General Hospital of Lamia

Lamía, Greece

General Hospital of Lamia

Lamía, Greece
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Valachis A.,PACMeR Medical Oncology and Obstetrics and Gynaecology | Valachis A.,University General Hospital of Heraklion | Polyzos N.P.,PACMeR Medical Oncology and Obstetrics and Gynaecology | Georgulias V.,University General Hospital of Heraklion | And 3 more authors.
Gynecologic Oncology | Year: 2010

Objectives: Recent data suggest that fractures might affect quality of life and survival in early breast cancer patients. Bisphosphonates are effective in treatment and prevention of cancer treatment-induced bone loss, but their value in the prevention of fractures is still investigational. Our aim was to evaluate the fracture rate in breast cancer patients receiving adjuvant bisphosphonates compared with those receiving no treatment or placebo. Methods: Our study is a systematic review and meta-analysis of randomized clinical trials. Trials were located through PubMed, ISI, Cochrane Library and major cancer scientific meetings searches. We identified 21 potentially eligible trials. Of these, 14 studies reported fracture data and were included in the analyses. Overall, 7461 early breast cancer patients were randomized, 3691 received bisphosphonates and 3770 received either placebo or no treatment. Results: Adjuvant breast cancer treatment with bisphosphonates did not reduce the fracture rate compared to placebo or no use either in intent to treat analysis (12 trials, OR = 0.99, 95% CI = 0.73-1.34, p = 0.932) and in comprehensive analysis (all 14 trials included, OR = 0.84, 95% CI = 0.65-1.09 p = 0.197). Treatment with bisphosphonates was not beneficial in postmenopausal patients (7 trials, OR = 0.82, 95% CI = 0.55-1.20 p = 0.298) and in patients receiving aromatase inhibitors (6 trials, OR = 0.79, 95% CI = 0.53-1.17 p = 0.242). Conclusion: Our meta-analysis provides substantial evidence that bisphosphonates in the adjuvant setting among women with breast cancer do not decrease the number of fractures compared with placebo or no treatment. © 2009 Elsevier Inc. All rights reserved.

Kaufmann M.,Goethe University Frankfurt | Von Minckwitz G.,German Breast Group | Mamounas E.P.,Aultman Cancer Center | Cameron D.,University of Edinburgh | And 15 more authors.
Annals of Surgical Oncology | Year: 2012

The use of neoadjuvant systemic therapy (NST) for the treatment of primary breast cancer has constantly increased, especially in trials of new therapeutic regimens. In the 1980 s, NST was shown to substantially improve breast-conserving surgery rates and was first typically used for patients with inoperable locally advanced or inflammatory breast cancer. Investigators have since also used NST as an in vivo test for chemosensitivity by assessing pathologic complete response. Today, by using pathologic response and other biomarkers as intermediate end points, results from trials of new regimens and therapies that use NST are aimed to precede and anticipate the results from larger adjuvant trials. In 2003, a panel of representatives from various breast cancer clinical research groups was first convened in Biedenkopf to formulate recommendations on the use of NST. The obtained consensus was updated in two subsequent meetings in 2004 and 2006. The most recent conference on recommendations on the use of NST took place in 2010 and forms the basis of this report. Since the last consensus meeting on neoadjuvant systemic therapy (NST) in 2006, knowledge has increased on intrinsic subtype responses, different chemotherapy and trastuzumab regimens' response evaluation, and the use of sentinel lymph node biopsy (SLNB).1 The aim of this update was to integrate this new knowledge into the current practice of NST in primary breast cancer. © Society of Surgical Oncology 2011.

