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Population-Based Comparison Of The Risks Of Serious Adverse Events From Intermittent Versus Continuous Androgen Deprivation Therapy In Advanced Prostate Cancer Patients
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or anemia (p= 0.262) between sb-paclitaxel and nab-P. Conclusions: Among commercially insured patients with mBC, those initiating nab-P had significantly lower rates of hypersensitivity. Even though nab-P patients remained on therapy longer, they were also significantly less likely to have inpatient stays. PCN3 Intraoperative Anastomotic Leaks Following Colorectal Resection: A Systematic Literature Review Update Schiff A1, Sprengel ML2, Ruetsch C2, Ghosh SK3, Fegelman E1, Roy S4 1Johnson & Johnson (Ethicon), Cincinnati, OH, USA, 2Health Analytics, Columbia, MD, USA, 3Global Health Economics and Market Access, Ethicon, Inc., Cincinnati, OH, USA, 4Johnson and Johnson Global Surgery, Somerville, NJ, USA
Objectives: Although there are methods to test for anastomotic leaks intraoperatively, the effectiveness of this testing in the prevention of postoperative leaks remains unclear. Intraoperative leak testing and reporting of such tests are currently not standard practice in colon resection surgery with physicians sometimes instituting selective testing in groups considered to be at a higher risk of developing postoperative leaks. The purpose of this review was to estimate the rate of intraoperative anastomotic leak, as well as procedural and patient related factors associated with intraoperative testing. Methods: Using a set of predetermined search terms describing low anterior resection (LAR) (LAR and laparoscopic colorectal resection -related surgery, anastomosis, and intraoperative leak), a systematic literature review of the PubMed database was performed for articles published between January 1st, 2003 and August 8th, 2015. Consistent with guidelines for conducting systematic reviews, individual case studies, conference abstracts, letters to the editor, expert opinion without original or other supporting empiric evidence, and editorials were excluded. All other empirical papers were included. Each abstract was reviewed by two trained, independent reviewers. Results: Nineteen published articles met the final criteria for inclusion. Of the 4,878 participants in these 19 articles, 91.6% received a stapled anastomosis, 7.9% received a hand sewn anastomosis and 1% received an unspecified colo-anal anastomosis.Most patients (87.4%) were reported to have received intraoperative testing. Pooled data yielded a range of positive intraoperative leak test results in 1-14.5% of procedures with a mean of 7.7%. Conclusions: The findings of this study indicate that intraoperative testing is performed during most anterior colon resection surgeries, suggesting that intraoperative testing is becoming the standard of care for colon resection surgeries. Further, testing appears to be performed regardless of the method of anastomosis closure employed, although within this dataset stapled anastomosis was the most common. PCN4 Association Between The Use Of Doxorubicin And Risk Of Developing Hepatotoxicity Among Cancer Patients Bhandari NR, Shewale AR, Kathe NJ, Shah AB, Painter JT University of Arkansas for Medical Sciences, Little Rock, AR, USA
Objectives: To estimate the risk of developing hepatotoxicity with the use of doxorubicin among cancer patients. Methods: A nested case-control study was conducted using IMS LifeLink Plus (2006-2013) claims dataset. Types of cancers wherein doxorubicin is likely to be prescribed as an antineoplastic agent were included in the nest. Among the nest, those with hepatotoxicity were categorized as cases and those without were categorized as controls. Hepatotoxicity was defined as a diagnosis of either acute/sub-acute necrosis of liver, or toxic hepatitis, or hepatic coma. Each case was matched up to 5 controls on age, gender, length of pre-event period (+/-90 days), date of event (+/-90 days) and type of cancer. Adjusted and unadjusted conditional logistic regression analyses were conducted to estimate the risk of hepatotoxicity with the exposure to doxorubicin. Sub-group analysis