Clinical registry of non-small cell lung cancer (NSCLC) patients who have been treated with bevacizumab (Avastin®), erlotinib (Tarceva®), gefitinib (Iressa®), pemetrexed (Alimta®), afatinib (Giotrif®) and/or nintedanib (Vargatef®).
start of the project: April 2011
The term “lung cancer” encompasses both malignant neoplasms of bronchi and tumours having their origin in the lung parenchyma. In clinical practice, lung cancer is most frequently classified as small cell lung cancer (SCLC) or non-small cell lung cancer (NSCLC). These groups have different biological properties, resulting into a different approach to treatment.
NSCLCs grow at a slower rate and form metastases at a later stage, but are relatively insensitive to radiation therapy and chemotherapy compared with SCLCs. NSCLC patients who have been diagnosed with resectable disease and who have undergone surgery have a much better prognosis than those who have been diagnosed at a later stage. Most patients, however, relapse within 2 years, even after having undergone a radical resection of tumour and affected lymph nodes. Despite the progress made over the last 20 years in the area of conventional chemotherapy, patients with advanced and inoperable disease or generalized disease have a poor prognosis.
Targeted therapies are known to affect cancer cells in a selective manner and to stop tumour growth, raising hopes for even more successful treatments of many types of cancer, including NSCLC.
The Tulung registry focuses on the collection of epidemiological and clinical data on NSCLC patients treated with targeted therapies in the Czech Republic.
Over the last few years, the number of targeted therapies for NSCLC has gradually risen, and so has the number of Czech drug registries which have been launched to monitor treatment of NSCLC with individual targeted drugs; namely, Alimta, Tarceva and Avastin (part of the registry dealing with NSCLC), which monitored treatment with pemetrexed (Alimta®), erlotinib (Tarceva®) and bevacizumab (Avastin®), respectively. The Board of the Czech Society for Oncology has therefore agreed to solve this complicated situation by creating a new unified registry which would integrate all data collected so far within original registries. Apart from drugs which were previously monitored in the above-mentioned registries, the Tulung registry nowadays also monitors treatment with gefitinib (Iressa®), afatinib (Giotrif®), and nintedanib (Vargatef®) – new targeted therapies which have become available only recently. If a new drug is approved by health care payers for targeted NSCLC treatment, it can be easily integrated into the Tulung registry.
Data collected previously in the above-mentioned registries have been transferred into the Tulung registry. This procedure has eliminated the necessity of entering data on treatment of any given NSCLC patient into several different registries; moreover, coherent and well-arranged information has been obtained on the overall treatment of that patient, the potential sequence of targeted therapies, and the patient's response to treatment. The new project has therefore not only improved the quality of collected data, but also simplified the work for registry users. Apart from providing epidemiological characteristics of NSCLC patients, the registry also enables researchers to assess risk factors on patients' survival and to analyze adverse effects. The registry can also be used to make pharmacoeconomic assessments such as planning costs for cancer therapy. The project was initiated in April 2011 at the Institute of Biostatistics and Analyses of the Masaryk University (IBA MU) and has continued at the Institute of Biostatistics and Analyses Ltd (IBA Ltd), a university company.
Primary objectives of the project:
Secondary objectives of the project:
Other important information: