ACS Surgery News

Fewer than 10% of pancreaticoduodenectomy patients required postoperative nasogastric drainage, the current postoperative standard of care for pancreaticoduodenectomy, the results of a longitudinal observational cohort study have shown.

Dr. John W. Kunstman and his colleagues in the surgery department of Yale University, New Haven, Conn., observed two consecutive cohorts of 125 pancreaticoduodenectomy (PD) patients. The first cohort had nasogastric tubes (NGTs) maintained postoperatively until clinically indicated, while the second cohort had NGTs maintained postoperatively "only in rare circumstances, such as inability to extubate the patient postoperatively," the authors said. All patients were treated by the same surgeon between July 2003 and February 2012, most commonly for pancreatic neoplasm.

There were no statistically significant differences between the two groups in patient demographics, including indications for surgery. The routine NGT group was 51% male with an average age of 63 years, while the selective NGT group was 46% male with an average age of 67 years. Bias was reduced in that both cohorts were analyzed in an intent-to-treat manner.

Pylorus-preserving pancreaticoduodenectomy (PPPD) was performed in the absence of oncologic or other disease-specific considerations; otherwise, a classic (Kausch-Whipple) PD was performed. The most common comorbidity overall was hypertension, although the routine NGT group had a higher incidence of coronary artery disease than the selective NGT group (20.8% vs. 8.8%) and a higher mean creatinine level (0.97 vs. 0.88 mg/dL) (J. Am. Coll. Surgeons 2013;217:481-8).

Primary outcomes included postoperative NGT insertion and reinsertion, delayed gastric emptying (DGE) incidence, time to dietary tolerance, and length of stay.

In the selective NGT cohort, only 9 patients required continued NGT, 5 of them for postoperative endotracheal intubation and 4 for surgical considerations.

Neither the incidence of NGT insertion and reinsertion, nor the duration of NGT replacement, differed significantly between groups. Overall complication rates were also similar, although patients in the selective NGT group were less likely to have DGE. Compared with the routine NGT cohort, the selective cohort had a shorter mean length of stay (10 vs. 7 days) and mean time to dietary tolerance.

Additionally, multivariate analysis of all outcome variables indicated that DGE, the most common adverse event associated with PD, was independently correlated with the routine use of NGT.

"This is of particular interest given the role that gastric decompression plays in treatment of DGE. However, this finding must be interpreted with care, as incidence of DGE varies from 10% to 50% of PD cases, depending on the reporting group," the authors wrote.

In terms of the study’s limitations, the higher number of PPPD and retrocolic gastroenteric anastomoses performed in the routine cohort may have been a factor in the differing DGE incidence rates, since pylorus preservation and anastomotic positioning are considered historically correlated to DGE, the authors said.

Among individually examined adverse events, routine NGT patients were more likely than selective patients to be reintubated (11.2% vs. 3.2%), require a postoperative blood transfusion (16.0% vs. 6.4%), and be diagnosed with DGE (18.4% vs. 8.0%).

There were a total of four deaths in the 30-day postoperative period, all occurring in patients over age 80. There were eight octogenarians in each cohort; three of the deaths occurred in the routine group.

Improvements in perioperative care and the surgeon’s increased skill over time may also have affected the results. However, the authors concluded, "based on these data, persistent concerns, such as fear of increased anastomotic leak or DGE, which have mandated customary nasogastric decompression after PD, can be safely reevaluated."

Dr. Kunstman and his coauthors reported no relevant disclosures.

[email protected]

Fewer than 10% of pancreaticoduodenectomy patients required postoperative nasogastric drainage, the current postoperative standard of care for pancreaticoduodenectomy, the results of a longitudinal observational cohort study have shown.

Dr. John W. Kunstman and his colleagues in the surgery department of Yale University, New Haven, Conn., observed two consecutive cohorts of 125 pancreaticoduodenectomy (PD) patients. The first cohort had nasogastric tubes (NGTs) maintained postoperatively until clinically indicated, while the second cohort had NGTs maintained postoperatively "only in rare circumstances, such as inability to extubate the patient postoperatively," the authors said. All patients were treated by the same surgeon between July 2003 and February 2012, most commonly for pancreatic neoplasm.

There were no statistically significant differences between the two groups in patient demographics, including indications for surgery. The routine NGT group was 51% male with an average age of 63 years, while the selective NGT group was 46% male with an average age of 67 years. Bias was reduced in that both cohorts were analyzed in an intent-to-treat manner.

Pylorus-preserving pancreaticoduodenectomy (PPPD) was performed in the absence of oncologic or other disease-specific considerations; otherwise, a classic (Kausch-Whipple) PD was performed. The most common comorbidity overall was hypertension, although the routine NGT group had a higher incidence of coronary artery disease than the selective NGT group (20.8% vs. 8.8%) and a higher mean creatinine level (0.97 vs. 0.88 mg/dL) (J. Am. Coll. Surgeons 2013;217:481-8).

Primary outcomes included postoperative NGT insertion and reinsertion, delayed gastric emptying (DGE) incidence, time to dietary tolerance, and length of stay.

In the selective NGT cohort, only 9 patients required continued NGT, 5 of them for postoperative endotracheal intubation and 4 for surgical considerations.

Neither the incidence of NGT insertion and reinsertion, nor the duration of NGT replacement, differed significantly between groups. Overall complication rates were also similar, although patients in the selective NGT group were less likely to have DGE. Compared with the routine NGT cohort, the selective cohort had a shorter mean length of stay (10 vs. 7 days) and mean time to dietary tolerance.

Additionally, multivariate analysis of all outcome variables indicated that DGE, the most common adverse event associated with PD, was independently correlated with the routine use of NGT.

"This is of particular interest given the role that gastric decompression plays in treatment of DGE. However, this finding must be interpreted with care, as incidence of DGE varies from 10% to 50% of PD cases, depending on the reporting group," the authors wrote.

In terms of the study’s limitations, the higher number of PPPD and retrocolic gastroenteric anastomoses performed in the routine cohort may have been a factor in the differing DGE incidence rates, since pylorus preservation and anastomotic positioning are considered historically correlated to DGE, the authors said.

Among individually examined adverse events, routine NGT patients were more likely than selective patients to be reintubated (11.2% vs. 3.2%), require a postoperative blood transfusion (16.0% vs. 6.4%), and be diagnosed with DGE (18.4% vs. 8.0%).

There were a total of four deaths in the 30-day postoperative period, all occurring in patients over age 80. There were eight octogenarians in each cohort; three of the deaths occurred in the routine group.

Improvements in perioperative care and the surgeon’s increased skill over time may also have affected the results. However, the authors concluded, "based on these data, persistent concerns, such as fear of increased anastomotic leak or DGE, which have mandated customary nasogastric decompression after PD, can be safely reevaluated."

Dr. Kunstman and his coauthors reported no relevant disclosures.

[email protected]

Fewer than 10% of pancreaticoduodenectomy patients required postoperative nasogastric drainage, the current postoperative standard of care for pancreaticoduodenectomy, the results of a longitudinal observational cohort study have shown.

Dr. John W. Kunstman and his colleagues in the surgery department of Yale University, New Haven, Conn., observed two consecutive cohorts of 125 pancreaticoduodenectomy (PD) patients. The first cohort had nasogastric tubes (NGTs) maintained postoperatively until clinically indicated, while the second cohort had NGTs maintained postoperatively "only in rare circumstances, such as inability to extubate the patient postoperatively," the authors said. All patients were treated by the same surgeon between July 2003 and February 2012, most commonly for pancreatic neoplasm.

There were no statistically significant differences between the two groups in patient demographics, including indications for surgery. The routine NGT group was 51% male with an average age of 63 years, while the selective NGT group was 46% male with an average age of 67 years. Bias was reduced in that both cohorts were analyzed in an intent-to-treat manner.

