United States Military Cancer Institute

Rockville, MD, United States

United States Military Cancer Institute

Rockville, MD, United States
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Nissan A.,Beilinson Hospital | Nissan A.,United States Military Cancer Institute | Protic M.,United States Military Cancer Institute | Protic M.,University of Novi Sad | And 7 more authors.
Annals of Surgery | Year: 2012

Objective: Our randomized controlled trial previously demonstrated improved staging accuracy with targeted nodal assessment and ultrastaging (TNA-us) in colon cancer (CC). Our objective was to test the hypothesis that TNA-us improves disease-free survival (DFS) in CC. Methods: In this randomized trial, targeted nodal assessment and ultrastaging resulted in enhanced lymph node diagnostic yield associated with improved staging accuracy, which was further associated with improved disease-free survival in early colon cancer. Results: Clinical parameters of the control (n = 94) and TNA-us (n = 98) groups were comparable. Median (interquartile range) lymph node yield was higher in the TNA-us arm: 16 (12-22) versus 13 (10-18); P = 0.002. Median follow-up was 46 (29-70) months. Overall 5-year DFS was 61% in the control arm and 71% in the TNA-us arm (P = 0.11). Clinical parameters of node-negative patients in the control (n = 51) and TNA-us (n = 55) groups were comparable. Lymph node yield was higher in the TNA-us arm: 15 (12-21) versus 13 (8-18); P = 0.03. Five-year DFS differed significantly between groups with node-negative CC (control 71% vs TNA-us 86%; P = 0.04). Survival among stage II CC alone was higher in the TNA-us group, 83% versus 65%; P = 0.03. Adjuvant chemotherapy use was nearly identical between groups. TNA-us stratified CC prognosis; DFS differed significantly between ultrastaged and conventionally staged node-negative patients [control pN0 72% vs TNA-us pN0(i-) 87%; P = 0.03]. Survival varied according to lymph node yield in patients with node-negative CC [5-year DFS: <12 lymph nodes = 57% vs 12+ lymph nodes = 85%; P = 0.011] but not in stage III CC. Conclusions: TNA-us is associated with improved nodal diagnostic yield and enhanced staging accuracy (stage migration), which is further associated with improved DFS in early CC. © 2012 Lippincott Williams & Wilkins.

Stojadinovic A.,Uniformed Services University of the Health Sciences | Stojadinovic A.,United States Military Cancer Institute | Gaitonde D.Y.,U.S. Army | Wallace M.K.,U.S. Army | And 3 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2012

Context: Decisions regarding initial therapy and subsequent surveillance in patients with differentiated thyroid cancer (DTC) depend upon an accurate assessment of the risk of persistent or recurrent disease. Objective: The objective of this study was to examine the predictive value of a single measurement of serum thyroglobulin (Tg) just before radioiodine remnant ablation (preablation Tg) on subsequent disease-free status. Data Sources: Sources included MEDLINE and BIOSYS databases between January 1996 and June 2011 as well as data from the author's tertiary-care medical center. Study Selection: Included studies reported preablation Tg values and the outcome of initial therapy at surveillance testing or during the course of long-term follow-up. Data Extraction: Two investigators in dependently extracted data and rated study quality using the Quality Assessment of Studies of Diagnostic Accuracy included in Systematic Reviews-2 (QUADAS-2) tool. Data Synthesis: Fifteen studies involving 3947 patients with DTC were included. Seventy percent of patients had preablation Tg values lower than the threshold value being examined.The negative predictive value (NPV) of a preablation Tg below threshold was 94.2 (95% confidence interval = 92.8-95.3) for an absence of biochemical or structural evidence of disease at initial surveillance or subsequent follow-up. The summary receiver operator characteristic curve based on a bivariate mixed-effects binomial regression model showed a clustering of studies using a preablation Tg below 10 ng/ml near the summary point of optimal test sensitivity and specificity. Conclusion: Preablation Tg testing is a readily available and in expensive tool with a high NPV for future disease-free status. A low preablation Tg should be considered a favorable risk factor in patients with DTC. Further study is required to determine whether a low preablation Tg may be used to select patients for whom radio iodine remnant ablation can be avoided. Copyright © 2012 by The Endocrine Society.

