TEC与TE方案在乳腺癌新辅助化疗中的临床疗效观察分析

发布时间：2018-08-09 12:42

【摘要】：[目的]回顾性研究分析多西他赛+表柔比星+环磷酰胺(TEC)方案与多西他赛+表柔比星(TE)方案在乳腺癌新辅助化疗中的临床疗效、相关影响因素以及毒副反应差异,并间接探讨乳腺癌分子分型与新辅助化疗疗效的关系,以期为乳腺癌新辅助化疗方案选择及个体化治疗方案的制定提供参考。[方法]连续性收集2008年1月至2011年12月云南省肿瘤医院收治的TNM分期为Ⅱa-Ⅲc期乳腺癌患者106例,均为女性,经空心针穿刺病理活检证实为浸润性乳腺癌,并行免疫组化检查,确定雌激素受体(estrogenreceptor,ER)、孕激素受体(progesterone receptor,PR)和人表皮生长因子受体2 (human epidermal growth factor receptor 2,HER-2)、Ki-67 水平。将患者分为 2 组:TEC 方案组与TE方案组,其中行TEC方案化疗患者61例;行TE方案化疗患者45例。收集患者病理及临床相关信息,通过电话随访及门诊随访了解患者的治疗、复发、转移及生存情况。所选病例患者术前均行3-6周期TEC方案或TE方案新辅助化疗,化疗结束均接受手术,术后根据病理检查结果规范完成相关治疗。临床疗效评价参照RECIST1.1实体瘤疗效评价标准,病理疗效评价依据Miller Payne (MP)系统。应用spss21.0统计学软件对数据进行卡方检验和fisher的精确检验,P0. 05视为差异有统计学意义,分别比较2种化疗方案组临床有效率、病理完全缓解(pCR)率、化疗毒副反应等是否具有统计学差异,不同年龄分组、月经情况、初潮年龄、哺乳情况、化疗周期数、病理类型、初诊肿瘤大小、初诊临床分期、初诊淋巴结状态等在两种化疗方案的临床疗效情况,以及探讨乳腺癌分子分型与新辅助化疗疗效的关系等,采用COX风险回归模型分析不同化疗方案与患者总生存及无病生存的关系。[结果]TE组45例患者的pCR率、临床有效率分别为17.8%和68.9%,均高于TEC组61例患者的14.8%和65.6%,但差异无统计学意义(P=0.675,0.720);TE组及TEC组的保乳率分别为6.7%、3.3%,无显著性差异(P=0.416);两组的常见不良反应为粒细胞减少症及肝功能损伤,均没有显著性差异(P=0.272,0.123)。但是TE组26人(57.80%)出现Ⅳ°骨髓抑制,TEC组23人(37.7%)出现Ⅳ °骨髓抑制,两组之间Ⅳ °骨髓抑制发生率比较,P=0.040,具有统计学差异。TE组5年总生存率为86.7%; TEC组5年总生存率为83.6%。生存函数采用COX回归分析,P=0.352,无统计学差异。患者年龄、绝经情况、初潮年龄、哺乳情况、初诊临床分期、不同化疗周期数等在两组化疗方案间比较均没有统计学差异。临床有效率与pCR率在Luminal A型中分别为47.4%和0%,在Luminal B型中分别为64%和10%,在HER2过表达型中分别为50%和25%,在TNBC中分别为87.9%和33.3%,有统计学差异(P=0.014,0.004),进一步研究三阴性乳腺癌(TNBC)的病理缓解率、临床有效率分别为33.3%和87.9%,均高于非TNBC组的8.2%和58.9%,差异具体统计学意义(P=0.020,0.030)。[结论]1.TE方案与TEC方案两组之间临床有效率、病理完全缓解率、保乳率、总生存、无病生存均无统计学差异。2. TE方案与TEC方案两组之间骨髓抑制与肝功能损伤发生率无统计学差异,但是,TEC组Ⅳ°骨髓抑制较TE组发生率更低。3.分子分型亚组中TNBC型、HER-2过表达型、LuminalA型、LuminalB型4组之间临床有效率、pCR率均有统计学差异。TNBC与非TNBC临床有效率、pCR率均有统计学差异。TNBC较非TNBC有更好的临床有效率及pCR率。因此,结合临床疗效及化疗不良反应,在新辅助化疗中TEC方案更值得推荐;不同分子分型的新辅助化疗中,TNBC更易从中获益。
[Abstract]:[Objective] to review and analyze the clinical efficacy of docetaxel + epirubicin + cyclophosphamide (TEC) and docetaxel + epirubicin (TE) in the new adjuvant chemotherapy of breast cancer, related factors and differences in toxic and side effects, and indirectly discuss the relationship between the molecular classification of breast cancer and the therapeutic effect of neoadjuvant chemotherapy in order to be a new adjuvant for breast cancer. The selection of chemotherapeutic regimen and the formulation of the individualized treatment scheme provided reference. [Methods] the TNM stage of the TNM stage of stage II a- III C of breast cancer patients was collected from January 2008 to December 2011 in 106 cases of breast cancer patients, all of which were female. Through biopsy of hollow needle biopsy proved to be invasive breast cancer, parallel immunohistochemical examination and determination of female. The hormone receptor (estrogenreceptor, ER), progesterone receptor (progesterone receptor, PR) and human epidermal growth factor receptor 2 (human epidermal growth factor receptor 2, HER-2) and Ki-67 levels were divided into 2 groups: 61 patients with chemotherapy regimens and 45 chemotherapy patients. The treatment, recurrence, metastasis and survival of the patients were understood by telephone follow-up and outpatient follow-up. 3-6 cycles of TEC or TE regimen were performed before the operation. All the patients received surgery at the end of the chemotherapy, and the related treatment was completed according to the pathological examination results. The clinical efficacy evaluation referred to RECIST1.. 