Pylorus-preserving pancreaticoduodenectomy (PPPD) was performed in the absence of oncologic or other disease-specific considerations; otherwise, a classic (Kausch-Whipple) PD was performed. The most common comorbidity overall was hypertension, although the routine NGT group had a higher incidence of coronary artery disease than the selective NGT group (20.8% vs. 8.8%) and a higher mean creatinine level (0.97 vs. 0.88 mg/dL) (J. Am. Coll. Surgeons 2013;217:481-8).

Primary outcomes included postoperative NGT insertion and reinsertion, delayed gastric emptying (DGE) incidence, time to dietary tolerance, and length of stay.

In the selective NGT cohort, only 9 patients required continued NGT, 5 of them for postoperative endotracheal intubation and 4 for surgical considerations.

Neither the incidence of NGT insertion and reinsertion, nor the duration of NGT replacement, differed significantly between groups. Overall complication rates were also similar, although patients in the selective NGT group were less likely to have DGE. Compared with the routine NGT cohort, the selective cohort had a shorter mean length of stay (10 vs. 7 days) and mean time to dietary tolerance.

Additionally, multivariate analysis of all outcome variables indicated that DGE, the most common adverse event associated with PD, was independently correlated with the routine use of NGT.

"This is of particular interest given the role that gastric decompression plays in treatment of DGE. However, this finding must be interpreted with care, as incidence of DGE varies from 10% to 50% of PD cases, depending on the reporting group," the authors wrote.

In terms of the study’s limitations, the higher number of PPPD and retrocolic gastroenteric anastomoses performed in the routine cohort may have been a factor in the differing DGE incidence rates, since pylorus preservation and anastomotic positioning are considered historically correlated to DGE, the authors said.

Among individually examined adverse events, routine NGT patients were more likely than selective patients to be reintubated (11.2% vs. 3.2%), require a postoperative blood transfusion (16.0% vs. 6.4%), and be diagnosed with DGE (18.4% vs. 8.0%).

There were a total of four deaths in the 30-day postoperative period, all occurring in patients over age 80. There were eight octogenarians in each cohort; three of the deaths occurred in the routine group.

Improvements in perioperative care and the surgeon’s increased skill over time may also have affected the results. However, the authors concluded, "based on these data, persistent concerns, such as fear of increased anastomotic leak or DGE, which have mandated customary nasogastric decompression after PD, can be safely reevaluated."

Dr. Kunstman and his coauthors reported no relevant disclosures.

[email protected]

DENVER – Oral vancomycin at a dose of 125 mg four times daily is just as effective as is a dose of 250 mg or higher given at the same frequency in the treatment of diarrhea associated with Clostridium difficile infection, judging from the results from a retrospective study.

Use of the lower dosing regimen has the potential to decrease treatment costs without worsening outcomes, Philip Chung, Pharm.D., said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

According to current recommendations, oral vancomycin 125 mg q.i.d. is the treatment of choice for severe uncomplicated C. difficile infection. To date, no studies have shown the use of oral vancomycin doses higher than 125 mg q.i.d. to be more efficacious than the recommended 125 mg q.i.d. in this setting, said Dr. Chung, clinical pharmacy manager of infectious diseases at Montefiore Medical Center, New York.

"Prior to 2008, prescribers at our institution frequently requested vancomycin doses higher than the recommended 125 mg q.i.d. for treatment of [C. difficile infection] despite the absence of data showing added benefits with the higher dosing regimens," he said. "This practice not only increases medication and/or preparation costs, but it may also increase the potential for untoward effects in patients being treated with the higher doses (e.g., increased risks for vancomycin-resistant enterococci colonization or higher likelihood to further alter the GI flora)."

Since the inception of the Antimicrobial Stewardship Program at Montefiore Medical Center in 2008, Dr. Chung and his associates observed a shift in oral vancomycin prescribing practices from a higher dosing regimen to a lower dosing regimen. "Because of this change in practice, we wished to evaluate the efficacy of the different oral vancomycin dosing regimen in order to ensure treatment outcomes remained unchanged at our institution," he said. To do so, the researchers retrospectively reviewed clinical outcomes of 300 adult patients treated with oral vancomycin at the medical center between 2006 and 2010. They looked at clinical parameters, concomitant antibiotics, in-hospital mortality, and 30-day readmission.

The primary endpoint was clinical improvement at 72 hours of oral vancomycin. Secondary endpoints included clinical improvement at end of therapy or discharge, length of stay, in-hospital mortality, and 30-day readmission rate.

Of the 300 patients, 197 were prescribed oral vancomycin 125 mg q.i.d. (low-dose group) and 103 patients were prescribed 250 mg or higher q.i.d. (high-dose group). Dr. Chung and his associates reported that clinical improvement assessed 72 hours after starting oral vancomycin therapy was observed in 85% and 86% of patients in the low- and high-dose groups, respectively (P less than 0.05). Rates of clinical improvement at end of therapy or time of hospital discharge between the two groups were also found to be similar (93% vs. 96%), as were total length of hospital stay (20 days vs. 19 days), in-hospital mortality (15% vs. 23%), and rates of 30-day readmission (34% vs. 24%).

"The finding that oral vancomycin 125 mg q.i.d. works as well as higher doses for severe uncomplicated C. difficile infection for the most part is not a surprise to us, as some evidence already exists in the literature," said Dr. Chung, also of Albert Einstein College of Medicine in New York. "Our finding only confirmed what is already known."

Limitations include the fact that this is a single-center study, and that it is subject to selection bias because of its retrospective design, Dr. Chung said. "However, we took steps to ensure that all patients treated with oral vancomycin who had laboratory-confirmed [C. difficile infection] and symptoms consistent with [C. difficile infection] were included in the study," he said.

Dr. Chung said that he had no relevant financial conflicts to disclose.

[email protected]

DENVER – Oral vancomycin at a dose of 125 mg four times daily is just as effective as is a dose of 250 mg or higher given at the same frequency in the treatment of diarrhea associated with Clostridium difficile infection, judging from the results from a retrospective study.

Use of the lower dosing regimen has the potential to decrease treatment costs without worsening outcomes, Philip Chung, Pharm.D., said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

According to current recommendations, oral vancomycin 125 mg q.i.d. is the treatment of choice for severe uncomplicated C. difficile infection. To date, no studies have shown the use of oral vancomycin doses higher than 125 mg q.i.d. to be more efficacious than the recommended 125 mg q.i.d. in this setting, said Dr. Chung, clinical pharmacy manager of infectious diseases at Montefiore Medical Center, New York.

"Prior to 2008, prescribers at our institution frequently requested vancomycin doses higher than the recommended 125 mg q.i.d. for treatment of [C. difficile infection] despite the absence of data showing added benefits with the higher dosing regimens," he said. "This practice not only increases medication and/or preparation costs, but it may also increase the potential for untoward effects in patients being treated with the higher doses (e.g., increased risks for vancomycin-resistant enterococci colonization or higher likelihood to further alter the GI flora)."

Since the inception of the Antimicrobial Stewardship Program at Montefiore Medical Center in 2008, Dr. Chung and his associates observed a shift in oral vancomycin prescribing practices from a higher dosing regimen to a lower dosing regimen. "Because of this change in practice, we wished to evaluate the efficacy of the different oral vancomycin dosing regimen in order to ensure treatment outcomes remained unchanged at our institution," he said. To do so, the researchers retrospectively reviewed clinical outcomes of 300 adult patients treated with oral vancomycin at the medical center between 2006 and 2010. They looked at clinical parameters, concomitant antibiotics, in-hospital mortality, and 30-day readmission.

The primary endpoint was clinical improvement at 72 hours of oral vancomycin. Secondary endpoints included clinical improvement at end of therapy or discharge, length of stay, in-hospital mortality, and 30-day readmission rate.

