多西他赛联合洛铂方案与多西他赛联合顺铂方案同步放化疗治疗晚期非小细胞肺癌的随机对照研究

摘要

Objective To compare the clinical effectiveness and adverse reactions of treating a NSCLC using docetaxel+lobaplatin ( DL) and docetaxel+cisplatin ( DP ) regimens with concurrent radiotherapy. Methods Sixty-four patients with phase Ⅲor phase Ⅳ without operation options, were randomly assigned to two groups for DL or DP regimen. The DL regimen ( 32 cases) involved chemotherapy of docetaxel 75 mg/m2 on day 1, iv drip;lobaplatin 30 mg/m2 on day 1, iv drip, and radiation therapy beginning on day 1, three dimensional conformal radiotherapy or intensity modula-ted radiation therapy gross tumor volume 2. 00—2. 12 Gy/d, with a total dosage of 60—74 Gy/30—35 F. The DP regimen involved chemotherapy of docetaxel 75 mg/m2 on day 1, iv drip, cisplatin 25 mg/m2 day 1 through day 3, iv drip;and radiotherapy in the same with DL regimen. Results The DL regimen achieved complete remission ( CR) of 9. 7﹪, partial remission ( PR) of 64. 5﹪, stable disease ( SD) of 16. 1﹪ and progression disease ( PD) of 9. 7﹪. The DP regimen achieved CR of 6. 2﹪, PR of 71. 9﹪, SD of 12. 5﹪ and PD of 9. 4﹪. The effectiveness for DL and DP regimen was 74. 2﹪ and 78. 1﹪ respectively. The one-year and two-year survival rate were 74. 2﹪ and 50. 0﹪ for DL regimen, 75. 0﹪ and 45. 5﹪ for DP regimen respectively. The comparison showed no difference of statistical significance ( P>0. 05) between the DL and DP regimens. The main adverse reactions included myelosuppression, gastrointestinal reaction, radioactive esophagitis and radiation pneumonitis. The white blood cells and platelets decreased by 29. 0﹪ and 16. 1﹪ for phase Ⅲ re-spectively, 25. 0﹪ and 6. 2﹪ respectively for phase iv, both bearing no significant difference ( P>0. 05) . The digestive tract reaction rates were 3. 2﹪ and 28. 1﹪ for phaseⅢand phaseⅣrespec-tively, bearing a significant difference (P=0. 007). The radiation esophagitis and pneumonitis in two groups showed no significant difference ( P>0. 05) . Conclusion DL and DP regimens showed no significant difference in the effectivenes of treating NSCLC, with DP regimen resulting in more adverse reactions of digestive tract than the DL regimen.%目的：比较多西他赛+洛铂( docetaxel+lobaplatin,DL)方案与多西他赛+顺铂( docetaxel+cisplatin, DP )方案同步放化疗治疗晚期非小细胞肺癌的近期疗效和不良反应。方法64例不能手术的Ⅲ～Ⅳ期非小细胞肺癌患者随机分为DL组和DP组。 DL组32例,化疗方案为多西他赛75 mg/m2第l天、洛铂30 mg/m2第l天,静脉滴注；放射治疗从第1天开始,三维适形放疗或调强放疗,肿瘤靶区2.00～2.12 Gy/d,总剂量60～74 Gy/30～35 F。 DP组32例,化疗方案为多西他赛75 mg/m2第l天、顺铂25 mg/m2第1～3天,静脉滴注；放射治疗方案同DL组。结果 DL组获完全缓解9.7﹪,部分缓解64.5﹪,稳定16.1﹪,进展9.7﹪；DP组获完全缓解6.2﹪,部分缓解71.9﹪,稳定12.5﹪,进展9.4﹪。 DL组和DP组的有效率分别为74.2﹪和78.1﹪；DL组1年和2年生存率分别为74.2﹪和50.0﹪,DP组1年和2年生存率分别为75.0﹪和45.5﹪。2组疗效比较差异无统计学意义( P＞0.05)。治疗的不良反应主要为骨髓抑制、消化道反应、放射性食管炎和放射性肺炎。2组Ⅲ～Ⅳ级白细胞计数和血小板下降率分别为29.0﹪、25.0﹪和16.1﹪、6.2﹪,差异均无统计学意义( P＞0.05)；Ⅲ～Ⅳ级消化道反应的发生率分别为3.2﹪、28.1﹪,差异有统计学意义( P＝0.007)；放射性食管炎和放射性肺炎2组相比差异无统计学意义( P＞0.05)。结论 DL方案和DP方案的联合同步放疗疗效没有明显差异。不良反应DP方案消化道反应的发生率高于DL方案。