Publications by authors named "Alessandra Spagnoli"

35 Publications

Assessment of a new score for capsule endoscopy in pediatric Crohn's disease (CE-CD).

Endosc Int Open 2021 Oct 16;9(10):E1480-E1490. Epub 2021 Sep 16.

Children's Center for Digestive Health Care, Children's Healthcare of Atlanta, and Emory University, Atlanta, Georgia, United States.

Two scores have been implemented to standardize capsule endoscopic (CE) findings in patients with Crohn's disease (CD): Lewis score (LS) and Capsule Endoscopy Crohn's Disease Activity Index (CECDAI). Both have limitations and are not well validated in the pediatric population. The aim of our study was to assess a new score (capsule endoscopy - Crohn's disease index, CE-CD) in pediatric patients with CD and to compare it to preexisting scores. This was a double-center, retrospective study involving pediatric subjects with CD who underwent CE. Correlation analyses between CE-CD, endoscopy scores and noninvasive markers of disease activities were performed. The ability of different CE scores to predict clinical and endoscopic outcomes was evaluated with regression and survival analyses. A total of 312 subjects were analyzed. The CE-CD score showed a moderate (Pearson's r = 0.581,  < 0.001) and strong (r = 0.909,  < 0.001) association with LS and CECDAI, respectively. CE-CD was a statistically significant predictor of hospitalization (hazard ratio [HR]1.061), treatment escalation (HR 1.062), steroid therapy (HR 1.082), clinical (HR 1.064) and endoscopic (HR 1.060) relapse over the twenty-four months (  < 0.001). Subjects with mucosal inflammation according to CE-CD (CE-CD ≥ 9) had worse outcomes compared to patients without inflammation (CE-CD < 9) (Log rang test < 0.001). The CE-CD score is a simple, reliable, reproducible, and predictive score for evaluation of small bowel inflammation in pediatric patients with CD. Prospective validation is needed to confirm the applicability of this new index in clinical practice.
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http://dx.doi.org/10.1055/a-1522-8723DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8445685PMC
October 2021

Low serum magnesium concentration is associated with the presence of viable hepatocellular carcinoma tissue in cirrhotic patients.

Sci Rep 2021 07 26;11(1):15184. Epub 2021 Jul 26.

Department of Translational and Precision Medicine, Sapienza University of Rome, Viale dell'Università 37, 00185, Rome, Italy.

This study aimed to ascertain, for the first time, whether serum magnesium (Mg) concentration is affected by the presence of hepatocellular carcinoma (HCC). We retrospectively enrolled consecutive cirrhotic patients with a diagnosis of HCC (n = 130) or without subsequent evidence of HCC during surveillance (n = 161). Serum levels of Mg were significantly (P < 0.001) lower in patients with HCC than in those without (median [interquartile range]: 1.80 [1.62-1.90] mg/dl vs. 1.90 [1.72-2.08] mg/dl). On multivariate logistic regression, low serum Mg was associated with the presence of HCC (OR 0.047, 95% CI 0.015-0.164; P < 0.0001), independently from factors that can influence magnesaemia and HCC development. In a subset of 94 patients with HCC, a linear mixed effects model adjusted for confounders showed that serum Mg at diagnosis of HCC was lower than before diagnosis of the tumor (β = 0.117, 95% CI 0.039-0.194, P = 0.0035) and compared to after locoregional treatment of HCC (β = 0.079, 95% CI 0.010-0.149, P = 0.0259), with two thirds of patients experiencing these changes of serum Mg over time. We hypothesize that most HCCs, like other cancers, may be avid for Mg and behave like a Mg trap, disturbing the body's Mg balance and resulting in lowering of serum Mg levels.
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http://dx.doi.org/10.1038/s41598-021-94509-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8313704PMC
July 2021

Risk of falls in patients with cirrhosis evaluated by timed up and go test: Does muscle or brain matter more?

Dig Liver Dis 2021 Jul 4. Epub 2021 Jul 4.

Department of Public Health and Infectious Diseases, "Sapienza" University of Rome, Rome 00185, Italy.

Background: Minimal hepatic encephalopathy (MHE) is considered a risk factor for falls in patients with liver cirrhosis. However, MHE is prevalent in patients with muscle alterations (sarcopenia and myosteatosis) probably due to the role of muscle in ammonia handling.

Aim: To assess the respective role of muscle alterations and MHE on the risk of falls in cirrhotic patients.

Methods: Fifty cirrhotics were studied for MHE detection by using Psychometric Hepatic Encephalopathy Score (PHES) and Animal Naming Test (ANT). CT scan was used to quantify the skeletal muscle index (SMI) and muscle attenuation, as a measure of myosteatosis. The risk of falls was evaluated by the Timed Up&Go test (TUG). The occurrence of falls during follow up was also detected.

Results: 32 patients (64%) had an abnormal TUG (< 14 s). In the group with TUG ≥ 14 s, MHE (72vs31%, p<0.005) and myosteatosis (94vs50%, p = 0.002) were significantly more frequent than in patients with TUG<14 s. At multivariate the variables independently associated to TUG ≥ 14 s were myosteatosis, MHE and chronic beta-blockers use. During a mean follow-up of 25±16.9 months, 12 patients fell; the percentage of falls was significantly higher in patients with TUG ≥ 14 s (50%vs9%, p = 0.001) as well as in patients with myosteatosis (33%vs6%, p = 0.03), but similar in patients with or without MHE (35%vs15%, NS).

Conclusion: In cirrhotic patients both muscle alterations and cognitive impairment, as well as chronic beta-blockers use, are associated to the risk of falls.
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http://dx.doi.org/10.1016/j.dld.2021.06.019DOI Listing
July 2021

Risks and Protective Factors Associated With Mental Health Symptoms During COVID-19 Home Confinement in Italian Children and Adolescents: The #Understandingkids Study.

Front Pediatr 2021 11;9:664702. Epub 2021 Jun 11.

Department of Human Neuroscience, Sapienza - University of Rome, Rome, Italy.

To identify risk and protective factors for mental health symptoms associated with lifestyle changes caused by home confinement in pediatric subjects and in children and adolescents with a neuropsychiatric disorder. This was a prospective, cross-sectional study conducted from May 10 to May 31, 2020. Two online anonymous surveys were developed: population-based and clinical-based (children with neuropsychiatric disorders). Outcomes included emotional and behavioral symptoms, as assessed by psychometric scales (BPSC, PPSC, PSC, CES-DC and SCARED, respectively), and lifestyle changes during home confinement (i.e., physical activity, screen time, home schooling, reading). The sample included 9,688 pediatric subjects, and 289 children and adolescents with a neuropsychiatric disorder. The presence of siblings was a protective factor in all ages. In pre- and school children: male sex, a diagnosis of autism, residency in highly affected areas, high parental educational level or job loss, and screen time (>2 h/day) were risk factors. Physical activity, home-schooling, reading, talking with other people were protective factors. Residency in highly affected areas, a diagnosis of mood disorder, parental job loss, and screen time, were associated with a worsening of the depressive symptoms, whereas physical activity, talking with other people, playing with parents were protective activities. Screen time was also a risk factor for anxiety symptoms, while physical activity, reading and talking with other people were protective factors. This study identified risk and protective factors for mental health symptoms associated with lifestyle changes caused by COVID-19 home confinement to promote mental well-being in pediatrics during pandemic times.
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http://dx.doi.org/10.3389/fped.2021.664702DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8225997PMC
June 2021

Ultrasonography Tight Control and Monitoring in Crohn's Disease During Different Biological Therapies: A Multicenter Study.