Of the 300 patients, 197 were prescribed oral vancomycin 125 mg q.i.d. (low-dose group) and 103 patients were prescribed 250 mg or higher q.i.d. (high-dose group). Dr. Chung and his associates reported that clinical improvement assessed 72 hours after starting oral vancomycin therapy was observed in 85% and 86% of patients in the low- and high-dose groups, respectively (P less than 0.05). Rates of clinical improvement at end of therapy or time of hospital discharge between the two groups were also found to be similar (93% vs. 96%), as were total length of hospital stay (20 days vs. 19 days), in-hospital mortality (15% vs. 23%), and rates of 30-day readmission (34% vs. 24%).

"The finding that oral vancomycin 125 mg q.i.d. works as well as higher doses for severe uncomplicated C. difficile infection for the most part is not a surprise to us, as some evidence already exists in the literature," said Dr. Chung, also of Albert Einstein College of Medicine in New York. "Our finding only confirmed what is already known."

Limitations include the fact that this is a single-center study, and that it is subject to selection bias because of its retrospective design, Dr. Chung said. "However, we took steps to ensure that all patients treated with oral vancomycin who had laboratory-confirmed [C. difficile infection] and symptoms consistent with [C. difficile infection] were included in the study," he said.

Dr. Chung said that he had no relevant financial conflicts to disclose.

[email protected]

DENVER – Oral vancomycin at a dose of 125 mg four times daily is just as effective as is a dose of 250 mg or higher given at the same frequency in the treatment of diarrhea associated with Clostridium difficile infection, judging from the results from a retrospective study.

Use of the lower dosing regimen has the potential to decrease treatment costs without worsening outcomes, Philip Chung, Pharm.D., said in an interview before the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

According to current recommendations, oral vancomycin 125 mg q.i.d. is the treatment of choice for severe uncomplicated C. difficile infection. To date, no studies have shown the use of oral vancomycin doses higher than 125 mg q.i.d. to be more efficacious than the recommended 125 mg q.i.d. in this setting, said Dr. Chung, clinical pharmacy manager of infectious diseases at Montefiore Medical Center, New York.

"Prior to 2008, prescribers at our institution frequently requested vancomycin doses higher than the recommended 125 mg q.i.d. for treatment of [C. difficile infection] despite the absence of data showing added benefits with the higher dosing regimens," he said. "This practice not only increases medication and/or preparation costs, but it may also increase the potential for untoward effects in patients being treated with the higher doses (e.g., increased risks for vancomycin-resistant enterococci colonization or higher likelihood to further alter the GI flora)."

Since the inception of the Antimicrobial Stewardship Program at Montefiore Medical Center in 2008, Dr. Chung and his associates observed a shift in oral vancomycin prescribing practices from a higher dosing regimen to a lower dosing regimen. "Because of this change in practice, we wished to evaluate the efficacy of the different oral vancomycin dosing regimen in order to ensure treatment outcomes remained unchanged at our institution," he said. To do so, the researchers retrospectively reviewed clinical outcomes of 300 adult patients treated with oral vancomycin at the medical center between 2006 and 2010. They looked at clinical parameters, concomitant antibiotics, in-hospital mortality, and 30-day readmission.

The primary endpoint was clinical improvement at 72 hours of oral vancomycin. Secondary endpoints included clinical improvement at end of therapy or discharge, length of stay, in-hospital mortality, and 30-day readmission rate.

Of the 300 patients, 197 were prescribed oral vancomycin 125 mg q.i.d. (low-dose group) and 103 patients were prescribed 250 mg or higher q.i.d. (high-dose group). Dr. Chung and his associates reported that clinical improvement assessed 72 hours after starting oral vancomycin therapy was observed in 85% and 86% of patients in the low- and high-dose groups, respectively (P less than 0.05). Rates of clinical improvement at end of therapy or time of hospital discharge between the two groups were also found to be similar (93% vs. 96%), as were total length of hospital stay (20 days vs. 19 days), in-hospital mortality (15% vs. 23%), and rates of 30-day readmission (34% vs. 24%).

"The finding that oral vancomycin 125 mg q.i.d. works as well as higher doses for severe uncomplicated C. difficile infection for the most part is not a surprise to us, as some evidence already exists in the literature," said Dr. Chung, also of Albert Einstein College of Medicine in New York. "Our finding only confirmed what is already known."

Limitations include the fact that this is a single-center study, and that it is subject to selection bias because of its retrospective design, Dr. Chung said. "However, we took steps to ensure that all patients treated with oral vancomycin who had laboratory-confirmed [C. difficile infection] and symptoms consistent with [C. difficile infection] were included in the study," he said.

Dr. Chung said that he had no relevant financial conflicts to disclose.

[email protected]

DENVER – The incidence of Clostridium difficile infections in United States hospitals nearly doubled between 2001 and 2010, with little evidence of recent decline. In addition, there does not appear to be a significant decline in mortality or hospital length of stay among patients with the infection, an analysis of national data showed.

"These data underscore the importance of directing resources to the prevention of [C. difficile infection], as well as developing public policy for reducing the incidence of these infections in U.S. hospitals," Kelly R. Daniels, Pharm.D., said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"Judicious use of antibiotics is essential to reducing these infections, as antibiotics are the main risk factor for the development of CDI," she noted. "Compliance with other infection control measures, such as hand washing, is also key. Further research is needed to identify effective measures for preventing CDI and improving outcomes in patients with CDI."

Dr. Daniels, a graduate student in the translational science PhD program at the University of Texas, Austin, and her associates retrospectively reviewed U.S. National Hospital Discharge Surveys from 2001 to 2010. They included patients aged 18 years and older who were discharged from the hospital with an ICD-9-CM diagnosis code for CDI (008.45) and used data weights to determine national estimates. They presented incidence rates as CDI cases per 1,000 hospitalizations, and they used multivariable logistic and linear regression models to compare mortality and hospital length of stay between primary and secondary CDI.

Over the 10-year study period, 2.2 million patients were discharged from the hospital with CDI. Their median age was 75 years, most (86%) were white, and more than half (59%) were female. One-third of cases (33%) were primary CDI, while the remainder were secondary CDI. The three most common concomitant infectious diagnoses were urinary tract infection (21%), pneumonia (14%), and sepsis/septicemia (12%).

Dr. Daniels reported that the incidence of CDI increased from 4.5 cases/1,000 hospitalizations in 2001 to 8.2 cases/1,000 hospitalizations in 2010. Similar trends were observed in patients with primary and secondary CDI.

The overall mortality rate was 7.1% for the study period and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (8.8% vs. 3.3%, respectively; relative risk, 1.8). The median hospital length of stay was 8 days and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (9 days vs. 5 days, respectively; RR, 13.3).

"We found that in-hospital mortality among patients with primary CDI is decreasing, while mortality among patients with secondary CDI is increasing," Dr. Daniels said. "This trend is different from prior studies, which demonstrated increases in CDI-related mortality from the 1990s to the early 2000s."

The decline in in-hospital mortality among patients with primary CDI might reflect improvements in care in recent years, she explained. In contrast, the increase in mortality among those with secondary CDI may be caused by changes in the frequency or severity of other comorbid illnesses. However, "this was not specifically examined as part of our study," Dr. Daniels added.

She acknowledged certain limitations of the analysis, including the fact that it relied on administrative codes to identify cases of CDI. "Although CDI codes have high accuracy for identifying CDI, they cannot be considered equivalent to medical chart reviews," Dr. Daniels explained. Also, "the use of administrative codes precludes our ability to confirm the CDI diagnosis using laboratory methods or to identify the causative strain of C. difficile." In addition, the National Hospital Discharge Surveys don’t include federal hospitals and long-term care hospitals. "Therefore, our estimates may not be generalizable to those settings and may underestimate the true burden of CDI in the United States," Dr. Daniels explained.

