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Consensus Guidelines: Neoadjuvant Therapy in Breast Cancer

Lidia Schapira, MD

Recommendations From an International Consensus Conference on the Current Status and Future of Neoadjuvant Systemic Therapy in Primary Breast Cancer
Kaufmann M, von Minckwitz G, Mamounas EP, et al Ann Surg Oncol. 2011 Dec 23. [Epub ahead of print] Study Summary This article summarizes the recommendations from a panel of experts that met in Biedenkopf, Germany, in September 2010. This was the fourth meeting of this group, which comprised experts in medical oncology, breast surgery, diagnostics, radiology, radiation oncology, pathology, and genomics -- 6 of whom were from the United States and 13 from Europe. Panel members were charged with reviewing all available data from published prospective clinical trials of neoadjuvant therapy as well as unpublished presentations made at major scientific meetings. The major recommendations concerned 5 management issues. Goals and indications of neoadjuvant therapy. The most important clinical goals remain to improve disease-free and overall survival and enable more limited surgery. Neoadjuvant therapy increases the rates of conservation for patients with locally advanced disease. There is still controversy about proper management in patients whose response to neoadjuvant therapy is suboptimal, as well as the extent of axillary surgery in patients who had involved nodes at presentation. Any patient who is a candidate for adjuvant systemic therapy can be considered for neoadjuvant treatment. However, neoadjuvant therapy should not be recommended if there is any uncertainty about the appropriateness of or need for systemic therapy. Assessing response to therapy. Pathologic complete response (pCR) should be defined as the absence of invasive cancer in both breast and lymph nodes. The presence, extent, and classification of ductal carcinoma in situ should be reported separately. pCR has been consistently shown to be associated with excellent long-term survival. That said, 60%-85% of patients treated with neoadjuvant therapy do not achieve pCR. It is important to bear in mind that the differences between treatment arms in clinical trials may not translate into survival differences. To monitor response to therapy, physical examination and standard pathologic, staging, and receptor studies should be performed.

The group recommended imaging studies of axillary nodes and diagnostic fine-needle aspiration biopsy for patients in whom incomplete response is suspected. Sentinel node biopsy should be considered for patients with a clinically negative axilla. For those with an initially uninvolved axilla, the group recommends sentinel lymph node biopsy after neoadjuvant therapy. No data support the use of imaging modalities during neoadjuvant therapy, and practices vary. Treatment options. In practice, the same regimens should be used for neoadjuvant therapy as for adjuvant therapy. All chemotherapy should be provided before surgery, not split into preoperative and postoperative phases. Trastuzumab-based chemotherapy is indicated for patients with human epidermal growth factor receptor-positive (HER+) disease. Given recent studies showing the efficacy of anti-HER2 therapy alone without chemotherapy, this could be considered in the future. Neoajduvant endocrine therapy with aromatase inhibition is effective for postmenopausal woman with estrogen receptor-positive (ER+) disease. Role of surgery and radiation therapy. Surgery is necessary in every patient. In cases of clinical complete remission, resection is still required. After breast-conserving therapy, radiation is indicated to decrease the risk for local recurrence. In general, radiation is guided by the initial clinical stage and pathologic findings at the time of surgery. Follow-up care. In cases of a switch in receptors (estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2) between the initial biopsy and the biopsy obtained at the time of surgery, patients with at least 1 ER+ biopsy should be given adjuvant endocrine therapy. For HER2+ disease, 1 year of trastuzumab therapy is also considered the standard of care. Viewpoint This article is a helpful review of state-of-the-art neoadjuvant therapy for breast cancer. We are well aware of the benefits for research, but this focus on treatment of patients in a nonresearch setting is clear and sets the standards we should use routinely. These experts remind us of areas of ongoing controversy. Axillary staging needs to be personalized: Fine-needle aspiration biopsy of suspicious axillary nodes is a useful resource, but sentinel node biopsy remains essential for patients with a clinically negative axilla. Practices vary considerably in terms of the frequency and type of imaging studies that are used during neoadjuvant therapy. Perhaps the most valuable reminder for medical oncologists is to choose regimens with a proven track record in the adjuvant setting and to make judicious recommendations for additional treatment after a suboptimal response to neoadjuvant chemotherapy. These situations remain challenging, and we hope that future trials will provide direction and guidance.