Clin Gastroenterol Hepatol 2021 Mar 26. Epub 2021 Mar 26.

Gastroenterology, Department of Clinical Medicine and Surgery, Federico II, School of Medicine, Naples.

Background & Aims: Bowel ultrasonography (BUS) is a noninvasive tool for evaluating bowel activity in Crohn's disease (CD) patients. Aim of our multicenter study was to assess whether BUS helps to monitor intestinal activity improvement/resolution following different biological therapies.

Methods: Adult CD patients were prospectively enrolled at 16 sites in Italy. Changes in BUS parameters [i.e. bowel wall thickening (BWT), lesion length, echo pattern, blood flow changes and transmural healing (TH: normalization of all BUS parameters)] were analyzed at baseline and after 3, 6 and 12 months of different biological therapies.

Results: One hundred eighty-eight out of 201 CD patients were enrolled and analyzed (116 males [62%]; median age 36 years). Fifty-five percent of patients were treated with adalimumab, 16% with infliximab, 13% with vedolizumab and 16% with ustekinumab. TH rates at 12 months were 27.5% with an NNT of 3.6. TH at 12 months after adalimumab was 26.8%, 37% after infliximab, 27.2% after vedolizumab and 20% after ustekinumab. Mean BWT improvement from baseline was statistically significant at 3 and 12 months (P < .0001). Median Harvey-Bradshaw index, C-reactive protein and fecal calprotectin decreased after 12 months from baseline (P < .0001). Logistic regression analysis showed colonic lesion was associated with a higher risk of TH at 3 months and a greater BWT at baseline was associated with a lower risk of TH at 3 months [P = .03 (OR 0.70, 95% CI 0.50-0.97)] and 12 months [P = .01 (OR 0.58, 95% CI 0.38-0.89)]. At 3 months therapy optimization during the study was the only independent factor associated with a higher risk of no ultrasonographic response [P = .02 (OR 3.34, 95% CI 1.18-9.47)] and at 12 months disease duration [P = .02 (OR 3.03, 95% CI 1.15-7.94)].

Conclusions: Data indicate that BUS is useful to monitor biologics-induced bowel activity improvement/resolution in CD.
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http://dx.doi.org/10.1016/j.cgh.2021.03.030DOI Listing
March 2021

Relevance of Spontaneous Portosystemic Shunts Detected with CT in Patients with Cirrhosis.

Radiology 2021 04 2;299(1):133-140. Epub 2021 Feb 2.

From the Department of Translational and Precision Medicine (S.N., O.R., S. Gioia, M.P., L.R., F.A.), Department of Radiological Sciences, Oncology, and Anatomical Pathology (M.D.M.), and Department of Public Health and Infectious Diseases (A.S., A.D.R.), Sapienza University of Rome, Viale dell'Università 37, 00161 Rome, Italy; Departments of Gastroenterology (L.T., M.B., S. Gitto, F.S.) and Radiology (G.M., C.C.), University of Modena and Reggio Emilia, Modena, Italy; Department of Interventional Radiology, Santa Maria Goretti Hospital, Latina, Italy (G.P.); and Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy (S. Gitto).

Background Cirrhosis leads to portal hypertension and to the consequent formation of spontaneous portosystemic shunts (SPSSs), leading to complications related to the diversion of portal blood into the systemic circulation, which is called portosystemic shunt syndrome. Purpose To investigate the characteristics of patients with cirrhosis and an SPSS and secondarily to assess the prognostic impact of SPSSs on portal hypertension-related complications and transplant-free survival. Materials and Methods A retrospective database review of patients with cirrhosis (observed from March 2015 to July 2019) was performed to identify patients with CT imaging and outcomes data. For each patient, clinical and biochemical data were collected, and the presence, types, and sizes of SPSSs were investigated with CT. Patients were followed for a mean of 27.5 months ± 22.8. Multivariable logistic analysis was used to identify the clinical characteristics associated with the presence of SPSSs (any size) and presence of SPSSs 1 cm or larger. Competitive risk analysis (Fine and Gray model) was used to identify the association between SPSSs and complications and mortality. Results Two hundred twenty-two patients with cirrhosis (157 male, 65 female; mean age, 62 years ± 12 [standard deviation]) were evaluated. An SPSS was found in 141 of 222 patients (63.5%), and 40 of 222 (18%) had a shunt diameter of at least 1 cm. At presentation, variables independently associated with the presence of SPSSs (any size) were portal vein thrombosis (odds ratio, 5.5; = .008) and Child-Pugh class C (odds ratio, 3.0; = .03). Previous hepatic encephalopathy (odds ratio, 4.4; = .001) and portal vein thrombosis (odds ratio, 5.3; = .001) were the only variables associated with SPSSs larger than 1 cm. Patients with SPSSs of any size had higher mortality (subdistribution hazard ratio, 1.9; < .001) and higher frequency of hepatic encephalopathy (subdistribution hazard ratio, 2.3; = .023), gastrointestinal bleeding (subdistribution hazard ratio, 2.9; = .039), and portal vein thrombosis (subdistribution hazard ratio, 7.6; = .005). Conclusion The presence of spontaneous portosystemic shunts on CT images in patients with cirrhosis was associated with higher mortality and complications, including portal vein thrombosis, hepatic encephalopathy, and gastrointestinal bleeding. © RSNA, 2021 See also the editorial by Reeder in this issue.
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http://dx.doi.org/10.1148/radiol.2021203051DOI Listing
April 2021

Association of Sarcopenia and Body Composition With Short-term Outcomes After Liver Resection for Malignant Tumors.

JAMA Surg 2020 11 18;155(11):e203336. Epub 2020 Nov 18.

Department of General Surgery and Liver Transplantation, San Camillo Forlanini Hospital, Rome, Italy.

Importance: Previous retrospective studies have shown that sarcopenia substantially alters the postoperative and oncological outcomes after liver resection for malignant tumors. However, the evidence is limited to small retrospective studies with heterogeneous results and the lack of standardized measurements of sarcopenia.

Objective: To investigate the role of sarcopenia as a risk factor associated with 90-day morbidity after liver resection for malignant tumors.

Design, Setting, And Participants: This cohort study included 234 consecutive patients undergoing liver resection for malignant tumors at San Camillo Forlanini Hospital, Rome, Italy, between June 1, 2018, and December 15, 2019. Muscle mass and strength were assessed using the skeletal muscle index (SMI) on preoperative computed tomographic scans and the handgrip strength test, respectively. Patients were then divided into the following 4 groups: group A (normal muscle mass and strength), group B (reduced muscle strength), group C (reduced muscle mass), and group D (reduced muscle mass and strength).

Main Outcomes And Measures: The primary outcome of the study was 90-day morbidity. The following secondary outcomes were investigated: 90-day mortality, hospital stay, and readmission rate.

