Phase III clinical study promising drug against prostate cancer reveals surprising results -
A recently published clinical international phase III trial of a promising drug for the treatment of advanced prostate cancer ended with surprising results: the new agent failed to achieve a significant improvement in overall survival compared with the established standard treatment. This and other data from the study were published in the leading magazine "Journal of Clinical Oncology." MedUni Vienna researchers have played an important role in the study. The study was coordinated by the recently named "best hospital" in the United States, Massachusetts General Hospital (MGH) Harvard Medical School.
The "Urologic Neoplasms" working group in the Department of Viennese medical MedUni I Vienna Hospital General is known for oncologists worldwide as a research team with recognized expertise in the modern treatment Prostate cancer. In 2012, the team was invited to participate in an international study for a new drug (cabozantinib) for the treatment of advanced - so-called castration-resistant - prostate cancer. Group Michael Krainer, head of the Urological Tumours work and is currently working as a visiting scholar in the US at the invitation of MGH, had this to say about the results: "Although in most cases, increased cabozantinib the overall survival of patients with one to two months, this effect was not statistically significant compared to the current standard treatment. this surprised us, insofar Phase II studies have shown a clear improvement for patients in many areas. "
Cabozantinib is an inhibitor administered orally certain cell signaling pathways (such as MET receptor tyrosine kinase and the vascular endothelial Growth Factor (VEGF), that are closely associated with the development and progression of prostate cancer. and, in fact, initial clinical studies have shown that administration of cabozantinib had a beneficial effect on disease progression for patients with cancer of the prostate. progression-free survival of patients was extended and improved quality of life
Following these promising results, we decided to measure overall survival in the subsequent Phase III randomized study with over 1000 patients " says Krainer. "It took many more patients and a lot more time to determine this criterion as necessary in previous studies." Patients with metastases, prostate cancer resistant to castration, which had bone metastases, were specifically chosen. The fact that no significant improvement in overall survival was seen in this group, despite the advantages previously measured, came as a surprise - especially as the phase III study again showed significant improvements in secondary endpoints such as response of bone scintigraphy and radiological progression free survival. The active agent was also associated with a reduction in circulating tumor cells, improved biological parameters and reduced bone-onset skeletal problems. Krainer: "However, there was no significant response in terms of PSA (Prostate Specific Antigen) level."
For researchers MedUni Vienna, this once again underscores the value of comprehensive clinical studies, the working group is respected internationally for support: "Of course, it is disappointing for patients when a promising therapeutic approach ends being no better than the current treatment Nevertheless, results such as those obtained for cabozantinib teach us a lot about the challenges we still face on. how to provide better treatments against prostate cancer. It is therefore extremely important to take part in such studies, not only for the research centers, but especially for our patients. There is no better care for cancer patients than the care they receive as participants in clinical studies. "
EmoticonEmoticon