower pretreatment serum hepcidin was associated with better clinical response. Serum hepcidin measurements may help predict response to ESAs plus supplemental iron in future trials," Dr. Patricia Ganz of the University of California Los Angeles schools of medicine and public health said in an invited discussion of the study.

"The relative underdosing of IV iron in the [original] trial may explain the negative results, but the potential risks of higher doses of IV iron, e.g., iron overload, must also be considered," she said.

Asked whether this research would change his clinical practice, Dr. Steensma said that no serum hepcidin assay is commercially available, but that one is in development.

"I think that in the future I’ll probably use serum hepcidin to help distinguish a subset of patients who may have relative iron deficiency, or who may benefit from IV iron, and perhaps use that to help target patients who should receive combination therapy, versus those [for whom] maybe an ESA alone would be just fine," he said. "Especially if this is confirmed in other data sets."

The study was sponsored by Amgen. Dr. Steensma disclosed a consultant or advisory role with Amgen, maker of ESAs darbepoetin alfa and erythropoietin alfa. Dr. Ganz disclosed that her husband, Dr. Tomas Ganz, discovered hepcidin (Blood 2003;102:783-8), and that he has employment and stock ownership in Intrinsic LifeSciences, which is developing a test for hepcidin, has received research funding from Amgen, and has been a paid consultant to several companies including Ortho Biotech, which markets erythropoietin.

CHICAGO – Serum hepcidin levels may help predict which cancer patients would benefit from the combination of erythropoiesis-stimulating agents and supplemental iron in the treatment of chemotherapy-associated anemia, new data suggest.

Investigators found a positive association between serum hepcidin levels and clinical response to the combination of darbepoetin alfa (Aranesp) and intravenous iron in a planned analysis of 489 patients in a randomized, phase III trial. The original study did not find a benefit from the combination, but the new analysis showed it was effective with higher doses of intravenous iron in people who had lower levels of hepcidin.

Overall, the analysis showed that patients who received four or five 187.5-mg doses of intravenous iron were the most likely to achieve a hemoglobin response (80%, vs. 65% for placebo, 67% for oral iron, and 56% for fewer than four doses of IV iron – all given in addition to darbepoetin). They also had the least need of red blood cell transfusions (9% vs. 13%-17% in the other groups).

The highest hemoglobin response rates in the study (92%-95%) occurred in 47 patients who had serum hepcidin levels below 64.3 ng/mL and received four to five doses of IV iron – and these patients required no red blood cell transfusions, Dr. David P. Steensma of Dana-Farber Cancer Institute, Boston, and his coauthors reported in a poster at the annual meeting of the American Society of Clinical Oncology.

"We found, interestingly, that patients who have lower hepcidin levels were much more likely to have positive response to the IV iron plus darbepoetin combination," Dr. Steensma said in an interview.

Hepcidin, a peptide made by hepatocytes, is a critical regulator of systemic iron homeostasis, and low serum hepcidin concentrations may predict iron deficiency, according to the poster.

This planned analysis followed a Mayo Clinic Cancer Research Consortium study which compared darbepoetin with darbepoetin plus oral iron and darbepoetin plus IV iron (ferrous sulfate) in two doses. The investigators reported that supplemental IV iron provided no additional benefit compared with oral placebo or oral iron in the trial (J. Clin. Oncol. 2011;29:97-105).

Serum hepcidin concentration was measured from samples taken before treatment from 405 (83%) of the 489 eligible patients. Stratification by tertiles showed the lowest tertile had up to 20.2 ng/mL, the middle greater than 20.ng/mL to 64.3 ng/mL, and the highest greater than 64.3 ng/mL.

"The conclusions from this evaluation were that lower pretreatment serum hepcidin was associated with better clinical response. Serum hepcidin measurements may help predict response to ESAs plus supplemental iron in future trials," Dr. Patricia Ganz of the University of California Los Angeles schools of medicine and public health said in an invited discussion of the study.

"The relative underdosing of IV iron in the [original] trial may explain the negative results, but the potential risks of higher doses of IV iron, e.g., iron overload, must also be considered," she said.

Asked whether this research would change his clinical practice, Dr. Steensma said that no serum hepcidin assay is commercially available, but that one is in development.

"I think that in the future I’ll probably use serum hepcidin to help distinguish a subset of patients who may have relative iron deficiency, or who may benefit from IV iron, and perhaps use that to help target patients who should receive combination therapy, versus those [for whom] maybe an ESA alone would be just fine," he said. "Especially if this is confirmed in other data sets."

The study was sponsored by Amgen. Dr. Steensma disclosed a consultant or advisory role with Amgen, maker of ESAs darbepoetin alfa and erythropoietin alfa. Dr. Ganz disclosed that her husband, Dr. Tomas Ganz, discovered hepcidin (Blood 2003;102:783-8), and that he has employment and stock ownership in Intrinsic LifeSciences, which is developing a test for hepcidin, has received research funding from Amgen, and has been a paid consultant to several companies including Ortho Biotech, which markets erythropoietin.

CHICAGO – Serum hepcidin levels may help predict which cancer patients would benefit from the combination of erythropoiesis-stimulating agents and supplemental iron in the treatment of chemotherapy-associated anemia, new data suggest.

Investigators found a positive association between serum hepcidin levels and clinical response to the combination of darbepoetin alfa (Aranesp) and intravenous iron in a planned analysis of 489 patients in a randomized, phase III trial. The original study did not find a benefit from the combination, but the new analysis showed it was effective with higher doses of intravenous iron in people who had lower levels of hepcidin.

Overall, the analysis showed that patients who received four or five 187.5-mg doses of intravenous iron were the most likely to achieve a hemoglobin response (80%, vs. 65% for placebo, 67% for oral iron, and 56% for fewer than four doses of IV iron – all given in addition to darbepoetin). They also had the least need of red blood cell transfusions (9% vs. 13%-17% in the other groups).

The highest hemoglobin response rates in the study (92%-95%) occurred in 47 patients who had serum hepcidin levels below 64.3 ng/mL and received four to five doses of IV iron – and these patients required no red blood cell transfusions, Dr. David P. Steensma of Dana-Farber Cancer Institute, Boston, and his coauthors reported in a poster at the annual meeting of the American Society of Clinical Oncology.

"We found, interestingly, that patients who have lower hepcidin levels were much more likely to have positive response to the IV iron plus darbepoetin combination," Dr. Steensma said in an interview.

Hepcidin, a peptide made by hepatocytes, is a critical regulator of systemic iron homeostasis, and low serum hepcidin concentrations may predict iron deficiency, according to the poster.

This planned analysis followed a Mayo Clinic Cancer Research Consortium study which compared darbepoetin with darbepoetin plus oral iron and darbepoetin plus IV iron (ferrous sulfate) in two doses. The investigators reported that supplemental IV iron provided no additional benefit compared with oral placebo or oral iron in the trial (J. Clin. Oncol. 2011;29:97-105).

Serum hepcidin concentration was measured from samples taken before treatment from 405 (83%) of the 489 eligible patients. Stratification by tertiles showed the lowest tertile had up to 20.2 ng/mL, the middle greater than 20.ng/mL to 64.3 ng/mL, and the highest greater than 64.3 ng/mL.

"The conclusions from this evaluation were that lower pretreatment serum hepcidin was associated with better clinical response. Serum hepcidin measurements may help predict response to ESAs plus supplemental iron in future trials," Dr. Patricia Ganz of the University of California Los Angeles schools of medicine and public health said in an invited discussion of the study.

"The relative underdosing of IV iron in the [original] trial may explain the negative results, but the potential risks of higher doses of IV iron, e.g., iron overload, must also be considered," she said.

Asked whether this research would change his clinical practice, Dr. Steensma said that no serum hepcidin assay is commercially available, but that one is in development.

"I think that in the future I’ll probably use serum hepcidin to help distinguish a subset of patients who may have relative iron deficiency, or who may benefit from IV iron, and perhaps use that to help target patients who should receive combination therapy, versus those [for whom] maybe an ESA alone would be just fine," he said. "Especially if this is confirmed in other data sets."

The study was sponsored by Amgen. Dr. Steensma disclosed a consultant or advisory role with Amgen, maker of ESAs darbepoetin alfa and erythropoietin alfa. Dr. Ganz disclosed that her husband, Dr. Tomas Ganz, discovered hepcidin (Blood 2003;102:783-8), and that he has employment and stock ownership in Intrinsic LifeSciences, which is developing a test for hepcidin, has received research funding from Amgen, and has been a paid consultant to several companies including Ortho Biotech, which markets erythropoietin.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – Total dietary fats and saturated fatty acids were found to be positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus, in a prospective cohort study reported at the annual Digestive Disease Week.

"The role of fats may therefore be important in the change from metaplasia into neoplasia," said principal investigator Dr. Max Yates of the Norfolk and Norwich (England) University Hospital. "Dietary fats and saturated fats should therefore be measured in future etiological studies of adenocarcinoma."

The study, funded by Cancer Research UK and the U.K. Medical Research Council, was intended to evaluate the role of dietary fat in the etiology of Barrett’s esophagus and esophageal adenocarcinoma. Barrett’s esophagus is characterized by metaplastic change in the cells of the lower esophagus, Dr. Yates said, and is recognized as a risk factor for esophageal adenocarcinoma.

A prospective cohort design was selected because the alternative case-control designs are subject to recall bias and selection bias, which can lead to inaccuracies in the dietary information.

The cohort was recruited from the EPIC (European Prospective Investigation into Cancer and Nutrition) Norfolk county database. The EPIC study overall has recruited over 500,000 participants in 10 countries, and the EPIC-Norfolk cohort consists of 23,750 participants (aged 45-74 years) from rural, suburban, and inner-city areas.

There were three groups in the study: 3,667 randomly selected controls, 100 cases of Barrett’s esophagus, and 61 cases of esophageal adenocarcinoma. Controls were about the same age as were patients with Barrett’s esophagus (median, 59-60 years at recruitment), whereas those with esophageal adenocarcinoma were about 7 years older (median, 67 years). More than 80% of both groups were male. In this prospective cohort, the median age at diagnosis was 67 years for the Barrett’s patients and 73 years for the esophageal adenocarcinoma patients.

At enrollment and with the help of a nutritionist, participants began a 7-day food diary, which is "the most accurate, validated form of pragmatic nutritional assessment in large-scale epidemiological studies," said Dr. Yates. Patients recorded all food and beverages consumed, along with brands, portion sizes, and recipes. The diaries were coded using the DINER (Data Into Nutrients for Epidemiological Research) computer program.

Quintiles of dietary fat intake were generated, and hazard ratios were estimated using Cox regression analysis adjusted for age, sex, body mass index, smoking, alcohol use, and total energy intake.

The study population was divided into quintiles of dietary fat intake, and no association was found between total dietary fat intake and the diagnosis of Barrett’s esophagus. However, for esophageal adenocarcinoma, a stepwise increase in risk was observed across all quintiles of fat intake.

"The fifth (or highest) quintile has just under four times greater risk, compared to the lowest," said Dr. Yates, noting that this finding nevertheless did not quite reach statistical significance. However, he said, the trend from one quintile to the next was 50%, and this was statistically significant (hazard ratio, 1.50; 95% confidence interval, 1.05-2.14; P = .03).

The results were similar for saturated fats. No association was found between dietary saturated fat intake and a diagnosis of Barrett’s esophagus. However, there was an increased risk for esophageal adenocarcinoma with greater saturated fat intake.

"The fifth (highest) quintile had around three times greater risk, compared to the lowest," said Dr. Yates. The trend, or average increase between quintiles, was statistically significant (HR, 1.35; 95% CI, 1.01-1.85; P = 04).

Dr. Yates concluded that total fats and saturated fatty acids were positively associated with esophageal adenocarcinoma, but not with Barrett’s esophagus. "This has been demonstrated for the first time using food diaries, in a prospective cohort," he said, adding that fats may play a role in the transition of tissue from metaplasia to neoplasia. The study is ongoing, with a goal of assessing many different dietary factors, to determine whether they are involved in the development of this type of cancer.

The study was funded by Cancer Research UK and the U.K. Medical Research Council. Dr. Yates stated that he had no relevant financial disclosures.

CHICAGO – The combination of white light endoscopy and magnifying narrow-band imaging shows promise for achieving accurate diagnosis of early gastric cancer, based on a prospective, randomized, controlled trial conducted in Japan.

"Magnifying narrow-band imaging improved [the] diagnostic performance of white light endoscopy for discriminating gastric cancer from benign small depressed lesions," said Dr. Noriya Uedo, the principal investigator. "Adding magnifying narrow-band imaging to white light endoscopy could make accurate diagnosis of early gastric cancer [possible] without biopsy."

Currently, a diagnosis is made primarily via biopsy, said Dr. Uedo at the annual Digestive Disease Week.

Narrow-band imaging (NBI) is a novel optical technology for examining the surface structure and vascular architecture in the superficial mucosa. "Using magnifying endoscopy, it enables us to evaluate detailed morphological features of both epithelium and vasculature corresponding to histology," he said.

This study was designed to compare the real-time diagnostic performance of conventional white light endoscopy vs. magnifying NBI for gastric lesions no larger than 1 cm.

The trial included patients with a history of endoscopic treatment of early gastric cancer who were at high risk for developing recurrent gastric cancer. The study’s primary objective was to contrast the diagnostic accuracy of the two modalities.

On enrollment, patients were screened with white light endoscopy, and those who were found to have a previously undiagnosed small depressed lesion were randomized to either the white light group or the magnifying NBI group. In the white light group, after the endoscopic finding was documented, the lesion was then evaluated with magnifying NBI.

Between June 2008 and May 2010, 1,365 patients were enrolled, and 362 were found to have small depressed lesions. These patients were randomized to the white light endoscopy group or the magnifying narrow-band imaging group. There were 20 patients with gastric carcinoma in each group.

The diagnostic accuracy of white light endoscopy was 65% (114 of 176), whereas that of magnifying NBI was 90% (160 of 177), and this difference was statistically significant (P less than .001). Sensitivity was also higher in the magnifying NBI group at 60% (12 of 20) vs. 40% (8 of 20), but this difference did not reach statistical significance. Specificity was significantly higher in the magnifying NBI group at 94% (148 of 157), compared with the white light endoscopy group at 68% (106 of 156; P less than .001).

The time required to make a diagnosis with magnifying NBI was about 30 seconds longer than with white light endoscopy. "The difference would be acceptable in a clinical setting, instead of taking a biopsy, I think," said Dr. Uedo of the department of gastrointestinal oncology, Osaka (Japan) Medical Center for Cancer and Cardiovascular Diseases.

The diagnostic performance of magnifying NBI following white light imaging, compared with white light imaging alone, was significantly better in terms of accuracy, sensitivity, and specificity (P less than .001 in each case).

Dr. Uedo said that the specificity of white light endoscopy was not very high, and the number of false-positive lesions was large. "So, the number of biopsies is also large," he said. Only 40% of carcinomas were correctly diagnosed based on their endoscopic appearance. However, he said, the number of false-positive lesions in the magnifying NBI group was small, because of the higher specificity, and in turn the number of biopsies was lower.

As for the combination of the two modalities, he said that it "shows extremely excellent performance for differentiation of carcinoma from [a] benign depressed lesion."

Gastric cancer is the second leading cause of cancer death worldwide, and the earlier the diagnosis, the better the patient’s prognosis.

The study was funded by a grant-in-aid for cancer research from the Ministry of Health, Labor, and Welfare of Japan. Dr. Uedo does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services discussed during the presentation.

CHICAGO – The combination of white light endoscopy and magnifying narrow-band imaging shows promise for achieving accurate diagnosis of early gastric cancer, based on a prospective, randomized, controlled trial conducted in Japan.

"Magnifying narrow-band imaging improved [the] diagnostic performance of white light endoscopy for discriminating gastric cancer from benign small depressed lesions," said Dr. Noriya Uedo, the principal investigator. "Adding magnifying narrow-band imaging to white light endoscopy could make accurate diagnosis of early gastric cancer [possible] without biopsy."

Currently, a diagnosis is made primarily via biopsy, said Dr. Uedo at the annual Digestive Disease Week.

Narrow-band imaging (NBI) is a novel optical technology for examining the surface structure and vascular architecture in the superficial mucosa. "Using magnifying endoscopy, it enables us to evaluate detailed morphological features of both epithelium and vasculature corresponding to histology," he said.

This study was designed to compare the real-time diagnostic performance of conventional white light endoscopy vs. magnifying NBI for gastric lesions no larger than 1 cm.

The trial included patients with a history of endoscopic treatment of early gastric cancer who were at high risk for developing recurrent gastric cancer. The study’s primary objective was to contrast the diagnostic accuracy of the two modalities.

On enrollment, patients were screened with white light endoscopy, and those who were found to have a previously undiagnosed small depressed lesion were randomized to either the white light group or the magnifying NBI group. In the white light group, after the endoscopic finding was documented, the lesion was then evaluated with magnifying NBI.

Between June 2008 and May 2010, 1,365 patients were enrolled, and 362 were found to have small depressed lesions. These patients were randomized to the white light endoscopy group or the magnifying narrow-band imaging group. There were 20 patients with gastric carcinoma in each group.