Results: Sixty-four major and 170 minor hepatectomies were performed in 234 patients (median age, 66.50 [interquartile range, 58.00-74.25] years; 158 men [67.5%]). The median SMI of the entire population was 46.22 (interquartile range, 38.60-58.20) cm/m2. The median handgrip strength was 30.80 (interquartile range, 22.30-36.90) kg. Patients in group D had a statistically significantly higher rate of 90-day morbidity than patients in the other groups (51.5% [35 of 68] vs 38.7% [29 of 75] in group C, 23.1% [3 of 13] in group B, and 6.4% [5 of 78] in group A; P < .001). Compared with patients in the other groups, those in group D had a longer hospital stay (10 days vs 8 days in group C, 9 days in group B, and 6 days in group A; P < .001), and more patients in this group were readmitted to the hospital (8.8% [6 of 68] vs 5.3% [4 of 75] in group C, 7.7% [1 of 13] in group B, and 0% [0 of 78] in group A; P = .02). Sarcopenia, portal hypertension, liver cirrhosis, and biliary reconstruction were independent risk factors associated with 90-day morbidity.

Conclusions And Relevance: Sarcopenia appears to be associated with adverse outcomes after liver resection for malignant tumors. Both muscle mass measurements on computed tomographic scans and muscle strength assessments with the handgrip strength test should be performed at the first clinical encounter to better classify patients and to minimize the risk of morbidity.
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http://dx.doi.org/10.1001/jamasurg.2020.3336DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7512123PMC
November 2020

The Crucial Role of Surgical Treatment in BIA-ALCL Prognosis in Early- and Advanced-Stage Patients.

Plast Reconstr Surg 2020 11;146(5):530e-538e

From the Directorate General of Medical Devices and Pharmaceutical Services, Medical Device Vigilance System and Inspections, and the Directorate General of Digitalization, Health Informative System and Statistics, Italian Ministry of Health; and the Department of Public Health and Infectious Diseases, Sapienza University of Rome.

Background: Studies on breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) are trying to optimize medical and surgical treatments for early and advanced stages of this disease. The aim of this article is to share the experience gathered on the authors' prospectively collected 46 well-documented cases.

Methods: Italian physicians are obliged to report BIA-ALCL cases to the Italian Ministry of Health. Because of this cooperation with health care professionals, the competent authority has coordinated and centralized the collection of information for each patient in 46 cases of BIA-ALCL. Statistical analyses with cumulative incidence and corresponding 95 percent confidence interval are provided for each year, dividing the number of new cases that occurred in a defined year and the population at risk of experiencing BIA-ALCL during the same year.

Results: The mean time to the onset of symptoms is reduced to 6.4 ± 3.77 years (range, 1 to 22 years). Increased knowledge has also shortened the average time to diagnosis, at 7.2 ± 3.71 years (range, 2 to 22 years). A late seroma appears in 91 percent of cases. The patient who died underwent limited surgery. The Italian incidence has been estimated as 2.8 per 100,000 patients receiving implants (95 percent CI, 0.88 to 4.84) in 2015; 2.1 (95 percent CI, 0.43 to 3.86) in 2016; 3.2 (95 percent CI, 1.11 to 5.31) in 2017; and 3.5 (95 percent CI, 1.36 to 5.78) in 2018.

Conclusion: Although the number of cases has risen slightly, BIA-ALCL is still a rare disease with a stable incidence, easily recognized and with a favorable prognosis also in advanced stages if complete surgical excision is performed.
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http://dx.doi.org/10.1097/PRS.0000000000007240DOI Listing
November 2020

Association Between Metabolic and Hormonal Derangements and Professional Exposure to Urban Pollution in a High Intensity Traffic Area.

Front Endocrinol (Lausanne) 2020 11;11:509. Epub 2020 Aug 11.

Institute of Translational Pharmacology, CNR, Rome, Italy.

Studies suggest a relation between exposure to air particulate matter (PM) pollution and greater cardiovascular morbidity, as well as increased risk for obesity and diabetes. We aimed to identify association(s) between nutritional and metabolic status and exposure to environmental pollution in a cohort of policemen exposed to high levels of air pollution. We considered adult municipal policemen, working in an urban area at high-traffic density with documented high levels of air PM (exposed group) compared to non-exposed policemen. Clinical characteristics, including the presence/absence of metabolic syndrome, were recorded, and serum biomarkers, including adiponectin, leptin, and ghrelin, were assessed. One hundred ninety-nine participants were enrolled, 100 in the exposed group and 99 in the non-exposed group. Metabolic syndrome was documented in 32% of exposed group and in 52.5% of non-exposed group ( = 0.008). In the exposed group, we found a positive correlation between body mass index and serum leptin as well as in the non-exposed group ( < 0.0001). Within the exposed group, subjects with metabolic syndrome showed lower serum adiponectin ( < 0.0001) and higher leptin ( = 0.002) levels with respect to those without metabolic syndrome, whereas in the non-exposed group, subjects with metabolic syndrome showed only higher leptin levels when compared to those without metabolic syndrome ( = 0.01). Among the participants with metabolic syndrome, we found lower adiponectin levels in those of the exposed group with respect to the non-exposed ones ( = 0.007). When comparing the exposed and non-exposed groups, after stratifying participants for Homeostatic Model Assessment for Insulin Resistance >2.5, we found lower adiponectin levels in those of the exposed group with respect to the non-exposed ones ( = 0.038). Exposure to air PM pollution was associated with lower levels of adiponectin in adult males with metabolic syndrome.
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http://dx.doi.org/10.3389/fendo.2020.00509DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7431614PMC
June 2021

Association Between Metabolic and Hormonal Derangements and Professional Exposure to Urban Pollution in a High Intensity Traffic Area.

Front Endocrinol (Lausanne) 2020 11;11:509. Epub 2020 Aug 11.

Institute of Translational Pharmacology, CNR, Rome, Italy.

Studies suggest a relation between exposure to air particulate matter (PM) pollution and greater cardiovascular morbidity, as well as increased risk for obesity and diabetes. We aimed to identify association(s) between nutritional and metabolic status and exposure to environmental pollution in a cohort of policemen exposed to high levels of air pollution. We considered adult municipal policemen, working in an urban area at high-traffic density with documented high levels of air PM (exposed group) compared to non-exposed policemen. Clinical characteristics, including the presence/absence of metabolic syndrome, were recorded, and serum biomarkers, including adiponectin, leptin, and ghrelin, were assessed. One hundred ninety-nine participants were enrolled, 100 in the exposed group and 99 in the non-exposed group. Metabolic syndrome was documented in 32% of exposed group and in 52.5% of non-exposed group ( = 0.008). In the exposed group, we found a positive correlation between body mass index and serum leptin as well as in the non-exposed group ( < 0.0001). Within the exposed group, subjects with metabolic syndrome showed lower serum adiponectin ( < 0.0001) and higher leptin ( = 0.002) levels with respect to those without metabolic syndrome, whereas in the non-exposed group, subjects with metabolic syndrome showed only higher leptin levels when compared to those without metabolic syndrome ( = 0.01). Among the participants with metabolic syndrome, we found lower adiponectin levels in those of the exposed group with respect to the non-exposed ones ( = 0.007). When comparing the exposed and non-exposed groups, after stratifying participants for Homeostatic Model Assessment for Insulin Resistance >2.5, we found lower adiponectin levels in those of the exposed group with respect to the non-exposed ones ( = 0.038). Exposure to air PM pollution was associated with lower levels of adiponectin in adult males with metabolic syndrome.
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http://dx.doi.org/10.3389/fendo.2020.00509DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7431614PMC
June 2021

Hiatal Surface Area's CT scan measurement is useful in hiatal hernia's treatment of bariatric patients.

