- Email: [email protected]
Validation of the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) risk calculator to estimate serious complications in patients undergoing major gastrointestinal oncologic resection
Vol. 221, No. 4S2, October 2015
CONCLUSIONS: The therapeutic value of lymphadenectomy for station no.5 or 6 LNM was low in UGC. DET might be one of indicators for proximal gastrectomy in UGC. Transient retroviral transfection for single patient cancer immunotherapy Isaac R Kriley, MD, Steve A Feldman, Eric Tran, Mary Black, Hui Xu, Steven A Rosenberg, MD, PhD, Stephanie Goff, MD National Cancer Institute, Bethesda, MD INTRODUCTION: Cancer immunotherapy with autologous tumor infiltrating lymphocytes (TIL) target immunogenic mutated peptides and resulted in the regression metastatic melanoma and more recently for cholangiocarcinoma. TIL targeting immunogenic mutated peptides cannot always be expanded to large cell doses with appropriate anti-tumor reactivity. Production of stable retroviral vectors now required to introduce T-cell receptors (TCR) can take 4 months and is expensive, making it unsuitable for single patient cancer immunotherapy. Transient retroviral vectors targeting immunogenic mutated peptides could potentially generate single patient cancer immunotherapies quickly, safely, and affordably. METHODS: Peripheral blood lymphocytes (PBL) were transduced with a transient retroviral vector encoding a TCR targeting mutated ERBB2IP. Transduction efficiency was analyzed by flow cytometry and T-cell function was analyzed by coculture and interferon-gamma ELISA. Several Benzonase treatments were compared for residual plasmid DNA digestion. Residual plasmid DNA was measured by quantitative PCR. Residual Benzonase was measured by ELISA. RESULTS: Transduction efficiency ranged from 59-80%. Transduced PBL specifically secreted interferon-gamma when stimulated with mutated ERBB2IP. Less than 0.08 ng/mL of plasmid DNA remained after treatment with 50 U Benzonase/mL vector supernatant. Benzonase concentration was below 0.2 ng/mL in the final product. CONCLUSIONS: Transduced PBL expressed the TCR and secreted interferon-gamma when stimulated by the mutated peptide. Safety goals related to residual plasmid DNA and Benzonase were met. Testing for replication competent retrovirus and host cell DNA is ongoing. Additional safety testing may demonstrate the feasibility of using transient viral vectors for generating single patient cancer immunotherapies. Transoral robotic surgery for recurrent or residual head and neck cancers: a prospective study of feasibility and functional outcomes Himanshu Shukla, MB, BS, Surender Dabas, Anant Dinesh, MB, BS, Reetesh Ranjan Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India
Scientific Poster Presentations: 2015 Clinical Congress
e135
INTRODUCTION: Surgical salvage may be the only viable treatment option for recurrent tumors of the oropharynx. Open surgical approach has been known to have poor oncologic and functional outcomes. So, transoral robotic surgery (TORS) is an alternative with better surgical outcomes. We conducted this study to determine the feasibility of TORS in recurrent or residual head and neck cancers. METHODS: Twenty previously irradiated patients with head and neck cancers having residual or recurrent disease were enrolled in this study. They underwent TORS with or without neck dissection. Patients were observed and data were recorded on feasibility, surgical and functional outcome. RESULTS: 20 patients underwent TORS with neck dissection being performed in 6 (30%) patients. Site of primary disease was oropharyngeal in 18 (90%) and hypopharynx (10%) in 2 patients. Positive margin was seen in 1 (5%) patient. 1 patient required tracheostomy during the procedure. Postoperative complications such as hemorrhage requiring active intervention occurred in 3 (15%) patients. Average blood loss was 28.023.13 mL with no patient requiring transfusion. Postoperatively, majority of the patients had adequate swallowing and speech function with nasal twang reported in 2 patients. Patients started tolerating oral feeds within a week of procedure (5.683.67 days) with nasogastric tube being removed on 13th post op day (12.758.04 days). PEG insertion was done in 2 (10%) patients. Average hospital stay was 3.881.57 days. CONCLUSIONS: This study demonstrates that TORS offers a safe, feasible and minimally