ALEXANDRIA, Va. –– The American Society of Clinical Oncology (ASCO) has released a research statement, “Measuring Ovarian Toxicity in Clinical Trials,” outlining new recommendations for appropriate assessment of ovarian toxicity in cancer clinical trials. The statement, published today in Lancet Oncology, emphasizes the urgent need to understand the long-term impacts of cancer therapies on ovarian function.
Why It Matters
Each year, approximately 1.4 million women under the age of 45 are diagnosed with cancer worldwide. Many receive treatments that could damage their ovaries, potentially causing premature menopause. Premature menopause results in infertility and adversely affects bone and cardiovascular health. Cancer clinical trials usually don’t collect information on whether the anticancer treatment under study causes ovarian toxicity, creating a significant information gap for patients making critical treatment decisions. For example, between 2008 and 2019, only 9% of phase III breast cancer trials specifically looked at how the treatment could affect ovarian function.
“We've long been aware that cancer treatments can significantly impact fertility and increase the risk for certain diseases. However, this issue has been inadequately addressed in clinical trials. This knowledge shortfall compromises the ability of clinicians and patients to make well-informed treatment choices,” said Julie R. Gralow, MD, FACP, FASCO, ASCO's Chief Medical Officer and Executive Vice President. “Our new recommendations establish a benchmark for what ovarian toxicity data should be assessed as essential aspects of research in this field.”
Key ASCO Recommendations:
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Inclusion of Ovarian Toxicity Measurement: Include assessment of ovarian toxicity in all relevant clinical trials, focused on curative intent or primary prevention, of anticancer agents that enroll premenopausal, post-pubertal patients with ovaries. Ovarian toxicity assessment may also be considered in clinical trials enrolling patients with advanced and metastatic cancer, especially trials enrolling treatment naïve patients.
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Timeframes for Data Collection: Collect ovarian function measures at baseline and at 12–24 months after cessation of the anticancer agent, as a minimum, and at later timepoints in line with the trial schedule. For trials of anticancer agents, for which the mechanism and extent of ovarian toxicity (if any), and the time to recovery are not known, additional data collection every 6–12 months during treatment, at the end of treatment, and after cessation of treatment is considered optimal.
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Use of Clinical Measures and Biomarkers: Assess both clinical measures and biomarkers of ovarian function. If ovarian function biomarkers cannot be assessed, clinical measures (menstruation, pregnancy, and live birth) and data on possible confounders (hysterectomy, bilateral oophorectomy, attempt at pregnancy, and use of hormonal contraceptives, endocrine therapy, GnRH agonists, and assisted reproductive technology) should be collected as a minimum. The type of assay used to measure anti-Mullerian hormone, follicle-stimulating hormone, and oestradiol should be considered during trial design.
The statement serves as a comprehensive framework, offering recommendations regarding the optimal data points that should be collected during clinical research. Notably, ASCO acknowledges the potential additional costs involved in these assessments but emphasizes that this is a small price to pay for vital evidence that could substantially influence patient decisions and treatment plans.
“There is a glaring lack of data on whether and to what extent new cancer drug treatments might damage the ovaries. This leaves pre-menopausal patients without crucial information to help them choose between treatment options of similar effectiveness and to weigh up the need for expensive fertility preservation interventions, such as egg freezing, prior to their cancer treatment.” said Wanda Cui, MBBS BMedSci FRACP, lead author of the ASCO statement. “Our new recommendations aim to fill this void by encouraging researchers to collect these essential data and offering them a framework to do so. The ultimate goal is to empower individuals with comprehensive information about the risks they may face, from fertility concerns to other long-term health implications from early-onset menopause. This isn't just about refining the structure of clinical trials; it's about enriching the quality of life for countless people navigating cancer treatment."
For more information, read the full Research Statement.
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About ASCO:
Founded in 1964, the American Society of Clinical Oncology, Inc. (ASCO®) is committed to making a world of difference in cancer care. As the world’s leading organization of its kind, ASCO represents nearly 50,000 oncology professionals who care for people living with cancer. Through research, education, and promotion of the highest-quality patient care, ASCO works to conquer cancer and create a world where cancer is prevented or cured, and every survivor is healthy. ASCO is supported by its affiliate organization, the Conquer Cancer Foundation. Learn more at www.ASCO.org, explore patient education resources at www.Cancer.Net, and follow us on Facebook, Twitter, LinkedIn, Instagram, and YouTube.