Publications by authors named "Giovanni Capelli"

35 Publications

Pathological features, immunoprofile and mismatch repair protein expression status in uterine endometrioid carcinoma: focus on MELF pattern of myoinvasion.

Eur J Surg Oncol 2021 Feb 14;47(2):338-345. Epub 2020 Jul 14.

Unità di Gineco-Patologia e Patologia Mammaria, Dipartimento Scienze Della Salute Della Donna, Del Bambino e di Sanità Pubblica, Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma, Italy; Istituto di Anatomia Patologica, Università Cattolica Del Sacro Cuore, Roma, Italy. Electronic address:

Aims: Microcystic, elongated, and fragmented (MELF) pattern of myoinvasion has been related with increased risk of lympho-vascular space invasion (LVSI) and lymph node metastasis. We analysed a cohort of endometrioid endometrial carcinomas (EECs) to examine the relationships between the MELF pattern of invasion and the clinico-pathological and immunohistochemical features of EEC.

Methods And Results: 129 EECs were evaluated for the presence of MELF pattern and immunohistochemically tested for Mismatch repair (MMR) proteins, p16, p53 and beta-catenin. We observed 28 MELF + EECs and 101 MELF- EECs. LVSI was observed in 20 MELF + cases and in MELF- tumors. Lymph-node metastases were observed in 7 MELF + cases (2 macrometastases, 3 micrometastases and 2 ITCs). None of the MELF- cases showed micrometastases or ITCs, 18 cases had macrometastatic lymph-nodes. Statistical analysis showed that MELF + tumors carry an increased risk of developing nodal metastasis independent of tumor dimension and LVSI. Loss of MMR proteins expression was observed in 11 MELF + cases and 45 MELF- cases, respectively. Our data showed a higher frequency of immunohistochemical MLH1-PMS2 loss in MELF- pattern of invasion (32.67% of MELF- cases vs 21.43% of MELF + cases) but a higher prevalence of MSH2-MSH6 loss in MELF + pattern (7.14% in MELF + population vs 3.96% of MELF- population) CONCLUSIONS: The morphological recognition of MELF pattern is more reliable than immunohistochemical and molecular signatures of EEC in predicting the risk of nodal involvement. The observed higher prevalence of MSH2-MSH6 loss in MELF + group and MLH1-PMS2 loss in MELF- group may suggest a different molecular signature.
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http://dx.doi.org/10.1016/j.ejso.2020.06.041DOI Listing
February 2021

Incidence and prevalence of Huntington disease (HD) in the Sultanate of Oman: the first Middle East post- service-based study.

J Neurol Neurosurg Psychiatry 2020 Dec 31;91(12):1359-1360. Epub 2020 Jul 31.

Bioinformatics Unit, Fondazione IRCCS Casa Sollievo della Sofferenza Research Hospital, San Giovanni Rotondo, Italy.

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http://dx.doi.org/10.1136/jnnp-2020-323241DOI Listing
December 2020

Strategies to Increase Flu Vaccination Coverage among Healthcare Workers: A 4 Years Study in a Large Italian Teaching Hospital.

Vaccines (Basel) 2020 Feb 13;8(1). Epub 2020 Feb 13.

Section of Hygiene, Institute of Public Health, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.

Flu vaccination is recommended among healthcare workers (HCWs). The low vaccination coverage registered in our hospital among HCWs called for new engaging approaches to improve flu vaccination coverage. The aim of this study was to evaluate the efficacy of different strategies implemented during the last four years (2015-2019). A quasi-experimental study was conducted, involving almost 4000 HCWs each year. Starting from the 2015-2016 campaign, new evidence-based strategies were progressively implemented. At the end of each campaign, an evaluation of the vaccination coverage rate reached was performed. Moreover, during the last three campaigns, differences in coverage among job category, wards involved or not in on-site vaccination (OSV) intervention, age classes and gender were analyzed. An increasing flu vaccination coverage rate was registered, from 6% in 2015-2016 to almost 22% at the end of 2018-2019. The overall number of vaccinated HCWs increased, especially at younger ages. OSV strategy always leads to better results, and physicians always show a higher vaccination coverage than nurses and other HCWs. The implemented strategies were effective in achieving higher flu vaccination coverage among HCWs in our hospital and therefore can be considered valuable examples of good prevention practices in hospital settings.
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http://dx.doi.org/10.3390/vaccines8010085DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7157643PMC
February 2020

A Large, Multicenter, Retrospective Study on Efficacy and Safety of Stereotactic Body Radiotherapy (SBRT) in Oligometastatic Ovarian Cancer (MITO RT1 Study): A Collaboration of MITO, AIRO GYN, and MaNGO Groups.

Oncologist 2020 02 10;25(2):e311-e320. Epub 2019 Oct 10.

Fondazione Policlinico Universitario A. Gemelli, IRCCS, Unità Operativa Complessa Ginecologia Oncologica, Dipartimento per la Salute della Donna e del Bambino e della Salute Pubblica, Roma, Italy.

Background: Recent studies have reported improvement of outcomes (progression-free survival, overall survival, and prolongation of androgen deprivation treatment-free survival) with stereotactic body radiotherapy (SBRT) in non-small cell lung cancer and prostate cancer. The aim of this retrospective, multicenter study (MITO RT-01) was to define activity and safety of SBRT in a very large, real-world data set of patients with metastatic, persistent, and recurrent ovarian cancer (MPR-OC).

Materials And Methods: The endpoints of the study were the rate of complete response (CR) to SBRT and the 24-month actuarial local control (LC) rate on "per-lesion" basis. The secondary endpoints were acute and late toxicities and the 24-month actuarial late toxicity-free survival. Objective response rate (ORR) included CR and partial response (PR). Clinical benefit (CB) included ORR and stable disease (SD). Toxicity was evaluated by the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC) and Common Terminology Criteria for Adverse Events (CTCAE) scales, according to center policy. Logistic and Cox regression were used for the uni- and multivariate analysis of factors predicting clinical CR and actuarial outcomes.

Results: CR, PR, and SD were observed in 291 (65.2%), 106 (23.8%), and 33 (7.4%) lesions, giving a rate of CB of 96.4%. Patient aged ≤60 years, planning target volume (PTV) ≤18 cm , lymph node disease, and biologically effective dose α/β10 > 70 Gy were associated with higher chance of CR in the multivariate analysis. With a median follow-up of 22 months (range, 3-120), the 24-month actuarial LC rate was 81.9%. Achievement of CR and total dose >25 Gy were associated with better LC rate in the multivariate analysis. Mild toxicity was experienced in 54 (20.7%) patients; of 63 side effects, 48 were grade 1, and 15 were grade 2. The 24-month late toxicity-free survival rate was 95.1%.

