Tamir Ben-Menachem

Sociodemographic differences in the receipt of colorectal cancer surveillance care following treatment with curative intent.

Background.Despite limited evidence of its effectiveness, most guidelines recommend colorectal cancer survivors undergo posttreatment surveillance care. This article describes the posttreatment use of colon e-aminations, carcinoembryonic antigen (CEA) testing, and metastatic disease testing among a managed care population. Methods.Two hundred fifty-one patients with colorectal cancer enrolled in a managed care organization at diagnosis (1/1/90–12/31/95) and treated with curative intent. Patients were identified via a Cancer Registry maintained by a large group practice. Cumulative incidences of service receipt were estimated using actuarial (Kaplan-Meier) survival analyses. Co- Proportional Hazard Models were used to evaluate the relation of patient sociodemographic and clinical characteristics to service receipt. Average 8-year medical care e-penditures were calculated. Results.Within 18 months of treatment, 55% of the cohort received a colon examination, 71% received CEA testing, and 59% received metastatic disease testing. Whites were more likely than minorities to receive CEA testing (RR = 1.47, P = 0.04) and tended to be more likely to receive a colon examination (RR = 1.43, P = 0.09). As the median household income of a patient’s zip code of residence increased, so too did the likelihood of colon examination and metastatic disease testing receipt (RR = 1.09, P = 0.03 and RR = 1.12, P <0.01, respectively). Average 8-year medical care expenditures among the cohort were

Prophylaxis for stress-related gastrointestinal hemorrhage: A cost effectiveness analysis

30,247. Conclusions.Among a population with financial access to care, differences were found in the receipt of colorectal cancer surveillance care by race and income. Additional investigations are needed to understand why minorities and those residing in low-income areas are less likely to receive surveillance care.

Relationship of Gastroesophageal Reflux Disease with Adenocarcinoma of the Distal Esophagus and Cardia

OBJECTIVE To assess the cost-effectiveness of prophylaxis for stress-related gastrointestinal hemorrhage in patients admitted to the intensive care unit. DESIGN Decision model of the cost and efficacy of sucralfate and cimetidine, two commonly used drugs for prophylaxis of stress-related hemorrhage. Outcome estimates were based on data from published studies. Cost data were based on cost of medications and costs of treatment protocols at our institutions. MEASUREMENTS AND MAIN RESULTS The marginal cost-effectiveness of prophylaxis, as compare with no prophylaxis, was calculated separately for sucralfate and cimetidine and expressed as cost per bleeding episode averted. An incremental cost-effectiveness analysis was subsequently employed to compare the two agents. Sensitivity analyses of the effects of the major clinical outcomes on the cost per bleeding episode averted were performed. At the base-case assumptions of 6% risk of developing stress-related hemorrhage and 50% risk-reduction due to prophylaxis, the cost of sucralfate was

Abstract B100: Panvac-F and Panvac-V: Phase I study of intratumoral and systemic vaccination

1,144 per bleeding episode averted. The cost per bleeding episode averted was highly dependent on the risk of hemorrhage and, to a lesser degree, on the efficacy of sucralfate prophylaxis, ranging from a cost per bleeding episode averted of

Artificial Neural Network (ANN) Is Superior to the Pre-Endoscopic Rockall Score in Predicting Which Patients Will Benefit From Urgent EGD in Acute Upper GI Bleeding (UGIB)

103,725 for low-risk patients to cost savings for very high-risk patients. The cost per bleeding episode averted increased significantly if the risk of nosocomial pneumonia was included in the analysis. The effect of pneumonia was greater for populations at low risk of hemorrhage. Assuming equal efficacy, the cost per bleeding episode averted of cimetidine was 6.5-fold greater than the cost per bleeding episode averted of sucralfate. CONCLUSIONS The cost of prophylaxis in patients at low risk of stress-related hemorrhage is substantial, and may be prohibitive. Further research is needed to identify patient populations that are at high risk of developing stress-related hemorrhage, and to determine whether prophylaxis increases the risk of nosocomial pneumonia.

