紫杉醇脂质体联合吡柔比星同步放射治疗对局部晚期乳腺癌患者的疗效

Chemotherapy of paclitaxel liposome plus pirarubicin combined with radiotherapy for locally advanced breast cancer

目的分析紫杉醇脂质体联合吡柔比星同步放射治疗对局部晚期乳腺癌患者的疗效和不良反应。方法选取2008年1月至2012年12月在重庆市肿瘤研究所乳腺外科住院治疗的216例局部晚期乳腺癌患者进行前瞻性研究。根据患者意愿将其分为研究组和对照组,研究组112例,对照组104例。研究组患者第1天接受紫杉醇脂质体及吡柔比星静脉滴注,同时接受20 d同步放射治疗;对照组患者第1天接受紫杉醇脂质体及吡柔比星静脉滴注。在两组患者完成4个周期的新辅助化疗之后,评价其疗效和不良反应的差异。两组患者间总有效率、手术切除率及癌转移率的比较采用χ^2检验,肿瘤细胞凋亡指数的比较采用t检验,不良反应的比较采用非参数检验,生存率的比较采用Log-rank检验。结果 （1）研究组患者的总有效率、手术切除率分别为86.6%（97/112）和95.5%（107/112）,明显高于对照组的68.3%（71/104）和82.7%（86/104）（χ^2=10.492、9.349,P=0.001、0.002）。治疗之后,研究组患者肿瘤细胞凋亡指数为（64.76±5.39）%,明显高于对照组的（53.81±4.91）%（t=15.567、P=0.000）。研究组患者2年无进展生存率、OS率分别为83.0%（93/112）和88.4%（99/112）,明显高于对照组的70.2%（73/104）和77.9%（81/104）（χ^2=5.000、4.287,P=0.025、0.038）。两组患者的远处转移率相似[17.9%（20/112）比27.9%（29/104）,χ^2=3.092,P=0.079]。（2）研究组患者骨髓抑制、胃肠道反应、心脏毒性及肝功能损害的发生率分别为65.2%（73/112）、67.0%（75/112）、14.3%（16/112）和13.4%（15/112）,对照组的分别为61.5%（64/104）、64.4%（67/104）、11.5%（12/104）和12.5%（13/104）,两组比较,差异均无统计学意义（Z=-0.867、-0.688、-0.614、-0.183,P=0.386、0.491、0.539、0.855）。结论紫杉醇脂质体联合吡柔比星同步放射治疗对局部晚期乳腺癌患者有确切疗效,且未增加患者的不良反应,值得临床推广应用。

Objective To analyze the curative and adverse effects of paclitaxel liposome plus pirarubicin combined with radiotherapy for the patients with locally advanced breast cancer. Methods Totally216 locally advanced breast cancer patients treated in Department of Breast Surgery,Chongqing Cancer Institute between January 2008 and December 2012 were involved for a prospective study. According to their wishes,the patients were divided into research group（n = 112）and control group（n = 104）. In research group,the patients received intervenous drop infusion of paclitaxel liposome and paclitaxel on day 1,and synchronous radiotherapy for 20 days. In control group,the patients received intervenous drop infusion of paclitaxel liposome and paclitaxel on day 1. After 4 cycles of neoadjuvant chemotherapy,the curative and adverse effects were evaluated. The total effective rate,surgical resection rate and cancer metastasis rate between two groups were compared using χ~2test,the tumor cell apoptosis index using t test,adverse reaction rates using nonparametric test and survival rate using Log-rank test. Results The total effective rate in research group was 86. 6%（97 /112）,significantly higher than 68. 3% in control group（71 / 104）（χ^2= 10. 492,P = 0. 001）;the surgical resection rate in research group was 95. 5%（107 / 112）,significantly higher than the 82. 7% in control group（86/ 104）（χ^2= 9. 349,P = 0. 002）. After treatment,tumor cell apoptosis index in research group was（64. 76±5. 39）%,significantly higher than（53. 81 ± 4. 91）% in control group（t = 15. 567,P = 0. 000）;2-year progression-free survival in research group was 83. 0%（93 / 112）,significantly higher than 70. 2%（73 / 104）in control group（χ^2= 5. 000,P = 0. 025）;overall survival in research group was 88. 4%（99 / 112）,significantly higher than 77. 9%（81 / 104）in control group（χ^2= 4. 287,P = 0. 038）. Distant metastasis rate showed a significant difference between two groups [17. 9%（20 / 112）than 27. 9%（29 / 104）,χ~2= 3. 092,P = 0. 079].The incidences of myelosuppression,gastrointestinal reaction,cardiac toxicity and liver dysfunction were65. 2%（73 / 112）,67. 0%（75 / 112）,14. 3%（16 / 112）and 13. 4%（15 / 112）in research group,61. 5%（64/ 104）,64. 4%（67/ 104）,11. 5%（12/ 104）and 12. 5%（13/ 104）in control group respectively,indicating no statistically significant diffenrence（Z =-0. 867,-0. 688,-0. 614,-0. 183,P = 0. 386,0. 491,0. 539,0. 855）. Conclusion Chemotherapy of paclitaxel liposome plus pirarubicin combined with radiotherapy has definite efficacy for locally advanced breast cancer patients,with no obvious adverse effect,thus it is worthy of clinical application.