Conclusions: This study confirms the activity and safety of SBRT in patients with MPR-OC and identifies clinical and treatment parameters able to predict CR and LC rate.

Implications For Practice: This study aimed to define activity and safety of stereotactic body radiotherapy (SBRT) in a very large, real life data set of patients with metastatic, persistent, recurrent ovarian cancer (MPR-OC). Patient age <60 years, PTV <18 cm , lymph node disease, and biologically effective dose α/β10 >70 Gy were associated with higher chance of complete response (CR). Achievement of CR and total dose >25 Gy were associated with better local control (LC) rate. Mild toxicity was experienced in 20.7% of patients. In conclusion, this study confirms the activity and safety of SBRT in MPR-OC patients and identifies clinical and treatment parameters able to predict CR and LC rate.
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http://dx.doi.org/10.1634/theoncologist.2019-0309DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7011643PMC
February 2020

Evaluation of Training Load During Suspension Exercise.

J Strength Cond Res 2019 Mar 18. Epub 2019 Mar 18.

Department of Human Sciences, Society and Health, University of Cassino and Lazio Meridionale, Cassino, Italy.

Giancotti, GF, Fusco, A, Varalda, C, Capelli, G, and Cortis, C. Evaluation of training load during suspension exercise. J Strength Cond Res XX(X): 000-000, 2019-The aims of this study were to evaluate body inclination and ground reaction force and to predict equations to estimate the training load distribution during suspension training (ST) static back-row at different lengths of the straps. Thirty volunteers (men = 16 and women = 14; age = 23.3 ± 1.7 years; body mass = 63.9 ± 13.3 kg; height = 167.9 ± 9.2 cm; body mass index [BMI] = 22.5 ± 3.4 kg·m) performed 14 static back-rows at 7 different lengths of the straps in 2 different elbow positions (flexed and extended). When the length of the straps increased, ground reaction force and body inclination decreased. Moreover, in the flexed elbow position, higher ground reaction force values were recorded with respect to the extended one. Two multilevel regression models (p < 0.05) were created. In the first one, ground reaction force was used as a dependent variable, whereas body inclination angle, body mass, height, BMI, and elbow position were used as independent variables. Significant (p < 0.05) effects were found for all variables included in the model, with an intraclass correlation coefficient (ICC) of 0.31. In the second model, the body inclination angle was replaced by the length of the ST device. Significant (p < 0.05) effects were found also in the second model for all variables included, with an ICC of 0.37. The proposed models could provide different methods to quantify the training load distribution, even if the use of the straps' length could result easier and faster than body inclination angle, helping practitioners and instructors to personalize the workout to reach specific purposes and provide load progression.
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http://dx.doi.org/10.1519/JSC.0000000000003100DOI Listing
March 2019

The impact of R1 resection for colorectal liver metastases on local recurrence and overall survival in the era of modern chemotherapy: An analysis of 1,428 resection areas.

Surgery 2019 04 25;165(4):712-720. Epub 2018 Oct 25.

Hepatobiliary Surgery Unit, Fondazione "Policlinico Universitario A. Gemelli," Catholic University of the Sacred Heart, Rome, Italy.

Background: It is still unclear whether a positive surgical margin after resection of colorectal liver metastases remains a poor prognostic factor in the era of modern perioperative chemotherapy. The aim of this study was to evaluate whether preoperative chemotherapy has an impact on reducing local recurrence after R1 resection, and the impact of local recurrence on overall survival.

Methods: Between 2000 and 2014, a total of 421 patients underwent resection for colorectal liver metastases at our unit after preoperative chemotherapy. The overall number of analyzed resection areas was 1,428.

Results: The local recurrence rate was 12.8%, significantly higher after R1 resection than after R0 (24.5% vs 8.7%; P < .001). These results were also confirmed in patients with response to preoperative chemotherapy (23.1% after R1 vs 11.2% after R0; P < .001). At multivariate analysis, R1 resection was the only independent risk factor for local recurrence (P < .001). At the analysis of the 1,428 resection areas, local recurrence significantly decreased according to the increase of the surgical margin width (from 19.1% in 0 mm margin to 2.4% in ≥10 mm). At multivariable logistic regression analysis for overall survival, the presence of local recurrence showed a significant negative impact on 5-year overall survival (P < .001).

Conclusion: Surgical margin recurrence after modern preoperative chemotherapy for colorectal liver metastases was still significantly higher after R1 resection than it was after R0 resection. Local recurrence showed a negative prognostic impact on overall survival. R0 resection should be recommended whenever technically achievable, as well as in patients treated by modern preoperative chemotherapy.
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http://dx.doi.org/10.1016/j.surg.2018.09.005DOI Listing
April 2019

Long-term efficacy and safety of human papillomavirus vaccination.

Int J Womens Health 2014 3;6:999-1010. Epub 2014 Dec 3.

Department of Human Sciences, Society and Health, University of Cassino and Southern Lazio, Cassino, Italy.

In this paper, we review the published evidence about the long-term efficacy of the available human papillomavirus (HPV) vaccines and their safety profile. Two prophylactic HPV vaccines - bivalent (bHPV) and quadrivalent (qHPV) - are now available, and vaccination programs are being widely implemented, primarily targeting adolescent girls. Efficacy has been widely demonstrated for both vaccines. Since the risk of HPV exposure potentially persists throughout a woman's sexual life, vaccine duration of protection is critical to overall effectiveness. Interpreting the results of long-term efficacy studies for the two HPV vaccines can be puzzling, due to the heterogeneity of studies, different methods used in the assessment of immunogenicity, histopathological and virological end points, and statistical power issues. Moreover, an immunologic correlate of protection has not yet been established, and it is unknown whether higher antibody levels will really result in a longer duration of protection. Disease prevention remains the most important measure of long-term duration of vaccine efficacy. To date, the longest follow-up of an HPV vaccine has been 9.4 years for the bHPV vaccine. Long-term follow-up for qHPV vaccine goes up to 8 years. The vaccine continues to be immunogenic and well tolerated up to 9 years following vaccination. All randomized controlled clinical trials of the bHPV and the qHPV vaccines provide evidence of an excellent safety profile. The most common complaint reported is pain in the injection site, which is self-limiting and spontaneously resolved. The incidence of systemic adverse events (AEs), serious AEs, and discontinuations due to a serious AE reported in clinical studies are similar between the two vaccines and their control groups. In particular, no increased risk of autoimmune disease has been shown among HPV-vaccinated subjects in long-term observation studies. As these are crucial topics in HPV vaccination, it is important to establish systems for continued monitoring of vaccine immunogenicity, efficacy, and safety over time.
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http://dx.doi.org/10.2147/IJWH.S50365DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4262378PMC
January 2015

Normal values of exhaled carbon monoxide in healthy subjects: comparison between two methods of assessment.

