ASCO recommends future cancer clinical trials take steps to assess ovarian toxicity
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ASCO released a research statement outlining new recommendations regarding the appropriate assessment of ovarian toxicity in cancer clinical trials.
Published in The Lancet Oncology, the statement’s three key recommendations aim to provide researchers with a way to measure ovarian toxicity in cancer clinical trials while also encouraging data acquisition. The goal is to provide patients and clinicians with information regarding potential long-term effects of certain treatments.
“Having healthy ovaries is important for the fertility and long-term health of young women. We know that chemotherapy can cause damage to the ovaries. However, we do not know if newer cancer treatments, such as immunotherapy, cause ovarian toxicity,” Wanda Cui, MBBS, BMedSci, FRACP, a consultant medical oncologist in the breast cancer and lung cancer service at Peter MacCallum Cancer Centre and lead author of the research statement, told Healio.
“Treatment-related ovarian toxicity — which can result in early menopause and infertility — is a major concern for women making treatment decisions,” Cui added. “Despite the importance of this information to patients, our previous research has shown that the issue of ovarian toxicity has largely been overlooked in cancer clinical trials. This research statement raises awareness regarding this issue and provides recommendations regarding how and when to collect information regarding ovarian toxicity in clinical trials.”
The recommendations — formulated by ASCO’s Ovarian Toxicity Taskforce — serve as a framework for researchers to utilize when preparing to include certain data points for collection during clinical research:
- Include ovarian toxicity measurement for all clinical trials of anticancer agents focused on curative intent or primary prevention that enroll premenopausal, post-pubertal patients with ovaries.
- Collect ovarian function measures at baseline and 12 to 24 months following cessation of the anticancer agent, as well as at later timepoints in line with the trial schedule. Trials of anticancer agents of which the mechanism and extent of potential ovarian toxicity or time to recovery are not known, additional data collection every 6 to 12 months during and at end of treatment, as well as after cessation of treatment, is recommended.
- Assess both clinical measures and biomarkers of ovarian function.
Loss of ovarian function is potentially irreversible from anticancer treatment, and although such data collection could be costly during some cancer clinical trials, Cui said the expenses are worth additional data on potentially life-altering treatments for women in this age bracket.
“We hope this statement will result in a paradigm shift in the existing approach to designing clinical trials enrolling premenopausal women, so that adequate information about treatment-related ovarian toxicity is collected routinely during the trial and is, therefore, available to patients when the drug is first used in clinical practice,” Cui told Healio.
“Currently, women need to make treatment decisions without the knowledge of how some therapies may affect their future fertility or ovarian function,” Cui added. “Although we recognize that collection of ovarian toxicity data may add complexity when designing trials, this issue is of such importance to patients that it cannot continue to be overlooked.”
References:
ASCO issues recommendations or assessing ovarian toxicity in cancer clinical trials (press release). Available at: https://old-prod.asco.org/about-asco/press-center/news-releases/asco-issues-recommendations-assessing-ovarian-toxicity-cancer. Published Oct. 2, 2023. Accessed Oct. 2, 2023.
Cui W, et al. Lancet Onc. 2023;doi:10.1016/S1470-2045(23)00390-X.
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