Vicente Valero, MD
Professor of Medicine, Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center Associate Professor of Medicine, The University of Texas Health Science Center Chief, Oncology Services, Lyndon B Johnson General Hospital

Edited comments by Dr Valero

Managing patients presenting with de novo metastatic disease

This woman represents the minority - about five percent - of breast cancer patients treated in the United States. Our traditional approach is somewhat different in patients who develop metastatic breast cancer after adjuvant therapy than in those who are chemotherapy-naïve. We studied more than 1,800 chemotherapy-naïve patients whose metastatic disease was treated with an anthracycline/cyclophosphamide-containing regimen, and we published the results in a study in the Journal of Clinical Oncology. Approximately 20 percent of these patients achieved a complete remission, and about four percent were free of disease 10 years later. The question is: Can we cure a few patients with de novo metastatic breast cancer? I believe it's possible, and although the likelihood is very small, it has been confirmed by a French study.

In a premenopausal patient with minimal disease and two metastatic liver lesions who wants to be treated aggressively, I would offer systemic chemotherapy followed by hormonal therapy. There are absolutely no randomized studies to confirm that administering chemotherapy for six or eight cycles, or until maximum response, followed by hormonal therapy is better than hormonal therapy alone, but that is my current approach with such patients. In a situation in which potential cure, rather than palliation, is the desired outcome, I would introduce a taxane-containing regimen, such as TAC. It would also be reasonable to use a sequential approach with FAC or AC followed by four cycles of docetaxel or paclitaxel.

Systemic treatment of isolated liver metastases after adjuvant therapy

If this patient had previously received adjuvant anthracycline therapy, I'd treat her with hormonal therapy. Patients with hormone-sensitive tumors - even those with visceral metastases - are appropriate candidates for hormonal therapy. This patient has one large metastasis, but she doesn't have diffuse infiltration of the liver. She's asymptomatic with normal liver enzymes and her disease is not bulky. In this scenario, hormonal therapy is an appropriate option.

Choice of hormonal therapy in patients remaining premenopausal after chemotherapy

This woman has a greater-than-50-percent chance of becoming postmenopausal after chemotherapy. She'll receive either four cycles of AC, which will be 2,400 mg of cyclophosphamide, or, at MD Anderson, she'd receive 2,000 mg because we use FAC 50.

If she's still premenopausal after receiving chemotherapy and we decide to use every tool available to give her a maximal chance of cure, data support the use of an LHRH agonist plus tamoxifen rather than an LHRH agonist alone.

A meta-analysis published in the Journal of Clinical Oncology demonstrated a survival advantage for the combination. There has been a great deal of controversy about the meta-analysis, because they didn't examine tamoxifen alone or sequential therapy with an LHRH agonist followed by tamoxifen. In Europe, an LHRH agonist and tamoxifen would be the standard of care. In the United States, it's more controversial.

There are limited data for the role of LHRH agonists with aromatase inhibitors in premenopausal women. I participate in a multicenter trial studying the combination of anastrozole and goserelin in premenopausal patients with hormone-sensitive tumors. The Spanish investigations are conducting a randomized study in the metastatic setting. While the preliminary data looks promising, I would utilize goserelin and tamoxifen or tamoxifen alone.

Choice of hormonal therapy in patients with chemotherapy-induced menopause

If this patient ceased menstruating and had a postmenopausal profile, I would consider using an aromatase inhibitor, based on the randomized studies documenting superior efficacy of the aromatase inhibitors compared to tamoxifen in the metastatic setting. In the only randomized study comparing anastrozole to letrozole in patients with metastatic disease, both agents were similar and both are acceptable options. Exemestane has been evaluated in patients with metastatic disease, but I'm not using it for first-line therapy.

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