Complications and Risks Associated with the Different Types of Abdominoplasties: An Analysis of 55,956 Patients.

BACKGROUND: Different types of abdominoplasties have been developed to address individual patient characteristics. However, complication rates and risk factors for complications between different types of abdominoplasties has yet to be reported. OBJECTIVES: The aim of this study was to evaluate the complication rates and risks associated with each type of abdominoplasty. METHODS: Using the CosmetAssure database, patients undergoing an abdominoplasty from 2015 to 2022 were identified. Demographic factors and major complications were recorded and analyzed using a chi-square test or ANOVA. A logistic regression was performed to identify the risk associated with each type of abdominoplasty for developing complications. RESULTS: A total of 55,596 patients underwent an abdominoplasty procedure by any method. The overall complication rate was 2.1%. There was a significant difference in the overall complication rate between all seven types of abdominoplasties (p<0.05), with Fleur-de-lis abdominoplasty having the highest complication rate. The year of surgery, being underweight or morbidly obese, diabetes, and being male placed patients at a significantly higher risk for developing a post-operative complication. Over 15,000 patients (27.2%) had concurrent procedures related to breast surgery, other body contouring, liposuction, or facial surgery. When accounting for various risk factors in a regression model, there was no significant added risk for major complications after a combination procedure with an abdominoplasty compared to abdominoplasty alone. CONCLUSIONS: Among the different types of abdominoplasties, a Fleur-de-lis abdominoplasty has the highest complication rate. Concurrent cosmetic procedures in addition to an abdominoplasty showed no added risk for major complications compared to abdominoplasty alone.

Assessment of x-ray efficacy for intraoperative microneedle retrieval using a cadaveric model.

INTRODUCTION: Institutional protocols often mandate the use of x-rays when a microneedle is lost intraoperatively. Although x-rays can reliably show a macroneedle, the benefit of x-rays in detecting microneedles in human tissues has not been established as available data on this topic are investigated in anthropometric models. The current study aims to evaluate whether x-rays can reliably detect retained microneedles in a human cadaveric model. We hypothesize that microneedles would be detected at a significantly lower rate than macroneedles by x-ray in human tissues. MATERIALS AND METHODS: Needles ranging from 4-0 to 10-0 were placed randomly throughout a cadaveric hand and foot. Each tissue sample was x-rayed using a Fexitron X-Ray machine, taking both anteroposterior and lateral views. A total of six x-ray images were then evaluated by 11 radiologists, independently. The radiologists circled over the area where they visualized a needle. The accuracy of detecting macroneedles (size 4-0 to 7-0) was compared with that of microneedles (size 8-0 to 10-0) using a chi-square test. RESULTS: The overall detection rate for the microneedles was significantly lower than the detection rate for macroneedles (13.5% vs 88.8%, p < .01). When subcategorized between the hand and the foot, the detection rate for microneedles was also significantly lower than the rate for macroneedles (hand: 7.6% for microneedles, 93.2% for macroneedles, p < .01; foot: 19.5% for microneedles, 84.4% for macroneedles, p < .01). The detection rate, in general, significantly decreased as the sizes of needles became smaller (7-0:70.5%, 8-0:18.2%, 9-0:16.7%, 10-0:2.3%, p < .01). CONCLUSION: X-rays, while useful in detecting macroneedles, had a significantly lower rate of detecting microneedles in a cadaveric model. The routine use of x-rays for a lost microneedle may not be beneficial. Further investigation with fresh tissue and similar intraoperative x-ray systems is warranted to corroborate and support these findings.

Association study between genetic polymorphisms in MTHFR and stroke susceptibility in Egyptian population: a case-control study.

