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白蛋白结合型紫杉醇联合顺铂作为转移性食管鳞癌一线治疗方案。

Nanoparticle albumin-bound paclitaxel combined with cisplatin as the first-line treatment for metastatic esophageal squamous cell carcinoma.

机构信息

Department of Multimodality Therapy of Oncology, General Hospital of CPLA, Beijing, People's Republic of China.

出版信息

Onco Targets Ther. 2013 May 27;6:585-91. doi: 10.2147/OTT.S44406. Print 2013.

Abstract

Esophageal cancer is a major health hazard in many parts of the world and is often diagnosed late. The objective of this study was to explore the efficacy and safety of nanoparticle albumin-bound paclitaxel (Nab-PTX) combined with cisplatin (DDP) in patients with metastatic esophageal squamous cell carcinoma (ESCC). Patients with histologically confirmed ESCC were treated with Nab-PTX 250 mg/m(2) and DDP 75 mg/m(2) intravenously on day 1, every 21 days. Evaluation was performed after every two cycles of therapy and the therapy was continued until disease progression or unacceptable toxicity. From April 2010 to December 2012, 33 patients were enrolled. Ten patients had recurrent and metastatic tumors after surgery and 23 patients were diagnosed with unresectable metastatic disease. Patients received a median of four cycles of therapy (ranging from two to six cycles). Twenty patients achieved partial response and nine patients achieved stable disease; no complete response was observed. The objective response rate was 60.6% and the disease control rate was 87.9%. The median progression-free survival was 6.2 months (95% confidence interval: 4.0 to 8.4 months) and the median overall survival was 15.5 months (95% CI: 7.6 to 23.4 months). Only four patients experienced grade 3 adverse events, including vomiting, neutropenia, and sensory neuropathy. The most common adverse events were nausea/vomiting (81.8%), neutropenia (63.6%), leucopenia (48.5%), anemia (24.2%) and sensory neuropathy (24.2%). In conclusion, the combination of Nab-PTX and DDP is a highly effective and well-tolerated first-line treatment in metastatic ESCC.

摘要

食管癌是世界上许多地区的主要健康危害,且通常诊断较晚。本研究旨在探讨白蛋白结合型紫杉醇(Nab-PTX)联合顺铂(DDP)治疗转移性食管鳞状细胞癌(ESCC)患者的疗效和安全性。经组织学证实的 ESCC 患者接受 Nab-PTX 250 mg/m²和 DDP 75 mg/m²静脉滴注,每 21 天一次。每两个周期治疗后进行评估,并继续治疗直至疾病进展或不可接受的毒性。从 2010 年 4 月至 2012 年 12 月,共纳入 33 例患者。10 例患者手术后出现复发和转移瘤,23 例患者诊断为不可切除的转移性疾病。患者接受中位数为 4 个周期的治疗(范围为 2 至 6 个周期)。20 例患者获得部分缓解,9 例患者获得稳定疾病;未观察到完全缓解。客观缓解率为 60.6%,疾病控制率为 87.9%。中位无进展生存期为 6.2 个月(95%置信区间:4.0 至 8.4 个月),中位总生存期为 15.5 个月(95%CI:7.6 至 23.4 个月)。仅有 4 例患者出现 3 级不良事件,包括呕吐、中性粒细胞减少和感觉神经病变。最常见的不良事件是恶心/呕吐(81.8%)、中性粒细胞减少(63.6%)、白细胞减少(48.5%)、贫血(24.2%)和感觉神经病变(24.2%)。总之,Nab-PTX 联合 DDP 是转移性 ESCC 患者一种高效且耐受良好的一线治疗方案。

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