多西紫杉醇对可切除的淋巴结阳性乳腺癌的疗效分析

The effect of adjuvant docetaxel for operable node- positive breast cancer

目的:比较含多西紫杉醇的化疗方案(TEC)与FEC方案对可切除的淋巴结阳性乳腺癌的疗效。方法:2005年7月至2007年7月,将我科62例行乳腺癌改良根治术后的腋窝淋巴结阳性病人随机分为TEC组(试验组)和FEC组(对照组),并行6个周期化疗,分析5年DFS、OS和毒副反应。结果:FEC组(n=32)和TEC组(n=30)的5年DFS分别为40.6%(13/32)和70.0%(21/30)(P=0.020);5年OS分别为50.0%(16/32)和76.7%(23/30)(P=0.030)。粒细胞减少症为3或4级者FEC组、TEC组发生率分别为53.1%(17/32)和63.3%(19/30)(P=0.416);粒细胞减少所致发热两组分别为6.3%(2/32)和10.0%(3/30)(P=0.587);肝、肾及心脏损害两组无显著差异(P>0.05)。化疗期间生活质量评分下降,于化疗结束后恢复正常,在第6个周期化疗结束后24个月时,FEC组评分明显低于TEC组(P=0.032)。结论:TEC方案较FEC方案能明显提高可切除的腋窝淋巴结阳性乳腺癌病人的5年DFS和OS,骨髓抑制等毒副反应可接受。

To compare docetaxel plus epirubicin and cyclophosphamide（TEC）with fluorouracil plus epirubicin and cyclophosphamide（FEC）as adjuvant chemotherapy for operable node - positive breast cancer. Methods：From July 2005 to July 2007,we randomly assigned 62 women with axillary node - positive breast cancer to six cycles of treatment with either trial group（TEC）or control group（FEC）as adjuvant chemotherapy after modified rad-ical mastectomy to analyse 5 - year disease - free survival,overall survival and adverse effect. Results：The rate of five- year disease - free was 70. 0%（21 / 30）in the TEC group significantly higher than that[40. 6%（13 / 32）]in the FEC group（P = 0. 020）. The rate of five - year overall survival was 50. 0%（16 / 32）in the FEC group significantly lower than that[76. 7%（23 / 30）]in the TEC group（P = 0. 030）. The incidence of grade 3 or 4 neutropenia was 53 . 1 %（ 17 / 32 ）in the FEC group and 63. 3%（19 / 30）in the TEC group（P = 0. 416）. Rates of febrile neutro-penia were 6. 3%（2 / 32）and 10. 0%（3 / 30）,respectively（P = 0. 587）. The damages to liver,kindey and cardia were not significantly different in the two groups（P ﹥ 0. 05）. Quality of life scores decreased during chemotherapy but returned to baseline levels after therapy,but scores in the FEC group were significantly lower than those in the TEC group on the 24th month after completing the sixth chemotherapy（P = 0. 032）. Conclusion：Adjuvant chemotherapy with TEC as compared with FEC significantly improves the rates of five - year disease - free and overall survival among women with operable node -positive breast cancer,and its adverse effects such as myelosuppression are not unacceptable.