Stroke is a major global disability cause, and genetic variables for multifactorial illnesses like stroke are crucial for precision medicine. The purpose of this study is to see if genetic variants in the MTHFR gene are associated with a higher risk of ischemic stroke among the Egyptian population. A case-control study was conducted at Mansoura University Hospital, involving 100 stroke patients and 150 healthy volunteers as the control group. Peripheral blood genomic DNA was isolated and single-nucleotide polymorphisms were genotyped using ARMS-PCR. The CT and TT genotypes of the C677T gene polymorphism exhibited substantial risks for having stroke disease [(OR 3.856; P ≤ 0.001); (OR 4.026; P ≤ 0.001), respectively]. The T allele was significantly more prevalent among patients compared to controls. (OR 2.517; (P = 0.001)). The over-dominant and dominant models demonstrated a substantial relationship between stroke groups at risk of developing stroke but not the Recessive model. An extensive connection was found between the MTHFR A1298C and stroke danger in three different inheritance models: dominant (CC + CA vs. AA), over-dominant (AA + CC vs AC), and allelic (C allele) (P < 0.001). A highly significant difference in blood pressure, total cholesterol, and triglycerides levels was found between patients and control. While there was no meaningful link discovered between genetic polymorphism with SBP, DBP, TG, LDL, VLDL among stroke group (P > 0.05 for each) except the CC genotype that was significantly associated with lower levels of TC and HDL when compared to CT + TT genotypes. The study evaluates a strong link among MTHFR mutations in genes and the probability to get stroke. The research significantly supports the use of MTHFR ((rs1801133) and (rs1801131) variations in stroke prediction.

Addressing Current Deficits in Patient Education Materials Through Crowdsourcing.

BACKGROUND: Patient education materials are commonly reported to be difficult to understand. OBJECTIVES: We aimed to use crowdsourcing to improve patient education materials at our institution. METHODS: This was a department-wide quality improvement project to increase organizational health literacy. There are 6 phases of this pilot study: (1) evaluating preexisting patient education materials, (2) evaluating online patient education materials at the society (the American Society of Plastic Surgeon) and government level (Medline Plus), (3) redesigning our patient education material and reevaluating the education material, (4) crowdsourcing to evaluate understandability of the new patient education material, (5) data analysis, and (6) incorporating crowdsourcing suggestions to the patient education material. RESULTS: Breast-related patient education materials are not easy to read at the institution level, the society level, and the government level. Our new implant-based breast reconstruction patient education material is easy to read as demonstrated by the crowdsourcing evaluation. More than 90% of the participants reported our material is "very easy to understand" or "easy to understand." The crowdsourcing process took 1.5 days, with 700 workers responding to the survey. The total cost was $9. After incorporating participants' feedback into the finalized material, the readability of the material is at the recommended reading level. The material also had the recommended length (between 400 and 800 words). DISCUSSION: Our study demonstrated a pathway for clinicians to efficiently obtain a large amount of feedback to improve patient education materials. Crowdsourcing is an effective tool to improve organizational health literacy.

Easing the Burden on Caregivers- Applications of Artificial Intelligence for Physicians and Caregivers of Children with Cleft Lip and Palate.

OBJECTIVE: Many caregivers of children with cleft lip and palate experience a high level of anxiety throughout their child's medical and surgical care. We aim to evaluate artificial intelligence (AI) as a tool to mitigate these feelings and can aid clinicians in the development of robust pediatric educational materials for caregivers and families. DESIGN: Thirteen of the most common postoperative questions following cleft lip and/or palate repair were developed by an expert panel of senior Pediatric Plastic Surgeons and were posed to ChatGPT. Professional answers from the expert panel were provided and compared to responses from ChatGPT. A literature review was also conducted to generate a new support model for caregivers with children undergoing a surgical procedure. SETTING: Department of Pediatric Plastic Surgery at a metropolitan Children's Hospital. PARTICIPANTS: Senior Pediatric Plastic Surgeons at a metropolitan Children's Hospital. INTERVENTIONS: None. MAIN OUTCOME MEASURE: The primary outcome was to determine the ability of ChatGPT to respond to common postoperative questions and to develop a model for AI assistance in family-centered perioperative care. RESULTS: ChatGPT had a postoperative question response accuracy rate of 69% when compared with subject matter expert responses, with its greatest errors being information errors. An extensive literature search revealed that AI can assist in multiple traditional perioperative strategies to reduce caregivers and patient anxiety. CONCLUSIONS: Artificial Intelligence can help to reduce the burden of generating patient education materials as well as support caregivers in multiple aspects and perioperative care.

