74.18 Development of an Approach to Characterize the Complexity of Gastric Cancer Surgery

Posted on December 22, 2014

S. Mohanty1,2, J. Paruch1,3, K. Y. Bilimoria1,4, M. Cohen1, V. E. Strong5, S. M. Weber6  1American College Of Surgeons,Division Of Research And Optimal Patient Care,Chicago, IL, USA 2Henry Ford Hospital,Department Of Surgery,Detroit, MI, USA 3University Of Chicago Pritzker School Of Medicine,Department Of Surgery,Chicago, IL, USA 4Northwestern University Feinberg School Of Medicine,Department Of Surgery, Surgical Outcomes And Improvement Center,Chicago, IL, USA 5Memorial Sloan-Kettering Cancer Center,Department Of Surgery,New York, NY, USA 6University Of Wisconsin School Of Medicine And Public Health,Department Of Surgery,Madison, WI, USA

Introduction:

To allow fair comparisons of hospital quality, most risk adjustment approaches adjust for patient comorbidities and the primary procedure.  However, secondary procedures done at the same time as the index case may increase operative risk and merit inclusion in adjustment models. Including such information could also improve individual patient risk prediction. Our objectives were to evaluate the impact of complexity adjustment on (1)postoperative outcomes, (2)model performance and (3)hospital rankings in gastric cancer surgery. 

Methods:

Using 2007-2012 American College of Surgeons National Surgical Quality Improvement Program data, patients who underwent surgery for gastric adenocarcinoma were identified. Procedure complexity was characterized using secondary procedure CPT© codes and total work relative value units (RVUs).  Regression models were developed to evaluate the association between complexity variables and outcomes. The influence of procedure complexity on model performance and hospital comparisons was examined. 

Results:

Among 3,467 patients who underwent gastrectomy for adenocarcinoma, a secondary procedure was reported for 81.9% of total gastrectomies and 69.6% of partial gastrectomies. The presence of secondary procedures was associated with greater odds for adverse outcomes. For example, patients who underwent a synchronous bowel resection had a higher risk of mortality (OR=2.14, 95%CI: 1.07-4.29) and reoperation (OR=2.09, 95%CI: 1.26-3.47) (Table 1). Model performance was slightly better for nearly all outcomes with complexity adjustment (morbidity c-statistics: standard model, 0.690; RVU model, 0.694; secondary procedure model, 0.701). Hospital ranking did not change significantly after complexity adjustment (mortality, weighted κ 0.84).

Conclusion:

Surgical complexity adjustment improved individual risk prediction but did not appreciably affect hospital rankings. Inclusion of complexity variables into risk prediction tools, such as the ACS NSQIP Risk Calculator, should be considered. 

7.11 Robotic and Laparoscopic Surgery for Colorectal Cancer Offer Comparable 3-5 Year Oncologic Outcomes

Posted on December 22, 2014

F. G. Wilder1,2, A. Burnett1, J. Oliver1, R. J. Chokshi1  1Rutgers – New Jersey Medical School,Surgery,Newark, NJ, USA 2Memorial Sloan-Kettering Cancer Center,New York, NY, USA

Introduction: Robotic surgery has been demonstrated to be a viable option for the resection of benign and malignant colorectal diseases. However, data thus far is lacking with regards to long-term oncologic outcomes. We sought to compare the longer term oncologic outcomes of robotic versus laparoscopic resection of colorectal cancer.

Methods: A literature search was performed using the Pubmed, EMBASE, Cochrane, and Medline databases for studies published between 2000 and 2014.  Search terms were: colon, rectal, robot, cancer, laparoscopic, oncologic and outcomes.  Studies that compared the overall and disease free survival of robotic versus laparoscopic surgery for patients with colon or rectal cancer were included.  Meta-analysis was performed using OpenMeta[Analyst] for Windows 8.

