BRUSSELS, BELGIUM – A unique drug, “Glivec” (STI571) produced and supplied by Novartis, has shown the firm evidence that for the first time, patients with “Unresectable or Metastatic Gastro-intestinal Stromal Tumors” (GIST), can see a significant improvement after taking the drug. The function of the gene responsible for the development of the disease has been altered with the use of the drug. “The drug clearly blocks the cancerous cells in patients with either CML or GIST”, said one of the trial co-ordinators.
One of the studies in GIST was executed as an EORTC (European Organisation for Research and Treatment of Cancer) study in Europe in collaboration with Novartis. The data shown in the case report of a patient in Finland published by the New England Journal of Medicine had led to the setting up of a trial in Europe.
The study was carried out by Prof. A.T van Oosterom, Belgium (Leuven); by Prof. Jaap Verweij, EORTC Vice-President, in Holland (Rotterdam); and by Dr Judson, in United Kingdom (London). The findings from the 40 patient (among these, 36 patients had GIST) multi-center study carried out by three EORTC centers (affiliated institutions) will be presented at the plenary session of the ASCO (American Society of Clinical Oncology) meeting in San Francisco.
Professor A.T van Oosterom, one of the trial co-ordinators, informed delegates at today’s EORTC soft tissue and bone sarcoma meeting in Aarhus (Denmark) that the full scope of the results is not yet ready but these study results are significant. A clinical response to the drug has been observed in a majority of patients and has led to the initiation, a month ago, of a large clinical study carried out in EORTC Centers in collaboration with the Italian and Scandinavian Sarcoma Groups and with the AGITG (Australian Gastrointestinal Trial Group) with already 31 patients accrued.
It is unknown whether the drug is effective for other cancers, but for patients with GIST, which is a rare cancer type (i.e. 4 patients out of one million have GIST), it is a relief.
The drug is not yet registered in the European Union, and it is only distributed to the EORTC investigational centers.