Liaska A.,General Hospital of Lamia | Papaconstantinou D.,National and Kapodistrian University of Athens | Georgalas I.,National and Kapodistrian University of Athens | Koutsandrea C.,National and Kapodistrian University of Athens | And 2 more authors.
Seminars in Ophthalmology | Year: 2014

Background: To examine the efficacy and safety of combined phaco-trabeculectomy in patients with cataract and controlled, open-angle advanced glaucoma and to identify preoperative predictive factors of postoperative glaucoma course. Setting: Departments of Ophthalmology, University of Athens, and General Hospital of Lamia, Greece. Methods: Prospective, interventional, parallel, cluster (units=examinations), randomized clinical study. 60 patients with visually significant cataract, visual field Mean Deviation (MD) worse than-15.0dB, and preoperative intraocular pressure (IOP), controlled (consistently below 22mmHg) on topical medications and with no previous ocular surgery, were randomly allocated (1:1) to phacoemulsification alone or phaco-trabeculectomy group. Intention-to-treat analysis was performed to compare the postoperative outcome and adjusted multivariate longitudinal linear regression analysis was performed to identify predictive factors of the main outcome measures, with postoperative visual field MD change up to two years postoperatively. Participant recruiters and data collectors were masked to group assignment. Results: 31 and 29 patients were randomized to phacoemulsification alone and phaco-trabeculectomy groups, respectively. Patients assigned to the phaco-trabeculectomy group experienced a 1.7mmHg [95% CI:-3.1 to-0.23] reduction in IOP, a 1.4dB [95% CI:-0.17 to 2.96] improvement in visual fields MD, a 0.6 [95% CI:-1.2 to-0.05] reduction in the number of glaucoma medications needed postoperatively, while the visual acuity improvement was similar between the two groups. Best predictors for visual field MD: degree of nuclear sclerosis, relative afferent pupilary defect (RAPD), preoperative MD deviation from-19.0dB and preoperative cup-disc ratio deviation from 0.9. The phacoemulsification group experienced more IOP spikes (>25mmHg) with Odds Ratio (OR) of 0.34 [95% CI: 0.11-1.02]. No patient lost light perception. Conclusion: Phaco-trabeculectomy in advanced, controlled, open-angle glaucoma patients with cataract results in better postoperative visual field MD with no major adverse events. © 2014 Informa Healthcare USA, Inc.

Valachis A.,Central Hospital of Eskilstuna | Tsali L.,General Hospital of Lamia | Tsali L.,Aristotle University of Thessaloniki | Pesce L.L.,University of Chicago | And 5 more authors.
Obstetrical and Gynecological Survey | Year: 2010

Background: An increased number of women are expected to conceive after the diagnosis of early breast cancer. Most physicians recommend that pregnancy be delayed by 2 to 3 years after diagnosis of early breast cancer, but this recommendation is based on data from trials with small patient cohorts. Furthermore, a healthy mother effect (HME) selection bias may be operative in most of these studies, because women undergoing childbearing after treatment were healthier when compared with the control group. AIM:: To perform a systematic review and meta-analysis of published trials corrected for HME bias so as to assess the effect of pregnancy (at least 10 months after diagnosis) versus no pregnancy on overall survival of primary breast cancer patients less than 45 years. METHODS:: We searched MEDLINE and Thomson Reuters (ISI) Web of Knowledge for eligible studies. From each study we extracted the relative hazard ratio or, if not provided, all the necessary data to impute it. In cases where the duration from diagnosis to pregnancy was not reported, we extracted relevant data to estimate it. RESULTS:: Our electronic search strategy yielded 1623 hits pertaining to 20 potentially eligible studies involving 49,370 premenopausal breast cancer patients. Ten studies were eligible after considering HME potential bias in matching controls. Among these, 9 studies (pregnant 1089, matched-controls 13051) contained data appropriate for analysis. Overall survival was statistically higher among patients who became pregnant compared to controls: fixed effect model estimated pooled hazard ratio for death 0.51 (95% confidence interval: 0.42-0.62). No study heterogeneity was observed: Q = 10.4, P = 0.17; I = 48%. Conclusion: The pooled available evidence indicates that in early breast cancer patients, pregnancy that occurs at least 10 months after diagnosis does not jeopardize prognosis and may actually confer significant survival benefit. Target Audience: Obstetricians & Gynecologists, Family Physicians Learning Objectives: After completing this CME activity, physicians should be better able to assess the effect pregnancy has on long-term survival in primary breast cancer patients under age 45; counsel patients on the safety of pregnancy after breast cancer diagnosis and treatment; and interpret how pregnancy may be associated with improved breast cancer survival. Copyright © 2011 by Lippincott Williams & Wilkins.

