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Abstract: Objective: Measurements from health-related quality-of-life (HRQoL) studies, although usually of an ordered categorical nature, are typically treated as continuous variables, allowing the calculation of mean values and the administration of parametric statistics, such as t-tests. We investigated whether parametric, compared to nonparametric, analyses of ordered categorical data may lead to different conclusions. Study Design and Setting: HRQoL data were obtained from patients with a diagnosis of asthma (n =192) and chronic obstructive pulmonary disease (COPD; n =88) at two time points. The impact of the group factor (asthma vs. COPD) and the time factor (t1 vs. t2) on HRQoL was analyzed with a metric approach (repeated measures ANOVA) and two ordinal approaches (each with a nonparametric repeated measures ANOVA). Results: Using the metric approach, a significant effect of “group” (P =0.0061) and “time” (P =0.0049) on HRQoL was found. The first ordinal approach (ranked total score) still showed a significant effect for “group” (P =0.0033) with a worse HRQoL for patients suffering from COPD. In the second approach (ranks for each HRQoL item and summed ranks), there were no significant effects. Conclusion: Applying simple parametric methods to ordered categorical HRQoL scores led to different results from those obtained with nonparametric methods. In these cases, an ordinal approach will prevent inappropriate conclusions. [Copyright &y& Elsevier]

Abstract: Objectives: Guidelines recommend using the lowest effective dose of oestrogen for the management of vasomotor symptoms in postmenopausal women. The primary aim of this double-blind, multi-centre, randomised study was to assess the efficacy of oral ultra-low dose continuous combined hormone replacement therapy with 17β-oestradiol and dydrogesterone. Study design: 313 women with ≥50 moderate to severe hot flushes during the previous week were randomised to 0.5mg 17β-oestradiol/2.5mg dydrogesterone (E 0.5mg/D 2.5mg), 1mg 17β-oestradiol/5mg dydrogesterone (E 1mg/D 5mg) or placebo for 13 weeks. The placebo group then switched to E 0.5mg/D 2.5mg for a further 39 weeks, whilst the other groups continued on the same treatment. Results: After 13 weeks, the reduction in the number of moderate to severe hot flushes/day in the E 0.5mg/D 2.5mg group was greater than in the placebo group (−6.4 vs. −4.9, p <0.001) and comparable to that in the 1/5mg group (−6.3). E 0.5mg/D 2.5mg and E 1mg/D 5mg significantly improved the total Menopause Rating Scale score. The number of bleeding/spotting days was lower with E 0.5mg/D 2.5mg than with E 1mg/D 5mg. The overall amenorrhoea rate with E 0.5mg/D 2.5mg was 81%; this increased to 91% in months 10–12. Conclusions: Continuous combined 0.5mg 17β-oestradiol and 2.5mg dydrogesterone was effective in alleviating vasomotor symptoms and improving quality of life, and was associated with a high amenorrhoea rate and a good tolerability profile. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To investigate the influence of different bleaching techniques on subsurface physical properties of composite and polyacid modified composite tested via determination of micro-hardness. Methods: Specimens of Tetric Flow, Tetric EvoCeram and Compoglass were light cured (2.5mm thickness) and stored in artificial saliva for 2 weeks (n =12/group). The samples were only removed for application of the following bleaching agents in a humid atmosphere: Either Vivastyle (1h/d), Whitestrips (30min/d), sodium-perborate–water mixture (once for 72h), Simply White (1h/d), or Opalescence XtraBoost (1st and 5th day for 15min) were applied on the surfaces of the samples. Untreated specimens served as negative controls, samples treated with ethyl alcohol for 1h acted as positive controls. After the bleaching period, samples were cross-sectioned and the micro-hardness (Knoop) of different subsurface levels (0.1mm–2.0mm) was determined. Results: All bleaching techniques significantly reduced the Knoop-hardness of the restoratives compared to untreated controls. Thereby, bleaching significantly affected not only superficial but also the deep layers of the specimens: in superficial layers (0.1mm, 0.2mm) lowest micro-hardness values amounted to 69.5% and 76.3% of the respective untreated controls (Compoglass/Vivastyle). In deeper subsurface levels, the lowest hardness was observed with Opalescence/Tetric EvoCeram (0.3mm: 78.3%; 0.4mm: 80%; 0.5mm: 80.5%; 1.0mm: 84.2%; 2.0mm: 84.4%). Significance: Bleaching with the tested bleaching agents softens the adhesive restorative materials examined. Due to the fact that subsurface layers are also affected, polishing of the surface may not suffice for re-establishing the physical properties of the surface of the fillings. [Copyright &y& Elsevier]

