Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement.

Female Humans United States Neoplasms / therapy Antineoplastic Agents / adverse effects Ovary Medical Oncology

Journal

The Lancet. Oncology
ISSN: 1474-5488
Titre abrégé: Lancet Oncol
Pays: England
ID NLM: 100957246

Informations de publication

Date de publication:
Oct 2023
Historique:
received: 26 06 2023
revised: 24 07 2023
accepted: 03 08 2023
medline: 1 11 2023
pubmed: 6 10 2023
entrez: 5 10 2023
Statut: ppublish

Résumé

Anticancer agents can impair ovarian function, resulting in premature menopause and associated long-term health effects. Ovarian toxicity is not usually adequately assessed in trials of anticancer agents, leaving an important information gap for patients facing therapy choices. This American Society of Clinical Oncology (ASCO) statement provides information about the incorporation of ovarian toxicity measures in trial design. ASCO recommends: (1) measurement of ovarian toxicity in relevant clinical trials of anticancer agents that enrol post-pubertal, pre-menopausal patients; (2) collection of ovarian function measures at baseline and at 12-24 months after anticancer agent cessation, as a minimum, and later in line with the trial schedule; and (3) assessment of both clinical measures and biomarkers of ovarian function. ASCO recognises that routine measurement of ovarian toxicity and function in cancer clinical trials will add additional complexity and burden to trial resources but asserts that this issue is of such importance to patients that it cannot continue to be overlooked.

Identifiants

DOI: 10.1016/S1470-2045(23)00390-X PMID: 37797647
pubmed: 37797647
pii: S1470-2045(23)00390-X
doi: 10.1016/S1470-2045(23)00390-X
pii:
doi:

Substances chimiques

Antineoplastic Agents 0

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

e415-e423

Informations de copyright

Copyright © 2023 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Declaration of interests WC reports honoraria from AstraZeneca, Pfizer, Merck Serono, and Eisai. RAA reports grants or contracts (research funding) and consulting fees from Roche Diagnostics. ND reports employment by AstraZeneca; grants or contracts (research funding) from Amgen, Novartis, Genentech, Lilly, Pfizer, Daiichi Sankyo, and Immunomedics; and travel, accommodations, expenses, and stock options from AstraZeneca. DS reports grants or contracts (research funding) from Janssen; consulting fees (advisory role) from Janssen Oncology, AstraZeneca, Boston Scientific, Bayer, Blue Earth, Varian Medical Systems, Pfizer, and Myovant Sciences; and honoraria from Varian Medical Systems. All other authors declare no competing interests.

Auteurs

Wanda Cui (W)

Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC, Australia.

Rodney P Rocconi (RP)

The University of Mississippi Medical Center, Cancer Center & Research Institute, Jackson, MS, USA.

Ramya Thota (R)

Intermountain Health, Murray, UT, USA.

Richard A Anderson (RA)

Medical Research Council Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.

Suanna S Bruinooge (SS)

American Society of Clinical Oncology, Alexandria, VA, USA.

Ioanna A Comstock (IA)

Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Division of Urology, Obstetrics, and Gynecology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Neelima Denduluri (N)

AstraZeneca, Gaithersburg, MD, USA.

Audrey Gassman (A)

Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Division of Urology, Obstetrics, and Gynecology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Julie Gralow (J)

American Society of Clinical Oncology, Alexandria, VA, USA.

Karla J Hutt (KJ)

Development and Stem Cell Program and Department of Anatomy and Developmental Biology, Biomedicine Discovery Institute, Monash University, Clayton, VIC, Australia.

Laleh Amiri-Kordestani (L)

Division of Oncology 1, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Matteo Lambertini (M)

Department of Internal Medicine and Medical Specialties, School of Medicine, University of Genova, Genoa, Italy; Department of Medical Oncology, UO Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

John Leighton (J)

Division of Hematology Oncology Toxicity, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Karen H Lu (KH)

Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Sogol Mostoufi-Moab (S)

Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Philadelphia, PA, USA.

Teri Pollastro (T)

Metastatic Breast Cancer Alliance, New York, NY, USA.

Shan Pradhan (S)

Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Haleh Saber (H)

Division of Hematology Oncology Toxicity, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Caroline Schenkel (C)

American Society of Clinical Oncology, Alexandria, VA, USA. Electronic address: caroline.schenkel@asco.org.

Daniel Spratt (D)

Moffitt Cancer Center and Research Institute, Cleveland, OH, USA.

Suparna Wedam (S)

Division of Oncology 1, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.

Kelly-Anne Phillips (KA)

Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia.

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Classifications MeSH

questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Measuring ovarian toxicity in clinical trials:...
questionsmedicales.fr › Régions géographiques › Amériques › Amérique du Nord › États-Unis › Measuring ovarian toxicity in clinical trials:...
questionsmedicales.fr › Tumeurs › Measuring ovarian toxicity in clinical trials:...
questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Antinéoplasiques › Measuring ovarian toxicity in clinical trials:...
questionsmedicales.fr › Système endocrine › Glandes endocrines › Gonades › Ovaire › Measuring ovarian toxicity in clinical trials:...
questionsmedicales.fr › Professions de santé › Médecine › Médecine interne › Oncologie médicale › Measuring ovarian toxicity in clinical trials:...