TY - JOUR
T1 - Measuring ovarian toxicity in clinical trials
T2 - an American Society of Clinical Oncology research statement
AU - Cui, Wanda
AU - Rocconi, Rodney P.
AU - Thota, Ramya
AU - Anderson, Richard A.
AU - Bruinooge, Suanna S.
AU - Comstock, Ioanna A.
AU - Denduluri, Neelima
AU - Gassman, Audrey
AU - Gralow, Julie
AU - Hutt, Karla J.
AU - Amiri-Kordestani, Laleh
AU - Lambertini, Matteo
AU - Leighton, John
AU - Lu, Karen H.
AU - Mostoufi-Moab, Sogol
AU - Pollastro, Teri
AU - Pradhan, Shan
AU - Saber, Haleh
AU - Schenkel, Caroline
AU - Spratt, Daniel
AU - Wedam, Suparna
AU - Phillips, Kelly Anne
N1 - Publisher Copyright:
© 2023 Elsevier Ltd
PY - 2023/10
Y1 - 2023/10
N2 - 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.
AB - 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.
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U2 - 10.1016/S1470-2045(23)00390-X
DO - 10.1016/S1470-2045(23)00390-X
M3 - Review article
C2 - 37797647
AN - SCOPUS:85173159580
SN - 1470-2045
VL - 24
SP - e415-e423
JO - The lancet oncology
JF - The lancet oncology
IS - 10
ER -