Minim Invasive Ther Allied Technol 2021 Apr 31;30(2):86-93. Epub 2019 Oct 31.

Department of General Surgery and Bariatric Center of Excellence IFSO-EC, University La Sapienza of Rome, Latina, Italy.

Introduction: Hiatal surface area (HSA) measurement has been recently proposed as useful tool for tailored treatment of hiatal defects. Multidetector CT scan (MDCT) of the hiatal area was shown to be useful in hiatal hernia (HH) management.

Purpose: MDCT preoperative HSA measurements validation as a useful method in the surgical repair decision making process of hiatal defects in candidates to antireflux ± bariatric surgery.

Material And Methods: Twenty-five obese patients (group A), candidates to laparoscopic cruroplasty ± bariatric surgery, were prospectively evaluated preoperatively and after one year, using an original MDCT algorithm, compared with intraoperative HSA measurement. Twelve non-obese (group B) and 12 obese patients (group C), without GERD or HH, were used as control groups.

Results: Median preoperative HSA was 7.9 cm, (interquartile IQR 5.97-9.80) while intraoperative median HSA was 6 cm (6-9.5),  = .84. Postoperative median HSA was 3.8 cm (3.21-4.8), showing the efficacy of cruroplasty, comparable with HSA calculated in the control groups (3.98 for B and 3.69 cm for C,  = .8547). No statistically significant difference between MDCT preoperative measurement and intraoperative findings was observed.

Conclusions: Preliminary results demonstrate MDCT scan HSA measurements as a valid, non-invasive method to predict intraoperative findings. It allows the HSA monitoring in order to correlate the symptoms onset and failure of cruroplasty.
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http://dx.doi.org/10.1080/13645706.2019.1683033DOI Listing
April 2021

Upfront debulking surgery versus interval debulking surgery for advanced tubo-ovarian high-grade serous carcinoma and diffuse peritoneal metastases treated with peritonectomy procedures plus HIPEC.

J Surg Oncol 2019 Dec 17;120(7):1208-1219. Epub 2019 Sep 17.

Cytoreductive Surgery and HIPEC Unit, Department of Surgery "Pietro Valdoni", Sapienza University of Rome, Rome, Italy.

Background: Whether patients with advanced tubo-ovarian high-grade serous cancer (HGSC) fare better after upfront debulking surgery (UDS) or neoadjuvant chemotherapy with interval debulking surgery (NACT-IDS) remains controversial.

Methods: We studied patients with HGSC who underwent UDS or NACT-IDS between July 2000 and December 2015, with peritonectomy procedures combined with hyperthermic intraperitoneal chemotherapy (HIPEC). Clinical reports were included peritoneal cancer index (PCI), NACT responses, surgical complexity score (SCS), completeness of cytoreduction (CC), complete follow-up with timing, site, and treatment of recurrence. Outcome measures were morbidity, progression-free survival (PFS), PFS2, and overall survival during a mean 5-year follow-up.

Results: A total of 34 patients (23.6%) underwent UDS and 110 (76.4%) NACT-IDS both combined with HIPEC. At a median 66.3-month follow-up, patients who underwent UDS or NACT-IDS had similar outcomes. NACT subgroup responses correlated with PCI, SCS, morbidity, and CC. Patients who underwent UDS had lower recurrence rates than those who responded partly or poorly to NACT (PFS, P < .04; PFS2, P < .01). Despite HIPEC, the peritoneal disease recurred in 42.5% of the overall patients.

Conclusion: In patients with primary HGSC who undergo UDS or NACT-IDS, despite similar outcomes, peritonectomy procedures combined with HIPEC seem unable to prevent peritoneal recurrence.
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http://dx.doi.org/10.1002/jso.25703DOI Listing
December 2019

A Randomized Double-Blind, Cross-Over Trial of very Low-Calorie Diet in Overweight Migraine Patients: A Possible Role for Ketones?

Nutrients 2019 Jul 28;11(8). Epub 2019 Jul 28.

Department of Experimental Medicine, Sapienza University of Rome, 00161 Roma, Italy.

Here we aimed at determining the therapeutic effect of a very low-calorie diet in overweight episodic migraine patients during a weight-loss intervention in which subjects alternated randomly between a very low-calorie ketogenic diet (VLCKD) and a very low-calorie non-ketogenic diet (VLCnKD) each for one month. In a nutritional program, 35 overweight obese migraine sufferers were allocated blindly to 1-month successive VLCKD or VLCnKD in random order (VLCKD-VLCnKD or VLCnKD-VLCD). The primary outcome measure was the reduction of migraine days each month compared to a 1-month pre-diet baseline. Secondary outcome measures were 50% responder rate for migraine days, reduction of monthly migraine attacks, abortive drug intake and body mass index (BMI) change. Only data from the intention-to-treat cohort ( = 35) will be presented. Patients who dropped out ( = 6) were considered as treatment failures. Regarding the primary outcome, during the VLCKD patients experienced -3.73 (95% CI: -5.31, -2.15) migraine days respect to VLCnKD ( < 0.0001). The 50% responder rate for migraine days was 74.28% (26/35 patients) during the VLCKD period, but only 8.57% (3/35 patients) during VLCnKD. Migraine attacks decreased by -3.02 (95% CI: -4.15, -1.88) during VLCKD respect to VLCnKD ( < 0.00001). There were no differences in the change of acute anti-migraine drug consumption ( = 0.112) and BMI ( = 0.354) between the 2 diets. A VLCKD has a preventive effect in overweight episodic migraine patients that appears within 1 month, suggesting that ketogenesis may be a useful therapeutic strategy for migraines.
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http://dx.doi.org/10.3390/nu11081742DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6722531PMC
July 2019

Longitudinal Physical Activity Change During Hemodialysis and Its Association With Body Composition and Plasma BAIBA Levels.

Front Physiol 2019 25;10:805. Epub 2019 Jun 25.

Department of Translational and Precision Medicine, Sapienza University of Rome, Rome, Italy.