No outside funding was obtained for the conduct of this study. Dr. Daniels disclosed that she is supported by the National Institutes of Health National Center for Advancing Translational Sciences Loan Repayment Program.

[email protected]

DENVER – The incidence of Clostridium difficile infections in United States hospitals nearly doubled between 2001 and 2010, with little evidence of recent decline. In addition, there does not appear to be a significant decline in mortality or hospital length of stay among patients with the infection, an analysis of national data showed.

"These data underscore the importance of directing resources to the prevention of [C. difficile infection], as well as developing public policy for reducing the incidence of these infections in U.S. hospitals," Kelly R. Daniels, Pharm.D., said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"Judicious use of antibiotics is essential to reducing these infections, as antibiotics are the main risk factor for the development of CDI," she noted. "Compliance with other infection control measures, such as hand washing, is also key. Further research is needed to identify effective measures for preventing CDI and improving outcomes in patients with CDI."

Dr. Daniels, a graduate student in the translational science PhD program at the University of Texas, Austin, and her associates retrospectively reviewed U.S. National Hospital Discharge Surveys from 2001 to 2010. They included patients aged 18 years and older who were discharged from the hospital with an ICD-9-CM diagnosis code for CDI (008.45) and used data weights to determine national estimates. They presented incidence rates as CDI cases per 1,000 hospitalizations, and they used multivariable logistic and linear regression models to compare mortality and hospital length of stay between primary and secondary CDI.

Over the 10-year study period, 2.2 million patients were discharged from the hospital with CDI. Their median age was 75 years, most (86%) were white, and more than half (59%) were female. One-third of cases (33%) were primary CDI, while the remainder were secondary CDI. The three most common concomitant infectious diagnoses were urinary tract infection (21%), pneumonia (14%), and sepsis/septicemia (12%).

Dr. Daniels reported that the incidence of CDI increased from 4.5 cases/1,000 hospitalizations in 2001 to 8.2 cases/1,000 hospitalizations in 2010. Similar trends were observed in patients with primary and secondary CDI.

The overall mortality rate was 7.1% for the study period and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (8.8% vs. 3.3%, respectively; relative risk, 1.8). The median hospital length of stay was 8 days and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (9 days vs. 5 days, respectively; RR, 13.3).

"We found that in-hospital mortality among patients with primary CDI is decreasing, while mortality among patients with secondary CDI is increasing," Dr. Daniels said. "This trend is different from prior studies, which demonstrated increases in CDI-related mortality from the 1990s to the early 2000s."

The decline in in-hospital mortality among patients with primary CDI might reflect improvements in care in recent years, she explained. In contrast, the increase in mortality among those with secondary CDI may be caused by changes in the frequency or severity of other comorbid illnesses. However, "this was not specifically examined as part of our study," Dr. Daniels added.

She acknowledged certain limitations of the analysis, including the fact that it relied on administrative codes to identify cases of CDI. "Although CDI codes have high accuracy for identifying CDI, they cannot be considered equivalent to medical chart reviews," Dr. Daniels explained. Also, "the use of administrative codes precludes our ability to confirm the CDI diagnosis using laboratory methods or to identify the causative strain of C. difficile." In addition, the National Hospital Discharge Surveys don’t include federal hospitals and long-term care hospitals. "Therefore, our estimates may not be generalizable to those settings and may underestimate the true burden of CDI in the United States," Dr. Daniels explained.

No outside funding was obtained for the conduct of this study. Dr. Daniels disclosed that she is supported by the National Institutes of Health National Center for Advancing Translational Sciences Loan Repayment Program.

[email protected]

DENVER – The incidence of Clostridium difficile infections in United States hospitals nearly doubled between 2001 and 2010, with little evidence of recent decline. In addition, there does not appear to be a significant decline in mortality or hospital length of stay among patients with the infection, an analysis of national data showed.

"These data underscore the importance of directing resources to the prevention of [C. difficile infection], as well as developing public policy for reducing the incidence of these infections in U.S. hospitals," Kelly R. Daniels, Pharm.D., said in an interview prior to the annual Interscience Conference on Antimicrobial Agents and Chemotherapy, where the study was presented.

"Judicious use of antibiotics is essential to reducing these infections, as antibiotics are the main risk factor for the development of CDI," she noted. "Compliance with other infection control measures, such as hand washing, is also key. Further research is needed to identify effective measures for preventing CDI and improving outcomes in patients with CDI."

Dr. Daniels, a graduate student in the translational science PhD program at the University of Texas, Austin, and her associates retrospectively reviewed U.S. National Hospital Discharge Surveys from 2001 to 2010. They included patients aged 18 years and older who were discharged from the hospital with an ICD-9-CM diagnosis code for CDI (008.45) and used data weights to determine national estimates. They presented incidence rates as CDI cases per 1,000 hospitalizations, and they used multivariable logistic and linear regression models to compare mortality and hospital length of stay between primary and secondary CDI.

Over the 10-year study period, 2.2 million patients were discharged from the hospital with CDI. Their median age was 75 years, most (86%) were white, and more than half (59%) were female. One-third of cases (33%) were primary CDI, while the remainder were secondary CDI. The three most common concomitant infectious diagnoses were urinary tract infection (21%), pneumonia (14%), and sepsis/septicemia (12%).

Dr. Daniels reported that the incidence of CDI increased from 4.5 cases/1,000 hospitalizations in 2001 to 8.2 cases/1,000 hospitalizations in 2010. Similar trends were observed in patients with primary and secondary CDI.

The overall mortality rate was 7.1% for the study period and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (8.8% vs. 3.3%, respectively; relative risk, 1.8). The median hospital length of stay was 8 days and was significantly higher among patients with secondary CDI, compared with those who had primary CDI (9 days vs. 5 days, respectively; RR, 13.3).

"We found that in-hospital mortality among patients with primary CDI is decreasing, while mortality among patients with secondary CDI is increasing," Dr. Daniels said. "This trend is different from prior studies, which demonstrated increases in CDI-related mortality from the 1990s to the early 2000s."

The decline in in-hospital mortality among patients with primary CDI might reflect improvements in care in recent years, she explained. In contrast, the increase in mortality among those with secondary CDI may be caused by changes in the frequency or severity of other comorbid illnesses. However, "this was not specifically examined as part of our study," Dr. Daniels added.

She acknowledged certain limitations of the analysis, including the fact that it relied on administrative codes to identify cases of CDI. "Although CDI codes have high accuracy for identifying CDI, they cannot be considered equivalent to medical chart reviews," Dr. Daniels explained. Also, "the use of administrative codes precludes our ability to confirm the CDI diagnosis using laboratory methods or to identify the causative strain of C. difficile." In addition, the National Hospital Discharge Surveys don’t include federal hospitals and long-term care hospitals. "Therefore, our estimates may not be generalizable to those settings and may underestimate the true burden of CDI in the United States," Dr. Daniels explained.

No outside funding was obtained for the conduct of this study. Dr. Daniels disclosed that she is supported by the National Institutes of Health National Center for Advancing Translational Sciences Loan Repayment Program.

[email protected]

SAN DIEGO – Analyses of a single-center cohort of nearly 3,400 patients with unruptured aneurysms who underwent either treatment or observation suggest that aneurysms larger than 5 mm should be treated.

"Treatment, of course, has complications, and some patients deteriorate clinically. However, we find that unruptured aneurysm treatment-related complications leave no effect on function, as measured by modified Rankin Scale scores. On the other hand, once an aneurysm ruptures, there is a high incidence of death and disability. Based on that, we conclude unruptured aneurysms larger than 5 mm should be treated," Dr. Yuichi Murayama said at the annual meeting of the American Society of Neuroradiology.

