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食管癌同期放化疗中奈达铂剂量递增临床Ⅰ期试验
A Phase Ⅰ Clinical Trial of Dose Escalation of Nedaplatin in Concurrent Chemoradiotherapy for Patients with Esophageal Carcinoma
【摘要】 [目的]探讨在食管癌同期放化疗中多西紫杉醇固定周剂量时奈达铂(NDP)的周最大耐受剂量(MTD),并观察其不良反应。[方法]共入选20例初治食管鳞癌患者,采用三维适形放疗方法,DT:60~64Gy/30~32f,42~44d,同步化疗方案固定多西紫杉醇剂量20mg/w,共6w,NDP采用周剂量递增方法,起始剂量12mg/m2,递增剂量为6 mg/m2。剂量限制性毒性(DLT)定义为≥3级不良反应,出现DLT的前一剂量即为MTD。[结果]NDP 24mg/m2剂量水平时共有2例患者发生3~4级的DLT;NDP 18mg/m2、多西紫杉醇20mg即为MTD。主要不良反应为放射性食管炎、放射性肺炎、乏力和骨髓抑制。[结论]食管癌同步放化疗中固定多西紫杉醇20mg每周剂量时奈达铂每周最大耐受剂量为 18mg/m2。
【Abstract】 [Purpose] To investigate the weekly maximum-tolerated dose(MTD) of nedaplatin when combined with weekly docetaxel fixed dose in concurrent chemoradiotherapy for esophageal carcinoma,and its toxicity.[Methods] Twenty initial treatment cases with esophageal squamous cell carcinoma were enrolled in this study.All patients received 3-dimensional conformal radiation therapy,the total radiation dose was 60~64Gy/30~32f for 42~44 days.Concurrent chemotherapy was implemented by dose-escalating.The starting dose of nedaplatin was 12mg/m2 and docetaxel was 20mg,this regimen was repeated every week with the escalating doses of nedaplatin 6mg/m2.Dose-limiting toxicity(DLT) was defined as ≥grade 3 toxicity.MTD was defined as last one dose level before induced DLT.[Results] The DLT defined as grade 3 or 4 was found in 2 patients at the level of nedaplatin 24mg/m2,MTD of nedaplatin was 18mg/m2.The main toxicity was radiation esophagitis,radiation pneumonitis,hypodynamia and myelosuppression.[Conclusion] Weekly maximum tolerated dose of nedaplatin is 18mg/m2 when combined with docetaxel fixed 20mg per week in concurrent chemoradiotherapy for patients with esophageal carcinoma.
【Key words】 esophageal neoplasm; radiation therapy; drug therapy; concurrent chemoradiotherapy; nedaplatin; dose escalation;
- 【文献出处】 肿瘤学杂志 ,Journal of Chinese Oncology , 编辑部邮箱 ,2011年08期
- 【分类号】R735.1
- 【被引频次】5
- 【下载频次】85