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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[J]. 肿瘤防治研究, 2005, 32(02): 116-118. DOI: 10.3971/j.issn.1000-8578.2905
引用本文: 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[J]. 肿瘤防治研究, 2005, 32(02): 116-118. DOI: 10.3971/j.issn.1000-8578.2905
A Phase ⅠClinical Trial of Topotecan Plus Radiotherapy in Patients with Local AdvancedStage of Non-small Cell Lung Cancer[J]. Cancer Research on Prevention and Treatment, 2005, 32(02): 116-118. DOI: 10.3971/j.issn.1000-8578.2905
Citation: A Phase ⅠClinical Trial of Topotecan Plus Radiotherapy in Patients with Local AdvancedStage of Non-small Cell Lung Cancer[J]. Cancer Research on Prevention and Treatment, 2005, 32(02): 116-118. DOI: 10.3971/j.issn.1000-8578.2905

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

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

  • 摘要: 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

     

    Abstract: Abstract :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 patient s with histologically confirmed diagnosis of local late-stage NSCLC, radiotherapy include primary tumor site of lung and the area of lymph node. Patient s were treated with Topotecan at three dose level (0. 5mg/ m2, 0. 75mg/ m2 and 1mg/ m2 ) 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 patient s 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/ m2 . Conclusion  Combined radiotherapy and Topotecan for t reatment of local late-stage NSCLC is well tolerant . We recommend that the dose for phase II clinical t rial is 0. 5mg/ m2 .

     

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