Department of Medical Oncology, National Cancer Institute, Cairo University, Cairo, Egypt.
Department of Biochemistry, National Cancer Institute, Cairo University, Cairo, Egypt.
Clin Breast Cancer. 2017 Dec;17(8):618-628. doi: 10.1016/j.clbc.2017.05.001. Epub 2017 May 8.
Metronomic chemotherapy (MC) has shown efficacy in patients with metastatic breast cancer (MBC). We therefore tested the efficacy and toxicity of MC in pretreated MBC.
This prospective phase II study included 50 patients with heavily pretreated MBC who received MC in the form of continuous oral cyclophosphamide 50 mg/day and oral methotrexate 2.5 mg twice per day on days 1 and 2 every week. The primary end point was progression-free survival (PFS), whereas the secondary end points were response rate, overall survival (OS), and safety.
Forty-eight patients were assessed. One patient achieved complete response and 10 patients had partial response, whereas 19 patients had stable disease. The median PFS was 5 months, whereas the median OS was 7 months. Patients with negative progesterone receptors, Eastern Cooperative Oncology Group performance status (PS) 1, achieving response, and those who developed leucopenia, neutropenia, and anemia had significant prolonged PFS, whereas patients with early stage at presentation, receiving < 5 previous treatment lines, achieving response, and experiencing anemia with MC had significant superior OS. In multivariate analysis, achieving response, PS 1, a longer time interval from initial diagnosis until starting MC, and anemia were independent prognostic factors for longer PFS. Initial stage at presentation, number of previous treatment lines, and response were independent prognostic factors for OS.
MC is an attractive treatment approach that is effective and less toxic. There are certain groups of patients who seem to benefit more, especially those who experienced toxicity with treatment. Larger trials are warranted to assess this approach early in the course of the disease and with other more active agents.
节拍化疗（MC）在转移性乳腺癌（MBC）患者中显示出疗效。因此，我们测试了 MC 在预处理 MBC 中的疗效和毒性。
这是一项前瞻性的 II 期研究，纳入了 50 例预处理过的 MBC 患者，他们接受了 MC 治疗，形式为每天口服环磷酰胺 50mg 和甲氨蝶呤 2.5mg，每天两次，每周 1 天和 2 天。主要终点是无进展生存期（PFS），次要终点是反应率、总生存期（OS）和安全性。
48 例患者可评估。1 例患者完全缓解，10 例部分缓解，19 例疾病稳定。中位 PFS 为 5 个月，中位 OS 为 7 个月。孕激素受体阴性、东部肿瘤协作组体力状况（PS）1、有反应的患者以及发生白细胞减少、中性粒细胞减少和贫血的患者 PFS 显著延长，而早期发病、接受<5 线治疗、有反应和接受 MC 治疗后出现贫血的患者 OS 显著延长。多因素分析显示，有反应、PS 1、从初始诊断到开始 MC 的时间间隔较长以及贫血是 PFS 延长的独立预后因素。初始发病阶段、治疗前的治疗线数和反应是 OS 的独立预后因素。
MC 是一种有效且毒性较小的有吸引力的治疗方法。有一些患者群体似乎受益更多，特别是那些在治疗中经历毒性的患者。需要更大的试验来评估这种方法在疾病早期和使用其他更有效的药物的效果。
