使用卡培他滨和环磷酰胺治疗转移性乳腺癌的节拍化疗——II 期 METRO 试验的疗效、耐受性和生活质量结果。
Metronomic chemotherapy using capecitabine and cyclophosphamide in metastatic breast cancer - efficacy, tolerability and quality of life results from the phase II METRO trial.
发表日期:2024 Sep 01
作者:
Karolina Larsson, Jamila Adra, Leif Klint, Barbro Linderholm
来源:
BREAST
摘要:
化疗通常用于治疗转移性乳腺癌 (MBC),以延长生命并提高生活质量 (QoL)。二线治疗之外的最佳剂量和顺序尚不清楚,并且存在过度治疗的风险。对于 MBC 患者,使用卡培他滨 500 mg 每日 3 次和环磷酰胺 50 mg 每日一次 (MCT-CX) 进行持续低剂量口服节律化疗 (MCT-CX) 可能是一种有效且可耐受的治疗选择。 II 期试验 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。主要终点是临床受益率(CBR),定义为在任何时间达到完全缓解(CR)或部分缓解(PR)或疾病稳定(SD)≥24周的最佳总体缓解(SD)的参与者比例。放射学评估。根据通用毒性标准 v 4.0 评估毒性。采用 EORTC-30 问卷评估生活质量。总共纳入 40 名患者。大多数参与者 (72%) 出现内脏疾病,并接受了二线以上的 MCT-CX (58%)。 CBR 为 45%(8 个 PR 和 10 个 SD ≥ 24 周)。毒性程度较低,其中最常见的是手足综合征。前 24 周内,生活质量没有显着变化。MCT-CX 是晚期乳腺癌的一种可行的治疗选择,几乎一半的试验参与者对治疗有反应,没有生活质量受损。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。
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.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.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.MCT-CX is a plausible treatment option in far advanced breast cancer, with almost half of trial participants responding to treatment without QoL impairments.Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.