The diagnostic accuracy of white light endoscopy was 65% (114 of 176), whereas that of magnifying NBI was 90% (160 of 177), and this difference was statistically significant (P less than .001). Sensitivity was also higher in the magnifying NBI group at 60% (12 of 20) vs. 40% (8 of 20), but this difference did not reach statistical significance. Specificity was significantly higher in the magnifying NBI group at 94% (148 of 157), compared with the white light endoscopy group at 68% (106 of 156; P less than .001).

The time required to make a diagnosis with magnifying NBI was about 30 seconds longer than with white light endoscopy. "The difference would be acceptable in a clinical setting, instead of taking a biopsy, I think," said Dr. Uedo of the department of gastrointestinal oncology, Osaka (Japan) Medical Center for Cancer and Cardiovascular Diseases.

The diagnostic performance of magnifying NBI following white light imaging, compared with white light imaging alone, was significantly better in terms of accuracy, sensitivity, and specificity (P less than .001 in each case).

Dr. Uedo said that the specificity of white light endoscopy was not very high, and the number of false-positive lesions was large. "So, the number of biopsies is also large," he said. Only 40% of carcinomas were correctly diagnosed based on their endoscopic appearance. However, he said, the number of false-positive lesions in the magnifying NBI group was small, because of the higher specificity, and in turn the number of biopsies was lower.

As for the combination of the two modalities, he said that it "shows extremely excellent performance for differentiation of carcinoma from [a] benign depressed lesion."

Gastric cancer is the second leading cause of cancer death worldwide, and the earlier the diagnosis, the better the patient’s prognosis.

The study was funded by a grant-in-aid for cancer research from the Ministry of Health, Labor, and Welfare of Japan. Dr. Uedo does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services discussed during the presentation.

CHICAGO – The combination of white light endoscopy and magnifying narrow-band imaging shows promise for achieving accurate diagnosis of early gastric cancer, based on a prospective, randomized, controlled trial conducted in Japan.

"Magnifying narrow-band imaging improved [the] diagnostic performance of white light endoscopy for discriminating gastric cancer from benign small depressed lesions," said Dr. Noriya Uedo, the principal investigator. "Adding magnifying narrow-band imaging to white light endoscopy could make accurate diagnosis of early gastric cancer [possible] without biopsy."

Currently, a diagnosis is made primarily via biopsy, said Dr. Uedo at the annual Digestive Disease Week.

Narrow-band imaging (NBI) is a novel optical technology for examining the surface structure and vascular architecture in the superficial mucosa. "Using magnifying endoscopy, it enables us to evaluate detailed morphological features of both epithelium and vasculature corresponding to histology," he said.

This study was designed to compare the real-time diagnostic performance of conventional white light endoscopy vs. magnifying NBI for gastric lesions no larger than 1 cm.

The trial included patients with a history of endoscopic treatment of early gastric cancer who were at high risk for developing recurrent gastric cancer. The study’s primary objective was to contrast the diagnostic accuracy of the two modalities.

On enrollment, patients were screened with white light endoscopy, and those who were found to have a previously undiagnosed small depressed lesion were randomized to either the white light group or the magnifying NBI group. In the white light group, after the endoscopic finding was documented, the lesion was then evaluated with magnifying NBI.

Between June 2008 and May 2010, 1,365 patients were enrolled, and 362 were found to have small depressed lesions. These patients were randomized to the white light endoscopy group or the magnifying narrow-band imaging group. There were 20 patients with gastric carcinoma in each group.

The diagnostic accuracy of white light endoscopy was 65% (114 of 176), whereas that of magnifying NBI was 90% (160 of 177), and this difference was statistically significant (P less than .001). Sensitivity was also higher in the magnifying NBI group at 60% (12 of 20) vs. 40% (8 of 20), but this difference did not reach statistical significance. Specificity was significantly higher in the magnifying NBI group at 94% (148 of 157), compared with the white light endoscopy group at 68% (106 of 156; P less than .001).

The time required to make a diagnosis with magnifying NBI was about 30 seconds longer than with white light endoscopy. "The difference would be acceptable in a clinical setting, instead of taking a biopsy, I think," said Dr. Uedo of the department of gastrointestinal oncology, Osaka (Japan) Medical Center for Cancer and Cardiovascular Diseases.

The diagnostic performance of magnifying NBI following white light imaging, compared with white light imaging alone, was significantly better in terms of accuracy, sensitivity, and specificity (P less than .001 in each case).

Dr. Uedo said that the specificity of white light endoscopy was not very high, and the number of false-positive lesions was large. "So, the number of biopsies is also large," he said. Only 40% of carcinomas were correctly diagnosed based on their endoscopic appearance. However, he said, the number of false-positive lesions in the magnifying NBI group was small, because of the higher specificity, and in turn the number of biopsies was lower.

As for the combination of the two modalities, he said that it "shows extremely excellent performance for differentiation of carcinoma from [a] benign depressed lesion."

Gastric cancer is the second leading cause of cancer death worldwide, and the earlier the diagnosis, the better the patient’s prognosis.

The study was funded by a grant-in-aid for cancer research from the Ministry of Health, Labor, and Welfare of Japan. Dr. Uedo does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services discussed during the presentation.

CHICAGO – The combination of white light endoscopy and magnifying narrow-band imaging shows promise for achieving accurate diagnosis of early gastric cancer, based on a prospective, randomized, controlled trial conducted in Japan.

"Magnifying narrow-band imaging improved [the] diagnostic performance of white light endoscopy for discriminating gastric cancer from benign small depressed lesions," said Dr. Noriya Uedo, the principal investigator. "Adding magnifying narrow-band imaging to white light endoscopy could make accurate diagnosis of early gastric cancer [possible] without biopsy."

Currently, a diagnosis is made primarily via biopsy, said Dr. Uedo at the annual Digestive Disease Week.

Narrow-band imaging (NBI) is a novel optical technology for examining the surface structure and vascular architecture in the superficial mucosa. "Using magnifying endoscopy, it enables us to evaluate detailed morphological features of both epithelium and vasculature corresponding to histology," he said.

This study was designed to compare the real-time diagnostic performance of conventional white light endoscopy vs. magnifying NBI for gastric lesions no larger than 1 cm.

The trial included patients with a history of endoscopic treatment of early gastric cancer who were at high risk for developing recurrent gastric cancer. The study’s primary objective was to contrast the diagnostic accuracy of the two modalities.

On enrollment, patients were screened with white light endoscopy, and those who were found to have a previously undiagnosed small depressed lesion were randomized to either the white light group or the magnifying NBI group. In the white light group, after the endoscopic finding was documented, the lesion was then evaluated with magnifying NBI.

Between June 2008 and May 2010, 1,365 patients were enrolled, and 362 were found to have small depressed lesions. These patients were randomized to the white light endoscopy group or the magnifying narrow-band imaging group. There were 20 patients with gastric carcinoma in each group.

The diagnostic accuracy of white light endoscopy was 65% (114 of 176), whereas that of magnifying NBI was 90% (160 of 177), and this difference was statistically significant (P less than .001). Sensitivity was also higher in the magnifying NBI group at 60% (12 of 20) vs. 40% (8 of 20), but this difference did not reach statistical significance. Specificity was significantly higher in the magnifying NBI group at 94% (148 of 157), compared with the white light endoscopy group at 68% (106 of 156; P less than .001).

The time required to make a diagnosis with magnifying NBI was about 30 seconds longer than with white light endoscopy. "The difference would be acceptable in a clinical setting, instead of taking a biopsy, I think," said Dr. Uedo of the department of gastrointestinal oncology, Osaka (Japan) Medical Center for Cancer and Cardiovascular Diseases.

The diagnostic performance of magnifying NBI following white light imaging, compared with white light imaging alone, was significantly better in terms of accuracy, sensitivity, and specificity (P less than .001 in each case).

Dr. Uedo said that the specificity of white light endoscopy was not very high, and the number of false-positive lesions was large. "So, the number of biopsies is also large," he said. Only 40% of carcinomas were correctly diagnosed based on their endoscopic appearance. However, he said, the number of false-positive lesions in the magnifying NBI group was small, because of the higher specificity, and in turn the number of biopsies was lower.

As for the combination of the two modalities, he said that it "shows extremely excellent performance for differentiation of carcinoma from [a] benign depressed lesion."

Gastric cancer is the second leading cause of cancer death worldwide, and the earlier the diagnosis, the better the patient’s prognosis.

The study was funded by a grant-in-aid for cancer research from the Ministry of Health, Labor, and Welfare of Japan. Dr. Uedo does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services discussed during the presentation.

CHICAGO – The combination of white light endoscopy and magnifying narrow-band imaging shows promise for achieving accurate diagnosis of early gastric cancer, based on a prospective, randomized, controlled trial conducted in Japan.

