老年Ⅲ期非小细胞肺癌同步放化疗的临床对照研究

Clinical control study of concurrent chemoradiotherapy for stage Ⅲ non-small cell lung cancer in elderly patients

目的:探讨不同方案同步放化疗和单纯放疗对老年Ⅲ期非小细胞肺癌(NSCLC)的疗效和安全性。方法:老年Ⅲ期NSCLC患者193例,根据患者入组顺序,采用随机数字表法,按不同治疗方案分为4组(A、B、C和D组),均接受三维适形放疗,照射剂量60～66.6Gy,常规分割剂量1.8～2.0Gy/次,6～8周内完成放疗。A组仅行单纯放疗;B组接受同步榄香烯乳治疗;C组联合吉西他滨(GEM)加顺铂(DDP)化疗,放疗期间同步化疗1～2个周期,放疗结束后巩固化疗2～3个周期;D组联合紫杉醇脂质体(PL)加DDP化疗,同步化疗1～2个周期,放疗结束2～4周后巩固化疗2～3个周期。定期复查并观察疗效及不良反应,主要研究终点为疾病无进展时间(PFS)及总生存时间(OS)。结果:全组中位随访21个月,中位PFS 13个月,中位OS 19个月。各组治疗有效率(CR+PR)依次为43.6%、54.3%、70.8%和75.0%。有效率组间比较,C组较A、B两组高,差异有统计学意义,P值均<0.05。D组亦较A、B两组高,差异有统计学意义,P值均<0.05。各组的1、3和5年生存率比较,C组最高,依次为72.9%、39.6%和16.4%,A组最低,依次为46.2%、15.4%和0。C组较A、B组均显著延长PFS和OS,差异均有统计学意义,P值均<0.05。D组也较A组显著延长了PFS和OS,且差异有统计学意义,P值均<0.05。D组对B组也有生存优势,但仅OS的差异有统计学意义,P值均<0.05。在放射性肺炎、放射性食管炎、骨髓抑制和胃肠道反应方面,同步放化疗组不良反应发生率高于单纯放疗组,差异有统计学意义,P值均<0.05。结论:对于老年Ⅲ期NSCLC患者,同步放化疗可显著提高有效率,延长PFS和OS。

OBJECTIVE： To study the efficacy and security of radiotherapy alone and radiotherapy combine with chemotherapy of different regimens for stage Ⅲ non-small cell lung cancer（NSCLC） in elderly patients.METHODS： Totally 193 cases with stage Ⅲ NSCLC were divided randomly into 4 groups.All the cases were treated with three dimensional conformal radiation therapy（3D-CRT） to a total dose of 60-66.6 Gy over 30-37 fractions at 1.8-2.0 Gy per fraction,5 fractions per week for 6-8 weeks.Group A received 3D-CRT alone.Group B received concurrent therapy with elemene.Group C received concurrent chemotherapy with the regimen of gemcitabine plus cisplatin,3 weeks per cycle for total 1-2 cycles during radiotherapy,followed by gemcitabine behind radiotherapy.Group D received concurrent chemotherapy with the regimen of paclitaxel plus cisplatin,3 weeks per cycle for total 1-2 cycles during radiotherapy,followed by paclitaxel,3 weeks per cycle for total 2-3 cycles behind radiotherapy.Clinical evaluations of tumor response and adverse effects were performed periodically.The primary end points were disease progression-free survival（PFS） and overall survival（OS）.RESULTS：In all cases,median follow-up was 21 months.Median PFS and OS were 13 and 19 months,respectively.The therapy effective（CR＋PR） rate in each group was 43.6%,54.3%,70.8% and 75.0%,respectively.The total effective rates in group C and group D were higher than the other two groups,the difference was significant（P0.05）.The 1-,3-and 5-year survival rates in group C were 72.9%,39.6% and 16.4%,respectively,which were the highest in 4 groups.Those in group A were 46.2%,15.4% and 0,respectively,which were the lowest.Chemoradiotherapy lengthened PFS and OS than radiotherapy alone,but increased the esophagitis and pneu-monitis of radiation-induced,hematological toxicity and gastrointestinal adverse effects,the difference was significant（P0.05）.CONCLUSION：To elderly patients with stage Ⅲ NSCLC,concomitant chemoradiotherapy can improve effective rate and extend PFS and OS.