Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Observational Study
. 2016 May:95:73-81.
doi: 10.1016/j.lungcan.2016.02.011. Epub 2016 Feb 26.

BE-POSITIVE: Beyond progression after tyrosine kinase inhibitor in EGFR- positive non small cell lung cancer patients: Results from a multicenter Italian observational study

Tiziana Vavalà  1 , Alessandro Follador  2 , Marcello Tiseo  3 , Domenico Galetta  4 , Alessandro Morabito  5 , Massimo Di Maio  6 , Olga Martelli  7 , Orazio Caffo  8 , Pier Luigi Piovano  9 , Diego Cortinovis  10 , Nicoletta Zilembo  11 , Clelia Casartelli  12 , Giuseppe Luigi Banna  13 , Antonio Ardizzoia  14 , Maria Luisa Barzelloni  15 , Alessandra Bearz  16 , Giovenzio Genestreti  17 , Claudia Mucciarini  18 , Virginio Filipazzi  19 , Jessica Menis  2 , Elisa Rizzo  20 , Fausto Barbieri  21 , Erika Rijavec  22 , Fabiana Cecere  23 , Emilio Bria  24 , Gianluca Spitaleri  25 , Antonio Rossi  26 , Silvia Novello  27
Affiliations
Free article
Observational Study

BE-POSITIVE: Beyond progression after tyrosine kinase inhibitor in EGFR- positive non small cell lung cancer patients: Results from a multicenter Italian observational study

Tiziana Vavalà et al. Lung Cancer. 2016 May.
Free article

Abstract

Objectives: Non-small-cell-lung-cancer (NSCLC) patients harbouring epidermal growth factor receptor (EGFR) mutations develop drug resistance after 9-12 months of EGFR tyrosine kinase inhibitors (TKIs) therapy pointing out the issue of the second-line treatment choice.

Materials and methods: From June 2009 until May 2013 patients affected by advanced NSCLC harbouring EGFR mutations receiving first-line TKI were collected mainly retrospectively in 24 Italian Centers. Primary objective was to describe the percentage of EGFR mutated patients receiving second-line therapy after progression to first-line EGFR-TKIs assessing the type, the activity in terms of objective response rate (ORR), efficacy in terms of progression free survival (PFS) and overall survival (OS), and safety of second-line treatment. Secondary objective was to describe the efficacy of first-line EGFR-TKIs.

Results: 312 patients were included. Most of them were females (203, 65.1%), never smokers (200, 64.1%), with adenocarcinoma histology (290, 92.9%). The most common mutations were EGFR exon 19 deletion and L858R, detected in 186 and 97 cases (59.6% and 31.1%), respectively. At data cut-off, 274 patients (95.1%) received any second-line treatment (including best supportive care or local treatments only). A total of 163 patients received second-line systemic therapy with an ORR of 20.9% (95% CI:14.62-27.10), a median PFS and OS of 4.7 (95% CI:3.81-5.26) and 24.5 (95% CI:21.65-27.37) months, respectively. Grade 3-4 hematological and non-hematological toxicities were reported in 9% and 6.3% of 144 patients treated with chemotherapy while non-hematological toxicity was reported in 4 cases of the 17 patients receiving second-line target agents.

Conclusions: BE-Positive is the first multicenter observational study reporting outcomes of therapies in a "real-life Caucasian EGFR-mutated population", highlighting the need of further researches about new treatment strategies in this setting.

Keywords: Acquired resistance; EGFR mutation; EGFR tyrosine kinase inhibitors; First line; Non small cell lung cancer; Second line.

PubMed Disclaimer

Publication types

MeSH terms