Results:There were 5 studies published between 2000-2014 that reported on overall survival (OS), disease free survival (DFS), lymph node (LN) extraction, circumferential resection margin (CRM), short and long-term recurrence. 317 patients across the 5 studies underwent either totally robotic or hybrid (robotic-assisted) resection of colon or rectal cancer.  Mean DFS with laparoscopic resection versus robotic resection was 86.2% (±4.4) and 86.9% (±4.0), respectively.  Mean OS with laparoscopic resection versus robotic resection was 93.4% (±3.2) and 91.3% (±4.1), respectively. Except for the Park study whose values were at 5 years, all groups reported DFS and OS at 3 years. At 5 years, Park found a DFS of 78.7% (±4.5) for LCS and 81.9% (±3.3) for RCS.  OS was 93.5% (±3.2) for LCS and 92.8% (±2.2) for RCS.  Robotic surgery was associated with slightly smaller resection margins (0.318cm, p=0.042), resection of fewer nodes (2.173 fewer nodes, p=0.0001), but equivalent odds of a positive CRM (OR 1.08, p=0.859).  

Conclusion: Robotic surgery offers comparable overall and disease free survival when compared to laparoscopic surgery for colorectal cancer.  However, longer-term follow up and larger patient populations need to be studied before official recommendations can be made.

 

64.10 Current Trends in FFP Transfusion & VTE Prophylaxis Following Hepatectomy: A Survey Analysis

Posted on December 22, 2014

J. N. Leal1, T. P. Kingham1, P. J. Allen1, R. P. DeMatteo1, W. R. Jarnagin1, M. I. D’Angelica1  1Memorial Sloan-Kettering Cancer Center,Surgery,New York, NY, USA

Introduction:

Following hepatectomy INR is often elevated and elicits concern regarding increased bleeding risk. This can lead to transfusion of fresh frozen plasma (FFP) and/or delay the institution of venous thromboembolism (VTE) prophylaxis.  INR, however, does not accurately reflect coagulation status following hepatectomy, and despite observed elevations, hypercoaguability and thrombosis are common. The clinical usefulness of the INR following hepatectomy is therefore questionable. The purpose of this study is to characterize current practice patterns regarding INR, FFP transfusion triggers and VTE prophylaxis following hepatectomy amongst a group of liver surgeons.

Methods:
A survey addressing FFP transfusion triggers and characteristics of VTE administration following hepatectomy was developed and distributed to the active membership of America’s Hepatopancreaticobiliary Association (AHPBA). Results were summarized for the group as a whole and then stratified into groups based on reported number of hepatectomies/year; Group A (≥50 hepatectomies/year) and Group B (< 50 hepatectomies/year), and responses compared.

Results:
Surveys were emailed to active members of the AHPBA (n=971). Overall 174(18%) surveys were completed. Post operative FFP transfusion rate was estimated to be <25% by the majority or respondents (149, 86%). The most commonly reported trigger for FFP transfusion was clinical evidence of bleeding (42%). However, over a third of participants (63, 36%) reported using isolated INR elevation as the sole trigger for FFP transfusion.  Amongst these respondents the level of INR triggering FFP transfusion varied considerably (range 1.5-2.0). VTE prophylaxis following liver resection was reported to be utilized by 94% of respondents, however, only 54% of gave it in accordance with current guidelines. Elevated INR was reported as the reason for not implementing VTE prophylaxis at all (8, 5%) or delaying implementation for >24 hrs (61, 35%). No differences between groups A (n=82) and B (n=90) in terms of type of transfusion trigger was observed (p=0.18). However, a trend towards use of a higher INR (>1.8) as the trigger point in group A compared to group B was observed (Figure 1, p=0.07). No differences between groups were observed with regards to type and timing of VTE prophylaxis.

Conclusion:

Despite recent evidence questioning the accuracy of INR following liver resection; its use as a trigger for transfusion and/or delay in VTE prophylaxis remains common. In centers where higher numbers of hepatectomies are performed it appears tolerance for higher INR prior to transfusion may exist.

