PMID- 35641222
OWN - NLM
STAT- MEDLINE
DCOM- 20220602
LR  - 20230818
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 27
IP  - 2
DP  - 2022 Mar 4
TI  - First-Line Osimertinib in Patients with EGFR-Mutant Advanced Non-Small Cell Lung 
      Cancer: Outcome and Safety in the Real World: FLOWER Study.
PG  - 87-e115
LID - 10.1002/onco.13951 [doi]
AB  - 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.
CI  - (c) The Author(s) 2021. Published by Oxford University Press.
FAU - Lorenzi, Martina
AU  - Lorenzi M
AD  - Department of Surgery, Oncology, and Gastroenterology, University of Padova, 
      Padova, Italy.
AD  - Division of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, 
      Italy.
FAU - Ferro, Alessandra
AU  - Ferro A
AD  - Department of Surgery, Oncology, and Gastroenterology, University of Padova, 
      Padova, Italy.
AD  - Division of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, 
      Italy.
FAU - Cecere, Fabiana
AU  - Cecere F
AD  - Oncology 1, Regina Elena National Cancer Institute - IRCCS, Padova, Italy.
FAU - Scattolin, Daniela
AU  - Scattolin D
AD  - Department of Surgery, Oncology, and Gastroenterology, University of Padova, 
      Padova, Italy.
FAU - Del Conte, Alessandro
AU  - Del Conte A
AD  - Medical Oncology and Immunorelated Tumors, National Cancer Institute Centro di 
      Riferimento Oncologico (CRO) - IRCCS, Aviano (PN), Italy.
FAU - Follador, Alessandro
AU  - Follador A
AD  - Department of Medical Oncology, Azienda Sanitaria Universitaria Integrata of 
      Udine, Santa Maria della Misericordia Hospital, Udine, Italy.
FAU - Pilotto, Sara
AU  - Pilotto S
AD  - Oncology Department, Azienda Ospedaliera Universitaria Integrata di Verona, 
      Verona, Italy.
FAU - Polo, Valentina
AU  - Polo V
AD  - Oncology Unit, Azienda Unita Locale Socio Sanitaria (AULSS 2) Marca Trevigiana, 
      Ca' Foncello Hospital, Treviso, Italy.
FAU - Santarpia, Mariacarmela
AU  - Santarpia M
AD  - Medical Oncology, Azienda Ospedaliera Policlinico Universitario "G. Martino," 
      Messina, Italy.
FAU - Chiari, Rita
AU  - Chiari R
AD  - Medical Oncology, AULSS 6 Euganea, South Padua Hospital, Monselice (PD), Italy.
FAU - Pavan, Alberto
AU  - Pavan A
AD  - Medical Oncology, AULSS 6 Euganea, South Padua Hospital, Monselice (PD), Italy.
FAU - Dal Maso, Alessandro
AU  - Dal Maso A
AD  - Department of Surgery, Oncology, and Gastroenterology, University of Padova, 
      Padova, Italy.
AD  - Division of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, 
      Italy.
FAU - Da Ros, Valentina
AU  - Da Ros V
AD  - Medical Oncology and Immunorelated Tumors, National Cancer Institute Centro di 
      Riferimento Oncologico (CRO) - IRCCS, Aviano (PN), Italy.
FAU - Targato, Giada
AU  - Targato G
AD  - Department of Medical Oncology, Azienda Sanitaria Universitaria Integrata of 
      Udine, Santa Maria della Misericordia Hospital, Udine, Italy.
FAU - Vari, Sabrina
AU  - Vari S
AD  - Oncology 1, Regina Elena National Cancer Institute - IRCCS, Rome, Italy.
FAU - Indraccolo, Stefano
AU  - Indraccolo S
AD  - Immunology and Molecular Oncology Unit, Veneto Institute of Oncology IOV - IRCCS, 
      Padua, Italy.
FAU - Calabrese, Fiorella
AU  - Calabrese F
AD  - Cardiovascular Pathology Unit, Department of Cardio-Thoracic and Vascular 
      Sciences, University of Padova, Padova, Italy.
FAU - Frega, Stefano
AU  - Frega S
AD  - Division of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, 
      Italy.
FAU - Bonanno, Laura
AU  - Bonanno L
AD  - Division of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, 
      Italy.
FAU - Conte, Pier Franco
AU  - Conte PF
AD  - Department of Surgery, Oncology, and Gastroenterology, University of Padova, 
      Padova, Italy.
AD  - Division of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, 
      Italy.
FAU - Guarneri, Valentina
AU  - Guarneri V
AD  - Department of Surgery, Oncology, and Gastroenterology, University of Padova, 
      Padova, Italy.
AD  - Division of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, 
      Italy.
FAU - Pasello, Giulia
AU  - Pasello G
AD  - Department of Surgery, Oncology, and Gastroenterology, University of Padova, 
      Padova, Italy.
AD  - Division of Medical Oncology 2, Veneto Institute of Oncology - IRCCS, Padova, 
      Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (Acrylamides)
RN  - 0 (Aniline Compounds)
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Protein Kinase Inhibitors)
RN  - 3C06JJ0Z2O (osimertinib)
RN  - EC 2.7.10.1 (EGFR protein, human)
RN  - EC 2.7.10.1 (ErbB Receptors)
SB  - IM
CIN - Oncologist. 2022 Mar 4;27(2):79-81. PMID: 35641221
MH  - Acrylamides/therapeutic use
MH  - Aniline Compounds/therapeutic use
MH  - *Antineoplastic Agents/therapeutic use
MH  - Brain Neoplasms/drug therapy/secondary
MH  - *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics/pathology
MH  - ErbB Receptors/genetics
MH  - Humans
MH  - *Lung Neoplasms/drug therapy/genetics/pathology
MH  - Prospective Studies
MH  - *Protein Kinase Inhibitors/therapeutic use
MH  - Venous Thromboembolism
PMC - PMC9714585
OTO - NOTNLM
OT  - epidermal growth factor receptor
OT  - non-small cell lung cancer
OT  - osimertinib
OT  - real
OT  - world study
EDAT- 2022/06/01 06:00
MHDA- 2022/06/03 06:00
PMCR- 2021/08/23
CRDT- 2022/05/31 21:24
PHST- 2021/06/24 00:00 [received]
PHST- 2021/08/17 00:00 [accepted]
PHST- 2022/05/31 21:24 [entrez]
PHST- 2022/06/01 06:00 [pubmed]
PHST- 2022/06/03 06:00 [medline]
PHST- 2021/08/23 00:00 [pmc-release]
AID - 6542368 [pii]
AID - onco.13951 [pii]
AID - 10.1002/onco.13951 [doi]
PST - ppublish
SO  - Oncologist. 2022 Mar 4;27(2):87-e115. doi: 10.1002/onco.13951.