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Forlì del Sannio, Italy

Ardizzoni A.,Oncologia Medica | Tiseo M.,Oncologia Medica | Boni L.,Azienda Ospedaliero Universitaria Careggi | Vincent A.D.,Netherlands Cancer Institute | And 20 more authors.
Journal of Clinical Oncology | Year: 2012

Purpose: To compare efficacy of pemetrexed versus pemetrexed plus carboplatin in pretreated patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with advanced NSCLC, in progression during or after first-line platinum-based chemotherapy, were randomly assigned to receive pemetrexed (arm A) or pemetrexed plus carboplatin (arm B). Primary end point was progression-free survival (PFS). A preplanned pooled analysis of the results of this study with those of the NVALT7 study was carried out to assess the impact of carboplatin added to pemetrexed in terms of overall survival (OS). Results: From July 2007 to October 2009, 239 patients (arm A, n = 120; arm B, n = 119) were enrolled. Median PFS was 3.6 months for arm A versus 3.5 months for arm B (hazard ratio [HR], 1.05; 95% CI, 0.81 to 1.36; P = .706). No statistically significant differences in response rate, OS, or toxicity were observed. A total of 479 patients were included in the pooled analysis. OS was not improved by the addition of carboplatin to pemetrexed (HR, 90; 95% CI, 0.74 to 1.10; P = .316; P heterogeneity = .495). In the subgroup analyses, the addition of carboplatin to pemetrexed in patients with squamous tumors led to a statistically significant improvement in OS from 5.4 to 9 months (adjusted HR, 0.58; 95% CI, 0.37 to 0.91; P interaction test = .039). Conclusion: Second-line treatment of advanced NSCLC with pemetrexed plus carboplatin does not improve survival outcomes as compared with single-agent pemetrexed. The benefit observed with carboplatin addition in squamous tumors may warrant further investigation. © 2012 by American Society of Clinical Oncology.

Meggiolaro E.,L.E.S.S. | Berardi M.A.,L.E.S.S. | Andritsch E.,Medical University of Graz | Nanni M.G.,University of Ferrara | And 12 more authors.
Palliative and Supportive Care | Year: 2016

Objective: As a part of a European study, we cross-culturally examined the rate of emotional distress and maladaptive coping and their association with cancer patients' satisfaction with their interactions with the physician responsible for their care. Methods: Cancer patients (n = 302) from one Middle European (Austria) and two Southern European (Italy, Spain) countries completed the NCCN Distress Thermometer (DT), the Mini-Mental Adjustment to Cancer (Mini-MAC) Anxious Preoccupation (AP) and Hopelessness (H) sub-scales, and the Physician Patient Satisfaction with Doctors Questionnaire (PSQ). Results: The prevalence of emotional distress (DT caseness) was 60% (26.1% mild, 18.8% moderate, and 14.9% severe distress). Maladaptive coping (Mini-MAC cases) was found in 22.8% (hopeless cases), and 22.5% (anxious preoccupation cases). PSQ-MD was significantly correlated with Mini-MAC/H and Mini-Mac/AP, while PSQ-PS was negatively correlated with Mini-MAC/H. DT cases and those with higher levels of hopelessness reported higher scores on PSQ-MD and lower on PSQ-PS than non-cases. Some differences were found between countries both as far as patients' coping and perception of the interaction with doctors. In hierarchical multiple regression analysis, after adjusting for socio-demographic and medical variables, Mini-MAC/H significantly predicted the scores on PSQ-MD (positive direction) and PSQ-PS (negative direction). Significance of results: The study confirms that about one out of three cancer patients have moderate to high level of emotional distress and about one out of four, clinically significant maladaptive coping. Also, patients showing hopelessness and distress tended to perceive their doctors as both disengaged and less supportive. These results highlights the need for physicians to monitor their patient's level of distress and coping mechanisms and to adjust their own relational and communication style according to patients' psychological condition. Also, cross-cultural issues should be taken into account when exploring psychosocial variables and cancer patients' perception of and satisfaction with the interaction with their doctors. © Copyright Cambridge University Press 2015.