Low physical activity is frequent in end stage renal disease. We evaluated the longitudinal change in physical activity and its barriers in hemodialysis (HD) patients and the association between the patterns of physical activity change, body composition, and beta-aminoisobutyric acid (BAIBA), as circulating myokine. This is an observational study, where HD patients were considered in a 24-month follow-up. We assessed overtime the change of physical inactivity and its barriers by validated questionnaires, body composition by bioimpedance analysis, muscle strength by hand-dynamometer, and plasma BAIBA levels by liquid chromatography spectrometry. Parametric and non-parametric analyses were performed, as appropriate. Out of the 49 patients studied at baseline, 39 completed the first-year follow-up, and 29 completed the second year. At month 12, active patients had higher intracellular water (ICW) ( = 0.001) and cellular mass ( < 0.001), as well as at month 24 ( = 0.012, = 0.002; respectively) with respect to inactive. A significant reduction in ICW was shown at month 12 ( = 0.011) and month 24 ( = 0.014) in all patients. The barrier "reduced walking ability" was more frequent in inactive patients with respect to active at month 12 ( = 0.003) and at month 24 ( = 0.05). At month 24, plasma BAIBA levels were higher among active patients with respect to inactive ( = 0.043) and a correlation was seen between muscle strength and ICW ( = 0.51, = 0.005); normalizing BAIBA per body mass index, we found it lower with respect to baseline ( = 0.004), as well as after correcting per ICW ( = 0.001), as marker of muscle mass. A high prevalence of physical inactivity persisted during a 24-month follow-up in this cohort. We found an association between physical activity and a decline in marker of muscularity and reduced plasma BAIBA levels.
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http://dx.doi.org/10.3389/fphys.2019.00805DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6603089PMC
June 2019

DHA Oral Supplementation Modulates Serum Epoxydocosapentaenoic Acid (EDP) Levels in Breast Cancer Patients.

Oxid Med Cell Longev 2019 5;2019:1280987. Epub 2019 Mar 5.

Department of Translational and Precision Medicine, Sapienza University of Rome, v.le dell'Università 37, 00185 Rome, Italy.

Introduction: The omega-3 polyunsaturated fatty acids, as docosahexaenoic acid (DHA), are considered mediators regulating the resolution of inflammation during cancer and may be associated with better outcomes. Epoxydocosapentaenoic acids (EDPs), metabolites of the DHA, are hypothesized to be responsible for some beneficial effects. In the present study, we aimed to assess the circulating 19,20-EDP levels in breast cancer (BC) patients and in healthy controls before and after DHA oral supplementation and the potential differences in the DHA conversion in 19,20-EDPs between patients with different BC presentations.

Methods: BC patients and healthy controls were supplemented with DHA (algal oil) for 10 days (2 g/day). Blood samples were collected at baseline (T0) and after supplementation (T1) to assess EDP (19,20-EDP) serum levels by liquid chromatography spectrometry.

Results: 33 BC patients and 10 controls were studied. EDP values at T0 were not different between patients and controls. At T1, we found an increase in 19,20-EDP levels in BC patients ( < 0.00001) and in controls ( < 0.001), whereas no differences in 19,20-EDPs were present between the two groups; when considering the type of BC presentation, patients with BRCA1/2 mutation showed lower 19,20-EDPs levels with respect to BC patients without the mutation ( = 0.03). According to immunohistochemical subtype, luminal A-like BC patients showed at T1 higher 19,20-EDP levels compared to nonluminal A ( = 0.02).

Conclusions: DHA oral supplementation was associated with increased 19,20-EDP serum levels in BC patients, independent of the type of BC presentation, and in controls. Patients carrier of BRCA1/2 mutation seem to possess lower ability of DHA epoxidation, whereas luminal A-like BC patients showed higher EDP conversion. This behavior should be tested in a larger population.
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http://dx.doi.org/10.1155/2019/1280987DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6425377PMC
July 2019

Sarcopenia and cardiovascular risk indices in patients with chronic kidney disease on conservative and replacement therapy.

Nutrition 2019 06 11;62:108-114. Epub 2018 Dec 11.

Department of Translational and Precision Medicine, Sapienza University of Rome, Italy.

Objective: Chronic kidney disease (CKD) is a condition with high cardiovascular mortality associated with emerging risk factors, including sarcopenia. Several mechanisms can affect muscle mass, such as vitamin D deficiency, low protein intake, physical inactivity, metabolic acidosis, and inflammation leading to a worsening of cardiovascular outcomes and cognitive function. We aimed to evaluate the prevalence of sarcopenia in CKD patients on conservative and replacement therapy and the associations between sarcopenia and markers of atherosclerosis, endothelial dysfunction, psychological and cognitive function.

Methods: We enrolled CKD patients (stage 3/5 KDIGO [Kidney Disease: Improving Global Outcomes]) and hemodialysis, peritoneal dialysis, and post-kidney transplant patients. Clinical, laboratory and instrumental assessments, including bioimpedance analysis, hand-grip strength, intima media thickness, flow-mediated dilation, and epicardial adipose tissue, were performed in addition to analysis of psychological and cognitive status by the Montreal Cognitive Assessment, Mini-Mental State Examination, and Geriatric Depression Scale.

Results: A total of 77 patients (43 male) with a mean age of 69.6 ± 9.85 y were studied. According to validated criteria (using bioimpedance analysis and hand-grip strength), the prevalence of sarcopenia was 49.4%. Sarcopenic patients had higher values of intima media thickness (P = 0.032) and epicardial adipose tissue (P = 0.012) and lower flow-mediated dilation (P = 0.002), total cholesterol (P = 0.005), and high-density lipoprotein cholesterol (P = 0.008) with respect to non-sarcopenic patients. We found higher Geriatric Depression Scale scores (P = 0.04) in sarcopenic patients, whereas we did not find differences between the two groups in Mini-Mental State Examination and Montreal Cognitive Assessment score.

Conclusion: Sarcopenia is highly prevalent in CKD/end stage renal disease patients and is associated with changes in early systemic indices of atherosclerosis and endothelial dysfunction, known as markers of worse prognosis.
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http://dx.doi.org/10.1016/j.nut.2018.12.005DOI Listing
June 2019

A cross-sectional study investigating frequency and features of definitely diagnosed diabetic painful polyneuropathy.

Pain 2018 Dec;159(12):2658-2666

Department of Human Neuroscience, University Sapienza, Rome, Italy.

This cross-sectional multicentre study aimed at investigating frequency and features of painful diabetic polyneuropathy. We consecutively enrolled 816 patients attending hospital diabetic outpatient clinics. We first definitely diagnosed diabetic polyneuropathy and pure small-fibre polyneuropathy using clinical examination, nerve conduction study, and skin biopsy or quantitative sensory testing. Adhering to widely agreed criteria, we then identified neuropathic pain and diagnosed painful polyneuropathy using a combined approach of clinical examination and diagnostic tests. Of the 816 patients, 36% had a diabetic polyneuropathy associated with male sex, age, and diabetes severity; 2.5% of patients had a pure small-fibre polyneuropathy, unrelated to demographic variables and diabetes severity. Of the 816 patients, 115 (13%) suffered from a painful polyneuropathy, with female sex as the only risk factor for suffering from painful polyneuropathy. In this large study, providing a definite diagnosis of diabetic polyneuropathy and pure small-fibre polyneuropathy, we show the frequency of painful polyneuropathy and demonstrate that this difficult-to-treat complication is more common in women than in men.
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http://dx.doi.org/10.1097/j.pain.0000000000001378DOI Listing
December 2018

Learning Curve Under Proctorship of Pure Laparoscopic Living Donor Left Lateral Sectionectomy for Pediatric Transplantation.

Ann Surg 2020 03;271(3):542-548

Organ Transplant Center, King Faisal Specialist Hospital and Research Center, Riyadh, Kingdom of Saudi Arabia.

Objective: To evaluate the learning curve of an expert liver transplantation surgeon approaching fully laparoscopic living donor left lateral sectionectomy (L-LLS) under proctorship.