Summary: Although considerable knowledge exists on the tumor biology of lung cancer, there is still a need to assess molecular events for the clinical management of the disease. We studied the pattern of chromosomal imbalances in 45 non-small cell lung carcinomas (NSCLC) by comparative genomic hybridization (CGH) and correlated the results with clinicopathological features including immunohistochemical (IHC) expression of the epidermal growth factor receptor (EGFR). Twenty-one tumors were squamous cell carcinomas (SCC) and 24 non-squamous cell lung carcinomas (NSCC) comprising 9 adenocarcinomas (ADC), 9 large cell carcinomas (LCC), 4 sarcomatoid carcinomas and 2 adenosquamous carcinomas. The mean number of individual imbalances was 7.1 for SCC (mean gains, 3.8; mean losses, 3.4) and 6.4 for NSCC (mean gains, 4.5; mean losses, 1.9). Several individual imbalances correlated significantly with increasing number of imbalances, that were +1q, −3p, +3q, −5q, −8p, +8q, +7p, +12p, and +14q. Altogether, the most frequent imbalances were +3q (49%), +5p (49%), −5q (36%), +8q (29%), −8p (24%), −3p (22%), +7p (22%), +12p (22%), +14q (20%), +18p (20%), +1q (18%), and +7q (18%). Among these, +3q and +18p correlated significantly with SCC, and +5p and +14q with NSCC. Remarkably, overlapping imbalances included +3q26, +7p11 in SCC and +1q21, +3q24, +12p11, and +14q12 in NSCC. EGFR expression was higher in SCC than in NSCC and correlated with +3q in the entire series. In addition, +12p correlated significantly with disease progress with the exception of nodal involvement in NSCC as well as with disease progress, regardless of nodal involvement, in the entire series. In conclusion, the present study contributes to the molecular biological characterization of NSCLC histological subtypes and through evaluation of molecular events to the recently emergent focus on novel markers for lung cancer treatment. [Copyright &y& Elsevier]

Purpose: The aim of this study was to evaluate the efficacy of adjuvant radiotherapy after transoral laser microsurgery for advanced recurrent head-and-neck squamous cell carcinoma (HNSCC). Patients and Methods: Between 1988 and 2000, 37 patients with advanced local recurrences (23 local and 14 locoregional recurrences) of HNSCC without distant metastases were treated in curative intent with organ-preserving transoral laser microsurgery and adjuvant radiotherapy (before 1994 split-course radiotherapy with carboplatinum, after 1994 conventional radiotherapy). Initial therapy of the primary (8.1% oral cavity, 35.1% oropharynx, 13.5% hypopharynx, and 43.3% larynx) before relapse was organ-preserving transoral laser microsurgery without any adjuvant therapy. Results: After a median follow-up of 124 months, the 5-year overall survival rate was 21.3%, the loco-regional control rate 48.3%, respectively. In multivariate analysis, stage of original primary tumor (Stage I/II vs. Stage III/IV), and patient age (<58 years vs. ≥58 years) showed statistically significant impact on prognosis. In laryngeal cancer, larynx preservation rate after treatment for recurrent tumor was 50% during follow-up. Conclusion: Our data show that organ-preserving transoral laser microsurgery followed by adjuvant radiotherapy is a curative option for patients who have advanced recurrence after transoral laser surgery and is an alternative to radical treatment. [Copyright &y& Elsevier]

Purpose: To evaluate the efficacy of an adjuvant radiotherapy after transoral laser microsurgery for advanced squamous cell carcinoma of the head and neck and to show that a less invasive surgery with organ preservation in combination with radiotherapy is an alternative to a radical treatment. Patients and Methods: Between 1987 and 2000, 208 patients with advanced squamous cell carcinoma of the head and neck were treated with postoperative radiotherapy after surgical CO2 laser resection. Primary sites included oral cavity, 38; oropharynx, 88; larynx, 36; hypopharynx, 46. Disease stages were as follows: Stage III, 40 patients; Stage IV, 168 patients. Before 1994, the treatment consisted of a split-course radiotherapy with carboplatinum (Treatment A). After 1994, the patients received a conventional radiotherapy (Treatment B). Results: Patients had 5-year locoregional control and disease-specific survival (DSS) rates of 68% and 48%, respectively. The 5-year DSS was 70% and 44% for Stages III and IV, respectively (p = 0.00127). Patients treated with a hemoglobin level greater or equal to 13.5 g/dL before radiotherapy had a 5-year DSS of 55% as compared with 39% for patients treated with a hemoglobin level greater than 13.5 g/dL (p = 0.0054). Conclusion: In this series of patients with advanced head-and-neck tumors, transoral laser surgery in combination with adjuvant radiotherapy resulted in locoregional control and DSS rates similar to those reported for radical surgery followed by radiotherapy. Treatment B has clearly been superior to Treatment A. A further improvement of our treatment regimen might be expected by the combination of adjuvant radiotherapy with concomitant platinum-based chemotherapy. [Copyright &y& Elsevier]