BMC Pulm Med 2014 Dec 16;14:204. Epub 2014 Dec 16.

Institute of Public Health, Hygiene Division, Catholic University "Sacro Cuore", Largo Francesco Vito, 1, 00168 Rome, Italy.

Background: In a previous study, exhaled carbon monoxide (eCO) has been assessed in healthy non-smokers with a photo acoustic spectrometer Brüel&Kjær 1312. Unexpectedly, values were higher than those reported in literature, which were mostly obtained with electrochemical analysers. This study was aimed to compare eCO values obtained with Brüel&Kjær 1312 and PiCO + Smokerlyzer, a largely utilized electrochemical analyser.

Methods: Thirty-four healthy subjects, 15 non-smokers and 19 smokers, underwent eCO assessment with Brüel&Kjær 1312 and PiCO + Smokerlyzer during a prolonged expiration (15 seconds). Brüel&Kjær 1312 assessed CO concentration 7 and 12 seconds after the beginning of expiration and displayed the mean value. PiCO + Smokerlyzer was utilized according to the manufacturer's recommendations. In vitro, the two devices were tested with standard concentrations of CO in nitrogen (5, 9.9, 20, and 50 ppm), and the time needed by PiCO + Smokerlyzer readings to stabilize was assessed at different gas flows.

Results: Both Brüel&Kjær 1312 and PiCO + Smokerlyzer presented very good internal consistency. The values provided were strictly correlated, but at low test concentrations, the Brüel&Kjær 1312 readings were greater than the PiCO + Smokerlyzer, and vice versa. PiCO + Smokerlyzer overestimated the CO standard concentrations at 5 and 9.9 ppm by 20%, while Brüel&Kjær 1312 measures were correct. PiCO + Smokerlyzer readings stabilized in 12 seconds during in vitro tests and in 15 seconds during in vivo measurements, suggesting that the values displayed corresponded to the initial phase of expiration.

Conclusions: Differences between Brüel&Kjær 1312 and PiCO + Smokerlyzer may be explained because Brüel&Kjær 1312 measured CO levels in the middle and at the end of expiration while PiCO + Smokerlyzer assessed them in the initial part of expiration.
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http://dx.doi.org/10.1186/1471-2466-14-204DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4275957PMC
December 2014

[A cross-sectional study on physical activity in a sample of secondary school students in the province of Frosinone, Italy].

Ig Sanita Pubbl 2014 Mar-Apr;70(2):197-209

Laboratorio di Epidemiologia, Attività Motorie e Stili di Vita - Dipartimento di Scienze Umane, Sociali e della Salute - Università degli Studi di Cassino e del Lazio Meridionale.

Background: Physical activity is influenced by individual, socio-cultural and environmental factors. The aim of the study is to describe the practice of physical activity in 11-18 year old students and to identify its correlates in a specific area of central Italy.

Methods: Data were collected in secondary schools of the province of Frosinone (central Italy) using an opportunity sample on 856 students by means of a self administered questionnaire.

Results: More than 50% of students reported to practice physical activity 2-3 times a week. Most of the students practiced football or five-a-side football as main sport (25.3%), followed by gymnastic and fitness (19.8%) and swimming (18.8%). Active commuting to school was reported by less than 20% of the sample while private car was the most common mean of transport (52.8%). Differences in physical activity practice were shown according to the residential municipality. Parents' educational level and their physical activity attitudes were positively associated to children's physical activity. These associations persisted after adjusting for age, gender and residential area.

Conclusions: Socio-economic position and parental behaviours are important predictors of physical activity practice in children and adolescents.
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November 2014

NOTCH1 mutations identify a chronic lymphocytic leukemia patient subset with worse prognosis in the setting of a rituximab-based induction and consolidation treatment.

Ann Hematol 2014 Oct 13;93(10):1765-74. Epub 2014 Jun 13.

Clinical and Experimental Onco-Hematology Unit, Centro di Riferimento Oncologico, I.R.C.C.S., Aviano, PN, Italy.

Induction therapy with fludarabine followed by rituximab and consolidation plus maintenance with rituximab improved response duration (RD) and overall survival (OS) in our patients with chronic lymphocytic leukemia (CLL). The aim of our study was to investigate the clinical impact of NOTCH1 mutations in this setting of patients. The study included 123 progressive CLL patients homogeneously assigned to first-line induction treatment with fludarabine followed by rituximab. Fifty-nine patients either in complete remission (CR) minimal residual disease positive (MRD+) after induction (n = 39) or in partial remission (PR, n = 20) underwent consolidation/maintenance therapy with rituximab. Sixteen patients in CR MRD + or PR underwent observation only. The presence of NOTCH1 mutations was investigated by amplification refractory mutation system (ARMS) PCR and by Sanger sequencing. NOTCH1 mutations occurred in 20 out of 123 (16.3 %) cases. Consolidated patients showed longer OS than unconsolidated patients (p = 0.030). Both NOTCH1 mutated and CR MRD+ or PR NOTCH1 mutated patients showed significantly shorter OS after treatment (p = 0.00014 and p = 0.0021, respectively). Moreover, NOTCH1 wild-type consolidated cases experienced significantly longer RD and OS than NOTCH1 mutated consolidated or not consolidated cases (p = 0.00001 and p = 0.018, respectively). Finally, the independent prognostic impact of NOTCH1 mutations for OS was confirmed in multivariate analysis (p < 0.001). The presence of NOTCH1 mutations identifies a CLL subset with worse prognosis in the setting of a rituximab-based induction and consolidation treatment.
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http://dx.doi.org/10.1007/s00277-014-2117-xDOI Listing
October 2014

Looking at the smoking epidemic through the lens of population pyramids: sociodemographic patterns of smoking in Italy, 1983 to 2005.

Popul Health Metr 2012 Nov 28;10(1):23. Epub 2012 Nov 28.

Department of Human Sciences, Society and Health, University of Cassino and Southern Lazio, Cassino, Italy.

Unlabelled:

Background: Surveillance systems often present data by means of summary measures, like age-standardised rates. In this study, we aimed at comparing information derived from commonly used measures of smoking with that presented in modified population pyramids (PPs), using the example of the diffusion of smoking in Italy over the past two decades.

Methods: Data were derived from four National Health Interview Surveys carried out in 1983, 1990 to 1991, 1999 to 2000, and 2004 to 2005. After computing both age-specific and age-standardised rates of current, former, and never smoking, we constructed modified PPs by stratifying the male and female populations according to smoking status and educational level.