"Magnifying narrow-band imaging improved [the] diagnostic performance of white light endoscopy for discriminating gastric cancer from benign small depressed lesions," said Dr. Noriya Uedo, the principal investigator. "Adding magnifying narrow-band imaging to white light endoscopy could make accurate diagnosis of early gastric cancer [possible] without biopsy."

Currently, a diagnosis is made primarily via biopsy, said Dr. Uedo at the annual Digestive Disease Week.

Narrow-band imaging (NBI) is a novel optical technology for examining the surface structure and vascular architecture in the superficial mucosa. "Using magnifying endoscopy, it enables us to evaluate detailed morphological features of both epithelium and vasculature corresponding to histology," he said.

This study was designed to compare the real-time diagnostic performance of conventional white light endoscopy vs. magnifying NBI for gastric lesions no larger than 1 cm.

The trial included patients with a history of endoscopic treatment of early gastric cancer who were at high risk for developing recurrent gastric cancer. The study’s primary objective was to contrast the diagnostic accuracy of the two modalities.

On enrollment, patients were screened with white light endoscopy, and those who were found to have a previously undiagnosed small depressed lesion were randomized to either the white light group or the magnifying NBI group. In the white light group, after the endoscopic finding was documented, the lesion was then evaluated with magnifying NBI.

Between June 2008 and May 2010, 1,365 patients were enrolled, and 362 were found to have small depressed lesions. These patients were randomized to the white light endoscopy group or the magnifying narrow-band imaging group. There were 20 patients with gastric carcinoma in each group.

The diagnostic accuracy of white light endoscopy was 65% (114 of 176), whereas that of magnifying NBI was 90% (160 of 177), and this difference was statistically significant (P less than .001). Sensitivity was also higher in the magnifying NBI group at 60% (12 of 20) vs. 40% (8 of 20), but this difference did not reach statistical significance. Specificity was significantly higher in the magnifying NBI group at 94% (148 of 157), compared with the white light endoscopy group at 68% (106 of 156; P less than .001).

The time required to make a diagnosis with magnifying NBI was about 30 seconds longer than with white light endoscopy. "The difference would be acceptable in a clinical setting, instead of taking a biopsy, I think," said Dr. Uedo of the department of gastrointestinal oncology, Osaka (Japan) Medical Center for Cancer and Cardiovascular Diseases.

The diagnostic performance of magnifying NBI following white light imaging, compared with white light imaging alone, was significantly better in terms of accuracy, sensitivity, and specificity (P less than .001 in each case).

Dr. Uedo said that the specificity of white light endoscopy was not very high, and the number of false-positive lesions was large. "So, the number of biopsies is also large," he said. Only 40% of carcinomas were correctly diagnosed based on their endoscopic appearance. However, he said, the number of false-positive lesions in the magnifying NBI group was small, because of the higher specificity, and in turn the number of biopsies was lower.

As for the combination of the two modalities, he said that it "shows extremely excellent performance for differentiation of carcinoma from [a] benign depressed lesion."

Gastric cancer is the second leading cause of cancer death worldwide, and the earlier the diagnosis, the better the patient’s prognosis.

The study was funded by a grant-in-aid for cancer research from the Ministry of Health, Labor, and Welfare of Japan. Dr. Uedo does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services discussed during the presentation.

CHICAGO – The combination of white light endoscopy and magnifying narrow-band imaging shows promise for achieving accurate diagnosis of early gastric cancer, based on a prospective, randomized, controlled trial conducted in Japan.

"Magnifying narrow-band imaging improved [the] diagnostic performance of white light endoscopy for discriminating gastric cancer from benign small depressed lesions," said Dr. Noriya Uedo, the principal investigator. "Adding magnifying narrow-band imaging to white light endoscopy could make accurate diagnosis of early gastric cancer [possible] without biopsy."

Currently, a diagnosis is made primarily via biopsy, said Dr. Uedo at the annual Digestive Disease Week.

Narrow-band imaging (NBI) is a novel optical technology for examining the surface structure and vascular architecture in the superficial mucosa. "Using magnifying endoscopy, it enables us to evaluate detailed morphological features of both epithelium and vasculature corresponding to histology," he said.

This study was designed to compare the real-time diagnostic performance of conventional white light endoscopy vs. magnifying NBI for gastric lesions no larger than 1 cm.

The trial included patients with a history of endoscopic treatment of early gastric cancer who were at high risk for developing recurrent gastric cancer. The study’s primary objective was to contrast the diagnostic accuracy of the two modalities.

On enrollment, patients were screened with white light endoscopy, and those who were found to have a previously undiagnosed small depressed lesion were randomized to either the white light group or the magnifying NBI group. In the white light group, after the endoscopic finding was documented, the lesion was then evaluated with magnifying NBI.

Between June 2008 and May 2010, 1,365 patients were enrolled, and 362 were found to have small depressed lesions. These patients were randomized to the white light endoscopy group or the magnifying narrow-band imaging group. There were 20 patients with gastric carcinoma in each group.

The diagnostic accuracy of white light endoscopy was 65% (114 of 176), whereas that of magnifying NBI was 90% (160 of 177), and this difference was statistically significant (P less than .001). Sensitivity was also higher in the magnifying NBI group at 60% (12 of 20) vs. 40% (8 of 20), but this difference did not reach statistical significance. Specificity was significantly higher in the magnifying NBI group at 94% (148 of 157), compared with the white light endoscopy group at 68% (106 of 156; P less than .001).

The time required to make a diagnosis with magnifying NBI was about 30 seconds longer than with white light endoscopy. "The difference would be acceptable in a clinical setting, instead of taking a biopsy, I think," said Dr. Uedo of the department of gastrointestinal oncology, Osaka (Japan) Medical Center for Cancer and Cardiovascular Diseases.

The diagnostic performance of magnifying NBI following white light imaging, compared with white light imaging alone, was significantly better in terms of accuracy, sensitivity, and specificity (P less than .001 in each case).

Dr. Uedo said that the specificity of white light endoscopy was not very high, and the number of false-positive lesions was large. "So, the number of biopsies is also large," he said. Only 40% of carcinomas were correctly diagnosed based on their endoscopic appearance. However, he said, the number of false-positive lesions in the magnifying NBI group was small, because of the higher specificity, and in turn the number of biopsies was lower.

As for the combination of the two modalities, he said that it "shows extremely excellent performance for differentiation of carcinoma from [a] benign depressed lesion."

Gastric cancer is the second leading cause of cancer death worldwide, and the earlier the diagnosis, the better the patient’s prognosis.

The study was funded by a grant-in-aid for cancer research from the Ministry of Health, Labor, and Welfare of Japan. Dr. Uedo does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services discussed during the presentation.

CHICAGO – The combination of white light endoscopy and magnifying narrow-band imaging shows promise for achieving accurate diagnosis of early gastric cancer, based on a prospective, randomized, controlled trial conducted in Japan.

"Magnifying narrow-band imaging improved [the] diagnostic performance of white light endoscopy for discriminating gastric cancer from benign small depressed lesions," said Dr. Noriya Uedo, the principal investigator. "Adding magnifying narrow-band imaging to white light endoscopy could make accurate diagnosis of early gastric cancer [possible] without biopsy."

Currently, a diagnosis is made primarily via biopsy, said Dr. Uedo at the annual Digestive Disease Week.

Narrow-band imaging (NBI) is a novel optical technology for examining the surface structure and vascular architecture in the superficial mucosa. "Using magnifying endoscopy, it enables us to evaluate detailed morphological features of both epithelium and vasculature corresponding to histology," he said.

This study was designed to compare the real-time diagnostic performance of conventional white light endoscopy vs. magnifying NBI for gastric lesions no larger than 1 cm.

The trial included patients with a history of endoscopic treatment of early gastric cancer who were at high risk for developing recurrent gastric cancer. The study’s primary objective was to contrast the diagnostic accuracy of the two modalities.

On enrollment, patients were screened with white light endoscopy, and those who were found to have a previously undiagnosed small depressed lesion were randomized to either the white light group or the magnifying NBI group. In the white light group, after the endoscopic finding was documented, the lesion was then evaluated with magnifying NBI.

Between June 2008 and May 2010, 1,365 patients were enrolled, and 362 were found to have small depressed lesions. These patients were randomized to the white light endoscopy group or the magnifying narrow-band imaging group. There were 20 patients with gastric carcinoma in each group.

The diagnostic accuracy of white light endoscopy was 65% (114 of 176), whereas that of magnifying NBI was 90% (160 of 177), and this difference was statistically significant (P less than .001). Sensitivity was also higher in the magnifying NBI group at 60% (12 of 20) vs. 40% (8 of 20), but this difference did not reach statistical significance. Specificity was significantly higher in the magnifying NBI group at 94% (148 of 157), compared with the white light endoscopy group at 68% (106 of 156; P less than .001).

