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Single-agent capecitabine maintenance therapy after response to capecitabine-based combination chemotherapy in patients with metastatic breast cancer

机译:基于卡培他滨的联合化疗对转移性乳腺癌患者的单药卡培他滨维持治疗

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We performed an analysis of the efficacy of capecitabine monotherapy as maintenance treatment for metastatic breast cancer (MBC) after response to capecitabine-based chemotherapy [capecitabine plus docetaxel (XT) or vinorelbine (XN)] as a first-line or a second-line treatment. Sixty-four Chinese patients with histologically confirmed MBC received capecitabine maintenance therapy after disease stabilization or maximal response to capecitabine-based combination chemotherapy. Single-agent capecitabine was administered at a dose of 1000 mg/m twice daily for 14 days, followed by a 7-day rest period, every 3 weeks. The median time to progression, the primary endpoint of the study, was 4.4 months (95% confidence interval, 3.4-5.4 months). Fifty-nine patients were evaluable for response. Capecitabine maintenance therapy produced an objective response rate of 5.1% (95% confidence interval, 3.9-6.3%). The incidence of grade 3/4 leukopenia (3.1%) and neutropenia (4.7%) was significantly lower (P<0.001) with capecitabine monotherapy than with combination chemotherapy (46.9 and 54.7%, respectively). Conversely, the incidence of grade 3 hand-foot syndrome was higher with capecitabine maintenance therapy than with combination therapy (14.1 vs. 0%, respectively; P=0.003). Capecitabine monotherapy is an effective maintenance treatment after response to capecitabine-based combination chemotherapy in MBC with a favorable safety profile.
机译:我们对以卡培他滨为基础的化疗[卡培他滨加多西他赛(XT)或长春瑞滨(XN)]为一线或二线治疗后的卡培他滨单一疗法作为转移性乳腺癌(MBC)维持治疗的疗效进行了分析。治疗。 64例经组织学证实为MBC的中国患者在疾病稳定或对以卡培他滨为基础的联合化疗产生最大反应后接受了卡培他滨维持治疗。每天两次以1000 mg / m的剂量单剂卡培他滨给药,共14天,然后每3周休息7天。研究的主要终点指标为进展时间的中位数为4.4个月(95%置信区间为3.4-5.4个月)。有59名患者的反应可评估。卡培他滨维持疗法的客观缓解率为5.1%(95%置信区间为3.9-6.3%)。卡培他滨单药治疗的3/4级白细胞减少症(3.1%)和中性粒细胞减少症(4.7%)的发生率显着低于联合化疗(分别为46.9和54.7%)(P <0.001)。相反,卡培他滨维持治疗的3级手足综合征发生率高于联合治疗(分别为14.1%和0%; P = 0.003)。卡培他滨单药治疗是对以卡培他滨为基础的联合化疗对MBC产生反应后的有效维持治疗,具有良好的安全性。

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