Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement - 03/10/23

Doi : 10.1016/S1470-2045(23)00390-X

Wanda Cui, MBBS ^a,^b, Rodney P Rocconi, ProfMD ^d, Ramya Thota, MBBS ^e, Richard A Anderson, ProfMD ^f, Suanna S Bruinooge, MPH ^g, Ioanna A Comstock, MD ^h, Neelima Denduluri, MD ^l, Audrey Gassman, MD ^h, Julie Gralow, MD ^g, Karla J Hutt, MD ^m, Laleh Amiri-Kordestani, MD ⁱ, Matteo Lambertini, PhD ^n,^o, John Leighton, MD ^j, Karen H Lu, ProfMD ^p, Sogol Mostoufi-Moab, MD ^q, Teri Pollastro, BS ^r, Shan Pradhan, MD ^k, Haleh Saber, MD ^j, Caroline Schenkel, MSc ^g,⁎ , Daniel Spratt, ProfMD ^s, Suparna Wedam, MD ⁱ, Kelly-Anne Phillips, ProfMD ^a,^b,^c

^a Department of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia

^b Sir Peter MacCallum Department of Oncology, The University of Melbourne, Parkville, VIC, Australia

^c Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Parkville, VIC, Australia

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

^e Intermountain Health, Murray, UT, USA

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

^g American Society of Clinical Oncology, Alexandria, VA, USA

^h 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

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

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

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

^l AstraZeneca, Gaithersburg, MD, USA

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

ⁿ Department of Internal Medicine and Medical Specialties, School of Medicine, University of Genova, Genoa, Italy

^o Department of Medical Oncology, UO Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Genoa, Italy

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

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

^r Metastatic Breast Cancer Alliance, New York, NY, USA

^s Moffitt Cancer Center and Research Institute, Cleveland, OH, USA

^* Correspondence to: Caroline Schenkel, Center for Research and Analytics, American Society of Clinical Oncology, Alexandria, VA 22302, USA Center for Research and Analytics American Society of Clinical Oncology Alexandria VA 22302 USA

Summary

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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Plan

Introduction

Current knowledge regarding the effects of systemic anticancer treatment on ovarian function

Cytotoxic chemotherapy

Immune checkpoint inhibitors

Other targeted therapies

Measures of ovarian function

Search strategy and selection criteria

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Vol 24 - N° 10

P. e415-e423 - octobre 2023 Retour au numéro

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Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement - 03/10/23

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