Results: Modified PPs showed several features of the smoking epidemic in Italy that were not apparent from conventional surveillance techniques. First, they showed that the population of smokers is aging, with most current smokers in 2005 being males aged 25 to 39 and females aged 40 to 49, whereas in 1983 most smokers belonged to the youngest age groups. Second, they showed that in 2005 most smokers were found among subjects with middle and higher education, whereas two decades earlier most smokers were (male) subjects with the lowest education.

Conclusions: Modified PPs were able to show how absolute numbers of smokers were distributed by age and sex, how these numbers varied between population subgroups, and how they changed over time. PPs may help provide information on past and future trends in the absolute number of smokers and in their sociodemographic characteristics, which may be missed using only traditional surveillance methods.
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http://dx.doi.org/10.1186/1478-7954-10-23DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3573981PMC
November 2012

Socioeconomic differences in sport and physical activity among Italian adults.

J Sports Sci 2013 29;31(4):451-8. Epub 2012 Oct 29.

University of Cassino, Department of Health and Sport Sciences, via S, Angelo (Folcara), Cassino (FR), 03043, Italy.

We aimed to assess the extent of socioeconomic differences in sport and physical activity among Italian adults. A secondary data analysis of a multipurpose survey carried out by the National Institute of Statistics in 2006 in Italy was performed. We found marked differences in the practice of physical activity and sport by socioeconomic position. Subjects with a higher educational level were more likely to be physically active, practising more frequently both sport and physical activity. The Odds Ratio (OR) of regular physical activity for the highest educated compared to the lowest educated males was 1.70 (95% Confidence Interval [CI]: 1.38, 2.08), and the OR of sport participation was 2.03 (95% CI: 1.51, 2.72). Among females, the corresponding ORs were 1.32 (95% CI: 1.08, 1.63) and 2.26 (95% CI: 1.51, 3.38). Similar differences in physical activity and sport were found in relation to occupation and material conditions. Almost all sports were more frequently practised by subjects of higher socioeconomic status. Socioeconomic differences in sport and physical activity may derive from economic or cultural barriers. Policies to reduce inequalities and ensure access to sport independently of socioeconomic position are strongly needed.
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http://dx.doi.org/10.1080/02640414.2012.736630DOI Listing
July 2013

Seeking Huntington disease biomarkers by multimodal, cross-sectional basal ganglia imaging.

Hum Brain Mapp 2013 Jul 22;34(7):1625-35. Epub 2012 Feb 22.

Department of Radiology, IRCCS Santa Lucia, Rome, Italy.

Neurodegeneration of the striatum in Huntington disease (HD) is characterized by loss of medium-spiny neurons, huntingtin nuclear inclusions, reactive gliosis, and iron accumulation. Neuroimaging allows in vivo detection of the macro- and micro-structural changes that occur from presymptomatic stages of the disease (preHD). The aim of our study was to evaluate the reliability of multimodal imaging as an in vivo biomarker of vulnerability and development of the disease and to characterize macro- and micro-structural changes in subcortical nuclei in HD. Macrostructure (T1-weighted images), microstructure (diffusion tensor imaging), and iron content (R 2* relaxometry) of subcortical nuclei and medial temporal lobe structures were evaluated by a 3 T scanner in 17 preHD carriers, 12 early-stage patients and 29 matched controls. We observed a volume reduction and microstructural changes in the basal ganglia (caudate, putamen, and globus pallidus) and iron accumulation in the globus pallidus in both preHD and symptomatic subjects; all these features were significantly more pronounced in patients, in whom degeneration extended to the other subcortical nuclei (i.e., thalamus and accumbens). Mean diffusivity (MD) was the most powerful predictor in models explaining more than 50% of the variability in HD development in the caudate, putamen, and thalamus. These findings suggest that the measurement of MD may further enhance the well-known predictive value of striatal volume to assess disease progression as it is highly sensitive to tissue microimpairment. Multimodal imaging may detect brain changes even in preHD stages.
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http://dx.doi.org/10.1002/hbm.22019DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6870326PMC
July 2013

[World Health Organization (WHO) Guidelines for coastal and fresh waters: Italian translation by the Society of Hygiene, Preventive Medicine and Public Health (SItI) Working Group "Movement Sciences for Health"].

Ig Sanita Pubbl 2011 May-Jun;67(3):351-64

Gruppo di Lavoro SItI - "Scienze Motorie per la Salute" (GSMS).

The Working Group "Movement Sciences for Health" of the Italian Society of Hygiene, Preventive Medicine and Public Health has promoted the Italian translation of the WHO Guidelines for Safe Recreational Water Environments, relating to coastal and freshwater environments. In this article the authors briefly summarize the main areas covered in the guidelines, namely drowning and injury, exposure to cold, heat and sunlight, water quality, contamination of beach sand, exposure to algae and their products, aesthetic issues, exposure to chemical and physical agents, dangerous aquatic organisms, monitoring and assessment hazards and risks.
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December 2011

Body mass index has a curvilinear relationship with the percentage of body fat among children.

BMC Res Notes 2011 Aug 18;4:301. Epub 2011 Aug 18.

Department of Health and Sport Sciences, University of Cassino, Cassino, Italy.

Background: Body Mass Index (BMI), which is defined as the ratio between weight (in kg) and height (in m2), is often used in clinical practice as well as in large scale epidemiological studies to classify subjects as underweight, normal weight, overweight or obese. Although BMI does not directly measure the percentage of Body Fat (BF%), it is widely applied because it is strongly related with BF%, it is easy to measure and it is an important predictor of mortality. Among children, age and sex-specific reference values of BMI, known as percentiles, are used. However, it is not clear how strong the relationship between BMI and BF% is among children and whether the association is linear. We performed a cross-sectional study aiming at evaluating the strength and shape of the relationship between BMI and BF% among school-aged children aged 6-12 years.

Findings: The study was conducted on a sample of 361 football-playing male children aged 6 to 12 years in Rome, Italy. Age, weight, height and skinfold thickness were collected. BF% was estimated using 4 skinfold equations whereas BMI was converted into BMI-for-age z-score. The relationship between these variables was examined using linear regression analyses. Mean BMI was 18.2 (± 2.8), whereas BF% was influenced by the skinfold equation used, with mean values ranging from 15.6% to 23.0%. A curvilinear relationship between BMI-for-age zscore and BF % was found, with the regression line being convex. The association between BMI-for-age zscore and BF% was stronger among overweight/obese children than among normal/underweight children. This curvilinear pattern was evident in all 4 skinfold equations used.

Conclusions: The association between BMI-for-age zscore and BF% is not linear among male children aged 6-12 years and it is stronger among overweight and obese subjects than among normal and underweight subjects. In this age group, BMI is a valid index of adiposity only among overweight and obese subjects.
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http://dx.doi.org/10.1186/1756-0500-4-301DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3169475PMC
August 2011

Socio-economic inequalities in physical activity practice among Italian children and adolescents: a cross-sectional study.