Valachis A.,Malarjukhuset | Polyzos N.P.,Vrije Universiteit Brussel | Nearchou A.,Malarjukhuset | Lind P.,Malarjukhuset | And 2 more authors.
Journal of Clinical Oncology | Year: 2012

Purpose: A potential financial relationship between investigators and pharmaceutical manufacturers has been associated with an increased likelihood of reporting favorable conclusions about a sponsor's proprietary agent in pharmacoeconomic studies. The purpose of this study is to investigate whether there is an association between financial relationships and outcome in economic analyses of new targeted therapies in oncology. Materials and Methods: We searched PubMed (last update June 2011) for economic analyses of targeted therapies (including monoclonal antibodies, tyrosine-kinase inhibitors, and mammalian target of rapamycin inhibitors) in oncology. The trials were qualitatively rated regarding the cost assessment as favorable, neutral, or unfavorable on the basis of prespecified criteria. Results Overall, 81 eligible studies were identified. Economic analyses that were funded by pharmaceutical companies were more likely to report favorable qualitative cost estimates (28 [82%] of 34 v 21 [45%] of 47; P = .003). The presence of an author affiliated with manufacturer was not associated with study outcome. Furthermore, if only studies including a conflict of interest statement were included (66 of 81), studies that reported any financial relationship with manufacturers (author affiliation and/or funding and/or other financial relationship) were more likely to report favorable results of targeted therapies compared with studies without financial relationship (32 [71%] of 45 v nine [43%] of 21; P = .025). Conclusion: Our study reveals a potential threat for industry-related bias in economic analyses of targeted therapies in oncology in favor of analyses with financial relationships between authors and manufacturers. A more balanced funding of economic analyses from other sources may allow greater confidence in the interpretation of their results. © 2012 by American Society of Clinical Oncology.

Mauri D.,General Hospital of Lamia | Tsiara A.,General Hospital of Lamia | Valachis A.,Onkologkliniken Sormland | Kalopita K.,General Hospital of Lamia | And 3 more authors.
BMJ Supportive and Palliative Care | Year: 2013

Background: Cancer cachexia is a common associate of cancer and has a negative impact on patients' survival. Nonetheless, cancer cachexia assessment and management are frequently less than satisfactory in daily practice. Aim: To scrutinise global cancer cachexia awareness and relative web guideline implementation among oncology societies. Methods: Systematical identification of scientific and policymaker oncology societies and their guideline implementation on cancer cachexia. Assessment of the general level of awareness on cancer cachexia and evaluation of intercontinental and national variations on guideline implementation. Results: 144 000 web pages were scrutinised, and 275 oncology societies identified covering a large array of oncology setting (educational/ clinical/research/policymaker); 71 were international (African, American, Asian, European, Oceania and Intercontinental), 110 belonged to the top 10 countries with the highest development index and 94 pertained to 10 countries with a long lasting tradition in medical oncology (not included in the top 10 high developed countries). Overall, only 10/275 web sites provided guidelines; six of them (2.2%) provided guidelines for physicians and four (0.7%) for patients. Half of the guidelines (4/10) were outdated. All guidelines for physicians reported references, while only one of the recommendations for patients reported references to support its sentences. Conclusions: Cancer cachexia global awareness appears extremely low; guideline implementation on the web was inconsistent for any category analysed (nation vs continent vs international vs society type vs physician vs patient oriented) and for updating.