Prophylaxis for stress-related gastric hemorrhage in the medical intensive care unit: A randomized, controlled, single-blind study

Background: Recent studies have suggested that gastroesophageal reflux disease (GERD) increases the risk of developing adenocarcinoma of the distal esophagus and cardia. In order to further define this risk, we studied the relationship of GERD in patients with or without gastroesophageal junction adenocarcinomas. Methods: The records of all patients with adenocarcinoma of the distal esophagus and cardia treated between 1991 and 1999 were reviewed for the following data: gender, age of diagnosis, presence of GERD, presence of GERD for >4 years, and GERD treatment. A control group of patients without gastroesophageal junction adenocarcinoma were matched for age and gender. Data obtained from the control group included presence of GERD and treatment for GERD. Results: 60 patients with adenocarcinoma of the distal esophagus and cardia were identified. 40% of cancer patients had GERD at the time of diagnosis, (odds ratio 39, p < 0.0001). 27% of cancer patients had GERD for >4 years (odds ratio 21, p < 0.0001). 50% of cancer patients with GERD were being treated with either H2-blockers or proton pump inhibitors at the time of cancer diagnosis, with an average duration of treatment of 17 months, compared to none of the patients without GERD (p = 0.006). Conclusions: Patients with gastroesophageal junction adenocarcinoma had a higher prevalence of GERD-like symptoms compared to age- and gender-matched controls. This supports an association between GERD and gastroesophageal junction cancers. In addition, cancer patients with GERD may be treated for prolonged periods of time with acid-suppression medication prior to the diagnosis of cancer, masking the symptoms of cancer. Patients with long-standing GERD or older patients with new onset GERD may need endoscopy or imaging studies to evaluate for cancer of the distal esophagus or cardia.

Balancing service and education: improving internal medicine residencies in the managed care era

Patients with adenocarcinoma of the pancreas were treated using a combination of EUS-guided intrapancreatic tumor injection and systemic boost using PANVAC-F and PANVAC-V in this first-in-man Phase I trial. The study represents the translation of our unique demonstration in murine models of bladder and orthotopic mammary tumors that anergy to systemic immunization using antigen encoding vaccinia recombinants could be overcome by immunization into the tumor microenvironment. Consented patients with locally advanced or minimally metastatic pancreatic cancer received EUS-guided intrapancreatic injections (IT) of recombinant Panvac-F (Fowlpox encoding MUC-1, CEA, TRICOM), systemic subcutaneous (SC) Panvac-V (vaccinia) and SC Panvac-F boosts. Systemic SC vaccines were accompanied by subcutaneous rH-GM-CSF, 100 mcg X 4 days. Patients received 2 intrapancreatic injections of Panvac-F (2 weeks apart) with systemic Panvac-V and Panvac-F boosts given with GMCSF extending to day 71 (total of 2 IT Panvac-F, 1 SC Panvac-V, 4 SC Panvac-F). Patients were allowed to transition to standard care at day 31. Patients were evaluated for toxicity and tumor progression. Follow-up care was provided by referring oncologists. In this dose escalation study, the first cohort of 6 pts received IT Panvac-F (10 8 PFU), SC Panvac-V (2 X 10 8 PFU), and SC Panvac-F (10 9 PFU). The second dose cohort of 8 pts received IT Panvac-F (10 9 PFU), SC Panvac-V (2 X 10 8 PFU), and SC Panvac-F (10 9 PFU ). At dose level 1, two of six patients were removed from study after approximately two weeks due to rapid disease progression and died one and six months after trial initiation. At dose level 2, one patient was removed due to rapidly progressive disease and died at 1 mo and a second patient withdrew following 1 IT inoculation and died at month 16. Of the remaining 10 pts, 3 presented with distant metastatic disease (Median Survival 7 mos, range 1-25) and 7 presented without distant metastases (Median Survival 16 mos, range 3-35). Of note, none of the 7 patients presenting without metastatic disease developed distant visceral metastases, by imaging available to us but died of sequellae associated with progressive local disease. Of the above 10 pts, all but one transitioned initially to treatment with gemcitabine-based therapy. (the remaining pt did not begin systemic treatment). Initial RNAseq transcriptome analysis of Fine Needle Aspirate (FNA) comparing Day 1 and Day 14 samples demonstrated a significant increase in a series of chemokines associated with the induction of an immune response in the tumor microenvironment. A planned series of immunologic and genetic analyses are underway. Results demonstrate that the “first in man” intrapancreatic administration of recombinant poxvirus was well tolerated with the complete regimen suggesting an encouraging period of stable disease. The finding that none of the patients who presented without distant visceral metastases developed such would be consistent with the generation of a systemic immune response with effects on seeded metastatic cells. Analysis of local and systemic immune responses is currently proceeding and may provide further insights. This study is supported by the NCI Cancer Therapeutics Evaluation Program (CTEP) and by NCI U01-CA07031 and P30-CA72720. Citation Format: Elizabeth A. Poplin, David A. August, Rebecca A. Moss, Tamir Ben-Menachem, Hazar Michael, Aparna Repaka, Renee Artymyshyn, Chang Chan, James L. Gulley, Robert S. DiPaola, Edmund C. Lattime. Panvac-F and Panvac-V: Phase I study of intratumoral and systemic vaccination. [abstract]. In: Proceedings of the AACR Special Conference on Pancreatic Cancer: Innovations in Research and Treatment; May 18-21, 2014; New Orleans, LA. Philadelphia (PA): AACR; Cancer Res 2015;75(13 Suppl):Abstract nr B100.

