Martina Lorenzi1,2, Alessandra Ferro1,2, Fabiana Cecere3, Daniela Scattolin1, Alessandro Del Conte4, Alessandro Follador5, Sara Pilotto6, Valentina Polo7, Mariacarmela Santarpia8, Rita Chiari9, Alberto Pavan9, Alessandro Dal Maso1,2, Valentina Da Ros4, Giada Targato5, Sabrina Vari10, Stefano Indraccolo11, Fiorella Calabrese12, Stefano Frega2, Laura Bonanno2, Pier Franco Conte1,2, Valentina Guarneri1,2, Giulia Pasello1,2. 1. Department of Surgery, Oncology, and Gastroenterology, University of Padova, Padova, Italy. 2. Division of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, Italy. 3. Oncology 1, Regina Elena National Cancer Institute - IRCCS, Padova, Italy. 4. Medical Oncology and Immunorelated Tumors, National Cancer Institute Centro di Riferimento Oncologico (CRO) - IRCCS, Aviano (PN), Italy. 5. Department of Medical Oncology, Azienda Sanitaria Universitaria Integrata of Udine, Santa Maria della Misericordia Hospital, Udine, Italy. 6. Oncology Department, Azienda Ospedaliera Universitaria Integrata di Verona, Verona, Italy. 7. Oncology Unit, Azienda Unità Locale Socio Sanitaria (AULSS 2) Marca Trevigiana, Ca' Foncello Hospital, Treviso, Italy. 8. Medical Oncology, Azienda Ospedaliera Policlinico Universitario "G. Martino," Messina, Italy. 9. Medical Oncology, AULSS 6 Euganea, South Padua Hospital, Monselice (PD), Italy. 10. Oncology 1, Regina Elena National Cancer Institute - IRCCS, Rome, Italy. 11. Immunology and Molecular Oncology Unit, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy. 12. Cardiovascular Pathology Unit, Department of Cardio-Thoracic and Vascular Sciences, University of Padova, Padova, Italy.
Abstract
BACKGROUND: Osimertinib became the standard treatment for patients with untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) following results reported in the phase III randomized FLAURA trial. Because of strict exclusion criteria, patient populations included in pivotal trials are only partially representative of real-world patients. METHODS: We designed an observational, prospective, multicenter study enrolling patients with EGFR-mutant aNSCLC receiving first-line osimertinib to evaluate effectiveness, safety, and progression patterns in the real-world. RESULTS: At data cutoff, 126 White patients from nine oncology centers were included. At diagnosis, 16 patients (12.7%) had a performance status (PS) ≥2 and 38 (30.2%) had brain metastases. Overall response rate (ORR) was 73%, disease control rate (DCR) 96.0%. After a median follow-up of 12.3 months, median time to treatment discontinuation (mTTD) was 25.3 months, median progression-free-survival (mPFS) was 18.9 months and median overall survival (mOS) was not reached (NR). One hundred and ten patients (87%) experienced adverse events (AEs), 42 (33%) of grade 3-4, with venous thromboembolism (VTE) as the most common (n = 10, 7.9%). No difference in rates of VTE was reported according to age, PS, comorbidity, and tumor load. We observed longer mTTD in patients without symptoms (NR vs. 18.8 months) and with fewer than three metastatic sites at diagnosis (NR vs. 21.4 months). Patients without brain metastases experienced longer mPFS (NR vs. 13.3 months). No difference in survival outcome was observed according to age, comorbidity, and type of EGFR mutation. Isolated progression and progression in fewer than three sites were associated with longer time to treatment discontinuation (TTD). CONCLUSION: Osimertinib confirmed effectiveness and safety in the real world, although thromboembolism was more frequent than previously reported.
BACKGROUND: Osimertinib became the standard treatment for patients with untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) following results reported in the phase III randomized FLAURA trial. Because of strict exclusion criteria, patient populations included in pivotal trials are only partially representative of real-world patients. METHODS: We designed an observational, prospective, multicenter study enrolling patients with EGFR-mutant aNSCLC receiving first-line osimertinib to evaluate effectiveness, safety, and progression patterns in the real-world. RESULTS: At data cutoff, 126 White patients from nine oncology centers were included. At diagnosis, 16 patients (12.7%) had a performance status (PS) ≥2 and 38 (30.2%) had brain metastases. Overall response rate (ORR) was 73%, disease control rate (DCR) 96.0%. After a median follow-up of 12.3 months, median time to treatment discontinuation (mTTD) was 25.3 months, median progression-free-survival (mPFS) was 18.9 months and median overall survival (mOS) was not reached (NR). One hundred and ten patients (87%) experienced adverse events (AEs), 42 (33%) of grade 3-4, with venous thromboembolism (VTE) as the most common (n = 10, 7.9%). No difference in rates of VTE was reported according to age, PS, comorbidity, and tumor load. We observed longer mTTD in patients without symptoms (NR vs. 18.8 months) and with fewer than three metastatic sites at diagnosis (NR vs. 21.4 months). Patients without brain metastases experienced longer mPFS (NR vs. 13.3 months). No difference in survival outcome was observed according to age, comorbidity, and type of EGFR mutation. Isolated progression and progression in fewer than three sites were associated with longer time to treatment discontinuation (TTD). CONCLUSION: Osimertinib confirmed effectiveness and safety in the real world, although thromboembolism was more frequent than previously reported.
Authors: Giulia Pasello; Martina Lorenzi; Giulia Pretelli; Giovanni Maria Comacchio; Federica Pezzuto; Marco Schiavon; Alessandra Buja; Stefano Frega; Laura Bonanno; Valentina Guarneri; Fiorella Calabrese; Federico Rea Journal: Front Oncol Date: 2022-06-29 Impact factor: 5.738