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

Cui, W; Rocconi, RP; Thota, R; Anderson, RA; Bruinooge, SS; Comstock, IA; Denduluri, N; Gassman, A; Gralow, J; Hutt, KJ; Amiri-Kordestani, L; Lambertini, M; Leighton, J; Lu, KH; Mostoufi-Moab, S; Pollastro, T; Pradhan, S; Saber, H; Schenkel, C; Spratt, D; Wedam, S; Phillips, KA

Author(s): Cui, W; Rocconi, RP; Thota, R; Anderson, RA; Bruinooge, SS; Comstock, IA; Denduluri, N; Gassman, A; Gralow, J; Hutt, KJ; Amiri-Kordestani, L; Lambertini, M; Leighton, J; Lu, KH; Mostoufi-Moab, S; Pollastro, T; Pradhan, S; Saber, H; Schenkel, C; Spratt, D; Wedam, S; Phillips, KA;
Details: Publication Year 2023-10,Volume 24,Issue #10,Page e415-e423
Journal Title: Lancet Oncology
Publication Type: Review
Abstract: 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.
Publisher: Elsevier
Keywords: Female; Humans; United States; *Neoplasms/therapy; *Antineoplastic Agents/adverse effects; Ovary; Medical Oncology
Department(s): Medical Oncology
PubMed ID: 37797647
Publisher's Version: https://doi.org/10.1016/S1470-2045(23)00390-X
Terms of Use/Rights Notice: Refer to copyright notice on published article.

Creation Date: 2023-11-30 02:33:21

Last Modified: 2024-07-09 06:20:02