Deterioration Index in Critically Injured Patients: A Feasibility Analysis.

INTRODUCTION: Continuous prediction surveillance modeling is an emerging tool giving dynamic insight into conditions with potential mitigation of adverse events (AEs) and failure to rescue. The Epic electronic medical record contains a Deterioration Index (DI) algorithm that generates a prediction score every 15 min using objective data. Previous validation studies show rapid increases in DI score (≥14) predict a worse prognosis. The aim of this study was to demonstrate the utility of DI scores in the trauma intensive care unit (ICU) population. METHODS: A prospective, single-center study of trauma ICU patients in a Level 1 trauma center was conducted during a 3-mo period. Charts were reviewed every 24 h for minimum and maximum DI score, largest score change (Δ), and AE. Patients were grouped as low risk (ΔDI <14) or high risk (ΔDI ≥14). RESULTS: A total of 224 patients were evaluated. High-risk patients were more likely to experience AEs (69.0% versus 47.6%, P = 0.002). No patients with DI scores <30 were readmitted to the ICU after being stepped down to the floor. Patients that were readmitted and subsequently died all had DI scores of ≥60 when first stepped down from the ICU. CONCLUSIONS: This study demonstrates DI scores predict decompensation risk in the surgical ICU population, which may otherwise go unnoticed in real time. This can identify patients at risk of AE when transferred to the floor. Using the DI model could alert providers to increase surveillance in high-risk patients to mitigate unplanned returns to the ICU and failure to rescue.

Angioembolization in Severe Pelvic Trauma is Associated with Venous Thromboembolism.

INTRODUCTION: Management of hemorrhage from pelvic fractures is complex and requires multidisciplinary attention. Pelvic angioembolization (AE) has become a key intervention to aid in obtaining definitive hemorrhage control. We hypothesized that pelvic AE would be associated with an increased risk of venous thromboembolism (VTE). METHODS: All adults (age >16) with a severe pelvic fracture (Abbreviated Injury Scale ≥ 4) secondary to a blunt traumatic mechanism in the 2017-2019 American College of Surgeons Trauma Quality Improvement Program database were included. Patients who did not receive VTE prophylaxis during their admission were excluded. Patients who underwent pelvic AE during the first 24 h of admission were compared to those who did not using propensity score matching. Matching was performed based on patient demographics, admission physiology, comorbidities, injury severity, associated injuries, other hemorrhage control procedures, and VTE prophylaxis type, and time to initiation of VTE prophylaxis. The rates of VTE (deep vein thrombosis and pulmonary embolism) were compared between the matched groups. RESULTS: Of 72,985 patients with a severe blunt pelvic fracture, 1887 (2.6%) underwent pelvic AE during the first 24 h of admission versus 71,098 (97.4%) who did not. Pelvic AE patients had a higher median Injury Severity Score and more often required other hemorrhage control procedures, with laparotomy being most common (24.7%). The median time to initiation of VTE prophylaxis in pelvic AE versus no pelvic AE patients was 60.1 h (interquartile range = 36.6-98.6) versus 27.7 h (interquartile range = 13.9-52.4), respectively. After propensity score matching, pelvic AE patients were more likely to develop VTE compared to no pelvic AE patients (11.8% versus 9.5%, P = 0.03). CONCLUSIONS: Pelvic AE for control of hemorrhage from severe pelvic fractures is associated with an increased risk of in-hospital VTE. Patients who undergo pelvic AE are especially high risk for VTE and should be started as early as safely possible on VTE prophylaxis.

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.

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.

Bacterial community in the biofilm of granular activated carbon (GAC) PreBiofilter in bench-scale pilot plants for surface water pretreatment.

Biofilters of granular activated carbon (GAC) are responsible for the removal of organic matters in drinking water treatments. PreBiofilters, which operate as the first unit in a surface water treatment train, are a cost-effective pretreatment for conventional surface water treatment and provide more consistent downstream water quality. This study investigated bacterial communities from the samples of raw surface water, biofilm on the PreBiofilter, and filtrates for surface water pretreatment. A bench-scale pilot plant of PreBiofilter was constructed to pretreat surface water from the Canoochee River, GA, USA. PreBiofilter exhibited a significant reduction of total organic carbon and dissolved organic carbon. The evenness and Shannon diversity of bacterial operational taxonomic units (OTUs) were significantly higher on the biofilm of PreBiofilter than in raw water and filtrates. Similar bacteria communities were observed in the raw water and filtrates using relative abundance of bacterial OTUs. However, the bacterial communities in the filtrates became relatively similar to those in the biofilm using presence/absence of bacterial OTUs. GAC biofilm or raw water and filtrates greatly contributed to the abundance of bacteria; whereas, bacteria sheared from colonized biofilm and entered filtrates. Evenly distributed, diverse and unique bacteria in the biofilm played an important role to remove organic matters from surface water for conventional surface water pretreatment.