The time required to make a diagnosis with magnifying NBI was about 30 seconds longer than with white light endoscopy. "The difference would be acceptable in a clinical setting, instead of taking a biopsy, I think," said Dr. Uedo of the department of gastrointestinal oncology, Osaka (Japan) Medical Center for Cancer and Cardiovascular Diseases.

The diagnostic performance of magnifying NBI following white light imaging, compared with white light imaging alone, was significantly better in terms of accuracy, sensitivity, and specificity (P less than .001 in each case).

Dr. Uedo said that the specificity of white light endoscopy was not very high, and the number of false-positive lesions was large. "So, the number of biopsies is also large," he said. Only 40% of carcinomas were correctly diagnosed based on their endoscopic appearance. However, he said, the number of false-positive lesions in the magnifying NBI group was small, because of the higher specificity, and in turn the number of biopsies was lower.

As for the combination of the two modalities, he said that it "shows extremely excellent performance for differentiation of carcinoma from [a] benign depressed lesion."

Gastric cancer is the second leading cause of cancer death worldwide, and the earlier the diagnosis, the better the patient’s prognosis.

The study was funded by a grant-in-aid for cancer research from the Ministry of Health, Labor, and Welfare of Japan. Dr. Uedo does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services discussed during the presentation.

CHICAGO – The combination of white light endoscopy and magnifying narrow-band imaging shows promise for achieving accurate diagnosis of early gastric cancer, based on a prospective, randomized, controlled trial conducted in Japan.

"Magnifying narrow-band imaging improved [the] diagnostic performance of white light endoscopy for discriminating gastric cancer from benign small depressed lesions," said Dr. Noriya Uedo, the principal investigator. "Adding magnifying narrow-band imaging to white light endoscopy could make accurate diagnosis of early gastric cancer [possible] without biopsy."

Currently, a diagnosis is made primarily via biopsy, said Dr. Uedo at the annual Digestive Disease Week.

Narrow-band imaging (NBI) is a novel optical technology for examining the surface structure and vascular architecture in the superficial mucosa. "Using magnifying endoscopy, it enables us to evaluate detailed morphological features of both epithelium and vasculature corresponding to histology," he said.

This study was designed to compare the real-time diagnostic performance of conventional white light endoscopy vs. magnifying NBI for gastric lesions no larger than 1 cm.

The trial included patients with a history of endoscopic treatment of early gastric cancer who were at high risk for developing recurrent gastric cancer. The study’s primary objective was to contrast the diagnostic accuracy of the two modalities.

On enrollment, patients were screened with white light endoscopy, and those who were found to have a previously undiagnosed small depressed lesion were randomized to either the white light group or the magnifying NBI group. In the white light group, after the endoscopic finding was documented, the lesion was then evaluated with magnifying NBI.

Between June 2008 and May 2010, 1,365 patients were enrolled, and 362 were found to have small depressed lesions. These patients were randomized to the white light endoscopy group or the magnifying narrow-band imaging group. There were 20 patients with gastric carcinoma in each group.

The diagnostic accuracy of white light endoscopy was 65% (114 of 176), whereas that of magnifying NBI was 90% (160 of 177), and this difference was statistically significant (P less than .001). Sensitivity was also higher in the magnifying NBI group at 60% (12 of 20) vs. 40% (8 of 20), but this difference did not reach statistical significance. Specificity was significantly higher in the magnifying NBI group at 94% (148 of 157), compared with the white light endoscopy group at 68% (106 of 156; P less than .001).

The time required to make a diagnosis with magnifying NBI was about 30 seconds longer than with white light endoscopy. "The difference would be acceptable in a clinical setting, instead of taking a biopsy, I think," said Dr. Uedo of the department of gastrointestinal oncology, Osaka (Japan) Medical Center for Cancer and Cardiovascular Diseases.

The diagnostic performance of magnifying NBI following white light imaging, compared with white light imaging alone, was significantly better in terms of accuracy, sensitivity, and specificity (P less than .001 in each case).

Dr. Uedo said that the specificity of white light endoscopy was not very high, and the number of false-positive lesions was large. "So, the number of biopsies is also large," he said. Only 40% of carcinomas were correctly diagnosed based on their endoscopic appearance. However, he said, the number of false-positive lesions in the magnifying NBI group was small, because of the higher specificity, and in turn the number of biopsies was lower.

As for the combination of the two modalities, he said that it "shows extremely excellent performance for differentiation of carcinoma from [a] benign depressed lesion."

Gastric cancer is the second leading cause of cancer death worldwide, and the earlier the diagnosis, the better the patient’s prognosis.

The study was funded by a grant-in-aid for cancer research from the Ministry of Health, Labor, and Welfare of Japan. Dr. Uedo does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services discussed during the presentation.

CHICAGO – The combination of white light endoscopy and magnifying narrow-band imaging shows promise for achieving accurate diagnosis of early gastric cancer, based on a prospective, randomized, controlled trial conducted in Japan.

"Magnifying narrow-band imaging improved [the] diagnostic performance of white light endoscopy for discriminating gastric cancer from benign small depressed lesions," said Dr. Noriya Uedo, the principal investigator. "Adding magnifying narrow-band imaging to white light endoscopy could make accurate diagnosis of early gastric cancer [possible] without biopsy."

Currently, a diagnosis is made primarily via biopsy, said Dr. Uedo at the annual Digestive Disease Week.

Narrow-band imaging (NBI) is a novel optical technology for examining the surface structure and vascular architecture in the superficial mucosa. "Using magnifying endoscopy, it enables us to evaluate detailed morphological features of both epithelium and vasculature corresponding to histology," he said.

This study was designed to compare the real-time diagnostic performance of conventional white light endoscopy vs. magnifying NBI for gastric lesions no larger than 1 cm.

The trial included patients with a history of endoscopic treatment of early gastric cancer who were at high risk for developing recurrent gastric cancer. The study’s primary objective was to contrast the diagnostic accuracy of the two modalities.

On enrollment, patients were screened with white light endoscopy, and those who were found to have a previously undiagnosed small depressed lesion were randomized to either the white light group or the magnifying NBI group. In the white light group, after the endoscopic finding was documented, the lesion was then evaluated with magnifying NBI.

Between June 2008 and May 2010, 1,365 patients were enrolled, and 362 were found to have small depressed lesions. These patients were randomized to the white light endoscopy group or the magnifying narrow-band imaging group. There were 20 patients with gastric carcinoma in each group.

The diagnostic accuracy of white light endoscopy was 65% (114 of 176), whereas that of magnifying NBI was 90% (160 of 177), and this difference was statistically significant (P less than .001). Sensitivity was also higher in the magnifying NBI group at 60% (12 of 20) vs. 40% (8 of 20), but this difference did not reach statistical significance. Specificity was significantly higher in the magnifying NBI group at 94% (148 of 157), compared with the white light endoscopy group at 68% (106 of 156; P less than .001).

The time required to make a diagnosis with magnifying NBI was about 30 seconds longer than with white light endoscopy. "The difference would be acceptable in a clinical setting, instead of taking a biopsy, I think," said Dr. Uedo of the department of gastrointestinal oncology, Osaka (Japan) Medical Center for Cancer and Cardiovascular Diseases.

The diagnostic performance of magnifying NBI following white light imaging, compared with white light imaging alone, was significantly better in terms of accuracy, sensitivity, and specificity (P less than .001 in each case).

Dr. Uedo said that the specificity of white light endoscopy was not very high, and the number of false-positive lesions was large. "So, the number of biopsies is also large," he said. Only 40% of carcinomas were correctly diagnosed based on their endoscopic appearance. However, he said, the number of false-positive lesions in the magnifying NBI group was small, because of the higher specificity, and in turn the number of biopsies was lower.

As for the combination of the two modalities, he said that it "shows extremely excellent performance for differentiation of carcinoma from [a] benign depressed lesion."

Gastric cancer is the second leading cause of cancer death worldwide, and the earlier the diagnosis, the better the patient’s prognosis.

The study was funded by a grant-in-aid for cancer research from the Ministry of Health, Labor, and Welfare of Japan. Dr. Uedo does not have any relevant financial or other relationship with any manufacturer or provider of commercial products or services discussed during the presentation.

CHICAGO – Prophylaxis with semuloparin, an experimental ultralow-molecular-weight heparin, achieved a significant 64% reduction in relative risk for venous thromboembolism events among cancer patients undergoing chemotherapy in a large, randomized, double-blind, phase III trial called SAVE-ONCO.