Background: Laparoscopic liver resections necessitate a long learning curve trough a stepwise fulfillment of difficulties. L-LLS requires expertise in both living donor liver transplantation and advanced laparoscopic liver surgery. There is currently no data about the learning curve of L-LLS.

Methods: A total of 72 pure L-LLS were included in this study. A Broken line model was used to identify the periods of the learning curve. A CUSUM analysis of the operative time was performed to evaluate improvements of outcomes with time. To evaluate the relationship between operative time and progressive number of procedures, a linear regression model was applied. A receiver operating characteristic (ROC) curve was carried out to identify the cutoff for completion of the learning curve.

Results: Operative time decreased with the progressive increase of procedures. Two cutoffs and 3 different periods were identified: cases 1 to 22, cases 23 to 55, and cases 56 to 72. A significant decrease in blood loss and operative time was noted. The CUSUM analysis showed an increase in operative time in the first period, a stable duration in the second period, and a decrease in the last. Blood loss was significantly associated with an increase in operative time (P = 0.003). According to the ROC curve, the learning curve was completed after 25 procedures.

Conclusions: L-LLS is a safe procedure that can be standardized and successfully taught to surgeons with large experience in donor hepatectomy through a proctored learning curve.
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http://dx.doi.org/10.1097/SLA.0000000000002948DOI Listing
March 2020

Comparative analysis of azacitidine and intensive chemotherapy as front-line treatment of elderly patients with acute myeloid leukemia.

Ann Hematol 2018 Oct 10;97(10):1767-1774. Epub 2018 Jun 10.

Division of Hematology, Tor Vergata Foundation Polyclinic, Viale Oxford 81, 00133, Rome, Italy.

The present observational study aimed to compare the efficacy of azacitidine (AZA) and intensive chemotherapy (IC) in elderly patients with untreated acute myeloid leukemia (AML), diagnosed according to WHO criteria. In the two groups, we evaluated complete remission (CR), overall survival (OS), and disease-free survival (DFS). The AZA group included 89 patients; median age was 73 years (range 61-80) and median white blood cell count (WBCc) 2.5 × 10/L (range 0.27-83), 45% of the patients had BM blasts ≥ 30%, and 44 (49%) had a secondary AML (sAML). Karyotype was evaluable in 69 patients: 51 (74%) had intermediate-risk abnormalities and 18 (26%) an unfavorable risk karyotype. IC group consisted of 110 patients who received an induction course with mitoxantrone, cytarabine, and etoposide, followed by two consolidation cycles including idarubicin, cytarabine, and etoposide. Median age was 67 years (range 61-78) and median WBCc 8.0 × 10/L (range 0.69-258); 44 (40%) had a sAML. Karyotype was evaluable in 88 patients, 71 (81%) had intermediate risk, and 17 (19%) unfavorable risk karyotype. To minimize the effects of treatment selection bias, adjustments were made using the propensity-score matching method, which yielded 74 patient pairs. CR rate was significantly higher in IC vs AZA group (73 vs 25%, respectively) (p < 0.0001), but the 3-year OS rates and median OS were not significantly different (21.6 vs 11% and 15.8 vs 13 months, respectively). Our analysis suggests similar outcomes with AZA compared to IC. Controlled, randomized clinical trials are warranted to confirm this conclusion.
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http://dx.doi.org/10.1007/s00277-018-3374-xDOI Listing
October 2018

A bidimensional finite mixture model for longitudinal data subject to dropout.

Stat Med 2018 09 5;37(20):2998-3011. Epub 2018 Jun 5.

Dipartimento di Scienze Statistiche, Sapienza Università di Roma, Rome, Italy.

In longitudinal studies, subjects may be lost to follow up and, thus, present incomplete response sequences. When the mechanism underlying the dropout is nonignorable, we need to account for dependence between the longitudinal and the dropout process. We propose to model such a dependence through discrete latent effects, which are outcome-specific and account for heterogeneity in the univariate profiles. Dependence between profiles is introduced by using a probability matrix to describe the corresponding joint distribution. In this way, we separately model dependence within each outcome and dependence between outcomes. The major feature of this proposal, when compared with standard finite mixture models, is that it allows the nonignorable dropout model to properly nest its ignorable counterpart. We also discuss the use of an index of (local) sensitivity to nonignorability to investigate the effects that assumptions about the dropout process may have on model parameter estimates. The proposal is illustrated via the analysis of data from a longitudinal study on the dynamics of cognitive functioning in the elderly.
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http://dx.doi.org/10.1002/sim.7698DOI Listing
September 2018

Cytoreductive Surgery Plus Hyperthermic Intraperitoneal Chemotherapy for Patients with Peritoneal Metastases from Endometrial Cancer.

Ann Surg Oncol 2018 Mar 27;25(3):679-687. Epub 2017 Dec 27.

First Department of Surgical Oncology, Metaxa Cancer Hospital, Pireaus, Greece.

Background: More information is needed for selection of patients with peritoneal metastases from endometrial cancer (EC) to undergo cytoreductive surgery (CRS) plus hyperthermic intraperitoneal chemotherapy (HIPEC).

Methods: This study analyzed clinical, pathologic, and treatment data for patients with peritoneal metastases from EC who underwent CRS plus HIPEC at two tertiary centers. The outcome measures were morbidity, overall survival (OS), and progression-free survival (PFS) during a median 5 year follow-up period. Uni- and multivariate analyses were performed to identify significant factors related to outcome.

Results: A total of 33 patients met the inclusion criteria and completed the follow-up period. At laparotomy, the median peritoneal cancer index (PCI) was 15 (range 3-35). The CRS procedure required a mean 8.3 surgical procedures per patient, and for 22 patients (66.6%), a complete cytoreduction was achieved. The mean hospital stay was 18 days, and major morbidity developed in 21% of the patients. The operative mortality was 3%. When surgery ended, HIPEC was administered with cisplatin 75 mg/m for 60 min at 43 °C. During a median follow-up period of 73 months, Kaplan-Meier analysis indicated a 5 year OS of 30% (median 33.1 months) and a PFS of 15.5% (median 18 months). Multivariate analysis identified the completeness of cytoreduction (CC) score as the only significant factor independently influencing OS. Logistic regression for the clinicopathologic variables associated with complete cytoreduction (CC0) for patients with metachronous peritoneal spread from EC who underwent secondary CRS plus HIPEC identified the PCI as the only outcome predictor.

Conclusions: For selected patients with peritoneal metastases from EC, when CRS leaves no residual disease, CRS plus HIPEC achieves outcomes approaching those for other indications such as colon and ovarian carcinoma.
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http://dx.doi.org/10.1245/s10434-017-6307-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5814516PMC
March 2018

The role of dietary sodium intake on the modulation of T helper 17 cells and regulatory T cells in patients with rheumatoid arthritis and systemic lupus erythematosus.

PLoS One 2017 6;12(9):e0184449. Epub 2017 Sep 6.

Department of Internal Medicine and Medical Specialties, Rheumatology; Sapienza University of Rome, Rome, Italy.

