Discrepancies in Mass Shootings and Access to Trauma Care Across the United States, 2014-2018.

INTRODUCTION: The United States has one of the highest rates of gun violence and mass shootings. Timely medical attention in such events is critical. The objective of this study was to assess geographic disparities in mass shootings and access to trauma centers. METHODS: Data for all Level I and II trauma centers were extracted from the American College of Surgeons and the Trauma Center Association of America registries. Mass shooting event data (4+ individuals shot at a single event) were taken from the Gun Violence Archive between 2014 and 2018. RESULTS: A total of 564 trauma centers and 1672 mass shootings were included. Ratios of the number of mass shootings vs trauma centers per state ranged from 0 to 11.0 mass shootings per trauma center. States with the greatest disparity (highest ratio) included Louisiana and New Mexico. CONCLUSION: States in the southern regions of the US experience the greatest disparity due to a high burden of mass shootings with less access to trauma centers. Interventions are needed to increase access to trauma care and reduce mass shootings in these medically underserved areas.

Compression of the Right Atrium and Inferior Vena Cava from an Extrahepatic Biloma Following Liver Trauma.

A 26-year-old male presented to a Level 1 trauma center following a motorcycle crash. Workup of his injuries demonstrated a grade 5 liver laceration with active extravasation, grade 5 kidney laceration, right apical pneumothorax, and a sternal fracture. The patient underwent hepatic artery embolization with interventional radiology (IR) followed by an exploratory laparotomy, liver packing, and small bowel resection with primary anastomosis. Four days post-op, the patient developed dyspnea, tachycardia, and decreasing oxygen saturation. Computed tomography pulmonary angiography demonstrated perihepatic fluid compressing the right atrium and inferior vena cava. Percutaneous perihepatic drain placement with aspiration of 700 mL bilious fluid resulted in immediate resolution of the compression. He subsequently underwent endoscopic retrograde cholangiopancreatography (ERCP) with stenting of the ampulla nine days later. The patient was discharged ten days post-ERCP with oral amoxicillin/clavulanic acid for polymicrobial coverage and follow-up with gastroenterology and IR for stent removal and drain maintenance.

Multi-institutional, prospective, randomized, double-blind, placebo-controlled phase IIb trial of the tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine to prevent recurrence in high-risk melanoma patients: A subgroup analysis.

BACKGROUND: Checkpoint inhibitors (CPI) in combination with cell-based vaccines may produce synergistic antitumor immunity. The primary analysis of the randomized and blinded phase IIb trial in resected stage III/IV melanoma demonstrated TLPLDC is safe and improved 24-month disease-free survival (DFS) in the per treatment (PT) analysis. Here, we examine efficacy within pre-specified and exploratory subgroups. METHODS: Stage III/IV patients rendered disease-free by surgery were randomized 2:1 to TLPLDC vaccine versus placebo. The pre-specified PT analysis included only patients completing the primary vaccine/placebo series at 6 months. Kaplan-Meier analysis was used to compare 24-month DFS among subgroups. RESULTS: There were no clinicopathologic differences between subgroups except stage IV patients were more likely to receive CPI. In stage IV patients, 24-month DFS was 43% for vaccine versus 0% for placebo (p = 0.098) in the ITT analysis and 73% versus 0% (p = 0.002) in the PT analysis. There was no significant difference in 24-month DFS when stratified by use of immunotherapy or CPI. For patients with resected recurrent disease, 24-month DFS was 88.9% versus 33.3% (p = 0.013) in the PT analysis. All benefit from vaccination was in the PT analysis; no benefit was found in patients receiving up to three doses. CONCLUSION: The TLPLDC vaccine improved DFS in patients completing the primary vaccine series, particularly in the resected stage IV patients. The efficacy of the TLPLDC vaccine will be confirmed in a phase III study evaluating adjuvant TLPLDC + CPI versus Placebo + CPI in resected stage IV melanoma patients.

Prospective, randomized, single-blinded, multi-center phase II trial of two HER2 peptide vaccines, GP2 and AE37, in breast cancer patients to prevent recurrence.

