DNK-study: Follow-up of 920 breast carcinoma patients. Basic data published in Clinical Cancer Research (Clin. Cancer Res. 7:4122-4129, 2001). Follow-up March 2002 (medium observation time 49 months) reveals that 181 patients have relapse. 97 were dead of disease. In the breast cancer N1 group we did find a statistical significant survival difference between BM positive and B negative groups. In the N0 group no difference has appeared, but longer follow-up is needed. In the N0 group characterization of primary tumours reveals prognostic impact.
Comparison of direct immunocytochemistry examination, positive immunomagnetic separation by rosettes and RT-PCR for cytokeratin 19, shows that so far only direct immunocytochemistry findings predicts relapse-free survival. 420 of the 920 pateints have undergone new bone marrow examination after 3 years. Further detailed clinicopatholical analyses are being performed.
To settle the importance of number of BM cells examined, number of aspiration foci, and comparisons of findings from aspirations of crista ilica anterior versus crista ilica posterior have been performed. The findings are under preparation for publication.
Further characterization of circulating tumour cells. Multifluorescens characterization has been established and material is being tested both for protein, mRNA and DNA markers. The finding are important for further treatment of the patients with positive events.
Gene expression analyses of primary breast carcinomas and relation to detection of ciruclating tumour cells. In collaboration with Professor Anne-Lise Børresen-Dale, Dept. of Genetics and Professor Pat Brown and David Botstein, Stanford University, we obtain gene expression microarray data from 127 primary carcinomas from the DNK-series. At the same time we develop tissue-microarrays from the whole series (920 cases), which will be used for testing of markers of interest revealed from the mRNA expression features. The work is ongoing and will continue in 2004.
Testing of Normal bone marrow/International collaboration. The collaborative study between Hamburg (Pantel), Augsburg ( Schlimok) and ourselves is now performed and the data are prepared for publication by us.
The method comparison project. In order to find the optimal method for diagnostic use, various methods have been extensively tested. So far approximately 150 patients have been included. Further testing will continue in 2003/2004.
Secondary adjuvant treatment stage II breast carcinoma. This new trial, which is planned to start in 2003. Patients with BM positive events will receive treatment with Herceptin if tumour is Her2 positive, with Docetaxcel and Trastuzumal after specific protocol of Iressa combined with Docetaxol after specific protocol. The last protocol is under critical evaluation based on reports from Japan about increased death rate among patients receiving Iressa.