The NAME trial: a direct comparison of classical oral Navelbine versus Metronomic Navelbine in metastatic breast cancer.

Chemotherapy for metastatic breast cancer (MBC) is in general given in cycles of maximum tolerated doses to potentially maximize the therapeutic outcome. However, when compared with targeted therapies for MBC, conventional and dose intensified chemotherapy has caused only modest survival benefits during the recent decades, often compromising the quality of life considerably. Navelbine is an antineoplastic agent that has shown efficacy in the treatment of a variety of cancer types, including breast cancer.

Sensitivity of CA 15-3, CEA and serum HER2 in the early detection of recurrence of breast cancer.

Background: The aim of this project was to investigate the sensitivity of CA 15-3, CEA and HER2 in the early diagnosis of metastatic breast cancer.

Methods: Serial serum values of CA 15-3, CEA and HER2 were determined in 107 patients with recurrence after breast cancer. Fifteen of the patients had primary disseminated disease, nine patients only developed local recurrence during the follow-up period and the remaining 83 developed distant metastases.

Changes in the use of antimicrobials and the effects on productivity of swine farms in Denmark.

Objective: To evaluate changes in antimicrobial consumption and productivity by Danish swine farms during 1992 to 2008.

Sample Population: All Danish swine farms for antimicrobial consumption data and a representative sample of Danish swine herds for productivity data.

Procedures: Antimicrobial consumption by Danish swine farms from 1992 to 2008 was determined and evaluated in light of policies to regulate antimicrobial consumption, changes in disease patterns, and productivity data.

Tamoxifen for one year versus two years versus 6 months of Tamoxifen and 6 months of megestrol acetate: a randomized comparison in postmenopausal patients with high-risk breast cancer (DBCG 89C).

From January 1, 1990 to December 31, 1994, DBCG conducted a randomised trial in 1 615 postmenopausal women with operable, high-risk, receptor-positive or -unknown breast cancer. The patients were after surgery randomised to Tamoxifen for 1 year (TAM1), Tamoxifen for 2 years (TAM 2) or Tamoxifen for 6 months followed by megestrol acetate for 6 months (TAM/MA). When the preplanned sample size of 1 500 patients was reached it was decided to continue randomisation to TAM1 or TAM2 and the study was finally closed December 31, 1996.

Psychosocial aspects of lung cancer.

Background: Lung cancer is one of the commonest cancers in the industrialised world, and persons with this grave disease must deal not only with the physical effects but also with the psychosocial aspects.

Methods: This review is based on an examination of intervention, prospective and case-control studies with more than 50 participants published between 1966 and 2003.

Results: The studies show that on average one out of four persons with lung cancer experience periods of depression or other psychosocial problems during their illness.

[The inspection by the Danish Medical Products Agency of drug clinical trials].

An official review by the regulatory authorities of the conduct of a clinical trial is called a GCP-inspection and is an important element of Good Clinical Practice. The Danish Medicines Agency initiated GCP-inspections in Denmark in 1992. The article gives a short description of the inspections together with a few examples of findings during the inspections.

[Hypodynamic respiratory insufficiency. Diagnostic investigation].

Patients with restrictive lung disease, owing to respiratory muscle dysfunction, have no parenchymal involvement. Their vital capacity (VC) and total lung capacity (TLC) are reduced to less than 50% and can lead to pneumonia and nocturnal hypercapnia and hypoxia. Their diffusion capacity is normal.