Nissan A.,Hebrew University of Jerusalem | Nissan A.,United States Military Cancer Institute | Protic M.,United States Military Cancer Institute | Bilchik A.,United States Military Cancer Institute | And 6 more authors.
Annals of Surgery | Year: 2010

Background: Improvement in staging accuracy is the principal aim of targeted nodal assessment in colorectal carcinoma. Technical factors independently predictive of false negative (FN) sentinel lymph node (SLN) mapping should be identified to facilitate operative decision making. Purpose: To define independent predictors of FN SLN mapping and to develop a predictive model that could support surgical decisions. PATIENTS AND Methods: Data was analyzed from 2 completed prospective clinical trials involving 278 patients with colorectal carcinoma undergoing SLN mapping. Clinical outcome of interest was FN SLN(s), defined as one(s) with no apparent tumor cells in the presence of non-SLN metastases. To assess the independent predictive effect of a covariate for a nominal response (FN SLN), a logistic regression model was constructed and parameters estimated using maximum likelihood. A probabilistic Bayesian model was also trained and cross validated using 10-fold train-and-test sets to predict FN SLN mapping. Area under the curve (AUC) from receiver operating characteristics curves of these predictions was calculated to determine the predictive value of the model. Results: Number of SLNs (<3; P = 0.03) and tumor-replaced nodes (P < 0.01) independently predicted FN SLN. Cross validation of the model created with Bayesian Network Analysis effectively predicted FN SLN (area under the curve = 0.84-0.86). The positive and negative predictive values of the model are 83% and 97%, respectively. Conclusion: This study supports a minimum threshold of 3 nodes for targeted nodal assessment in colorectal cancer, and establishes sufficient basis to conclude that SLN mapping and biopsy cannot be justified in the presence of clinically apparent tumor-replaced nodes. Copyright © 2010 by Lippincott Williams & Wilkins.

Chen S.L.,University of California at Davis | Steele S.R.,U.S. Army | Eberhardt J.,DecisionQ Corporation | Zhu K.,United States Military Cancer Institute | And 5 more authors.
Annals of Surgery | Year: 2011

Background: The presence and number of nodal metastasis significantly impact colon cancer prognosis. Similarly, the number of resected/evaluated nodes impacts staging accuracy. This ratio of metastatic to examined nodes or lymph node ratio (LNR) may have independent prognostic value in colon carcinoma. PURPOSE:: To evaluate the impact of LNR on overall survival in colon cancer patients with fewer than 12 or 12 examined nodes or more. Methods: Patients (n = 36,712) with node-positive nonmetastatic colon cancer diagnosed between 1992 and 2004 were identified from the Surveillance, Epidemiology, and End Results database and stratified according to LNR and number of nodes examined. Survival was estimated by Kaplan-Meier method, and differences analyzed by log-rank test. A Cox proportional hazards model was used for multivariate analysis. Results: Patients with fewer than 12 nodes were older and male and had lower primary tumor stage, grade, and N stage (P < 0.01). Survival appeared greater with 12 total nodes examined or more (median 53 vs. 66 months, P < 0.001). Within each LNR stratum, survival with 12 nodes or more was improved for those with less than 10% of nodes positive for cancer, but was worse with higher LNRs (P < 0.01). Lymph node ratio was significantly associated with survival independent of total nodes (HR 1.24-5.12, P < 0.001). Other significant factors included age, race, tumor grade, stage, location, and N stage. Conclusion: Metastatic LNR independently estimates survival in Stage III colon cancer, irrespective of number of nodes examined. However, statistically significant differences in each LNR stratum between those with resection of fewer than 12 or 12 nodes or more would indicate that a 12-node minimum may still be necessary for accurate staging. © 2010 Lippincott Williams & Wilkins.

Steele S.R.,U.S. Army | Chen S.L.,University of California at Davis | Stojadinovic A.,United States Military Cancer Institute | Stojadinovic A.,U.S. Army | And 6 more authors.
Journal of the American College of Surgeons | Year: 2011