 

3.06 Immunotherapeutic Virus GLV-1h153 Fascilitates 131I Radiotherapy and Imaging in Cholangiocarcinoma

Posted on December 22, 2014

C. Johnsen1, J. W. Ady1, K. Mojica1, A. Pugalenthi1, D. Love1, V. Longo6, P. Zanzonico6, N. G. Chen5, R. J. Aguilar5, Y. A. Yu5, A. A. Szalay5, Y. Fong2  1Memorial Sloan-Kettering Cancer Center,Surgery,New York, NY, USA 2City Of Hope National Medical Center,Surgery,Duarte, CA, USA 3University Of California – San Diego,4Department Of Radiation Medicine And Applied Sciences, Rebecca & John Moores Comprehensive Cancer Center,San Diego, CA, USA 4University Of Würzburg,5Department Of Biochemistry, Rudolph Virchow Center For Experimental Biomedicine, And Institute For Molecular Infection Biology,Würzburg, BAVARIA, Germany 5Genelux,Research And Development,San Diego, CA, USA 6Memorial Sloan-Kettering Cancer Center,Small Animal Imaging Core,New York, NY, USA

Introduction:  Cholangiocarcinoma (CC), a deadly carcinoma of the bile ducts, is clinically silent in the majority of patients until curative surgery is no longer an option. With most patients succumbing to the disease within 6 months of diagnosis, novel treatment options are needed.  Oncolytic viruses are promising cancer therapy agents because they selectively infect, replicate within, and kill cancer cells.  In this study, we assess the ability of the human sodium iodide symporter (hNIS) expressing recombinant oncolytic vaccinia virus GLV-1h153 to kill and image CC when combined with 131I radiotherapy.

Methods:  Three human CC cell lines were assayed for infectivity, cytotoxicity and viral replication in vitro.  hNIS mediated 131I radiouptake was assayed in vitro. Flank CC xenografts were treated with intratumoral GLV-1h153 alone and/or with 131I to assess tumor burden reduction. SPECT/CT was performed to visualize 131I uptake in infected tumor in vivo.

Results: All cell lines demonstrated infectivity and oncolysis in a time and concentration dependent manner. Significant viral replication was supported in all cell lines. Flank xenografts treated with GLV-1h153 combined with 131I demonstrated significant tumor reduction as compared to controls.  131I mediated SPECT/CT demonstrated significant uptake in infected tumors. 

Conclusion: GLV-1h153 efficiently kills human CC in vitro. When combined with 131I, GLV-1h153 allows for SPECT/CT imaging of CC tumors and significantly reduces tumor burden in vivo. These results indicate that GLV-1h153 is a promising novel imaging and therapeutic agent for patients with CC.

 

3.03 Oncolytic Recombinant Vaccinia Virus GLV-2b372 Efficiently Kills Hepatocellular Carcinoma

Posted on December 22, 2014

J. W. Ady1, C. Johnsen1, K. Mojica1, J. Heffner1, D. Love1, A. Pugalenthi1, J. Belin1, J. R. Aguilar5, N. Chen5, Y. A. Yu5, A. Szalay5, Y. Fong4  1Memorial Sloan-Kettering Cancer Center,Surgery,New York, NY, USA 2University Of California – San Diego,3Department Of Radiation Medicine And Applied Sciences, Rebecca & John Moores Comprehensive Cancer Center,San Diego, CA, USA 3University Of Würzburg,4Department Of Biochemistry, Rudolph Virchow Center For Experimental Biomedicine, And Institute For Molecular Infection Biology,Würzburg, BAVARIA, Germany 4City Of Hope National Medical Center,Surgery,Duarte, CA, USA 5Genelux,Research And Development,San Diego, CALIFORNIA, USA

Introduction:  Hepatocellular carcinoma (HCC) is the most common primary malignancy of the liver with limited treatment options and poor prognosis. Therefore, there is a great need to develop novel therapies for HCC.   Oncolytic viruses that specifically infect, replicate within, and kill cancer cells represent an emerging and promising platform for cancer therapy.   In this study we assess at the ability of GLV-2b372, a novel nonattenuated vaccinia virus derived from the Lister 1.1.1 strain, to kill HCC.

Methods:  The infectivity, viral replication and cytotoxicity of GLV-2b372 was assayed in 4 human HCC cell lines.  Huh-7 flank xenografts were generated in athymic nude mice.  Mice were treated with intratumoral injections of GLV-2b372.  Biodistribution of viral presence in animals treated with GLV-2b372 was assessed.

