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Cancer Experts Say, "Stick to Tamoxifen Until We Know More"

Postmenopausal women receiving tamoxifen treatment for early-stage breast cancer following surgery, should not switch to a new class of drugs. At least not yet...

This is the latest news from the American Society of Clinical Oncology, the nation's leading group of cancer specialists.

Tamoxifen has been the standard treatment in postmenopausal breast cancer patients for sixteen years. But a newer class of hormonal therapies, called aromatase inhibitors, has shown very promising preliminary results in a recent clinical study comparing their safety and efficacy to that of tamoxifen, in early-stage breast cancer patients following surgery.

Aromatase inhibitors, on the other hand, are more effective in postmenopausal women because they only target the non-ovarian production of estrogen. In premenopausal women, most of the estrogen is produced by the ovaries, so aromatase inhibitors are only useful in premenopausal women if ovarian production of estrogen is stopped first. This can be done by surgery (removing ovaries), radiation (destroying ovaries) or chemically (LHRH agonists like goserelin or buserelin).

What is the ATAC trial, and why is it so significant?
The ATAC trial is the first adjuvant hormonal therapy trial to be reported involving an aromatase inhibitor. It involved more than 9,000 women, and approximately 20 percent of these women had received prior chemotherapy in addition to hormonal therapy as part of their post-operative treatment. Therefore, the majority of women in this trial received hormonal therapy as their only postoperative treatment, which is not the typical scenario for the majority of women treated in the United States. The women in this trial were randomly divided into three groups. One group was given tamoxifen, another anastrozole (an aromatase inhibitor), and the third group was given a combination of anastrozole and tamoxifen.

After a 33-month follow-up period, researchers found that women who were given anastrozole had an improved disease-free survival over the groups who were given either tamoxifen or the combination of tamoxifen and anastrozole. Also, anastrozole further reduced the number of contralateral breast cancers (when cancer spreads to the other breast) when compared with tamoxifen, which is important, since we know that tamoxifen also reduces the number of contralateral breast cancers. The results were really above and beyond what tamoxifen was able to achieve in the contralateral breast, and I think it's very promising for the future.

And side-effects?
Anastrozole had different side-effects than tamoxifen in the ATAC trial. Although anastrozole left more women feeling achy in their muscles and joints compared with tamoxifen, fewer women experienced hot flashes, blood clots, vaginal bleeding, or endometrial cancer.

These aromatase inhibitors have been standard care for late stage cancer, but do you foresee that they will become standard care for early stages?
Tamoxifen has been around since the late 1970s, and has been the gold standard in the postoperative adjuvant setting, and the long-term effects of tamoxifen on bone density and cholesterol have been well characterized. I think that the aromatase inhibitors hold much promise for the future, but we await long-term safety data, particularly with regards to bone density and risk of osteoporotic fractures, before changing our standard of care.

Anastrozole, however, now offers another option for hormonal therapy in the adjuvant setting for women who have a contraindication to taking tamoxifen (e.g. history of blood clots or high risk of stroke). Other trials using aromatase inhibitors either after tamoxifen or instead of tamoxifen are presently ongoing, and these trials will help us determine the optimal post-operative hormonal therapy in the near future.

Do you find that hormonal therapies are changing the way you treat patients, and is it exciting to you?
Oh, it's very exciting, yes. It's wonderful to delay chemotherapy in the metastatic setting and to give therapies that are equally effective but with fewer side-effects. With more data, I suspect that the aromatase inhibitors will be used more frequently in the adjuvant setting, and I hope that this will continue to improve the trends for improved survival in women diagnosed with this disease. There are trials presently ongoing or in the planning stages that will look at the aromatase inhibitors as drugs for breast cancer prevention as well, which is also very exciting.