Maria Lucia Reale1, Rita Chiari2, Marcello Tiseo3, Fabiana Vitiello4, Fausto Barbieri5, Diego Cortinovis6, Giovanni Luca Ceresoli7, Giovanna Finocchiaro8, Gianpiero Diego Romano9, Pier Luigi Piovano10, Alessandro Del Conte11, Gloria Borra12, Francesco Verderame13, Vieri Scotti14, Daniela Nonnis15, Domenico Galetta16, Concetta Sergi17, Maria Rita Migliorino18, Giuseppe Tonini19, Fabiana Cecere20, Rossana Berardi21, Maria Simona Pino22, Olga Martelli23, Alain Gelibter24, Annamaria Carta25, Emanuela Vattemi26, Maria Pagano27, Alessandro Zullo28, Silvia Ferrari29, Antonio Rossi30, Silvia Novello31. 1. Department of Oncology, University of Turin, AOU San Luigi Gonzaga, Regione Gonzole, 10, 10043, Orbassano, TO, Italy. Electronic address: realemarialucia@gmail.com. 2. UOC Oncology, Ospedali Riuniti Padova Sud-AULSS6 Euganea, Via Albere, 30, Monselice, PD, Italy(1). Electronic address: ritachiar@gmail.com. 3. Department of Medicine and Surgery, University of Parma and Medical Oncology Unit, Azienda Ospedaliero-Universitaria, Viale Antonio Gramsci, 14, 43126, Parma, Italy. Electronic address: mtiseo@ao.pr.it. 4. U.O.S.D. DH Pneumoncologico A.O. dei Colli - Monaldi, Via Leonardo Bianchi, 80131, Napoli, Italy. Electronic address: fabianavitiello@libero.it. 5. Dipartimento Oncologia ed Ematologia, AOU Policlinico, Largo del Pozzo, 71, 41125, Modena, Italy. Electronic address: barbieri.fausto@aou.mo.it. 6. UO Oncologia Medica, ASST Ospedale San Gerardo, Via G. B. Pergolesi, 33, 20900, Monza, MB, Italy. Electronic address: d.cortinovis@hsgerardo.org. 7. Unità di Oncologia Toracica e Urologica, Humanitas Gavazzeni, Via Mauro Gavazzeni, 21, 24125, Bergamo, Italy. Electronic address: giovanni_luca.ceresoli@gavazzeni.it. 8. U.O Oncologia Medica ed Ematologia, Humanitas Cancer Center, Istituto Clinico Humanitas-IRCCS, Via Alessandro Manzoni, 56, 20089, Rozzano, MI, Italy. Electronic address: giovanna.finocchiaro@cancercenter.humanitas.it. 9. Oncologia, Ospedale Vito Fazzi, Piazza Filippo Muratore, 1, 73100, Lecce, Italy. Electronic address: giampieroromano@tiscali.it. 10. SC Oncologia, ASO SS Antonio e Biagio e C Arrigo, Via Venezia, 16, 15121, Alessandria, Italy. Electronic address: plpiovano@ospedale.al.it. 11. S.C. Oncologia Medica e dei Tumori Immunocorrelati (OMTI), Centro di Riferimento Oncologico (CRO) - IRCCS, Via Franco Gallini, 2, 33081, Aviano, PN, Italy. Electronic address: alessandro.delconte@cro.it. 12. Dipartimento Medico Specialistico ed Oncologico, AOU Maggiore della Carità, corso Mazzini 18, Novara, Italy. Electronic address: gloria.borra@libero.it. 13. U.O Oncologia Medica, AO Riuniti Villa Sofia - Cervello, Via Trabucco 180, 90146, Palermo, Italy. Electronic address: f.verderame@villasofia.it. 14. Unità di Radioterapia Oncologica - Dipartimento di Oncologia, Azienda Ospedaliero-universitaria Careggi, Largo G. Alessandro Brambilla, 3, 50134, Florence, Italy. Electronic address: vieri.scotti@unifi.it. 15. Oncologia Medica, ASST Spedali Civili, Piazzale Spedali Civili, 1, 25123, Brescia, Italy. Electronic address: daninonnis@yahoo.it. 16. SSD Oncologia Medica Patologia Toracica IRCCS Oncologico Giovanni Paolo II, Viale Orazio Flacco, 65, 70124, Bari, Italy. Electronic address: galetta@teseo.it. 17. U.O.C Oncologia Medica, AO di rilievo Nazionale, ARNAS Garibaldi-Nesima, Via Palermo, 636, Catania, Italy. Electronic address: consergi1974@gmail.com. 18. U.O.C Pneumologia Oncologica, AO S. Camillo Forlanini, Circonvallazione Gianicolense, 87, 00152, Roma, Italy. Electronic address: ritamigliorino@tiscali.it. 19. Dipartimento di Oncologia, Università Campus Bio-Medico, Via Alvaro del Portillo 200, 00128, Roma, Italy. Electronic address: G.Tonini@unicampus.it. 20. U.O. Oncologia Medica, Istituto Tumori Regina Elena, Via Elio Chianesi, 53, 00128, Roma, Italy. Electronic address: fabianacecere@gmail.com. 21. SOD Clinica Oncologica, AOU Ospedali Riuniti, Via Conca, 71, 60126, Ancona, Italy. Electronic address: r.berardi@univpm.it. 22. U.O. Oncologia Medica, Ospedale S. Maria Annunziata, Via Antella, 58, 50012, Ponte a Niccheri, Bagno a Ripoli, FI, Italy. Electronic address: mariasimona.pino@uslcentro.toscana.it. 23. U.O Oncologia Medica, Azienda Ospedaliera S Giovanni-Addolorata, Via dell'Amba Aradam 8, 00184, Roma, Italy. Electronic address: omartelli@hsangiovanni.roma.it. 24. U.O Oncologia Medica, Policlinico Umberto I, Via del Policlinico 155, Roma, Italy. Electronic address: agelibter@yahoo.it. 25. U.O Oncologia Medica, Ospedale A. Businco, Via Edward Jenner, 1, 09121, Cagliari, Italy. Electronic address: deventer1975@gmail.com. 26. U.O Oncologia Medica, Ospedale Regionale, Via Lorenz Böhler, 5, 39100, Bolzano, Italy. Electronic address: EMANUELA.VATTEMI@sabes.it. 27. Azienda Unità Sanitaria Locale-IRCCS, Via Giovanni Amendola, 2, 42122, Reggio Emilia, Italy. Electronic address: pagano.maria@ausl.re.it. 28. MediNeos, Viale Virgilio, 54/U, 41123, Modena, Italy. Electronic address: a.zullo@medineos.com. 29. AstraZeneca S.p.A., Via Ludovico il Moro, 6/C, 20080, Basiglio, MI, Italy. Electronic address: Silvia.Ferrari@astrazeneca.com. 30. Oncology Unit, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini, 1, 71013, San Giovanni Rotondo, FG, Italy. Electronic address: arossi_it@yahoo.it. 31. Department of Oncology, University of Turin, AOU San Luigi Gonzaga, Regione Gonzole, 10, 10043, Orbassano, TO, Italy. Electronic address: silvia.novello@unito.it.
