Abstract
Purpose
LIFE (non-small cell Lung cancer management In patients progressing after First-linE of treatment in the metastatic setting) is a multicentre Italian observational study, including a cross-sectional and a longitudinal phase, with the aim of describing the therapeutic approach in clinical practice for advanced non-small cell lung cancer (NSCLC) patients, progressing after first-line treatment.
Methods
In this paper, the cross-sectional phase is outlined, with the primary endpoint of describing the proportion of patients receiving second-line treatment among those progressed during or after first-line treatment according to clinical practice.
Results
From July 2011 to January 2012, 603 patients were enrolled and 541 (90 %) were evaluable. A total of 464 (86 %) patients received a second-line therapy outside clinical trials. Chemotherapy and targeted therapies were administered to 65 and 34 % of patients, respectively (1 % both). No tissue collection was required within the observational trial, and biomarkers analysis was performed at diagnosis or later in 314 patients (58 %). In details, activating epidermal growth factor receptor mutations were detected in 21 % of 311 evaluable patients, Kirsten rat sarcoma 2 viral oncogene homolog mutation in 22 % of the 77 evaluable patients and anaplastic lymphoma kinase translocations analysis was performed in 74 patients and resulted positive in 23 % of cases. These high proportions were probably due to enriched patient population tested.
Conclusions
These results showed a pattern of care for NSCLC second-line therapy which reflects international guidelines recommendations and current expected clinical practice. Interestingly, biomarkers analyses were performed in a higher percentage than expected.
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Acknowledgments
Study sponsored by Boehringer Ingelheim. Scientific and technical coordination by Medidata. A special thanks goes to Carmine Ferrara from A.O.R.N. San Giuseppe Moscati (Avellino) and to Ester Del Signore from AO San Camillo Forlanini (Rome) for scientific and technical support.
Conflict of interest
The authors declare to have full control of all primary data, and they agree to allow the journal to review their data if requested. Authors declare the following conflict of interest: Gridelli Cesare, Grossi Francesco had received advisory/speaker honoraria and/or research funding from Boehringer Ingelheim Italy. de Marinis Filippo has received advisory/speaker honoraria and/or research funding from Boehringer Ingelheim Italy and Roche. Ardizzoni Andrea has received advisory/speaker honoraria and/or research funding from Boehringer Ingelheim Italy, Glaxo Smith-Kline, Eli Lilly, Pfizer, Pierre Fabre, Daiicki-Sankyo. Novello Silvia, Cortinovis Diego had received advisory/speaker honoraria and/or research funding from Boehringer Ingelheim Italy, Roche, Astra Zeneca, Eli Lilly. The following authors declare no conflict of interest instead: Cappuzzo Federico, Favaretto Adolfo, Bettini Anna, Siena Salvatore, Caprioli Alberto, Iurlaro Monica, Fontanini Gabriella, Santo Antonio, Lorusso Vito, Galetta Domenico.
Ethical standard
This study was approved by appropriate ethics committees and was therefore performed in accordance with ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments.
Informed consent
All persons gave their informed consent prior to their inclusion in the study.