invasive salvage surgical approach for previously irradiated patients with residual or recurrent disease with an acceptable oncological and functional outcome. Validation of the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) risk calculator to estimate serious complications in patients undergoing major gastrointestinal oncologic resection Jennifer Ford, MD, Kimberly R Coughlin, Dennis Van Dorp, MD, Richard N Berri, MD, FACS St John Hospital and Medical Center, Detroit, MI INTRODUCTION: The ACS NSQIP Risk Calculator was developed to estimate the chance of complications or death after surgery. We sought to validate use of the calculator for estimating serious complications in patients undergoing gastrointestinal oncologic resection. METHODS: From August 2012 to November 2014, 255 oncologic resections were performed by a single surgeon in the setting of a multidisciplinary Surgical Oncology Program. A database was maintained that included serious postoperative complications as defined by the ACS. A retrospective chart review was
e136
Scientific Poster Presentations: 2015 Clinical Congress
performed; the 21 input variables for the calculator were collected. The calculator was then used to obtain the risk frequencies for each patient prior to resection. Frequency tables for estimated and observed complications were created and compared using paired two tailed t-tests. P value was significant if p<0.05. RESULTS: Of the 255 patients included in this analysis, 72 patients underwent Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy, 60 hepatopancreaticobiliary, 36 colorectal, 38 cytoreduction, 28 gastrectomies, and 21 other resections. The estimated mean frequency of serious complications for
J Am Coll Surg
the group was 11.93%, while the observed mean frequency was 8.5%. When the estimated risk for serious complications reached 16.04%, observed complications were significantly higher (SD 9.3, p¼0.011) in that subset of patients. CONCLUSIONS: The ACS NSQIP risk calculator can be used to estimate the likelihood of serious complications for patients undergoing oncologic resection. The utilization of the risk calculator for this group of patients will allow clinicians and patients to make informed decisions in the preoperative period regarding patient and procedure-specific postoperative risks.
CONCLUSIONS: The therapeutic value of lymphadenectomy for station no.5 or 6 LNM was low in UGC. DET might be one of indicators for proximal gastrectomy in UGC. Transient retroviral transfection for single patient cancer immunotherapy Isaac R Kriley, MD, Steve A Feldman, Eric Tran, Mary Black, Hui Xu, Steven A Rosenberg, MD, PhD, Stephanie Goff, MD National Cancer Institute, Bethesda, MD INTRODUCTION: Cancer immunotherapy with autologous tumor infiltrating lymphocytes (TIL) target immunogenic mutated peptides and resulted in the regression metastatic melanoma and more recently for cholangiocarcinoma. TIL targeting immunogenic mutated peptides cannot always be expanded to large cell doses with appropriate anti-tumor reactivity. Production of stable retroviral vectors now required to introduce T-cell receptors (TCR) can take 4 months and is expensive, making it unsuitable for single patient cancer immunotherapy. Transient retroviral vectors targeting immunogenic mutated peptides could potentially generate single patient cancer immunotherapies quickly, safely, and affordably. METHODS: Peripheral blood lymphocytes (PBL) were transduced with a transient retroviral vector encoding a TCR targeting mutated ERBB2IP. Transduction efficiency was analyzed by flow cytometry and T-cell function was analyzed by coculture and interferon-gamma ELISA. Several Benzonase treatments were compared for residual plasmid DNA digestion. Residual plasmid DNA was measured by quantitative PCR. Residual Benzonase was measured by ELISA. RESULTS: Transduction efficiency ranged from 59-80%. Transduced PBL specifically secreted interferon-gamma when stimulated with mutated ERBB2IP. Less than 0.08 ng/mL of plasmid DNA remained after treatment with 50 U Benzonase/mL vector supernatant. Benzonase concentration was below 0.2 ng/mL in the final product. CONCLUSIONS: Transduced PBL expressed the TCR and secreted interferon-gamma when stimulated by the mutated peptide. Safety goals related to residual plasmid DNA and Benzonase were met. Testing for replication competent retrovirus and host cell DNA is ongoing. Additional safety testing may demonstrate the feasibility of using transient viral vectors for generating single patient cancer immunotherapies. Transoral robotic surgery for recurrent or residual head and neck cancers: a prospective study of feasibility and functional outcomes Himanshu Shukla, MB, BS, Surender Dabas, Anant Dinesh, MB, BS, Reetesh Ranjan Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, India
