紫杉醇脂质体诱导加同期放化疗与序贯放化疗治疗局部晚期非小细胞肺癌的随机对照研究

A Randomized study on the Effects of Paclitaxel Liposme and Cisplatin Induction Chemotherapy Followed Concurrent Chemoradiotherapy and Sequential Radiotherapy on Locally Advanced Non-small Cell Lung Cancer Patients

背景与目的序贯放化疗及同期放化疗在局部晚期肺癌治疗中得以广泛研究,而诱导加同期放化疗的研究尚少。紫杉醇脂质体副作用少,可使诱导加同期放化疗更顺利地实施。本文旨在比较紫杉醇脂质体加顺铂(TP方案)诱导加同期放化疗和序贯放化疗治疗局部晚期非小细胞肺癌(non-small celllung cancer,NSCLC)的疗效及毒副作用。方法我院60例局部晚期NSCLC患者随机分为诱导加同期放化疗组(A组)和序贯放化疗组(B组)。A组:诱导化疗2个-3个周期后行同期放化疗,放疗的第1天及第22天予TP方案化疗(紫杉醇脂质体135mg/m2-175mg/m2,d1;顺铂70mg/m2-80mg/m2,d2),期间持续放疗。B组:化疗方案同前,化疗4个-6个周期后,行放疗。两组放疗方式均为三维适形放疗,总剂量为56Gy-70Gy。观察和比较两组的疗效和毒副作用。结果 A组、B组总有效率分别为80.3%和60%,组间有统计学差异(P=0.042);1年生存率分别为71.4%和53.2%,组间无统计学差异(P=0.18);骨髓抑制发生率分别为90%和73.3%,组间无统计学差异(P=0.09);放射性食管炎发生率分别为50%和36.7%,组间无统计学差异(P=0.147);肺纤维化发生率分别为30%和20%,组间无统计学差异(P=0.276)。结论在晚期NSCLC的局部治疗中,TP方案诱导加同期放化疗较序贯放化疗的近期疗效好,但毒副反应无明显区别。

Background and objective Sequential and concurrent chemoradiotherapy were widely studied in locally advanced non-small cell lung cancer （NSCLC）, but the reports ofinduction chemotherapy followed concurrent chemoradiotherapy are rare so far. The little side effects of paclitaxel liposme may be convenient to carry out induction chemotherapy followed concurrent chemoradiotherapy. The aim of this study is to compare the effects and side effects of TP regimen （Paclitaxel liposme and cisplatin） induction chemotherapy followed concurrent chemoradiotherapy with sequential radiotherapy on locally advanced NSCLC. Methods Sixty locally advanced NSCLC patients were randomly divided into group A, induction chemotherapy followed concurrent chemoradiotherapy and group B, sequential radiotherapy group. The patients in group A received 2-3 cycles ofinduced chemotherapy included of Paclitaxel liposme 135 mg/m^2-175 mg/m^2, d1 and cisplatin 70 mg/m^2-80 mg/m^2, d2, 3 weeks repeat and after 2-3 cycles followed by concurrent chemoradiotherapy. The patients in group B received chemotherapy, （as described above in group A） 4-6 cycles of chemotherapy followed one cycle of radiotherapy. The three-dimensional conformal radiotherapy at the total dose of 56 Gy-70 Gy was applied in all patients. Results The response rate in group A and group B were 80.3% and 60%, respectively （P=0.042）. 1-year survival rates were 71.4% and 53.2%, respectively （P=0.18）. And there were no significant difference of myelosuppression, radiation esophagitis and pulmonary fibrosis between the two groups （P=0.09, P=0.147, P=0.276, respectively）. Conclusion The recent effects ofinduction chemotherapy followed by concurrent chemoradiotherapy group were better than sequential radiotherapy group on locally advanced NSCLC and there was no significant difference in side effects between the two groups.