Z Gesundh Wiss 2009 Dec 9;17(6):377-384. Epub 2009 Apr 9.

AIM: The aim of the study was to evaluate whether socio-economic inequalities in the practice of physical activity existed among children and adolescents, using different indicators of socio-economic status (SES). SUBJECTS AND METHODS: Data were derived from the Italian National Health Interview Survey carried out in 2004-2005, which examined a large random sample of the Italian population using both an interviewer-administered and a self-compiled questionnaire. This study was based on a sample of 15,216 individuals aged 6-17 years. The practice of physical activity was measured on the basis of questions regarding frequency and intensity of activity during leisure time over the past 12 months. Parents' educational and occupational level, as well as family's availability of material resource, were used as indicators of SES. Multivariable logistic regression analyses were performed to estimate the contribution of each SES indicator to the practice of physical activity, adjusting for potential confounding factors. The results of the regression models are expressed as odds ratio (OR) with 95% confidence intervals (95% CI). RESULTS: About 64% of children and adolescents in the sample declared that they participated in moderate or vigorous physical activity at least once a week. After adjustment for gender, age, parental attitudes towards physical activity and geographical area, the practice of physical activity increased with higher parental educational and occupational level and greater availability of material resources. Children and adolescents whose parents held a middle or high educational title were 80% more likely to practice moderate or vigorous physical activity than subjects whose parents had a lower level of education (OR = 1.80, 95% CI: 1.40-2.33), while subjects with unemployed parents had an odds of practicing moderate or vigorous physical activity 0.43 times that of those children whose parents belonged to the top job occupation category (administrative/professionals). Socio-economic differences were about the same when the practice of vigorous physical activity only was considered instead of that of moderate or vigorous physical activity. CONCLUSION: Interventions that promote the practice of physical activity, and especially those aimed at the wider physical and social environment, are strongly needed to contrast socio-economic differences in physical activity among children and adolescents.
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http://dx.doi.org/10.1007/s10389-009-0267-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2967259PMC
December 2009

[Health risks associated with night shifts: trasversal study in a sample of nurses at the Cassino hospital].

Prof Inferm 2010 Apr-Jun;63(2):77-85

Corso di Laurea in Infermieristica - Università Sapienza di Roma, sede di Cassino.

For nurses, night work can have a negative influence not only on the quality of care and the incidence of accidents and errors but also affect their private life and health. In shift workers sleep pattern disturbances are particularly frequent. Females are more at risk than males due to their different health conditions and socio-family pressure. This transversal study , by means of a self-administered questionnaire, evaluated the incidence of mental and physical problems in 58 nurses at the "Santa Scolastica" Hospital in Cassino to identify the principal factors responsible for sleep disturbances and to implement preventive strategies. Results showed that in many cases disturbances were attributable to lack of rest . Shorter and more irregular sleep was associated with age and amount of working years, together with poor organizational capacities : irregular shifts , upbringing of children and family burdens aggravated this situation. More than half the nurses replied that they slept before starting a night shift and again when they finished in a dark room , rather than in silence with the telephone turned off.. The authors conclude that a system to monitor disturbances deriving from night work should be implemented so that preventive measures can be taken.
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November 2010

The genotype nucleophosmin mutated and FLT3-ITD negative is characterized by high bax/bcl-2 ratio and favourable outcome in acute myeloid leukaemia.

Br J Haematol 2010 May 8;149(3):383-7. Epub 2010 Feb 8.

Department of Haematology, Ospedale S.Eugenio, University Tor Vergata, Rome, Italy.

Nucleophosmin gene (NPM1) mutations characterize acute myeloid leukaemia (AML) with normal karyotype and frequently co-exist with FLT3 internal tandem duplications (ITD). We evaluated bcl-2, bax, NPM1 and FLT3-ITD in 222 AML patients. Bax/bcl-2 ratio >0.35 and NPM1 without FLT3-ITD were significantly associated (P = 0.0001). NPM1-mutated (mt)/FLT3-ITD negative patients showed a higher complete remission (CR) rate (90%, P = 0.0002) and a longer overall survival (OS, P = 0.00007). NPM1-mt/FLT3-ITD negative plus bax/bcl-2 > 0.35 subset showed a very high CR rate (96%), very long OS (P = 0.00005) and disease-free survival (P = 0.004). The favourable prognosis of NPM1-mt/FLT3-ITD negative patients might be explained by a higher bax/bcl-2 ratio.
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http://dx.doi.org/10.1111/j.1365-2141.2010.08098.xDOI Listing
May 2010

Implementation of perceptual channels in children implanted with a HiRes 90K device.

Acta Otolaryngol 2009 Dec;129(12):1442-50

Department of Neurology and Otolaryngology, I Medical School, La Sapienza University of Rome, Rome, Italy.

Conclusions: The increased spectral resolution that characterizes the HiRes 120 device contributes to improvement of performance. Discrimination and identification in noise are consistent with reports of improved perception under everyday listening situations.

Objectives: This work focuses on speech perception findings after implementation of current steering in HiResolution strategy of children implanted with Clarion HiRes 90K.

Subjects And Methods: Comparison was made between three groups of children: standard HiRes control group, a second group switched over from HiRes to HiRes 120 and the third group switched on with HiRes 120. Children were tested before and 12 months after implementation of HiRes 120. A standard test battery was administered to obtain a speech perception development profile. The Auditory Speech Sound Evaluation (A section signE) test was carried out to evaluate discrimination and identification of phonemes in quiet and in noise.

Results: The HiRes and HiRes 120 switch-over groups showed quite similar results for speech perception in quiet. However, the HiRes 120 switch-over group achieved these results within a shorter time after conversion. Switch-on children showed improvement in all speech perception categories, reaching approximately 60% recognition and 30% comprehension in quiet. Results for A section signE discrimination scores in quiet and noise showed a clear improvement for both HiRes 120 switch-on and switch-over groups compared with the HiRes group.
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http://dx.doi.org/10.3109/00016480902777131DOI Listing
December 2009

Clinical performance of human papillomavirus E6 and E7 mRNA testing for high-grade lesions of the cervix.

J Clin Microbiol 2009 Dec 14;47(12):3895-901. Epub 2009 Oct 14.

Institute of Microbiology, Università Cattolica del Sacro Cuore, Largo A Gemelli 8, Rome 00168, Italy.

