Metastatic Women and Clinical Trials

By Lilla

From Mets Matters Blog

To hear the pharmaceutical companies tell it, you would think that metastatic women are just NOT enrolling in their clinical trials. Dig a little deeper and you discover that more often than not, they are being turned away.

There are a myriad of exclusion criteria, not least of which is the "too heavily pretreated" clause. Yes, 3 or more chemotherapies and many companies won't consider you. They prefer 'virgin' or 'chemo naïve' women. Well, who doesn't? But how many metastatic women who are seeking out a trial fit that bill?

But that's not the only reason. Unless the trial is in the patient's own hospital, very few doctors will recommend it to their patient. Perhaps they don't know about each and every trial available – but shouldn't there be a department or a trial nurse assigned to help match patients with trials (in other hospitals)? Or is it that the doctor is afraid of losing a patient to another doctor or hospital?

My experience may be different from yours (I'd like to hear yours). I've been metastatic for 10 years. I'm a great believer in trials but this is how the dialog has gone every time we have changed treatments.

Me: Doctor, Do you think there is a trial that would be right for me?

Doctor: Well, there might be, but I've used this protocol successfully many times before and I think it could work for you. Besides which you would have to be off chemo for 6 weeks prior to entering the trial.

Me: Okay Doctor, let's go with the new protocol.

Last summer, my options were down to a bare minimum. This was the time to get on a trial. I got the names and contact numbers of the principle Investigator and trial nurse for a particular trial and thus began my clinical trial experience. My doctor, realizing there weren't many 'successful protocols' left, wholeheartedly agreed. Well, he was right. I had to be off chemo for 6 weeks. Nevertheless, we forged ahead.

Into the fourth week we discovered that my overexpression of Her2 wasn't quite enough. It needed to be +3 and was only +2. "Sorry. No trial for you."  So, I jumped to another Phase1 trial. After all, I had been off chemo, so, make the most of it, right? Three weeks in, we realized that I had been too heavily pretreated. The next scan showed progression. Was that due to 6 weeks without chemo? Who knows?

So, is anyone at fault? Of course the pharmas want to test the cream of the crop so that their drugs will show good results and lead to a faster FDA approval. That is understandable, but couldn't there be a 3rd arm where statistics are looked at in a slightly different way and positive data could work FOR the pharmaceutical company? And, does all the burden of the grunt work of finding the right trial (remember, NOT in your own hospital) have to fall on the metastatic patient who may not be functioning at 100%?

How can we make this become an easier and more user-friendly system?

Posted April 5, 2010.