Burn Injury-related Growth Factor Expressions and Their Potential Roles in Burn-related Neuropathies.

In the context of burn injury, growth factors (GFs) play a significant role in mediating the complex local and systematic processes that occur. Among the many systemic complications that arise following a burn injury, peripheral neuropathy remains one of the most common. Despite the broad understanding of the effects GFs have on multiple tissues, their potential implications in both wound healing and neuropathy remain largely unexplored. Therefore, this review aims to investigate the expression patterns of GFs prominent during the burn wound healing process and explore the potential contributions these GFs have on the development of burn-related peripheral neuropathy.

Systematic Review and Meta-Analysis of Global Neuroma Incidence in Upper Extremity Amputees.

BACKGROUND: Neuromas substantially decrease a patient's quality of life and obstruct the use of prosthetics. This systematic review and meta-analysis aimed to determine the global incidence of neuroma formation in upper extremity amputees. METHODS: A literature search was performed using 3 databases: Web of Science, MEDLINE, and Cochrane. Inclusion criteria for the systematic review were those studies investigating only upper extremity amputees and reported postamputation neuroma. A random-effects, inverse-variance analysis was conducted to determine the pooled proportion of neuromas within the upper extremity amputation population. Critical appraisal using the JBI Checklist for Studies Reporting Prevalence Data of each individual article were performed for the systematic review. RESULTS: Eleven studies met the inclusion criteria collating a total of 1931 patients across 8 countries. More than three-fourth of patients are young men (77%; age range, 19-54 years) and had an amputation due to trauma. The random-effects analysis found the pooled combined proportion of neuromas to be 13% (95% confidence interval, 8%-18%). The treatment of neuroma is highly variable, with some patients receiving no treatment. CONCLUSIONS: The pooled proportion of neuroma incidence in the 1931 patients was 13%. With the known global prevalence of upper extremity amputees, this translates to nearly 3 million amputees suffering from a neuroma globally. Increasing training in preventative surgical methods could contribute to lowering this incidence and improving the outcomes of this patient population.

Comparison of Patient Education Materials Generated by Chat Generative Pre-Trained Transformer Versus Experts: An Innovative Way to Increase Readability of Patient Education Materials.

INTRODUCTION: Improving patient education materials may improve patient outcomes. This study aims to explore the possibility of generating patient education materials with the assistance of a large language model, Chat Generative Pre-Trained Transformer (ChatGPT). In addition, we compare the accuracy and readability of ChatGPT-generated materials versus expert-generated materials. METHODS: Patient education materials in implant-based breast reconstruction were generated by experts and ChatGPT independently. Readability and accuracy of the materials are the main outcomes. Readability of the materials was compared using Flesch-Kincaid score. Accuracy of the materials generated by ChatGPT was evaluated by 2 independent reviewers. Content errors are categorized into information errors, statistical errors, and multiple errors (errors more than 2 types). RESULTS: The content generated by experts had higher readability. The Flesch-Kincaid score is at the 7.5 grade for expert-generated materials, whereas the content generated by ChatGPT is at the 10.5 grade (despite ChatGPT being asked to generate content at the seventh grade level). The accuracy of ChatGPT-generated content is 50%, with most errors being information errors. ChatGPT often provides information about breast reduction or breast augmentation, despite being asked specifically about breast reconstruction. Despite its limitation, ChatGPT significantly reduced the time required to generate patient education materials. Although it takes experts 1 month to generate patient education materials, ChatGPT generates materials within 30 minutes. CONCLUSIONS: ChatGPT can be a powerful starting tool to generate patient education materials. However, its readability and accuracy still require improvements.