PURPOSE: AE37 and GP2 are HER2 derived peptide vaccines. AE37 primarily elicits a CD4+ response while GP2 elicits a CD8+ response against the HER2 antigen. These peptides were tested in a large randomized trial to assess their ability to prevent recurrence in HER2 expressing breast cancer patients. The primary analyses found no difference in 5-year overall disease-free survival (DFS) but possible benefit in subgroups. Here, we present the final landmark analysis. METHODS: In this 4-arm, prospective, randomized, single-blinded, multi-center phase II trial, disease-free node positive and high-risk node negative breast cancer patients enrolled after standard of care therapy. Six monthly inoculations of vaccine (VG) vs. control (CG) were given as the primary vaccine series with 4 boosters at 6-month intervals. Demographic, safety, immunologic, and DFS data were evaluated. RESULTS: 456 patients were enrolled; 154 patients in the VG and 147 in CG for AE37, 89 patients in the VG and 91 in CG for GP2. The AE37 arm had no difference in DFS as compared to CG, but pre-specified exploratory subgroup analyses showed a trend towards benefit in advanced stage (p = 0.132, HR 0.573 CI 0.275-1.193), HER2 under-expression (p = 0.181, HR 0.756 CI 0.499-1.145), and triple-negative breast cancer (p = 0.266, HR 0.443 CI 0.114-1.717). In patients with both HER2 under-expression and advanced stage, there was significant benefit in the VG (p = 0.039, HR 0.375 CI 0.142-0.988) as compared to CG. The GP2 arm had no significant difference in DFS as compared to CG, but on subgroup analysis, HER2 positive patients had no recurrences with a trend toward improved DFS (p = 0.052) in VG as compared to CG. CONCLUSIONS: This phase II trial reveals that AE37 and GP2 are safe and possibly associated with improved clinical outcomes of DFS in certain subgroups of breast cancer patients. With these findings, further evaluations are warranted of AE37 and GP2 vaccines given in combination and/or separately for specific subsets of breast cancer patients based on their disease biology.

Final analysis of a phase I/IIa trial of the folate-binding protein-derived E39 peptide vaccine to prevent recurrence in ovarian and endometrial cancer patients.

BACKGROUND: E39, an HLA-A2-restricted, immunogenic peptide derived from the folate-binding protein (FBP), is overexpressed in multiple malignancies. We conducted a phase I/IIa trial of the E39 + GM-CSF vaccine with booster inoculations of either E39 or E39' (an attenuated version of E39) to prevent recurrences in disease-free endometrial and ovarian cancer patients(pts). Here, we present the final 24-month landmark analysis. PATIENTS AND METHODS: HLA-A2 + patients receiving E39 + GM-CSF were included in the vaccine group (VG), and HLA-A2- pts (or HLA-A2 + patients refusing vaccine) were followed as the control group (CG). VG group received 6 monthly inoculations as the primary vaccine series (PVS) and were randomized to receive either E39 or E39' booster inoculations. Demographic, safety, immunologic, and disease-free survival (DFS) data were collected and evaluated. RESULTS: Fifty-one patients were enrolled; 29 in the VG and 22 in the CG. Fourteen patients received <1000 µg and 15 received 1000 µg of E39. There were no clinicopathologic differences between VG and CG or between dose groups. E39 was well tolerated. At the 24 months landmark, DFS was 55.5% (VG) vs 40.0% (CG), P = 0.339. Patients receiving 1000 µg and boosted patients also showed improved DFS (P < 0.03). DFS was improved in the 1000 µg group after treatment of primary disease (90.0% vs CG:42.9%, P = 0.007), but not in recurrent patients. In low-FBP expressing patients, DFS was 100.0% (1000 µg), 50.0% (<1000 µg), and 25.0% (CG), P = 0.029. CONCLUSIONS: This phase I/IIa trial reveals that E39 + GM-CSF is safe and may be effective in preventing recurrence in high-risk ovarian and endometrial cancer when optimally dosed (1000 µg) to FBP low patients being treated for primary disease.

Mesenchymal stem cell therapy to promote limb transplant functional recovery.