We aimed at investigating whether the frequency and function of T helper 17 (Th17) and regulatory T cells (Treg) are affected by a restriction of dietary sodium intake in patients with rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). We enrolled RA and SLE patients not receiving drugs known to increase urinary sodium excretion. Patients underwent a dietary regimen starting with a restricted daily sodium intake followed by a normal-sodium daily intake. The timepoints were identified at baseline (T0), after 3 weeks of low-sodium dietary regimen (T3), after 2 weeks of normal-sodium dietary regimen (T5). On these visits, we measured the 24-hour urinary sodium excretion, the frequency and function of Th17 and Treg cells in the peripheral blood, the serum levels of cytokines. Analysis of urinary sodium excretion confirmed adherence to the dietary regimen. In RA patients, a trend toward a reduction in the frequencies of Th17 cells over the low-sodium dietary regimen followed by an increase at T5 was observed, while Treg cells exhibited the opposite trend. SLE patients showed a progressive reduction in the percentage of Th17 cells that reached a significance at T5 compared to T0 (p = 0.01) and an increase in the percentage of Treg cells following the low-sodium dietary regimen at both T1 and T3 compared to T0 (p = 0.04 and p = 0.02, respectively). No significant apoptosis or proliferation modulation was found. In RA patients, we found a reduction at T5 compared to T0 in serum levels of both TGFβ (p = 0.0016) and IL-9 (p = 0.0007); serum IL-9 levels were also reduced in SLE patients at T5 with respect to T0 (p = 0.03). This is the first study investigating the effects of dietary sodium intake on adaptive immunity. Based on the results, we hypothesize that a restricted sodium dietary intake may dampen the inflammatory response in RA and SLE patients.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0184449PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5587319PMC
October 2017

Second cancer incidence in primary mediastinal B-cell lymphoma treated with methotrexate with leucovorin rescue, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin regimen with or without rituximab and mediastinal radiotherapy: Results from a monoinstitutional cohort analysis of long-term survivors.

Hematol Oncol 2017 Dec 12;35(4):554-560. Epub 2017 Jan 12.

Department of Cellular Biotechnologies and Hematology, Policlinico Umberto I, "Sapienza" University of Rome, Rome, Italy.

Our aim is to assess the incidence of second cancer in long-time surviving primary mediastinal B-cell lymphoma (PMBCL) patients treated with combined radiochemoimmunotherapy (standard methotrexate with leucovorin rescue, doxorubicin, cyclophosphamide, vincristine, prednisone, and bleomycin with rituximab and mediastinal radiation therapy at a dose of 30 to 36 Gy). For this purpose, 92 points were evaluated. After a median overall survival of 137 months (range 76-212), we recorded second cancer in 3 of 80 long-surviving patients (3.75%) with cumulative incidence of 3.47% at 15 years and 11% at 17 years, with a 17-year second cancer-free survival of 82%. We observed 2 papillary thyroid cancers with a standardized incidence ratio (SIR) of 7.97 and an absolute excess risk (AER) of 17. 84 and 1 acute myeloid leukemia (AML) with an SIR of 66.53 and an AER of 10.05. No breast cancer occurred. Although we should take into account the limits of the proposed statistical analysis, combined modality treatment was related to a significant SIR and AER for thyroid cancer and acute myeloid leukemia.
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http://dx.doi.org/10.1002/hon.2377DOI Listing
December 2017

Cytokines, fatigue, and cutaneous erythema in early stage breast cancer patients receiving adjuvant radiation therapy.

Biomed Res Int 2014 31;2014:523568. Epub 2014 Mar 31.

Department of Translational Medicine, Institute of Radiation Oncology, "Sapienza" University, Sant'Andrea Hospital, Via di Grottarossa 1035-1039, 00189 Rome, Italy.

We investigated the hypothesis that patients developing high-grade erythema of the breast skin during radiation treatment could be more likely to present increased levels of proinflammatory cytokines which may lead, in turn, to associated fatigue. Forty women with early stage breast cancer who received adjuvant radiotherapy were enrolled from 2007 to 2010. Fatigue symptoms, erythema, and cytokine levels (IL-1β, IL-2, IL6, IL-8, TNF-α, and MCP-1) were registered at baseline, during treatment, and after radiotherapy completion. Seven (17.5%) patients presented fatigue without associated depression/anxiety. Grade ≥2 erythema was observed in 5 of these 7 patients. IL-1β, IL-2, IL-6, and TNF-α were statistically increased 4 weeks after radiotherapy (P < 0.05). After the Heckman two-step analysis, a statistically significant influence of skin erythema on proinflammatory markers increase (P = 0.00001) was recorded; in the second step, these blood markers showed a significant impact on fatigue (P = 0.026). A seeming increase of fatigue, erythema, and proinflammatory markers was observed between the fourth and the fifth week of treatment followed by a decrease after RT. There were no significant effects of hormone therapy, breast volume, and anemia on fatigue. Our study seems to suggest that fatigue is related to high-grade breast skin erythema during radiotherapy through the increase of cytokines levels.
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http://dx.doi.org/10.1155/2014/523568DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3988916PMC
December 2014

Field performance of the Skindex-17 quality of life questionnaire: a comparison with the Skindex-29 in a large sample of dermatological outpatients.

J Invest Dermatol 2013 Jan 26;133(1):104-9. Epub 2012 Jul 26.

Health Services Research Unit, Istituto Dermopatico dell'Immacolata IDI-IRCCS, Rome, Italy.

The utilization of health-related quality of life (HRQoL) questionnaires in routine clinical practice is hampered by several factors, including their length and thus the time needed to complete and score them. For this reason, growing efforts are devoted both to create short questionnaires and to shorten existing ones. The Skindex-17 is a dermatological HRQoL instrument that was derived from the Skindex-29 using Rasch analysis. It consists of 17 items instead of 29, and answers are given on a three-point scale instead of a five-point scale. The aim of this study was to compare information obtained by the Skindex-29 and the Skindex-17 in a large sample of dermatological outpatients. We compared the Skindex-29 with the Skindex-17 scores in 2,487 patients with several dermatological conditions, using intraclass correlation coefficients. The overall correlation was 0.957 for the symptoms scale and 0.940 for the psychosocial scale. The values were very similar for all diseases. The concordance between the levels of severity of the Skindex subscales in the two instruments was also very high. In conclusion, the Skindex-17 provided very similar information compared with the Skindex-29, with the advantage of being shorter and including some important psychometric properties.
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http://dx.doi.org/10.1038/jid.2012.244DOI Listing
January 2013

Azacitidine for the treatment of patients with acute myeloid leukemia: report of 82 patients enrolled in an Italian Compassionate Program.

Cancer 2012 Feb 14;118(4):1014-22. Epub 2011 Jul 14.

Institute of Hematology, Tor Vergata Foundation Polyclinic, Rome, Italy.

Background: The efficacy of azacitidine for the treatment of high-risk myelodysplastic syndromes has prompted the issue of its potential role even in the treatment of acute myeloid leukemia (AML).

Methods: The authors analyzed 82 patients with AML who were diagnosed according to World Health Organization criteria. The median patient age was 72 years (range, 29-87 years), and 27 patients (33%) had secondary AML. Of 62 patients with evaluable cytogenetics, 18 patients (29%) had a poor-risk karyotype, and 44 patients (71%) had an intermediate karyotype. Thirty-five patients (43%) received azacitidine as front-line treatment, and 47 patients (57%) had previously received 1 or more line of chemotherapy.

