Call for routine monitoring of ovarian function in cancer clinical trials
03 October 2023
Young women with cancer who enrol in clinical trials should be monitored to check if new treatments have any impact on their ovaries, say Peter Mac experts as new international guidelines are published.
The American Society of Clinical Oncology (ASCO) today released a Research Statement outlining new recommendations for appropriate assessment of ovarian toxicity in cancer clinical trials.
The statement notes worldwide each year about 1.4 million women under the age of 45 are diagnosed with cancer.
Cancer treatment can affect a woman’s ovaries, potentially causing early menopause leading to infertility and increasing the chance of osteoporosis and cardiovascular disease later in life.
And yet most trials of new cancer drugs do not monitor ovarian function, meaning doctors are unable to provide women with the information they need to make informed decisions about their care.
Lead authors of the ASCO statement, which is published today in the journal Lancet Oncology, are Dr Wanda Cui and Professor Kelly-Anne Phillips from Peter Mac.
“There are inadequate data regarding whether newer cancer treatments can cause treatment-related infertility and early-onset menopause, despite the importance of this information to young women,” says Dr Cui, a consultant medical oncologist at Peter Mac.
She says while the impact of older chemotherapy drugs on ovarian function was well recognised, little was known about emerging drug classes such as immunotherapies.
Dr Cui’s research found only 9% of Phase III breast cancer trials conducted globally between 2008 to 2019 had ovarian function as an endpoint, and only 20% collected pre-intervention and post-intervention ovarian function data.
The statement is the result of an ASCO Ovarian Toxicity Taskforce with input from experts, patients and drug regulatory bodies from around the world.
It calls for ovarian toxicity monitoring to be standard in cancer clinical trials involving premenopausal patients, and outlines the optimal way to do this – including ovarian function tests at trial outset and 12 to 24 months after women stop taking the trial drug.
The need for monitoring was also due to improving cure rates for cancers affecting young women, and this placing a heightened focus on longer-term health.
Beyond infertility, ovarian toxicity can negatively affect a woman’s cardiovascular and bone health, cognition and sexual health.
Professor Phillips says: “It is hoped this statement will encourage and help those designing trials of new anti-cancer drugs to routinely assess the effect of the new anti-cancer drugs on ovarian function and fertility."
"This would be a paradigm shift in clinical trial design that potentially has implications in other diseases beyond cancer.”
Having a better understanding of the impact of newer cancer treatments on ovarian function would benefit young women like Mariana Corrales, a lab manager at Peter Mac.
Mariana was diagnosed with breast cancer in early 2022.
In addition to standard treatment, Mariana opted for the extra step of taking an immunotherapy drug.
While there was evidence this would improve her chances of beating cancer, the picture was less clear about any effect on ovarian function.
Mariana says having this information “would have prepared me a lot more psychologically".
"There’s so many unknowns, that to have some more information I think makes you feel a lot better.”
Fortuitously Mariana froze some of her eggs before her she was diagnosed with cancer.
She is now cancer free thanks to treatment, though is under regular surveillance.
The new guidelines are titled “Measuring ovarian toxicity in clinical trials: an American Society of Clinical Oncology research statement” - read it online.
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Peter MacCallum Cancer Centre is a world-leading cancer research, education and treatment centre and Australia’s only public health service solely dedicated to caring for people affected by cancer.