Associations of social vulnerability with truncal and extremity melanomas in the United States.

BACKGROUND: Prior studies in social determinants (SDoH) of truncal-extremity melanomas (TEM) have analyzed race, income, and environmental factors relative to their effect on health disparities. However, they are limited by the narrow scopes of SDoH and study population, while lacking analyses of interrelational contribution of SDoH on TEM disparities. METHODS: This retrospective cohort study of adult TEM patients (1975-2017) assessed linear regression trends in months of survival, as well as logistic regression trends in advanced presenting stage, surgery, and chemotherapy receipt across TEM subtypes with increasing overall social vulnerability and vulnerability in 15 SDoH variables grouped into socioeconomic status (SES), minority-language status (ML), household composition (HH), and housing-transportation (HT) themes measured by the SVI. SVI measures are ranked/compared across all US counties for relative vulnerability in a specific SDH and their total composite while accounting for sociodemographic-regional differences. RESULTS: Across 325 760 TEM patients, increasing overall social vulnerability demonstrated significant decreases in the survival period for 7/13 TEM histology types (p < 0.001), with relative decreases in the survival period as high as 44.0% (67.0-37.5 months) for epithelioid cell. SES and HH were the highest-magnitude contributors to these overall trends. For many patients with TEM, increased odds of advanced presenting stage (highest with acral-lentiginous: odds ratio [OR], -1.18; 95% confidence interval [CI], 1.02-1.36), decreased odds of indicated surgery receipt (lowest with amelanotic, 0.79; 0.71-0.87), and increased odds of indicated chemotherapy (highest with melanoma in giant nevi: 1.50; 1.01-2.44) were observed; SES and ML followed by HH and HT contributed to these trends. CONCLUSIONS: There were detriments in TEM care & prognosis in the United States with increasing social vulnerability. Identifying which SDH quantifiably are associated more with disparities in interrelational, real-world contexts is important to provide nuance to inform future research and initiatives to address TEM disparity.

The associations of food environment with gastrointestinal cancer outcomes in the United States.

BACKGROUND: Social conditions and dietary behaviors have been implicated in the rising burden of gastrointestinal cancers (GIC). The "food environment" reflects influences on a community level relative to food availability, nutritional assistance, and social determinants of health. Using the US Department of Agriculture-Food Environment Atlas (FEA), we sought to characterize the association of food environment on GIC presenting stage and long-term survival. METHODS: Patients diagnosed with GIC between 2013 and 2017 were identified using the SEER database. FEA-scores were based on 282 county-level food security variables, store-restaurant availability, SNAP/WIC enrollment, pricing/taxes, and producer vicinity adjusted-for factors of socioeconomic status, race-ethnicity, transportation access, and comorbidities. Relative FEA rankings across US counties were averaged into a composite score and assigned to patients by county-of-residence. The association of FEA, cancer stage, and survival were analyzed using multiple logistic regression and cox-proportional hazard models relative to White/non-White race/ethnicity. RESULTS: Among 287,148 patients, the most common GIC-sites were colon (n = 97,942, 34%), pancreas (n = 49,785, 17.3%), liver (n = 31,098, 11.0%) and esophagus (n = 16,271, 5.7%). A worse food environment was independently associated with increased odds of late-stage diagnosis (esophageal odds ratio [OR]: 1.03, 95% confidence interval [CI]: 1.01-1.05; hepatic OR: 1.06, 95% CI: 1.03-1.08; pancreatic OR: 1.04, 95% CI: 1.01-1.06) among all patients; in contrast, food environment was associated with colorectal cancer stage among non-White patients only (OR: 1.04, 95% CI: 1.03-1.06). Worse food environment was associated with worse 3-year survival (colon OR: 1.03, 95% CI: 1.01-1.04; hepatic OR: 1.12, 95% CI: 1.08-1.17; gastric OR: 1.07, 95% CI: 1.01-1.13). Similar associations were noted relative to overall survival among the entire cohort (biliary tract hazard ratio [HR]: 1.03, 95% CI: 1.01-1.05; esophageal HR: 1.02, 95% CI: 1.01-1.04; hepatic HR: 1.07, 95% CI: 1.06-1.09; pancreatic HR: 1.04, 95% CI: 1.02-1.05; rectum HR: 1.03, 95% CI: 1.01-1.04; gastric HR: 1.05, 95% CI: 1.03-1.07), as well as among non-White patients (biliary HR: 1.04, 95% CI: 1.01-1.07; colon HR: 1.03, 95% CI: 1.01-1.05; esophageal HR: 1.05, 95% CI: 1.02-1.08; hepatic HR: 1.08, 95% CI: 1.06-1.10) (all p < 0.003). CONCLUSIONS: Food environment was independently associated with late-stage tumor presentation and worse 3-year and overall survival among GIC patients. Interventions to address inequities across communities relative to food environments are needed to alleviate disparities in cancer care.

