Evidence map›Paper›PMID 38520745›Full record

Observational studyThe oncologist2024

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.

Giulia Pasello, Martina Lorenzi, Daniela Scattolin, Alessandro Del Conte, Fabiana Cecere, Alberto Pavan, Marianna Macerelli, Valentina Polo, Sara Pilotto, Mariacarmela Santarpia and 9 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in The oncologist, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04965701 (First Line Osimertinib in the Real World), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
2.1field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04965701 completednot on this map

First Line Osimertinib in the Real World: an Inter-regional Prospective Study: FLOWER

TypeobservationalSponsorIstituto Oncologico Veneto IRCCSRan2018 to 2023Enrolled200ConditionsEGF-R Positive Non-Small Cell Lung CancerArmsOsimertinib 80 MG
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 5 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 8 institutions in 1 country.

Giulia PaselloDepartment of Surgery, Oncology, and Gastroenterology, University of Padova, Padova, Italy.ORCID 0000-0002-8741-6038
Martina LorenziDepartment of Surgery, Oncology, and Gastroenterology, University of Padova, Padova, Italy.ORCID 0000-0003-4874-0422
Daniela ScattolinDepartment of Surgery, Oncology, and Gastroenterology, University of Padova, Padova, Italy.
Alessandro Del ConteMedical Oncology and Immunorelated Tumors, National Cancer Institute Centro di Riferimento Oncologico (CRO) - IRCCS, Aviano (PN), Italy.
Fabiana CecereOncology 1, Regina Elena National Cancer Institute - IRCCS, Roma, Italy.
Alberto PavanMedical Oncology Department, Azienda Unità Locale Socio Sanitaria (AULSS 3) Serenissima, Mestre-Venezia, Italy.
Marianna MacerelliDepartment of Oncology, Azienda Sanitaria Universitaria Friuli Centrale (ASUFC), Udine, Italy.
Valentina PoloOncology Unit, AULSS 2 Marca Trevigiana, Ca' Foncello Hospital, Treviso, Italy.
Sara PilottoSection 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.ORCID 0000-0003-2229-4874
Mariacarmela SantarpiaMedical Oncology Unit, Department of Human Pathology "G. Barresi," Messina, Italy.
Enrico CumerlatoMedical Oncology, AULSS 6 Euganea, South Padua Hospital, Monselice (PD), Italy.
Valentina Da RosMedical Oncology and Immunorelated Tumors, National Cancer Institute Centro di Riferimento Oncologico (CRO) - IRCCS, Aviano (PN), Italy.
Giada TargatoDepartment of Oncology, Azienda Sanitaria Universitaria Friuli Centrale (ASUFC), Udine, Italy.
Alberto BortolamiVeneto Oncology Network, Istituto Oncologico Veneto, I.R.C.C.S., Padua, Italy.
Laura BonannoDivision of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, Italy.ORCID 0000-0001-5218-4970
Alessandra FerroDivision of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, Italy.ORCID 0000-0002-1163-3765
Alessandro Dal MasoDivision of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, Italy.ORCID 0000-0003-3743-717X
Stefano FregaDivision of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, Italy.ORCID 0000-0002-2998-5072
Valentina GuarneriDepartment of Surgery, Oncology, and Gastroenterology, University of Padova, Padova, Italy.ORCID 0000-0002-2375-8397
Istituto Oncologico Veneto · ITUniversity of Padua · ITCentro di Riferimento Oncologico · ITOspedale Santa Maria della Misericordia di Udine · ITCa' Foncello Hospital · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITUniversity of Messina · ITUniversity of Verona · IT

Funding

Ricerca Corrente Istituto Oncologico Veneto
6 · The paper itself

Abstract

introductionThe 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.

methodsHerein, 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.

resultsOverall, 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.

conclusionsThis 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.

Indexed as

AcrylamidesAniline CompoundsCarcinoma, Non-Small-Cell LungErbB ReceptorsLung NeoplasmsAdultAgedAged, 80 and overAntineoplastic AgentsCost-Benefit AnalysisDisease ProgressionErlotinib HydrochlorideFemaleGefitinibHumansIndolesAcrylamidesAniline CompoundsAntineoplastic AgentsEGFR protein, humanErbB ReceptorsErlotinib HydrochlorideGefitinibIndolesosimertinibPyrimidinescost effectivenessepidermal growth factor receptornon-small-cell lung cancerosimertinibreal-world study

Identifiers

PMID38520745
PMCPMC11224988
OpenAlexW4393110238

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.