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New Breast Cancer Guidelines Include Changes to Adjuvant Therapy in Invasive Disease: Presented at NCCN

By Mark Fuerst

HOLLYWOOD, FL -- March 15, 2004 -- New guidelines on breast cancer include major changes in systemic adjuvant therapy for invasive disease.

The National Comprehensive Cancer Network released the new guidelines here March 11^th at their 9^th Annual Conference on Clinical Practice Guidelines and Outcomes Data in Oncology. Robert W. Carlson, MD, professor of medicine in the division of oncology and Stanford Medical Informatics at Stanford University Medical Center, Stanford, California, announced the guidelines, which he said would result in significant changes in clinical practice.

The new guidelines call for earlier stratification by hormone receptors, "utilizing hormone receptor status as a primary stratification factor," said Dr. Carlson. If tumors are estrogen-receptor positive, the guidelines suggest that physicians consider tamoxifen for risk reduction and to diminish the small risk of disease recurrence.

The guidelines provide the option of post-tamoxifen therapy with the aromatase inhibitor letrozole. Adjuvant hormonal therapy for premenopausal women should consist of tamoxifen for 5 years. For post-menopausal women, adjuvant hormonal therapy should consist of tamoxifen or the aromatase inhibitor anastrozole for 5 years, or letrozole for 5 years following the 5-year course of adjuvant tamoxifen, which is "reasonable," commented Dr. Carlson.

Dose-dense adjuvant chemotherapy regimens have been added to the guidelines. These include dose-dense A-C (doxorubicin and cyclophosphamide) followed by paclitaxel and dose-dense A-T-C (doxorubicin followed by paclitaxel followed by cyclophosphamide).

The guidelines provide a long list of specified chemotherapy doses and regimens, but the guidelines panelists are "not willing to specify a preferred sequence of single agents," said Dr. Carlson. Gemcitabine has been moved to the preferred single agent list for metastatic disease.

The monoclonal antibody trastuzumab is also included as a component of chemotherapy combinations, along with paclitaxel, docetaxel, and vinorelbine. The guidelines state that trastuzumab should be used as adjuvant therapy only in the setting of a clinical trial. Again, the order of the many chemotherapy combinations listed "have no significance in terms of panelist preference," he said.

The selection, dosing, and administration of anti-cancer agents and the management of associated toxicities are complex. The guidelines state that modifications of drug dose and schedule and initiation of supportive care interventions are often necessary because of expected toxicities and because of individual patient variability, prior treatment, and comorbidity. The optimal delivery of anti-cancer agents, therefore, requires a health care delivery team experienced in the use of anti-cancer agents and the management of associated toxicities.


[Study Title: Update: Breast Cancer Guidelines]

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