among breast cancer cases was also conducted. Analyses were adjusted for conditions and drugs that are known to be associated with increased risk of hepatotoxicity. Results: A total of 2462 cases of hepatotoxicity met our inclusion-exclusion criteria among the nest population. Use of doxorubicin increased the risk of hepatotoxicity among all cancer types by 1.26 times compared to those with no doxorubicin use (OR: 1.26, 95% CI: 1.045-1.52). Similarly, among breast cancer patients, use of doxorubicin increased the risk of hepatotoxicity by 1.32 times (OR: 1.315, 95% CI: 1.063-1.627). After adjusting for potential confounders, use of doxorubicin among all cancer types increased the risk of hepatotoxicity by 1.29 times compared to those with no doxorubicin use (OR: 1.293, 95% CI: 1.069-1.563). Likewise, among breast cancer patients, use of doxorubicin increased the risk of hepatotoxicity by 1.33 times (OR: 1.333, 95% CI: 1.075-1.653). Conclusions: The use of doxorubicin is associated with an increase in the risk of developing hepatotoxicity especially among breast cancer patients. PCN5 Population-Based Comparison Of The Risks Of Serious Adverse Events From Intermittent Versus Continuous Androgen Deprivation Therapy In Advanced Prostate Cancer Patients Tsai H1, Pfeiffer R2, Philips G3, Barac A4, Fu AZ1, Zhou Y1, Potosky A1 1Georgetown University, Washington, DC, USA, 2National Cancer Institute, Rockville, MD, USA, 3Georgetown University Hospital, Washington, DC, USA, 4MedStar Washington Hospital Center, Washington, DC, USA
Objectives: Randomized trials have reported that intermittent androgen deprivation therapy (IADT) for advanced prostate cancer improves quality of life more than conventional continuous administration of ADT (CADT) while providing a similar survival benefit. It is unknown whether IADT lowers the risk of ADT-related adverse events more than with CADT. Methods: We conducted a retrospective cohort study of 9,772 advanced prostate cancer patients aged 66 or older, diagnosed during 2002- 2011 who received ADT as primary treatment for their prostate cancer. We identified incidence of serious adverse events, including acute myocardial infarction, stroke, heart failure, type-2-diabetes, and fracture, using inpatient and outpatient claims. We used the coxproportional hazard model to assess hazard ratios (HRs) of ADT-associated serious
adverse events in IADT and CADT users. Results: The cohort included 5,026 and 4,746 men with metastatic and non-metastatic prostate cancer at diagnosis. A total of 1,709 (17%), 678 (7%), and 945 (10%) men were newly diagnosed with a serious cardiovascular event, diabetes, or fracture, respectively, during the first 5 years after ADT initiation. We did not find differences in risk of other serious cardiovascular events, diabetes, or fracture between IADT and CADT, although we observed a lower risk of heart failure in IADT than CADT in the metastatic group (HR=0.58, 95%CI=0.036-0.92, p=0.02). Conclusions: This large population-based study showed that compared to CADT, IADT may not alter the risk of serious ADT-associated adverse events in advanced prostate cancer. For elderly men with advanced prostate cancer, physicians should carefully evaluate risks and benefits when initiating ADT and consider IADT to have similar toxicity as CADT, despite its intermittent schedule. PCN6 Postoperative Anastomotic Leaks Following Colorectal Resection: A Systematic Literature Review Update Schiff A1, Sprengel ML2, Ruetsch C2, Ghosh SK3, Fegelman E1, Roy S4 1Johnson & Johnson (Ethicon), Cincinnati, OH, USA, 2Health Analytics, Columbia, MD, USA, 3Global Health Economics and Market Access, Ethicon, Inc., Cincinnati, OH, USA, 4Johnson and Johnson Global Surgery, Somerville, NJ, USA