TVB-2640 (FASN Inhibitor) for the Treatment of Nonalcoholic Steatohepatitis: FASCINATE-1, a Randomized, Placebo-Controlled Phase 2a Trial.

BACKGROUND & AIMS: Increased de novo lipogenesis creates excess intrahepatic fat and lipotoxins, propagating liver damage in nonalcoholic steatohepatitis. TVB-2640, a fatty acid synthase inhibitor, was designed to reduce excess liver fat and directly inhibit inflammatory and fibrogenic pathways. We assessed the safety and efficacy of TVB-2640 in patients with nonalcoholic steatohepatitis in the United States. METHODS: 3V2640-CLIN-005 (FASCINATE-1) was a randomized, placebo-controlled, single-blind study at 10 US sites. Adults with ≥8% liver fat, assessed by magnetic resonance imaging proton density fat fraction, and evidence of liver fibrosis by magnetic resonance elastography ≥2.5 kPa or liver biopsy were eligible. Ninety-nine patients were randomized to receive placebo or 25 mg or 50 mg of TVB-2640 (orally, once-daily for 12 weeks). The primary end points of this study were safety and relative change in liver fat after treatment. RESULTS: Liver fat increased in the placebo cohort by 4.5% relative to baseline; in contrast TVB-2640 reduced liver fat by 9.6% in the 25-mg cohort (n = 30; least squares mean: -15.5%; 95% confidence interval, -31.3 to -0.23; P = .053), and 28.1% in the 50-mg cohort (n = 28; least squares mean: -28.0%; 95% confidence interval, -44.5 to -11.6; P = .001). Eleven percent of patients in the placebo group achieved a ≥30% relative reduction of liver fat compared to 23% in the 25-mg group, and 61% in the 50-mg group (P < .001). Secondary analyses showed improvements of metabolic, pro-inflammatory and fibrotic markers. TVB-2640 was well tolerated; adverse events were mostly mild and balanced among the groups. CONCLUSIONS: TVB-2640 significantly reduced liver fat and improved biochemical, inflammatory, and fibrotic biomarkers after 12 weeks, in a dose-dependent manner in patients with nonalcoholic steatohepatitis. ClinicalTrials.gov, Number NCT03938246.

Oncologic Outcomes of Multi-Institutional Minimally Invasive Inguinal Lymph Node Dissection for Melanoma Compared with Open Inguinal Dissection in the Second Multicenter Selective Lymphadenectomy Trial (MSLT-II).

