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At least 289 records · Page 16Linked to original sources
PubMed2004

Sentinel lymph node biopsy versus axillary clearance in operable breast cancer: The RACS SNAC trial, a multicenter randomized trial of the Royal Australian College of Surgeons (RACS) Section of Breast Surgery, in collaboration with the National Health and Medical Research Council Clinical Trials Center.

The aim of the SNAC trial is to determine if sentinel node biopsy (SNB) produces less morbidity and equivalent cancer-related outcomes in comparison with immediate axillary clearance (AC) in women with early breast cancer. The intervention is SNB followed by immediate AC, or SNB followed by AC only if the SNB specimen is positive. This is a multicenter, centrally randomized phase III trial of 1000 women stratified according to age, tumor palpability, lymphatic mapping technique, and center. Accrual rate is 26 women per month; 789 women have been randomized to date. Analysis of the first 150 women indicates good compliance with study treatment and acceptable surgical technique.

Adult↗
PubMed2004

Systemic treatment of advanced non-small cell lung cancer.

Lung cancer, a highly lethal malignancy, is the leading cause of cancer-related mortality in the US, accounting for 28% of all deaths related to cancer. Non-small cell lung cancer comprises 80-85% of lung cancer diagnoses and includes the histologies of adenocarcinoma and its subtype bronchoalveolar carcinoma, squamous cell carcinoma and large cell carcinoma. This article reviews the use of cytotoxic chemotherapies and other systemic treatments for patients with advanced (metastatic and/or recurrent) non-small cell lung cancer. Despite great efforts, only minor gains have been made over the past decade in the treatment of advanced non-small cell lung cancer for patients with a good performance status in terms of prolonging survival and improving quality of life. Currently, the standard of treatment is a platinum-based doublet, with the second agent being selected contingent upon the comorbidities of the patient and the toxicity profile of the drug. The focus of clinical research is centered on the application of the use of targeted, molecularly directed therapies, likely used in combination with either cytotoxics and/or other novel targeted agents, in an attempt to improve the therapeutic ratio of systemic treatments for this large population.

Carcinoma, Non-Small-Cell Lung↗
PubMed2004

Maribavir (ViroPharma).

ViroPharma, under license from GlaxoSmithKline, is developing maribavir, a DNA synthesis inhibitor for the potential prevention and treatment of human cytomegalovirus infections related to transplants (including solid organ and hematopoietic stem cells), congenital transmission, and in patients with HIV infection. In July 2004, a phase II trial was initiated.

Animals↗
PubMedDate not supplied

Treatment of unresectable glioblastoma multiforme.

Uncertainty exists about the adequate treatment of adult patients with unresectable, primary, biopsy-proven glioblastoma multiforme (GBM), because the different options for this group of patients have not been evaluated in randomized clinical trials to date. Usually, these patients are lumped together in studies of radiotherapy or combined modality treatment with patients who have undergone extensive surgical resection, although they represent an unfavorable subgroup. This fact led us to review the recently published results for combined radio- and chemotherapy and to compare them with historical data. Management with best supportive care after biopsy resulted in a median survival time of 3 months. Median survival in a historical series of radiotherapy was of the order of 6-7 months and 2-year survival was less than 10%. Combined treatment consistently resulted in a 2-year survival rate of 10-18%. However, the median survival in contemporary series is highly variable, still ranging from 5 to 13 months. Even with the same regimen, large differences in outcome were observed (median survival 5 vs. 9.4 months). In a large randomized trial of radiotherapy vs. radiotherapy plus temozolomide, the subgroup with biopsy only did not benefit significantly from combined treatment. With different radiochemotherapy approaches, the median survival was approximately 5 months in recursive partitioning analysis (RPA) class VI, but 8-14 months in classes IV and V Thus, careful patient selection is necessary to avoid overtreatment in prognostically unfavorable groups with unresectable GBM. In patients qualifying for lengthy regimens of radio-chemotherapy, prospective randomized trials should study whether simultaneous radio- and chemotherapy is superior to radiotherapy alone and, if so, what are the effects of addition of either upfront chemotherapy orpostradiation chemotherapy. Recent data suggest that class prediction models, based on defined molecular profiles, and assessment of MGMT promoter methylation might contribute to improved patient stratification and decision making.

Antineoplastic Agents, Alkylating↗
PubMed1996

An analysis of papers published in the British and European Journals of Orthodontics.