Infection with high-risk (HR) human papillomavirus (HPV) is the major cause of cervical cancer. However, relatively few infections progress to malignant disease. Progression to malignancy requires the overexpression of the E6 and E7 genes in the integrated HPV genome. It follows that the E6 and E7 transcripts could be useful markers of disease progression. The study presented here tests this possibility, using data from colposcopy and from cytological and histological tests to compare RNA assays for the E6 and E7 genes with DNA testing. A total of 180 women underwent colposcopy, cytology, and biopsy of suspected lesions (143 cases). Cervical brush specimens were analyzed for HPV DNA and for E6 and E7 mRNA. DNA from HR HPV was found in 57.8% of the specimens; E6 and E7 transcripts were found in 45%. The rates of detection of HPV DNA and of E6 and E7 transcripts were 33.3% and 25%, respectively, for specimens with normal findings; 51.4% and 31.9%, respectively, for specimens with cervical intraepithelial neoplasia grade 1 (CIN1); and 61.1% and 44.2% for specimens with CIN2, respectively. All specimens with CIN3 and 95.5% of specimens from patients with squamous cell carcinoma were positive by both assays. Thirty-seven patients with normal colposcopy findings did not undergo biopsy. HPV DNA and mRNA transcripts were found in 32.4% and 18.9% of these cases, respectively. Comparisons with cytological tests produced similar results. Overall, the mRNA tests showed a higher specificity than the DNA tests for high-grade lesions (72.7% and 56.2%, respectively) and a higher positive predictive value (59.3% and 49.0%, respectively). These findings suggest that mRNA assays could be more powerful than DNA testing for predicting the risk of progression and offer a strong potential as a tool for triage and patient follow-up.
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http://dx.doi.org/10.1128/JCM.01275-09DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2786669PMC
December 2009

Treatment of cervical cancer in Italy: strategies and their impact on the women.

Vaccine 2009 May;27 Suppl 1:A39-45

Gynaecologic Oncology Unit, Catholic University of the Sacred Heart, Rome, Italy.

Treatment of cervical cancer greatly varies according to the stage of the disease. Laparoscopic surgical staging is emerging as a valid approach, compared to clinical and imaging staging, to better identify the treatment plan. Minimally invasive surgery plays the greatest role in the treatment of early cervical carcinoma (ECC). Laparoscopically assisted radical vaginal hysterectomy (LARVH) is an alternative surgical strategy in this subset of patients. Interest has been increasing in using conservative fertility-sparing surgery such as laparoscopic vaginal radical trachelectomy (LVRT) or chemo-conization, options to be preferred in selected patients, with early-stage disease and asking for future fertility. Chemoradiotherapy currently represents the gold standard in the treatment of patient with locally advanced cervical cancer (LACC). In Italy, neoadjuvant chemotherapy (NACT) followed by radical surgery is today emerging as a valid alternative to the standard chemoradiation and the paclitaxel, ifosfamide and cisplatin (TIP) regimen is one of the most active neoadjuvant chemotherapeutic treatments. Moreover, the combination of different strategies to maximize local control should be considered. Among different approaches to this issue the use of a three-modality treatment, including radiotherapy, chemotherapy and surgery has been investigated. Our data on a large single-institutional series of LACC patients treated with chemoradiation followed by radical surgery confirm that this three-modality treatment can achieve overall survival (OS) and Disease Free Survival (DFS) rates at least comparable to chemoradiation alone, with an acceptable rate of complications. Tailoring of radical surgery, on the basis of intraoperative findings, such as lympho-nodes status, might play an important role in diminishing the overall rate of complications and eventually improve quality of life (QoL) of these patients. Cervical cancer generally has an aggressive impact on relatively young women and, as we experienced, the relevance of psychosocial aspects in gynaecologic oncology has become a main issue.
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http://dx.doi.org/10.1016/j.vaccine.2008.11.110DOI Listing
May 2009

Quality of life and psychological distress in locally advanced cervical cancer patients administered pre-operative chemoradiotherapy.

Gynecol Oncol 2008 Oct 8;111(1):144-50. Epub 2008 Aug 8.

Department Obstetrics and Gynecology, Gynecologic Oncology Unit, Catholic University, Rome, Italy.

Objective: The aim of the study was to analyze the Quality of life (QoL) scores in a single institution series of locally advanced cervical cancer patients (LACC) administered preoperative chemoradiation, compared to early stage disease (ECC) patients undergoing radical surgery.

Methods: The following criteria were required in order to enroll patients: age between 18 and 65years at initial diagnosis, at least 12 months from the end of treatment, no evidence of recurrence/second malignancy. The SF-36 questionnaire on general health, and the HADS questionnaire on mental distress were utilized.

Results: 93 subjects were available for the analysis. At time of analysis, median follow-up was 30 months (range 12-120). LACC patients showed QoL scores comparable to ECC patients with the exception of physical functioning (mean+/-SD=69.0+/-13.1 versus mean+/- SD=85.4+/-16.2, p value=0.0007). In the group of LACC patients, the presence of co-morbidities was significantly associated with the impairment of almost all subscales of QoL. A low education level and the status of unemployment were documented to negatively impact on the vast majority of SF-36 subscale scores. In the multivariate analysis, the presence of co-morbidities, low educational level, age> 50 years, and unemployment maintained their independent negative association with poor QoL scores. The percentage of cases with high levels HADS-anxiety was higher in LACC than ECC patients (27.6% versus 8.6%, p value=0.034).

Conclusions: LACC patients administered preoperative chemoradiation showed QoL scores comparable to EEC patients, and a higher proportion of anxiety disorders; low educational level and unemployment status were mainly associated with poor QoL scores.
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http://dx.doi.org/10.1016/j.ygyno.2008.06.034DOI Listing
October 2008

[Indoor air quality in school facilities in Cassino (Italy)].

Ig Sanita Pubbl 2008 Jan;64(1):53-66

Dipartimento di Scienze Motorie e della Salute, Università degli Studi di Cassino, Cassino, Italy.

This study evaluated the indoor air quality of 26 classrooms of secondary schools in the city of Cassino (Italy). Two types of school buildings were assessed: buildings specifically designed as schools, and former dwellings converted to schools. Measurements were taken in both winter and spring months, before students entered the classrooms and while the classrooms were occupied. Lower thermal comfort levels were observed during the winter months; in fact, during the winter, ideal temperature, humidity and air speed parameters were found in only a small percentage of classrooms and students were found to experience thermal discomfort as a result. Air velocity was often found to be inadequate both in winter and spring months and in both types of school buildings evaluated. Illumination levels measured during the winter months with both natural daylight and mixed illumination, were found to be below 200 lux, the minimum recommended level recommended by the ministerial decree 18.12.1975. Noise levels above the maximum level recommended by the ministerial decree 01.03.1991 were also frequently observed. The symptoms most frequently reported by students were headache, difficulties in concentrating, cough, and unusual tiredness. The various discomfort situations observed in both types of school buildings point toward a need for greater attention toward indoor air quality of schools as this can have affect students' attention, concentration, productivity and comfort.
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January 2008

Consolidation and maintenance immunotherapy with rituximab improve clinical outcome in patients with B-cell chronic lymphocytic leukemia.