Objectives: Surgical resection and anastomosis is the standard of care for many colon and rectal pathologies. Postoperative anastomotic leak is a major complication of these procedures and results in a significant burden to the healthcare system. The goal of this literature review is to identify the rate of postoperative anastomotic leaks and the factors associated with their occurrence. Methods: Predetermined search terms were used to systematically identify articles that referred to postoperative leaks in left colon and rectal resection surgery from January 1st, 2003 to August 8th, 2015 (using the PubMed database). Individual case studies, conference abstracts, letters to the editor, expert opinion without original or other supporting empiric evidence, and editorials were excluded. References from the identified articles were cross-referenced to ensure that no major articles were excluded. Each abstract was reviewed by two trained, independent reviewers. Results: Forty-nine published articles met the final criteria for inclusion. Pooled data yielded a mean post-operative anastomotic leak rate of 5.96% (range .4-19.2%). Nineteen articles reported on the mean, median and/or range of post-operative days (PODs) when the leak developed. The first diagnosis of the post-operative leak was 10.6 PODs (weighted mean) from the date of surgery. The most commonly reported patient risk factors were males between the ages of 60-70, cigarette smoking, and having a BMI > 25. Most common medical risk factors were tumor and/or anastomosis location. Procedural risk factors included approach for anastomosis creation (stapled vs. sewn): patients receiving stapled anastomosis were less likely to develop postoperative anastomotic leak. Conclusions: The rate of postoperative anastomotic leak reported in this review is lower than the rates that have been reported earlier. This may be attributed to improved surgical technique and the availability of improved equipment, such as stapling devices, used to create the anastomoses. PCN7 Complications Of Delayed Breast Reconstructions: A PopulationBased Study Tien Y University of Iowa, Coralville, IA, USA
Objectives: Breast cancer patients after receiving mastectomy can undergo immediate breast reconstructions (IBR), or wait months later and undergo delayed breast reconstructions (DBR), depending on physicians’ evaluation, patients’ preference, and types of BR. Current guidelines were inconclusive regarding the timings of BR because of the inconsistent evidence about post-operative complications. Recent studies showed that IBR gradually replaced DBR because of surgical improvements. Yet, there is a need to continuously evaluate complications associated with DBR to justify recommendations. The objective of this study is to assess the relationship between complications and the timing of procedures controlling for types of BR. Methods: A retrospective cohort of 13,257 women underwent BR was identified from 2009 National Inpatient Sample. Patients were grouped into 1) DBR if she underwent BR alone or 2) IBR if underwent mastectomy and BR during the same hospitalization. Complications included, for example, wound complications, infection, hematoma, fat necrosis (identified by ICD-9 procedures and diagnosis) and complications related to the device, surgical procedure, and medical care (identified by HCUP CCS diagnoses). To control for patient and hospital characteristics, and BR types, a multivariate analysis was conducted. Results: Of all the inpatient BR visits, 50.3% were for DBR. About 46.7% versus 14.8% of women who received DBR versus IBR experienced complications respectively. The differences in complication rates were most pronounced for women who received implant reconstructions (64.2% versus 10.1% for DBR versus IBR). Women who received DBR were about 7.6 times more likely to have infections (18.5% versus 2.4% for DBR versus IBR). After adjusting for covariates, women who underwent DBR were significantly more likely to have complications (P< 0.0001). For women who underwent DBR, the odds of experiencing complications were 1.2-19.9% higher than the odds for women who underwent IBR depending on the BR approach. Conclusions: Complications were significantly higher among women who underwent DBR and the complication rates varied by the BR approach. PCN8 The Benefit Of A “Light Touch” In Identifying Melanoma In Natalizumab Treated Patients: A Southern Network On Adverse Reactions (Sonar) Analysis Based On The Tysabri Outreach Commitment To Health Registry (Touch) Noxon V1, Sartor O2, Yarnold P3, Bennett CL4, Raisch DW4 of South Carolina, Columbia, SC, USA, 2Tulane Cancer Center, New Orleans, LA, USA, 3Optimal Data Analysis LLC, Chicago, IL, USA, 4University of New Mexico College of Pharmacy, Albuquerque, NM, USA