BACKGROUND: Limb transplantation is a viable option for reconstruction after traumatic limb loss; however, functional recovery can be suboptimal. The aim of this study was to determine whether mesenchymal stem cell (MSC) administration can improve limb transplant functional recovery. METHODS: Orthotopic syngeneic hindlimb transplants were performed in Lewis rats, followed by topical and intravenous injections of syngeneic MSCs (5 × 106 ) or vehicle. Transplanted limb sensory and motor functions were tested by cutaneous pain reaction and walking track analysis, respectively. RESULTS: MSCs expanded ex vivo were CD29+ , CD31- , CD34- , CD44+ , CD45low , CD90+ , MHC Class-I+ , Class-II- , and pluripotent. Greater than 90% of limb transplants survived. At 4 weeks post-transplantation, the mean sensory nerve (tibial, peroneal, or sural) function in MSC (n = 9) and vehicle (n = 9) groups was <0.3 on a scale of Grades 0-3 (0 = No function; 3 = Normal). By 8 weeks, the sensory scores for tibial, peroneal, and sural nerves were 2.2 ± 0.7, 1.2 ± 0.5, and 1.7 ± 0.9 in the vehicle, and 2.6 ± 0.4, 1.0 ± 0.9, and 1.7 ± 0.9 in the MSC group, respectively (n = 9/group). At 4, 8, 16, and 24 weeks, the overall sensory function was higher in MSC group (≥7/group). Sciatic Function Index (SFI), a measure of motor function, could not be calculated because of poor foot prints; therefore, a novel grading system was developed. Bone fusion/vascularization as determined by X-ray films/laser Doppler (≥2 week post-transplantation) were normal (n = 3/group). Gastrocnemius muscle was atrophied (P < 0.05), and flexion contractures were evident by 24 weeks. CONCLUSIONS: Bone marrow-derived MSC therapy appears to improve sensory function recovery in a rat limb transplant model. Published 2016. This article is a U.S. Government work and is in the public domain in the USA Microsurgery 37:222-234, 2017.

The weekend effect: does time of admission impact management and outcomes of small bowel obstruction?

AIMS: To determine whether day and time of admission influences the practice patterns of the admitting general surgeon and subsequent outcomes for patients diagnosed with small bowel obstruction. METHODS: A retrospective database review was carried out, covering patients admitted with the presumed diagnosis of partial small bowel obstruction from 2004-2011. RESULTS: A total of 404 patients met the inclusion criteria. One hundred and thirty-nine were admitted during the day, 93 at night and 172 on the weekend. Overall 30.2% of the patients were managed operatively with no significant difference between the groups (P = 0.89); however, of patients taken to the operating room, patients admitted during the day received operative intervention over 24 hours earlier than those admitted at a weekend, 0.79 days vs 1.90 days, respectively (P = 0.05). Overall mortality was low at 1.7%, with no difference noted between the groups (P = 0.35). Likewise there was no difference in morbidity rates between the three groups (P = 0.90). CONCLUSIONS: Despite a faster time to operative intervention in those patients admitted during the day, our study revealed that time of admission does not appear to correlate to patient outcome or mortality.

Examining the accuracy and clinical usefulness of intraoperative frozen section analysis in the management of pancreatic lesions.

BACKGROUND: Intraoperative frozen section analysis is often performed in the surgical management of pancreatic lesions. This test is used to obtain histologic diagnosis, to assess resectability because of unanticipated locoregional spread, and to ensure negative margins after resection. We sought to define the accuracy and clinical usefulness of intraoperative frozen section analysis in patients with pancreatic lesions and to determine the impact on long-term outcomes. METHODS: A retrospective database review was performed for all patients who underwent pancreatic resection at our institution from 2002 to 2011. Patient demographics, indications for frozen section analysis, final pathology, and long-term outcomes were analyzed. Five-year survival was compared using the Kaplan-Meier method. RESULTS: Sixty-eight patients were identified (mean age 65 ± 14 years, 52% female). Malignancy was identified on final pathology in 38 (56%) patients. Intraoperative frozen section analysis was performed in 59 (87%) patients. Frozen section analysis was performed for histologic diagnosis in 6 (10%) cases, to determine resectability in 15 (25%) cases, and to evaluate margin status in 58 (98%) cases. Frozen section analysis for histologic diagnosis was associated with a sensitivity of 80%, a specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 50% with an overall accuracy of 83%. Frozen section analysis for the determination of resectability was associated with a sensitivity of 38%, specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 58% with an overall accuracy of 66%. Intraoperative frozen section analysis for the determination of the final margin status was associated with a sensitivity of 33%, specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 97% with an overall accuracy of 97%. There were no false-positive results on frozen section analysis. Errors on frozen section analysis interpretation did not negatively impact survival outcomes (mean survival = 2.2 years in those with concordant frozen section analysis vs 1.7 years in those with discordant frozen section analysis, P = .69). CONCLUSIONS: Although intraoperative frozen section analysis is helpful for ensuring negative final margins, its usefulness for obtaining histologic diagnosis and determining resectability is limited by low negative predictive potential. These results highlight the importance of preoperative staging and intraoperative surgical judgment for questionable resectable disease.

