학술논문
BE-POSITIVE: Beyond progression after tyrosine kinase inhibitor in EGFR- positive non small cell lung cancer patients: Results from a multicenter Italian observational study.
Document Type
Article
Author
Vavalà, Tiziana; Follador, Alessandro; Tiseo, Marcello; Galetta, Domenico; Morabito, Alessandro; Di Maio, Massimo; Martelli, Olga; Caffo, Orazio; Piovano, Pier Luigi; Cortinovis, Diego; Zilembo, Nicoletta; Casartelli, Clelia; Banna, Giuseppe Luigi; Ardizzoia, Antonio; Barzelloni, Maria Luisa; Bearz, Alessandra; Genestreti, Giovenzio; Mucciarini, Claudia; Filipazzi, Virginio; Menis, Jessica
Source
Subject
*NON-small-cell lung carcinoma
*CANCER treatment
*CANCER invasiveness
*PROTEIN-tyrosine kinase inhibitors
*DRUG resistance in cancer cells
*ITALIANS
*EPIDERMAL growth factor receptors
*CANCER chemotherapy
*PATIENTS
*DISEASES
*THERAPEUTICS
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Language
ISSN
0169-5002
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. [ABSTRACT FROM AUTHOR]