An intent-to-treat analysis found that the rate of venous thromboembolism (VTE) events – a composite of symptomatic deep vein thrombosis, any pulmonary embolism, and VTE-related death – was 1.2% in patients treated with semuloparin vs. 3.4% in a control group treated with placebo (hazard ratio, 0.36; P less than .0001).

Benefits trended in favor of semuloparin for all components of the composite end point, including any pulmonary embolism (odds ratio, 0.41) and VTE-related death (OR, 0.77), reported Dr. Daniel J. George, who presented the paper on behalf of Dr. Giancarlo Agnelli of Perugia (Italy) University at the annual meeting of the American Society of Clinical Oncology.

Although the incidence of clinically relevant bleeding was higher at 2.8% with semuloparin vs. 2% for placebo, Dr. George added that a safety analysis found that the incidence of major bleeding was similarly low, at 1.2% and 1.1%, respectively.

Based on the trial results, Dr. Elias Zerhouni, president of global research and development at trial sponsor Sanofi-Aventis, announced that the company plans "to submit semuloparin for regulatory filing" in the third quarter of 2011. Still investigational, the selectively engineered anticoagulant has high anti–coagulation factor Xa activity and minimal anti–coagulation factor IIa activity with a half-life of 16-20 hours.

Although it is advocated for cancer patients who are hospitalized or undergoing surgery and is not contraindicated for anticoagulation, the routine prophylaxis of ambulatory cancer patients receiving chemotherapy is not currently recommended.

"So this leaves us with the question, Which cancer patients should we now consider for thromboprophylaxis?" said Dr. George of Duke University Medical Center in Durham, N.C. "Already our guidelines suggest that those patients with cancer undergoing major surgery, or hospitalized, or acutely ill, ought to be anticoagulated with low-molecular-weight heparin during those periods of time.

"I would now submit that the SAVE ONCO data would support having patients initiating chemotherapy, in the setting of locally advanced or metastatic disease, as a third population that we could consider for thromboprophylaxis," he said.

Although discussant Dr. Vered Stearns of Johns Hopkins University in Baltimore viewed the findings favorably, she cautioned that "SAVE-ONCO should not change current practice for the overall population."

Dr. Stearns emphasized that predictive models are needed to determine which ambulatory patients are at the highest risk for VTE, "and who should be offered prophylaxis in the context of expected clinical outcomes." Biomarkers such as circulating coagulating factors are also important, she added.

"Semuloparin is an efficacious and safe agent. That’s very exciting," Dr. Stearns said. "The reduction in [VTE] events is consistent throughout the report, and my understanding is [that] the group is conducting subgroup analysis and evaluation of predictive markers that may help us select the population that would benefit from primary prophylaxis."

A multinational study, the SAVE-ONCO trial enrolled 3,200 patients who were at high risk of VTE. Participants had metastatic or locally advanced solid tumors such as lung, pancreas, stomach, colon/rectal, bladder, or ovarian tumors for which they were starting a new course of chemotherapy with minimum treatment intent of 3 months.

Patients were randomized 1:1 to standard-care chemotherapy plus either placebo or semuloparin 20 mg subcutaneously once daily for the length of their chemotherapy.

Patient characteristics were well balanced across both arms: The median age was 60 years, and 60% of patients were men. More than two-thirds had metastatic disease. Lung cancer was the most common tumor type (36%) followed by colon/rectal cancer (28%). The remainder had cancer of the stomach, ovary, pancreas, or bladder. Treatment duration was approximately 3.5 months in both groups.

In response to audience questions, Dr. George said that the study did not show a survival benefit, but "there is likely a subset of patients" for whom this made a dramatic impact in their early morbidity and mortality.

The study did not address cost, but that will be a factor if prophylaxis is introduced for a large population of cancer patients, he acknowledged, "It really comes down to safety and cost," he said.

The study was sponsored by Sanofi-Aventis. Dr. George disclosed numerous relationships with pharmaceutical companies, including consultant or advisory role, honoraria, and speakers bureau with Sanofi-Aventis. Dr. Agnelli disclosed receiving honoraria from Sanofi-Aventis and relationships with other companies. Dr. Stearns disclosed honoraria and research funding from other companies.

CHICAGO – Prophylaxis with semuloparin, an experimental ultralow-molecular-weight heparin, achieved a significant 64% reduction in relative risk for venous thromboembolism events among cancer patients undergoing chemotherapy in a large, randomized, double-blind, phase III trial called SAVE-ONCO.

An intent-to-treat analysis found that the rate of venous thromboembolism (VTE) events – a composite of symptomatic deep vein thrombosis, any pulmonary embolism, and VTE-related death – was 1.2% in patients treated with semuloparin vs. 3.4% in a control group treated with placebo (hazard ratio, 0.36; P less than .0001).

Benefits trended in favor of semuloparin for all components of the composite end point, including any pulmonary embolism (odds ratio, 0.41) and VTE-related death (OR, 0.77), reported Dr. Daniel J. George, who presented the paper on behalf of Dr. Giancarlo Agnelli of Perugia (Italy) University at the annual meeting of the American Society of Clinical Oncology.

Although the incidence of clinically relevant bleeding was higher at 2.8% with semuloparin vs. 2% for placebo, Dr. George added that a safety analysis found that the incidence of major bleeding was similarly low, at 1.2% and 1.1%, respectively.

Based on the trial results, Dr. Elias Zerhouni, president of global research and development at trial sponsor Sanofi-Aventis, announced that the company plans "to submit semuloparin for regulatory filing" in the third quarter of 2011. Still investigational, the selectively engineered anticoagulant has high anti–coagulation factor Xa activity and minimal anti–coagulation factor IIa activity with a half-life of 16-20 hours.

Although it is advocated for cancer patients who are hospitalized or undergoing surgery and is not contraindicated for anticoagulation, the routine prophylaxis of ambulatory cancer patients receiving chemotherapy is not currently recommended.

"So this leaves us with the question, Which cancer patients should we now consider for thromboprophylaxis?" said Dr. George of Duke University Medical Center in Durham, N.C. "Already our guidelines suggest that those patients with cancer undergoing major surgery, or hospitalized, or acutely ill, ought to be anticoagulated with low-molecular-weight heparin during those periods of time.

"I would now submit that the SAVE ONCO data would support having patients initiating chemotherapy, in the setting of locally advanced or metastatic disease, as a third population that we could consider for thromboprophylaxis," he said.

Although discussant Dr. Vered Stearns of Johns Hopkins University in Baltimore viewed the findings favorably, she cautioned that "SAVE-ONCO should not change current practice for the overall population."

Dr. Stearns emphasized that predictive models are needed to determine which ambulatory patients are at the highest risk for VTE, "and who should be offered prophylaxis in the context of expected clinical outcomes." Biomarkers such as circulating coagulating factors are also important, she added.

"Semuloparin is an efficacious and safe agent. That’s very exciting," Dr. Stearns said. "The reduction in [VTE] events is consistent throughout the report, and my understanding is [that] the group is conducting subgroup analysis and evaluation of predictive markers that may help us select the population that would benefit from primary prophylaxis."

A multinational study, the SAVE-ONCO trial enrolled 3,200 patients who were at high risk of VTE. Participants had metastatic or locally advanced solid tumors such as lung, pancreas, stomach, colon/rectal, bladder, or ovarian tumors for which they were starting a new course of chemotherapy with minimum treatment intent of 3 months.

Patients were randomized 1:1 to standard-care chemotherapy plus either placebo or semuloparin 20 mg subcutaneously once daily for the length of their chemotherapy.

Patient characteristics were well balanced across both arms: The median age was 60 years, and 60% of patients were men. More than two-thirds had metastatic disease. Lung cancer was the most common tumor type (36%) followed by colon/rectal cancer (28%). The remainder had cancer of the stomach, ovary, pancreas, or bladder. Treatment duration was approximately 3.5 months in both groups.

In response to audience questions, Dr. George said that the study did not show a survival benefit, but "there is likely a subset of patients" for whom this made a dramatic impact in their early morbidity and mortality.

The study did not address cost, but that will be a factor if prophylaxis is introduced for a large population of cancer patients, he acknowledged, "It really comes down to safety and cost," he said.

The study was sponsored by Sanofi-Aventis. Dr. George disclosed numerous relationships with pharmaceutical companies, including consultant or advisory role, honoraria, and speakers bureau with Sanofi-Aventis. Dr. Agnelli disclosed receiving honoraria from Sanofi-Aventis and relationships with other companies. Dr. Stearns disclosed honoraria and research funding from other companies.

CHICAGO – Prophylaxis with semuloparin, an experimental ultralow-molecular-weight heparin, achieved a significant 64% reduction in relative risk for venous thromboembolism events among cancer patients undergoing chemotherapy in a large, randomized, double-blind, phase III trial called SAVE-ONCO.

