Medical Oncology and Breast Unit, A. Perrino Hospital, Brindisi, Italy.
Eur J Cancer. 2012 Jan;48(1):24-9. doi: 10.1016/j.ejca.2011.06.040. Epub 2011 Jul 19.
Registered dose capecitabine monotherapy is active against metastatic breast cancer (MBC), but retrospective analyses indicate that lower doses may be as effective and better tolerated. This study was conducted to assess the safety and efficacy of metronomic capecitabine in heavily pretreated patients with MBC.
In this phase II study 60 MBC patients received continuous metronomic capecitabine monotherapy (1500 mg once a day). Primary endpoint was clinical benefit rate, secondary end points were clinical benefit rates (CBRs), tumour response rates (RRs), overall survival (OS), time to progression (TTP), duration of response (DOR) and toxicity.
Fifty eight assessable patients received two or more 28-day cycles of metronomic capecitabine. The CBR was 62%. Median DOR was 7 months. Median TTP and OS were 7 and 17 months, respectively. Two partial responses and 7 cases of stable disease were recorded in 13 patients who had previously received capecitabine intermittently (2000 mg/m(2)/day on days 1-14 every 21 days) as first- or subsequent-line treatment for MBC. Grade 3-4 adverse events were uncommon; haematologic toxicity was infrequent (5%) and consistently mild.
This regimen of metronomic capecitabine displayed good activity and excellent tolerability in MBC patients, including those who had previously received the drug at standard doses.
卡培他滨单药注册剂量对转移性乳腺癌（MBC）有效，但回顾性分析表明，较低剂量可能同样有效且耐受性更好。本研究旨在评估节拍式卡培他滨治疗MBC 中大量预处理患者的安全性和疗效。
在这项 II 期研究中，60 例 MBC 患者接受连续节拍式卡培他滨单药治疗（每天 1500mg）。主要终点为临床获益率，次要终点为临床获益率（CBR）、肿瘤缓解率（RR）、总生存期（OS）、无进展生存期（TTP）、缓解持续时间（DOR）和毒性。
58 例可评估患者接受了两个或更多 28 天周期的节拍式卡培他滨治疗。CBR 为 62%。中位 DOR 为 7 个月。中位 TTP 和 OS 分别为 7 个月和 17 个月。在 13 例先前曾接受过间歇卡培他滨治疗（MBC 一线或二线治疗，2000mg/m2/天，每 21 天服用 14 天）的患者中，有 2 例部分缓解，7 例疾病稳定。3-4 级不良事件不常见；血液学毒性罕见（5%）且始终轻微。
节拍式卡培他滨方案在 MBC 患者中显示出良好的疗效和极好的耐受性，包括那些先前曾接受标准剂量药物治疗的患者。
