Project Tarceva
The Tarceva project was launched in January 2008 as a clinical registry of patients with advanced non-small cell lung cancer (NSCLC) who have been treated with Tarceva. The Czech Society for Oncology (CSO) and the Czech Pneumological and Phthiseological Society (CPPS) were expert guarantors of this project. Tarceva usage was later extended to treat pancreatic cancer, and relevant data have been recorded into the registry since then. Data collection for the NSCLC part of the Tarceva registry was terminated in July 2011. Data on Tarceva administration to NSCLC patients are currently being entered into the Tulung registry, while data on Tarceva administration to pancreatic cancer patients continue to be entered into the Tarceva registry. Objectives of the Tarceva project involve monitoring treatment safety and effectiveness, making it possible to analyze epidemiological characteristics of cancer patients and their treatment response, to model the influence of risk factors on survival, and to perform a detailed analysis of adverse reactions.

Lung carcinoma and pancreatic carcinoma

Lung carcinoma and pancreatic carcinoma belong to the most serious cancer diagnoses, with respect to the high incidence (lung carcinoma: 2nd most frequent cancer in the Czech Republic; pancreatic carcinoma: 9th most frequent cancer in the Czech Republic) and low long-term survival (5-year survival: 9,2% for lung carcinoma, 4,4% for pancreatic carcinoma) [Source of data: National Cancer Registry of the Czech Republic]. The so-called biological therapy is very promising, as it takes advantage of immune system properties to fight cancer cells.

Biological anticancer therapy involves drugs such as Tarceva, which specifically attacks cancer cells to stop the cell division, and consequently stops tumour growth. The mechanism of Tarceva action is based on the inhibition of HER1/EGFR receptor (epidermal growth factor receptor). Under normal circumstances, the tyrosin kinase activity of this receptor plays a role in normal cell division; however, a certain type of mutation leads to over-expression of EGFR resulting in its uncontrolled activity and neoplastic transformation of the cell.

The Tarceva project will not only allow monitoring treatment results in patients with advanced lung carcinoma and pancreatic carcinoma, but will also provide background to estimate costs of anticancer therapy in the future, as it will contain a clinically unique dataset of patients treated with Tarceva. Here are the main objectives of the Tarceva project:

Primary objectives of the project:

  • Monitoring the total number of patients treated with Tarceva in the Czech Republic.
  • Assessing the treatment safety of Tarceva.
  • Assessing the treatment effectiveness of Tarceva.

Secondary objectives of the project:

  • Analysis of patients' survival in relation to monitored clinical factors.
  • Analysis of data from patients treated with Tarceva in relation to reference population data of the Czech Republic.

The parametric structure of the registry contains clinical data concerning the diagnosis and extent of disease, as well as data on patient's treatment. The latter are further divided into records related to periods before and after start of treatment by Tarceva. Separate forms are used to record potential adverse drug reactions which could occur during the treatment.

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