BACKGROUND: Minimally invasive inguinal lymphadenectomy (MILND) is safe and feasible, but limited data exist regarding oncologic outcomes. METHODS: This study performed a multi-institutional retrospective cohort analysis of consecutive MILND performed for melanoma between January 2009 and June 2016. The open ILND (OILND) comparative cohort comprised patients enrolled in the second Multicenter Selective Lymphadenectomy Trial (MSLT-II) between December 2004 and March 2014.The pre-defined primary end point was the same-basin regional nodal recurrence, calculated using properties of binomial distribution. Time to events was calculated using the Kaplan-Meier method. The secondary end points were overall survival, progression-free survival, melanoma-specific survival (MSS), and distant metastasis-free survival (DMFS). RESULTS: For all the patients undergoing MILND, the same-basin regional recurrence rate was 4.4 % (10/228; 95 % confidence interval [CI], 2.1-7.9 %): 8.2 % (4/49) for clinical nodal disease and 3.4 % (6/179) for patients with a positive sentinel lymph node (SLN) as the indication. For the 288 patients enrolled in MSLT-II who underwent OILND for a positive SLN, 17 (5.9 %) had regional node recurrence as their first event. After controlling for ulceration, positive LN count and positive non-SLNs at the time of lymphadenectomy, no difference in OS, PFS, MSS or DMFS was observed for patients with a positive SLN who underwent MILND versus OILND. CONCLUSION: This large multi-institutional experience supports the oncologic safety of MILND for melanoma. The outcomes in this large multi-institutional experience of MILND compared favorably with those for an OILND population during similar periods, supporting the oncologic safety of MILND for melanoma.

Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma.

BACKGROUND: Sentinel-lymph-node biopsy is associated with increased melanoma-specific survival (i.e., survival until death from melanoma) among patients with node-positive intermediate-thickness melanomas (1.2 to 3.5 mm). The value of completion lymph-node dissection for patients with sentinel-node metastases is not clear. METHODS: In an international trial, we randomly assigned patients with sentinel-node metastases detected by means of standard pathological assessment or a multimarker molecular assay to immediate completion lymph-node dissection (dissection group) or nodal observation with ultrasonography (observation group). The primary end point was melanoma-specific survival. Secondary end points included disease-free survival and the cumulative rate of nonsentinel-node metastasis. RESULTS: Immediate completion lymph-node dissection was not associated with increased melanoma-specific survival among 1934 patients with data that could be evaluated in an intention-to-treat analysis or among 1755 patients in the per-protocol analysis. In the per-protocol analysis, the mean (±SE) 3-year rate of melanoma-specific survival was similar in the dissection group and the observation group (86±1.3% and 86±1.2%, respectively; P=0.42 by the log-rank test) at a median follow-up of 43 months. The rate of disease-free survival was slightly higher in the dissection group than in the observation group (68±1.7% and 63±1.7%, respectively; P=0.05 by the log-rank test) at 3 years, based on an increased rate of disease control in the regional nodes at 3 years (92±1.0% vs. 77±1.5%; P<0.001 by the log-rank test); these results must be interpreted with caution. Nonsentinel-node metastases, identified in 11.5% of the patients in the dissection group, were a strong, independent prognostic factor for recurrence (hazard ratio, 1.78; P=0.005). Lymphedema was observed in 24.1% of the patients in the dissection group and in 6.3% of those in the observation group. CONCLUSIONS: Immediate completion lymph-node dissection increased the rate of regional disease control and provided prognostic information but did not increase melanoma-specific survival among patients with melanoma and sentinel-node metastases. (Funded by the National Cancer Institute and others; MSLT-II ClinicalTrials.gov number, NCT00297895 .).

Surgical approach, management, and oncologic outcomes of primary leiomyosarcoma of the inferior vena cava: An institutional case series.

BACKGROUND: Leiomyosarcoma of the inferior vena cava (IVC) is a rare tumor arising from the smooth muscle of vessel walls. Surgery is the only potential curative treatment. Given its rarity, optimal surgical, and oncologic management is not well described. We review our institutional series of primary leiomyosarcomas treated with resection and IVC reconstruction over the last decade. METHODS: Retrospective chart review of all patients who underwent surgical resection of primary leiomyosarcoma of the IVC from November 2009 to March 2020 at a single tertiary care center was performed. RESULTS: Among the eight patients treated, the majority were female (87.5%) with a median age of 52 years (range, 44-63). Tumor was located in the infrarenal IVC in five patients (62.5%). IVC was reconstructed using a ring-enforced PTFE graft in six patients (75%). All but one patient had an intermediate (grade 2) or high grade (grade 3) tumor, and all resections achieved grossly negative margins. The 1- and 3-year disease-free survival was 85.7% and 64.3%, respectively. There were no disease-specific deaths during a median follow-up of 36 months (interquartile range, 10-51 months). CONCLUSIONS: With a well-coordinated multidisciplinary approach, primary leiomyosarcoma of the IVC can be safely resected with good long-term survival.