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Appendix: The LIFE study team
Appendix: The LIFE study team
Filippo | De Marinis | AO San Camillo Forlanini | Roma |
Cesare | Gridelli | A.O.R.N. San Giuseppe Moscati | Avellino |
Antonio | Santo | Gruppo Interdisciplinare Veronese Oncologia Polmonare, AOUI | Verona |
Diego | Cortinovis | Ospedale San Gerardo | Monza |
Adolfo | Favaretto | Istituto Oncologico Veneto—IOV | Padova |
Vito | Lorusso | Ospedale V. Fazzi | Lecce |
Annamaria | Catino | IRCCS “Giovanni Paolo II” Ospedale Oncologico | Bari |
Salvatore | Siena | Ospedale Niguarda Ca’ Granda | Milano |
Anna | Bettini | Az. Osp. Ospedali Riuniti | Bergamo |
Alberto | Caprioli | Spedali Civili di Brescia | Brescia |
Andrea | Ardizzoni | Azienda Ospedaliera di Parma | Parma |
Silvia | Novello | A.O.U. San Luigi Gonzaga | Orbassano |
Paolo | Pedrazzoli | IRCCS Policlinico San Matteo | Pavia |
Oscar | Alabiso | A.O.U. Maggiore della Carità | Novara |
Domenico | Bilancia | Azienda Ospedaliera San Carlo | Potenza |
Saverio | Cinieri | P.O. Antonio Perrino | Brindisi |
Michele | Milella | Istituto Regina Elena | Roma |
Giacomo | Cartenì | AORN “A. Cardarelli” | Napoli |
Alfredo | Falcone | Azienda Ospedaliero Universitaria Pisana | Pisa |
Gianpiero | Fasola | Azienda Ospedaliera Universitaria di Udine | Udine |
Francesco | Ferraù | Ospedale San Vincenzo | Taormina |
Antonio | Contu | Ospedale Civile SS. Annunziata | Sassari |
Dario | Giuffrida | Istituto Oncologico del Mediterraneo | Viagrande |
Alfonso | Illiano | A.O.R.N. Monaldi | Napoli |
Alberto | Ravaioli | Ospedale degli Infermi | Rimini |
Alberto | Zaniboni | Fondazione Poliambulanza | Brescia |
Sandro | Barni | Ospedale Treviglio-Caravaggio | Treviglio |
Giorgio | Cruciani | Ospedale di Lugo Umberto I | Lugo |
Flavia | Longo | Policlinico Umberto I | Roma |
Federico | Cappuzzo | Ospedale di Livorno | Livorno |
Efisio | Defraia | Ospedale Oncologico Businico | Cagliari |
Francesco | Di Costanzo | A.O.U. Ospedale Careggi | Firenze |
Teresa | Gamucci | Ospedale S.S. Trinità | Sora |
Dino | Amadori | IRST di Meldola | Meldola |
Michele | Caruso | Humanitas Centro Catanese di Oncologia | Catania |
Mario | Clerico | Ospedale degli Infermi | Biella |
Francesco | Grossi | IRCCS Azienda Ospedaliera Universitaria San Martino-IST, Istituto Nazionale per la Ricerca sul Cancro | Genova |
Graziella | Pinotti | Ospedale di Circolo e Fondazione Macchi | Varese |
Stefano | Iacobelli | Ospedale SS Annunziata | Chieti Scalo |
Daniele | Pozzessere | Ospedale Misericordia e Dolce AUSL4 di Prato | Prato |
Roberto | Bianco | A.O.U. Federico II | Napoli |
Evaristo | Maiello | Casa Sollievo della Sofferenza | San Giovanni Rotondo |
Paolo | Marchetti | Azienda Ospedaliera Sant’Andrea | Roma |
Rodolfo | Passalacqua | Azienda Istituti Ospitalieri | Cremona |
Lorenzo | Pavesi | Fondazione S. Maugeri IRCCS | Pavia |
Stefano | Tamberi | Ospedale degli Infermi | Faenza |
Giampaolo | Tortora | Policlinico G.B. Rossi di Borgo Roma | Verona |
Massimo | Aglietta | IRCC Istituto per la Ricerca e la Cura del Cancro | Candiolo |
Alba | Brandes | Ospedale Bellaria | Bologna |
Libero | Ciuffreda | Azienda Ospedaliera Città della Salute e della Scienza | Torino |
Bruno | Daniele | Ospedale G. Rummo | Benevento |
Claudio | Demichelis | Ospedale Unificato d’Imperia | Imperia |
Sante | Romito | Az. Osp. Univ. Ospedali Riuniti | Foggia |
Fausto | Barbieri | Az. Osp. Univ. Policlinico | Modena |
Lucio | Crinò | Azienda Ospedaliera Perugia | Perugia |
Monica | Giordano | Az. Osp. Sant’ Anna | San Fermo della Battaglia |
Sergio | Bracarda | Ospedale San Donato | Arezzo |
Nicola | Marzano | Ospedale San Paolo | Bari |
Marco | Merlano | A.S.O. S. Croce e Carle | Cuneo |
Gianmauro | Numico | Ospedale Regionale U.Parini | Aosta |
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Gridelli, C., de Marinis, F., Ardizzoni, A. et al. Advanced non-small cell lung cancer management in patients progressing after first-line treatment: results of the cross-sectional phase of the Italian LIFE observational study. J Cancer Res Clin Oncol 140, 1783–1793 (2014). https://doi.org/10.1007/s00432-014-1715-2
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DOI: https://doi.org/10.1007/s00432-014-1715-2