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Overview of Conference

William C. Wood, M.D., FACS

Carcinoma of the breast remains the most common cancer in women in the United States.

It is exceeded only by lung cancer as a cause of cancer death in women. In the 10 years since the last NIH consensus development conference (CDC) on this subject, large-scale randomized clinical trials have provided further evidence regarding all types of adjuvant therapy. In order to base consensus on clear evidence, the scope of this conference will be limited to operable, invasive breast cancer. This is where the survival of women with breast cancer can be significantly affected by choice of therapy.

The questions to be addressed by the panel meet two criteria:

• They are of crucial interest to breast cancer patients and their health care team.

• A body of scientific evidence exists to allow an informed consensus.

A CDC in 1980 also addressed the efficacy of adjuvant chemotherapy in breast cancer (NIH, 1980). In 1985, another CDC focused on issues of survival and adjuvant chemotherapy and hormonal therapy (NIH, 1986). In 1990, the question of whether breast conservation was appropriate for primary therapy was teamed with consideration of the role of adjuvant therapy in women without lymph node involvement (NIH, 1992). The subsequent decade has seen trials worldwide addressing the combination of chemotherapy with hormonal therapies, the introduction of new cytotoxic agents of great efficacy, questions of dose and schedule, and the evaluation of both prognostic and predictive tumor markers. These were topics recommended for further investigation in the report of the 1990 CDC. There now appears to be sufficient data to discuss the question of when adjuvant therapy is appropriate and the degree to which evidence supports tailoring the therapy to both patient and tumor.

There are new and promising strategies that are still a part of numerous ongoing clinical trials. These include the mapping and evaluation of sentinel lymph nodes to select patients for nodal staging and therapy, and the role of immunohistochemical (IHC) evaluation of bone marrow biopsies. Herceptin as a single agent and in combination with cytotoxic and hormonal agents is emerging as a major subject of large-scale clinical trials addressing schedule, duration, and optimal combination. The role of bisphosphonates as adjuvant therapy and parameters that may predict those patients most likely to benefit from their use are also in the process of definition. The delayed use of chemotherapy or hormonal adjuvant therapy and the role of “maintenance” in adjuvant therapy are being studied in a few trials. At a still earlier phase are trials of small molecule inhibitors, antisense gene constructs, antiangiogenesis compounds, and vaccines. None of these were judged by the planning committee to have sufficient evidence from mature trials to be placed on the agenda at this time, but they are worthy topics for ongoing clinical research.

References

National Institutes of Health. Adjuvant chemotherapy of breast cancer. Consens Dev Conf Summ 1980;3:21-4. Abstract

NIH Consensus Development Conference Statement: Adjuvant chemotherapy for breast cancer. September 9-11, 1985. CA Cancer J Clin 1986;36:42-7. Abstract

NIH Consensus Development Panel. Treatment of early stage breast cancer. J Natl Cancer Inst Monogr 1992;11:137-42. No abstract available.