Follow-up of the melanoma patient.

Follow-up of the melanoma patient involves many different methods of surveillance. Specific guidelines for modalities and frequency are flexible and largely open to physician preference. Patient education and self-examination are generally viewed as crucial and cost-effective for recurrence detection. Increased frequency of clinical follow-up, laboratory studies, and imaging has not demonstrated survival benefit in surveillance. However, appropriate application of these different methods is controversial and evolving, especially with changing surgical management and new medical therapies.

Guidance of sentinel lymph node biopsy decisions in patients with T1-T2 melanoma using gene expression profiling.

AIM: Can gene expression profiling be used to identify patients with T1-T2 melanoma at low risk for sentinel lymph node (SLN) positivity? PATIENTS & METHODS: Bioinformatics modeling determined a population in which a 31-gene expression profile test predicted <5% SLN positivity. Multicenter, prospectively-tested (n = 1421) and retrospective (n = 690) cohorts were used for validation and outcomes, respectively. RESULTS: Patients 55-64 years and ≥65 years with a class 1A (low-risk) profile had SLN positivity rates of 4.9% and 1.6%. Class 2B (high-risk) patients had SLN positivity rates of 30.8% and 11.9%. Melanoma-specific survival was 99.3% for patients ≥55 years with class 1A, T1-T2 tumors and 55.0% for class 2B, SLN-positive, T1-T2 tumors. CONCLUSION: The 31-gene expression profile test identifies patients who could potentially avoid SLN biopsy.

Performance of a prognostic 31-gene expression profile in an independent cohort of 523 cutaneous melanoma patients.

BACKGROUND: The heterogeneous behavior of patients with melanoma makes prognostication challenging. To address this, a gene expression profile (GEP) test to predict metastatic risk was previously developed. This study evaluates the GEP's prognostic accuracy in an independent cohort of cutaneous melanoma patients. METHODS: This multi-center study analyzed primary melanoma tumors from 523 patients, using the GEP to classify patients as Class 1 (low risk) and Class 2 (high risk). Molecular classification was correlated to clinical outcome and assessed along with AJCC v7 staging criteria. Primary endpoints were recurrence-free (RFS) and distant metastasis-free (DMFS) survival. RESULTS: The 5-year RFS rates for Class 1 and Class 2 were 88% and 52%, respectively, and DMFS rates were 93% versus 60%, respectively (P < 0.001). The GEP was a significant predictor of RFS and DMFS in univariate analysis (hazard ratio [HR] = 5.4 and 6.6, respectively, P < 0.001 for each), along with Breslow thickness, ulceration, mitotic rate, and sentinel lymph node (SLN) status (P < 0.001 for each). GEP, tumor thickness and SLN status were significant predictors of RFS and DMFS in a multivariate model that also included ulceration and mitotic rate (RFS HR = 2.1, 1.2, and 2.5, respectively, P < 0.001 for each; and DMFS HR = 2.7, 1.3 and 3.0, respectively, P < 0.01 for each). CONCLUSIONS: The GEP test is an objective predictor of metastatic risk and provides additional independent prognostic information to traditional staging to help estimate an individual's risk for recurrence. The assay identified 70% of stage I and II patients who ultimately developed distant metastasis. Its role in consideration of patients for adjuvant therapy should be examined prospectively.

Soft Tissue Sarcoma, Version 2.2018, NCCN Clinical Practice Guidelines in Oncology.

Soft tissue sarcomas (STS) are rare solid tumors of mesenchymal cell origin that display a heterogenous mix of clinical and pathologic characteristics. STS can develop from fat, muscle, nerves, blood vessels, and other connective tissues. The evaluation and treatment of patients with STS requires a multidisciplinary team with demonstrated expertise in the management of these tumors. The complete NCCN Guidelines for STS provide recommendations for the diagnosis, evaluation, and treatment of extremity/superficial trunk/head and neck STS, as well as intra-abdominal/retroperitoneal STS, gastrointestinal stromal tumors, desmoid tumors, and rhabdomyosarcoma. This portion of the NCCN Guidelines discusses general principles for the diagnosis, staging, and treatment of STS of the extremities, superficial trunk, or head and neck; outlines treatment recommendations by disease stage; and reviews the evidence to support the guidelines recommendations.