Abstract
OBJECTIVES: Molecular diagnostics and care of non-small cell lung cancer (NSCLC) are continuously evolving. Few data document the current strategies to manage advanced NSCLC patients beyond progression in clinical practice. PATIENTS AND METHODS: Be-TeaM is an Italian multi-center observational study conducted on consecutive EGFR-mutated stage IV NSCLC patients, progressed during/after a first-line EGFR-TKI. It consists of a retrospective phase, from first-line EGFR-TKI therapy start until study entry (i.e. beginning of the diagnostic process), and a prospective phase, until treatment choice or for 3 months if no therapy was prescribed. Primary objective was to describe the diagnostic and therapeutic approaches adopted after progression in a real-world setting. RESULTS: Of 308 patients enrolled in 63 centers from July 2017 to June 2018, 289 were included in the analysis. In first line, 53.3 % received gefitinib, 32.5 % afatinib and 14.2 % erlotinib. The testing rate (i.e. rate of all patients undergone any biopsy -liquid and/or tissue- for the T790 M detection) was 90.7 %, with liquid biopsy being the most frequently executed. Of 262 biopsied patients, 64.5 % underwent only 1 liquid biopsy, 10.7 % only 1 tissue biopsy and 18.3 % >1 biopsy, both liquid and solid in 85.4 %. The T790M positivity rate was 45.3 %; of 166 patients undergone only a liquid biopsy and tested for the mutation, 39.8 % were T790M+ and 60.2 % T790M-/undetermined. By the observation end, 87.9 % patients had a post-progression treatment chosen, osimertinib being the most frequent among the T790M+. CONCLUSION: Be-TeaM provides the first snapshot of current practices for the management of NSCLC patients beyond progression in Italy; in clinical practice, assessing the T790M status is not always feasible.
OBJECTIVES: Molecular diagnostics and care of non-small cell lung cancer (NSCLC) are continuously evolving. Few data document the current strategies to manage advanced NSCLCpatients beyond progression in clinical practice. PATIENTS AND METHODS: Be-TeaM is an Italian multi-center observational study conducted on consecutive EGFR-mutated stage IV NSCLCpatients, progressed during/after a first-line EGFR-TKI. It consists of a retrospective phase, from first-line EGFR-TKI therapy start until study entry (i.e. beginning of the diagnostic process), and a prospective phase, until treatment choice or for 3 months if no therapy was prescribed. Primary objective was to describe the diagnostic and therapeutic approaches adopted after progression in a real-world setting. RESULTS: Of 308 patients enrolled in 63 centers from July 2017 to June 2018, 289 were included in the analysis. In first line, 53.3 % received gefitinib, 32.5 % afatinib and 14.2 % erlotinib. The testing rate (i.e. rate of all patients undergone any biopsy -liquid and/or tissue- for the T790 M detection) was 90.7 %, with liquid biopsy being the most frequently executed. Of 262 biopsied patients, 64.5 % underwent only 1 liquid biopsy, 10.7 % only 1 tissue biopsy and 18.3 % >1 biopsy, both liquid and solid in 85.4 %. The T790M positivity rate was 45.3 %; of 166 patients undergone only a liquid biopsy and tested for the mutation, 39.8 % were T790M+ and 60.2 % T790M-/undetermined. By the observation end, 87.9 % patients had a post-progression treatment chosen, osimertinib being the most frequent among the T790M+. CONCLUSION: Be-TeaM provides the first snapshot of current practices for the management of NSCLCpatients beyond progression in Italy; in clinical practice, assessing the T790M status is not always feasible.
Authors: Sung Yong Lee; Chang-Min Choi; Yoon Soo Chang; Kye Young Lee; Seung Joon Kim; Sei Hoon Yang; Jeong Seon Ryu; Jeong Eun Lee; Shin Yup Lee; Ji Young Park; Young-Chul Kim; In-Jae Oh; Chi Young Jung; Sang Hoon Lee; Seong Hoon Yoon; Juwhan Choi; Tae Won Jang Journal: Transl Lung Cancer Res Date: 2021-12