NCCN VERSION 2 2015

NCCN Guidelines Version 2.2015 Breast Cancer

NCCN Guidelines Index Breast Cancer Table of Contents Discussion

adjuvant chemotherapy in breast cancer with 0 to 3 positive nodes. 247 The findings from this trial will help determine the prognostic value of MammaPrint and the benefit of treating intermediate-risk patients with adjuvant chemotherapy. Axillary Lymph Node-Negative Tumors Small tumors (up to 0.5 cm in greatest diameter) that do not involve the lymph nodes are so favorable that adjuvant systemic therapy is of minimal incremental benefit and is not recommended as treatment of the invasive breast cancer. Endocrine therapy may be considered to reduce the risk for a second contralateral breast cancer, especially in those with ER-positive disease. The NSABP database demonstrated a correlation between the ER status of a new contralateral breast tumor and the original primary tumor, which reinforced the notion that endocrine therapy is not an effective strategy to reduce the risk for contralateral breast cancer in patients diagnosed with ER-negative tumors. 250 Patients with invasive ductal or lobular tumors 0.6 to 1 cm in diameter and no lymph node involvement may be divided into patients with a low risk of recurrence and those with unfavorable prognostic features that warrant consideration of adjuvant therapy. Unfavorable prognostic features include intramammary angiolymphatic invasion, high nuclear grade, high histologic grade, HER2-positive status, or hormone receptor-negative status (category 2B). The use of endocrine therapy and chemotherapy in these relatively lower risk subsets of women must be based on balancing the expected absolute risk reduction and the individual patient’s willingness to experience toxicity to achieve that incremental risk reduction. Patients with lymph node involvement or with tumors greater than 1 cm in diameter are appropriate candidates for adjuvant systemic therapy (category 1). For women with lymph node-negative, hormone

receptor-negative tumors greater than 1 cm in diameter, chemotherapy is recommended (category 1). For those with lymph node-negative, hormone receptor-positive breast cancer tumors greater than 1 cm, endocrine therapy with chemotherapy is recommended (category 1). Incremental benefit of combination chemotherapy in patients with lymph node-negative, hormone receptor-positive breast cancer may be relatively small. 251 Therefore, the panel recommends that tumor hormone receptor status be included as one of the factors considered when making chemotherapy-related treatment decisions for patients with node-negative, hormone receptor-positive breast cancer. Patients for whom this evaluation may be especially important are those with tumors characterized as 0.6 to 1.0 cm and hormone receptor-positive that are grade 2 or 3 or have unfavorable features, or tumors greater than 1 cm and hormone receptor-positive and HER2-negative. However, chemotherapy should not be withheld from these patients solely based on ER-positive tumor status. 3,251,252 The use of genomic/gene expression array data that also incorporate additional prognostic/predictive biomarkers (eg, Oncotype DX recurrence score) may provide additional prognostic and predictive information beyond anatomic staging and determination of ER/PR and HER2 status. Assessment of the role of the genomic/gene expression array technology is difficult because of the retrospective nature of the studies, the evolution of chemotherapy and hormone therapy regimens, and the overall more favorable prognosis of the patients with lymph node-negative disease compared with those enrolled in the historically controlled clinical trials. Some NCCN Member Institutions consider performing RT-PCR analysis (eg, Oncotype DX assay) to further refine risk stratification for adjuvant chemotherapy for patients with node-negative, ER-positive, HER2-negative breast cancers >0.5 cm, whereas others do not.

Version 2.2015, 03/11/15 © National Comprehensive Cancer Network, Inc. 2015, All rights reserved. The NCCN Guidelines® and this illustration may not be reproduced in any form without the express written permission of NCCN®. MS-27