PMID- 37665777
OWN - NLM
STAT- MEDLINE
DCOM- 20231004
LR  - 20231005
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 28
IP  - 10
DP  - 2023 Oct 3
TI  - Left Ventricular Ejection Fraction in Patients With Ovarian Cancer Treated With 
      Avelumab, Pegylated Liposomal Doxorubicin, or Both.
PG  - e977-e980
LID - 10.1093/oncolo/oyad213 [doi]
AB  - In the phase III JAVELIN Ovarian 200 trial, 566 patients with 
      platinum-resistant/refractory ovarian cancer were randomized 1:1:1 to receive 
      avelumab alone, avelumab plus pegylated liposomal doxorubicin (PLD), or PLD 
      alone. Cardiac monitoring was included for all patients. We report left 
      ventricular ejection fraction (LVEF) data from the trial. Grade >/=3 cardiac 
      adverse events (AEs) occurred in 4 (2.1%), 1 (0.5%), and 0 patients in the 
      avelumab, combination, and PLD arms, respectively. LVEF decreases of >/=10% to 
      below institutional lower limit of normal at any time during treatment were 
      observed in 1 (0.8%), 3 (1.9%), and 2 (1.5%) patients, respectively; 4 had 
      subsequent assessments, and these showed transient decreases. No patient had a 
      cardiovascular AE related to LVEF decrease. This analysis is, to our knowledge, 
      the first analysis of LVEF in patients receiving immune checkpoint inhibitors. 
      CLINICALTRIALS.GOV IDENTIFIER: NCT02580058.
CI  - (c) The Author(s) 2023. Published by Oxford University Press.
FAU - Bonaca, Marc P
AU  - Bonaca MP
AD  - Colorado Prevention Center Clinical Research, Division of Cardiology, Department 
      of Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
FAU - Moslehi, Javid J
AU  - Moslehi JJ
AD  - Section of Cardio-Oncology and Immunology, Division of Cardiology and the 
      Cardiovascular Research Institute, UCSF School of Medicine, Cardiovascular 
      Research Institute (CVRI), San Francisco, CA, USA.
FAU - Ledermann, Jonathan A
AU  - Ledermann JA
AD  - UCL Cancer Institute and UCL Hospitals, London, UK.
FAU - Michelon, Elisabete
AU  - Michelon E
AD  - Pfizer, New York, NY, USA.
FAU - Wei, Caimiao
AU  - Wei C
AD  - Pfizer, Groton, CT, USA.
FAU - Moran, Michael
AU  - Moran M
AD  - Pfizer Pharma GmbH, Berlin, Germany (Affiliation at the time the research was 
      conducted).
FAU - Monk, Bradley J
AU  - Monk BJ
AD  - Arizona Oncology (US Oncology Network), University of Arizona and Creighton 
      University, Phoenix, AZ, USA.
FAU - Pujade-Lauraine, Eric
AU  - Pujade-Lauraine E
AD  - ARCAGY-GINECO, Paris, France.
LA  - eng
SI  - ClinicalTrials.gov/NCT02580058
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - KXG2PJ551I (avelumab)
RN  - 0 (liposomal doxorubicin)
RN  - 80168379AG (Doxorubicin)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
SB  - IM
MH  - Humans
MH  - Female
MH  - Stroke Volume
MH  - *Ventricular Function, Left
MH  - *Ovarian Neoplasms/drug therapy
MH  - Doxorubicin/adverse effects
MH  - Carcinoma, Ovarian Epithelial
MH  - Polyethylene Glycols/adverse effects
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects
PMC - PMC10546816
OTO - NOTNLM
OT  - carcinoma
OT  - clinical trial
OT  - immune checkpoint inhibitors
OT  - immunotherapy
OT  - left
OT  - ovarian epithelial
OT  - phase III
OT  - ventricular function
COIS- Marc Bonaca has received grant support for Brigham and Women's Hospital from 
      Pfizer and grant support for CPC Clinical Research from Amgen, AstraZeneca, 
      Bayer, Janssen, Novo Nordisk, and Sanofi. Javid J. Moslehi has served on advisory 
      boards for Amgen, AstraZeneca, Audentes, Bristol Myers Squibb, Boston Biomedical, 
      Cytokinetics, Deciphera, Immunocore, Ipsen, Janssen, Myovant, Pfizer, Regeneron, 
      Takeda, and Triple-Gene/Precigen and is supported by the National Institute of 
      Health (R01HL141466, R01HL155990, R01HL156021). Jonathan A. Ledermann reports 
      serving as a consultant or advisor for Artios Pharma, AstraZeneca, Bristol Myers 
      Squibb, Clovis Oncology, Eisai, GSK, Immagene, Miltenyni, MSD, Novocure, 
      Nuvation, and Pfizer; has received research funding from AstraZeneca and MSD; has 
      received honoraria from AstraZeneca, Clovis Oncology, Eisai, and GSK; and has 
      other relationships with Mersana and Sutro Bio. Elisabete Michelon is an employee 
      of and holds stocks in Pfizer. Caimiao Wei is an employee of and holds stock in 
      Pfizer. Michael Moran was an employee of Pfizer Pharma GmbH at the time the study 
      was conducted and is currently an employee of AbbVie Deutschland GmbH & Co KG; 
      has stock or other ownership in Pfizer and AbbVie; and has received travel, 
      -accommodations, or expenses from Pfizer. Bradley J. Monk reports serving as a 
      consultant or advisor for and has received honoraria from Agenus, Akeso Bio, 
      Aravive, AstraZeneca, Clovis Oncology, Eisai, Elevar Therapeutics, Genmab/Seagen, 
      GOG Foundation, Gradalis, ImmunoGen, Iovance, Karyopharm, Mersana Therapeutics, 
      MSD, Myriad Pharmaceuticals, Novocure, Pfizer, Puma Biotechnology, 
      Roche/Genentech, Tesaro/GSK, and VBL Therapeutics; is a member of a speakers 
      bureau for AstraZeneca, Clovis Oncology, Eisai, MSD, Roche/Genentech, and 
      Tesaro/GSK; and reports employment at McKesson/US Oncology. Eric Pujade-Lauraine 
      reports personal fees from AstraZeneca, Clovis Oncology, Incyte, Pfizer, Roche, 
      and Tesaro; nonfinancial support from AstraZeneca, Roche, and Tesaro; and is the 
      chair of ARCAGY Research.
EDAT- 2023/09/04 18:41
MHDA- 2023/10/04 06:43
PMCR- 2023/09/04
CRDT- 2023/09/04 15:12
PHST- 2023/02/16 00:00 [received]
PHST- 2023/06/22 00:00 [accepted]
PHST- 2023/10/04 06:43 [medline]
PHST- 2023/09/04 18:41 [pubmed]
PHST- 2023/09/04 15:12 [entrez]
PHST- 2023/09/04 00:00 [pmc-release]
AID - 7259791 [pii]
AID - oyad213 [pii]
AID - 10.1093/oncolo/oyad213 [doi]
PST - ppublish
SO  - Oncologist. 2023 Oct 3;28(10):e977-e980. doi: 10.1093/oncolo/oyad213.