Department of Oncology, Sahlgrenska University Hospital, Sweden; Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Sweden.
Department of Oncology, Sahlgrenska University Hospital, Sweden.
Breast. 2024 Dec;78:103795. doi: 10.1016/j.breast.2024.103795. Epub 2024 Sep 1.
BACKGROUND: Chemotherapy is commonly used in metastatic breast cancer (MBC) to prolong life and improve quality of life (QoL). The optimal dosing and sequencing beyond the second line of treatment are unknown and pose a risk of overtreatment. Continuous low oral doses of metronomic chemotherapy using capecitabine 500 mg three times daily and cyclophosphamide 50 mg once daily (MCT-CX) may be an effective and tolerable treatment option for patients with MBC. METHODS: In this open-label, single-arm single-centre phase II trial patients with MBC received MCT-CX until disease progression or unacceptable toxicity. The primary endpoint was the clinical benefit rate (CBR), defined as the proportion of participants with a best overall response of complete (CR) or partial response (PR) at any time, or stable disease (SD) for ≥24 weeks according to radiological evaluation. Toxicity was assessed according to the Common Toxicity Criteria v 4.0. QoL was assessed with the EORTC-30 questionnaire. RESULTS: In total, 40 patients were included. Most participants (72 %) presented with visceral disease and received MCT-CX beyond the second line (58 %). The CBR was 45 % (8 PR and 10 SD ≥ 24 weeks). Toxicities were low grade with hand-foot syndrome being the most common. There was no significant change in QoL over the first 24 weeks. CONCLUSION: MCT-CX is a plausible treatment option in far advanced breast cancer, with almost half of trial participants responding to treatment without QoL impairments.
背景:化疗常用于转移性乳腺癌(MBC)以延长生命并提高生活质量(QoL)。二线治疗后的最佳剂量和序贯方案尚不清楚,存在过度治疗的风险。使用卡培他滨 500mg 每日三次和环磷酰胺 50mg 每日一次的连续低口服剂量节拍化疗(MCT-CX)可能是 MBC 患者的一种有效且耐受良好的治疗选择。
方法:在这项开放标签、单臂、单中心的 II 期试验中,MBC 患者接受 MCT-CX 治疗,直至疾病进展或出现不可接受的毒性。主要终点是临床获益率(CBR),定义为根据影像学评估,任何时间达到完全缓解(CR)或部分缓解(PR)或稳定疾病(SD)≥24 周的参与者比例。毒性根据通用毒性标准 v 4.0 进行评估。QoL 使用 EORTC-30 问卷进行评估。
结果:共纳入 40 名患者。大多数参与者(72%)存在内脏疾病,并接受了二线以上的 MCT-CX 治疗(58%)。CBR 为 45%(8 例 PR 和 10 例 SD≥24 周)。毒性为低级别,手足综合征最常见。在最初的 24 周内,QoL 没有明显变化。
结论:MCT-CX 是晚期乳腺癌的一种合理治疗选择,近一半的试验参与者对治疗有反应,且没有 QoL 受损。
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