Mauri D.,General Hospital of Lamia | Mauri D.,Panhellenic Association for Continual Medical Research PACMeR | Kamposioras K.,Panhellenic Association for Continual Medical Research PACMeR | Tsali L.,General Hospital of Lamia | And 9 more authors.
Cancer Treatment Reviews | Year: 2010

Background: Taxanes have been extensively tested in patients with advanced breast cancer, but it is unclear whether their weekly use might offer any benefits against standard every three weeks administration. We therefore performed a meta-analysis of randomized controlled trials that compared weekly and every three weeks taxanes regimens in advanced breast cancer. Methods: The endpoints that we assessed were objective response rate, progression free survival (PFS) and overall survival. Efficacy data for paclitaxel and docetaxel were separately analyzed. Trials were located through PubMed and Cochrane Library searches and abstracts of major international conferences. Results: Οbjective response rate was notably better when paclitaxel was used as every three weeks regimen (7 studies, 1772 patients, fixed effect model pooled RR 1.20 95%CI 1.08-1.32 p < 0.001). No difference were found for PFS (6 studies, 1610 patients, random effect model HR 1.02, 95%CI 0.81-1.30 p = 0.860); while OS was statistically higher among patients receiving weekly paclitaxel (5 studies, 1471 patients, fixed effect model pooled HR 0.78, 95%CI 0.67-0.89 p = 0.001). No differences were observed for the weekly compared to the every three weeks use of docetaxel either for objective response, PFS and OS. Overall, the incidence of serious adverse events, neutropenia, neutropenic fever, and peripheral neuropathy were significantly lower in weekly taxanes schedules. The incidence of nail changes and epiphora were significantly lower in the every three weeks docetaxel regimens. Conclusions: Use of paclitaxel in weekly regimen give overall survival advantages compared with the standard every three weeks regimen. The observed survival benefit does not seem to stem from an increased potency of the drug with weekly regimens. The use of weekly paclitaxel regimens is therefore recommended for the treatment of locally advanced/metastatic breast cancer. © 2009 Elsevier Ltd. All rights reserved.

Salanti G.,University of Ioannina | Dias S.,University of Bristol | Welton N.J.,University of Bristol | Ades A.E.,University of Bristol | And 7 more authors.
Statistics in Medicine | Year: 2010

Multiple-treatments meta-analyses are increasingly used to evaluate the relative effectiveness of several competing regimens. In some fields which evolve with the continuous introduction of new agents over time, it is possible that in trials comparing older with newer regimens the effectiveness of the latter is exaggerated. Optimism bias, conflicts of interest and other forces may be responsible for this exaggeration, but its magnitude and impact, if any, needs to be formally assessed in each case. Whereas such novelty bias is not identifiable in a pair-wise meta-analysis, it is possible to explore it in a network of trials involving several treatments. To evaluate the hypothesis of novel agent effects and adjust for them, we developed a multiple-treatments meta-regression model fitted within a Bayesian framework. When there are several multiple-treatments meta-analyses for diverse conditions within the same field/specialty with similar agents involved, one may consider either different novel agent effects in each meta-analysis or may consider the effects to be exchangeable across the different conditions and outcomes. As an application, we evaluate the impact of modelling and adjusting for novel agent effects for chemotherapy and other non-hormonal systemic treatments for three malignancies. We present the results and the impact of different model assumptions to the relative ranking of the various regimens in each network. We established that multiple-treatments meta-regression is a good method for examining whether novel agent effects are present and estimation of their magnitude in the three worked examples suggests an exaggeration of the hazard ratio by 6 per cent (2-11 per cent). © 2010 John Wiley & Sons, Ltd.

