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        Predictive factors of surgical complications after pelvic exenteration for gynecological malignancies: a large single-institution experience

        Lucia Tortorella,Cintoni Marco,Matteo Loverro,Conte Carmine,Nicolò Bizzarri,Costantini Barbara,Santullo Francesco,Nazario Foschi,Valerio Gallotta,Giacomo Avesani 대한부인종양학회 2024 Journal of Gynecologic Oncology Vol.35 No.1

        Objective: To evaluate pre-operative predictors of early (<30 days) severe complications (gradeDindo 3+) in patients with gynecological malignancy submitted to pelvic exenteration (PE). Methods: We retrospectively analyzed 129 patients submitted to surger y at FondazionePoliclinico Gemelli between 2010 and 2019. We included patients affected by primar yor recurrent/persistent cer vical, endometrial, or vulvar/vaginal cancers. Post-operativecomplications were graded according to the Dindo classification. Logistic regression wasused to analyze potential predictors of complications. Results: We performed 63 anterior PE, 10 posterior PE, and 56 total PE. The incidence ofearly severe post-operative complications was 27.9% (n=36), and the early mortality rate was2.3% (n=3). More frequent complications were related to the urinar y diversion and intestinalsurger y. In univariable analysis, hemoglobin ≤10 g/dL (odds ratio [OR]=4.2; 95% confidenceinter val [CI]=1.65–10.7; p=0.003), low albumin levels (OR=3.9; 95% CI=1.27–12.11; p=0.025),diabetes (OR=4.15; 95% CI=1.22–14.1; p=0.022), 2+ comorbidities at presentation (OR=5.18;95% CI=1.49–17.93; p=0.012) were predictors of early severe complications. In multivariableanalysis, only low hemoglobin and comorbidities at presentation were independent predictors of complications. Conclusion: Pelvic exenteration is an aggressive surger y characterized by a high rate of post-operative complications. Pre-operative assessment of comorbidities and patient health statusare crucial to better select the right candidate for this type of surgery.

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        One-year antibody persistence and safety of a 4-dose schedule of MenACWY-CRM in healthy infants from South Korea

        이환종,조대선,김윤경,이현주,김경효,이도경,Carlo Curina,Marco Costantini,Silvia Barbi,Yan Miao,Michele Pellegrini 대한백신학회 2019 Clinical and Experimental Vaccine Research Vol.8 No.2

        Purpose: Results from a post-marketing study to generate evidence on 1-year antibody persistence and safety following vaccination of infants from South Korea with the quadrivalent meningococcal conjugate vaccine MenACWY-CRM. Materials and Methods: In this phase IV, open-label, multi-center study (NCT02446691), 128 infants received MenACWY-CRM at ages 2, 4, 6, and 12 months. One-year antibody persistence following the full vaccination course was evaluated (primary objective) for the four meningococcal serogroups (Men) by serum bactericidal activity assay using human or rabbit complement (hSBA/rSBA). Immune responses at 1-month post-vaccination and safety were also assessed. Results: The percentage of children with hSBA titers ≥8 ranged between 94% (MenA) and 100% (MenY/W) 1-month post-vaccination, and from 39% (MenA) to 89% (MenY) 1-year post-vaccination. At least 99% and 92% of children had rSBA titers ≥8 and ≥128 against each meningococcal serogroup, 1-month post-vaccination. One-year post-vaccination, the percentage of children with rSBA titers ≥8 and ≥128 ranged from 54% (MenC) to 99% (MenA) and from 30% (MenC) to 98% (MenA). Geometric mean titers declined from 1-month to 1-year post-vaccination, when they varied between 6.8 (MenA) and 53.6 (MenW) by hSBA and between 17.2 (MenC) and 2,269.5 (MenA) by rSBA. At least one solicited and unsolicited adverse event was reported for 79% and 66% of children. Of 36 serious adverse events reported, none were vaccination-related. Conclusion: Antibody persistence (hSBA/rSBA titers ≥8) was determined in 39%-99% of children 1 year after a 4-dose MenACWY-CRM series during infancy, with an acceptable clinical safety profile.

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