1University
VA L U E I N H E A LT H 1 9 ( 2 0 1 6 ) A 1 - A 3 1 8
or anemia (p= 0.262) between sb-paclitaxel and nab-P. Conclusions: Among commercially insured patients with mBC, those initiating nab-P had significantly lower rates of hypersensitivity. Even though nab-P patients remained on therapy longer, they were also significantly less likely to have inpatient stays. PCN3 Intraoperative Anastomotic Leaks Following Colorectal Resection: A Systematic Literature Review Update Schiff A1, Sprengel ML2, Ruetsch C2, Ghosh SK3, Fegelman E1, Roy S4 1Johnson & Johnson (Ethicon), Cincinnati, OH, USA, 2Health Analytics, Columbia, MD, USA, 3Global Health Economics and Market Access, Ethicon, Inc., Cincinnati, OH, USA, 4Johnson and Johnson Global Surgery, Somerville, NJ, USA
Objectives: Although there are methods to test for anastomotic leaks intraoperatively, the effectiveness of this testing in the prevention of postoperative leaks remains unclear. Intraoperative leak testing and reporting of such tests are currently not standard practice in colon resection surgery with physicians sometimes instituting selective testing in groups considered to be at a higher risk of developing postoperative leaks. The purpose of this review was to estimate the rate of intraoperative anastomotic leak, as well as procedural and patient related factors associated with intraoperative testing. Methods: Using a set of predetermined search terms describing low anterior resection (LAR) (LAR and laparoscopic colorectal resection -related surgery, anastomosis, and intraoperative leak), a systematic literature review of the PubMed database was performed for articles published between January 1st, 2003 and August 8th, 2015. Consistent with guidelines for conducting systematic reviews, individual case studies, conference abstracts, letters to the editor, expert opinion without original or other supporting empiric evidence, and editorials were excluded. All other empirical papers were included. Each abstract was reviewed by two trained, independent reviewers. Results: Nineteen published articles met the final criteria for inclusion. Of the 4,878 participants in these 19 articles, 91.6% received a stapled anastomosis, 7.9% received a hand sewn anastomosis and 1% received an unspecified colo-anal anastomosis.Most patients (87.4%) were reported to have received intraoperative testing. Pooled data yielded a range of positive intraoperative leak test results in 1-14.5% of procedures with a mean of 7.7%. Conclusions: The findings of this study indicate that intraoperative testing is performed during most anterior colon resection surgeries, suggesting that intraoperative testing is becoming the standard of care for colon resection surgeries. Further, testing appears to be performed regardless of the method of anastomosis closure employed, although within this dataset stapled anastomosis was the most common. PCN4 Association Between The Use Of Doxorubicin And Risk Of Developing Hepatotoxicity Among Cancer Patients Bhandari NR, Shewale AR, Kathe NJ, Shah AB, Painter JT University of Arkansas for Medical Sciences, Little Rock, AR, USA
Objectives: To estimate the risk of developing hepatotoxicity with the use of doxorubicin among cancer patients. Methods: A nested case-control study was conducted using IMS LifeLink Plus (2006-2013) claims dataset. Types of cancers wherein doxorubicin is likely to be prescribed as an antineoplastic agent were included in the nest. Among the nest, those with hepatotoxicity were categorized as cases and those without were categorized as controls. Hepatotoxicity was defined as a diagnosis of either acute/sub-acute necrosis of liver, or toxic hepatitis, or hepatic coma. Each case was matched up to 5 controls on age, gender, length of pre-event period (+/-90 days), date of event (+/-90 days) and type of cancer. Adjusted and unadjusted conditional logistic regression analyses were conducted to estimate the risk of hepatotoxicity with the exposure to doxorubicin. Sub-group analysis among breast cancer cases was also conducted. Analyses were adjusted for conditions and drugs that are known to