放射治疗合并盐酸拓普替康治疗局部晚期非小细胞肺癌的Ⅰ期临床研究

 目的 通过局部晚期非小细胞肺癌放射治疗合并盐酸拓普替康(TPT)的综合治疗，进行Ⅰ期临床研究，观察其毒性、耐受剂量及临床可行性。方法 局部晚期肺癌16例，病理或细胞学证实为非小细胞肺癌。放射治疗肺部原发灶及淋巴引流区。化疗(TPT)：放射治疗开始应用拓普替康，每周2次。每个剂量水平治疗4个星期。拓普替康分3个剂量级，0．5mg／m²，0.75mg／m²，1mg／m²，每个剂量级至少入选3个病人，如无明显毒副反应进入下一个剂量水平，直至找到最大耐受量(MTD)。结果 主要毒副反应为骨髓抑制和放射性食管炎。MTD为0．75mg／m²。结论 局部晚期非小细胞肺癌合并TPT综合治疗具有临床可行性，最大耐受剂量0．75mg／m²，推荐Ⅱ期临床剂量为0．5mg／m²。

A Phase Ⅰ Clinical Trial of Topotecan Plus Radiotherapy in Patients with Local Advanced Stage of Non-small Cell Lung Cancer

Objective The current study was designed to determine the dose-limiting toxicities and clinical practicable of radiotherapy with Topotecan for local advanced non-small cell lung cancer. Methods Sixteen patients with histologically confirmed diagnosis of local late-stage NSCLC,radiotherapy include primary tumor site of lung and the area of lymph node.Patients were treated with Topotecan at three dose level ((0.5)mg/m~(2),(0.75)mg/m~(2 )and 1mg/m~(2))while the radiotherapy started. Topotecan was given intravenously twice a week over total four weeks . Dose escalation was based ,on each level ,of a minimum of three patients in cohort if severe toxicity had not been observed until the maximum tolerance dose(MTD). Results The predominant form of toxicity is hematologic toxicity and radiation esophagitis. The MTD was 0.75mg/m~(2). Conclusion Combined radiotherapy and Topotecan for treatment of local late-stage NSCLC is well tolerant. We recommend that the dose for phase II clinical trial is 0.5mg/m~(2).