Training surgeons and the informed consent process: routine disclosure of trainee participation and its effect on patient willingness and consent rates.

OBJECTIVES: To examine patient perceptions and willingness to participate in resident education and to assess the effect on patient willingness and consent rates. DESIGN: Anonymous questionnaire designed to capture demographics, overall opinions of teaching programs, and willingness to consent to various scenarios of trainee participation. Descriptive and univariate analyses were performed. SETTING: Tertiary-level referral center. PATIENTS: Three hundred sixteen individuals scheduled for elective surgery. MAIN OUTCOME MEASURES: Consent rates for various scenarios. RESULTS: Of the 316 patients who completed the questionnaire, most expressed overall support of resident training: 91.2% opined that their care would be equivalent to or better than that of a private hospital, 68.3% believed they derived benefit from participation, and most consented to having an intern (85.0%) or a resident (94.0%) participate in their surgical procedure. However, when given specific, realistic scenarios involving trainee participation, major variations in the consent rate were observed. Affirmative consent rates decreased from 94.0% to 18.2% as the level of resident participation increased. Patients also were more willing to consent to the participation of a senior resident (83.1%) vs a junior resident (57.6%) or an intern (54.5%). Patients overwhelmingly opined that they should be informed of the level of resident participation and that this information could change their decision of whether to consent. CONCLUSIONS: Most patients expressed approval of teaching facilities and resident education. However, consent rates were significantly altered when more detailed information was provided and they declined with increasing levels of resident participation. Providing detailed informed consent is preferred by patients but it could adversely affect resident participation and training.

Transcriptional analysis of novel hormone receptors PGRMC1 and PGRMC2 as potential biomarkers of breast adenocarcinoma staging.

BACKGROUND: The expression of progesterone receptor membrane component 1 (PGRMC1) in breast cancer has generated interest in this recently discovered protein because of its role in tumorigenesis. However, correlations between patient age, PGRMC1 gene expression, breast cancer morphology, and breast cancer stage have not been adequately studied. Furthermore, very little is known about possible roles for other PGRMC isoforms in breast cancer, like PGRMC2. Thus, we examined the expression of PGRMC1 and PGRMC2 mRNA by relative quantitative PCR (RelqPCR) and determined whether transcript levels correlate with age, breast cancer staging, estrogen receptor alpha (ERα) status, and other morphometric features routinely used during the pathological examination of breast ductal adenocarcinomas. METHODS: Twenty-eight frozen or paraffin embedded breast cancer samples (ductal carcinoma in situ and stages I thru IV invasive ductal adenocarcinoma) and 10 control benign breast tissue samples were randomly selected and interrogated by RelqPCR to determine PGRMC1, 2, and ERα mRNA transcript levels. To control for slight variations in sample preparation, receptor transcript was normalized to the housekeeping gene phosphoglycerate kinase 1 (PGK1). Descriptive statistics and ANOVA of multiparametric datasets were used to correlate transcript levels with pathological staging parameters. RESULTS: PGRMC1 mRNA levels decreased significantly with patient age (Pearson's correlation -0.369; P=0.035), whereas PGRMC2 levels did not. Although the mean relative expression of PGRMC1 significantly decreased in stage II breast cancer compared with controls (P=0.050), it was no longer significant when age was considered a covariance (P=0.371). On the other hand, PGRMC2 mRNA transcript was significantly decreased in stage II breast cancer when compared to stage III cancer (P=0.028) in a manner independent of age (corrected model Bonferroni pair wise comparison, P=0.036). Furthermore, PGRMC2 levels positively correlated with ERα mRNA transcripts in patients with ER positive tumors (Pearson's correlation 0.503, P=0.096). CONCLUSIONS: Decreases in PGRMC1 mRNA are partially explained by increasing patient age. On the other hand, compared to stage III, PCRMC2 mRNA was significantly decreased in stage II adenocarcinoma of the breast in an age-independent manner. Additionally, PGRMC2 mRNA levels displayed a positive correlation with ERα transcripts. Thus, in addition to morphometric pathologic staging criteria, measurements of PGRMC2 mRNA may be useful for distinguishing low stage tumors from higher stages that require more aggressive clinical management, and may be a useful test when tumor ER IHC results are equivocal.

