NCCN VERSION 2 2015

NCCN Guidelines Version 2.2015 Breast Cancer

NCCN Guidelines Index Breast Cancer Table of Contents Discussion

Symposium were similar showing that surgical treatment of primary tumors in woman presenting with stage IV disease does not produce an increase in OS. 510,511 Nevertheless, the panel recognizes the need for randomized clinical trials that will address the risks and benefits of local therapy for patients with stage IV disease while eliminating selection biases. Patient enrollment in such trials is encouraged. Distant Sites of Recurrence Requiring Consideration of Therapies Local to the Metastatic Site Surgery, radiation, or regional chemotherapy (eg, intrathecal methotrexate) may be indicated as needed for localized clinical scenarios such as brain metastases, leptomeningeal disease, choroid metastases, pleural effusion, pericardial effusion, biliary obstruction, ureteral obstruction, impending pathologic fracture, cord compression, localized painful bone, or soft-tissue disease. The guidelines include consideration of the addition of hyperthermia to irradiation for localized recurrences/metastasis (category 3). There have been several prospective randomized trials comparing radiation to radiation plus hyperthermia in the treatment of locally advanced/recurrent cancers, primarily breast cancer chest wall recurrences. 512,513 While there is heterogeneity among the study results, a series with strict quality assurance demonstrated a statistically significant increase in local tumor response and greater duration of local control with the addition of hyperthermia to radiation compared to radiation alone. 512 No differences in OS have been demonstrated. Delivery of local hyperthermia is technically demanding and requires specialized expertise and equipment (eg, the monitoring of temperatures and management of possible tissue burns). The panel thus recommends that the use of hyperthermia be limited to treatment

centers with appropriate training, expertise, and equipment. The addition of hyperthermia generated substantial discussion and controversy among the panel and is a category 3 recommendation. Monitoring Metastatic Disease Monitoring the treatment of metastatic breast cancer involves a wide array of assessments and the need for the clinician to integrate several different forms of information, to make a determination of the effectiveness of treatment and the acceptability of toxicity. The information includes those from direct observations of the patient including patient reported symptoms, performance status, change in weight, and physical examination; laboratory tests such as alkaline phosphatase, liver function, blood counts, and calcium; radiographic imaging; functional imaging; and, where appropriate, tumor biomarkers. The results of these evaluations generally 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. The panel recommends using widely accepted criteria for reporting response, stability, and progression of disease such as the RECIST criteria 514 and the WHO criteria. 515 The NCCN Panel also recommends using the same method of assessment over time. For example, an abnormality initially found on diagnostic CT scan of the chest should be monitored with repeat diagnostic CT scans of the chest. The optimal frequency of testing is uncertain, and is primarily based on the monitoring strategies utilized in breast cancer clinical trials. The page titled Principles of Monitoring Metastatic Disease in the algorithms

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-57