UNLABELLED: The aims of this study were to assess the type, subject, setting and methods of papers published in British Journal of Orthodontics (BJO) and European Journal of Orthodontics (EJO) between 1989 and 1993 to allow all published randomized controlled trials (RCTs) to be identified and a comparison of the papers published in the journals to be made. A hand search of all papers published in BJO and EJO between 1989 and 1993 was performed, and the type, subject, setting, and methods of each paper were classified and recorded. Of the studies, 59.3 per cent related to clinical orthodontics, but only three RCTs were identified in each journal. This comprised 2.8 per cent of the clinical research papers which were analysed. The remaining studies used non-randomized controls or were uncontrolled. Significant differences were found between the type (P < 0.001), subject (P < 0.001), setting (P < 0.01) and methods (P < 0.05) of papers published in the two journals. Relatively more papers in BJO were case reports, clinical opinions and update articles, reported on orthodontic materials or assessed methods of measuring the outcome of treatment. Ninety per cent of papers in EJO reported the results of research projects and relatively more papers, than in BJO, were related to animal studies, and were laboratory based or epidemiological. OBJECTIVES: To identify all randomized controlled trials (RCTs) and compare papers published in two orthodontic journals. DESIGN: A retrospective, observational study. SETTING: The British Journal of Orthodontics (BJO) and European Journals of Orthodontics) (EJO). DATA SOURCE: Papers published between 1989 and 1993. METHOD: A hand search of all papers was performed. The type, subject, setting and methods of each paper were classified and recorded. RESULTS: 200 papers were identified in BJO and 275 in EJO. Six RCTs were identified which represents 2.8 per cent of clinical research papers. Significant differences were found between the type (P < 0.001), subject (P < 0.001), setting (P < 0.01), and methods (P < 0.05) of papers published in the two journals. More papers in BJO were case reports, clinical opinions, and update articles, and reported on orthodontic materials or assessed methods of measuring the outcome of treatment. Ninety per cent of papers in EJU reported the results of research projects. More papers were related to animal studies; were laboratory based on epidemiological. CONCLUSION: Despite the RCT being regarded as the 'Gold Standard' for the evaluation of therapeutic interventions and materials only six (5.1 per cent) of such studies used this method. Significant differences in the type, setting and subject of papers published in BJO and EJO between 1989 and 1993 were found.

Animals↗
PubMed1998

A qualitative assessment of randomized controlled trials in otolaryngology.

In 1996 the CONSORT statement made recommendations on the strict reporting of randomized controlled trials (RCT). This will facilitate the future assessment of such trials and will highlight those trials that have been performed suboptimally and whose results may be biased. We have devised a scoring system, based on CONSORT, to assess RCT quality and by reading each original paper in full we have now assessed the quality of trials published from 1966 to 1995. The mean score for trials identified was 7.3 out of a maximum 12 points. No one journal was significantly better than the others. Trials in rhinology are reported better than head and neck oncology trials (mean scores 7.6 and 6.5 respectively). The past 30 years has not seen an improvement in the quality of the trials. The reporting of RCTs in the ENT literature is poor. CONSORT guidelines now exist and trialists are encouraged to adopt them when conducting future clinical trials.

Head and Neck Neoplasms↗
PubMed2000

[Scandinavian guidelines for management of head injuries. Evidence-based management of minimal, mild and moderate head injuries].

The Scandinavian Neurotrauma Committee (SNC) was created by the Scandinavian Neurosurgical Society in order to develop evidence-based guidelines for improved care of neurotrauma patients. A MEDLINE search identified 475 papers dealing with the management of minimal, mild and moderate head injuries. Forty-two studies presenting Class II evidence on the initial management of such injuries were reviewed, and management guidelines were developed. Implementation of the Head Injury Severity Scale is advocated. Patients with Minimal injuries (no loss of consciousness (LOC), Glasgow Coma Scale (GCS) score 15) can be safely discharged. Routine early computerized tomography (CT) scan is recommended in cases with Mild injuries (history of LOC, GCS 14-15) and patients with normal scans may be discharged. CT scan and admission is mandatory in Moderate injuries (GCS 9-13). All patients with additional risk factors should be scanned and admitted. A flow-chart for clinical decision making and a Head Injury Instruction card is introduced. The SNC suggests guidelines that should be safe and cost-effective for the initial management of minimal, mild and moderate head injuries.

Consciousness↗
PubMed2005

A review of entecavir in the treatment of chronic hepatitis B infection.

BACKGROUND: Infection with the hepatitis B virus (HBV) affects two billion people worldwide, and an estimated 400 million people are chronically infected. Currently, FDA-approved regimens for the treatment of chronic HBV include interferon-alpha2b, peginterferon-alpha2a, lamivudine, adefovir dipivoxil, and recently, entecavir. OBJECTIVE: The purpose of this review is to evaluate the pharmacokinetic and pharmacodynamic properties, and the clinical efficacy and safety of entecavir in the treatment of nucleoside-naĩve and nucleoside-resistant HBeAg-positive and HBeAg-negative chronic hepatitis B (CHB). SEARCH METHODOLOGY: Computerized searches of PubMed and International Pharmaceutical Abstracts from 1985 to July 10, 2005, were performed with the search headings: entecavir, BMS-200475, and chronic hepatitis B. FINDINGS: Entecavir, a new deoxyguanosine analog, represents a third agent within the nucleoside/nucleotide HBV polymerase inhibitor class with distinct advantages over lamivudine and adefovir dipivoxil: it has a three-step mechanism of action, is the most potent inhibitor of HBV DNA polymerase, is not associated with any major adverse effects, and has a limited potential for resistance. In phase II and III clinical trials, entecavir was found to be superior to lamivudine for all primary endpoints evaluated in both nucleoside-naïve and lamivudine-resistant patients. Entecavir was effective in both HBeAg-positive and HBeAg-negative nucleoside-naïve patients. At this time, optimal duration of entecavir therapy is unknown. CONCLUSION: Entecavir represents a new first- or second-line treatment option for patients chronically infected with HBV. Long-term efficacy and safety studies as well as studies of entecavir in combination with interferon products or other nucleoside/nucleotide analogs are eagerly awaited.

Animals↗