The treatment of radial scars in the modern era--surgical excision is not required.

The clinical significance of isolated radial scars (RS) diagnosed on core needle biopsy (CNB) remains unclear. By determining the pathologic concordance rate, we sought to define the indications for surgical excision for RS diagnosed on CNB. Between January 1994 and December 2007, 38 RS were diagnosed by CNB. Twenty-eight underwent surgical excision with 27 (96%) patients having further benign diagnoses. One patient, who was found to have invasive cancer on CNB, was also found to have malignancy on open biopsy. Fourteen lesions were diagnosed by 8-gauge, 13 lesions by 11-gauge, and one lesion by 14-gauge biopsy needles. Seven studies met inclusion criteria for analysis; 341 lesions with follow-on surgical biopsy were identified. Sixteen (5%) radial'scars were found to harbor malignancy and all were percutaneously biopsied with 14-gauge needles. With the inclusion of the current study, none of the isolated radial scars diagnosed by the larger 11- or 8-gauge biopsy needles resulted in upgraded lesions on follow-on surgical biopsy. Based on the current review, histologic radial scars are infrequently associated with occult malignancy and do not mandate surgical excision. Indications for excision include the mammographic diagnosis of RS and specimens associated with atypia that would otherwise require open biopsy.

Effect of race on thyroid cancer care in an equal access healthcare system.

BACKGROUND: Thyroid cancer is more likely to present at an advanced age with larger tumor size in black patients. The aim of this study was to assess the influence of race on the presentation, treatment, and survival in an equal access healthcare system. METHODS: This retrospective study included all black and white patients with thyroid cancer who were treated at a Department of Defense facility from 1986 to 2008. Patients' age, tumor size, lymph node status, treatment, and survival were compared. RESULTS: A total of 4,625 patients were identified. There was no difference between black and white patients in regards to age at presentation, tumor size, use of surgical and/or radiation therapy, and overall 5-year survival rate. Black patients had a lower rate of lymph node involvement. CONCLUSIONS: In an equal access healthcare system, black patients have similar disease presentation, undergo similar treatment, and have the same survival as white patients.

Gallbladder duplication: evaluation, treatment, and classification.

Duplicate gallbladder is a rare congenital anomaly resulting from abnormalities in embryogenesis during the fifth and sixth weeks of gestation. Approximately 210 cases have been described. Variations include duplicate, triplicate, and septated gallbladder. We encountered a 15-year-old girl with both a duplicated gallbladder and a duplicated cystic duct who underwent successful laparoscopic cholecystectomy. This combination is extremely unusual, and based upon our findings in this case and a review of the literature, we propose the Unified Classification of Multiple Gallbladders.

Natural course and outcome of cystic lesions in the pancreas.

BACKGROUND: The number of patients identified with cysts of the pancreas is increasing. The current study was undertaken to assess the natural course and malignant potential of pancreatic cysts. METHODS: From 1995 to 2008, radiology records were reviewed for the presence of cystic lesions of the pancreas (CLP) characteristics, patient demographics, and follow-up. RESULTS: Eighty-two patients met the study inclusion criteria, with a mean age at time of diagnosis of 64.4 +/- 16.7 years. Mean cyst size was 1.36 +/- 1.05 cm, with 75.6% of patients having a solitary cyst. Thirteen patients underwent surgery. Operative intervention was statistically related to symptomatic, loculated cysts with the presence of calcifications (all P <.05). Malignancy was statistically related to symptomatic (P <.05), loculated cysts (P <.01), and male gender (P <.05). CONCLUSIONS: Our data show that most pancreatic cysts found on radiographic imaging are asymptomatic, solitary, and small and can be followed safely radiographically.