National practice patterns of completion lymph node dissection for sentinel node-positive melanoma.

BACKGROUND AND OBJECTIVES: Close observation may be an appropriate alternative to completion lymph node dissection (CLND) for selected patient populations, especially those with minimal tumor burden in the sentinel lymph node (SLN). In this study, we examined the practice patterns of CLND utilization. METHODS: Using the National Cancer Database, we examined CLND utilization in SLN-positive patients diagnosed with clinically node-negative Stage III melanoma from 2012 to 2015. Hierarchical logistic regression models were constructed to assess the factors associated with observation after positive SLN biopsy (SLNB). RESULTS: Of the 131 171 patients identified, 55 688 (42.5%) underwent SLNB and 7200 (12.9%) had an SLN with a metastatic disease. CLND was performed in 57.0% of the patients with a positive SLNB. Patients were more likely to forgo CLND if the primary tumor was located on the lower extremity (odds ratio [OR], 1.65, 95% confidence interval [CI], 1.40-1.94), were older (P < 0.001), had multiple comorbidities (OR, 1.61, 95% CI, 1.19-2.20), or were diagnosed with melanoma in 2015 (OR, 1.33, 95% CI, 1.13-1.56 vs 2012). CONCLUSIONS: CLND utilization varied based on patient factors and decreased over time. As evidence supports close observation in selected patient populations with low SLN tumor burden, monitoring is needed to ensure that CLND is performed in the appropriate patient populations. However, this will require improvements in the data collected by cancer registries.

Safety and Feasibility of Minimally Invasive Inguinal Lymph Node Dissection in Patients With Melanoma (SAFE-MILND): Report of a Prospective Multi-institutional Trial.

BACKGROUND: Minimally invasive inguinal lymph node dissection (MILND) is a novel approach to inguinal lymphadenectomy. SAFE-MILND (NCT01500304) is a multicenter, phase I/II clinical trial evaluating the safety and feasibility of MILND for patients with melanoma in a group of surgeons newly adopting the procedure. METHODS: Twelve melanoma surgeons from 10 institutions without any previous MILND experience, enrolled patients into a prospective study after completing specialized training including didactic lectures, participating in a hands-on cadaveric laboratory, and being provided an instructional DVD of the procedure. Complications and adverse postoperative events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events Version 4.0. RESULTS: Eighty-seven patients underwent a MILND. Seventy-seven cases (88.5%) were completed via a minimally invasive approach. The median total inguinal lymph nodes pathologically examined (SLN + MILND) was 12.0 (interquartile range 8.0, 14.0). Overall, 71% of patients suffered an adverse event (AE); the majority of these were grades 1 and 2, with 26% of patients experiencing a grade 3 AE. No grade 4 or 5 AEs were observed. CONCLUSIONS: After a structured training program, high-volume melanoma surgeons adopted a novel surgical technique with a lymph node retrieval rate that met or exceeded current oncologic guidelines and published benchmarks, and a favorable morbidity profile.

Adjusted Hospital Sentinel Lymph Node Positivity Rates in Melanoma: A Novel Potential Measure of Quality.