Cancer 2008 Jan;112(1):119-28

Department of Hematology, University Tor Vergata, S. Eugenio Hospital, Rome, Italy.

Background: Rituximab in sequential combination with fludarabine (Flu) allowed patients with B-cell chronic lymphocytic leukemia (B-CLL) to achieve higher remission rates and longer response duration. Based on their recent experience in indolent non-Hodgkin lymphomas, in this study, the authors attempted to demonstrate whether consolidation/maintenance therapy with rituximab could prolong the response duration in this patient population.

Methods: This Phase II study was based on a consolidation/maintenance therapy with rituximab for patients in complete remission (CR) or partial remission (PR) who were positive for minimal residual disease (MRD), as determined by flow cytometry. Seventy-five symptomatic, untreated patients with B-CLL received 6 monthly cycles of Flu (25 mg/m(2) for 5 days) followed by 4 weekly doses of rituximab (375 mg/m(2)). Then, 28 patients who were positive for MRD were consolidated with 4 monthly cycles of rituximab (375 mg/m(2)) followed by 12 monthly low doses of rituximab (150 mg/m(2)).

Results: Based on National Cancer Institute criteria, 61 of 75 patients (81%) achieved a CR, 10 of 75 patients (13%) had a PR, and 4 of 75 patients (5%) had either no response or disease progression. MRD-positive patients in CR or PR who received consolidation therapy (n = 28 patients) had a significantly longer response duration (87% vs 32% at 5 years; P = .001) compared with a subset of patients who did not receive consolidation therapy (n = 18 patients). All patients experienced a long progression-free survival from the end of induction treatment (73% at 5 years). It was noteworthy that, within the subset of ZAP-70-positive patients, MRD-positive, consolidated patients (n = 12 patients) had a significantly longer response duration (69% vs 0% at 2.6 years; P = .007) compared with MRD-positive, unconsolidated patients (n = 11 patients).

Conclusions: The addition of a consolidation and maintenance therapy with rituximab prolonged response duration significantly in patients with MRD-positive B-CLL.
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http://dx.doi.org/10.1002/cncr.23144DOI Listing
January 2008

High prevalence of asymptomatic vertebral fractures in post-menopausal women receiving chronic glucocorticoid therapy: a cross-sectional outpatient study.

Bone 2006 Aug 30;39(2):253-9. Epub 2006 Mar 30.

Internal Medicine, University of Turin, Italy.

Glucocorticoid (GC)-induced osteoporosis mostly affects trabecular bone of vertebrae. Only 30% of vertebral fractures are symptomatic, yet both clinical and radiological vertebral fractures have been associated with increased mortality and morbidity. The aims of this cross-sectional, outpatient-based study were to measure the prevalence of asymptomatic vertebral fractures in a large sample of post-menopausal women given GCs for different diseases; to compare prevalence of asymptomatic vertebral fractures according to disease, GC treatment and major risk factors; and to assess the quality of life in GC users with and without asymptomatic vertebral fractures. 551 patients referring to 39 centers as outpatients for their programmed follow-up and satisfying the inclusion criteria were included in the analysis. Each patient underwent structured medical interview (including dose and duration of GC therapy, major risk factors for osteoporosis, the quality of life questionnaire of the European Foundation for Osteoporosis (QUALEFFO) and a back function score questionnaire), thoraco-lumbar radiographs and subsequent morphometry; for 253 and 437 patients, respectively, lumbar spine bone mineral density (BMD) assessed by dual energy X-ray absorptiometry and calcaneal bone stiffness assessed by quantitative ultrasonometry were available. The prevalence of asymptomatic vertebral fractures resulted >37%, with >14% of patients having two or more asymptomatic vertebral fractures and was much higher than that found in epidemiological studies on healthy women. Distribution of asymptomatic vertebral fractures along the spine showed a bimodal pattern, with two peaks at T7 and T11. The prevalence of asymptomatic vertebral fractures clearly increased with age. Differences in prevalence among diseases were evidenced. When controlled for age, GC cumulative dose, duration of therapy and personal history of fractures, the adjusted prevalences were 30.77% for systemic lupus erythematosus, 33.78% for rheumatoid arthritis, 37.78% for asthma/chronic obstructive pulmonary disease, 43.20% for polymyalgia rheumatica and 43.36% for diseases grouped as "other vasculitides/connective tissue diseases". No significant association was found with GC cumulative dose and duration of therapy. Established risk factors for osteoporosis (except for age, years since menopause and personal history of fractures), lumbar spine BMD, calcaneal stiffness and QUALEFFO score were not associated with number and severity of asymptomatic vertebral fractures. Underlying disease is likely to contribute to the risk of fracture, but disease by itself could not be dissected from GC regimen. Vertebral fractures should be looked for carefully in all post-menopausal women receiving long-term systemic GCs since they can be asymptomatic and are scarcely predictable.
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http://dx.doi.org/10.1016/j.bone.2006.02.005DOI Listing
August 2006

Extra-curricular physical activity and socioeconomic status in Italian adolescents.

BMC Public Health 2006 Jan 31;6:22. Epub 2006 Jan 31.

Institute of Hygiene, Catholic University Rome, Italy.

Background: The relationship between physical activity and health status has been thoroughly investigated in several studies, while the relation between physical activity and socio-economic status (SES) is less investigated. The aim of this study was to measure the extra-curricular physical activity of adolescents related to the socio-economic status (SES) of their families.

Methods: The survey was carried out by submitting an anonymous questionnaire to junior high school students in the following Regions: Lazio, Abruzzo, Molise, Campania, Puglia, during the school year 2002-2003. Extra-curriculum physical activity was evaluated considering whether or not present and hours of activity weekly conducted. 2411 students agreed to participate in the study.

Results: Participants were 1121 males (46.5%) and 1290 females (53.5%), aged between 11 and 17 years (median age: 12 years). 71.1% of the students reported to practice extra-curricular physical activity. Parents' educational levels and work activities play an important role in predicting students' physical activity, with the more remunerative activities and higher educational levels being more predictive.

Conclusion: The results confirm the relationship between adolescents' physical activity and their families' SES. In particular, a positive relationship between participation in extra-curricular physical activity and their families high SES was found. These data will be useful for school administrators and for politicians in order to reduce the gap between adolescents from the least and most disadvantaged families.
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http://dx.doi.org/10.1186/1471-2458-6-22DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1431521PMC
January 2006

Sequential BCG and electromotive mitomycin versus BCG alone for high-risk superficial bladder cancer: a randomised controlled trial.