Detection of dengue virus serotype 4 in Sudan.

Background: Dengue virus infection is spreading globally and most parts of Sudan have witnessed repeated dengue outbreaks, with the detection of DENV-1, DENV-2 and DENV-3 serotypes. Aims: In this report we describe the dengue fever outbreaks that occurred in eastern Sudan (Kassala and Port Sudan cities) from August to November 2019. Methods: We enrolled 79 (29.8%) suspected cases from Kassala and 186 (70.2%) from Port Sudan who presented with fever. The participants were medically examined and their clinical signs recorded. Blood samples were collected for complete blood count, detection of anti-dengue virus IgM, detection of NS1 dengue antigen and identification of the virus serotype using RT-PCR. Results: The main clinical presentations were fever, abdominal pain, joint pain and vomiting, and thrombocytopenia was the main laboratory finding. One hundred and twenty-five blood samples tested positive for the anti-dengue IgM antibody, and 145 were positive for the NS1 antigen. Using RT-PCR, we identified 35 (24%) infections with DENV-2, 100 (69%) with DENV-3 and 10 (7%) with DENV-4 serotypes. Conclusions: We identified multiple serotypes - DENV-2, DENV-3 and DENV-4 - as the causes of the outbreak. The presence of DENV-4 serotype was documented for the first time in Sudan.

Clinical updates in neoadjuvant immunotherapy for melanoma before surgery.

INTRODUCTION: Locoregionally advanced melanoma represents a large group of high-risk melanoma patients at presentation and poses major challenges in relation to management and the risks of relapse and death. AREAS COVERED: Melanoma systemic therapy has undergone substantial advancements with the advent of immune checkpoint inhibitors and molecularly targeted therapies, which have been translated to the neoadjuvant setting for the management of locoregionally advanced disease. Notably, PD1 blockade as monotherapy, in combination with CTLA4 blockade or LAG3 inhibition, has demonstrated significant progress in reducing the risk of relapse and mortality, attributed to high pathologic response rates. Likewise, BRAF-MEK inhibition for BRAF mutant melanoma has yielded comparable outcomes, albeit with lower response durability than immunotherapy. Localized intralesional therapies such as Talimogene laherparepvec (T-VEC) and Tavokinogene Telseplasmid (TAVO) electro-gene-transfer combined with anti-PD1 have demonstrated favorable pathologic responses and increased immune activation. Most importantly, the S1801 randomized trial has demonstrated for the first time the advantage of the neoadjuvant approach over standard surgery followed by adjuvant therapy. EXPERT OPINION: Current evidence supports neoadjuvant therapy as a standard of care for locoregionally advanced melanoma. Ongoing research will define the optimal regimens and the biomarkers of therapeutic predictive and prognostic value.

Comparison of Complication Rates Between Subpectoral vs Prepectoral Techniques in Prosthetic Breast Reconstruction.

BACKGROUND: The location of tissue expanders in implant-based breast reconstruction remains controversial due to variation in surgical techniques and devices. OBJECTIVES: The aim of this study was to provide a comprehensive assessment of early and late complication rates between prepectoral and subpectoral placement of tissue expanders. METHODS: A retrospective cohort study was conducted of all adult female patients who had undergone 2-stage implant-based breast reconstruction between 2013 and 2019 in our institution. Early complication was defined as complications that occurred within 30 days after surgery. Time-to-event analyses were performed and Cox proportional hazard models were used to adjust for confounders. RESULTS: In total, 854 patients were included; 76% of patients underwent a subpectoral tissue expander placement. After the first-stage procedure, the early complication rate was 34% and the late complication rate was 36.4%. After the second-stage procedure, the early complication rate was 16.3% and the late complication rate was 16.1%. Location of the tissue expander did not predict either overall early or late complication rates, regardless of the stages of reconstruction, after adjusting for confounders. Tissue expanders placed in prepectoral plane were associated with a higher hazard ratio (HR) for developing early and late infection after the first stage of reconstruction (HR, 2.1 and 2.4, respectively) as well as late infection after the second stage of reconstruction (HR, 5.3; all P < .05). CONCLUSIONS: Location of tissue expanders did not predict risk of complication. However, the prepectoral group was associated with an increased risk of developing infection.

