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Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement.
Cui, Wanda; Rocconi, Rodney P; Thota, Ramya; Anderson, Richard A; Bruinooge, Suanna S; Comstock, Ioanna A; Denduluri, Neelima; Gassman, Audrey; Gralow, Julie; Hutt, Karla J; Amiri-Kordestani, Laleh; Lambertini, Matteo; Leighton, John; Lu, Karen H; Mostoufi-Moab, Sogol; Pollastro, Teri; Pradhan, Shan; Saber, Haleh; Schenkel, Caroline; Spratt, Daniel; Wedam, Suparna; Phillips, Kelly-Anne.
Afiliación
  • 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.
  • Rocconi RP; The University of Mississippi Medical Center, Cancer Center & Research Institute, Jackson, MS, USA.
  • Thota R; Intermountain Health, Murray, UT, USA.
  • Anderson RA; Medical Research Council Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.
  • Bruinooge SS; American Society of Clinical Oncology, Alexandria, VA, USA.
  • 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.
  • Denduluri N; AstraZeneca, Gaithersburg, MD, USA.
  • 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.
  • Gralow J; American Society of Clinical Oncology, Alexandria, VA, USA.
  • Hutt KJ; Development and Stem Cell Program and Department of Anatomy and Developmental Biology, Biomedicine Discovery Institute, Monash University, Clayton, VIC, Australia.
  • Amiri-Kordestani L; Division of Oncology 1, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • 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.
  • Leighton J; Division of Hematology Oncology Toxicity, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Lu KH; Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.
  • Mostoufi-Moab S; Center for Childhood Cancer Research, Children's Hospital of Philadelphia, Philadelphia, PA, USA.
  • Pollastro T; Metastatic Breast Cancer Alliance, New York, NY, USA.
  • Pradhan S; Office of Oncologic Diseases, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Saber H; Division of Hematology Oncology Toxicity, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • Schenkel C; American Society of Clinical Oncology, Alexandria, VA, USA. Electronic address: caroline.schenkel@asco.org.
  • Spratt D; Moffitt Cancer Center and Research Institute, Cleveland, OH, USA.
  • Wedam S; Division of Oncology 1, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
  • 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
Lancet Oncol ; 24(10): e415-e423, 2023 Oct.
Article en En | MEDLINE | ID: mdl-37797647
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.
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Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Neoplasias / Antineoplásicos Límite: Female / Humans País/Región como asunto: America do norte Idioma: En Revista: Lancet Oncol Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: Australia
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Banco de datos: MEDLINE Asunto principal: Neoplasias / Antineoplásicos Límite: Female / Humans País/Región como asunto: America do norte Idioma: En Revista: Lancet Oncol Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: Australia