Lancet Oncol 2006 Jan;7(1):43-51

Department of Surgery/Urology, Tor Vergata University, Rome, Italy.

Background: The rationale for combining anticancer drugs has not been applied consistently to use of intravesical agents for treatment of superficial bladder cancer, for which immunotherapeutic BCG and chemotherapeutic mitomycin seem to be a potentially effective combination. We aimed to do a prospective, randomised comparison of BCG alone with that of sequential BCG and electromotive mitomycin in patients with stage pT1 bladder cancer.

Methods: After transurethral resection and multiple biopsies, 212 patients with stage pT1 bladder cancer were randomly assigned to: 81 mg BCG infused over 120 min once a week for 6 weeks (n=105); or to 81 mg BCG infused over 120 min once a week for 2 weeks, followed by 40 mg electromotive mitomycin (intravesical electric current 20 mA for 30 min) once a week as one cycle for three cycles (n=107). Complete responders underwent maintenance treatment: those assigned BCG alone had one infusion of 81 mg BCG once a month for 10 months, and those assigned BCG and mitomycin had 40 mg electromotive mitomycin once a month for 2 months, followed by 81 mg BCG once a month as one cycle for three cycles. The primary endpoint was disease-free interval; secondary endpoints were time to progression; overall survival; and disease-specific survival. Analyses were done by intention to treat. This trial has been submitted for registration at the US National Cancer Institute website .

Findings: Median follow-up was 88 months (IQR 63-110). Patients assigned sequential BCG and electromotive mitomycin had higher disease-free interval than did those assigned BCG alone (69 months [95% CI 55-86] vs 21 months [15-54]; difference between groups 48 months [42-54], log-rank p=0.0012). Patients assigned sequential BCG and electromotive mitomycin also had lower recurrence (41.9% [32.7-51.5] vs 57.9% [48.7-67.5]; difference between groups 16.0% [2.7-29.3], log-rank p=0.0012); progression (9.3% [3.8-14.8] vs 21.9% [17.9-25.9]; difference between groups 12.6% [3.0-22.2], log-rank p=0.004); overall mortality (21.5% [13.5-29.5] vs 32.4% [23.4-41.4], difference between groups 10.9% [0.6-21.2], log-rank p=0.045); and disease-specific mortality (5.6% [1.2-10.0] vs 16.2% [6.1-23.3], difference between groups 10.6% [2.5-18.7], log-rank p=0.01). Side-effects were mainly localised to the bladder.

Interpretation: BCG-induced inflammation might increase the permeability of the bladder mucosa such that mitomycin can reach the target tissue more easily and exert its anticancer effect.
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http://dx.doi.org/10.1016/S1470-2045(05)70472-1DOI Listing
January 2006

The addition of rituximab to fludarabine improves clinical outcome in untreated patients with ZAP-70-negative chronic lymphocytic leukemia.

Cancer 2005 Dec;104(12):2743-52

Cattedra di Ematologia, Universitá Tor Vergata, Roma, Italy.

Background: Clinical trials of monoclonal antibodies in combination with chemotherapy have reported previously unattained response rates in patients with B-cell chronic lymphocytic leukemia (B-CLL); however, the analysis of ZAP-70 protein and/or CD38 may explain better the discordant outcomes independent of treatment.

Methods: The authors conducted a Phase II study, in which rituximab was added to fludarabine for patients with symptomatic, untreated CLL, to evaluate clinical outcomes. Sixty patients with B-CLL received 6 monthly courses of fludarabine (25 mg/m(2) for 5 days) followed by 4 weekly doses of rituximab (375 mg/m(2)).

Results: On the basis of National Cancer Institute criteria, 47 of 60 patients (78%) achieved a complete remission, 9 of 60 patients (15%) achieved a partial remission, and 4 of 60 patients (7%) had no response or progressive disease. It is noteworthy that the patients experienced a long progression-free survival (PFS) from treatment (68% at 3 yrs). A significantly shorter PFS was observed in ZAP-70-positive patients (25% vs. 100% at 3 yrs; P = 0.00005), in CD38-positive patients (18% vs. 91% at 3 yrs; P = 0.0002), and in patients who had more minimal residual disease (36% vs. 77% at 2.5 yrs; P = 0.001).

Conclusions: With the addition of rituximab to fludarabine, improved clinical outcomes were obtained, and the stratification of patients by using ZAP-70 and CD38 may help clinicians offer more aggressive and/or experimental approaches to the treatment of patients with high-risk B-CLL subtypes.
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http://dx.doi.org/10.1002/cncr.21535DOI Listing
December 2005

Bile duct injury during laparoscopic cholecystectomy: results of an Italian national survey on 56 591 cholecystectomies.

Arch Surg 2005 Oct;140(10):986-92

Department of Surgical Sciences, Hepato-Biliary Surgery Unit, Catholic University, School of Medicine, Largo Agostino Gemelli 8, 00168 Rome, Italy.

Hypothesis: Bile duct injury (BDI) remains the most serious complication of cholecystectomy. With laparoscopic cholecystectomy (LC), the incidence has become more frequent. This study verifies the current incidence, mechanism, presentation, and treatment of BDI occurring during LC in general surgical practice.

Design: Anonymous retrospective multicenter survey.

Setting: Department of surgery at a university referral center, collecting data from general surgical units.

Patients: Data from 56 591 patients who underwent LC between January 1, 1998, and December 31, 2000, in 184 hospitals in Italy were analyzed.

Main Outcome Measures: Current incidence, mechanism, presentation, and treatment of BDI occurring during LC in general surgical practice.

Results: Two hundred thirty-five BDIs were reported, with an overall incidence of 0.42%. There were no risk factors in 80.0% of the patients. Poor identification of the anatomical features of the hepatic pedicle was the most frequently reported cause (36.8%), and technical problems accounted for 27.0% of causes. The incidence of BDI was higher during cholecystitis (P<.001) and decreased with increasing number of LCs performed by the surgical teams (P<.01). There was no difference in incidence according to technique (French or US) or to routine or selective intraoperative cholangiography. One hundred eight BDIs (46.0%) were recognized intraoperatively and immediately repaired in 89.8% of patients. One hundred twenty-seven BDIs (54.0%) were diagnosed postoperatively, the dominant manifestation being biliary fistula (44.1%).

Conclusions: This study confirms a higher incidence of BDI during LC. It highlights the relevance of the number of previously performed LCs and of the correct surgical technique to avoid BDI. The need for correct procedures, adequate expertise of the repairing surgeon in BDI repairs, and a multidisciplinary approach in the management of BDI is emphasized.
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http://dx.doi.org/10.1001/archsurg.140.10.986DOI Listing
October 2005