Scientific Poster Presentations: 2015 Clinical Congress
e135
INTRODUCTION: Surgical salvage may be the only viable treatment option for recurrent tumors of the oropharynx. Open surgical approach has been known to have poor oncologic and functional outcomes. So, transoral robotic surgery (TORS) is an alternative with better surgical outcomes. We conducted this study to determine the feasibility of TORS in recurrent or residual head and neck cancers. METHODS: Twenty previously irradiated patients with head and neck cancers having residual or recurrent disease were enrolled in this study. They underwent TORS with or without neck dissection. Patients were observed and data were recorded on feasibility, surgical and functional outcome. RESULTS: 20 patients underwent TORS with neck dissection being performed in 6 (30%) patients. Site of primary disease was oropharyngeal in 18 (90%) and hypopharynx (10%) in 2 patients. Positive margin was seen in 1 (5%) patient. 1 patient required tracheostomy during the procedure. Postoperative complications such as hemorrhage requiring active intervention occurred in 3 (15%) patients. Average blood loss was 28.023.13 mL with no patient requiring transfusion. Postoperatively, majority of the patients had adequate swallowing and speech function with nasal twang reported in 2 patients. Patients started tolerating oral feeds within a week of procedure (5.683.67 days) with nasogastric tube being removed on 13th post op day (12.758.04 days). PEG insertion was done in 2 (10%) patients. Average hospital stay was 3.881.57 days. CONCLUSIONS: This study demonstrates that TORS offers a safe, feasible and minimally invasive salvage surgical approach for previously irradiated patients with residual or recurrent disease with an acceptable oncological and functional outcome. Validation of the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP) risk calculator to estimate serious complications in patients undergoing major gastrointestinal oncologic resection Jennifer Ford, MD, Kimberly R Coughlin, Dennis Van Dorp, MD, Richard N Berri, MD, FACS St John Hospital and Medical Center, Detroit, MI INTRODUCTION: The ACS NSQIP Risk Calculator was developed to estimate the chance of complications or death after surgery. We sought to validate use of the calculator for estimating serious complications in patients undergoing gastrointestinal oncologic resection. METHODS: From August 2012 to November 2014, 255 oncologic resections were performed by a single surgeon in the setting of a multidisciplinary Surgical Oncology Program. A database was maintained that included serious postoperative complications as defined by the ACS. A retrospective chart review was
e136
Scientific Poster Presentations: 2015 Clinical Congress
performed; the 21 input variables for the calculator were collected. The calculator was then used to obtain the risk frequencies for each patient prior to resection. Frequency tables for estimated and observed complications were created and compared using paired two tailed t-tests. P value was significant if p<0.05. RESULTS: Of the 255 patients included in this analysis, 72 patients underwent Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy, 60 hepatopancreaticobiliary, 36 colorectal, 38 cytoreduction, 28 gastrectomies, and 21 other resections. The estimated mean frequency of serious complications for
J Am Coll Surg
the group was 11.93%, while the observed mean frequency was 8.5%. When the estimated risk for serious complications reached 16.04%, observed complications were significantly higher (SD 9.3, p¼0.011) in that subset of patients. CONCLUSIONS: The ACS NSQIP risk calculator can be used to estimate the likelihood of serious complications for patients undergoing oncologic resection. The utilization of the risk calculator for this group of patients will allow clinicians and patients to make informed decisions in the preoperative period regarding patient and procedure-specific postoperative risks.