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.

That's why it's a 5-year program: resident acquisition of anorectal disease management competence.

BACKGROUND: Although surgical residents are expected to be proficient in the diagnosis and management of anorectal pathology upon graduation, there is little data related to the timing and degree of proficiency acquired during training. METHODS: Prospective study of new patients presenting to a colorectal surgical clinic for evaluation of anorectal complaints over a 3-y period. Trainees performed an initial evaluation and recorded their exam findings, diagnosis, and treatment plan. A separate evaluation by a staff colorectal surgeon was performed, with results compared by an independent reviewer. RESULTS: A total of 236 patient evaluations were included. The accuracy of referral diagnosis was significantly better when originated from a surgeon than from all other referral sources (91.7% versus 59.1%, P = 0.031). The most common conditions were internal hemorrhoids (25%), anal fissures (22%), and external hemorrhoids (19.5%). Internal hemorrhoids were most commonly misdiagnosed as external hemorrhoids (58%). Anal fissures were missed 38% of the time, and were most often given the diagnosis of internal hemorrhoids (45%). Residents also demonstrated difficulty in identifying thrombosis in external hemorrhoids, with a 45% error rate. Medical students and residents had an overall correct primary diagnosis of 69.5%; however, there was a significant improvement in the accuracy of diagnosis from medical students and interns to upper level residents (62.9% versus 81.2%, P = 0.003). Medical treatment plans agreed between resident and staff in 74%, the surgical management agreed in 62%, and overall the residents had the correct diagnosis and corresponding treatment plan in 44%. Additional adjunctive procedures were proposed in 66 patients with residents stating the correct adjunct in 79%. The most frequently missed adjuncts were endorectal ultrasound (34%) and colonoscopy (28%). CONCLUSION: Surgical trainees demonstrated significant deficiencies in the ability to evaluate and manage anorectal pathology; however, marked improvement occurred with time in training. Common areas of misdiagnosis and therapeutic errors were identified which could aid in curriculum development.

How Did the COVID-19 Pandemic Affect Trauma Volume at an Urban Level I Trauma Center?

INTRODUCTION: The COVID-19 pandemic changed the face of health care worldwide. While the impacts from this catastrophe are still being measured, it is important to understand how this pandemic impacted existing health care systems. As such, the objective of this study was to quantify its effects on trauma volume at an urban Level 1 trauma center in one of the earliest and most significantly affected US cities. METHODS: A retrospective chart review of consecutive trauma patients admitted to a Level 1 trauma center from January 1, 2017 to December 31, 2020 was completed. The total trauma volume in the years prior to the pandemic (2017-2019) was compared to the volume in 2020. These data were then further stratified to compare quarterly volume across all 4 years. RESULTS: A total of 4138 trauma patients were treated in the emergency room throughout 2020 with 4124 seen during 2019, 3774 during 2018, and 3505 during 2017 in the pre-COVID-19 time period. No significant difference in the volume of minor trauma or trauma transfers was observed (P < .05). However, there was a significant increase in the number of major traumas in 2020 as compared to prior years (38.5% vs 35.6%, P < .01) and in the volume of penetrating trauma (29.1% vs 24.0%, P < .01). DISCUSSION: During the COVID-19 outbreak, trauma remained a significant health care concern. This study found an increase in volume of penetrating trauma, specifically gunshot wounds throughout 2020. It remains important to continue to devote resources to trauma patients during the ongoing COVID-19 pandemic.

New Injury Severity Score and Trauma Injury Severity Score are superior in predicting trauma mortality.

BACKGROUND: Trauma scores are used to give clinicians appropriate quantitative context in making decisions. Studies show that anatomical trauma scores predicted intensive care unit admission better, while physiological trauma scores predicted mortality better. We hypothesize that trauma scores have a hierarchy of efficacies at predicting mortality and operative decision making. METHODS: We performed a retrospective analysis of our trauma patient database at a level 1 trauma center from 2016 to 2020 and calculated the following trauma scores: Glasgow Coma Scale, Revised Trauma Score, Trauma Injury Severity Score, Injury Severity Score, Shock Index, and New Trauma Injury Severity Score (NISS). Receiver operating characteristic curves were used to evaluate the sensitivity and specificity of trauma scores for predicting mortality. RESULTS: A total of 738 patients were included (mean ± SD age, 35.7 ± 15.6 years). Area under the curve (AUC) results from the DeLong test showed that NISS predicted mortality the best compared with other trauma scores. New Trauma Injury Severity Score was superior in predicting mortality for penetrating trauma (AUC, 0.86 ± 0.02; p < 0.001) compared with blunt trauma (AUC, 0.73 ± 0.04; p < 0.001). Trauma Injury Severity Score was the best predictor of mortality for patients with gunshot wounds (AUC, 0.83; 95% confidence interval [CI], 0.73-0.92; p < 0.001), motor vehicle accidents (AUC, 0.80; 95% CI, 0.61-1.00; p = 0.01), and falls (AUC, 0.73; 95% CI, 0.61-0.85; p = 0.007). CONCLUSION: New Trauma Injury Severity Score was the best scoring index for predicting mortality in trauma patients, especially for penetrating trauma. Clinicians should consider incorporating other trauma scores, especially NISS and Trauma Injury Severity Score, in determining injury severity and the likelihood of mortality. These scores can help physicians determine the best course of action in patient management. LEVEL OF EVIDENCE: Prognostic and Epidemiologic; level IV.

