局部进展期鼻咽癌行放射治疗和每周同步泰素化疗的I期试验结果
这个帖子发布于 20 年零 247 天前，其中的信息可能已发生改变或有所发展。
Am J Clin Oncol 2004;27: 481–484)
Radiation Therapy Concurrent With Weekly Paclitaxel for Locoregionally Advanced Nasopharyngeal Carcinoma Outcomes of a Phase I Trial
Purpose: The purpose of this study was to define the maximum tolerated dose (MTD) by describing the dose-limiting toxicity (DLT) of paclitaxel given as a 3-hour intravenous infusion concurrently with conventional radiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC).
Materials and Methods: Patients with locoregionally advanced NPC were enrolled into a dose-escalating study. Toxicity was graded according to Common Toxicity Criteria 2.0. MTD was defined when 2 of 6 patients developed DLT. The starting dose of paclitaxel was 20 mg/m2 once weekly, with a subsequent dose escalation of 10 mg/m2 in cohorts of 3 new patients. Radiation therapy was administered in a conventional technique over 7 weeks in 2.0-Gy/daily fractions for 5 days/wk up to total doses of 68–70 Gy.
Results: From November 2000 to June 2001, 16 patients completed chemoradiotherapy. On the first-dose level (20 mg/m2), no patient experienced DLT. On the next dose level with 30 mg/m2, 1 patient experienced DLT with grade 3 mucositis, which lasted for 5 weeks, and among the additional 3 patients, no one developed DLT. On the third dose level with 40 mg/m2, 1 patient developed grade 3 mucositis and another grade 3 dermatitis, and both of them lasted more than 3 weeks. To make the trial more credible, another 4 patients were added to the 30-mg/m2 level, and no DLT occurred. Thus, the accrual of patients stopped.
Conclusion: Combined modality with paclitaxel given weekly, as a 3-hour infusion concomitant to conventional radiotherapy, is feasible for locoregionally advanced NPC. The dose recommended for a phase II trial is 30 mg/m2 with mucositis and dermatitis as DLT, and other toxicity is mild.
Am J Clin Oncol 2004;27: 481–484)
局部进展期鼻咽癌行放射治疗和每周同步泰素化疗的I期试验结果
目的: 这项研究的目的是对局部进展期鼻咽癌(NPC)进行3-hour静脉输注泰素加同步放射治疗的实验, 通过描述泰素剂量限制性毒性(DLT)定义泰素的最大耐受剂量(MTD).
材料和方法: 局部进展期鼻咽癌病人被召到剂量逐步升高试验. 毒性是依照毒性标准2.0评定等级. MTD是定义就6个病人的2人发展成DLT.
泰素每周20 mg/m2一次, 后来每3个新病人剂量扩大10 mg/m2. 放射治疗是用常规技术照射7星期,2.0Gy/天,5天/周,一直到总剂量68–70 Gy.
结果: 从2000年11月到2001年6月,16病人完成放化疗. 在初级剂量水平(20 mg/m2), 没有病人经历DLT. 在下一个剂量水平(30 mg/m2), 1个病人经历了持续5星期的3级粘膜炎DLT,另外的3个病人没有发展到DLT. 在第三剂量水平(40 mg/m2), 1个病人发展成持续3星期的3级粘膜炎和3级皮炎.为增加试验可信度, 另外4个病人加入到30-mg/m2剂量水平, 并没有DLT发生. 因而, 实验停止.
结束: 对局部进展期鼻咽癌(NPC)联合3-hour静脉输注泰素和同步放射治疗是可行的. II期试验推荐剂量是30 mg/m2, DLT为粘膜炎和皮炎,其他的毒性是温和的.
Radiation Therapy Concurrent With Weekly Paclitaxel for Locoregionally Advanced Nasopharyngeal Carcinoma Outcomes of a Phase I Trial
Purpose: The purpose of this study was to define the maximum tolerated dose (MTD) by describing the dose-limiting toxicity (DLT) of paclitaxel given as a 3-hour intravenous infusion concurrently with conventional radiotherapy in patients with locoregionally advanced nasopharyngeal carcinoma (NPC).
Materials and Methods: Patients with locoregionally advanced NPC were enrolled into a dose-escalating study. Toxicity was graded according to Common Toxicity Criteria 2.0. MTD was defined when 2 of 6 patients developed DLT. The starting dose of paclitaxel was 20 mg/m2 once weekly, with a subsequent dose escalation of 10 mg/m2 in cohorts of 3 new patients. Radiation therapy was administered in a conventional technique over 7 weeks in 2.0-Gy/daily fractions for 5 days/wk up to total doses of 68–70 Gy.
Results: From November 2000 to June 2001, 16 patients completed chemoradiotherapy. On the first-dose level (20 mg/m2), no patient experienced DLT. On the next dose level with 30 mg/m2, 1 patient experienced DLT with grade 3 mucositis, which lasted for 5 weeks, and among the additional 3 patients, no one developed DLT. On the third dose level with 40 mg/m2, 1 patient developed grade 3 mucositis and another grade 3 dermatitis, and both of them lasted more than 3 weeks. To make the trial more credible, another 4 patients were added to the 30-mg/m2 level, and no DLT occurred. Thus, the accrual of patients stopped.
Conclusion: Combined modality with paclitaxel given weekly, as a 3-hour infusion concomitant to conventional radiotherapy, is feasible for locoregionally advanced NPC. The dose recommended for a phase II trial is 30 mg/m2 with mucositis and dermatitis as DLT, and other toxicity is mild.
Am J Clin Oncol 2004;27: 481–484)
局部进展期鼻咽癌行放射治疗和每周同步泰素化疗的I期试验结果
目的: 这项研究的目的是对局部进展期鼻咽癌(NPC)进行3-hour静脉输注泰素加同步放射治疗的实验, 通过描述泰素剂量限制性毒性(DLT)定义泰素的最大耐受剂量(MTD).
材料和方法: 局部进展期鼻咽癌病人被召到剂量逐步升高试验. 毒性是依照毒性标准2.0评定等级. MTD是定义就6个病人的2人发展成DLT.
泰素每周20 mg/m2一次, 后来每3个新病人剂量扩大10 mg/m2. 放射治疗是用常规技术照射7星期,2.0Gy/天,5天/周,一直到总剂量68–70 Gy.
结果: 从2000年11月到2001年6月,16病人完成放化疗. 在初级剂量水平(20 mg/m2), 没有病人经历DLT. 在下一个剂量水平(30 mg/m2), 1个病人经历了持续5星期的3级粘膜炎DLT,另外的3个病人没有发展到DLT. 在第三剂量水平(40 mg/m2), 1个病人发展成持续3星期的3级粘膜炎和3级皮炎.为增加试验可信度, 另外4个病人加入到30-mg/m2剂量水平, 并没有DLT发生. 因而, 实验停止.
结束: 对局部进展期鼻咽癌(NPC)联合3-hour静脉输注泰素和同步放射治疗是可行的. II期试验推荐剂量是30 mg/m2, DLT为粘膜炎和皮炎,其他的毒性是温和的.
1 收藏点赞
