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

Wanda Cui, Rodney P Rocconi, Ramya Thota, Richard A Anderson, Suanna S Bruinooge, Ioanna A Comstock, Neelima Denduluri, Audrey Gassman, Julie Gralow, Karla J Hutt, Laleh Amiri-Kordestani, Matteo Lambertini, John Leighton, Karen H Lu, Sogol Mostoufi-Moab, Teri Pollastro, Shan Pradhan, Haleh Saber, Caroline Schenkel, Daniel SprattSuparna Wedam, Kelly-Anne Phillips

Research output: Contribution to journalReview articlepeer-review

Abstract / Description of output

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.

Original languageEnglish
Pages (from-to)e415-e423
JournalThe Lancet Oncology
Volume24
Issue number10
DOIs
Publication statusPublished - 1 Oct 2023

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