Improved rates of colorectal cancer screening in an equal access population.

BACKGROUND: National colorectal cancer (CRC) screening averages 50% to 60%. We aimed to identify screening prevalence in select Department of Defense (DOD) beneficiaries with equal access to care. METHODS: December 2007 cross-sectional data of patients over 50 years of age included patient demographics, screening modality, and compliance. RESULTS: Of 17,252 patients (52% male; mean age 63.2 +/- 8.1 years), 12,229 (71%) were up-to-date with national screening guidelines. Modalities included colonoscopy (83.0%), flexible sigmoidoscopy with fecal occult blood testing (FOBT) (32.2%), and air-contrast barium enema (0.7%). African American or Hispanic background (70% African American, 68% Hispanic vs 73% Caucasian), younger patients (66.1% <65 years vs 78.6% >65 years), and male gender (69.9% vs 72.1%; all P < .001) all had lower rates. Compared to 2005, more patients were current with guidelines (71% vs 64%) and colonoscopic screening (83% vs 71%). CONCLUSIONS: Although ethnicity-, gender-, and age-related disparities were observed, screening rates are improved in an equal access healthcare system.

Primary tumor location impacts breast cancer survival.

BACKGROUND: The prognostic significance of tumor location in breast cancer remains unclear. To better understand this relationship, we evaluated the Department of Defense tumor registry. METHODS: Patients with infiltrating ductal adenocarcinoma or lobular carcinoma over a 10-year period were identified and analyzed. RESULTS: Of the 13,984 tumors, 7,871 (58%) originated from the upper-outer quadrant or axillary tail, whereas the remainder were found at the nipple complex (9%), upper-inner quadrant (14%), lower-inner quadrant (9%), and lower-outer quadrant (10%). Univariate analysis of cancer-specific survival revealed a significant difference based on location of the primary breast cancer. Upper-outer quadrant lesions were associated with an independent contribution toward a survival benefit. CONCLUSIONS: Upper-outer quadrant breast cancers have a more favorable survival advantage when compared with tumors in other locations. Factors that negatively impacted survival included high-grade tumors, advanced stage, and race.

Lobular neoplasia: is surgical excision warranted?

The treatment of breast cancer associated with lobular neoplasia detected on core needle biopsy (CNB) remains controversial. The purpose of this study was to review the prevalence of lobular neoplasia in CNB specimens and to correlate CNB pathology to final surgical pathology. Patients with lobular neoplasia were included for analysis in this retrospective review. Patients with concomitant malignant or atypical lesions were excluded. Method of initial diagnosis, clinical history, pathology results, and follow-up data were then analyzed. From January 1994 to December 2005, 5257 CNBs were performed at our tertiary level medical facility. Of patients with lobular neoplasia, 42 of 50 (84%) patients had atypical lobular hyperplasia, whereas 8 (16%) patients were diagnosed with lobular carcinoma in situ on CNB specimens. There were no associated malignancies in 21 patients who underwent immediate surgical excision. Of those patients who were serially followed, four developed malignancies at an average of 73 months after the sentinel diagnosis. Three of the four (75%) malignancies occurred in the ipsilateral breast. Patients with a diagnosis of lobular neoplasia by CNB should not routinely undergo an open surgical biopsy. Lobular neoplasia should only be considered a risk marker for future invasive breast cancer.

Laparoscopic vs open colectomy for colon cancer: results from a large nationwide population-based analysis.

