吉西他滨同期放射治疗对不能手术的Ⅲ期非小细胞肺癌患者的疗效观察

Efficacy of Gemcitabine with Concurrent Radiotherapy on Stage Ⅲ, Inoperable Non-small Cell Lung Cancer

背景与目的:放射治疗是肺癌的一种有效的治疗方式,加入吉西他滨后能否提高放射治疗疗效尚无定论。本研究探讨吉西他滨同期放射治疗对不能手术的Ⅲ期非小细胞肺癌(non-small cell lung cancer,NSCLC)患者的疗效、毒副反应和生存情况。方法:共入选60例患者,分为试验组和对照组,每组各30例。试验组采用吉西他滨400mg/m2,30min内静滴完,每周一次,同期放射治疗,放射治疗为常规分割,DT60～66Gy/30～33F/6～6.5W,同时给予支持治疗。对照组除不给予吉西他滨外,其它与试验组相同。用WHO的标准评价疗效;用χ2检验比较有效率、毒副反应和长期生存;用Kaplan-Meier方法计算生存率。结果:58例患者随访资料完整,随访率为96.7%。试验组和对照组的有效率分别为70.0%和60.0%(P>0.05);消化道和血液学的毒副反应比较,差异无统计学意义(P>0.05)。Kaplan-Meier生存分析显示,试验组1、2、3年生存率分别为77.7%、58.6%、26.4%,对照组1、2、3年生存率分别为70.3%、30.1%、16.1%,经比较两者差异无统计学意义(P>0.05)。结论:对不能手术的Ⅲ期NSCLC患者,吉西他滨同期放射治疗的有效率和1、2、3年生存率均较单纯放疗有所提高,但两组比较未达统计学意义,不良反应可以耐受。

BACKGROUND ＆ OBJECTIVE： Radiotherapy is an effective treatment for lung cancer. It is still uncertain whether gemcitabine can improve the efficacy of radiotherapy on lung cancer. This study was to investigate the efficacy of gemcitabine with concurrent radiotherapy on stage Ⅲ , inoperable non-small cell lung cancer （NSCLC）, and observe the adverse events and long-term survival of the patients. METHODS： Sixty patients were enrolled and divided into trial group （30 cases） and control group （30 cases）. In trial group, the patients received weekly administration of gemcitabine （400 mg/ m^2） with concurrent radiotherapy at a total dose of 60-66 Gy （2.0 Gy dose fraction per day, 5 days per week）. In control group, the patients received only radiotherapy at the same dosage. The responses were evaluated according to WHO criteria. The efficacy, adverse events and long-term survival between the 2 groups were compared with Х^2 test. The long-term survival was also estimated by Kaplan-Meier method. RESULTS. Fifty-eight patients finished the trial. The follow-up rate was 96.7%. The response rate was 70.0% in trial group and 60.0% in control group （P〉0.05）. There was no significant difference in the incidence of hematologic and non-hematologic adverse events between the 2 groups （P〉0.05）. The 1-, 2-, and 3-year survival rates were 77.7%, 58.6%, 26.4% in trial group, and 70.3%, 30.1%, 16.1% in control group （P〉0.05）. CONCLUSIONS,. In this study, gemcitabine with concurrent radiotherapy, as compared with radiotherapy alone, prolonged the survival of stage Ⅲ , inoperable non-small cell lung cancer patients, but the improvement is not significant. In both groups, the adverse events are tolerable.