In the cohort of 3,395 patients with unruptured intracranial aneurysms (UIAs), 28% were treated while the remaining 72% were managed conservatively and underwent biannual 3D computed tomography angiography (CTA). They were referred to Jikei University in Tokyo between January 2003 and December 2012.

Most UIAs were measured using 3D CTA because magnetic resonance angiography (MRA) was thought to be less accurate and more invasive. Patients were recommended for treatment (with either endovascular coiling or microsurgical clipping) if the aneurysm was larger than 5 mm and considered safely treatable, multiple aneurysms were present and one had previously ruptured, or there was a family history of subarachnoid hemorrhage. Endovascularly treated patients underwent MRA follow-up at 3, 6, and 12 months after treatment and then subsequently underwent annual MRA and magnetic resonance imaging (MRI) studies. Surgically treated patients had angiography at 12 months after treatment and then 3D CTA.

Almost 1,700 patients with UIAs who were not treated were followed over the 10-year period with CTA. Overall, 49 (2.9%) aneurysms ruptured, yielding an annual rupture rate of 0.8%/year. The average size of aneurysms in the treatment group was 7.8 mm, compared with 4.4 mm in the observation group. The frequency of treatment increased with size: 10% of small aneurysms (up to 4.9 mm in diameter), 50% of medium aneurysms (5.0-9.9 mm), and almost 100% of large (10.0-24.9 mm) and giant aneurysms (greater than 25 mm), reported Dr. Murayama, director of the center of endovascular surgery at Jikei University.

Rupture rates were 0.35%/year for small aneurysms, 2.2%/year for medium, 10.75%/year for large, and 50%/year for giant. Although the risk of rupture of small aneurysms is low, 17 small aneurysms ruptured within the observation period. Furthermore, Dr. Murayama said that while most ruptures occurred within the first 2 years of discovery, even apparently stable aneurysms might rupture after 2 years. The most common sites for aneurysm rupture were the anterior cerebral, middle cerebral, vertebral, and posterior communicating arteries.

About 200 additional patients were followed with MRA rather than CTA, Dr. Murayama said after the meeting. Ongoing analyses of the rupture rates in these patients may change the rupture rates for various aneurysm sizes, he said.

Dr. Murayama compared the results from his institution to the findings of another Japanese cohort in the UCAS study, which included 5,700 patients with almost 6,700 aneurysms enrolled from 283 medical centers (N. Engl. J. Med. 2012;366:2474-82). The annual risk of rupture for small aneurysms was 0.36%, very similar to that found by the Jikei group (0.35%). Similarly, the annual risk for 7- to 10-mm aneurysms was 1.7%, which was very similar to that found by the Jikei group (1.5%).

There was a more substantial difference between the two studies in the annual risk of rupture for aneurysms measuring 5-7 mm (0.5% in the UCAS cohort vs. 2.3% in the Jikei cohort). "For this size, the decision to treat is difficult because the risk of rupture is relatively low but treatment risk also exists. That is why, in our database, 50% of patients with 5- to 7-mm-sized aneurysms went to observation," Dr. Murayama said.

Using 3D CTA, Dr. Murayama addressed the question whether UIAs grow. In the Jikei cohort, 10% of aneurysms grew in size (defined as a change of 1 mm or more between the baseline measurement and follow-up). "If you see a change in morphology, treat without delay," he said.

Dr. Murayama reported no relevant financial relationships.

SAN DIEGO – Analyses of a single-center cohort of nearly 3,400 patients with unruptured aneurysms who underwent either treatment or observation suggest that aneurysms larger than 5 mm should be treated.

"Treatment, of course, has complications, and some patients deteriorate clinically. However, we find that unruptured aneurysm treatment-related complications leave no effect on function, as measured by modified Rankin Scale scores. On the other hand, once an aneurysm ruptures, there is a high incidence of death and disability. Based on that, we conclude unruptured aneurysms larger than 5 mm should be treated," Dr. Yuichi Murayama said at the annual meeting of the American Society of Neuroradiology.

In the cohort of 3,395 patients with unruptured intracranial aneurysms (UIAs), 28% were treated while the remaining 72% were managed conservatively and underwent biannual 3D computed tomography angiography (CTA). They were referred to Jikei University in Tokyo between January 2003 and December 2012.

Most UIAs were measured using 3D CTA because magnetic resonance angiography (MRA) was thought to be less accurate and more invasive. Patients were recommended for treatment (with either endovascular coiling or microsurgical clipping) if the aneurysm was larger than 5 mm and considered safely treatable, multiple aneurysms were present and one had previously ruptured, or there was a family history of subarachnoid hemorrhage. Endovascularly treated patients underwent MRA follow-up at 3, 6, and 12 months after treatment and then subsequently underwent annual MRA and magnetic resonance imaging (MRI) studies. Surgically treated patients had angiography at 12 months after treatment and then 3D CTA.

Almost 1,700 patients with UIAs who were not treated were followed over the 10-year period with CTA. Overall, 49 (2.9%) aneurysms ruptured, yielding an annual rupture rate of 0.8%/year. The average size of aneurysms in the treatment group was 7.8 mm, compared with 4.4 mm in the observation group. The frequency of treatment increased with size: 10% of small aneurysms (up to 4.9 mm in diameter), 50% of medium aneurysms (5.0-9.9 mm), and almost 100% of large (10.0-24.9 mm) and giant aneurysms (greater than 25 mm), reported Dr. Murayama, director of the center of endovascular surgery at Jikei University.

Rupture rates were 0.35%/year for small aneurysms, 2.2%/year for medium, 10.75%/year for large, and 50%/year for giant. Although the risk of rupture of small aneurysms is low, 17 small aneurysms ruptured within the observation period. Furthermore, Dr. Murayama said that while most ruptures occurred within the first 2 years of discovery, even apparently stable aneurysms might rupture after 2 years. The most common sites for aneurysm rupture were the anterior cerebral, middle cerebral, vertebral, and posterior communicating arteries.

About 200 additional patients were followed with MRA rather than CTA, Dr. Murayama said after the meeting. Ongoing analyses of the rupture rates in these patients may change the rupture rates for various aneurysm sizes, he said.

Dr. Murayama compared the results from his institution to the findings of another Japanese cohort in the UCAS study, which included 5,700 patients with almost 6,700 aneurysms enrolled from 283 medical centers (N. Engl. J. Med. 2012;366:2474-82). The annual risk of rupture for small aneurysms was 0.36%, very similar to that found by the Jikei group (0.35%). Similarly, the annual risk for 7- to 10-mm aneurysms was 1.7%, which was very similar to that found by the Jikei group (1.5%).

There was a more substantial difference between the two studies in the annual risk of rupture for aneurysms measuring 5-7 mm (0.5% in the UCAS cohort vs. 2.3% in the Jikei cohort). "For this size, the decision to treat is difficult because the risk of rupture is relatively low but treatment risk also exists. That is why, in our database, 50% of patients with 5- to 7-mm-sized aneurysms went to observation," Dr. Murayama said.

Using 3D CTA, Dr. Murayama addressed the question whether UIAs grow. In the Jikei cohort, 10% of aneurysms grew in size (defined as a change of 1 mm or more between the baseline measurement and follow-up). "If you see a change in morphology, treat without delay," he said.

Dr. Murayama reported no relevant financial relationships.

SAN DIEGO – Analyses of a single-center cohort of nearly 3,400 patients with unruptured aneurysms who underwent either treatment or observation suggest that aneurysms larger than 5 mm should be treated.

"Treatment, of course, has complications, and some patients deteriorate clinically. However, we find that unruptured aneurysm treatment-related complications leave no effect on function, as measured by modified Rankin Scale scores. On the other hand, once an aneurysm ruptures, there is a high incidence of death and disability. Based on that, we conclude unruptured aneurysms larger than 5 mm should be treated," Dr. Yuichi Murayama said at the annual meeting of the American Society of Neuroradiology.

