Androcur- Interview of Pr Frouelich in Liberation on September 10, 2018
This interview follows the information given by the ANSM in the summer of 2018, of the sur-risk to develop meningiomas under acetate of Cyproterone (Androcur)
Sébastien Froelich: "Little risks below five years of treatment"
By Sabrina Champenois - September 10, 2018 at 7:36 pm
The Androcur can arouse meningiomas, but these are mild, underlines the neurosurgeon Sébastien Froelich, who participated in the study.
- Sébastien Froelich: "Little risks below five years of treatment"
Head of the neurosurgery department of the Lariboisière hospital in Paris, Sébastien Froelich is at the origin and part of the study on the Androcur conducted by the Health Insurance Fund, the results of which have just been made public by the National Agency for the Safety of Medicines and Health Products (ANSM).
A small panic wind started to circulate around Androcur. Is it legitimate?
The concern is legitimate. I understand that, for a patient who takes Androcur, these results are an anxiety factor. Because the risk is not negligible, and it is probably underestimated since we have only taken into account the meningiomas operated (1). And there are about 80,000 women who take Androcur in France.
Now what you need to know is that the risk of meningioma increases with the duration of treatment and according to the dosage. For example, the Diane 35 pill, which is no longer used, contained like the Androcur of cyproterone acetate but only 2 mg and, in my practice, I did not note a link between the taking of this pill and meningioma. The risk of meningioma under Androcur occurs in higher doses and, above all, when it is taken over a long period. Clearly: longer we take androcur in large doses, the more the risk of developing one or more meningiomas. The patients I have been led to consult after a diagnosis of meningioma rarely presented use less than five-six years. So I have little worries about patients who have been taking cyproterone acetate for two, three or four years. It would probably be necessary, for durations more than five years, to make an MRI of control. Precise recommendations will soon be discussed during the meeting organized in early October by the ANSM, which will bring together endocrinologists, gynecologists, neurosurgeons, experts from the National Health Insurance Fund (CNAM)…
"Meningioma", "tumor", these terms are anxiety ...
Yes, and having read and heard erroneous things these days, I want to specify the following: meningioma is not cancer. It is a benign tumor in 70 % to 80 % of cases, and in my experience, meningiomas linked to cyproterone acetate are always mild. I have never seen an aggressive. In the majority of cases, it is enough to stop [the drug] for meningioma stabilizing or regressing. Surgical intervention is nevertheless sometimes necessary, when the symptoms are severe and important.
Testimonials from patients evoke significant sequelae, especially visual ...
Meningioma is a tumor that develops at the expense of brain envelopes, around it. It leads to symptoms because it compresses it. The meningiomas linked to the Androcur occur mainly in the anterior parts of the cranial box (rather in the frontal regions) and on the anterior and medium parts of the base of the skull, the base on which the brain rests. And, in the anterior part of the base of the skull, are the optic nerves. So, in fact, one of the frequent symptoms of this type of meningioma is vision disorders linked to compression of the optic nerve or optical chiasma (part where the two nerves meet). But other symptoms are possible, depending on the exact location of the meningiomas, which is variable.
Why are men not affected?
Because this treatment is only used in men for prostate cancer. Its use is, I believe, quite rare and on shorter durations. It only happened to me once to see a patient with meningioma linked to Androcur.
What is the link between meningiomas and hormones?
Meningiomas are just over twice as frequent in women. These are tumors in which we find progesterone receptors and, to a lesser extent, to estrogens. However, progesterone increases in women during the second phase of their menstrual cycle, after ovulation, and during pregnancy. So, as a neurosurgeonian, we have long known that progestins (steroid hormones of action similar to progesterone, present in particular in substitute treatments of menopause) can have an influence on the speed of growth of meningiomas.
I started to read a possible link between meningioma and cyproterone acetate in 2004 when I was a young neurosurgeon at the Strasbourg University Hospital: I had to urgently operate a patient with many meningiomas and who was in the process of being seen. She was taking cyproterone acetate and I made her arrest this treatment, for the simple reason that it is also a progestogy. But, at that time, I had not yet become aware of the strong bond between this product and the meningiomas of this patient. Three years later, I saw two patients in consultation with similar multiple meningiomas, who also took Androcur. It put the chip in my ear. A third patient admitted shortly after, inoperable, saw her meningioma decrease when you stop treatment. It was from there that I was particularly interested in Androcur.
France alerted Europe in 2009 to the risk of meningioma linked to cyproterone acetate…
From 2008, I presented our observations in congresses of neurosurgery, internal medicine and endocrinology. The French health authorities then learned of the problem and alerted the European authorities in 2009, which had the medication of the drug changed by the Bayer laboratory - which produces and markets it. So France reacted rapidly and, as of 2011-2012, in the Androcur notice, the risk of meningioma was added in the adverse effects and the contraindicated Androcur in the event of meningiomas or a history of meningiomas. Knowing that France was not going to decide the ban on this medication when my observations were based on eight patients.
A study was published in 2011, with the support of Bayer, but it did not confirm a meningioma surgery in women taking cyproterone acetate. And for good reason: the patients studied, English, were exposed only to low doses. It did not help the demonstration or the recognition of this risk.
Nine years separate the French alert from the study, the results of which have just been made public. It's long ...
From 2013, with my new team at Lariboisière hospital, we organized a discussion group around Androcur, with gynecologists and endocrinologists. In 2015, with the help of a patient who is also a doctor and who helped us a lot, we convinced the CNAM of the relevance of a national study to assess the extent of the problem.
The CNAM has only had a database since 2006, or the meningiomas linked to cyproterone acetate only appear after a certain number of years of treatment. A decline was necessary so that we could highlight a link. If the study had been done before, we would most likely have not highlighted risk or a low risk because we could not have taken into account the duration of exposure to treatment, which is decisive.
(1) The study included 250,000 women on Androcur, who were followed for eight years. Only the cases of those which have been operated on for meningioma have been the subject of a comparative evaluation which made it possible to define the risk.
Androcur- interview with Profession of Liberation on September 10, 2018
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