Q&A with Dr. Karen Gelmon: We can’t allow decisions veiled as being evidence-based discriminate against young women

Photo by @sarah.smiles9

Q&A WITH DR. KAREN GELMON: “WE CAN’T ALLOW DECISIONS VEILED AS BEING EVIDENCE-BASED DISCRIMINATE AGAINST YOUNG WOMEN”

Dr. Karen Gelmon is a Professor of Medicine at the University of British Columbia and Medical Oncologist at BC Cancer Agency.  She is also the Vancouver Cancer Centre Chair of the BCC/UBC Research Ethics Committee and a member of Rethink’s Medical Advisory Board.

Tell us a bit about the situation?

When Ibrance was approved for funding in British Columbia, the criteria “mirrored” the PALOMA 2 clinical trial. What this means is that young premenopausal women with breast cancer who may benefit from this drug were required to have an oophorectomy (a surgery to remove the ovaries) to be eligible for the drug.

Do funding approvals usually mirror the clinical trial?

One has to understand clinical trial design and drug development to appreciate the eligibility criteria used in trials.

The PALOMA 1 trial (which we participated in at the Vancouver centre) was a randomized open-label phase II trial. The eligibility was for postmenopausal women only. This was designed a number of years ago when the similarity of premenopausal women on hormonal therapy and postmenopausal women was not yet fully understood.

The PALOMA 2 trial was designed to match PALOMA 1 exactly. This was done for both scientific and pragmatic regulatory reasons – including the option of going to the FDA with two trials showing efficacy, something that is usually required for rapid approval of a drug.

Since then, other studies such as PALOMA 3 and a number of the MONALEESA studies show that the efficacy of these drugs when used in premenopausal women that become postmenopausal with hormone therapy is equivalent to postmenopausal women. And more and more studies are showing that premenopausal women on hormone therapy behave the same as postmenopausal women in terms of response.

So, the way a woman becomes postmenopausal doesn’t matter clinically?

That’s exactly the point. The oophorectomy is medically unnecessary. A ‘medical oophorectomy’ that is achieved by hormone injections is equivalent usually to a surgical oophorectomy. That is why other jurisdictions have not required a surgery to be eligible for the drug. It left BC as an outlier for the months when this policy was in effect.

What does this mean for patients in BC or elsewhere when premenopausal women are not given the same opportunities for treatment?

The policy was discriminatory to premenopausal women. It goes against the scientific evidence, despite the fact that we claim to be evidence-based, and it’s against the common practice and guidelines internationally.

It also forces premenopausal women to have an oophorectomy. This is ethically questionable since there is always some risk when having a surgery.

And finally, there’s increased discussion about pregnancy, even in women with advanced disease. While many oncologists may not approve, advocacy groups focused on metastatic disease are quite strident in protecting this potential because it’s important to young women.

These things have to be considered when we make policies that affect premenopausal women and their access to drugs.

Do you have hope for this to change?

I do. Ontario and BC which both previously restricted access to premenopausal women recently updated their approval of Ibrance for premenopausal women without defining the way they become postmenopausal. This is terrific and sets a precedence future drug approvals. We need to treat young women in the optimal way that has been shown effective with evidence-based research.