Tumedei M.M.,Biosciences Laboratory | Silvestrini R.,Istituto Oncologico Romagnolo | Ravaioli S.,Biosciences Laboratory | Massa I.,Unit of Biostatistics and Clinical Trials | And 9 more authors.
International Journal of Biological Markers | Year: 2015

Background: Ductal carcinoma in situ (DCIS) is a heterogeneous disease that has not been investigated as widely as invasive breast cancer. Thus, the search for biomarkers capable of identifying DCIS lesions that may recur or progress to invasive cancer is ongoing. Although conventional steroid hormone receptors, cell proliferation and other important tumor markers have been extensively studied in invasive tumors, little is known about the role played by androgen receptors (ARs), widely expressed in breast cancer, in DCIS. Methods: We performed a retrospective study in a series of 43 DCIS patients treated with quadrantectomy only and followed up for a period ranging from 5 to 13 years, to evaluate the prognostic relevance of conventional biomarkers (estrogen receptor [ER], progesterone receptor [PgR], Ki67, human epidermal growth factor receptor 2 [HER2]) and AR. Results: Our findings showed that AR and ER were not independent prognostic variables and that an AR/ER ratio cutoff of 1.13 showed a sensitivity of 75% and a specificity of 94% in predicting in situ relapse or progression to the invasive phenotype. Moreover, while the variables considered singly showed area under the curve (AUC) values ranging from 0.52% to 0.77%, the AR/ER ratio reached a very high AUC (0.92%). Conclusions: These preliminary results highlight the potentially important role of AR and ER and, in particular, of their ratio, as prognostic indicators of DCIS evolution. © 2015 Wichtig Publishing.

Gorini G.,Cancer Prevention and Research Institute ISPO | Carreras G.,Cancer Prevention and Research Institute ISPO | Bosi S.,Lilt | Tamelli M.,Lilt | And 6 more authors.
Preventive Medicine | Year: 2014

Objective: We assessed the effectiveness of the Luoghi di Prevenzione-Prevention Grounds school-based smoking prevention programme. Methods: We undertook a cluster randomized controlled trial of 989 students aged 14-15. years in 13 secondary schools located in Reggio Emilia, Italy. The intervention consisted of the "Smoking Prevention Tour" (SPT) out-of-school workshop, one in-depth lesson on one Smoking Prevention Tour topic, a life-skills peer-led intervention, and enforcement surveillance of school antismoking policy. Self-reported past 30-day smoking of ≥. 20 or 1-19. days of cigarette smoking (daily or frequent smoking, respectively) was recorded in 2 surveys administered immediately before and 18. months after the beginning of the programme. Analysis was by intention to treat. The effect of the intervention was evaluated using random effects logistic regression and propensity score-matching analyses. Results: Past 30-day smoking and daily cigarette use at eighteen months follow-up were 31% and 46% lower, respectively, for intervention students compared to control students. Taking into account non-smokers at baseline only, daily smoking at eighteen months follow-up was 59% lower in intervention students than in controls. Past 30-day smoking in school areas was 62% lower in intervention students compared to controls. Conclusions: The Luoghi di Prevenzione-Prevention Grounds programme was effective in reducing daily smokers and in reducing smoking in school areas. © 2014 Elsevier Inc.

Bosi S.,Lilt | Gorini G.,Cancer Prevention and Research Institute ISPO | Tamelli M.,Lilt | Monti C.,Istituto Oncologico Romagnolo | And 6 more authors.
Tumori | Year: 2013

Aims and background. Few school programs are effective in preventing adolescents' tobacco smoking initiation. The "Lega contro i Tumori - Luoghi di Prevenzione" is a cluster randomized controlled trial designed to evaluate a school-based peer-led smoking prevention intervention with extracurricular activities for students aged 14- 15 years. This paper presents the study design and the baseline characteristics of the study population. Methods and study design. Twenty secondary schools located in the Reggio Emilia province took part in the study. Five schools were excluded because they already participated in smoking prevention interventions. The schools were randomized to control or intervention arms. The study population consisted of students attending the first grade. Components of the intervention included 1) the out-of-school "Smoking Prevention Tour" (SPT) at the "Luoghi di Prevenzione" Center, a 4-hour (4 sessions) extracurricular activity; 2) the "Smoke-free Schools" intervention, combining a life-skills-based peer-led intervention at school, an in-depth lesson on one of the SPT sessions, and enforcement surveillance of the school antismoking policy. Tobacco use was studied through a questionnaire administered before and 6 months after the intervention. Results. Eleven high schools and 9 vocational secondary schools took part in the study for a total of 2,476 out of 3,050 eligible students (81.2%). The proportions of respondents in high schools and vocational secondary schools were 90.9% and 64.5%, respectively (P <0.001). Intervention and control arms showed a different distribution of gender and school type, whereas no difference was observed in any tobacco-use characteristic. Conclusions. This study is one of the few Italian trials to evaluate the effectiveness of a school-based program for preventing smoking initiation.

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