1 the evaluation criteria for the curative effect of solid tumor, the evaluation of the pathological effect was based on the Miller Payne (MP) system. Spss21.0 statistics software was used to carry out the chi square test and the accurate test of Fisher, and the difference between the P0. 05 was statistically significant. The clinical efficiency of the 2 chemotherapy regimens, the complete pathological remission (pCR) rate, the side reaction of chemotherapy, and so on were compared. There were statistically different age groups, menstruation, age of menarche, age of menarche, breast feeding, number of chemotherapy, pathological type, primary diagnosis of tumor size, primary clinic stage, first diagnosis of lymph node status, and the relationship between the two types of chemotherapy and the relationship between the subclassification of breast cancer and the effect of neoadjuvant chemotherapy. The relationship between different chemotherapy regimens and patients' total survival and disease-free survival was analyzed. [results]TE group, group]TE, pCR rate, clinical effective rate was 17.8% and 68.9%, respectively higher than 14.8% and 65.6% in group TEC 61 patients, but the difference was not statistically significant (P=0.675,0.720); TE and TEC group were 6.7%, 3.3%, respectively (P =0.416): the common adverse reactions in the two groups were granulocytopenia and liver dysfunction (P=0.272,0.123). But in group TE, 26 (57.80%) had IV degree myelosuppression, 23 (37.7%) in group TEC had 4 degree myelosuppression, and the incidence rate of IV degree marrow suppression among the two groups was compared, P=0.040, with statistical difference of 5 year total birth in group.TE. The total survival rate was 86.7%, and the 5 year total survival rate of group TEC was 83.6%. survival function using COX regression analysis and P=0.352, there was no statistical difference. There was no statistical difference between the two groups of chemotherapy schemes, such as age, menopause, age of menarche, breast feeding, primary clinical stage and different chemotherapy cycle number. The clinical efficiency and pCR rate were Luminal A type. 47.4% and 0% in Luminal B respectively, 50% and 25% in HER2 overexpression, 87.9% and 33.3% in TNBC, respectively, with statistical difference (P=0.014,0.004). The pathological remission rate of three negative breast cancer (TNBC) was further studied, the clinical efficiency was 33.3% and 87.9% respectively, which were higher than those of non TNBC group 8.2% and 58.9%, The difference was statistically significant (P=0.020,0.030). [Conclusion The clinical efficiency, total remission rate, breast conserving rate, total survival, and disease free survival between the two groups of]1.TE and TEC regimen were not statistically different between the.2. TE scheme and the TEC scheme two groups, but there was no significant difference in the incidence of bone marrow suppression and liver function injury between the two groups, but the TEC Group IV degree of bone marrow suppression. Compared with the TE group, the incidence of TNBC, HER-2 overexpression, LuminalA and LuminalB in the subgroup of.3. was lower than that of the 4 groups. The pCR rate had a statistically difference between.TNBC and non TNBC, and the pCR rate had a statistically significant difference between non TNBC and non TNBC. In response to neoadjuvant chemotherapy, the TEC protocol is more recommended. TNBC is more likely to benefit from neoadjuvant chemotherapy with different molecular typing.
【学位授予单位】：昆明医科大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R737.9

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