Ambliopía no estrábica: revisión sistemática en Hispanoamérica, prevalencia de casos clínicos / Non-strabismic amblyopia: literature review in Hispanic America, prevalence of clinical cases / Ambliopia não estrabísmica: revisão da literatura na América espanhola, prevalência de casos clínicos

La ambliopía es una de las alteraciones que causa mayor impacto y es frecuente en la pérdida de agudeza visual, principalmente en los niños; su prevalencia varía entre 2% y 7%. Por otro lado, es la primera causa de afectación en la visión de adultos. Objetivo. Analizar la prevalencia de la ambliopía no estrábica en distintos grupos etarios en Hispanoamérica. Metodología. Se realizó una revisión sistemática de estudios realizados dentro del período 2014 al 2021 en las bases de datos como: Redalyc, Scielo, Medilib, Dialnet y Google Académico. Se presenta el análisis de cinco estudios relevantes en Colombia, Ecuador, Nicaragua, Chile y Cuba. Conclusión. En el estudio de Cuba, se encontró ambliopía en el 1.39%; en Colombia, el 8.10%; en Ecuador, el 5.30%; en Nicaragua el 2.9%; en Chile la incidencia fue del 2.41%, 2.55% y 3.51%, respectivamente para los grupos etarios de 18-38 años, 39-59 años y 60-79 años. Así Colombia es el país en el que se halló la mayor incidencia de ambliopía (8.10%), y Cuba el menor con el 1.39%. Además, la ambliopía refractiva es la más común en los estudios y en cuanto al género, no existen diferencias. Los estudios sobre ambliopía no estrábica son escasos a nivel regional o mundial sobre este tema, por lo que el presente análisis es relevante en esta área de conocimiento. Además, la información presentada aporta a visibilizar la necesidad de promover la realización de exámenes que permitan un diagnóstico y tratamiento adecuados y oportunos.

Amblyopia is one of the alterations that causes the greatest impact and is frequent in the loss of visual acuity, mainly in children; its prevalence varies between 2% and 7%. On the other hand, it is the first cause of vision impairment in adults. Objective. To analyze the prevalence of non-strabismic amblyopia in different age groups in Latin America. Methodology. A systematic review of studies conducted within the period 2014 to 2021 was performed in databases such as: Redalyc, Scielo, Medilib, Dialnet and Google Scholar. The analysis of five relevant studies in Colombia, Ecuador, Nicaragua, Chile and Cuba is presented. Conclusion. In the Cuban study, amblyopia was found in 1.39%; in Colombia, 8.10%; in Ecuador, 5.30%; in Nicaragua, 2.9%; in Chile the incidence was 2.41%, 2.55% and 3.51%, respectively for the age groups 18-38 years, 39-59 years and 60-79 years. Thus, Colombia is the country with the highest incidence of amblyopia (8.10%), and Cuba the lowest with 1.39%. In addition, refractive amblyopia is the most common in the studies and as for gender, there are no differences. Studies on non-strabismic amblyopia are scarce at regional or world level on this subject, so the present analysis is relevant in this area of knowledge. In addition, the information presented contributes to make visible the need to promote examinations that allow an adequate and timely diagnosis and treatment.