In the cohort of 3,395 patients with unruptured intracranial aneurysms (UIAs), 28% were treated while the remaining 72% were managed conservatively and underwent biannual 3D computed tomography angiography (CTA). They were referred to Jikei University in Tokyo between January 2003 and December 2012.

Most UIAs were measured using 3D CTA because magnetic resonance angiography (MRA) was thought to be less accurate and more invasive. Patients were recommended for treatment (with either endovascular coiling or microsurgical clipping) if the aneurysm was larger than 5 mm and considered safely treatable, multiple aneurysms were present and one had previously ruptured, or there was a family history of subarachnoid hemorrhage. Endovascularly treated patients underwent MRA follow-up at 3, 6, and 12 months after treatment and then subsequently underwent annual MRA and magnetic resonance imaging (MRI) studies. Surgically treated patients had angiography at 12 months after treatment and then 3D CTA.

Almost 1,700 patients with UIAs who were not treated were followed over the 10-year period with CTA. Overall, 49 (2.9%) aneurysms ruptured, yielding an annual rupture rate of 0.8%/year. The average size of aneurysms in the treatment group was 7.8 mm, compared with 4.4 mm in the observation group. The frequency of treatment increased with size: 10% of small aneurysms (up to 4.9 mm in diameter), 50% of medium aneurysms (5.0-9.9 mm), and almost 100% of large (10.0-24.9 mm) and giant aneurysms (greater than 25 mm), reported Dr. Murayama, director of the center of endovascular surgery at Jikei University.

Rupture rates were 0.35%/year for small aneurysms, 2.2%/year for medium, 10.75%/year for large, and 50%/year for giant. Although the risk of rupture of small aneurysms is low, 17 small aneurysms ruptured within the observation period. Furthermore, Dr. Murayama said that while most ruptures occurred within the first 2 years of discovery, even apparently stable aneurysms might rupture after 2 years. The most common sites for aneurysm rupture were the anterior cerebral, middle cerebral, vertebral, and posterior communicating arteries.

About 200 additional patients were followed with MRA rather than CTA, Dr. Murayama said after the meeting. Ongoing analyses of the rupture rates in these patients may change the rupture rates for various aneurysm sizes, he said.

Dr. Murayama compared the results from his institution to the findings of another Japanese cohort in the UCAS study, which included 5,700 patients with almost 6,700 aneurysms enrolled from 283 medical centers (N. Engl. J. Med. 2012;366:2474-82). The annual risk of rupture for small aneurysms was 0.36%, very similar to that found by the Jikei group (0.35%). Similarly, the annual risk for 7- to 10-mm aneurysms was 1.7%, which was very similar to that found by the Jikei group (1.5%).

There was a more substantial difference between the two studies in the annual risk of rupture for aneurysms measuring 5-7 mm (0.5% in the UCAS cohort vs. 2.3% in the Jikei cohort). "For this size, the decision to treat is difficult because the risk of rupture is relatively low but treatment risk also exists. That is why, in our database, 50% of patients with 5- to 7-mm-sized aneurysms went to observation," Dr. Murayama said.

Using 3D CTA, Dr. Murayama addressed the question whether UIAs grow. In the Jikei cohort, 10% of aneurysms grew in size (defined as a change of 1 mm or more between the baseline measurement and follow-up). "If you see a change in morphology, treat without delay," he said.

Dr. Murayama reported no relevant financial relationships.

The albumin-bound formulation of paclitaxel has been approved by the Food and Drug Administration as a first-line treatment for metastatic adenocarcinoma of the pancreas, in combination with gemcitabine, the agency announced on Sept. 6.

The expanded indication for Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound), a microtubule inhibitor, is based on a study that found survival and progression-free survival were a median of almost 2 months longer among those treated with Abraxane and gemcitabine, compared with those treated with gemcitabine alone, according to the FDA statement announcing the approval.

When pancreatic cancer is diagnosed in an advanced stage and is inoperable, which is often when pancreatic cancer is diagnosed, "and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.

The international study compared Abraxane plus gemcitabine with gemcitabine alone as a first-line treatment in 861 people with metastatic adenocarcinoma of the pancreas. Their median age was 63 years, and almost half had three or more sites of metastasis (84% had liver metastases).

Median overall survival was 8.5 months in those on the combination vs. 6.7 months among those on gemcitabine alone, a highly statistically significant difference. Median progression-free survival was 5.5 months among those on the combination vs. 3.7 months for those on gemcitabine alone, also a highly statistically significant difference. In addition, 23% of those in the combination arm had a confirmed complete or partial overall response, compared with 7% of those on gemcitabine, according to the prescribing information.

The results of the study, IMPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), have been submitted for publication, according to the Celgene statement announcing the approval, and were presented at the American Society of Clinical Oncology annual meeting this year.

Common adverse events associated with treatment with Abraxane and gemcitabine included neutropenia, thrombocytopenia, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, fever, vomiting, rash, and dehydration. Fever, dehydration, pneumonia, and vomiting were the most common serious adverse events. Other "clinically important" adverse events included sepsis and pneumonitis, according to the FDA.

According to the new prescribing information, for pancreatic cancer, Abraxane (125 mg/m²) is administered intravenously on days 1, 8, and 15 of each 28-day cycle, followed by gemcitabine immediately afterwards. In the United States, pancreatic cancer is the fourth-leading cause of cancer deaths, according to the FDA statement, which cites National Cancer Institute estimates that 45,220 patients will be diagnosed with pancreatic cancer and 38,460 will die from the disease in 2013.

Abraxane, marketed by Celgene, was approved for treating breast cancer in 2005 and non–small cell lung cancer in 2012. Gemcitabine, a nucleoside metabolic inhibitor marketed as Gemzar by Eli Lilly, was approved in 1996 and is also available in generic formulations. Gemcitabine is approved as a single agent to treat pancreatic cancer.

The revised label is available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s037lbl.pdf.

[email protected]

The albumin-bound formulation of paclitaxel has been approved by the Food and Drug Administration as a first-line treatment for metastatic adenocarcinoma of the pancreas, in combination with gemcitabine, the agency announced on Sept. 6.

The expanded indication for Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound), a microtubule inhibitor, is based on a study that found survival and progression-free survival were a median of almost 2 months longer among those treated with Abraxane and gemcitabine, compared with those treated with gemcitabine alone, according to the FDA statement announcing the approval.

When pancreatic cancer is diagnosed in an advanced stage and is inoperable, which is often when pancreatic cancer is diagnosed, "and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.

The international study compared Abraxane plus gemcitabine with gemcitabine alone as a first-line treatment in 861 people with metastatic adenocarcinoma of the pancreas. Their median age was 63 years, and almost half had three or more sites of metastasis (84% had liver metastases).

Median overall survival was 8.5 months in those on the combination vs. 6.7 months among those on gemcitabine alone, a highly statistically significant difference. Median progression-free survival was 5.5 months among those on the combination vs. 3.7 months for those on gemcitabine alone, also a highly statistically significant difference. In addition, 23% of those in the combination arm had a confirmed complete or partial overall response, compared with 7% of those on gemcitabine, according to the prescribing information.

The results of the study, IMPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), have been submitted for publication, according to the Celgene statement announcing the approval, and were presented at the American Society of Clinical Oncology annual meeting this year.

Common adverse events associated with treatment with Abraxane and gemcitabine included neutropenia, thrombocytopenia, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, fever, vomiting, rash, and dehydration. Fever, dehydration, pneumonia, and vomiting were the most common serious adverse events. Other "clinically important" adverse events included sepsis and pneumonitis, according to the FDA.

According to the new prescribing information, for pancreatic cancer, Abraxane (125 mg/m²) is administered intravenously on days 1, 8, and 15 of each 28-day cycle, followed by gemcitabine immediately afterwards. In the United States, pancreatic cancer is the fourth-leading cause of cancer deaths, according to the FDA statement, which cites National Cancer Institute estimates that 45,220 patients will be diagnosed with pancreatic cancer and 38,460 will die from the disease in 2013.

