Osimertinib in Patients With Treatment-Naive EGFR-Mutant Non-small Cell Lung Cancer: Overall Survival, Post-progression Management and Budget Impact Analysis in Real-World

Author:

Pasello Giulia12ORCID,Lorenzi Martina1ORCID,Scattolin Daniela12,Del Conte Alessandro3,Cecere Fabiana4,Pavan Alberto5,Macerelli Marianna6,Polo Valentina7,Pilotto Sara8ORCID,Santarpia Mariacarmela9,Cumerlato Enrico10,Da Ros Valentina3,Targato Giada6,Bortolami Alberto11,Bonanno Laura2ORCID,Ferro Alessandra2ORCID,Dal Maso Alessandro2ORCID,Frega Stefano2ORCID,Guarneri Valentina12ORCID

Affiliation:

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. Medical Oncology and Immunorelated Tumors, National Cancer Institute Centro di Riferimento Oncologico (CRO) – IRCCS , Aviano (PN) , Italy

4. Oncology 1, Regina Elena National Cancer Institute – IRCCS , Roma , Italy

5. Medical Oncology Department, Azienda Unità Locale Socio Sanitaria (AULSS 3) Serenissima , Mestre-Venezia , Italy

6. Department of Oncology, Azienda Sanitaria Universitaria Friuli Centrale (ASUFC) , Udine , Italy

7. Oncology Unit, AULSS 2 Marca Trevigiana, Ca’ Foncello Hospital , Treviso , Italy

8. Section of Innovation Biomedicine – Oncology Area, Department of Engineering for Innovation Medicine (DIMI), University of Verona and University and Hospital Trust (AOUI) of Verona , Verone , Italy

9. Medical Oncology Unit, Department of Human Pathology “G. Barresi,” Messina , Italy

10. Medical Oncology, AULSS 6 Euganea, South Padua Hospital , Monselice (PD) , Italy

11. Veneto Oncology Network, Istituto Oncologico Veneto, I.R.C.C.S. , Padua , Italy

Abstract

Abstract Introduction The observational multicenter prospective FLOWER study (NCT04965701) confirmed effectiveness and safety of osimertinib in the real-world (RW) management of untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) patients. Methods Herein, we report updated survival data, post-progression management, cost/effectiveness and budget impact (BI) of osimertinib compared with a RW population receiving gefitinib or erlotinib. Results Overall, 189 Caucasian patients receiving first-line osimertinib were included. After a follow-up of 20.7 months, 74(39.2%) patients discontinued osimertinib, median time-to-treatment discontinuation (mTTD) was 27.9 months, overall survival 36.8 months. At progression, tissue biopsy was performed in 29 (56.9%), liquid biopsy in 15 (29.4%) and both in 7 (13.7%) cases. The most frequent resistant mechanism was MET amplification (N = 14, 29.8%). At data cutoff, 13 (6.9%) patients were continuing osimertinib beyond progression; 52 (67.5%) received second-line treatment; no further treatments were administered in 25 (32.5%) cases. Thirty-three (63.4%) patients received chemotherapy, 12(23.1%) TKIs combination. Cost–effectiveness analysis showed a total cost per patient based on RW mTTD of 98,957.34€, 21,726.28€ and 19,637.83€ for osimertinib, erlotinib and gefitinib, respectively. The incremental cost-effectiveness ratio (ICER)/month for osimertinib was 359,806.0€/life-year-gained (LYG) and 197,789.77€/LYG compared to erlotinib and gefitinib. For osimertinib, the BI-gap between RW-TTD and theoretical-TTD was 16,501.0€ per patient. Conclusions This updated analysis confirms the effectiveness of osimertinib in RW. Although the ICER of osimertinib seems not cost-effective, additional costs for the management of disease progression to old generation TKIs were not considered in this study. The BI-gap suggests RW mTTD as a more reliable measure for expense estimation.

Funder

Ricerca Corrente Istituto Oncologico Veneto

Publisher

Oxford University Press (OUP)

Reference47 articles.

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