2014年美国临床肿瘤学会年会将于当地时间5月30日-6月3日在芝加哥召开，根据大会的会议日程，我国肿瘤专家徐兵河教授在6月2日上午有一项研究在“General Poster Session”中展出，下面和大家提前分享这项精彩研究。医脉通小编们今年也将继续奔赴ASCO年会现场，及时将各项最新研究进展整理、发布，欢迎大家保持关注！

多西他赛/卡培他滨（TX）是NCCN转移性乳腺癌指南推荐的标准治疗方案之一。很少有临床研究直接比较TX方案+后续卡培他滨维持用药和长春瑞滨/卡培他滨（NX）方案+后续卡培他滨维持用药的临床获益，尤其是先前接受过紫杉醇辅助化疗的晚期乳腺癌患者。本研究旨在比较TX方案+后续卡培他滨维持用药和NX方案+后续卡培他滨维持用药治疗转移性乳腺癌的疗效和安全性。

研究方法

共206例晚期转移性乳腺癌患者被随机分配到TX组（N = 104）和NX组（N = 102），两组都接受卡培他滨维持用药。主要终点是无进展生存期（PFS），次要终点包括总生存期（OS），缓解率（RR），缓解持续时间（DOR），以及安全性。

研究结果

与NX组相比，TX组中位PFS更长（8.4个月vs 7.1个月，P=0.0026，HR=1.65），中位DOR也更好（7.8个月vs 6.6个月，P=0.0451）。TX组48（46.2％）位患者和NX组42（41.2％）位患者接受维持用药。TX组的OS较NX组长（35.3个月vs 19.8个月），但无统计学意义。考虑到PFS和OS，年龄≥40岁患者，绝经后患者和肿瘤内脏转移的患者更有可能从TX方案获益。而激素、HER2受体阳性和紫杉醇治疗史并不影响TX组和NX组患者PFS和OS的差异。TX组肿瘤缓解率为55.3％，NX组肿瘤缓解率为54.9％。与NX组相比，TX组手足综合征发生率更高（47％对16.7％，P<0.0001），但两组其他轻微不良反应的发生率相似。

结论

与NX方案+后续卡培他滨维持用药相比，TX方案+后续卡培他滨维持用药可以使晚期乳腺癌患者获得更长的PFS和DOR，即使在先前接受过紫杉醇（新）辅助化疗的晚期乳腺癌患者中也是如此。临床试验信息：NCT01126138.

医脉通整理报道，转载请注明出处。

会议专题》》》2014年ASCO年会专题报道

阅读摘要原文

Survival with docetaxel plus capecitabine comparing with vinorelbine plus capecitabine followed by capecitabine maintenance treatment as first-line therapy in patients with advanced breast cancer: A phase III randomized clinical trial.（Abstract No:1049）

Authors: Binghe Xu, Jiayu Wang, Qing Li, Pin Zhang, Peng Yuan, Fei Ma, et al.

Session Type: General Poster Session

Background: Docetaxel/capecitabine (TX) is one of the standard regimens recommended by NCCN for metastatic breast cancer treatment. There are few clinical studies directly comparing TX and navelbine/capecitabine (NX), followed by capecitabine maintenance treatment, especially in advanced breast cancer patients previously treated with taxane in adjuvant setting. This study aimed to compare the efficacy and safety of TX and NX medications followed by capecitabine maintenance for patients with metastatic breast cancer. 

Methods: A total of 206 patients with advanced metastatic breast cancer were randomly assigned into TX (n=104) and NX (n=102) treatment groups, both with capecitabine maintenance medication. The primary endpoint was progression-free survival (PFS) and secondary endpoints included overall survival (OS), response rate (RR), duration of response (DOR) as well as safety. 

Results: The TX group achieved longer median PFS than the NX group (8.4 months vs. 7.1 months; p = 0.0026, HR = 1.65) and had better median DOR (7.8 months vs. 6.6 months, p = 0.0451). In the TX group 48 (46.2%) and in the NX group 42 (41.2%) patients attained maintenance medication. The OS period of the TX group was longer than in NX patients (35.3 months vs. 19.8 months), but without statistical significance. Patients ≥40 years of age, postmenopausal and with visceral metastases were more likely to benefit from a TX regimen in terms of PFS and OS, whereas hormone and positive HER2 receptor and history of taxane treatments did not affect PFS and OS differences between TX and NX patients. The tumor response rates were 55.3% in the TX vs. 54.9% in the NX group. In the TX group hand-foot syndrome occurred more frequently than in the NX group (47% vs. 16.7%, p < 0.0001), but frequencies of other minor adverse effects were similar in both groups. 

Conclusions: A TX regimen for advanced breast cancer followed by capecitabine maintenance medication led to longer PFS and DOR than a NX regimen even for patients who were previously treated with taxane in (neo) adjuvant settings. Clinical trial information: NCT01126138.