OVARIAN SUPPRESSION PLUS AROMATASE INHIBITORS

We need to study aromatase inhibitors in premenopausal women, because there is almost no data. We used to think tamoxifen wouldn’t work in premenopausal women, but it does. However, it doesn’t work as well as in an estrogen-deficient environment. We have learned over the years that suppressing ovarian function with tamoxifen in a premenopausal patient with metastatic breast cancer gives maximum benefit. We need studies with the AIs plus or minus ovarian suppression. There have been some small studies of ovarian suppression, making the women essentially postmenopausal, with pretty good response rates to AIs. This is a strategy that I have used clinically. If I am going to start a premenopausal woman on an AI, I do suppress ovarian function. Right now, you have to do that because we only have data on AIs in postmenopausal women. This is an area that really needs to be studied. Could you potentially treat a premenopausal woman by increasing the dose of the AIs to get estrogen suppression? We don’t know the answer to that.

—Stephen Jones, MD

CHOOSING A CHEMOTHERAPEUTIC AGENT FOR METASTATIC DISEASE

I would absolutely not have given this patient a paclitaxel-anthracycline combination off clinical trial. Outside of a clinical trial, I sort through this by trying to establish which single chemotherapeutic agent was likely to produce benefit for this patient with the most acceptable toxicity profile. Had I had the decision to make over again in this patient and without a clinical trial available, I probably would have given her a single-agent anthracycline.

Her neuropathy, albeit mild, has been a devastating consequence because this patient is an accomplished seamstress. The neuropathy has impaired her ability to do what she likes best. Unfortunately her passion for sewing did not come to light to me until she had already established a moderate degree of neuropathy ^53,54.

Looking back, I would have selected a non-neuropathic agent such as single-agent doxorubicin or a single-agent gemcitabine or capecitabine. Choosing among them requires experience with the drug toxicities and with dosing.

—Kevin Fox, MD

ALTRUISM AS A KEY COMPONENT IN TRIAL PARTICIPATION

Patients need to know that clinical trials are extraordinarily important and the key to progress. But, they also need to know what their choices are. Being heavy-handed about clinical trials — as though participation is the patient’s only choice — is not fair.

It would have been unethical for me to not tell the patient that combination chemotherapy was a departure from my normal recommendation under these circumstances, but this particular patient embraced the idea very quickly. She enrolled on this clinical trial for sincerely altruistic reasons, which was quite admirable.

Altruism is an essential ingredient in patients’ entering clinical trials, as the benefit to an individual patient is never as easily quantified as the benefit to all patients once the trial is completed. Without a sense of altruism, clinical trial participation is an uphill battle.

—Kevin Fox, MD

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