Tiziana Vavalà1, Alessandro Follador2, Marcello Tiseo3, Domenico Galetta4, Alessandro Morabito5, Massimo Di Maio6, Olga Martelli7, Orazio Caffo8, Pier Luigi Piovano9, Diego Cortinovis10, Nicoletta Zilembo11, Clelia Casartelli12, Giuseppe Luigi Banna13, Antonio Ardizzoia14, Maria Luisa Barzelloni15, Alessandra Bearz16, Giovenzio Genestreti17, Claudia Mucciarini18, Virginio Filipazzi19, Jessica Menis2, Elisa Rizzo20, Fausto Barbieri21, Erika Rijavec22, Fabiana Cecere23, Emilio Bria24, Gianluca Spitaleri25, Antonio Rossi26, Silvia Novello27. 1. Department of Oncology, University of Torino AOU San Luigi, Regione Gonzole 10, 10043 Orbassano (TO), Italy. 2. Department of Oncology, University Hospital of Udine, Piazzale S. Maria della Misericordia 15, 33100 Udine, Italy. 3. Medical Oncology Unit, University Hospital of Parma, via Gramsci, 14, 43126 Parma, Italy. 4. Medical Oncology Unit, Clinical Cancer Center Giovanni Paolo II, viale Orazio Flacco, 65, 70124 Bari, Italy. 5. Thoracic Medical Oncology, National Cancer Institute, Fondazione "G.Pascale", via Mariano Semmola 80131, Napoli, Italy. 6. Clinical Trials Unit, National Cancer Institute, Fondazione "G.Pascale", via Mariano Semmola, 80131 Napoli, Italy. 7. Medical Oncology, S.Giovanni-Addolorata Hospital, via di S. Stefano Rotondo 5a, 00184 Roma, Italy. 8. Medical Oncology Unit, Santa Chiara Hospital, Largo Medaglie D'oro 9, 38122 Trento, Italy. 9. Medical Oncology Unit, AO SS. Antonio Biagio e Cesare Arrigo, via S. Pio V 5, Alessandria, Italy. 10. Medical Oncology Unit, AOU San Gerardo, via Giambattista Pergolesi 33, 20900 Monza, Italy. 11. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, via Giacomo Venezian 1, Milano, Italy. 12. Medical Oncology Unit, Valduce Hospital, via Dante Alighieri 11, 22100 Como, Italy. 13. Division of Medical Oncology, AO Cannizzaro Hospital, via Messina 829, 95126 Catania, Italy. 14. Medical Oncology Unit, A.Manzoni Hospital via dell'Eremo 9/11, 23900 Lecco, Italy. 15. AOU San Giovanni di Dio e Ruggi d' Aragona c/o P.O. G. da Procida, largo Città di Ippocrate, 84131 Salerno, Italy. 16. Department of Medical Oncology, National Institute for Cancer Research, via Franco Gallini 2, Aviano (PN), Italy. 17. Department of Medical Oncology, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST), via Piero Maroncelli 40, 47014 Meldola, Italy. 18. Department of Oncological Medicine, Ramazzini Hospital, via Guido Molinari 2, 41012 Carpi (MO), Italy. 19. UOC Medical Oncology, AO Luigi Sacco, via Giovanni Battista Grassi 74, 20157 Milano,Italy. 20. EORTC Headquarters, Avenue E. Mounier 83, 1200 Bruxelles, Belgium. 21. Department of Oncology and Hemathology, AOU of Modena, viale del pozzo 71, Modena, Italy. 22. Lung Cancer Unit, IRCCS AOU San Martino-IST Istituto Nazionale per la Ricerca sul Cancro, Largo R. Benzi 10, 16132 Genova, Italy. 23. Medical Oncology Unit, University Hospital Careggi, Largo Brambilla 3, 50134 Firenze, Italy. 24. Medical Oncology, University of Verona, Azienda Ospedaliera Universitaria Integrata di Verona, P.zza L. A. Scuro 10, 37134 Verona, Italy. 25. Division of Thoracic Oncology, European Institute of Oncology, via Ripamonti 435, 20141 Milano, Italy. 26. Division of Medical Oncology, S.G. Moscati Hospital, Contrada Amoretta Avellino, Italy. 27. Department of Oncology, University of Torino AOU San Luigi, Regione Gonzole 10, 10043 Orbassano (TO), Italy. Electronic address: silvia.novello@unito.it.
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.
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.
Authors: A Cortellini; A Leonetti; A Catino; P Pizzutillo; B Ricciuti; A De Giglio; R Chiari; P Bordi; D Santini; R Giusti; M De Tursi; D Brocco; F Zoratto; F Rastelli; F Citarella; M Russano; M Filetti; P Marchetti; R Berardi; M Torniai; D Cortinovis; E Sala; C Maggioni; A Follador; M Macerelli; O Nigro; A Tuzi; D Iacono; M R Migliorino; G Banna; G Porzio; K Cannita; M G Ferrara; E Bria; D Galetta; C Ficorella; M Tiseo Journal: Clin Transl Oncol Date: 2019-08-07 Impact factor: 3.405
Authors: Paul Zarogoulidis; Mina Gaga; Haidong Huang; Kaid Darwiche; Aggeliki Rapti; Wolfgang Hohenforst-Schmidt Journal: Clin Transl Med Date: 2017-01-18