Mauri D.,General Hospital of Lamia | Mauri D.,Panhellenic Association for Continual Medical Research PACMeR | Valachis A.,Panhellenic Association for Continual Medical Research PACMeR | Valachis A.,University of Crete | And 5 more authors.
JNCCN Journal of the National Comprehensive Cancer Network | Year: 2010

To address whether the use of bisphosphonates in the adjuvant setting of breast cancer might have any effect on the natural course of the disease, a meta-analysis was conducted of published and unpublished randomized controlled trials found in PubMed, the Cochrane Central Register of Controlled Trials, the ISI Web of Knowledge, and abstracts of major international conferences up to January 2009. All trials that randomized patients with primary breast cancer to undergo adjuvant treatment with any bisphosphonate versus non-use were considered eligible. Analysis included data from 13 eligible trials involving 6886 patients randomized to treatment with bisphosphonates (n = 3414) or either placebo or no treatment (n = 3472). Compared with no use, adjuvant breast cancer treatment with bisphosphonates did not reduce the overall number of deaths (odds ratio [OR], 0.708; 95% Cl, 0.482-1.041; P = .079), bone metastases (OR, 0.925; 95% Cl, 0.768-1.114; P = .413), overall disease recurrences (OR, 0.843; 95% Cl, 0.602-1.181; P = .321), distant relapse (OR, 0.896; 95% Cl, 0.674-1.192; P = .453), visceral recurrences (OR, 1.051; 95% Cl, 0.686-1.609; P = .820), or local relapses (OR, 1.056; 95% Cl, 0.750-1.487; P = .756). No significant heterogeneity was observed among the trials except for estimates of deaths and disease recurrences (P = .034 and P = .016, respectively). In subgroup analyses, use of zoledronic acid was associated with a statistically significant lower risk for disease recurrence (OR, 0.675; 95% Cl, 0.479-0.952; P = .025). However, these results should be interpreted with caution because the statistical significance for this association was weak and might be attributed to chance from multi-test analyses. Use of zoledronic acid was not associated with any significant difference in death (OR, 0.642; 95% Cl, 0.388-1.063) and bone metastasis rates (OR, 0.661; 95% Cl, 0.379-1.151). Currently available evidence does not support the hypothesis that use of bisphosphonates in adjuvant treatment of early breast cancer will alter the natural course of the disease. Nonetheless, a nonsignificant trend seems to exist for better outcomes in patients undergoing bisphosphonate treatment. Until further evidence from new clinical trials becomes available, adjuvant bisphosphonates should not be recommended routinely. © Journal of the National Comprehensive Cancer Network.

Valachis A.,University General Hospital of Heraklion | Polyzos N.P.,PACMeR | Polyzos N.P.,University General Hospital of Larisa | Patsopoulos N.A.,Harvard University | And 4 more authors.
Breast Cancer Research and Treatment | Year: 2010

Abstract:: Numerous studies have demonstrated that angiogenesis and in particular VEGF over-expression play an essential role in the progression and metastatic potential of breast cancer. Bevacizumab is a humanized recombinant monoclonal antibody that specifically blocks the binding of VEGF to high-affinity receptors and it has been recently used for the treatment of metastatic breast cancer. We conducted a meta-analysis to synthesize available evidence for use of bevacizumab in metastatic breast cancer patients. Systematic review and meta-analysis of available trials. Primary outcomes were overall survival, progression free survival (PFS) and objective response rate (ORR). Five trials were identified with 3,163 eligible patients. Combination of bevacizumab and chemotherapy resulted in a statistically significant improvement in PFS (HR = 0.70, 95% CI 0.60-0.82, P = 9.3 × 10-6) and ORR (RR = 1.26, 95% CI 1.17-1.37, P = 9.96 × 10-9) compared with chemotherapy alone. Differences in objective response rates were substantial independently by the type of chemotherapy used, while PFS advantages were observed only for taxanes. The pooled HR for overall survival did not show significant advantage for the use of bevacizumab compared to placebo arm (HR = 0.90, 95% CI 0.80-1.03, P = 0.119). This meta-analysis shows that the addition of bevacizumab to chemotherapy offers meaningful improvement in PFS and ORR in patients with metastatic breast cancer. Bevacizumab treatment might be suggested for treatment of 1st line metastatic breast cancer, but more data are needed until statistical overall survival differences will be documented and firm guideline recommendation could be given. © 2010 Springer Science+Business Media, LLC.

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