彭培建, 赵充, 卢丽霞, 黄培钰, 韩非, 吴少雄, 张力. 放射治疗同期合并每周奥沙利铂治疗局部晚期鼻咽癌的随机Ⅱ期临床对照研究[J]. 中国肿瘤临床, 2006, 33(17): 995-998.
引用本文: 彭培建, 赵充, 卢丽霞, 黄培钰, 韩非, 吴少雄, 张力. 放射治疗同期合并每周奥沙利铂治疗局部晚期鼻咽癌的随机Ⅱ期临床对照研究[J]. 中国肿瘤临床, 2006, 33(17): 995-998.
Peng Peijian, Zhao Chong, Lu li-xia, . A Randomized Phase-II Clinical Control Study on Standard Radiotherapy in Combination with Weekly Oxaliplatin for Treatment of Loco-regional Advanced Nasopharyngeal Carcinoma[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2006, 33(17): 995-998.
Citation: Peng Peijian, Zhao Chong, Lu li-xia, . A Randomized Phase-II Clinical Control Study on Standard Radiotherapy in Combination with Weekly Oxaliplatin for Treatment of Loco-regional Advanced Nasopharyngeal Carcinoma[J]. CHINESE JOURNAL OF CLINICAL ONCOLOGY, 2006, 33(17): 995-998.

放射治疗同期合并每周奥沙利铂治疗局部晚期鼻咽癌的随机Ⅱ期临床对照研究

A Randomized Phase-II Clinical Control Study on Standard Radiotherapy in Combination with Weekly Oxaliplatin for Treatment of Loco-regional Advanced Nasopharyngeal Carcinoma

  • 摘要: 目的 :比较常规放射治疗与放射治疗同期合并每周奥沙利铂治疗局部晚期鼻咽癌的有效性,同时评价此联合治疗方式的安全性。 方法 :从2001年1月至2002年2月,77例局部晚期鼻咽癌患者(Ⅲ,Ⅳa,92分期)被随机分入同期放化疗组(CCRT)和单纯放疗组(RT),其中同期放化疗组39例,单纯放疗组38例。两组患者均接受常规的放射治疗方法;同期放化疗组于放射治疗的第1天开始,静脉滴注奥沙利铂70mg/m2,每周1次,连续6周。 结果 :77例患者均可评价毒副反应及客观疗效。97%的患者完成了计划剂量的放射治疗及奥沙利铂治疗,少见严重的毒性反应。中位随访24个月后,CCRT组2年总的生存率(OS)为100%,RT组为76%(P=0.02),2年无转移生存率(MFS)CCRT组为91%,RT组为76%(P=0.04),2年无复发生存率(RFS)CCRT组为95%,RT组为83%(P=0.11),CCRT组在OS,MFS方面均优于RT组,且差异有统计学意义。 结论 :以常规放疗同期联合每周奥沙利铂化疗的方式治疗局部晚期鼻咽癌,患者耐受性好,且可改善患者的生存,值得进一步研究。

     

    Abstract: Objective : A prospective study to compare the efficacy and safety profile of patients treated with standard radiotherapy versus the same radiotherapy associated with weekly Oxaliplatin in patients with locoregionally advanced nasopharyngeal carcinoma. Methods : From January 2001 to February 2002, 77 patients with loco-regional advanced NPC (Ⅲ, Ⅳa) were randomized into either the group of simple radiotherapy (RT arm, 38 patients) or the synchronous chemo-radiotherapy (CCRT arm, 39 patients). RT was administered with the same way in both arms. CCRT with Oxaliplatin 70 mg/m2 weekly was given for six doses from the first day of radiotherapy. Results : All patients were eligible for toxicity and response analysis. Compliance with the protocol treatment was excellent with 97% patients completing all planned doses of oxaliplatin and RT, and the lack of high-grade toxicity was observed. After a median follow-up of 24 months, the 2-year overall survival (OS) rates were 100% for the CCRT arm and 76% for the RT arm (P=0.02). The 2-year metastasis-free survival (MFS) rate was 91% for the CCRT arm versus 76% for the RT arm (P=0.04). The 2-year relapse-free survival (RFS) rate was 95% for the CCRT arm versus 83% for the RT arm (P=0.11), there was a significant difference in overall survival, and metastasis-free survival in favor of the CCRT arm. Conclusion : CCRT with weekly oxaliplatin is well tolerable and improves the OS rate and MFS rate in patients with locoregionally advanced NPC. Therefore, further randomized trails including oxaliplatin are warranted.

     

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