Abraxane, marketed by Celgene, was approved for treating breast cancer in 2005 and non–small cell lung cancer in 2012. Gemcitabine, a nucleoside metabolic inhibitor marketed as Gemzar by Eli Lilly, was approved in 1996 and is also available in generic formulations. Gemcitabine is approved as a single agent to treat pancreatic cancer.

The revised label is available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s037lbl.pdf.

[email protected]

The albumin-bound formulation of paclitaxel has been approved by the Food and Drug Administration as a first-line treatment for metastatic adenocarcinoma of the pancreas, in combination with gemcitabine, the agency announced on Sept. 6.

The expanded indication for Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound), a microtubule inhibitor, is based on a study that found survival and progression-free survival were a median of almost 2 months longer among those treated with Abraxane and gemcitabine, compared with those treated with gemcitabine alone, according to the FDA statement announcing the approval.

When pancreatic cancer is diagnosed in an advanced stage and is inoperable, which is often when pancreatic cancer is diagnosed, "and in situations when the cancer has progressed following surgery, options like Abraxane can help prolong a patient’s life," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the statement.

The international study compared Abraxane plus gemcitabine with gemcitabine alone as a first-line treatment in 861 people with metastatic adenocarcinoma of the pancreas. Their median age was 63 years, and almost half had three or more sites of metastasis (84% had liver metastases).

Median overall survival was 8.5 months in those on the combination vs. 6.7 months among those on gemcitabine alone, a highly statistically significant difference. Median progression-free survival was 5.5 months among those on the combination vs. 3.7 months for those on gemcitabine alone, also a highly statistically significant difference. In addition, 23% of those in the combination arm had a confirmed complete or partial overall response, compared with 7% of those on gemcitabine, according to the prescribing information.

The results of the study, IMPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), have been submitted for publication, according to the Celgene statement announcing the approval, and were presented at the American Society of Clinical Oncology annual meeting this year.

Common adverse events associated with treatment with Abraxane and gemcitabine included neutropenia, thrombocytopenia, peripheral neuropathy, nausea, alopecia, peripheral edema, diarrhea, fever, vomiting, rash, and dehydration. Fever, dehydration, pneumonia, and vomiting were the most common serious adverse events. Other "clinically important" adverse events included sepsis and pneumonitis, according to the FDA.

According to the new prescribing information, for pancreatic cancer, Abraxane (125 mg/m²) is administered intravenously on days 1, 8, and 15 of each 28-day cycle, followed by gemcitabine immediately afterwards. In the United States, pancreatic cancer is the fourth-leading cause of cancer deaths, according to the FDA statement, which cites National Cancer Institute estimates that 45,220 patients will be diagnosed with pancreatic cancer and 38,460 will die from the disease in 2013.

Abraxane, marketed by Celgene, was approved for treating breast cancer in 2005 and non–small cell lung cancer in 2012. Gemcitabine, a nucleoside metabolic inhibitor marketed as Gemzar by Eli Lilly, was approved in 1996 and is also available in generic formulations. Gemcitabine is approved as a single agent to treat pancreatic cancer.

The revised label is available at http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021660s037lbl.pdf.

[email protected]

The American Hospital Association (AHA) presented the Dick Davidson Quality Milestone Award, one of AHA’s top national awards, to hospital collaboratives in Tennessee and Florida participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP^®). In their nomination entries, the Tennessee Hospital Association (THA) and Florida Hospital Association (FHA) cited their states’ ACS NSQIP results as key quality achievements. THA helps lead the Tennessee Surgical Quality Collaborative (TSQC), the first ACS NSQIP collaborative that is a partnership between a hospital association, health plan, and an ACS local chapter. The 10 Tennessee hospitals participating in TSQC initially reduced complications by 36 percent and saved more than $5 million.. FHA partnered with ACS to create the Florida Surgical Care Initiative (FSCI), based on four ACS NSQIP measures. The 67 hospitals participating in FSCI reduced complications by 14.5 percent and saved $6.67 million in 15 months. Go to the AHA website at http://www.aha.org/about/awards/ davidson/index.shtml for more information about the Davidson Quality Awards.

The American Hospital Association (AHA) presented the Dick Davidson Quality Milestone Award, one of AHA’s top national awards, to hospital collaboratives in Tennessee and Florida participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP^®). In their nomination entries, the Tennessee Hospital Association (THA) and Florida Hospital Association (FHA) cited their states’ ACS NSQIP results as key quality achievements. THA helps lead the Tennessee Surgical Quality Collaborative (TSQC), the first ACS NSQIP collaborative that is a partnership between a hospital association, health plan, and an ACS local chapter. The 10 Tennessee hospitals participating in TSQC initially reduced complications by 36 percent and saved more than $5 million.. FHA partnered with ACS to create the Florida Surgical Care Initiative (FSCI), based on four ACS NSQIP measures. The 67 hospitals participating in FSCI reduced complications by 14.5 percent and saved $6.67 million in 15 months. Go to the AHA website at http://www.aha.org/about/awards/ davidson/index.shtml for more information about the Davidson Quality Awards.

The American Hospital Association (AHA) presented the Dick Davidson Quality Milestone Award, one of AHA’s top national awards, to hospital collaboratives in Tennessee and Florida participating in the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP^®). In their nomination entries, the Tennessee Hospital Association (THA) and Florida Hospital Association (FHA) cited their states’ ACS NSQIP results as key quality achievements. THA helps lead the Tennessee Surgical Quality Collaborative (TSQC), the first ACS NSQIP collaborative that is a partnership between a hospital association, health plan, and an ACS local chapter. The 10 Tennessee hospitals participating in TSQC initially reduced complications by 36 percent and saved more than $5 million.. FHA partnered with ACS to create the Florida Surgical Care Initiative (FSCI), based on four ACS NSQIP measures. The 67 hospitals participating in FSCI reduced complications by 14.5 percent and saved $6.67 million in 15 months. Go to the AHA website at http://www.aha.org/about/awards/ davidson/index.shtml for more information about the Davidson Quality Awards.

The National Quality Forum (NQF) has appointed Arden Morris, MD, MPH, FACS, colorectal surgeon and professor of surgery at the University of Michigan, Ann Arbor, to serve on the NQF Consensus Standards Approval Committee (CSAC). For more information on the committee, go to http://www. qualityforum.org/Measuring_Performance/Consensus_Development_Process%E2%80%99s_Principle/Consensus_Standards_Approval_Committee_Decision.aspx. The American College of Surgeons nominated Dr. Morris to serve on the CSAC, which is responsible for reviewing and approving proposed consensus standards and periodically assessing and recommending enhancements to the NQF’s consensus development process. Her term began in July.

The National Quality Forum (NQF) has appointed Arden Morris, MD, MPH, FACS, colorectal surgeon and professor of surgery at the University of Michigan, Ann Arbor, to serve on the NQF Consensus Standards Approval Committee (CSAC). For more information on the committee, go to http://www. qualityforum.org/Measuring_Performance/Consensus_Development_Process%E2%80%99s_Principle/Consensus_Standards_Approval_Committee_Decision.aspx. The American College of Surgeons nominated Dr. Morris to serve on the CSAC, which is responsible for reviewing and approving proposed consensus standards and periodically assessing and recommending enhancements to the NQF’s consensus development process. Her term began in July.

The National Quality Forum (NQF) has appointed Arden Morris, MD, MPH, FACS, colorectal surgeon and professor of surgery at the University of Michigan, Ann Arbor, to serve on the NQF Consensus Standards Approval Committee (CSAC). For more information on the committee, go to http://www. qualityforum.org/Measuring_Performance/Consensus_Development_Process%E2%80%99s_Principle/Consensus_Standards_Approval_Committee_Decision.aspx. The American College of Surgeons nominated Dr. Morris to serve on the CSAC, which is responsible for reviewing and approving proposed consensus standards and periodically assessing and recommending enhancements to the NQF’s consensus development process. Her term began in July.