An intent-to-treat analysis found that the rate of venous thromboembolism (VTE) events – a composite of symptomatic deep vein thrombosis, any pulmonary embolism, and VTE-related death – was 1.2% in patients treated with semuloparin vs. 3.4% in a control group treated with placebo (hazard ratio, 0.36; P less than .0001).

Benefits trended in favor of semuloparin for all components of the composite end point, including any pulmonary embolism (odds ratio, 0.41) and VTE-related death (OR, 0.77), reported Dr. Daniel J. George, who presented the paper on behalf of Dr. Giancarlo Agnelli of Perugia (Italy) University at the annual meeting of the American Society of Clinical Oncology.

Although the incidence of clinically relevant bleeding was higher at 2.8% with semuloparin vs. 2% for placebo, Dr. George added that a safety analysis found that the incidence of major bleeding was similarly low, at 1.2% and 1.1%, respectively.

Based on the trial results, Dr. Elias Zerhouni, president of global research and development at trial sponsor Sanofi-Aventis, announced that the company plans "to submit semuloparin for regulatory filing" in the third quarter of 2011. Still investigational, the selectively engineered anticoagulant has high anti–coagulation factor Xa activity and minimal anti–coagulation factor IIa activity with a half-life of 16-20 hours.

Although it is advocated for cancer patients who are hospitalized or undergoing surgery and is not contraindicated for anticoagulation, the routine prophylaxis of ambulatory cancer patients receiving chemotherapy is not currently recommended.

"So this leaves us with the question, Which cancer patients should we now consider for thromboprophylaxis?" said Dr. George of Duke University Medical Center in Durham, N.C. "Already our guidelines suggest that those patients with cancer undergoing major surgery, or hospitalized, or acutely ill, ought to be anticoagulated with low-molecular-weight heparin during those periods of time.

"I would now submit that the SAVE ONCO data would support having patients initiating chemotherapy, in the setting of locally advanced or metastatic disease, as a third population that we could consider for thromboprophylaxis," he said.

Although discussant Dr. Vered Stearns of Johns Hopkins University in Baltimore viewed the findings favorably, she cautioned that "SAVE-ONCO should not change current practice for the overall population."

Dr. Stearns emphasized that predictive models are needed to determine which ambulatory patients are at the highest risk for VTE, "and who should be offered prophylaxis in the context of expected clinical outcomes." Biomarkers such as circulating coagulating factors are also important, she added.

"Semuloparin is an efficacious and safe agent. That’s very exciting," Dr. Stearns said. "The reduction in [VTE] events is consistent throughout the report, and my understanding is [that] the group is conducting subgroup analysis and evaluation of predictive markers that may help us select the population that would benefit from primary prophylaxis."

A multinational study, the SAVE-ONCO trial enrolled 3,200 patients who were at high risk of VTE. Participants had metastatic or locally advanced solid tumors such as lung, pancreas, stomach, colon/rectal, bladder, or ovarian tumors for which they were starting a new course of chemotherapy with minimum treatment intent of 3 months.

Patients were randomized 1:1 to standard-care chemotherapy plus either placebo or semuloparin 20 mg subcutaneously once daily for the length of their chemotherapy.

Patient characteristics were well balanced across both arms: The median age was 60 years, and 60% of patients were men. More than two-thirds had metastatic disease. Lung cancer was the most common tumor type (36%) followed by colon/rectal cancer (28%). The remainder had cancer of the stomach, ovary, pancreas, or bladder. Treatment duration was approximately 3.5 months in both groups.

In response to audience questions, Dr. George said that the study did not show a survival benefit, but "there is likely a subset of patients" for whom this made a dramatic impact in their early morbidity and mortality.

The study did not address cost, but that will be a factor if prophylaxis is introduced for a large population of cancer patients, he acknowledged, "It really comes down to safety and cost," he said.

The study was sponsored by Sanofi-Aventis. Dr. George disclosed numerous relationships with pharmaceutical companies, including consultant or advisory role, honoraria, and speakers bureau with Sanofi-Aventis. Dr. Agnelli disclosed receiving honoraria from Sanofi-Aventis and relationships with other companies. Dr. Stearns disclosed honoraria and research funding from other companies.

CHICAGO – Prophylaxis with semuloparin, an experimental ultralow-molecular-weight heparin, achieved a significant 64% reduction in relative risk for venous thromboembolism events among cancer patients undergoing chemotherapy in a large, randomized, double-blind, phase III trial called SAVE-ONCO.

An intent-to-treat analysis found that the rate of venous thromboembolism (VTE) events – a composite of symptomatic deep vein thrombosis, any pulmonary embolism, and VTE-related death – was 1.2% in patients treated with semuloparin vs. 3.4% in a control group treated with placebo (hazard ratio, 0.36; P less than .0001).

Benefits trended in favor of semuloparin for all components of the composite end point, including any pulmonary embolism (odds ratio, 0.41) and VTE-related death (OR, 0.77), reported Dr. Daniel J. George, who presented the paper on behalf of Dr. Giancarlo Agnelli of Perugia (Italy) University at the annual meeting of the American Society of Clinical Oncology.

Although the incidence of clinically relevant bleeding was higher at 2.8% with semuloparin vs. 2% for placebo, Dr. George added that a safety analysis found that the incidence of major bleeding was similarly low, at 1.2% and 1.1%, respectively.

Based on the trial results, Dr. Elias Zerhouni, president of global research and development at trial sponsor Sanofi-Aventis, announced that the company plans "to submit semuloparin for regulatory filing" in the third quarter of 2011. Still investigational, the selectively engineered anticoagulant has high anti–coagulation factor Xa activity and minimal anti–coagulation factor IIa activity with a half-life of 16-20 hours.

Although it is advocated for cancer patients who are hospitalized or undergoing surgery and is not contraindicated for anticoagulation, the routine prophylaxis of ambulatory cancer patients receiving chemotherapy is not currently recommended.

"So this leaves us with the question, Which cancer patients should we now consider for thromboprophylaxis?" said Dr. George of Duke University Medical Center in Durham, N.C. "Already our guidelines suggest that those patients with cancer undergoing major surgery, or hospitalized, or acutely ill, ought to be anticoagulated with low-molecular-weight heparin during those periods of time.

"I would now submit that the SAVE ONCO data would support having patients initiating chemotherapy, in the setting of locally advanced or metastatic disease, as a third population that we could consider for thromboprophylaxis," he said.

Although discussant Dr. Vered Stearns of Johns Hopkins University in Baltimore viewed the findings favorably, she cautioned that "SAVE-ONCO should not change current practice for the overall population."

Dr. Stearns emphasized that predictive models are needed to determine which ambulatory patients are at the highest risk for VTE, "and who should be offered prophylaxis in the context of expected clinical outcomes." Biomarkers such as circulating coagulating factors are also important, she added.

"Semuloparin is an efficacious and safe agent. That’s very exciting," Dr. Stearns said. "The reduction in [VTE] events is consistent throughout the report, and my understanding is [that] the group is conducting subgroup analysis and evaluation of predictive markers that may help us select the population that would benefit from primary prophylaxis."

A multinational study, the SAVE-ONCO trial enrolled 3,200 patients who were at high risk of VTE. Participants had metastatic or locally advanced solid tumors such as lung, pancreas, stomach, colon/rectal, bladder, or ovarian tumors for which they were starting a new course of chemotherapy with minimum treatment intent of 3 months.

Patients were randomized 1:1 to standard-care chemotherapy plus either placebo or semuloparin 20 mg subcutaneously once daily for the length of their chemotherapy.

Patient characteristics were well balanced across both arms: The median age was 60 years, and 60% of patients were men. More than two-thirds had metastatic disease. Lung cancer was the most common tumor type (36%) followed by colon/rectal cancer (28%). The remainder had cancer of the stomach, ovary, pancreas, or bladder. Treatment duration was approximately 3.5 months in both groups.

In response to audience questions, Dr. George said that the study did not show a survival benefit, but "there is likely a subset of patients" for whom this made a dramatic impact in their early morbidity and mortality.

The study did not address cost, but that will be a factor if prophylaxis is introduced for a large population of cancer patients, he acknowledged, "It really comes down to safety and cost," he said.

The study was sponsored by Sanofi-Aventis. Dr. George disclosed numerous relationships with pharmaceutical companies, including consultant or advisory role, honoraria, and speakers bureau with Sanofi-Aventis. Dr. Agnelli disclosed receiving honoraria from Sanofi-Aventis and relationships with other companies. Dr. Stearns disclosed honoraria and research funding from other companies.

