NCCN指南2015v3——转移性乳腺癌的监测原则

PRINCIPLES OF MONITORING METASTATIC DISEASEMonitoring of patient symptoms and cancer burden during treatment of metastatic breast cancer is

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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)

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.

Use of Objective Criteria for Response/Stability/Progression:

●The most accurate assessments of disease activity typically occur when previously abnormal studies are repeated on a serial and regular basis.

Generally, the same method of assessment should be used over time (eg, an abnormality found on chest CT scan should generally be monitored with repeat chest CT scans).

●Some non-clinically important variation in measurement of abnormalities by all serial studies is common and expected. Therefore, the use of objective and widely accepted criteria for response, stability, and progression of disease are encouraged.

Such systems include the Response Evaluation Criteria In Solid Tumors (RECIST) guidelines (Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009;45:228-247) and the WHO criteria (Miller AB, Hoogstraten B, Staquet M, and Winkler A. Reporting results of cancer treatment. Cancer 1981;47:207-214).

●Studies of functional imaging, such as radionuclide bone scans and PET imaging, are particularly challenging when used to assess response. In the case of bone scans, responding disease may result in a flare or increased activity on the scan that may be misinterpreted as disease progression, especially on the first follow-up bone scan after initiating a new therapy. PET imaging is challenging because of the absence of a reproducible, validated, and widely accepted set of standards for disease activity assessment.

Frequency of Monitoring:

The optimal frequency of repeat testing is uncertain, and is primarily based upon the monitoring strategies utilized in breast cancer clinical trials. The frequency of monitoring must balance the need to detect progressive disease, avoid unnecessary toxicity of any ineffective therapy, resource utilization, and determine cost. The following table is to provide guidance, and should be Modified for the individual patient based upon sites of disease, biology of disease, and length of time on treatment. Reassessment of disease activity should be performed in patients with new or worsening signs or symptoms of disease, regardless of the time interval from previous studies.

转移性疾病的监测原则

在转移性乳腺癌的治疗期间监测患者症状以及肿瘤负荷对确定治疗是否获益并且该患者不遭受无效治疗的毒性是重要的。

监测组成部分:

监测包括定期评估症状、体检、常规实验室检查、影像检查及血液生物标志物各种组合的合理性。

监测的结果分为应答/对治疗持续应答、疾病稳定、不确定或进展。

临床医师通常必须评估并平衡许多不同类型的信息以确定疾病是否正被控制以及治疗的毒性是否是可接受的。

有时候,信息可能互相矛盾。

疾病进展的定义:

根据一个或多个这些确定疾病进展所必需的因素,或者由于无效治疗或者疾病对所应用的治疗获得性耐药的疾病进展的明确证据。

可以通过在既往已知的疾病部位疾病发展或恶化和/或出现新部位的转移性疾病的证据确定疾病进展。

●与疾病进展有关的发现包括:

▲诸如疼痛或呼吸困难症状恶化

▲在体格检查时疾病恶化或新发疾病的证据

▲功能状态下滑

▲无法解释的体重减轻

▲碱性磷酸酶、丙氨酸转氨酶、天冬氨酸氨基转移酶或胆红素逐渐升高

▲高血钙症

▲新的放射影像异常或已有的放射影像异常增大

▲功能影像(例如骨扫描、PET/CT扫描)检查时新的异常区域

▲肿瘤标志物(如CEA、CA15-3、CA27.29)逐渐升高

肿瘤标志物(例如CEA、CA15-3、CA27.29)上升与肿瘤进展有关,但也可以见于疾病应答的情况下。

单独的肿瘤标志物升高应该很少用于断言疾病进展。

在普通或横断面放射学或骨扫描上评价骨损害的变化常常是困难的。

因此,在骨转移为主的患者中患者症状和血清肿瘤标志物可能更有帮助。

转移性疾病的监测原则

应答/稳定/进展客观标准的应用:

●当连续且规律地复查既往异常的检查时一般可最准确地评估疾病的活动性。

将来一般应该使用同样的评估手段(例如胸部CT扫描发现异常监测一般应该用复查胸部CT扫描)。

●某些非临床上重要的变化通常根据所有连续的检查测定异常并且是可预期的。

因此,鼓励使用客观且普遍接受的标准判断应答、稳定和进展。

这种体系包括实体瘤疗效反应评价标准(RECIST)指南

Eisenhauer EA, Therasse P, Bogaerts J, 等。新的实体瘤疗效反应评价标准:修订的RECIST指南(1.1版)。Eur J Cancer 2009;45:228-247) 以及 WHO标准(Miller AB, Hoogstraten B, Staquet M, and Winkler A. 癌症治疗结果记录。 Cancer 1981;47:207-214.

●功能影像检查,诸如骨放射性核素扫描和PET影像,当用于应答评估时是特别富有挑战性的。

在骨扫描患者中,应答疾病在扫描时可能产生复燃或活性增加可能被误解为疾病进展,尤其是在启动一种新疗法后的第一次随访骨扫描时。

PET影像因为缺少重现性、验证和普遍接受的评估疾病活动性的一套标准而富有挑战性。

监测频率:

复查的最佳频率尚不明确,因此主要基于乳腺癌临床试验中使用的监测策略。

监测频率必须平衡查明疾病进展的必要性、避免任何不必要的无效治疗的毒性、资源利用以及确定成本。

以下表格将提供指导,而对于具体的患者应该基于疾病部位、疾病生物学和治疗时间的长短进行调整。

在出现新的病症状或体征或恶化患者中应该重估疾病的活动性,不管离早先检查的时间间隔长短。

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