NCCN VERSION 2 2015

NCCN Guidelines Version 2.2015 Breast Cancer

NCCN Guidelines Index Breast Cancer Table of Contents Discussion

and placement of image-detectable marker(s) should be considered to demarcate the tumor bed for any future (post-chemotherapy) surgical management. Clinically positive ALN should be sampled by FNA or core biopsy and the positive nodes must be removed following preoperative systemic therapy at the time of definitive operation. Patients with clinically negative ALNs should have axillary ultrasound prior to neoadjuvant treatment. For those with clinically suspicious ALNs, the panel recommends consideration of either a core biopsy or FNA of these nodes. 152 . If FNA or core biopsy indicates any positive nodes, these should be removed following neoadjuvant therapy at the time of definitive surgery. According to the NCCN Panel, axillary staging after preoperative systemic therapy may include sentinel node biopsy or level I/II dissection. Level I/II dissection should be done when patients are proven node positive prior to neoadjuvant therapy (category 2B). The false-negative rate of SLN biopsy in either the pre- or post-chemotherapy settings is low. 132,153,154 Nevertheless, the possibility remains that a pathologic complete response (pCR) following chemotherapy may occur in lymph node metastases previously undetected by clinical exam. An SLN excision can be considered before administering preoperative systemic therapy, because it provides additional information to guide local and systemic treatment decisions. 155,156 In the event that SLN resection is performed after administration of preoperative systemic therapy, both the pre-chemotherapy clinical and the post-chemotherapy pathologic nodal stages must be used to determine the risk of local recurrence. Close communication between members of the multidisciplinary team, including the pathologist, is particularly important when any treatment strategy involving preoperative systemic therapy is planned.

In some patients, preoperative systemic therapy results in sufficient tumor response that makes breast-conserving therapy possible. Because complete or near-complete clinical responses are common, the use of percutaneously placed clips into the breast under mammographic or ultrasound guidance or other method of localizing pre-chemotherapy tumor volume aids in the post-chemotherapy resection of the original area of tumor and is encouraged. The results of the NSABP B-18 trial show that breast conservation rates are higher after preoperative systemic therapy. 157 However, preoperative systemic therapy has no demonstrated disease-specific survival advantage over postoperative adjuvant chemotherapy in patients with stage II tumors. NSABP B-27 is a three-arm, randomized, phase III trial of women with invasive breast cancer treated with preoperative systemic therapy with AC (doxorubicin/cyclophosphamide) for 4 cycles followed by local therapy alone, preoperative AC followed by preoperative docetaxel for 4 cycles followed by local therapy, or AC followed by local therapy followed by 4 cycles of postoperative docetaxel. Results from this study, which involved 2411 women, documented a higher rate of complete pathologic response at the time of local therapy in patients treated preoperatively with 4 cycles of AC followed by 4 cycles of docetaxel versus 4 cycles of preoperative AC. DFS and OS have not been shown to be superior with the addition of docetaxel treatment in B-27. 158 A DFS advantage was observed (HR, 0.71; 95% CI, 0.55–0.91; P = .007) favoring preoperative versus postoperative docetaxel in the subset of patients experiencing a clinical partial response to AC. Several chemotherapy regimens have been studied as preoperative systemic therapy. The panel believes that the regimens recommended in the adjuvant setting are appropriate to consider in the preoperative systemic therapy setting. The benefits of “tailoring” preoperative systemic therapy (ie, switching following limited response) or using

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