CHICAGO – Prophylaxis with semuloparin, an experimental ultralow-molecular-weight heparin, achieved a significant 64% reduction in relative risk for venous thromboembolism events among cancer patients undergoing chemotherapy in a large, randomized, double-blind, phase III trial called SAVE-ONCO.

An intent-to-treat analysis found that the rate of venous thromboembolism (VTE) events – a composite of symptomatic deep vein thrombosis, any pulmonary embolism, and VTE-related death – was 1.2% in patients treated with semuloparin vs. 3.4% in a control group treated with placebo (hazard ratio, 0.36; P less than .0001).

Benefits trended in favor of semuloparin for all components of the composite end point, including any pulmonary embolism (odds ratio, 0.41) and VTE-related death (OR, 0.77), reported Dr. Daniel J. George, who presented the paper on behalf of Dr. Giancarlo Agnelli of Perugia (Italy) University at the annual meeting of the American Society of Clinical Oncology.

Although the incidence of clinically relevant bleeding was higher at 2.8% with semuloparin vs. 2% for placebo, Dr. George added that a safety analysis found that the incidence of major bleeding was similarly low, at 1.2% and 1.1%, respectively.

Based on the trial results, Dr. Elias Zerhouni, president of global research and development at trial sponsor Sanofi-Aventis, announced that the company plans "to submit semuloparin for regulatory filing" in the third quarter of 2011. Still investigational, the selectively engineered anticoagulant has high anti–coagulation factor Xa activity and minimal anti–coagulation factor IIa activity with a half-life of 16-20 hours.

Although it is advocated for cancer patients who are hospitalized or undergoing surgery and is not contraindicated for anticoagulation, the routine prophylaxis of ambulatory cancer patients receiving chemotherapy is not currently recommended.

"So this leaves us with the question, Which cancer patients should we now consider for thromboprophylaxis?" said Dr. George of Duke University Medical Center in Durham, N.C. "Already our guidelines suggest that those patients with cancer undergoing major surgery, or hospitalized, or acutely ill, ought to be anticoagulated with low-molecular-weight heparin during those periods of time.

"I would now submit that the SAVE ONCO data would support having patients initiating chemotherapy, in the setting of locally advanced or metastatic disease, as a third population that we could consider for thromboprophylaxis," he said.

Although discussant Dr. Vered Stearns of Johns Hopkins University in Baltimore viewed the findings favorably, she cautioned that "SAVE-ONCO should not change current practice for the overall population."

Dr. Stearns emphasized that predictive models are needed to determine which ambulatory patients are at the highest risk for VTE, "and who should be offered prophylaxis in the context of expected clinical outcomes." Biomarkers such as circulating coagulating factors are also important, she added.

"Semuloparin is an efficacious and safe agent. That’s very exciting," Dr. Stearns said. "The reduction in [VTE] events is consistent throughout the report, and my understanding is [that] the group is conducting subgroup analysis and evaluation of predictive markers that may help us select the population that would benefit from primary prophylaxis."

A multinational study, the SAVE-ONCO trial enrolled 3,200 patients who were at high risk of VTE. Participants had metastatic or locally advanced solid tumors such as lung, pancreas, stomach, colon/rectal, bladder, or ovarian tumors for which they were starting a new course of chemotherapy with minimum treatment intent of 3 months.

Patients were randomized 1:1 to standard-care chemotherapy plus either placebo or semuloparin 20 mg subcutaneously once daily for the length of their chemotherapy.

Patient characteristics were well balanced across both arms: The median age was 60 years, and 60% of patients were men. More than two-thirds had metastatic disease. Lung cancer was the most common tumor type (36%) followed by colon/rectal cancer (28%). The remainder had cancer of the stomach, ovary, pancreas, or bladder. Treatment duration was approximately 3.5 months in both groups.

In response to audience questions, Dr. George said that the study did not show a survival benefit, but "there is likely a subset of patients" for whom this made a dramatic impact in their early morbidity and mortality.

The study did not address cost, but that will be a factor if prophylaxis is introduced for a large population of cancer patients, he acknowledged, "It really comes down to safety and cost," he said.

The study was sponsored by Sanofi-Aventis. Dr. George disclosed numerous relationships with pharmaceutical companies, including consultant or advisory role, honoraria, and speakers bureau with Sanofi-Aventis. Dr. Agnelli disclosed receiving honoraria from Sanofi-Aventis and relationships with other companies. Dr. Stearns disclosed honoraria and research funding from other companies.

CHICAGO – Prophylaxis with semuloparin, an experimental ultralow-molecular-weight heparin, achieved a significant 64% reduction in relative risk for venous thromboembolism events among cancer patients undergoing chemotherapy in a large, randomized, double-blind, phase III trial called SAVE-ONCO.

An intent-to-treat analysis found that the rate of venous thromboembolism (VTE) events – a composite of symptomatic deep vein thrombosis, any pulmonary embolism, and VTE-related death – was 1.2% in patients treated with semuloparin vs. 3.4% in a control group treated with placebo (hazard ratio, 0.36; P less than .0001).

Benefits trended in favor of semuloparin for all components of the composite end point, including any pulmonary embolism (odds ratio, 0.41) and VTE-related death (OR, 0.77), reported Dr. Daniel J. George, who presented the paper on behalf of Dr. Giancarlo Agnelli of Perugia (Italy) University at the annual meeting of the American Society of Clinical Oncology.

Although the incidence of clinically relevant bleeding was higher at 2.8% with semuloparin vs. 2% for placebo, Dr. George added that a safety analysis found that the incidence of major bleeding was similarly low, at 1.2% and 1.1%, respectively.

Based on the trial results, Dr. Elias Zerhouni, president of global research and development at trial sponsor Sanofi-Aventis, announced that the company plans "to submit semuloparin for regulatory filing" in the third quarter of 2011. Still investigational, the selectively engineered anticoagulant has high anti–coagulation factor Xa activity and minimal anti–coagulation factor IIa activity with a half-life of 16-20 hours.

Although it is advocated for cancer patients who are hospitalized or undergoing surgery and is not contraindicated for anticoagulation, the routine prophylaxis of ambulatory cancer patients receiving chemotherapy is not currently recommended.

"So this leaves us with the question, Which cancer patients should we now consider for thromboprophylaxis?" said Dr. George of Duke University Medical Center in Durham, N.C. "Already our guidelines suggest that those patients with cancer undergoing major surgery, or hospitalized, or acutely ill, ought to be anticoagulated with low-molecular-weight heparin during those periods of time.

"I would now submit that the SAVE ONCO data would support having patients initiating chemotherapy, in the setting of locally advanced or metastatic disease, as a third population that we could consider for thromboprophylaxis," he said.

Although discussant Dr. Vered Stearns of Johns Hopkins University in Baltimore viewed the findings favorably, she cautioned that "SAVE-ONCO should not change current practice for the overall population."

Dr. Stearns emphasized that predictive models are needed to determine which ambulatory patients are at the highest risk for VTE, "and who should be offered prophylaxis in the context of expected clinical outcomes." Biomarkers such as circulating coagulating factors are also important, she added.

"Semuloparin is an efficacious and safe agent. That’s very exciting," Dr. Stearns said. "The reduction in [VTE] events is consistent throughout the report, and my understanding is [that] the group is conducting subgroup analysis and evaluation of predictive markers that may help us select the population that would benefit from primary prophylaxis."

A multinational study, the SAVE-ONCO trial enrolled 3,200 patients who were at high risk of VTE. Participants had metastatic or locally advanced solid tumors such as lung, pancreas, stomach, colon/rectal, bladder, or ovarian tumors for which they were starting a new course of chemotherapy with minimum treatment intent of 3 months.

Patients were randomized 1:1 to standard-care chemotherapy plus either placebo or semuloparin 20 mg subcutaneously once daily for the length of their chemotherapy.

Patient characteristics were well balanced across both arms: The median age was 60 years, and 60% of patients were men. More than two-thirds had metastatic disease. Lung cancer was the most common tumor type (36%) followed by colon/rectal cancer (28%). The remainder had cancer of the stomach, ovary, pancreas, or bladder. Treatment duration was approximately 3.5 months in both groups.

In response to audience questions, Dr. George said that the study did not show a survival benefit, but "there is likely a subset of patients" for whom this made a dramatic impact in their early morbidity and mortality.

The study did not address cost, but that will be a factor if prophylaxis is introduced for a large population of cancer patients, he acknowledged, "It really comes down to safety and cost," he said.

The study was sponsored by Sanofi-Aventis. Dr. George disclosed numerous relationships with pharmaceutical companies, including consultant or advisory role, honoraria, and speakers bureau with Sanofi-Aventis. Dr. Agnelli disclosed receiving honoraria from Sanofi-Aventis and relationships with other companies. Dr. Stearns disclosed honoraria and research funding from other companies.