Results: The overall response rate was 32% (26 of 82 patients) and included 12 (15%) complete remissions (CRs), 4 (5%) CRs with incomplete blood count recovery (CRi), and 10 (12%) partial responses (PRs). Responses were observed more frequently among untreated patients compared with pretreated patients; in fact, 17 of 35 untreated patients (48%) responded, including 11 responses (31%) classified as CR/CRi. Conversely, only 9 of 47 pretreated patients (19%) responded, including 5 responses (11%) that were classified as CR/Cri. The response rate was significantly higher for untreated patients (P = .006) and those who had white blood cell counts <10 × 10(9) /L (P = .006). For untreated patients who achieved a response, the median overall response duration was 13 months, and the 1-year and 2-years overall survival rates were 58% and 24%, respectively.

Conclusions: The current results indicated that azacitidine promises to be an effective therapy for elderly patients with untreated AML and with white blood cell counts <10 × 10(9) /L.
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http://dx.doi.org/10.1002/cncr.26354DOI Listing
February 2012

Standard- versus high-dose lenograstim in adults with hematologic malignancies for peripheral blood progenitor cell mobilization.

Transfusion 2010 Nov;50(11):2432-46

Department of Hematology, Regina Elena National Cancer Institute, Rome, Italy.

Background: The aim of this retrospective, multicenter study was to compare high- versus standard-dose lenograstim after chemotherapy in collecting target dose of CD34+ peripheral blood progenitor cells (PBPCs) in adult candidates for autologous transplant.

Study Design And Methods: A total of 166 consecutive patients (28 acute leukemias [ALs], 77 lymphomas, 61 multiple myeloma [MM]) underwent 182 mobilization procedures. Only the first were analyzed. The CD34+ cell target was at least 2×10(6) , 4×10(6) , and 8×10(6) /kg and lenograstim started on days +19, +1, and +5 from the end of chemotherapy for AL, lymphomas, and MM, respectively. Eighty-seven and 79 patients, respectively, received 5 and 10µg/kg/day lenograstim subcutaneously (sc). An analysis to evaluate factors predicting satisfactory procedures and outcome of transplants performed with first-mobilization-procedure PBPCs was conducted. Most patients received 6mg of pegfilgrastim or 5µg/kg/day lenograstim sc after transplant.

Results: In multivariate analysis, high-dose lenograstim (p=0.053) in MM and male sex (p=0.028) were positive predictive factors for reaching cell target. Fludarabine negatively influenced stimulation length (p=0.002). Apheresis, CD34+ cells mobilized and collected, blood volume processed, side effects, transplants performed, and engraftment time were similar between lenograstim cohorts. Pegfilgrastim versus lenograstim delayed platelet (PLT) recovery times (13 days vs. 11 days, p=0.036).

Conclusions: High-dose lenograstim more efficiently mobilized MM patients requiring the highest PBPC target but did not influence transplants performed and engraftment time. Male patients mobilized more efficiently. Fludarabine negatively influenced stimulation length. Finally, pegfilgrastim seems to delay PLT recovery.
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http://dx.doi.org/10.1111/j.1537-2995.2010.02723.xDOI Listing
November 2010

Cytogenetic and molecular diagnostic characterization combined to postconsolidation minimal residual disease assessment by flow cytometry improves risk stratification in adult acute myeloid leukemia.

Blood 2010 Sep 14;116(13):2295-303. Epub 2010 Jun 14.

Hematology, Fondazione Policlinico Tor Vergata, Viale Oxford 81, Rome, Italy.

A total of 143 adult acute myeloid leukemia (AML) patients with available karyotype (K) and FLT3 gene mutational status were assessed for minimal residual disease (MRD) by flow cytometry. Twenty-two (16%) patients had favorable, 115 (80%) intermediate, and 6 (4%) poor risk K; 19 of 129 (15%) carried FLT3-ITD mutation. Considering postconsolidation MRD status, patients with good/intermediate-risk K who were MRD(-) had 4-year relapse-free survival (RFS) of 70% and 63%, and overall survival (OS) of 84% and 67%, respectively. Patients with good- and intermediate-risk K who were MRD(+) had 4-year RFS of 15% and 17%, and OS of 38% and 23%, respectively (P < .001 for all comparisons). FLT3 wild-type patients achieving an MRD(-) status, had a better outcome than those who remained MRD(+) (4-year RFS, 54% vs 17% P < .001; OS, 60% vs 23%, P = .002). Such an approach redefined cytogenetic/genetic categories in 2 groups: (1) low-risk, including good/intermediate K-MRD(-) with 4-year RFS and OS of 58% and 73%, respectively; and (2) high risk, including poor-risk K, FLT3-ITD mutated cases, good/intermediate K-MRD(+) categories, with RFS and OS of 22% and 17%, respectively (P < .001 for all comparisons). In AML, the integrated evaluation of baseline prognosticators and MRD improves risk-assessment and optimizes postremission therapy.
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http://dx.doi.org/10.1182/blood-2009-12-258178DOI Listing
September 2010

Azacitidine for the treatment of lower risk myelodysplastic syndromes : a retrospective study of 74 patients enrolled in an Italian named patient program.

Cancer 2010 Mar;116(6):1485-94

Unit of Hematology and Stem Cell Transplantation, IRCCS, Centro di Riferimento Oncologico della Basilicata, Via Padre Pio 1, 85028 Rionero in Vulture, Potenza, Italy.

Background: Azacitidine induces responses and prolongs overall survival compared with conventional care regimens in patients who have high-risk myelodysplastic syndromes (MDS). However, limited data are available concerning the efficacy and safety of azacitidine in patients who have lower risk MDS.

Methods: The authors retrospectively evaluated 74 patients with International Prognostic Scoring System low-risk or intermediate 1-risk MDS, who received azacitidine on a national named patient program. At baseline, 84% of patients were transfusion-dependent, 57% had received erythropoietin, and 51% were aged >70 years. Azacitidine was administered subcutaneously for 5 days (n = 29 patients), 7 days (n = 43 patients), or 10 days (n = 2 patients) every month at a dose of 75 mg/m(2) daily (n = 45 patients) or at a fixed dose of 100 mg daily (n = 29 patients) and for a median of 7 cycles (range, 1-30 cycles).

Results: According to the 2006 International Working Group criteria, overall response rate (ORR) was 45.9%, including complete responses (10.8%), partial responses (9.5%), hematologic improvements (20.3%), and bone marrow complete responses (5.4%). The ORR was 51.6% in 64 patients who completed > or = 4 cycles of treatment. The median duration of response was 6 months (range, 1-30 months). After a median follow-up of 15 months, 71% of patients remained alive. A survival benefit was observed in responders versus nonresponders (94% vs 54% of patients projected to be alive at 2.5 years, respectively; P < .0014). The most common grade 3 or 4 adverse events were myelosuppression (21.6%) and infection (6.8%).

Conclusions: The current results indicated that azacitidine may be a feasible and effective treatment for patients with lower risk MDS.
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http://dx.doi.org/10.1002/cncr.24894DOI Listing
March 2010
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