Background: Recently lymph node yield (LNY) has been endorsed as a quality measure of colon cancer resection adequacy. It is unclear whether this measure is relevant to all ages. We hypothesized that total lymph node yield (LNY) is negatively correlated with increasing age and overall survival (OS). Study Design: The Surveillance, Epidemiology and End Results (SEER) database was queried for all nonmetastatic colon cancer patients diagnosed from 1992 to 2004 (n = 101,767), grouped by age (<40, 41 to 45, 46 to 50, and in 5-year increments until 86+ years). Proportions of patients meeting the 12 LNY minimum criterion were determined in each age group and analyzed with multivariate linear regression adjusting for demographics and American Joint Committee on Cancer (AJCC) 6th Edition stage. OS comparisons in each age category were based on the guideline of 12 LNY. Results: Mean LNY decreased with increasing age (18.7 vs 11.4 nodes/patient, youngest vs oldest group, p < 0.001). The proportion of patients meeting the 12 LNY criterion also declined with each incremental age group (61.9% vs 35.2% compliance, youngest vs oldest, p < 0.001). Multivariate regression demonstrated a negative effect of each additional year in age and log (LNY) with coefficient of -0.003 (95% CI -0.003 to -0.002). When stratified by age and nodal yield using the 12 LNY criterion, OS was lower for all age groups in stage II colon cancer with less than 12 LNY, and each age group over 60 years with less than 12 LNY for stage III colon cancer (p < 0.05). Conclusions: Every attempt to adhere to proper oncologic principles should be made at the time of colon cancer resection regardless of age. The prognostic significance of the 12 LN minimum criterion should be applied even to elderly colon cancer patients.

Zheng L.,United States Military Cancer Institute | Enewold L.,United States Military Cancer Institute | Zahm S.H.,U.S. National Cancer Institute | Shriver C.D.,United States Military Cancer Institute | And 7 more authors.
Cancer Epidemiology Biomarkers and Prevention | Year: 2012

Background: Racial disparities in lung cancer outcomes have been observed in the general population. However, it is unclear whether survival differences persist when patients have equal access to health care. Our objective was to determine if lung cancer survival differed among black and white patients in the U.S. Military Health System (MHS), an equal access health care system. Methods: The study subjects were 10,181 black and white patients identified through the Department of Defense's Automated Central Tumor Registry, who were 20 years old or more and diagnosed with lung cancer between 1990 and 2003. Racial differences in all-cause survival were examined using the Kaplan-Meier method and Cox proportional hazards regression models stratified by histology. For comparison, survival rates in the general population were calculated using Surveillance Epidemiology and End Results-9 data. Results: Analyses included 9,154 white and 1,027 black patients: 1,834 small cell lung cancers, 3,876 adenocarcinomas, 2,741 squamous cell carcinomas, and 1,730 large cell carcinomas. Although more favorable crude survival was observed among black patients than white patients with small cell lung cancer (P = 0.04), survival was similar between the two groups after covariate adjustment. Racial differences in survival were nonsignificant for adenocarcinomas, squamous cell carcinomas, and large cell carcinomas. Survival rates appeared to be better in the MHS than in the general population. Conclusions and Impact: All-cause survival was similar among black and white lung cancer patients in the MHS. Providing equal access to health care may eliminate racial disparities in lung cancer survival while improving the outcome of all cases. ©2012 AACR.

Radowsky J.S.,U.S. Army | Baines L.,U.S. Army | Baines L.,Foundation Medicine | Howard R.S.,U.S. Army | And 5 more authors.
Pain Medicine (United States) | Year: 2012

Background. Disparity between patient report and physician perception of pain from radiotracer injection for sentinel node biopsy is thought to center on the severity of the intervention, ethnic composition of population queried, and socioeconomic factors. Objective. The objectives of this study were, first, to explore agreement between physicians' and their breast cancer patients' pain assessment during subareolar radionucleotide injection; and second, to evaluate potential ethnic differences in ratings. Methods. A trial was conducted, from January 2006 to April 2009, where 140 breast cancer patients were randomly assigned to standard topical lidocaine-4% cream and 99mTc-sulfur colloid injection, or to one of three other groups: placebo cream and 99mTc-sulfur colloid injection containing NaHCO3, 1% lidocaine, or NaHCO3+1% lidocaine. Providers and patients completed numeric pain scales (0-10) immediately after injection. Results. Patients and providers rated pain similarly over the entire cohort (median, 3 vs 2, P=0.15). Patients rated pain statistically significantly higher than physicians in the standard (6 vs 5, P=0.045) and placebo+NaHCO3 (5 vs 4, P=0.032) groups. No significant difference in scores existed between all African Americans and their physicians (3 vs 4, P=0.27). Conclusion. Patient-physician pain assessment congruence over the less painful injections and their statistically similar scores with the more painful methods suggests the importance of utilizing the least painful method possible. Providers tended to underestimate patients with the highest pain ratings-those in the greatest analgesic need. Lack of statistical difference between African American and physician scores may reflect the equal-access-to-care over the entire patient cohort, supporting the conclusion that socioeconomic factors may lie at the heart of previously reported discrepancies. Wiley Periodicals, Inc.

