Project Tarceva
The former Tarceva project was launched in January 2008 as a clinical registry of patients with advanced non-small cell lung cancer (NSCLC) who had been treated with Tarceva. In February 2009, Tarceva administration was approved for the treatment of 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 Pancreas (former Tarceva) registry. The project monitors both safety and effectiveness of treatment with erlotinib, making it possible to analyze epidemiological characteristics of pancreatic cancer patients and their treatment response, to model the influence of risk factors on survival, and to perform a detailed analysis of adverse reactions.

PLEASE NOTE: 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.

Pancreatic cancer

Incidence rates for pancreatic cancer are alarming in the Czech Republic, and have shown a continuous rise (Fig. 1) [2]. According to the latest figures released by IARC [2], Czech pancreatic cancer incidence rates rank 1st both in Europe and worldwide (Fig. 2). Czech pancreatic cancer mortality rates nowadays rank 3rd globally and 2nd in Europe, when taking both sexes into account (Fig. 3). Prognosis of this disease is rather poor. Despite every effort, the 5-year survival rate of pancreatic cancer patients only amounts to 5%.

Figure 1: Pancreatic cancer incidence and mortality in the Czech Republic (both sexes), per 100,000 persons. Data source: CNCR [1].

Figure 2: International comparison of pancreatic cancer incidence rates.
ASR(W) - age-standardised world incidence rate per 100,000 population.
Left to right: both sexes, men, women. Source: GLOBOCAN 2012 [1].

Figure 3: International comparison of pancreatic cancer mortality rates.
ASR(W) - age-standardised world mortality rate per 100,000 population.
Left to right: both sexes, men, women. Source: GLOBOCAN 2012 [1].

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 pancreatic cancer, 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.

References

  1. Institute of Health Information and Statistics of the Czech Republic: Czech National Cancer Registry (CNCR) [19.6.2014]. Available from WWW: http://www.uzis.cz/registry-nzis/nor.
  2. Ferlay, J., Soerjomataram, I., Ervik, M., Dikshit, R., Eser, S., Mathers, C., Rebelo, M., Parkin, D.M., Forman, D., Bray, F.: GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [online]. International Agency for Research on Cancer, Lyon (France) 2013. Available from WWW: http://globocan.iarc.fr.
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