NCCN VERSION 2 2015

NCCN Guidelines Version 2.2015 Invasive Breast Cancer

NCCN Guidelines Index Breast Cancer Table of Contents Discussion

PRINCIPLES OF MONITORING METASTATIC DISEASE Monitoring of patient symptoms and cancer burden during treatment of metastatic breast cancer is important to determine whether the treatment is providing benefit and that the patient does not have toxicity from an ineffective therapy. Components of Monitoring: Monitoring includes periodic assessment of varied combinations of symptoms, physical examination, routine laboratory tests, imaging studies, and blood biomarkers where appropriate. Results of monitoring are classified as response/continued response to treatment, stable disease, uncertainty regarding disease status, or progression of disease. The clinician typically must assess and balance multiple different forms of information to make a determination regarding whether disease is being controlled and the toxicity of treatment is acceptable. Sometimes, this information may be contradictory. Definition of Disease Progression: Unequivocal evidence of progression of disease by one or more of these factors is required to establish progression of disease, either because of ineffective therapy or acquired resistance of disease to an applied therapy. Progression of disease may be identified through evidence of growth or worsening of disease at previously known sites of disease and/or of the occurrence of new sites of metastatic disease. • Findings concerning for progression of disease include: Worsening symptoms such as pain or dyspnea Evidence of worsening or new disease on physical examination Declining performance status Unexplained weight loss Increasing alkaline phosphatase, ALT, AST, or bilirubin Hypercalcemia New radiographic abnormality or increase in the size of pre-existing radiographic abnormality New areas of abnormality on functional imaging (eg, bone scan, PET/CT scan) Increasing tumor markers (eg, CEA, CA15-3, CA27.29) 1

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1 Rising tumor markers (eg, CEA, CA15-3, CA27.29) are concerning for tumor progression, but may also be seen in the setting of responding disease. An isolated increase in tumor markers should rarely be used to declare progression of disease. Changes in bone lesions are often difficult to assess on plain or cross-sectional radiology or on bone scan. For these reasons, patient symptoms and serum tumor markers may be more helpful in patients with bone-dominant metastatic disease.

Note: All recommendations are category 2A unless otherwise indicated. Clinical Trials: NCCN believes that the best management of any cancer patient is in a clinical trial. Participation in clinical trials is especially encouraged.

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Version2.2015, 03/11/2015© 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 ® .