Veljkovic R.,Clinical Center Vojvodina | Protic M.,Clinical Center Vojvodina | Gluhovic A.,Clinical Center Vojvodina | Potic Z.,Novi Management | And 3 more authors.
Journal of the American College of Surgeons | Year: 2010

Background: Information-based scoring systems predictive of outcomes of midline laparotomy are needed; these systems can support surgical decisions with the aim of improving patient outcomes and quality of life, and reducing the risk of secondary surgical procedures. Study Design: All study subjects were followed for a minimum of 6 months after operation. Numerous demographic, clinical, treatment, and outcomes-related perioperative factors were recorded to determine statistical association with the primary end point: incisional hernia development. The first analysis was designed to establish the statistical model (scoring system) for estimating the risk of incisional hernia within 6 months of midline laparotomy. Univariate and multivariate analyses were performed. A simple additive model was constructed using stepwise logistic and linear regression. The second part of the study analysis was validation of the scoring systems developed initially. Results: A logistic linear minimum regression model was developed based on four covariates independently predictive of incisional hernia: Body mass index (BMI) > 24.4kg/m2; fascial suture to incision ratio (SIR) < 4.2; deep surgical site, deep space, or organ infection (SSI); and time to suture removal or complete epithelialization >16 days (TIME). The hernia risk scoring system equation [p(%) = 32(SIR) + 30(SSI) + 9(TIME) + 2(BMI)] provided accurate estimates of incisional hernia according to stratified risk groups based on total score: low (0 to 5 points), 1.0%; moderate (6 to 15 points), 9.7%; increased (16 to 50 points), 30.2%; and markedly increased (>50 points), 73.1%. Conclusions: A statistically valid, straightforward, and clinically useful predictive model was developed for estimating the risk of incisional hernia within 6 months of midline laparotomy. Prospective independent validation of this model appears indicated.

Radowsky J.S.,U.S. National Institutes of Health | Radowsky J.S.,Uniformed Services University of the Health Sciences | Howard R.S.,U.S. National Institutes of Health | Burch H.B.,Uniformed Services University of the Health Sciences | And 4 more authors.
Thyroid | Year: 2014

Background: The clinical importance of extrathyroidal extension (ETE) on outcome of papillary thyroid cancer (PTC), particularly with respect to disease extending to the surgical margin is not well established. This study assessed the importance of surgical margin and extrathyroidal invasion relative to local control of disease and oncologic outcome. Methods: A retrospective analysis of a prospective institutional endocrine database was conducted on 276 patients with PTC treated between 1955 and 2004 to determine the impact of margin-negative resection (n=199, 72%), disease up to within 1 mm of surgical margin (n=19, 7%), microscopic (n=39, 14%), and gross (n=19, 7%) ETE. Data were compared with Fisher's exact test or analysis of variance (ANOVA). Results: Median follow-up was 3.1-6.8 years per study group (disease-free survival, range 1-37 years). The proportion of those with age >45 years, prior radiation exposure, distant metastasis at presentation, and those undergoing total thyroidectomy was not significantly different between groups. Tumor size and multifocality correlated with extent of local disease, which in turn was significantly associated with regional nodal disease at time of primary operation as well as prevalence of persistence of disease after multimodality therapy. Extent of local disease correlated significantly with subsequent clinical recurrence after a disease-free period (p=0.006); however, recurrence rates were not significantly different between negative and close (≤1 mm) margin resection. Conclusion: Oncological outcome correlates with the extent of extrathyroidal invasion. Outcome is worse in patients with gross extrathyroidal disease extension than in those with microscopic local invasion apparent on histopathological assessment. However, the risk of clinical recurrence appears similar between patients undergoing margin-negative and "close margin" resection. © Copyright 2014, Mary Ann Liebert, Inc.

Avital I.,Bon Secours Cancer Institute | Avital I.,Uniformed Services University of the Health Sciences | Brucher B.L.D.M.,Theodor Billroth Academy | Nissan A.,Rabin Medical Center | And 3 more authors.
Surgical Oncology Clinics of North America | Year: 2012

Upwards of 40% of patient with colorectal cancer develop peritoneal carcinomatosis (CRCPC). Of the 2500 patients reported in the literature, 1000 underwent cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC), resulting in median survival of 22 to 63 months. However, level I data from prospective randomized trials are limited. Further trials are indicated to identify peritoneal carcinomatosis in at-risk patients early in the natural history of the disease and confirm the efficacy of multimodality therapy (CRS/HIPEC/systemic therapy) in those with CRCPC amenable to CRS in the modern era of novel targeted and cytotoxic systemic therapy. © 2012.

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