OBJECTIVE: Our objectives were to examine whether hospital characteristics are associated with lower- and higher-than-expected sentinel lymph node biopsy (SLNB) positivity rates and whether hospitals with lower- or higher-than-expected SLNB positivity rates have worse patient outcomes. BACKGROUND: Surgeon and pathologist SLNB technical errors may lead to incorrect melanoma staging. A hospital's SLNB positivity rate may reflect its SLNB proficiency for melanoma, but this has never been investigated. METHODS: Stage IA-III melanoma patients undergoing SLNB were identified from the National Cancer Data Base (2004-2010). Hospital-level SLNB positivity rates were adjusted for patient- and tumor factors. Hospitals were divided into terciles of adjusted SLNB positivity rates. Hospital characteristics (using multinomial logistic regression) and survival (using Cox modeling) were examined across terciles. RESULTS: Of 33,639 SLNB patients (from 646 hospitals), 2916 (8.7%) had at least 1 positive lymph node. Hospitals with lower- (low tercile) and higher-than-expected (high tercile) SLNB positivity rates were more likely to be low-volume hospitals (low tercile: relative risk ratio (RRR) = 2.57, P = 0.002; high tercile: RRR = 2.3, P = 0.004) compared to hospitals with expected rates (middle tercile). Stage I patients treated at lower-than-expected SLNB positivity rate hospitals had worse 5-year survival than those treated at expected SLNB positivity rate hospitals (90.0% vs 91.9%, P = 0.014; hazard ratio = 1.28, 95% CI: 1.05-1.57); survival differences were not observed by SLNB positivity rates for stage II/III. CONCLUSIONS: Adjusted hospital SLNB positivity rates varied widely. Surgery at hospitals with lower-than-expected SLNB positivity rates was associated with decreased survival. Hospital SLNB positivity rates may be a novel measure to confidentially report to hospitals for internal quality assessment.

National Evaluation of Hospital Performance on the New Commission on Cancer Melanoma Quality Measures.

INTRODUCTION: To increase adherence to cancer management guidelines, the Commission on Cancer (CoC) developed and approved five melanoma quality measures in 2015. Our objectives were to evaluate formally the national performance of these melanoma measures and to examine patient, tumor, and hospital characteristics associated with adherence. METHODS: From the National Cancer Data Base (2012), patients with invasive, nonmetastatic melanoma were identified. Inclusion and exclusion criteria were based on the CoC definition for each measure. Patient-level and hospital-level adherence rates were calculated for the five measures. A hospital was deemed "compliant" if it met the CoC standard, which requires 80 % of patients to receive the measure-specific recommended care. Patient, tumor, and hospital characteristics potentially associated with higher likelihood of adherence at the patient-level were estimated using hierarchical random-effects logistic regression models. RESULTS: A total of 31,598 patients from 1343 hospitals were examined. Patient-level adherence rates varied from 31.6 % (Measure 5: ≥10 axillary lymph nodes removed/examined) to 72.6 % (Measure 1: sentinel lymph node biopsy (SLNB) appropriateness measure). Hospital-level adherence rates, ranged from 19.3 % of hospitals (N = 538 hospitals for Measure 5) to 44.8 % of hospitals (N = 1090 hospitals for Measure 3: completion lymph node dissection after positive SLNB). No hospital-level factors (e.g., teaching status) were consistently associated with better adherence. CONCLUSIONS: National adherence rates to the five new CoC melanoma quality metrics are low, and most hospitals would not meet the CoC requirement of 80 % adherence. Feedback for performance of these measures to hospitals, decisions support tools, and educational initiatives are needed to improve guideline adherence.

Soft Tissue Sarcoma, Version 2.2016, NCCN Clinical Practice Guidelines in Oncology.

Soft tissue sarcomas (STS) are rare solid tumors of mesenchymal cell origin that display a heterogenous mix of clinical and pathologic characteristics. STS can develop from fat, muscle, nerves, blood vessels, and other connective tissues. The evaluation and treatment of patients with STS requires a multidisciplinary team with demonstrated expertise in the management of these tumors. The complete NCCN Guidelines for Soft Tissue Sarcoma (available at NCCN.org) provide recommendations for the diagnosis, evaluation, and treatment of extremity/superficial trunk/head and neck STS, as well as intra-abdominal/retroperitoneal STS, gastrointestinal stromal tumor, desmoid tumors, and rhabdomyosarcoma. This manuscript discusses guiding principles for the diagnosis and staging of STS and evidence for treatment modalities that include surgery, radiation, chemoradiation, chemotherapy, and targeted therapy.

