TY - JOUR
T1 - BE-POSITIVE
T2 - Beyond progression after tyrosine kinase inhibitor in EGFR- positive non small cell lung cancer patients. Results from a multicenter Italian observational study.
AU - Vavalà, Tiziana
AU - Follador, Alessandro
AU - Tiseo, Marcello
AU - Galetta, Domenico
AU - Morabito, Alessandro
AU - Di Maio, Massimo
AU - Martelli, Olga
AU - Caffo, Orazio
AU - Piovano, Pier Luigi
AU - Cortinovis, D. L.
AU - Zilembo, Nicoletta
AU - Casartelli, C.
AU - Banna, Giuseppe Luigi
AU - Ardizzoia, Antonio
AU - Barzelloni, Maria Luisa
AU - Bearz, Alessandra
AU - Genestreti, Giovenzio
AU - Mucciarini, C.
AU - Filipazzi, Virginio
AU - Menis, Jessica
AU - Rizzo, Elisa
AU - Barbieri, Fausto
AU - Rijavec, Erika
AU - Cecere, F.
AU - Bria, Emilio
AU - Spitaleri, Gianluca
AU - Rossi, Antonio
AU - Novello, Silvia
PY - 2016/5/1
Y1 - 2016/5/1
N2 - 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.
AB - 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.
KW - Acquired resistance
KW - EGFR mutation
KW - EGFR tyrosine kinase inhibitors
KW - First line
KW - Non small cell lung cancer
KW - Second line
UR - http://www.scopus.com/inward/record.url?scp=84960914105&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84960914105&partnerID=8YFLogxK
U2 - 10.1016/j.lungcan.2016.02.011
DO - 10.1016/j.lungcan.2016.02.011
M3 - Article
SN - 0169-5002
VL - 95
SP - 73
EP - 81
JO - Lung Cancer
JF - Lung Cancer
ER -