Onkologie
-
The market authorisation or extension of indication for all oncology drugs in Europe is now based on Regulation (EC) No. 726/2004, a centralised procedure of the European Medicines Agency (EMA). Studies in recent years have highlighted deficiencies in pivotal studies. For example, the requirements of the EMA are not always consistently followed and studies are stopped prematurely after only interim analysis that at this time point shows improved efficacy with regard to the comparator arm. ⋯ To answer patient-relevant issues following market authorisation, it is necessary to conduct independent clinical studies. Increased public funding needs to be provided and bureaucratic hurdles have to be reduced. Only this will permit a more efficient use of limited health care resources and allow to improve the quality of care for cancer patients.
-
Currently, many treatment options and new targets for cancer therapies for patients with advanced non-small cell lung cancer (NSCLC) are being evaluated. This article discusses in detail the significance of first-line and second-line epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) and inhibitors of the vascular endothelial growth factor receptor (VEGFR) and EML4-ALK. Furthermore, the article summarizes the implications and future prospects of using molecular testing in the field of NSCLC with focus on EGFR mutations, KRAS mutation, EML4-ALK fusion gene detection, and EGFR expression.
-
A port-A catheter implantation for cancer patients is popular as a route for chemotherapy. Potential complications exist, such as perforation during chemotherapeutic agent infusion, especially when the port-A tip is incorrectly positioned or when it is in long-term use. ⋯ Hoarseness is a rare complication of port-A perforation and extravasation. To avoid perforation, the tip of the catheter should be located in a high-flow vessel, such as the distal superior vena cava rather than higher in the caval vein, to prevent a locally increased concentration of drugs. We also recommend that a venogram be arranged if extravasation is suspected.