Online registration is now available for the American College of Surgeons’ (ACS) Surgical Research Committee 11th Clinical Trials Methods Course. The course will take place December 6-10 at ACS Headquarters in Chicago, IL.

The Clinical Trials Methods Course is a five-day intensive course based on four successfully conducted and published clinical trials. The course will provide surgeons concepts and skills in the following areas: design, implementation, and analysis of randomized clinical trials; observational studies; the use of large administrative databases; meta-analysis; funding mechanisms and budget development; outcomes (medical, patient-centered, cost); and dissemination of results. Participants will work in small groups mentored by leading surgeons and biostatisticians with expertise in clinical trials research.

Registration is limited to 50 participants, and ACS members will receive preference. The course is offered only every other year. Access the course website, registration, and additional course details at http://www.facs.org/cqi/src/clintrial.html, or contact Carla Manosalvas at [email protected].

Online registration is now available for the American College of Surgeons’ (ACS) Surgical Research Committee 11th Clinical Trials Methods Course. The course will take place December 6-10 at ACS Headquarters in Chicago, IL.

The Clinical Trials Methods Course is a five-day intensive course based on four successfully conducted and published clinical trials. The course will provide surgeons concepts and skills in the following areas: design, implementation, and analysis of randomized clinical trials; observational studies; the use of large administrative databases; meta-analysis; funding mechanisms and budget development; outcomes (medical, patient-centered, cost); and dissemination of results. Participants will work in small groups mentored by leading surgeons and biostatisticians with expertise in clinical trials research.

Registration is limited to 50 participants, and ACS members will receive preference. The course is offered only every other year. Access the course website, registration, and additional course details at http://www.facs.org/cqi/src/clintrial.html, or contact Carla Manosalvas at [email protected].

Online registration is now available for the American College of Surgeons’ (ACS) Surgical Research Committee 11th Clinical Trials Methods Course. The course will take place December 6-10 at ACS Headquarters in Chicago, IL.

The Clinical Trials Methods Course is a five-day intensive course based on four successfully conducted and published clinical trials. The course will provide surgeons concepts and skills in the following areas: design, implementation, and analysis of randomized clinical trials; observational studies; the use of large administrative databases; meta-analysis; funding mechanisms and budget development; outcomes (medical, patient-centered, cost); and dissemination of results. Participants will work in small groups mentored by leading surgeons and biostatisticians with expertise in clinical trials research.

Registration is limited to 50 participants, and ACS members will receive preference. The course is offered only every other year. Access the course website, registration, and additional course details at http://www.facs.org/cqi/src/clintrial.html, or contact Carla Manosalvas at [email protected].

Through the contributions of Fellows, Chapters, and friends, the American College of Surgeons (ACS) offers faculty research fellowships, effective July 1, 2014, to June 30, 2016, to surgeons entering academic careers in surgery or a surgical specialty. Applications are due November 1, 2013. The fellowship award of $40,000 annually is intended to assist a surgeon in establishing a new and independent research program. Applicants should have demonstrated their potential to work as independent investigators.

The Franklin H. Martin, MD, FACS, Faculty Research Fellowship honors the College’s founder. The C. James Carrico MD, FACS, Faculty Research Fellowship is dedicated to trauma and critical care research. The one-year Louis Argenta, MD, FACS, Faculty Research Fellowship is dedicated to wound care research.

The full requirements and application form are posted on the ACS website at http://www.facs.org/memberservices/acsfaculty.html. Questions may be directed to Kate Early, Scholarships Administrator, at [email protected].

Through the contributions of Fellows, Chapters, and friends, the American College of Surgeons (ACS) offers faculty research fellowships, effective July 1, 2014, to June 30, 2016, to surgeons entering academic careers in surgery or a surgical specialty. Applications are due November 1, 2013. The fellowship award of $40,000 annually is intended to assist a surgeon in establishing a new and independent research program. Applicants should have demonstrated their potential to work as independent investigators.

The Franklin H. Martin, MD, FACS, Faculty Research Fellowship honors the College’s founder. The C. James Carrico MD, FACS, Faculty Research Fellowship is dedicated to trauma and critical care research. The one-year Louis Argenta, MD, FACS, Faculty Research Fellowship is dedicated to wound care research.

The full requirements and application form are posted on the ACS website at http://www.facs.org/memberservices/acsfaculty.html. Questions may be directed to Kate Early, Scholarships Administrator, at [email protected].

Through the contributions of Fellows, Chapters, and friends, the American College of Surgeons (ACS) offers faculty research fellowships, effective July 1, 2014, to June 30, 2016, to surgeons entering academic careers in surgery or a surgical specialty. Applications are due November 1, 2013. The fellowship award of $40,000 annually is intended to assist a surgeon in establishing a new and independent research program. Applicants should have demonstrated their potential to work as independent investigators.

The Franklin H. Martin, MD, FACS, Faculty Research Fellowship honors the College’s founder. The C. James Carrico MD, FACS, Faculty Research Fellowship is dedicated to trauma and critical care research. The one-year Louis Argenta, MD, FACS, Faculty Research Fellowship is dedicated to wound care research.

The full requirements and application form are posted on the ACS website at http://www.facs.org/memberservices/acsfaculty.html. Questions may be directed to Kate Early, Scholarships Administrator, at [email protected].

The American College of Surgeons (ACS) along with more than 30 other health organizations sent a letter in opposition to recently introduced legislation that would limit access to in-office services provided by physicians. The letter, sent to all members of Congress, urges opposition to H.R. 2914, the Promoting Integrity in Medicare Act, which would eliminate the in-office ancillary services exception (IOASE) to the Stark self-referral law. The IOASE allows physicians to provide certain services including advanced diagnostic imaging (MRI, PET, and CT scans), radiation therapy, anatomic pathology, and physical therapy, with certain requirements and restrictions. The ACS maintains that the U.S. health care system must ease the coordination of care to patients, especially those with complex conditions. Eliminating the IOASE would make this process more difficult. View the letter online at http://www.facs.org/ahp/medicare/index.html.

The American College of Surgeons (ACS) along with more than 30 other health organizations sent a letter in opposition to recently introduced legislation that would limit access to in-office services provided by physicians. The letter, sent to all members of Congress, urges opposition to H.R. 2914, the Promoting Integrity in Medicare Act, which would eliminate the in-office ancillary services exception (IOASE) to the Stark self-referral law. The IOASE allows physicians to provide certain services including advanced diagnostic imaging (MRI, PET, and CT scans), radiation therapy, anatomic pathology, and physical therapy, with certain requirements and restrictions. The ACS maintains that the U.S. health care system must ease the coordination of care to patients, especially those with complex conditions. Eliminating the IOASE would make this process more difficult. View the letter online at http://www.facs.org/ahp/medicare/index.html.

The American College of Surgeons (ACS) along with more than 30 other health organizations sent a letter in opposition to recently introduced legislation that would limit access to in-office services provided by physicians. The letter, sent to all members of Congress, urges opposition to H.R. 2914, the Promoting Integrity in Medicare Act, which would eliminate the in-office ancillary services exception (IOASE) to the Stark self-referral law. The IOASE allows physicians to provide certain services including advanced diagnostic imaging (MRI, PET, and CT scans), radiation therapy, anatomic pathology, and physical therapy, with certain requirements and restrictions. The ACS maintains that the U.S. health care system must ease the coordination of care to patients, especially those with complex conditions. Eliminating the IOASE would make this process more difficult. View the letter online at http://www.facs.org/ahp/medicare/index.html.