PURPOSE: Laparoscopic colectomy has only recently become an accepted technique for the treatment of colon cancer. We sought to analyze factors that affect the type of resection performed and associated outcomes from a large nationwide database. METHODS: All admissions with a primary diagnosis of colon cancer undergoing elective resection were selected from the 2003 and 2004 Nationwide Inpatient Samples. Multiple linear and logistic regression analyses were used to compare outcome measures and identify independent predictors of a laparoscopic approach. RESULTS: We identified 98,923 admissions (mean age 69.2 years). They were predominately Caucasian (81%), had localized disease (63%), had private insurance (56%), and had surgery performed in urban hospitals (87%). Laparoscopic resection was performed in 3,296 cases (3.3%) and was associated with a lower complication rate (18% vs 22%), shorter length of stay (6 vs 7.6 days), decreased need for skilled aftercare (5% vs 11%), and lower mortality (0.6% vs 1.4%, all P<0.01). There was no significant difference in the total hospital charges between the groups ($34,685 vs $34,178, P=0.19). Independent predictors of undergoing laparoscopic resection were age<70 (odds ratio [OR]=1.2, P<0.01), national region (Midwest OR=1.9, West OR=2.0, P<0.01), and lower disease stage (OR=2.5, P<0.01). Ethnic category and insurance status showed no significant association with operative method (P>0.05). CONCLUSIONS: Laparoscopy for colon cancer is associated with improved outcomes in unadjusted analysis and similar charges compared to open resection. We found no influence of race or payer status on the utilization of a laparoscopic approach.

Prospective randomized study comparing sentinel lymph node evaluation with standard pathologic evaluation for the staging of colon carcinoma: results from the United States Military Cancer Institute Clinical Trials Group Study GI-01.

BACKGROUND: The principal role of sentinel lymph node (SLN) sampling and ultrastaging in colon cancer is enhanced staging accuracy. The utility of this technique for patients with colon cancer remains controversial. PURPOSE: This multicenter randomized trial was conducted to determine if focused assessment of the SLN with step sectioning and immunohistochemistry (IHC) enhances the ability to stage the regional nodal basin over conventional histopathology in patients with resectable colon cancer. PATIENTS AND METHODS: Between August 2002 and April 2006 we randomly assigned 161 patients with stage I-III colon cancer to standard histopathologic evaluation or SLN mapping (ex vivo, subserosal, peritumoral, 1% isosulfan blue dye) and ultrastaging with pan-cytokeratin IHC in conjunction with standard histopathology. SLN-positive disease was defined as individual tumor cells or cell aggregates identified by hematoxylin and eosin (H&E) and/or IHC. Primary end point was the rate of nodal upstaging. RESULTS: Significant nodal upstaging was identified with SLN ultrastaging (Control vs. SLN: 38.7% vs. 57.3%, P = 0.019). When SLNs with cell aggregates < or =0.2 mm in size were excluded, no statistically significant difference in node-positive rate was apparent between the control and SLN arms (38.7% vs. 39.0%, P = 0.97). However, a 10.7% (6/56) nodal upstaging was identified by evaluation of H&E stained step sections of SLNs among study arm patients who would have otherwise been staged node-negative (N0) by conventional pathologic assessment alone. CONCLUSION: SLN mapping, step sectioning, and immunohistochemistry (IHC) identifies small volume nodal disease and improves staging in patients with resectable colon cancer. A prospective trial is ongoing to determine the clinical significance of colon cancer micrometastasis in sentinel lymph nodes.

Prognostic significance of reactivation of telomerase in breast core biopsy specimens.

BACKGROUND: Telomerase is not expressed in most somatic tissues, but activity has been shown in breast carcinoma and up to 90% of solid tumors. We sought to determine whether activation of telomerase, as shown by immunohistochemical staining for human telomerase reverse transcriptase (hTERT), held prognostic significance in core breast biopsy specimens. METHODS: We identified women with atypical ductal hyperplasia (ADH) on core biopsy who either had underlying cancer or ADH. Immunohistochemistry with anti-hTERT antibody was performed on biopsy specimens, and staining was evaluated. RESULTS: Core biopsy specimens stained strongly with the hTERT antibody in 7 (70%) specimens with ADH on open biopsy and 6 (86%) with underlying cancer. The difference was not statistically significant (P = .43). CONCLUSIONS: Our study suggests telomerase may be activated early in the pathogenesis of breast cancer. The immunohistochemical evaluating expression of hTERT does not reliably identify those patients with ADH on core biopsy who are likely to have cancer.