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Mavroudis D.,University of Crete | Saloustros E.,Oncology Unit | Malamos N.,Elena Venizelou Hospital | Kakolyris S.,University General Hospital of Alexandroupolis | And 5 more authors.
Annals of Oncology | Year: 2015

Background: Adjuvant trastuzumab in combination with chemotherapy improves survival of women with HER2-positive early breast cancer. In this study, we compared 12 versus 6 months of adjuvant trastuzumab. Patients and methods: Axillary node-positive or high-risk node-negative women with HER2-positive early breast cancer were randomized to receive 12 or 6 months of adjuvant trastuzumab concurrently with dose-dense, granulocyte colony-stimulating factor (G-CSF)-supported docetaxel (75 mg/m2 every 14 days for four cycles). All patients received upfront dose-dense, G-CSF-supported FEC (5-fluorouracil 700 mg/m2, epirubicin 75 mg/m2, cyclophosphamide 700 mg/m2 every 14 days for four cycles). Randomization was carried out before commence of chemotherapy. The primary end point was the 3-year disease-free survival (DFS). Results: A total of 481 patients were randomized to receive 12 months (n = 241) or 6 months (n = 240) of adjuvant trastuzumab. Chemotherapy was completed in 99% and 98% of patients, while trastuzumab therapy in 100% and 96% of patients in the 12- and 6-month groups, respectively. After 47 and 51 months of median follow-up, there were 17 (7.1%) and 28 (11.7%) disease relapses in the 12- and 6-month groups (P = 0.08). The 3-year DFS was 95.7% versus 93.3% in favor of the 12-month treatment group (hazard ratio = 1.57; 95% confidence interval 0.86-2.10; P = 0.137). There was no difference in terms of overall survival and cardiac toxicity between the two groups. Conclusions: Our study failed to show noninferiority for the 6-month arm. The results further support the current standard of care that is administration of adjuvant trastuzumab for 12 months. © The Author 2015. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. Source

Tselebis A.,Sotiria General Hospital of Chest Diseases | Kosmas E.,Pulmonary Rehabilitation Center | Bratis D.,Sotiria General Hospital of Chest Diseases | Moussas G.,Sotiria General Hospital of Chest Diseases | And 5 more authors.
Annals of General Psychiatry | Year: 2010

Background: Chronic obstructive pulmonary disease (COPD) is a major health problem, especially in adults over 40 years of age, and has a great social and economic impact. The psychological morbidity of COPD patients with regard to anxiety and depressive symptoms has been extensively studied in the past. However, few studies have investigated the prevalence of alexithymia in these patients, as well as its association with this comorbidity. Based on this fact, we studied the prevalence of alexithymia and its association with anxiety and depressive symptoms in COPD outpatients.Methods: The present study included 167, randomly selected, outpatients diagnosed with COPD. Alexithymia, anxiety and depression were assessed using the Toronto Alexithymia Scale (TAS-20), Spielberger Trait Anxiety Inventory (STAI), and Beck Depression Inventory (BDI), respectively.Results: The mean BDI score was 12.88 (SD: 7.7), mean STAI score 41.8 (SD: 11.0) and mean TAS-20 score 48.2 (SD: 11.5). No differences were observed between genders regarding age and alexithymia (t test P > 0.05), while female patients presented higher depression and trait anxiety scores than males (t test P < 0.05). Clinically significant levels of anxiety were present in 37.1% of men, and in 45.7% of women. The mean depression score was also higher than the corresponding mean score in the general population (one-sample t test P < 0.01), while 27.7% and 30.5% of the sample presented mild and moderate to severe depression, respectively. Finally, a strong correlation was observed between alexithymia, depression and anxiety.Conclusions: This study confirms the high prevalence of anxiety and depression symptoms in Greek outpatients with COPD. The prevalence of alexithymia in COPD patients, contrary to what has been observed in patients with other chronic respiratory diseases, seem to be lower. However, we observed a strong association between alexithymia, depression and anxiety levels. This observation suggests that alexithymia should be taken into consideration when drafting specific psychotherapeutic interventions for these patients. © 2010 Tselebis et al; licensee BioMed Central Ltd. Source

Iavazzo C.,Iaso Maternity Hospital | Ntziora F.,Laiko General Hospital | Karachalios C.,Elena Venizelou Hospital | Iavazzo P.E.,Rural Practice | Gkegkes I.D.,Korinthos General Hospital
Acta Dermatovenerologica Croatica | Year: 2014

Extramammary Paget disease is a rare disease. Different treatment options are used for its management, among them treatment with imiquimod. Our aim is to clarify the efficacy and safety of the use of topical imiquimod cream in the treatment of extramammary Paget disease. In this article the current literature in Pubmed and Scopus on this topic is reviewed. According to the literature the topical use of imiquimod can be used as first-line treatment in different dosages and durations with excellent results, reaching a 87.5% cure rate with rare complications. The available evidence is currently limited to case reports and a single case series, but is definitely in favor of imiquimod use as an alternative treatment for extramammary Paget disease. Source

Kolokotroni P.,Panteion University | Anagnostopoulos F.,Panteion University | Tsikkinis A.,Elena Venizelou Hospital
Women and Health | Year: 2014

In this article, we reviewed quantitative studies regarding psychosocial factors associated with posttraumatic growth (PTG) in patients with breast cancer to elucidate our understanding of a model of PTG process. PsycInfo, Embase, Medline, Web of Knowledge were used for the search. Only quantitative, English written studies that used the Posttraumatic Growth Inventory (PTGI) measure administered to breast cancer patients were included. The initial search yielded 90 publications. Of those, 22 studies satisfied inclusion criteria and formed the basis of the review. Personality traits (e.g., optimism and openness), cognitive processing of cancer (e.g., deliberate rumination), perceived threat of the disease, coping strategies (e.g., problem-focused), and social support were identified to be related to PTG in women with breast cancer. Demographic characteristics (e.g., age at cancer diagnosis) were also found to play a key role in PTG. The findings of this review provided support to Tedeschi and Calhoun's functional-descriptive model of PTG process. Further directions for research and clinical implications are provided. © Taylor & Francis Group, LLC. Source

Elefsiniotis I.,National and Kapodistrian University of Athens | Tsoumakas K.,National and Kapodistrian University of Athens | Vezali E.,National and Kapodistrian University of Athens | Glynou I.,Elena Venizelou Hospital | And 2 more authors.
International Journal of Gynecology and Obstetrics | Year: 2010

Objective: To determine whether chronic hepatitis B virus (HBV) infection, as evidenced by serum levels of HBsAg and HBV DNA, is a risk factor for spontaneous preterm birth (SPB). Method: The prevalence of HBV infection and the SPB rate were prospectively investigated among 1826 pregnant women, 30.89% Albanian and the remainder of other European origins. Results: Overall, 70 (3.8%) of the women were chronically infected with HBV. HBsAg status was strongly linked to SPB, which incurred to 5 (7.3%) of 64 women with circulating HBsAg compared with 28 (1.6%) of 1703 without current HBV infection (odds ratio, 5.2; P = 0.007). SPB, however, was linked neither to HBsAg levels, nor to HBV DNA levels, nor to the presence or absence of viremia. Conclusion: Pregnant women were found to be at higher risk for SPB if they had circulating HBsAg, and the risk did not seem to be influenced by the levels of HBsAg or HBV DNA. © 2010 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved. Source

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