Reducing margins of wide local excision in head and neck melanoma for function and cosmesis: 5-year local recurrence-free survival.

BACKGROUND: The proximity of head and neck (H&N) melanomas to critical anatomical structures requires that surgeons achieve a balance between adequate margins of excision and the functional and cosmetic needs of patients. This study sought to determine the risk associated with reducing margins of wide local excision (WLE) in H&N melanoma and to identify risk factors of recurrence. METHODS: Seventy-nine cases of primary, invasive H&N melanoma were treated by WLE and followed prospectively for local recurrence. Forty-two WLEs were performed according to current practice guidelines (1cm for lesions<1.0 mm thick, 1-2 cm for lesions 1.01-2.0 mm thick, and 2 cm for lesions >2.0 mm thick). Reduced margins (0.5 cm for lesions ≤1.0 mm thick, 0.5-1.0 cm for lesions 1.01-2.0 mm thick, and 1.0 cm for lesion >2.0 mm thick) were utilized in 37 cases to preserve critical anatomical structures such as the eyelid, nose, mouth and auricle. RESULTS: Overall local recurrence rate was 8.9% over a mean follow-up period of 71.3 months and a minimum of 60 months. Reducing margins of WLE did not increase local recurrence rates as demonstrated by local recurrence-free survival (90.4% vs. 91.9%, P = 0.806). CONCLUSION: Margins of WLE may be safely reduced in melanomas in close proximity to structures of the H&N without affecting local recurrence rates.

Gene expression profiling for molecular staging of cutaneous melanoma in patients undergoing sentinel lymph node biopsy.

BACKGROUND: A gene expression profile (GEP) test able to accurately identify risk of metastasis for patients with cutaneous melanoma has been clinically validated. OBJECTIVE: We aimed for assessment of the prognostic accuracy of GEP and sentinel lymph node biopsy (SLNB) tests, independently and in combination, in a multicenter cohort of 217 patients. METHODS: Reverse transcription polymerase chain reaction (RT-PCR) was performed to assess the expression of 31 genes from primary melanoma tumors, and SLNB outcome was determined from clinical data. Prognostic accuracy of each test was determined using Kaplan-Meier and Cox regression analysis of disease-free, distant metastasis-free, and overall survivals. RESULTS: GEP outcome was a more significant and better predictor of each end point in univariate and multivariate regression analysis, compared with SLNB (P < .0001 for all). In combination with SLNB, GEP improved prognostication. For patients with a GEP high-risk outcome and a negative SLNB result, Kaplan-Meier 5-year disease-free, distant metastasis-free, and overall survivals were 35%, 49%, and 54%, respectively. LIMITATIONS: Within the SLNB-negative cohort of patients, overall risk of metastatic events was higher (∼30%) than commonly found in the general population of patients with melanoma. CONCLUSIONS: In this study cohort, GEP was an objective tool that accurately predicted metastatic risk in SLNB-eligible patients.

The pedicled lateral arm flap for oncologic reconstruction near the shoulder.

Oncologic resections near the shoulder create challenging reconstructive problems. In addition to severe contour defects and the risk for functional deficits resulting from contractures, there may be exposed bone and peripheral nerves rendering simple skin graft closures suboptimal long term. The lateral arm flap is a versatile septofasciocutaneous flap based on the posterior branch of the radial collateral artery in the lateral intermuscular septum of the upper arm. This paper details our experience with 3 patients who underwent wide local excision or radical resection of soft tissue tumors of the upper arm and closure with pedicled lateral arm fasciocutaneous flaps. Flap size ranged from 6 × 10 cm to 5 × 15 cm. Two flaps were transferred as 180-degree pivotal flaps; 1 flap was transferred as an advancement flap. There were no immediate postoperative complications or long-term functional deficits. The pedicled lateral arm flap is a safe and reliable option for soft tissue coverage of anterolateral shoulder defects. The vascular pedicle lies deep within the mid-upper arm and is rarely at risk during extensive tumor extirpation. The adjacent donor site allows for a single operative field without the need for repositioning and furthermore results in a skin paddle requirement that is one half the width of the original defect.