Clinical Applications of the Spyglass Direct Visualization System: A Multicenter Experience

Artificial Neural Network (ANN) Is Superior to the PreEndoscopic Rockall Score in Predicting Which Patients Will Benefit From Urgent EGD in Acute Upper GI Bleeding (UGIB) Ananya Das, Farees Farooq, Richard Wong, Tamir Ben-Menachem, Gregory Cooper, Amitabh Chak, Michael Sivak Introduction: In practice, not all patients with acute UGIB can receive urgent EGD (within 12 hours). A model for predicting need for urgent EGD based on nonendoscopic, clinical variables would be an important tool in patient triage. We have previously shown that ANN accurately predicts outcome in acute LGI bleeding (Lancet 2003;362:1261). Methods: We constructed an ANN to predict endoscopic stigmata of recent hemorrhage (SRH) and need for endoscopic therapy (ET) using prospectively collected data from 194 patients at an academic medical center who presented with acute UGIB over a 6-month period (training group). Confirmed variceal bleeding was excluded. The ANN model was a multi-layered perceptron network trained by back propagation using pre-endoscopic clinical input variables available at the time of triage. The trained ANN was applied to an internal validation (IV) group of 193 patients with UGIB during the same time period. The ANN was then applied to an external validation (EV) group of 200 patients at a tertiary care center in a different city over a 6-month period. The performance of the ANN was also compared to the widely used Rockall score. A pre-endoscopic Rockall score of 0 is considered low risk for adverse outcome. Results: The clinical characteristics of the EV group were different then the training and IV groups (increased men, CAD, cirrhosis, hematemesis, shock, ICU admit, rebleeding, and death). Using ANN, the areas under the ROC curve for predicting SRH and ETwere 0.94 & 0.84 in the IV group and 0.81 & 0.78 in the EV group, respectively. ANN had better specificity and predictive values than pre-endoscopic Rockall score in both validation groups and was comparable to total (post-endoscopic) Rockall score. Conclusions: ANN is an effective tool in the pre-endoscopic triage of patients with acute UGIB, even in a dissimilar external cohort. ANN is more specific than the preendoscopic Rockall score in identifying patients who may benefit from urgent EGD and may be used to exclude low risk patients.