卡培他滨+顺铂用于经蒽环及紫杉类药物治疗的转移性三阴性乳腺癌患者的II期临床研究

根据ASCO最新报道(摘要编号e12077):

背景：三阴性乳腺癌（TNBC）是临床治疗中的一个巨大挑战，治疗可选择的方式有限。DNA损伤药物如铂类已被证明对三阴性乳腺癌是有效的。此外，顺铂联合卡培他滨（XP）显著的协同细胞毒性也已被体外和体内实验证明；同时，顺铂联合卡培他滨对于多种晚期实体瘤是有效的、耐受性良好的。尽管如此，XP的联合应用对于治疗转移性三阴乳腺癌是否是一个合适的选择仍是未知的。本前瞻性临床试验研究的目的既旨在评估XP方案治疗经蒽环类及紫杉类药物治疗的转移性三阴性乳腺癌患者的有效性和安全性。

方法：以蒽环类及紫杉类药物作为前期治疗方案的转移性TNBC患者，接受卡培他滨+顺铂治疗，其中在每个治疗周期（共21天）的第1天至14天，给予卡培他滨2000mg/m2 P.O.，在每个治疗周期的第1天静脉给予顺铂 75mg/m2 iv，最多6个周期，此后单用卡培他滨进行维持治疗。主要终点是ORR，次要终点包括PFS，OS和安全性。

结果： 33例诊断为IV期TNBC的女性患者持续入组到该研究中。入组时的中位年龄为47岁（范围：25-71）。大部分（57.6%）的患者有2个或多个转移部位，69.7%的患者有内脏受累。所有患者共接受了148个治疗周期，平均每例患者的治疗中位周期数为5（范围：2-6）。主要终点ORR为63.6%。全体患者的中位PFS为6.0个月（95%CI: 3.1-8.9），缓解患者的中位PFS为9.0个月（95%CI: 3.4-14.6）。所有入组患者的1年生存率为68%(95%CI: 57.6-77.4)，在缓解患者中为95%(95%CI: 90.1-99.9)。大多数不良反应为轻度和可控的，其中最常见的是中性粒细胞减少和恶心、呕吐。 3/4级毒性包括白细胞减少（10，30.3％），中性粒细胞（10，30.3％），贫血（2，6.1％），血小板减少（13.0％），恶心/呕吐（3，9.1％），手动足综合征（1，3.0％），和感觉神经病（1，3.0％）。

结论：对于曾经接受蒽环类及紫杉类药物治疗的转移性TNBC患者，卡培他滨+顺铂方案显示出明确的有效性和可控的安全性。

临床试验信息：NCT01928680

摘要原文

Abstract No: e12077

Author(s): Qiao Li, Binghe Xu, Qing LI, Pin Zhang, Peng Yuan, Jiayu Wang, Fei Ma, Yang Luo, Ying Fan, Ruigang Cai; Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College, Beijing, China; Cancer Hosp Chinese Academy of Medcl Sciences, Beijing, China; Department of Medical Oncology, Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China; Chinese Academy of Medical Sciences, Beijing, China; Cancer Hospital & Institute, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China; Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China

Abstract:

Background: Triple-negative breast cancer (TNBC) is a huge clinical challenge with limited choices of treatment. DNA damage agents such as platinum have been proved effective in TNBC. Besides, significant synergistic cytotoxicity of cisplatin and capecitabine has been demonstrated by in vitro and in vivo studies. Furthermore, the combination of cisplatin and capecitabine (XP) was proved effective and well tolerated in multiple advanced solid tumors. However, whether combination of XP is a suitable choice for treatment of metastatic TNBC is unknown. This study was designed as a prospective clinical trial to evaluate the efficacy and safety of XP regimen in metastatic TNBC patients pretreated with anthracyclines and taxanes.

Methods: Patients with metastatic TNBC who had anthracyclines and taxanes as prior therapy were treated with capecitabine 2000 mg/m2 P.O. on day 1 through 14 plus cisplatin 75mg/m2 iv. on day 1 of a 21-day cycle for a maximum of 6 cycles, followed by capecitabine maintenance therapy. The primary end point was ORR and the secondary end points included PFS, OS and safety.

Results: Thirty-three consecutive women diagnosed with stage IV TNBC were enrolled. Median age at enrollment was 47 (range: 25-71). A majority of patients (57.6%) had 2 or more metastatic sites, and 69.7% of patients had visceral involvement. A total of 148 cycles was given, with a median of 5 cycles (Range 2-6) per patient. ORR was 63.6%. Median PFS was 6.0 (95%CI: 3.1-8.9) months in the entire population and 9.0 (95%CI: 3.4-14.6) months in responding patients. One-year survival rate was 68% (95%CI: 57.6-77.4) in all enrolled patients and 95% (95%CI: 90.1-99.9) in responding patients. Most adverse events were mild and manageable, with neutropenia and nausea/vomiting as most common toxicities. Grade 3/4 toxicities included leukopenia (10, 30.3%), neutropenia (10, 30.3%), anemia (2, 6.1%), thrombocytopenia (1, 3.0%), nausea/vomiting (3, 9.1%), hand-foot syndrome (1, 3.0%), and sensory neuropathy (1, 3.0%).

Conclusions: Capecitabine plus cisplatin demonstrated a clear activity and an acceptable safety profile in metastatic TNBC patients pretreated with anthracyclines and taxanes. Clinical trial information: NCT01928680

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