Does Time to Pelvic Fixation Influence Outcomes in Trauma Patients?

BACKGROUND: Pelvic fractures cause significant morbidity in the trauma population. Many factors influence time to fracture fixation. No previous study has determined the optimal time window for pelvic fixation. METHODS: A retrospective review of trauma patients with pelvic fractures from 2016 to 2020 was performed. Patients were stratified into EARLY and LATE groups, by time to fixation within 3 days or greater than 3 days whether from admission or from completion of a life-saving procedure. Unpaired Student's t-test and Fisher's exact test were performed with multiple linear regression for variables with P < .2 on univariate analysis. RESULTS: 287 patients were identified with a median fixation time of 3 days. There was no significant difference in demographics, incidence of preceding life-saving procedure, angioembolization, or mechanism of injury in the 2 groups (P > .05). Length of stay in the EARLY group was significantly reduced at 11.9 +/- .7 days compared to 18.0 +/-1.2 days in the LATE group (P < .001). There was no significant difference in rates of ventilator-associated pneumonia, deep vein thrombosis, pulmonary embolism (PE), acute kidney injury (AKI), pressure ulcer, or acute respiratory distress syndrome (ARDS) (P > .05). There were significantly more SSIs (surgical site infections) in the LATE group. After multiple linear regression adjusting for covariates of age and ISS, the difference in hospital LOS was 5.5 days (95% CI -8.0 to -3.1, P < .001). DISCUSSION: Fixation of traumatic pelvic fractures within 3 days reduced LOS. Prospective multi-center studies will help identify additional factors to decrease time to surgery and improve patient outcomes.

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.

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.

Flat epithelial atypia of the breast on core needle biopsy: an indication for surgical excision.

OBJECTIVES: Flat epithelial atypia (FEA) is an increasingly diagnosed breast lesion yet there remains a paucity of data regarding these findings and their clinical significance. By determining the pathologic concordance rate, we sought to evaluate the indications for surgical intervention for FEAs diagnosed on core needle biopsy (CNB). METHODS: Using a retrospective review of an international pathology referral center database, we included all breast CNB specimens with FEA as the most advanced diagnosis that underwent surgical excision. Patient demographics, caliber of biopsy needle, and pathology results were then analyzed. RESULTS: Between 2000 and 2009, 463 FEAs were diagnosed among 15,000 specimens referred for expert opinion. Twenty-four lesions (5%) met inclusion criteria. Sampling ranged from 8- to 18-guage needles. Two lesions (8.4%) were upgraded after surgical excision; one patient was found to have infiltrating ductal carcinoma and another with tubular carcinoma. Twelve patients who were diagnosed with FEA did not undergo surgical excision but had no immediate evidence of malignancy. CONCLUSIONS: Based on the 8.4% upgrade rate, FEA diagnosed on CNB requires follow-up surgical excision. Regardless of CNB caliber, the risk of sampling error precludes nonoperative management and FEA should be considered an at-risk lesion until more studies and pooled analysis prove otherwise.

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.

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.

"The malignant wart": a review of primary nodular melanoma of the foot and report of two cases.

The reported incidence of melanoma is rapidly rising and second only to lung cancer. Primary melanoma of the lower extremity accounts for approximately 30% of all cases reported, with half of these cases localized to the foot itself. Unfortunately, melanoma can be misdiagnosed and treatment delayed, as they are usually not painful. The overall 5- and 10-year survival rates improve with early diagnosis and aggressive treatment. This is a report of 2 cases of primary nodular melanoma of the foot initially misdiagnosed as a "wart." Following confirmation with biopsy, definitive surgical intervention in both cases consisted of resection of the primary malignancy and ipsilateral superficial inguinal lymph node basin resection using a multidisciplinary approach to patient care. Given the rapid increase in incidence of melanoma in the general population, one must have a high index of suspicion and low threshold for excisional biopsy of concerning dermatopathology on the foot and lower extremity. Early detection and combined appropriate surgical resection and adjunctive chemotherapeutic treatment of melanoma in a multidisciplinary setting are paramount in decreasing mortality rates.

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.

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.

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.