Prospective, open, multicentre Phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and cisplatin for esophageal carcinoma
Prospective, open, multicentre Phase I/II trial to assess safety and efficacy of neoadjuvant radiochemotherapy with docetaxel and cisplatin for esophageal carcinoma
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前瞻性、开放、多中心 I/II 期试验，评估多西紫杉醇和顺铂新辅助放化疗治疗食管癌的安全性和有效性
DOI：
10.1093/jjco/hyu181
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发表时间：
2015-02-01
影响因子：
2.4
通讯作者：
Ren, Juan
中科院分区：
文献类型：
--
作者：
Ma, Hong-Bing;Di, Zheng-Li;Ren, Juan
目的：食管鳞癌的治疗越来越多地采用三联疗法。本I/II期临床研究的目的是评估多西他赛和顺铂的新辅助放化疗和放疗在食管切除术后局部晚期食管鳞状细胞癌患者中的疗效和安全性。方法：食管鳞状细胞癌患者接受了放化疗（50戈伊/25次，第1-5周），使用三维适形放射治疗或调强放射治疗技术，每周一次多西他赛2009年1月至2011年12月，顺铂（剂量水平1和2 20 mg/m2，剂量水平3 25 mg/m2，第1-5周）和顺铂（剂量水平1 30 mg/m2，剂量水平2和3 40 mg/m2，第1-5周）。剂量限制性毒性反应和最大耐受剂量为主要终点，总有效率和无进展生存期为次要终点。13例患者接受剂量水平1治疗，21例患者接受剂量水平2治疗，15例患者接受剂量水平3治疗。多西他赛和顺铂的最大耐受剂量分别为20 mg/m2和40 mg/m2。26.5%（13/49）的患者观察到完全缓解或部分缓解。34例患者（69.4%）接受了新辅助放化疗，随后进行了手术切除。所有患者（n = 49）的中位无进展生存期和中位总生存期分别为8个月和17.2个月。剂量2组中位生存期为27.5个月。结论：多西他赛20 mg/m2+顺铂40 mg/m2新辅助放化疗诱导方案是治疗食管癌的有效诱导方案，可耐受。
Objective: Esophageal squamous cell carcinoma is increasingly treated with trimodality therapy. The objective of this Phase I/II clinical study is to assess the efficacy and safety of neoadjuvant radiochemotherapy with docetaxel and cisplatin and radiotherapy in patients with esophagectomy for locally advanced squamous cell carcinoma of the esophagus with neoadjuvant chemoradiotherapy.Methods: Patients with esophageal squamous cell carcinoma received radiochemotherapy (50 Gy/25 fractions during Weeks 1-5) using a three-dimensional conformal radiation therapy or intensity-modulated radiation therapy technique together with weekly docetaxel (20 mg/m(2) at dose levels 1 and 2, 25 mg/m(2) at dose level 3 on Weeks 1-5) and cisplatin (30 mg/m(2) at dose level 1, 40 mg/m(2) at dose levels 2 and 3 on Weeks 1-5) from January 2009 to December 2011. The dose-limiting toxicities and maximum tolerated dose were the primary endpoints and overall response rate and progression-free survival were the secondary endpoints.Results: Over this timeframe, a total of 49 patients completed trimodality therapy. Thirteen patients were treated at dose level 1, 21 patients at dose level 2 and 15 patients at dose level 3. The maximum tolerated dose for docetaxel was 20 mg/m(2) and cisplatin 40 mg/m(2). The complete response or partial response was observed in 26.5% (13/49) of patients. Thirty-four patients (69.4%) were treated with neoadjuvant radiochemotherapy followed by surgical resection. The median progression-free survival and median overall survival for all patients (n = 49) were 8 and 17.2 months, respectively. The median overall survival was 27.5 months for patients treated at dose level 2.Conclusion: Neoadjuvant radiochemotherapy with docetaxel 20 mg/m(2) and cisplatin 40 mg/m(2) was effective and tolerable induction regimen in patients with esophageal tumors.