Results: Infectivity increased in a time and concentration dependent manner in all cell lines. All cell lines supported efficient replication of virus. Flank xenografts treated with GLV-2b372 demonstrated complete erradication of tumor in 75% of animals with significant tumor reduction as compared to controls (p < 0.05).  Biodistribution confirmed sustained intratumoral presence of virus at 2 weeks post infection, with rapid clearance of tumor from all other tissues. 

Conclusion: Our results demonstrate that the novel oncolytic vaccinia virus GLV-2b372 selectively infects and replicates in HCC tissue.  We demonstrate infectivity and killing of HCC both in vitro and in vivo.  These findings indicate that GLV-2b372 is a potent oncolytic vector that could serve as a promising platform for oncolytic cancer immunotherapy.  

 

14.07 Rectal bleeding and hidden colorectal diseases in Nepal: A cross sectional countrywide survey

Posted on December 22, 2014

P. Ghimire7, S. Gupta1,2, J. Pathak6, T. P. Kingham2,3, A. L. Kushner2,5, B. C. Nwomeh2,4  1University Of California – San Francisco , East Bay,Surgery,Oakland, CA, USA 2Surgeons OverSeas,New York, NY, USA 3Memorial Sloan-Kettering Cancer Center,Surgery,New York, NY, USA 4Nationwide Children’s Hospital,Pediatric Surgery,Columbus, OH, USA 5Johns Hopkins Bloomberg School Of Public Health,International Health,Baltimore, MD, USA 6Kathmandu Medical College,Kathmandu, , Nepal 7B.P.Koirala Institute Of Health Science,Dharan, , Nepal

Introduction:  Because rectal bleeding is a cardinal symptom of many colorectal diseases including colorectal cancers, its presence alone could give insight into the prevalence of these conditions where direct population screening is lacking. In South Asia, which is home to over one fifth of the world’s population, there is paucity of epidemiologic data on colorectal diseases, particularly in the lower-income countries (LIC) such as Nepal.  The aim of this study is to enumerate the prevalence of rectal bleeding in Nepal and increase understanding of colorectal diseases as a health problem in the South Asian region.

Methods:  A countrywide survey utilizing the Surgeons OverSeas Assessment of Surgical Need (SOSAS) tool was administered from May 25th to June 12th 2014 in 15 of the 75 districts of Nepal, randomly selected proportional to population.  In each district, three Village Development Committees were selected randomly, two rural and one urban based on the Demographic Health Survey methodology.  Individuals were interviewed to determine the period and point prevalence of rectal bleeding, and patterns of health-seeking behavior related to surgical care for this problem.  Individuals aged over 18 were included in this analysis.

Results:  A total of 1350 households and 2,695 individuals were surveyed with a 97% response rate.   Thirty-eight individuals (55% male) of the 1,941 individuals 18 years and older stated they had experienced rectal bleeding (2.0%, 95% CI 1.4% to 2.7%), with a mean age of 45.5 (SD 2.2).  Of these 38 individuals, 30 stated they currently experience rectal bleeding.  Healthcare was sought in 18 participants with current rectal bleeding, with 2 major procedures performed, one an operation for an anal fistula.  For those who sought healthcare but did not receive surgical care, reasons included no need (4), not available (6), fear/no trust (5) and no money for healthcare (1).  For those with current rectal bleeding who did not seek healthcare, reasons included no need (1), not available (2), fear/no trust (6) and no money for healthcare (4).  Twenty-four individuals had an unmet surgical need secondary to rectal bleeding (1.2%, 95% CI 0.8% to 1.8%).

Conclusion:  The Nepal healthcare system at present does not emphasize the importance of surveillance colonoscopies or initial diagnostics by a primary care physician for rectal bleeding.  Our data demonstrate limited access for patients to undergo evaluation of rectal bleeding by a healthcare professional, and that potentially there are people in Nepal with rectal bleeding that may have undiagnosed colorectal cancer.  Further advocacy for preventative medicine and easier access to surgical care in LIC is crucial to avoid emergency surgeries, advanced stage malignancies or fatalities from treatable conditions.