A ambliopia é um dos distúrbios que causa maior impacto e é frequente na perda da acuidade visual, principalmente em crianças; sua prevalência varia entre 2% e 7%. Por outro lado, é a principal causa de deficiência visual em adultos. Objetivo. Analisar a prevalência da ambliopia não-estrabismo em diferentes faixas etárias na América Latina. Metodologia. Foi realizada uma revisão sistemática de estudos realizados entre 2014 e 2021 em bancos de dados como: Redalyc, Scielo, Medilib, Dialnet e Google Scholar. É apresentada a análise de cinco estudos relevantes na Colômbia, Equador, Nicarágua, Chile e Cuba. Conclusões. No estudo cubano, a ambliopia foi encontrada em 1,39%; na Colômbia, em 8,10%; no Equador, em 5,30%; na Nicarágua, em 2,9%; no Chile, a incidência foi de 2,41%, 2,55% e 3,51%, respectivamente, nas faixas etárias de 18 a 38 anos, 39 a 59 anos e 60 a 79 anos. Assim, a Colômbia é o país onde foi encontrada a maior incidência de ambliopia (8,10%), e Cuba a menor, com 1,39%. Além disso, a ambliopia refrativa é a mais comum nos estudos e não há diferenças em termos de gênero. Estudos sobre ambliopia não-estrabismo são escassos em nível regional ou global sobre esse tópico, portanto, a presente análise é relevante nessa área de conhecimento. Além disso, as informações apresentadas ajudam a tornar visível a necessidade de promover exames que permitam o diagnóstico e o tratamento adequados e oportunos.

Three siblings with variable degrees of neuromuscular involvement and congenital sideroblastic anemia: A peculiar phenotype and a surprise genotypic explanation.

INTRODUCTION: Congenital sideroblastic anemias (CSAs) are a group of inherited bone-marrow disorders manifesting with erythroid hyperplasia and ineffective erythropoiesis. METHODS: We describe a detailed clinical and genetic characterization of three siblings with CSA. RESULTS: Two of them had limb-girdle myopathy and global developmental delay. The two elder siblings performed allogenic hematopoietic stem-cell transplantation 5 and 3 years prior with stabilization of the hematological features. Exome sequencing in the non-transplanted sibling revealed a novel homozygous nonsense variant in SLC25A38 gene NM_017875.2:c.559C > T; p.(Arg187*) causing autosomal-recessive sideroblastic anemia type-2, and a second homozygous pathogenic previously reported variant in GMPPB gene NM_013334.3:c.458C > T; p.(Thr153Ile) causing autosomal-recessive muscular dystrophy-dystroglycanopathy type B14. With the established diagnosis, hematopoietic stem cell transplantation is now being scheduled for the youngest sibling, and a trial therapy with acetylcholine esterase inhibitors was started for the two neurologically affected patients with partial clinical improvement. CONCLUSION: This family emphasizes the importance of whole-exome sequencing for familial cases with complex phenotypes and vague neurological manifestations.

Examination of Outcome Disparities in Reports of Prepectoral and Subpectoral Direct-to-Implant Reconstruction: A Systematic Review and Meta-analysis.

BACKGROUND: There are mixed results in surgical complications regarding the usage of prepectoral versus subpectoral implant placement in direct-to-implant breast reconstruction. This study aimed to provide a comprehensive synthesis of surgical complications between the subpectoral and prepectoral reconstructive method. METHODS: PubMed, Embase, and Cochrane were searched for literature published up until December 2022. Studies that compared subpectoral and prepectoral breast reconstruction and reported at least one postoperative complication were included. The following 8 major outcomes were included: revision and reoperation, capsular contracture, explantation, seroma, hematoma, infection, skin necrosis, and animation deformity. Systematic review and meta-analysis were performed to compare outcomes of the 2 techniques. Subgroup analysis was performed to compare whether practice differences in different countries may have an impact on outcomes. RESULTS: A total of 18 studies were identified in our literature search. Two thousand three hundred sixty patients were included, representing a total of 3135 breasts. Our analysis demonstrated that prepectoral reconstruction had significantly lower odds of developing postoperative hematoma [odds ratio (OR), 0.62; P = 0.05], seroma (OR, 0.67; P = 0.01), infection (OR, 0.64; P = 0.03), revision and reoperation (OR, 0.44; P < 0.00001), and animation deformity (OR, 0.01; P < 0.00001), compared with the subpectoral method. Subgroup analysis showed that differences between 3 countries (United States, Korea, Italy) are low (all subgroup heterogeneity test P > 0.1). CONCLUSIONS: While both subpectoral and prepectoral are safe methods for breast reconstruction, the prepectoral technique may lead to lower odds of developing multiple major postoperative complications.

