Use of fulvestrant in postmenopausal women with ER-positive metastatic disease

We had a lot of experience with fulvestrant before it became commercially available. We presented data at the San Antonio Breast Cancer Symposium on approximately 40 patients whom we treated with the drug, initially as part of a compassionate-use program. These patients had received an average of at least three prior hormonal manipulations, and approximately 20 percent derived clinical benefit, meaning objective antitumor response or prolonged stable disease for longer than six months. Based on these data, I believe fulvestrant is definitely active, and some of the responses that we’ve seen have been quite durable, lasting beyond two years.

In the next year or two, we will start to see maturity of the clinical trials using higher doses of fulvestrant. Many of us, even outside the context of clinical trials, use loading doses as opposed to the standard 250 milligrams per month dosing. When we can get it approved with letters of medical necessity, we use 500 milligrams on days one and 14, followed by 250 milligrams starting on day 28 and thereafter. Regimens with even higher doses of fulvestrant are being investigated.

— Charles L Vogel, MD

Side effects associated with fulvestrant

Fulvestrant is a pure antiestrogen with no estrogen-agonist properties. We’ve seen very little in the way of toxicity from fulvestrant. Even with the large volume injected into the buttocks, we really haven’t received many complaints from our patients of pain at injection sites. If we look at the options available for patients failing tamoxifen, we have fulvestrant and the aromatase inhibitors. With the aromatase inhibitors, the more we use them, the more we find this troubling joint pain syndrome. That’s not to say that everybody develops arthralgias. Many of our patients sail through aromatase inhibitor therapy quite beautifully. It’s hard to quantify, but maybe as many as 15 or 20 percent of patients on aromatase inhibitors have significant joint discomfort, and we have not seen that with fulvestrant.

— Charles L Vogel, MD

Parenteral versus oral therapy

The choice of either a monthly injection of fulvestrant or an oral hormonal agent has an economic impact because of reimbursement, and we apprise patients of that. Compliance is another issue to be considered. Patients sometimes forget to take oral medications, and I believe that’s an issue in all diseases. Patients exhibit denial when it comes to medications. Receiving an injection at the office takes the weight off their shoulders, and they don’t have to think about it.

— Nancy Sokolowski, RNC, OCN

A real financial issue exists for patients on Medicare when considering oral hormonal therapy or injectable fulvestrant. The aromatase inhibitor is approximately twice as expensive as tamoxifen and currently is not being reimbursed, whereas fulvestrant is reimbursed. Also, as a doctor, if I am concerned about a patient being noncompliant, for whatever reason, it is reassuring to use fulvestrant and know the medication has been administered.

— Richard Zelkowitz, MD