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同步放化疗配合巩固化疗治疗局部晚期非小细胞肺癌的随机临床研究 被引量:10

Concurrent three dimension conformal radiation therapy and chemotherapy followed by consolidation chemotherapy for locally advanced non-small cell lung cancer
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摘要 目的探讨局部晚期非小细胞肺癌(NSCLC)的综合治疗方法,比较同时放化疗+巩固化疗(CCT)和同时放化疗(CRT)的近远期疗效及毒副反应。方法局部晚期NSCLC 90例,随机均分成2个组。CCT组采用先按CRT组进行治疗结束后再进行两周期巩固化疗,CRT组采用多西他赛和顺铂每周化疗同时放疗。放疗采用三维适形放疗,胸部照射2 Gy/次,5次/周,共5.5-6.6周,总剂量56-66 Gy。化疗CRT组采用多西他赛30 mg/m2和顺铂20 mg/m2,第1、8、22、29天分别在第1、6、16、21次放疗前2 h给予。CCT组先按CRT组方案治疗结束后再加用多西他赛75 mg/m2和顺铂100 mg/m2巩固化疗,每3周重复,共两周期。结果CRT组和CCT组有效率分别为69%和76%(P= 0.480)。CRT组和CCT组中位无进展生存时间分别为12.0个月(95%可信区间10.1~13.9个月)和14.5个月(95%可信区间11.8~17.2个月),中位生存时间分别为16.0个月(95%可信区间11.7 -20.3个月)和16.0个月(95%可信区间13.5-18.5个月)。CRT组和CCT组1、2、3年无进展生存率分别为56%和62%、12%和24%、3%和11%(P=0.044),总生存率分别为73%和78%、31%和32%、20%和21%(P=0.308)。CRT组和CCT组副反应无差异(P>0.05)。结论局部晚期NSCLC患者同时放化疗后巩固性化疗的无进展生存率有所提高而总生存率相似,且两组毒副反应无差别,但是否真正受益有待进一步多中心和扩大病例数研究。 Objective To investigate the comprehensive treatment of inoperable locally advanced non-small cell lung cancer ( NSCLC), and to compare the efficacy and toxicity of concurrent chemoradiotherapy (CRT group) with those of concurrent chemoradiotherapy followed by consolidation chemotherapy (CCT group). Methods Ninety patients with inoperable locally advanced NSCLC were randomized into CRT group or CCT group. CRT group was treated with weekly docetaxel and cisplatin based concurrent chemoradiotherapy. CCT group was treated with the same chemoradiotherapy followed by docetaxel and cisplatin based consolidation chemotherapy. For concurrent chemoradiotherapy, the total irradiation dose was 56-66 Gy given in 5-7 weeks, docetaxel 30 mg/m^2 and cisplatin 20 mg/m^2 were administrated on day 1,8, 22 and 29 ( ≤2 hours before radiation fraction 1, 6, 16, and 21 ). For consolidation chemotherapy, docetaxel 75 mg/m^2 and cisplatin 100 mg/m^2 were given every three weeks to a total of two cycles. Results For CRT group and CCT group, the response rates were 69% and 76% (P =0.480), respectively. The median pro- gression-free survival time was 12.0 (95% CI 10.1-13.9)months and 14.5 (95% CI lh 8-17.2)months, respectively. The median survival time was 16.0 (95% CI 11.7-20.3 ) months and 16.0 (95% CI 13.5- 18.5) months, respectively. The 1-, 2- and 3-year progression-free survival rates were 56% and 62%, 12% and 24% ,and 3% and 11% (P =0.044), respectively. The 1-, 2- and 3-year overall survival rates were 73% and 78%, 31% and 32%, and 20% and 21% (P =0.308), respectively. The difference of toxicity was not significant between the two group (P 〉 0.05). Conclusions For patients with locally advanced non-small cell lung cancer, concurrent conformal radiotherapy and chemotherapy followed by consolidation chemotherapy can improve the progression-free survival, but have few effects on overall survival and toxicity. Multicenter clinical trial with more patients should be carried out to confirm the benefit from the additional consolidation chemotherapy.
出处 《中华放射肿瘤学杂志》 CSCD 北大核心 2007年第6期427-431,共5页 Chinese Journal of Radiation Oncology
关键词 非小细胞肺/三维适形放射疗法 非小细胞肺/化学疗法 同时放化疗 巩固化疗 预后 Cancer, non-small cell lung/three dimension conformal radiotherapy Cancer, non small cell lung/chemotherapy Concurrent chemoradiotherapy Consolidation chemotherapy Prognosis
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参考文献18

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