Neoadjuvant Therapy in Melanoma: Where Are We Now?

PURPOSEOF REVIEW: This review summarizes the current state of neoadjuvant immunotherapy and targeted therapy for locoregionally advanced melanoma. RECENT FINDINGS: Melanoma systemic therapy has witnessed major advances with the development of immune checkpoint inhibitors and molecularly targeted therapy that have been translated into the neoadjuvant setting in managing locoregionally advanced disease. PD1 blockade as monotherapy and combined with CTLA4 blockade or LAG3 inhibition has demonstrated major improvements in reducing the risk of relapse and death that were associated with high pathologic response rates. Similar results were reported with BRAF-MEK inhibition for BRAF mutant melanoma with high pathologic response rates that appear to be less durable compared to immunotherapy. More importantly, in a recent randomized trial, event-free survival was significantly improved with neoadjuvant pembrolizumab compared to standard surgery and adjuvant therapy. Neoadjuvant therapy has become the standard of care for locoregionally advanced melanoma. Ongoing studies will define the most optimal combination regimens.

Enhanced immune activation within the tumor microenvironment and circulation of female high-risk melanoma patients and improved survival with adjuvant CTLA4 blockade compared to males.

BACKGROUND: We hypothesized that a gender difference in clinical response may exist to adjuvant CTLA4 blockade with ipilimumab versus high-dose IFNα (HDI). We investigated differences in candidate immune biomarkers in the circulation and tumor microenvironment (TME). PATIENTS AND METHODS: This gender-based analysis was nested within the E1609 trial that tested adjuvant therapy with ipilimumab 3 mg/kg (ipi3) and 10 mg/kg (ipi10) versus HDI in high risk resected melanoma. We investigated gender differences in treatment efficacy with ipi3 and ipi10 versus HDI while adjusting for age, stage, ECOG performance (PS), ulceration, primary tumor status and lymph node number. Forest plots were created to compare overall survival (OS) and relapse free survival (RFS) between ipi and HDI. Gene expression profiling (GEP) was performed on tumors of 718 (454 male, 264 female) patients. Similarly, serum and peripheral blood mononuclear cells (PBMC) samples were tested for soluble and cellular biomarkers (N = 321 patients; 109 female and 212 male). RESULTS: The subgroups of female, stage IIIC, PS = 1, ulcerated primary, in-transit metastasis demonstrated significant improvement in RFS and/or OS with ipi3 versus HDI. Female gender was significant for both OS and RFS and was further explored. In the RFS comparison, a multivariate Cox regression model including significant variables indicated a significant interaction between gender and treatment (P = 0.024). In peripheral blood, percentages of CD3+ T cells (P = 0.024) and CD3+ CD4+ helper T cells (P = 0.0001) were higher in females compared to males. Trends toward higher circulating levels of IL1ß (P = 0.07) and IL6 (P = 0.06) were also found in females. Males had higher percentages of monocytes (P = 0.03) with trends toward higher percentages of regulatory T cells (T-reg). Tumor GEP analysis supported enhanced infiltration with immune cells including gammadelta T cells (P = 0.005), NK cells (P = 0.01), dendritic cells (P = 0.01), CD4+ T cells (P = 0.03), CD8+ T cells (P = 0.03) and T-reg (P = 0.008) in the tumors of females compared to males and a higher T-effector and IFNγ gene signature score (P = 0.0244). CONCLUSION: Female gender was associated with adjuvant CTLA4 blockade clinical benefits and female patients were more likely to have evidence of type1 immune activation within the TME and the circulation. Trial registration ClinicalTrials.gov NCT01274338. Registered 11 January 2011, https://www. CLINICALTRIALS: gov/ct2/show/NCT01274338.