TORNA ALL’ELENCO

A comparative, retrospective observational study between experimental LUNG 7 studies and real practice of Afatinib and Gefitinib on patients with non-small cell lung cancer (NSCLC) with positive EGFR mutation treatment naive to tyrosine kinase inhibitors (TKI) treatment in Giornale Italiano di Farmacia Clinica

2017
ASL VCO

Tipo pubblicazione

Article

Autori/Collaboratori (7)Vedi tutti...

Lacerenza LG

Allegri P

Lerda C


et alii...

Abstract

Introduction. Afatinib and Gefitinib, pharmaceuticals used for treatment of non-squamous EGFR mutated non-small cell lung cancer, stage IIIB-IV, have been compared in the randomized controlled experimental study phase IIB LUNG 7, a multicenter, international study carried out in 64 centers of 13 different countries. Only patients who had never undergone oncological treatment have been recruited. The study was carried out in double blind and the selected end-points were the Progression Free Survival (PFS) and the Overall Survival (OS). The goal of our analysis was the comparison between the data obtained from the experimental study LUNG 7 and the "real practice" data from the Monitoring Database AIFA (Registro di Monitoraggio) collected from five Italian hospitals. Materials and Methods. The experimental data, obtained from the eligibility criteria mentioned in the AIFA database, have been compared using parameters such as: Age, gender, ethnic group, smoker/no smoker and molecular characterization of the lung tumor, with possible presence of metastasis. Results. The number of patients treated with Afatinib is 160 in the LUNG 7 study and 6 in the AIFA database. The PFS for Afatinib obtained in our analysis is smaller than the one from LUNG 7. The number of patients treated with Gefitinib is 159 in the LUNG 7 study and 33 in the AIFA database. In this case, the PFS calculated in the present study matches the results from LUNG 7. Conclusions. The number of cases is too small to obtain significant results, especially for Afatinib. In some cases, the data entered in the AIFA database by oncologists and pharmacists are not managed in real time, thus determining a bias in the analysis. By expanding the initiative to other hospitals and managing the AIFA database more efficiently, it will be possible to obtain more significant and reliable data. The present study has allowed a critical evaluation of an experimental study, taking advantage of the data from the AIFA dat

DOI : 10.1721/2784.28068

Keywords

overall survival; observational study; metastasis; non small cell lung cancer; major clinical study; smoking; retrospective study; progression free survival; human; gene mutation; gender; ethnicity; EGFR gene; drug efficacy; double blind procedure; data base; controlled study; comparative study; clinical practice; cancer staging; cancer prognosis; cancer classification; article; age; protein tyrosine kinase inhibitor; gefitinib; epidermal growth factor receptor; afatinib;