be associated with increased risk of hepatotoxicity. Results: A total of 2462 cases of hepatotoxicity met our inclusion-exclusion criteria among the nest population. Use of doxorubicin increased the risk of hepatotoxicity among all cancer types by 1.26 times compared to those with no doxorubicin use (OR: 1.26, 95% CI: 1.045-1.52). Similarly, among breast cancer patients, use of doxorubicin increased the risk of hepatotoxicity by 1.32 times (OR: 1.315, 95% CI: 1.063-1.627). After adjusting for potential confounders, use of doxorubicin among all cancer types increased the risk of hepatotoxicity by 1.29 times compared to those with no doxorubicin use (OR: 1.293, 95% CI: 1.069-1.563). Likewise, among breast cancer patients, use of doxorubicin increased the risk of hepatotoxicity by 1.33 times (OR: 1.333, 95% CI: 1.075-1.653). Conclusions: The use of doxorubicin is associated with an increase in the risk of developing hepatotoxicity especially among breast cancer patients. PCN5 Population-Based Comparison Of The Risks Of Serious Adverse Events From Intermittent Versus Continuous Androgen Deprivation Therapy In Advanced Prostate Cancer Patients Tsai H1, Pfeiffer R2, Philips G3, Barac A4, Fu AZ1, Zhou Y1, Potosky A1 1Georgetown University, Washington, DC, USA, 2National Cancer Institute, Rockville, MD, USA, 3Georgetown University Hospital, Washington, DC, USA, 4MedStar Washington Hospital Center, Washington, DC, USA
Objectives: Randomized trials have reported that intermittent androgen deprivation therapy (IADT) for advanced prostate cancer improves quality of life more than conventional continuous administration of ADT (CADT) while providing a similar survival benefit. It is unknown whether IADT lowers the risk of ADT-related adverse events more than with CADT. Methods: We conducted a retrospective cohort study of 9,772 advanced prostate cancer patients aged 66 or older, diagnosed during 2002- 2011 who received ADT as primary treatment for their prostate cancer. We identified incidence of serious adverse events, including acute myocardial infarction, stroke, heart failure, type-2-diabetes, and fracture, using inpatient and outpatient claims. We used the coxproportional hazard model to assess hazard ratios (HRs) of ADT-associated serious
adverse events in IADT and CADT users. Results: The cohort included 5,026 and 4,746 men with metastatic and non-metastatic prostate cancer at diagnosis. A total of 1,709 (17%), 678 (7%), and 945 (10%) men were newly diagnosed with a serious cardiovascular event, diabetes, or fracture, respectively, during the first 5 years after ADT initiation. We did not find differences in risk of other serious cardiovascular events, diabetes, or fracture between IADT and CADT, although we observed a lower risk of heart failure in IADT than CADT in the metastatic group (HR=0.58, 95%CI=0.036-0.92, p=0.02). Conclusions: This large population-based study showed that compared to CADT, IADT may not alter the risk of serious ADT-associated adverse events in advanced prostate cancer. For elderly men with advanced prostate cancer, physicians should carefully evaluate risks and benefits when initiating ADT and consider IADT to have similar toxicity as CADT, despite its intermittent schedule. PCN6 Postoperative Anastomotic Leaks Following Colorectal Resection: A Systematic Literature Review Update Schiff A1, Sprengel ML2, Ruetsch C2, Ghosh SK3, Fegelman E1, Roy S4 1Johnson & Johnson (Ethicon), Cincinnati, OH, USA, 2Health Analytics, Columbia, MD, USA, 3Global Health Economics and Market Access, Ethicon, Inc., Cincinnati, OH, USA, 4Johnson and Johnson Global Surgery, Somerville, NJ, USA
Objectives: Surgical resection and anastomosis is the standard of care for many colon and rectal pathologies. Postoperative anastomotic leak is a major complication of these procedures and results in a significant burden to the healthcare system. The goal of this literature review is to identify the rate of postoperative anastomotic leaks and the factors associated with their occurrence. Methods: Predetermined search terms were used to systematically identify articles that referred to postoperative leaks in left colon and rectal resection surgery from January 1st, 2003 to August 8th, 2015 (using the PubMed database). Individual case studies, conference abstracts, letters to the editor, expert opinion without original or other supporting empiric evidence, and editorials were excluded. References from the identified articles were cross-referenced to ensure that no major articles were excluded. Each abstract was reviewed by two trained, independent reviewers. Results: Forty-nine published articles met the final criteria for inclusion. Pooled data yielded a mean post-operative anastomotic leak rate of 5.96% (range .4-19.2%). Nineteen articles reported on the mean, median and/or range of post-operative days (PODs) when the leak developed. The first diagnosis of the post-operative leak was 10.6 PODs (weighted mean) from the date of surgery. The most commonly reported patient risk factors were males between the ages of 60-70, cigarette smoking, and having a BMI > 25. Most common medical risk factors were tumor and/or anastomosis location. Procedural risk factors included approach for anastomosis creation (stapled vs. sewn): patients receiving stapled anastomosis were less likely to develop postoperative anastomotic leak. Conclusions: The rate of postoperative anastomotic leak reported in this review is lower than the rates that have been reported earlier. This may be attributed to improved surgical technique and the availability of improved equipment, such as stapling devices, used to create the anastomoses. PCN7 Complications Of Delayed Breast Reconstructions: A PopulationBased Study Tien Y University of Iowa, Coralville, IA, USA
Objectives: Breast cancer patients after receiving mastectomy can undergo immediate breast reconstructions (IBR), or wait months later and undergo delayed breast reconstructions (DBR), depending on physicians’ evaluation, patients’ preference, and types of BR. Current guidelines were inconclusive regarding the timings of BR because of the inconsistent evidence about post-operative complications. Recent studies showed that IBR gradually replaced DBR because of surgical improvements. Yet, there is a need to continuously evaluate complications associated with DBR to justify recommendations. The objective of this study is to assess the relationship between complications and the timing of procedures controlling for types of BR. Methods: A retrospective cohort of 13,257 women underwent BR was identified from 2009 National Inpatient Sample. Patients were grouped into 1) DBR if she underwent BR alone or 2) IBR if underwent mastectomy and BR during the same hospitalization. Complications included, for example, wound complications, infection, hematoma, fat necrosis (identified by ICD-9 procedures and diagnosis) and complications related to the device, surgical procedure, and medical care (identified by HCUP CCS diagnoses). To control for patient and hospital characteristics, and BR types, a multivariate analysis was conducted. Results: Of all the inpatient BR visits, 50.3% were for DBR. About 46.7% versus 14.8% of women who received DBR versus IBR experienced complications respectively. The differences in complication rates were most pronounced for women who received implant reconstructions (64.2% versus 10.1% for DBR versus IBR). Women who received DBR were about 7.6 times more likely to have infections (18.5% versus 2.4% for DBR versus IBR). After adjusting for covariates, women who underwent DBR were significantly more likely to have complications (P< 0.0001). For women who underwent DBR, the odds of experiencing complications were 1.2-19.9% higher than the odds for women who underwent IBR depending on the BR approach. Conclusions: Complications were significantly higher among women who underwent DBR and the complication rates varied by the BR approach. PCN8 The Benefit Of A “Light Touch” In Identifying Melanoma In Natalizumab Treated Patients: A Southern Network On Adverse Reactions (Sonar) Analysis Based On The Tysabri Outreach Commitment To Health Registry (Touch) Noxon V1, Sartor O2, Yarnold P3, Bennett CL4, Raisch DW4 of South Carolina, Columbia, SC, USA, 2Tulane Cancer Center, New Orleans, LA, USA, 3Optimal Data Analysis LLC, Chicago, IL, USA, 4University of New Mexico College of Pharmacy, Albuquerque, NM, USA
1University